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Shing CH, Wang F, Lau LNL, Lam PM, Ho HC, Wong SSC. Skeletal muscle relaxant for the treatment of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials. Reg Anesth Pain Med 2024:rapm-2024-105776. [PMID: 39532464 DOI: 10.1136/rapm-2024-105776] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/16/2024] [Accepted: 10/18/2024] [Indexed: 11/16/2024]
Abstract
BACKGROUND/IMPORTANCE Fibromyalgia is a complex chronic pain disorder that significantly impairs patient well-being. Evaluating the efficacy of muscle relaxants for treating fibromyalgia is crucial for improving patient care. OBJECTIVE This study aimed to evaluate the analgesic efficacy of muscle relaxants in patients with fibromyalgia. EVIDENCE REVIEW A comprehensive literature search was conducted using PubMed, EMBASE, Web of Science, ClinicalTrials.gov, and the Cochrane Library. The search included randomized controlled trials (RCTs) comparing skeletal muscle relaxants with placebo/active analgesics for fibromyalgia. The primary outcome was pain intensity, measured by standardized mean difference (SMD) in pain scores. The risk of bias of included RCTs was assessed using the Cochrane Risk of Bias Assessment Instrument for Randomized Controlled Trials. FINDINGS 14 RCTs (1851 participants) were included. Muscle relaxants were associated with a small but statistically significant reduction in pain scores compared with placebo or active treatment (SMD=-0.24, 95% CI=-0.32 to -0.15, p<0.001, 95% prediction interval=-0.40 to -0.08), with no significant inconsistency (I2=0, 95% CI=0% to 50.79%) and a moderate Grading of Recommendation, Assessment, Development and Evaluation rating. Secondary outcomes showed small, but statistically significant improvements in depression, fatigue and sleep quality. Muscle relaxants were associated with increased incidence of overall adverse effects, fatigue, abnormal taste, and drug withdrawal due to adverse effects. CONCLUSIONS Moderate quality evidence showed that muscle relaxants were associated with a small reduction in pain intensity for patients with fibromyalgia.
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Affiliation(s)
- Chung Hin Shing
- Department of Anaesthesiology, The University of Hong Kong, Hong Kong, Hong Kong
| | - Fengfeng Wang
- Department of Anaesthesiology, The University of Hong Kong, Hong Kong, Hong Kong
| | - Lai Ning Lydia Lau
- Department of Anaesthesiology, The University of Hong Kong, Hong Kong, Hong Kong
| | - Pui Ming Lam
- Department of Anaesthesiology, The University of Hong Kong, Hong Kong, Hong Kong
| | - Hung Chak Ho
- Department of Public and International Affairs, City University of Hong Kong, Hong Kong, Hong Kong
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Pelletier J, Capistrant T, Nordt SP. Osteopathic manipulation and its applicability in the emergency department: A narrative review. Am J Emerg Med 2024; 84:74-80. [PMID: 39096712 DOI: 10.1016/j.ajem.2024.07.050] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2024] [Accepted: 07/25/2024] [Indexed: 08/05/2024] Open
Abstract
BACKGROUND Osteopathic manipulative treatment (OMT), also known as osteopathic manipulative medicine (OMM), is a set of manual techniques, developed by Dr. Andrew Taylor Still, founder of osteopathic medicine, initially limited to osteopathic medicine, for the treatment of painful conditions. This toolset is now used by allopathic physicians, international osteopaths, physical therapists, chiropractors, and other healthcare workers for the treatment of musculoskeletal pain. OMT can be used in the emergency department (ED) for the treatment of musculoskeletal complaints as an adjunct to pharmacologic agents (e.g., NSAIDs), or an alternative to opioids. OBJECTIVE This narrative review provides emergency clinicians with an understanding of OMT, including a broad overview of the basis, development, and common subtypes of OMT; data on OMT efficacy and on the use of conditions commonly encountered in the ED setting; and information on how to implement the use of OMT in emergency medicine and urgent care settings. DISCUSSION OMT can be used for a wide variety of acute and chronic pain conditions, particularly back pain, headaches, neck pain, and extremity pain (assuming that life-threatening conditions have been excluded). There are small studies and case series demonstrating both efficacy and subjective improvement with OMT, including in the ED. However, limitations to the current body of literature include: small numbers of patients, challenges with blinding and standardization, limited adverse event reporting, and most research has been outside of the ED setting. There is great opportunity for future studies and application of OMT in the ED. There are an increasing number of emergency clinicians incorporating OMT in their practice and despite the perception of OMT requiring extended periods of time to perform, current data suggests OMT does not prolong ED visits or cost to patients. OMT is a procedure with billing codes, and courses and training in OMT are available for both osteopathic and allopathic physicians. CONCLUSION OMT is being used and has great potential in the management of acute and chronic musculoskeletal pain in the ED in addition to, or instead of pharmacologic agents, in particular as an opioid-sparing option.
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Affiliation(s)
- J Pelletier
- Assistant Professor of Emergency Medicine, Assistant Residency Program Director, University of Missouri-Columbia, 1 Hospital Dr # M562, Columbia, MO 65201, United States of America.
| | - T Capistrant
- Osteopathic Manipulative Medicine, Tanana Valley Clinic, 1001 Noble Street, Fairbanks, Alaska 99701, United States of America.
| | - S P Nordt
- Professor of Emergency Medicine, Loma Linda University, School of Medicine, Department of Emergency Medicine, 11234, Anderson St Loma Linda, CA 92354, United States of America.
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Warren Z, Guymer E, Mezhov V, Littlejohn G. Significant use of non-evidence-based therapeutics in a cohort of Australian fibromyalgia patients. Intern Med J 2024; 54:568-574. [PMID: 37872879 DOI: 10.1111/imj.16257] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/07/2023] [Accepted: 09/24/2023] [Indexed: 10/25/2023]
Abstract
BACKGROUND Fibromyalgia is a common condition characterised by chronic widespread musculoskeletal pain and central sensitivity features. Appropriate management requires a multidisciplinary approach prioritising non-pharmacological strategies. Evidence-based fibromyalgia medications are not always easily available, effective or tolerated. AIM To characterise actual medication usage in Australian fibromyalgia patients. METHODS Demographic and clinical data, including medication use information, were gathered by chart review from patients attending the Monash Fibromyalgia Clinic between January 2019 and June 2022. Eligible patients were invited to complete an anonymous questionnaire between June and August 2022 to assess current therapeutic use. The questionnaire assessed fibromyalgia clinical features by using the Revised Fibromyalgia Impact Questionnaire and the 2016 modified American College of Rheumatology Fibromyalgia criteria. RESULTS The chart review included 474 patients, and 108 participants completed the questionnaire. Most chart review (78.7%) and questionnaire participants (85.2%) reported using at least one medication for their fibromyalgia. 48.5% of chart review patients and 58.3% of questionnaire participants reported using at least one evidence-based medication, usually amitriptyline, duloxetine or pregabalin. However, the most common individual medications for questionnaire participants were non-steroidal anti-inflammatory drugs (48.2%), paracetamol (59.3%) and opioids (34.3%), with most opioids being typical opioids. Among questionnaire participants, 14.8% reported using cannabinoids, and 70.4% reported using at least one supplement, vitamin or herbal/naturopathic preparation. Not all medication or substance use was recorded during clinic appointments. CONCLUSION Fibromyalgia patients engage in various pharmacotherapeutic strategies that are not always evidence-based or disclosed to their treating clinicians.
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Affiliation(s)
- Zachary Warren
- School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
| | - Emma Guymer
- School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
- Department of Rheumatology, Monash Health, Melbourne, Victoria, Australia
| | - Veronica Mezhov
- School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
- Department of Rheumatology, Monash Health, Melbourne, Victoria, Australia
| | - Geoffrey Littlejohn
- School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
- Department of Rheumatology, Monash Health, Melbourne, Victoria, Australia
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Akel A, Sarhan MY, Dwairy MA, Al-zu’bi B, Al-Qudah A, Alsmarat OA, Alsaraireh T, Abu-Jeyyab M. The prevalence of fibromyalgia in adults at Al-Karak Jordan: a cross-sectional study. Ann Med Surg (Lond) 2024; 86:1315-1321. [PMID: 38463111 PMCID: PMC10923264 DOI: 10.1097/ms9.0000000000001722] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/24/2023] [Accepted: 01/03/2024] [Indexed: 03/12/2024] Open
Abstract
Introduction Fibromyalgia is a chronic and intricate musculoskeletal disorder characterized by widespread pain, fatigue, and tenderness in specific anatomical regions. Although its prevalence varies among populations, understanding the prevalence in different geographical areas is crucial for healthcare planning. This cross-sectional study aims to determine the prevalence of fibromyalgia in adults residing in Al-Karak, Jordan. The city's unique demographic and environmental characteristics may influence the occurrence of fibromyalgia among its adult population. The study aims to address gaps in knowledge, provide localized insights, and shed light on fibromyalgia's burden on the community's health. Accurate prevalence data aids healthcare planning and resource allocation. Methods This research collected data from 965 social media participants using Google Forms. The American College of Rheumatology survey criteria for diagnosing fibromyalgia were used. To investigate the predictive value of various parameters, univariate and multivariate logistic regression analyses were performed. Results The study found a 26.5% prevalence of fibromyalgia in the studied population. Female gender, mental health illnesses, and comorbidities like irritable bowel syndrome, psychiatric disorders, and rheumatological and neurological diseases were significantly associated with fibromyalgia. Age, BMI, marital status, employment status, and certain comorbidities did not show statistically significant predictive value. Conclusion This study sheds light on fibromyalgia's prevalence and associated factors in the Al-Karak population. The identified predictors highlight the necessity for comprehensive healthcare strategies and interventions to mitigate the disease burden. These findings aid policymakers and healthcare professionals in planning and implementing effective measures for fibromyalgia management and prevention. Further research is warranted to deepen our understanding of fibromyalgia's complexity and its implications in this region.
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Affiliation(s)
- Alaa Akel
- Department of Special Surgery, Faculty of Medicine, Mutah University, Mu'tah
| | - Mohammed Y. Sarhan
- Department of Special Surgery, Faculty of Medicine, The Hashemite University, Zarqa
| | | | - Belal Al-zu’bi
- Department of Special Surgery, Faculty of Medicine, Mutah University, Mu'tah
| | - Ala Al-Qudah
- Internal Medicine, Stockport NHS Foundation Trust, Manchester, UK
| | | | | | - Mohammad Abu-Jeyyab
- School of Medicine, Mutah University, Al-Karak, Jordan, Red Cresent Hospital, Amman, Jordan
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Otón T, Carmona L, Rivera J. Patient-journey of fibromyalgia patients: A scoping review. REUMATOLOGIA CLINICA 2024; 20:96-103. [PMID: 38395498 DOI: 10.1016/j.reumae.2023.07.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/23/2023] [Accepted: 07/25/2023] [Indexed: 02/25/2024]
Abstract
BACKGROUND Fibromyalgia (FM) is a chronic disease characterized by widespread pain. Although much is known about this disease, research has focused on diagnosis and treatment, leaving aside factors related to patient's experience and the relationship with healthcare system. OBJECTIVES The aim was to analyze the available evidence on the experience of FM patients from the first symptoms to diagnosis, treatment, and follow-up. METHODS A scoping review was carried out. Medline and the Cochrane Library were searched for original studies or reviews dealing with FM and focusing on "patient journey". Results were organized using a deductive classification of themes. RESULTS Fifty-four articles were included in the qualitative synthesis. Five themes were identified: the patient journey, the challenge for the health systems, a complex doctor-patient relationship, the importance of the diagnosis, and the difficulty of standardizing the treatment. CONCLUSIONS This scoping review confirms the negative impact of FM on the patient, their social environment, and health systems. It is necessary to minimize the difficulties encountered throughout the diagnosis and follow-up of patients with FM.
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Affiliation(s)
- Teresa Otón
- Instituto de Salud Musculoesquelética (InMusc), Madrid, Spain.
| | - Loreto Carmona
- Instituto de Salud Musculoesquelética (InMusc), Madrid, Spain
| | - Javier Rivera
- Servicio de Reumatología, Hospital General Universitario Gregorio Marañón, Madrid, Spain
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Yu JS, Kim ES, Park KS, Lee YJ, Park YC, Nam D, Kim EJ, Ha IH. Trends in the treatment of fibromyalgia in South Korea between 2011 and 2018: a retrospective analysis of cross-sectional health insurance data. BMJ Open 2023; 13:e071735. [PMID: 38056939 PMCID: PMC10711815 DOI: 10.1136/bmjopen-2023-071735] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/12/2023] [Accepted: 11/21/2023] [Indexed: 12/08/2023] Open
Abstract
OBJECTIVES Fibromyalgia treatment trends vary globally; however, the trend in South Korea has not been investigated yet. This study aimed to analyse the fibromyalgia treatment trends in South Korea. DESIGN Retrospective, observational study using serial cross-sectional data. SETTING The National Patient Samples of the Korean Health Insurance Review & Assessment Service from 2011 to 2018 were used. PARTICIPANTS A total of 31 059 patients with fibromyalgia were included in this study. The basic characteristics of the patients were stratified by sex, age and comorbidity. A patient was considered to have a condition if it was recorded as a principal diagnosis at least once in a year. PRIMARY AND SECONDARY OUTCOME MEASURES Trends in the types of medical visits and prescribed treatments were investigated and the values are presented as rates per 100 patients. The types of pharmacological treatment were presented according to the existing clinical guidelines. Additionally, combination prescription trends and associated characteristics were investigated. RESULTS Of the patients, 66.2% were female. Visits to internal medicine departments showed the most significant increase (2011: 11.34; 2018: 21.99; p<0.001). Non-pharmacological treatment rates declined (physical therapy 2011: 18.11; 2018: 13.69; p<0.001, acupuncture 2011: 52.03; 2018: 30.83; p<0.001). Prescription rates increased for analgesics, relaxants, antiepileptics and antidepressants. Non-steroidal anti-inflammatory drug prescriptions had the highest increase (2011: 27.65; 2018: 40.02; p<0.001). Serotonin-norepinephrine reuptake inhibitor prescriptions showed significant growth (2011: 2.4; 2018: 8.05; p<0.001). Prescription durations were generally longer for women (p<0.001), with higher rate increases in this group. Combinations of ≥3 medication classes increased (2011: 8.2; 2018: 9.64; p=0.041). Women were more likely to receive combination prescriptions (crude OR 1.47 (95% CI 1.29 to 1.68), adjusted 1.18 (95% CI 1.03 to 1.36)). CONCLUSIONS Our findings provide basic reference data for the development and application of national guidelines for fibromyalgia.
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Affiliation(s)
- Jin-Sil Yu
- Jaseng Hospital of Korean Medicine, Seoul, South Korea
| | - Eun-San Kim
- Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, South Korea
| | | | - Yoon Jae Lee
- Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, South Korea
| | - Yeon Cheol Park
- Acupuncture and Moxibustion, Kyung Hee University Hospital at Gangdong, Seoul, South Korea
| | - Dongwoo Nam
- Department of Acupuncture and Moxibustion, Kyung Hee University, Seoul, South Korea
| | - Eun-Jung Kim
- Department of Acupuncture and Moxibustion, College of Oriental Medicine, Dongguk University, Seongnam-si, South Korea
| | - In-Hyuk Ha
- Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, South Korea
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Bidonde J, Fisher E, Perrot S, Moore RA, Bell RF, Makri S, Häuser W. Effectiveness of non-pharmacological interventions for fibromyalgia and quality of review methods: an overview of Cochrane Reviews. Semin Arthritis Rheum 2023; 63:152248. [PMID: 37598586 DOI: 10.1016/j.semarthrit.2023.152248] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2023] [Accepted: 07/25/2023] [Indexed: 08/22/2023]
Abstract
BACKGROUND Fibromyalgia syndrome (FMS) is defined as chronic widespread pain associated with sleep disorders, cognitive dysfunction, and somatic symptoms present for at least three months and cannot be better explained by another diagnosis. OBJECTIVES To examine efficacy and safety of non-pharmacological interventions for FMS in adults reported in Cochrane Reviews, and reporting quality of reviews. METHODS Systematic reviews of randomised controlled trials (RCTs) of non-pharmacological interventions for FMS were identified from the Cochrane Database of Systematic Reviews (CDSR 2022, Issue 3 and CDSR 2023 Issue 6). Methodological quality was assessed using the AMSTAR-2 tool and a set of methodological criteria critical for analgesic effects. The primary efficacy outcomes of interest were clinically relevant pain relief, improvement in health-related quality of life (HRQoL), acceptability, safety, and reduction of mobility difficulties as reported by study participants. No pooled analyses were planned. We assumed a clinically relevant improvement was a minimal clinically important difference (MCID) between interventions and controls of 15%, or a SMD of more than 0.2, or a MD of more than 0.5, on a 0 to 10 scale. RESULTS Ten Cochrane reviews were eligible, reporting 181 randomized or quasi- randomized trials (11,917 participants, average trial size 66 participants). The reviews examined exercise training, acupuncture, transcutaneous electrical nerve stimulation, and psychological therapies. One review was rated moderate according to AMSTAR 2, seven were rated low and two were rated critically low. All reviews met most of the additional methodological quality criteria. All reviews included studies with patient-reported outcomes for pain. We found low certainty evidence of clinically relevant positive effects of aerobic and mixed exercise training and for cognitive behavioural therapies (CBTs) at reducing mobility difficulties and for mixed exercise training and CBTs for improving HRQoL at the end of the intervention. Number needed to treat for an additional beneficial outcome (NNTB) values for a MCID of 15% ranged between 4 and 9. We found low certainty evidence that was clinically relevant for mixed exercise and CBTs for reducing mobility difficulties at an average follow up of 24 weeks. We found low certainty evidence of clinically relevant positive effects of mixed exercise on HRQoL at an average follow up of 24 weeks. NNTB values for a MCID of 15% ranged from 5 to 11. The certainty of evidence of the acceptability (measured by dropouts) of the different non-pharmacological interventions ranged from very low to moderate and the dropout rate for any reason did not differ across the interventions or the controls, except for biofeedback and movement therapies. All the systematic reviews stated that the reporting of adverse events was inconsistent in the studies analysed (very low certainty evidence). AUTHORS' CONCLUSIONS There is low certainty evidence of clinically relevant reduction of mobility difficulties and of improvement of HRQoL among individuals with FMS by aerobic and mixed exercise training and by CBTs at the end of the intervention. There is low certainty evidence that CBTs and mixed exercise training reduces mobility difficulties post-treatment and that mixed exercise training improves HRQoL at follow-up by clinically meaningful scores.
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Affiliation(s)
- Julia Bidonde
- Norwegian Institute of Public Health, Oslo, Norway; School of Rehabilitation Science, College of Medicine, University of Saskatchewan, Saskatoon, Canada.
| | - Emma Fisher
- Centre for Pain Research, University of Bath, UK
| | - Serge Perrot
- Centre de la Douleur, Hôpital Cochin, Université Paris Cité, INSERM U987, Paris, France
| | | | - Rae Frances Bell
- Regional Centre of Excellence in Palliative Care Haukeland University Hospital, Bergen, Norway
| | - Souzi Makri
- Cyprus League for People with Rheumatism, Nicosia, Cyprus
| | - Winfried Häuser
- Department of Psychosomatic Medicine and Psychotherapy, Technische Universität München, München, Germany
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Öznur Ö, Schlee C, Utz S, Langhorst J. Investigating the Influential Factors of Mild Water-Filtered Infrared-A Whole-Body Hyperthermia for Pain Relief in Fibromyalgia: A Mixed-Methods Approach Focusing on Predictors and Patient Perspectives. Biomedicines 2023; 11:2949. [PMID: 38001951 PMCID: PMC10669402 DOI: 10.3390/biomedicines11112949] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2023] [Revised: 10/26/2023] [Accepted: 10/30/2023] [Indexed: 11/26/2023] Open
Abstract
Fibromyalgia syndrome (FMS) is a chronic condition characterized by chronic widespread pain, persistent fatigue, and disrupted sleep, significantly impacting well-being. Mild water-filtered infrared-A (wIRA) whole-body hyperthermia (WBH) is emerging as a promising pain management approach to FMS. Within the present randomized controlled trial (ClinicalTrials ID: NCT05135936), FMS patients underwent six sessions of mild wIRA-WBH over 3 weeks. Their pain levels were assessed at baseline and at week 12, while body core temperature and plateau phase duration were monitored during WBH. Qualitative interviews were conducted at week 12. Results from this mixed-methods study revealed that baseline pain intensity and plateau phase duration significantly predicted pain intensity at week 12. Thematic analysis of the interviews revealed diverse patient experiences with the treatment, with all patients reporting improvements in perceived pain and overall well-being. The onset and duration of pain relief varied among individuals. Overall, the findings suggest that the duration of the plateau phase may serve as an indicator for long-term pain reduction, although individual factors may influence treatment outcomes. Despite varying experiences, a prevailing trend of positive patient evaluations emerged. This study sheds light on the potential of wIRA-WBH as a therapeutic option for alleviating pain for and enhancing the well-being of FMS patients.
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Affiliation(s)
- Özlem Öznur
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, 96049 Bamberg, Germany; (Ö.Ö.); (C.S.); (S.U.)
- Department of Integrative Medicine, Medicinal Faculty, University of Duisburg-Essen, 96049 Bamberg, Germany
| | - Christoph Schlee
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, 96049 Bamberg, Germany; (Ö.Ö.); (C.S.); (S.U.)
- Department of Integrative Medicine, Medicinal Faculty, University of Duisburg-Essen, 96049 Bamberg, Germany
- Department of Sociology, University of Bamberg, 96052 Bamberg, Germany
| | - Sandra Utz
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, 96049 Bamberg, Germany; (Ö.Ö.); (C.S.); (S.U.)
- Department of Integrative Medicine, Medicinal Faculty, University of Duisburg-Essen, 96049 Bamberg, Germany
| | - Jost Langhorst
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, 96049 Bamberg, Germany; (Ö.Ö.); (C.S.); (S.U.)
- Department of Integrative Medicine, Medicinal Faculty, University of Duisburg-Essen, 96049 Bamberg, Germany
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Glynos NG, Pierce J, Davis AK, McAfee J, Boehnke KF. Knowledge, Perceptions, and Use of Psychedelics among Individuals with Fibromyalgia. J Psychoactive Drugs 2023; 55:73-84. [PMID: 35001856 DOI: 10.1080/02791072.2021.2022817] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/16/2021] [Revised: 09/20/2021] [Accepted: 10/05/2021] [Indexed: 01/28/2023]
Abstract
Fibromyalgia (FM) is a difficult to treat chronic pain condition for which there is strong interest in alternative treatments. There is growing interest in the potential of psychedelic substances (e.g., psilocybin) in conjunction with psychotherapy to treat chronic pain. Via a cross-sectional, anonymous, online survey, we aimed to characterize knowledge, perceptions, and past use of serotonergic ("classic") and non-serotonergic psychedelics among a population of individuals with FM, and to investigate interest in psychedelic-based FM treatments. Among a North American population of 354 participants with FM, 29.9% reported past use of a psychedelic, with lysergic acid diethylamide (LSD) and psilocybin mushrooms being most commonly used. Perceptions of benefit from psychedelic use were generally neutral (59.4%) or positive (36.8%), with <3% reporting negative impacts on overall health or pain symptoms. Among 12 participants who used psychedelics with intentions of treating chronic pain, 11 reported improved symptoms. Regardless of past use, the majority of participants believed that psychedelics have potential for chronic pain treatments and would be willing to participate in a psychedelic-based clinical trial for their pain. These findings support the need for additional studies to understand the potential and effectiveness of psychedelic substances in managing FM symptoms.
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Affiliation(s)
- Nicolas G Glynos
- Department of Molecular & Integrative Physiology, University of Michigan, Ann Arbor, MI, USA
- Center for Consciousness Science, University of Michigan, Ann Arbor, MI, USA
| | - Jennifer Pierce
- Anesthesiology Department, University of Michigan Medical School, Ann Arbor, MI, USA
| | - Alan K Davis
- College of Social Work and Department of Psychiatry, Ohio State University, Columbus, OH, USA
- Center for Psychedelic and Consciousness Research, Johns Hopkins University, Baltimore, MD, USA
| | - Jenna McAfee
- Anesthesiology Department, University of Michigan Medical School, Ann Arbor, MI, USA
| | - Kevin F Boehnke
- Anesthesiology Department, University of Michigan Medical School, Ann Arbor, MI, USA
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Abstract
Purpose of Review This review will address the many uncertainties surrounding the medical use of cannabidiol (CBD). We will begin with an overview of the legal and commercial environment, examine recent preclinical and clinical evidence on CBD, explore questions concerning CBD raised by healthcare professionals and patients, investigate dosing regimens and methods of administration, and address current challenges in the accumulation of sound evidence. Recent Findings CBD has potential for relief of symptoms of pain, sleep, and mood disturbance in rheumatology patients, but sound clinical evidence is lacking. CBD is safe when accessed from a regulated source, whereas wellness products are less reliable regarding content and contaminants. Dosing for symptom relief has not yet been established. Summary As many rheumatology patients are trying CBD as a self-management strategy, the healthcare community must urgently accrue sound evidence for effect.
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Häuser W, Fisher E, Perrot S, Moore RA, Makri S, Bidonde J. Non-pharmacological interventions for fibromyalgia (fibromyalgia syndrome) in adults: an overview of Cochrane Reviews. Hippokratia 2022. [DOI: 10.1002/14651858.cd015074] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Affiliation(s)
- Winfried Häuser
- Department of Psychosomatic Medicine and Psychotherapy; Technische Universität München; München Germany
| | - Emma Fisher
- Cochrane Pain, Palliative and Supportive Care Group; Pain Research Unit, Churchill Hospital; Oxford UK
| | - Serge Perrot
- Service de Médecine Interne et Thérapeutique; Hôtel Dieu, Université Paris Descartes, INSERM U 987; Paris France
| | | | - Souzi Makri
- Cyprus League Against Rheumatism; Nicosia Cyprus
| | - Julia Bidonde
- School of Rehabilitation Science, College of Medicine; University of Saskatchewan; Saskatoon Canada
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12
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Holman A, Boehnke KF. Tackling the taboo: a sensible prescription for appropriate cannabis use in fibromyalgia. Pain Manag 2021; 12:117-122. [PMID: 34743594 DOI: 10.2217/pmt-2021-0096] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
Affiliation(s)
- Alexis Holman
- Department of Internal Medicine, Division of Rheumatology, University of Michigan, Ann Arbor, MI 48109, USA
| | - Kevin F Boehnke
- Anesthesiology Department, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, MI 48106, USA
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Gendelman O, Shapira R, Tiosano S, Kuntzman Y, Tsur AM, Hakimian A, Comaneshter D, Cohen AD, Buskila D, Amital H. Utilisation of healthcare services and drug consumption in fibromyalgia: A cross-sectional analysis of the Clalit Health Service database. Int J Clin Pract 2021; 75:e14729. [PMID: 34383362 DOI: 10.1111/ijcp.14729] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2021] [Revised: 08/07/2021] [Accepted: 08/09/2021] [Indexed: 12/21/2022] Open
Abstract
AIM To investigate the health care utilisation and drug consumption of patients with fibromyalgia (FM). MATERIALS AND METHODS This is a cross-sectional study using the Clalit Health Care database. Clalit is the largest HMO in Israel, serving more than 4.4 million enrollees. We identified FM patients and age and sex-matched controls. Indicators of healthcare utilisation and drug consumption were extracted and analysed for both groups. RESULTS The study included 14 296 FM patients and 71 324 controls. The mean age was 56 years, with a women predominance of 92%. The mean number of visits across of all healthcare services (hospitalisations, emergency department visit, general practitioner clinic visits, rheumatology clinic visits, and pain clinic visits) and the mean difference (MD) were significantly higher for FM patients compared with controls (MD 0.66, P < .001; MD 0.23, P < .001; MD 7.49, P < .001; MD 0.31, P < .001; MD 0.13, P < .001), respectively. Drug use was significantly and consistently higher among FM patients compared with controls; NSAIDs (non-steroidal anti-inflammatory drugs) OR 2.56, P < .001; Opioids OR 4.23, P < .001; TCA (tricyclic antidepressants) OR 8.21, P < .001; Gabapentinoids OR 6.31, P < .001; SSRI (selective serotonin reuptake inhibitors) OR 2.07, P < .001; SNRI (serotonin-norepinephrine reuptake inhibitor) OR 7.43, P < .001. CONCLUSION Healthcare utilisation and drug use are substantially higher among patients with FM compared with controls.
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Affiliation(s)
- Omer Gendelman
- Department of Medicine 'B', Sheba Medical Center, Tel-Hashomer, Israel
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
| | - Raz Shapira
- Department of Medicine 'B', Sheba Medical Center, Tel-Hashomer, Israel
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
| | - Shmuel Tiosano
- Department of Medicine 'B', Sheba Medical Center, Tel-Hashomer, Israel
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
| | - Yuval Kuntzman
- Department of Medicine 'B', Sheba Medical Center, Tel-Hashomer, Israel
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
| | - Avishai M Tsur
- Department of Medicine 'B', Sheba Medical Center, Tel-Hashomer, Israel
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
- Israel Defense Forces, Medical Corps, Tel Hashomer, Ramat Gan, Israel
| | - Aliza Hakimian
- Department of Medicine 'B', Sheba Medical Center, Tel-Hashomer, Israel
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
| | - Doron Comaneshter
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
- Chief Physician's Office, Faculty of Health Sciences, Clalit Health Services Tel Aviv, Tel Aviv, Israel
| | - Arnon D Cohen
- Chief Physician's Office, Faculty of Health Sciences, Clalit Health Services Tel Aviv, Tel Aviv, Israel
- Faculty of Health Sciences, Siaal Research Center for Family Medicine and Primary Care, Tel-Aviv, Israel
- Ben-Gurion University of the Negev, Beer Sheva, Israel
| | - Dan Buskila
- Ben-Gurion University of the Negev, Beer Sheva, Israel
| | - Howard Amital
- Department of Medicine 'B', Sheba Medical Center, Tel-Hashomer, Israel
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
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Bruce BK, Allman ME, Rivera FA, Abril A, Gehin JM, Oliphant LM, Nordan LM, White LJ, Martinez D, Niazi SK. Opioid Use in Fibromyalgia Continues Despite Guidelines That Do Not Support Its Efficacy or Risk. J Clin Rheumatol 2021; 27:187-193. [PMID: 32040055 DOI: 10.1097/rhu.0000000000001273] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/23/2023]
Abstract
BACKGROUND/OBJECTIVE The aim of this cross-sectional study is to determine the prevalence of opioid use in a large sample of fibromyalgia (FM) patients and examine the factors associated with opioid prescription/use despite multiple clinical guidelines that do not recommend opioid use in this population. METHODS Data were collected from a convenience sample of 698 patients admitted from August 2017 to May 2019 into an intensive 2-day Fibromyalgia Treatment Program at a tertiary medical center in the United States after FM diagnosis. Patients were administered the Fibromyalgia Impact Questionnaire-Revised, the Center for Epidemiologic Study of Depression Scale, and the Pain Catastrophizing Scale upon admission to the program. Demographic information and opioid use were self-reported. Logistic regression analysis was utilized to determine associations between patient-related variables and opioid use in this prospective study. RESULTS Of 698 patients, 27.1% (n = 189) were taking opioids at intake. Extended duration of symptoms (>3 years), increased age, higher degree of functional impairment, and increased pain catastrophizing were significantly associated with opioid use. CONCLUSIONS Opioids are not recommended for the treatment of FM under current guidelines. Greater burden of illness appeared to be associated with the prescription and use of opioids in this population. These findings suggest that some providers may not be aware of current recommendations that have been found to be effective in the management of FM that are contained in guidelines. Alternative approaches to the management of FM that do not involve opioids are reviewed in an effort to improve care.
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Affiliation(s)
- Barbara K Bruce
- From the Department of Psychiatry and Psychology, Mayo Clinic, Jacksonville, FL
| | | | | | | | - Jessica M Gehin
- From the Department of Psychiatry and Psychology, Mayo Clinic, Jacksonville, FL
| | - Loretta M Oliphant
- From the Department of Psychiatry and Psychology, Mayo Clinic, Jacksonville, FL
| | - Lisa M Nordan
- Kern Center for the Science of Health Care Delivery, Mayo Clinic, Jacksonville, FL
| | - Launia J White
- Kern Center for the Science of Health Care Delivery, Mayo Clinic, Jacksonville, FL
| | - Dayana Martinez
- Kern Center for the Science of Health Care Delivery, Mayo Clinic, Jacksonville, FL
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15
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Substituting Cannabidiol for Opioids and Pain Medications Among Individuals With Fibromyalgia: A Large Online Survey. THE JOURNAL OF PAIN 2021; 22:1418-1428. [PMID: 33992787 DOI: 10.1016/j.jpain.2021.04.011] [Citation(s) in RCA: 22] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/18/2021] [Revised: 04/12/2021] [Accepted: 04/23/2021] [Indexed: 12/16/2022]
Abstract
People report substituting cannabis for pain medications, but whether cannabidiol (CBD) is used similarly remains unknown. CBD products can be CBD alone (isolate), hemp extract (containing <0.3% Δ-9-tetrahydrocannabinol [THC], other cannabinoids, and terpenes), or CBD-cannabis (containing >0.3% THC). In a secondary analysis from a cross-sectional survey, we examined substitution patterns among n = 878 individuals with fibromyalgia who currently used CBD. We sub-grouped participants by most commonly used CBD product (CBD isolate, hemp, CBD-cannabis, no preference) and whether they substituted CBD for medications. We investigated rationale for substituting, substitution-driven medication changes, CBD use patterns, and changes in pain-related symptoms (eg, sleep, anxiety). The study population was 93.6% female and 91.5% Caucasian, with an average age of 55.5 years. The majority (n = 632, 72.0%) reported substituting CBD products for medications, most commonly NSAIDs (59.0%), opioids (53.3%), gabapentanoids (35.0%), and benzodiazepines (23.1%). Most substituting participants reported decreasing or stopping use of these pain medications. The most common reasons for substitution were fewer side effects and better symptom management. Age, hemp products, past-year use of marijuana, and higher somatic burden were all associated with substituting (P's ≤ .05). Those who substituted reported larger improvements in health and pain than those who did not. Participants using CBD-cannabis reported significantly more substitutions than any other group (P's ≤ .001) and larger improvements in health, pain, memory, and sleep than other subgroups. This widespread naturalistic substitution for pain medications suggests the need for more rigorous study designs to examine this effect. PERSPECTIVE: This article shows that people with fibromyalgia are deliberately substituting CBD products for conventional pain medications despite the dearth of evidence suggesting CBD products may be helpful for fibromyalgia. CBD's medication-sparing and therapeutic potential should be examined in more rigorous study designs.
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16
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Sałat K, Furgała-Wojas A. Serotonergic Neurotransmission System Modulator, Vortioxetine, and Dopaminergic D 2/D 3 Receptor Agonist, Ropinirole, Attenuate Fibromyalgia-Like Symptoms in Mice. Molecules 2021; 26:molecules26082398. [PMID: 33924258 PMCID: PMC8074757 DOI: 10.3390/molecules26082398] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2021] [Revised: 04/15/2021] [Accepted: 04/19/2021] [Indexed: 01/28/2023] Open
Abstract
Fibromyalgia is a disease characterized by lowered pain threshold, mood disorders, and decreased muscular strength. It results from a complex dysfunction of the nervous system and due to unknown etiology, its diagnosis, treatment, and prevention are a serious challenge for contemporary medicine. Impaired serotonergic and dopaminergic neurotransmission are regarded as key factors contributing to fibromyalgia. The present research assessed the effect of serotonergic and dopaminergic system modulators (vortioxetine and ropinirole, respectively) on the pain threshold, depressive-like behavior, anxiety, and motor functions of mice with fibromyalgia-like symptoms induced by subcutaneous reserpine (0.25 mg/kg). By depleting serotonin and dopamine in the mouse brain, reserpine induced symptoms of human fibromyalgia. Intraperitoneal administration of vortioxetine and ropinirole at the dose of 10 mg/kg alleviated tactile allodynia. At 5 and 10 mg/kg ropinirole showed antidepressant-like properties, while vortioxetine had anxiolytic-like properties. None of these drugs influenced muscle strength but reserpine reduced locomotor activity of mice. Concluding, in the mouse model of fibromyalgia vortioxetine and ropinirole markedly reduced pain. These drugs affected emotional processes of mice in a distinct manner. Hence, these two repurposed drugs should be considered as potential drug candidates for fibromyalgia. The selection of a specific drug should depend on patient’s key symptoms.
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17
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Lawson K, Singh A, Kantsedikas I, Jenner CA, Austen DK. Flupirtine as a Potential Treatment for Fibromyalgia. JOURNAL OF EXPLORATORY RESEARCH IN PHARMACOLOGY 2021; 000:000-000. [DOI: 10.14218/jerp.2020.00043] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
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18
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Boehnke KF, Litinas E, Worthing B, Conine L, Kruger DJ. Communication between healthcare providers and medical cannabis patients regarding referral and medication substitution. J Cannabis Res 2021; 3:2. [PMID: 33526140 PMCID: PMC7831240 DOI: 10.1186/s42238-021-00058-0] [Citation(s) in RCA: 25] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/04/2020] [Accepted: 01/15/2021] [Indexed: 01/25/2023] Open
Abstract
BACKGROUND People report using cannabis as a substitute for prescription medications but may be doing so without the knowledge of their primary health care providers (PCPs). This lack of integration creates serious concerns, e.g., using cannabis to treat medical conditions that have established treatment options. METHODS We conducted an anonymous, cross-sectional online survey among patrons of a medical cannabis dispensary in Michigan (n = 275) to examine aspects of their relationship with their PCP and their perceptions of PCP knowledge related to cannabis. RESULTS Overall, 64% of participants initiated medical cannabis use based on their own experiences vs. 24% citing advice from their PCP. Although 80% reported that their PCP knew they currently used medical cannabis, 41% reported that their PCP had not always known. Only 14% obtained their medical cannabis authorization from their PCP. Only 18% of participants rated their PCP's knowledge about medical cannabis as very good or excellent and only 21% were very or completely confident in their PCP's ability to integrate medical cannabis into their treatment. Although 86% had substituted cannabis for pharmaceutical medications, 69% (n = 134) of those who substituted reported some gap in their PCP's knowledge of their substitution, and 44% (n = 86) reported that their PCP was currently unaware of their substitution. CONCLUSIONS Patients frequently substitute cannabis for prescription drugs, often without PCP knowledge. Although most participants disclosed cannabis use to their PCP, their perceptions of PCP knowledge ranged widely and many obtained medical cannabis licensure from an outside physician. Our results highlight the need for standardized physician education around appropriate medical cannabis use.
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Affiliation(s)
- Kevin F Boehnke
- Anesthesiology Department, University of Michigan Medical School, 24 Frank Lloyd Wright Drive, Ann Arbor, MI, 48106, USA.
| | | | | | | | - Daniel J Kruger
- Population Studies Center, University of Michigan, Ann Arbor, MI, USA
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19
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Boehnke KF, Gagnier JJ, Matallana L, Williams DA. Cannabidiol Use for Fibromyalgia: Prevalence of Use and Perceptions of Effectiveness in a Large Online Survey. THE JOURNAL OF PAIN 2021; 22:556-566. [PMID: 33400996 DOI: 10.1016/j.jpain.2020.12.001] [Citation(s) in RCA: 21] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/29/2020] [Revised: 11/20/2020] [Accepted: 12/28/2020] [Indexed: 12/18/2022]
Abstract
Cannabidiol (CBD) is widely advertised as helpful for chronic pain management but research is limited. Using a cross-sectional, anonymous survey, we examined patterns of naturalistic CBD use among individuals with fibromyalgia (FM) and other chronic pain conditions. Our objective was to better understand rates of CBD use, reasons for use and discontinuation, communication with healthcare professionals about CBD, and perceptions of CBD effectiveness and safety among people with FM. After excluding incomplete surveys, our study population consisted of N = 2,701 participants with fibromyalgia, primarily in the United States. Overall, 38.1% reported never using CBD, 29.4% reported past CBD use, and 32.4% reported current CBD use. Past-year cannabis use was strongly associated with past or current CBD use. Those using CBD typically did so due to inadequate symptom relief, while those not using CBD typically cited safety concerns as their reason for not using CBD. Two-thirds of participants disclosed CBD use to their physician, although only 33% asked for physician advice on using CBD. Participants used CBD for numerous FM-related symptoms (most commonly pain), and generally reported slight to much improvement across symptom domains. Around half of participants reported side effects, which were typically minor. Our findings are limited by selection bias and our cross-sectional design, which prevents causal associations. In conclusion, CBD use is common among individuals with FM and many individuals using CBD report improvements across numerous FM-related symptoms. Our findings highlight the need for additional rigorous studies to better understand CBD's potential for FM management. PERSPECTIVE: This article indicates that CBD use is common among people with fibromyalgia, and the results suggest that many derive benefit from using CBD across multiple symptoms domains. Clinicians should discuss CBD use with fibromyalgia patients, and future studies are needed to rigorously assess CBD's therapeutic value for fibromyalgia symptoms.
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Affiliation(s)
- Kevin F Boehnke
- Anesthesiology Department, University of Michigan Medical School, Ann Arbor, Michigan.
| | - Joel J Gagnier
- Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan
| | - Lynne Matallana
- National Fibromyalgia Association, Newport Beach, California; Community Health Focus Inc., Ann Arbor, Michigan
| | - David A Williams
- Anesthesiology Department, University of Michigan Medical School, Ann Arbor, Michigan
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20
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De Sola H, Dueñas M, Salazar A, Ortega-Jiménez P, Failde I. Prevalence of Therapeutic use of Opioids in Chronic non-Cancer Pain Patients and Associated Factors: A Systematic Review and Meta-Analysis. Front Pharmacol 2020; 11:564412. [PMID: 33364942 PMCID: PMC7750787 DOI: 10.3389/fphar.2020.564412] [Citation(s) in RCA: 30] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2020] [Accepted: 09/16/2020] [Indexed: 02/01/2023] Open
Abstract
Objectives: To determine the prevalence and factors associated with the use of opioids among patients with chronic non-cancer pain (CNCP). Methods: A systematic review and meta-analysis. Comprehensive literature searches in Medline-PubMed, Embase and SCOPUS databases. Original studies published between 2009 and 2019 with a cross-sectional design were included. The quality of the studies was assessed with Critical Appraisal Checklist for Studies Reporting Prevalence Data from the Joanna Briggs Institute. Protocol registered in the International Prospective Register of Systematic Reviews with reference number: CRD42019137990. Results: Out of the 1,310 potential studies found, 25 studies fulfilled the inclusion criteria. Most of the studies were of high quality. High levels of heterogeneity were found in the studies included. In the general population, the prevalence of long-term opioid use was 2.3% (95% CI: 1.5–3.6%), the prevalence of short-term opioid use was 8.1% (95% CI: 5.6–11.6%), and among people with chronic low back pain it was 5.8% (95% CI: 0.5–45.5%). The prevalence of opioid use among patients from the health records or medical surveys was 41% (95% CI: 23.3–61.3%). Finally, in patients with musculoskeletal pain, the prevalence was 20.5% (95% CI: 12.9–30.9%) and in patients with fibromyalgia, 24.5% (95% CI: 22.9–26.2%). A higher prevalence of opioid use was observed among men, younger people, patients receiving prescriptions of different types of drugs, smokers and patients without insurance or with noncommercial insurance. In addition, non-white and Asian patients were less likely to receive opioids than non-Hispanic white patients. Conclusions: The prevalence of opioid use among patients with CNCP was higher in subjects with short or occasional use compared to those with long-term use. Men, younger people, more chronic pain conditions, and patients without insurance or with noncommercial insurance were most related to opioid use. However, non-white and Asian patients, and those treated by a physician trained in complementary medicine were less likely to use opioids.
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Affiliation(s)
- Helena De Sola
- The Observatory of Pain, University of Cádiz, Cádiz, Spain.,Preventive Medicine and Public Health Area, University of Cádiz, Cádiz, Spain.,Biomedical Research and Innovation Institute of Cádiz (INiBICA), Research Unit, Puerta del Mar University Hospital, University of Cádiz, Cádiz, Spain
| | - María Dueñas
- The Observatory of Pain, University of Cádiz, Cádiz, Spain.,Biomedical Research and Innovation Institute of Cádiz (INiBICA), Research Unit, Puerta del Mar University Hospital, University of Cádiz, Cádiz, Spain.,Department of Statistics and Operational Research, University of Cádiz, Cádiz, Spain
| | - Alejandro Salazar
- The Observatory of Pain, University of Cádiz, Cádiz, Spain.,Biomedical Research and Innovation Institute of Cádiz (INiBICA), Research Unit, Puerta del Mar University Hospital, University of Cádiz, Cádiz, Spain.,Department of Statistics and Operational Research, University of Cádiz, Cádiz, Spain
| | - Patricia Ortega-Jiménez
- The Observatory of Pain, University of Cádiz, Cádiz, Spain.,Department of Statistics and Operational Research, University of Cádiz, Cádiz, Spain
| | - Inmaculada Failde
- The Observatory of Pain, University of Cádiz, Cádiz, Spain.,Preventive Medicine and Public Health Area, University of Cádiz, Cádiz, Spain.,Biomedical Research and Innovation Institute of Cádiz (INiBICA), Research Unit, Puerta del Mar University Hospital, University of Cádiz, Cádiz, Spain
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21
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Valentini E, Fetter E, Orbell S. Treatment preferences in fibromyalgia patients: A cross-sectional web-based survey. Eur J Pain 2020; 24:1290-1300. [PMID: 32267582 DOI: 10.1002/ejp.1570] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/19/2019] [Revised: 03/24/2020] [Accepted: 03/27/2020] [Indexed: 11/09/2022]
Abstract
BACKGROUND Therapeutic approaches to fibromyalgia (FM) are shifting towards a combined multi-treatment approach to tackle the variety of symptoms experienced in FM. Importantly, little is known about FM patients' attitude towards the available treatments. METHODS A cross-sectional web survey obtained responses from 464 individuals who satisfied diagnostic criteria for FM. Respondents were asked to report which treatments they adopted in their past, present and intend to adopt in the future. They also rated their level of well-being, depression, anxiety and pain catastrophizing. RESULTS Data revealed a predominantly combined multi-treatment approach in a sample characterized by middle-aged, Caucasian women. Respondents reported pervasive use of pharmacological therapy but had also adopted non-pharmacological treatment in the past. Future intentions clustered on alternative treatment or no treatment. Regression analyses revealed that pharmacological treatment in the past was predictive of both pharmacological and non-pharmacological treatments in the present. However, use of non-pharmacological treatment in the past was uniquely predictive of its reuse in the present and future. This pattern was also accounted for by individual differences in pain magnification and well-being in the past. CONCLUSIONS Treatment preferences of FM individuals reveal an ambivalent combination of heavy reliance on pharmacological treatment with lower but consistent reliance on non-pharmacological treatment for those individuals who used it in the past and present. This finding may inform longitudinal research into the relationship between pharmacological and non-pharmacological treatment preference in FM patients, which could in turn inform guidelines for individualized therapeutic plans for clinicians. SIGNIFICANCE Individuals with fibromyalgia reported the use of non-pharmacological and pharmacological treatments in the past but a predominant use of a pharmacological approach overall. Patterns of treatment experienced in the past were differentially related to future preferences. Pharmacological treatment in the past was likely to lead to both pharmacological and non-pharmacological choices in the present. However, non-pharmacological treatment in the past was more likely to be chosen again in the present and future, but unlikely to lead to a pharmacological choice.
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Affiliation(s)
- Elia Valentini
- Department of Psychology and Centre for Brain Science, University of Essex, Colchester, UK
| | - Eleonora Fetter
- Department of Psychology and Centre for Brain Science, University of Essex, Colchester, UK
| | - Sheina Orbell
- Department of Psychology and Centre for Brain Science, University of Essex, Colchester, UK
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22
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Pérez-Fernández MR, Calvo-Ayuso N, Martínez-Reglero C, Salgado-Barreira Á, Muiño López-Álvarez JL. Efficacy of baths with mineral-medicinal water in patients with fibromyalgia: a randomized clinical trial. INTERNATIONAL JOURNAL OF BIOMETEOROLOGY 2019; 63:1161-1170. [PMID: 31161236 DOI: 10.1007/s00484-019-01729-7] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/31/2019] [Revised: 05/06/2019] [Accepted: 05/06/2019] [Indexed: 05/19/2023]
Abstract
The layout of this study, designed as a randomized crossover clinical trial, is to evaluate the efficacy of an intervention with mineral-medicinal water from As Burgas (Ourense) in patients suffering from fibromyalgia. This sample was randomly divided into two groups: group A and group B. In phase 1, group A had 14 baths in thermal water for a month and standard pharmacological treatment; group B, standard pharmacological treatment. Washout period is 3 months. In phase 2, group A had standard treatment and group B had 14 baths in thermal water for a month plus standard treatment. The Fibromyalgia Impact Questionnaire (FIQ) was used; this grades the impact of the illness from 1 (minimum) to 10 (maximum), which was measured in both phases. Twenty-five patients were included in each group and the study was concluded with 20 patients in group A and 20 in group B. The intervention group obtained, once the baths finished, a mean score of 60.3 (± 11.8) and the control group of 70.8 (± 13.0) (p < 0.001). Three months later, the intervention group presented a mean score of 64.4 (± 10.6) and the control group of 5.0 (± 11.3) (p < 0.001). We can therefore conclude that the simple baths with mineral-medicinal water from As Burgas can make an improvement on the impact caused by fibromyalgia.
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Affiliation(s)
- María Reyes Pérez-Fernández
- Escuela Universitaria de Enfermería de Ourense, SERGAS, Universidad de Vigo. Ourense, C/Ramón Puga 52-54, 32005, Ourense, Spain.
| | - Natalia Calvo-Ayuso
- Escuela Universitaria de Enfermería de Ourense, SERGAS, Universidad de Vigo. Ourense, C/Ramón Puga 52-54, 32005, Ourense, Spain
| | | | - Ángel Salgado-Barreira
- Unidad de Metodología y Estadística, Instituto de Investigación Sanitaria Galicia Sur, Vigo, Spain
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23
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Peschke D. [Appropriateness of physiotherapy care in Germany: a scoping review]. ZEITSCHRIFT FUR EVIDENZ, FORTBILDUNG UND QUALITAT IM GESUNDHEITSWESEN 2019; 141-142:33-44. [PMID: 31003901 DOI: 10.1016/j.zefq.2019.03.004] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/21/2018] [Revised: 03/10/2019] [Accepted: 03/12/2019] [Indexed: 11/24/2022]
Abstract
BACKGROUND Physiotherapy is applied for various indications in practices, hospitals and rehabilitation facilities and should be delivered according to the patients' needs. Empirical knowledge on the appropriateness of physiotherapy care in Germany is scarce. This scoping review aims to give an overview over the evidence base, to describe the results of previous studies and to evaluate the appropriateness of physiotherapy care. METHOD A systematic literature search was conducted in the databases PubMed, CINAHL, LIVIO and SPOLIT. Results were synthesized in a quantitative and qualitative narrative review. RESULTS The screening of 1,517 publications yielded 30 studies eligible for inclusion. The included studies encompass 16 different indications. The number of patients with appropriate physiotherapy care varies between indications (from 3 % for urinary incontinence up to 72 % for osteoporosis). DISCUSSION The review shows a lack of empirical evidence since sufficient empirical findings regarding the appropriateness of physiotherapy care are missing for many of the indications, in particular on physiotherapy in hospitals and rehabilitation facilities. The results of single studies are limited by insufficient assessment of therapeutic needs or the therapy modalities applied. Analyses which encompass multiple settings and/or providers of care have not been conducted in all studies, even though respective approaches would have been suitable. Nevertheless, suggestions for targeted improvement of the appropriateness of physiotherapy care can be derived from the results.
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Affiliation(s)
- Dirk Peschke
- Department für Angewandte Gesundheitswissenschaften, Studienbereich Physiotherapie Hochschule für Gesundheit Bochum, Bochum, Deutschland; Institut für Public Health und Pflegeforschung (IPP), Universität Bremen, Deutschland.
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24
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Taylor SJ, Steer M, Ashe SC, Furness PJ, Haywood-Small S, Lawson K. Patients' perspective of the effectiveness and acceptability of pharmacological and non-pharmacological treatments of fibromyalgia. Scand J Pain 2019; 19:167-181. [PMID: 30315738 DOI: 10.1515/sjpain-2018-0116] [Citation(s) in RCA: 21] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/19/2018] [Accepted: 09/19/2018] [Indexed: 02/07/2023]
Abstract
Background and aims Fibromyalgia is a complex condition characterised by widespread pain, sleep disturbance, fatigue and cognitive impairment, with a global mean prevalence estimated at 2.7%. There are inconsistencies in guidelines on the treatment of fibromyalgia leading to dissatisfaction from patients and healthcare professionals. This study investigated patient-reported outcomes of pharmacological and non-pharmacological treatment usage and effectiveness with an assessment of acceptability. Methods Nine hundred and forty-one participants completed a self-administered anonymous questionnaire giving quantitative data of demographics, treatment usage and treatment outcomes. Participant-reported effectiveness and side effects were compared in the following treatment classes: analgesics, antidepressants, gabapentinoids, gastrointestinal treatments, activity interventions, dietary-based treatments, and psychological, physical and alternative therapies. Participants also reported whether they knew about or had tried different treatments. Results The results from the online survey indicated that the range of mean effectiveness ratings were similar for pharmacological and non-pharmacological treatments, whereas non-pharmacological treatments had lower side effects ratings and higher acceptability relative to pharmacological treatments. Participants were not aware of some treatment options. Conclusions The results show lower side effects ratings and higher acceptability for non-pharmacological treatments compared to pharmacological treatments despite similar effectiveness ratings. Implications This article presents results from a large online survey on fibromyalgia patient perspectives of pharmacological and non-pharmacological treatments. Results will inform healthcare professionals and patients about optimal treatments based on ratings of effectiveness, side effects and acceptability that are tailored to patient symptom profiles. Some participants were unaware of treatment options highlighting the importance of patient education allowing collaboration between patients and healthcare professionals to find optimal treatments.
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Affiliation(s)
- Sophie J Taylor
- Centre for Behavioural Science and Applied Psychology, Faculty of Social Sciences and Humanities, Sheffield Hallam University, Sheffield, UK
| | - Michael Steer
- Centre for Behavioural Science and Applied Psychology, Faculty of Social Sciences and Humanities, Sheffield Hallam University, Sheffield, UK
| | - Simon C Ashe
- Centre for Behavioural Science and Applied Psychology, Faculty of Social Sciences and Humanities, Sheffield Hallam University, Sheffield, UK
| | - Penny J Furness
- Centre for Behavioural Science and Applied Psychology, Faculty of Social Sciences and Humanities, Sheffield Hallam University, Sheffield, UK
| | - Sarah Haywood-Small
- Biomolecular Sciences Research Centre, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, UK
| | - Kim Lawson
- Biomolecular Sciences Research Centre, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, UK
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White C, Kwong WJ, Armstrong H, Behling M, Niemira J, Lang K. Analysis of Real-World Dosing Patterns for the 3 FDA-Approved Medications in the Treatment of Fibromyalgia. AMERICAN HEALTH & DRUG BENEFITS 2018; 11:293-301. [PMID: 30464796 PMCID: PMC6207316] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Subscribe] [Scholar Register] [Received: 11/13/2017] [Accepted: 04/13/2018] [Indexed: 06/09/2023]
Abstract
BACKGROUND Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, and sleep disturbances that affects approximately 2% to 4% of the adult population in the United States, with minimal real-world data related to the use of medications and associated dosages for this condition. OBJECTIVE To analyze the real-world dosing patterns of the 3 medications approved by the US Food and Drug Administration for fibromyalgia-pregabalin, duloxetine, and milnacipran. METHODS Using QuintilesIMS' (now IQVIA) electronic medical record data linked to administrative claims, we identified adults with fibromyalgia who were newly prescribed pregabalin, duloxetine, or milnacipran between January 1, 2006, and December 31, 2014. We summarized and compared the starting and maximum doses with United States prescribing information (USPI) dosing recommendations. RESULTS In all, 1043 patients who were receiving pregabalin, 1281 receiving duloxetine, and 326 patients receiving milnacipran with similar age and comorbidity profiles were included in the study. The mean starting dose was 176 mg daily, 56 mg daily, and 95 mg daily for pregabalin, duloxetine, and milnacipran, respectively. More patients receiving pregabalin (35%) had a starting dose lower than recommended compared with patients receiving duloxetine (7%) or milnacipran (17%; P <.0001). Of the patients who received pregabalin, 27% had USPI-recommended maintenance dosing versus 91% of patients who received duloxetine and 80% who received milnacipran (P <.0001). The mean duration of treatment was longer for duloxetine (205 days; P <.0001) than for pregabalin (167 days) and milnacipran (167 days). The duration of using the maximum dose of each medication as a percentage of the total time of medication use was 77% for pregabalin, 84% for duloxetine, and 90% for milnacipran (P <.0001). CONCLUSIONS Patients using pregabalin were the most likely of the 3 cohorts to receive lower than label-recommended starting doses and the least likely to receive the recommended maintenance doses during follow-up compared with those receiving duloxetine or milnacipran. Real-world prescribing patterns indicate that factors other than label recommendations may be influencing prescribed dosing.
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Bernardy K, Klose P, Welsch P, Häuser W. Efficacy, acceptability and safety of Internet‐delivered psychological therapies for fibromyalgia syndrome: A systematic review and meta‐analysis of randomized controlled trials. Eur J Pain 2018; 23:3-14. [DOI: 10.1002/ejp.1284] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/30/2018] [Indexed: 01/20/2023]
Affiliation(s)
- K. Bernardy
- Department of Pain Medicine BG University Hospital Bergmannsheil GmbH Ruhr University Bochum Germany
| | - P. Klose
- Department Internal and Integrative Medicine Faculty of Medicine Kliniken Essen‐Mitte University of Duisburg‐Essen Germany
| | - P. Welsch
- Health Care Center for Pain Medicine and Mental Health Saarbrücken Germany
| | - W. Häuser
- Health Care Center for Pain Medicine and Mental Health Saarbrücken Germany
- Department Internal Medicine I Klinikum Saarbrücken Germany
- Department Psychosomatic Medicine and Psychotherapy Technische Universit€at Müunchen Germany
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Characteristics of fasting users among internal medicine patients in Germany. ADVANCES IN INTEGRATIVE MEDICINE 2018. [DOI: 10.1016/j.aimed.2017.12.005] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022]
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Clauw DJ, D'Arcy Y, Gebke K, Semel D, Pauer L, Jones KD. Normalizing fibromyalgia as a chronic illness. Postgrad Med 2017; 130:9-18. [PMID: 29256764 DOI: 10.1080/00325481.2018.1411743] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
Fibromyalgia (FM) is a complex chronic disease that affects 3-10% of the general adult population and is principally characterized by widespread pain, and is often associated with disrupted sleep, fatigue, and comorbidities, among other symptoms. There are many gaps in our knowledge of FM, such that, compared with other chronic illnesses including diabetes, rheumatoid arthritis, and asthma, it is far behind in terms of provider understanding and therapeutic approaches. The experience that healthcare professionals (HCPs) historically gained in developing approaches to manage and treat patients with these chronic illnesses may help show how they can address similar problems in patients with FM. In this review, we examine some of the issues around the management and treatment of FM, and discuss how HCPs can implement appropriate strategies for the benefit of patients with FM. These issues include understanding that FM is a legitimate condition, the benefits of prompt diagnosis, use of non-drug and pharmacotherapies, patient and HCP education, watchful waiting, and assessing patients by FM domain so as not to focus exclusively on one symptom to the detriment of others. Developing successful approaches is of particular importance for HCPs in the primary care setting who are in the ideal position to provide long-term care for patients with FM. In this way, FM may be normalized as a chronic illness to the benefit of both patients and HCPs.
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Affiliation(s)
- Daniel J Clauw
- a Department of Anesthesiology , University of Michigan , Ann Arbor , MI , USA
| | - Yvonne D'Arcy
- b Pain Management Nurse Practitioner , Ponte Vedra Beach , FL , USA
| | - Kevin Gebke
- c Department of Family Medicine , Indiana University School of Medicine , Indianapolis , IN , USA
| | | | | | - Kim D Jones
- f Schools of Nursing & Medicine , Oregon Health & Science University , Portland , OR , USA
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Johnson MI, Claydon LS, Herbison GP, Jones G, Paley CA. Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults. Cochrane Database Syst Rev 2017; 10:CD012172. [PMID: 28990665 PMCID: PMC6485914 DOI: 10.1002/14651858.cd012172.pub2] [Citation(s) in RCA: 34] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/16/2023]
Abstract
BACKGROUND Fibromyalgia is characterised by persistent, widespread pain; sleep problems; and fatigue. Transcutaneous electrical nerve stimulation (TENS) is the delivery of pulsed electrical currents across the intact surface of the skin to stimulate peripheral nerves and is used extensively to manage painful conditions. TENS is inexpensive, safe, and can be self-administered. TENS reduces pain during movement in some people so it may be a useful adjunct to assist participation in exercise and activities of daily living. To date, there has been only one systematic review in 2012 which included TENS, amongst other treatments, for fibromyalgia, and the authors concluded that TENS was not effective. OBJECTIVES To assess the analgesic efficacy and adverse events of TENS alone or added to usual care (including exercise) compared with placebo (sham) TENS; no treatment; exercise alone; or other treatment including medication, electroacupuncture, warmth therapy, or hydrotherapy for fibromyalgia in adults. SEARCH METHODS We searched the following electronic databases up to 18 January 2017: CENTRAL (CRSO); MEDLINE (Ovid); Embase (Ovid); CINAHL (EBSCO); PsycINFO (Ovid); LILACS; PEDRO; Web of Science (ISI); AMED (Ovid); and SPORTDiscus (EBSCO). We also searched three trial registries. There were no language restrictions. SELECTION CRITERIA We included randomised controlled trials (RCTs) or quasi-randomised trials of TENS treatment for pain associated with fibromyalgia in adults. We included cross-over and parallel-group trial designs. We included studies that evaluated TENS administered using non-invasive techniques at intensities that produced perceptible TENS sensations during stimulation at either the site of pain or over nerve bundles proximal (or near) to the site of pain. We included TENS administered as a sole treatment or TENS in combination with other treatments, and TENS given as a single treatment or as a course of treatments. DATA COLLECTION AND ANALYSIS Two review authors independently determined study eligibility by assessing each record and reaching agreement by discussion. A third review author acted as arbiter. We did not anonymise the records of studies before assessment. Two review authors independently extracted data and assessed risk of bias of included studies before entering information into a 'Characteristics of included studies' table. Primary outcomes were participant-reported pain relief from baseline of 30% or greater or 50% or greater, and Patient Global Impression of Change (PGIC). We assessed the evidence using GRADE and added 'Summary of findings' tables. MAIN RESULTS We included eight studies (seven RCTs, one quasi-RCT, 315 adults (299 women), aged 18 to 75 years): six used a parallel-group design and two used a cross-over design. Sample sizes of intervention arms were five to 43 participants.Two studies, one of which was a cross-over design, compared TENS with placebo TENS (82 participants), one study compared TENS with no treatment (43 participants), and four studies compared TENS with other treatments (medication (two studies, 74 participants), electroacupuncture (one study, 44 participants), superficial warmth (one cross-over study, 32 participants), and hydrotherapy (one study, 10 participants)). Two studies compared TENS plus exercise with exercise alone (98 participants, 49 per treatment arm). None of the studies measured participant-reported pain relief of 50% or greater or PGIC. Overall, the studies were at unclear or high risk of bias, and in particular all were at high risk of bias for sample size.Only one study (14 participants) measured the primary outcome participant-reported pain relief of 30% or greater. Thirty percent achieved 30% or greater reduction in pain with TENS and exercise compared with 13% with exercise alone. One study found 10/28 participants reported pain relief of 25% or greater with TENS compared with 10/24 participants using superficial warmth (42 °C). We judged that statistical pooling was not possible because there were insufficient data and outcomes were not homogeneous.There were no data for the primary outcomes participant-reported pain relief from baseline of 50% or greater and PGIC.There was a paucity of data for secondary outcomes. One pilot cross-over study of 43 participants found that the mean (95% confidence intervals (CI)) decrease in pain intensity on movement (100-mm visual analogue scale (VAS)) during one 30-minute treatment was 11.1 mm (95% CI 5.9 to 16.3) for TENS and 2.3 mm (95% CI 2.4 to 7.7) for placebo TENS. There were no significant differences between TENS and placebo for pain at rest. One parallel group study of 39 participants found that mean ± standard deviation (SD) pain intensity (100-mm VAS) decreased from 85 ± 20 mm at baseline to 43 ± 20 mm after one week of dual-site TENS; decreased from 85 ± 10 mm at baseline to 60 ± 10 mm after single-site TENS; and decreased from 82 ± 20 mm at baseline to 80 ± 20 mm after one week of placebo TENS. The authors of seven studies concluded that TENS relieved pain but the findings of single small studies are unlikely to be correct.One study found clinically important improvements in Fibromyalgia Impact Questionnaire (FIQ) subscales for work performance, fatigue, stiffness, anxiety, and depression for TENS with exercise compared with exercise alone. One study found no additional improvements in FIQ scores when TENS was added to the first three weeks of a 12-week supervised exercise programme.No serious adverse events were reported in any of the studies although there were reports of TENS causing minor discomfort in a total of 3 participants.The quality of evidence was very low. We downgraded the GRADE rating mostly due to a lack of data; therefore, we have little confidence in the effect estimates where available. AUTHORS' CONCLUSIONS There was insufficient high-quality evidence to support or refute the use of TENS for fibromyalgia. We found a small number of inadequately powered studies with incomplete reporting of methodologies and treatment interventions.
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Affiliation(s)
- Mark I Johnson
- Leeds Beckett UniversityFaculty of Health and Social SciencesCity CampusCalverley StreetLeedsUKLS1 3HE
| | - Leica S Claydon
- Postgraduate Medical InstituteAnglia Ruskin UniversityBishops Hall LaneChelmsfordUKCM1 1SQ
| | - G Peter Herbison
- Dunedin School of Medicine, University of OtagoDepartment of Preventive & Social MedicinePO Box 913DunedinNew Zealand9054
| | - Gareth Jones
- Leeds Beckett UniversityFaculty of Health and Social SciencesCity CampusCalverley StreetLeedsUKLS1 3HE
| | - Carole A Paley
- Airedale NHS Foundation TrustResearch & Development DepartmentAiredale General HospitalSteetonKeighleyWest YorkshireUKBD20 6TD
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Abstract
Fibromyalgia appears to present in subgroups with regard to biological pain induction, with primarily inflammatory, neuropathic/neurodegenerative, sympathetic, oxidative, nitrosative, or muscular factors and/or central sensitization. Recent research has also discussed glial activation or interrupted dopaminergic neurotransmission, as well as increased skin mast cells and mitochondrial dysfunction. Therapy is difficult, and the treatment options used so far mostly just have the potential to address only one of these aspects. As ambroxol addresses all of them in a single substance and furthermore also reduces visceral hypersensitivity, in fibromyalgia existing as irritable bowel syndrome or chronic bladder pain, it should be systematically investigated for this purpose. Encouraged by first clinical observations of two working groups using topical or oral ambroxol for fibromyalgia treatments, the present paper outlines the scientific argument for this approach by looking at each of the aforementioned aspects of this complex disease and summarizes putative modes of action of ambroxol. Nevertheless, at this point the evidence basis for ambroxol is not strong enough for clinical recommendation.
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Affiliation(s)
- Kai-Uwe Kern
- Institute of Pain Medicine/Pain Practice, Wiesbaden, Germany
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31
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Derry S, Wiffen PJ, Moore RA, McNicol ED, Bell RF, Carr DB, McIntyre M, Wee B. Oral nonsteroidal anti-inflammatory drugs (NSAIDs) for cancer pain in adults. Cochrane Database Syst Rev 2017; 7:CD012638. [PMID: 28700091 PMCID: PMC6369931 DOI: 10.1002/14651858.cd012638.pub2] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
BACKGROUND Pain is a common symptom with cancer, and 30% to 50% of all people with cancer will experience moderate to severe pain that can have a major negative impact on their quality of life. Non-opioid drugs are commonly used to treat cancer pain, and are recommended for this purpose in the World Health Organization (WHO) cancer pain treatment ladder, either alone or in combination with opioids.A previous Cochrane review that examined the evidence for nonsteroidal anti-inflammatory drugs (NSAIDs) or paracetamol, alone or combined with opioids, for cancer pain was withdrawn in 2015 because it was out of date; the date of the last search was 2005. This review, and another on paracetamol, updates the evidence. OBJECTIVES To assess the efficacy of oral NSAIDs for cancer pain in adults, and the adverse events reported during their use in clinical trials. SEARCH METHODS We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from inception to April 2017, together with reference lists of retrieved papers and reviews, and two online study registries. SELECTION CRITERIA We included randomised, double-blind, single-blind, or open-label studies of five days' duration or longer, comparing any oral NSAID alone with placebo or another NSAID, or a combination of NSAID plus opioid with the same dose of the opioid alone, for cancer pain of any pain intensity. The minimum study size was 25 participants per treatment arm at the initial randomisation. DATA COLLECTION AND ANALYSIS Two review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality and potential bias. We did not carry out any pooled analyses. We assessed the quality of the evidence using GRADE and created a 'Summary of findings' table. MAIN RESULTS Eleven studies satisfied inclusion criteria, lasting one week or longer; 949 participants with mostly moderate or severe pain were randomised initially, but fewer completed treatment or had results of treatment. Eight studies were double-blind, two single-blind, and one open-label. None had a placebo only control; eight compared different NSAIDs, three an NSAID with opioid or opioid combination, and one both. None compared an NSAID plus opioid with the same dose of opioid alone. Most studies were at high risk of bias for blinding, incomplete outcome data, or small size; none was unequivocally at low risk of bias.It was not possible to compare NSAIDs as a group with another treatment, or one NSAID with another NSAID. Results for all NSAIDs are reported as a randomised cohort. We judged results for all outcomes as very low-quality evidence.None of the studies reported our primary outcomes of participants with pain reduction of at least 50%, and at least 30%, from baseline; participants with Patient Global Impression of Change (PGIC) of much improved or very much improved (or equivalent wording). With NSAID, initially moderate or severe pain was reduced to no worse than mild pain after one or two weeks in four studies (415 participants in total), with a range of estimates between 26% and 51% in individual studies.Adverse event and withdrawal reporting was inconsistent. Two serious adverse events were reported with NSAIDs, and 22 deaths, but these were not clearly related to any pain treatment. Common adverse events were thirst/dry mouth (15%), loss of appetite (14%), somnolence (11%), and dyspepsia (11%). Withdrawals were common, mostly because of lack of efficacy (24%) or adverse events (5%). AUTHORS' CONCLUSIONS There is no high-quality evidence to support or refute the use of NSAIDs alone or in combination with opioids for the three steps of the three-step WHO cancer pain ladder. There is very low-quality evidence that some people with moderate or severe cancer pain can obtain substantial levels of benefit within one or two weeks.
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Affiliation(s)
| | | | | | - Ewan D McNicol
- Tufts Medical CenterDepartment of Anesthesiology and Perioperative MedicineBostonMAUSA
| | - Rae Frances Bell
- Haukeland University HospitalRegional Centre of Excellence in Palliative CareBergenNorway
| | - Daniel B Carr
- Tufts University School of MedicinePain Research, Education and Policy (PREP) Program, Department of Public Health and Community MedicineBostonMassachusettsUSA
| | | | - Bee Wee
- Churchill HospitalNuffield Department of Medicine and Sir Michael Sobell HouseOld RoadHeadingtonOxfordUKOX3 7LJ
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Derry S, Wiffen PJ, Moore RA, McNicol ED, Bell RF, Carr DB, McIntyre M, Wee B. Oral nonsteroidal anti-inflammatory drugs (NSAIDs) for cancer pain in adults. THE COCHRANE DATABASE OF SYSTEMATIC REVIEWS 2017. [DOI: 10.1002/14651858.cd012638] [Citation(s) in RCA: 28] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/12/2022]
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Derry S, Wiffen PJ, Häuser W, Mücke M, Tölle TR, Bell RF, Moore RA. Oral nonsteroidal anti-inflammatory drugs for fibromyalgia in adults. Cochrane Database Syst Rev 2017; 3:CD012332. [PMID: 28349517 PMCID: PMC6464559 DOI: 10.1002/14651858.cd012332.pub2] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
BACKGROUND Oral nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used in the treatment of pain in fibromyalgia, despite being considered not to be effective. OBJECTIVES To assess the analgesic efficacy, tolerability (drop-out due to adverse events), and safety (serious adverse events) of oral nonsteroidal anti-inflammatory drugs for fibromyalgia in adults. SEARCH METHODS We searched CENTRAL, MEDLINE, and Embase for randomised controlled trials from inception to January 2017. We also searched the reference lists of retrieved studies and reviews, and online clinical trial registries. SELECTION CRITERIA We included randomised, double-blind trials of two weeks' duration or longer, comparing any oral NSAID with placebo or another active treatment for relief of pain in fibromyalgia, with subjective pain assessment by the participant. DATA COLLECTION AND ANALYSIS Two review authors independently extracted data and assessed trial quality and potential bias. Primary outcomes were participants with substantial pain relief (at least 50% pain relief over baseline or very much improved on Patient Global Impression of Change scale (PGIC)) or moderate pain relief (at least 30% pain relief over baseline or much or very much improved on PGIC), serious adverse events, and withdrawals due to adverse events; secondary outcomes were adverse events, withdrawals due to lack of efficacy, and outcomes relating to sleep, fatigue, and quality of life. Where pooled analysis was possible, we used dichotomous data to calculate risk difference (RD) and number needed to treat for an additional beneficial outcome (NNT), using standard methods. We assessed the quality of the evidence using GRADE and created a 'Summary of findings' table. MAIN RESULTS Our searches identified six randomised, double-blind studies involving 292 participants in suitably characterised fibromyalgia. The mean age of participants was between 39 and 50 years, and 89% to 100% were women. The initial pain intensity was around 7/10 on a 0 to 10 pain scale, indicating severe pain. NSAIDs tested were etoricoxib 90 mg daily, ibuprofen 2400 mg daily, naproxen 1000 mg daily, and tenoxicam 20 mg daily; 146 participants received NSAID and 146 placebo. The duration of treatment in the double-blind phase varied between three and eight weeks.Not all studies reported all the outcomes of interest. Analyses consistently showed no significant difference between NSAID and placebo: substantial benefit (at least 50% pain intensity reduction) (risk difference (RD) -0.07 (95% confidence interval (CI) -0.18 to 0.04) 2 studies, 146 participants; moderate benefit (at least 30% pain intensity reduction) (RD -0.04 (95% CI -0.16 to 0.08) 3 studies, 192 participants; withdrawals due to adverse events (RD 0.04 (95% CI -0.02 to 0.09) 4 studies, 230 participants; participants experiencing any adverse event (RD 0.08 (95% CI -0.03 to 0.19) 4 studies, 230 participants; all-cause withdrawals (RD 0.03 (95% CI -0.07 to 0.14) 3 studies, 192 participants. There were no serious adverse events or deaths. Although most studies had some measures of health-related quality of life, fibromyalgia impact, or other outcomes, none reported the outcomes beyond saying that there was no or little difference between the treatment groups.We downgraded evidence on all outcomes to very low quality, meaning that this research does not provide a reliable indication of the likely effect. The likelihood that the effect could be substantially different is very high. This is based on the small numbers of studies, participants, and events, as well as other deficiencies of reporting study quality allowing possible risks of bias. AUTHORS' CONCLUSIONS There is only a modest amount of very low-quality evidence about the use of NSAIDs in fibromyalgia, and that comes from small, largely inadequate studies with potential risk of bias. That bias would normally be to increase the apparent benefits of NSAIDs, but no such benefits were seen. Consequently, NSAIDs cannot be regarded as useful for treating fibromyalgia.
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Affiliation(s)
| | | | - Winfried Häuser
- Technische Universität MünchenDepartment of Psychosomatic Medicine and PsychotherapyLangerstr. 3MünchenGermanyD‐81675
| | - Martin Mücke
- University Hospital of BonnDepartment of Palliative MedicineSigmund‐Freud‐Str. 25BonnGermany53127
| | - Thomas Rudolf Tölle
- Technische Universität MünchenDepartment of Neurology, Klinikum Rechts der IsarMöhlstrasse 28MunichGermany81675
| | - Rae Frances Bell
- Haukeland University HospitalRegional Centre of Excellence in Palliative CareBergenNorway
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Lawson K. Emerging pharmacological strategies for the treatment of fibromyalgia. World J Pharmacol 2017; 6:1-10. [DOI: 10.5497/wjp.v6.i1.1] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/29/2016] [Revised: 01/06/2017] [Accepted: 02/13/2017] [Indexed: 02/06/2023] Open
Abstract
Fibromyalgia (FM) has been described as a chronic clinical condition related to multisensory hypersensitivity presenting with a complex of symptoms dominated by chronic widespread pain associated with the existence of a range of co-morbidities, such as fatigue, sleep disturbance, cognitive impairment, anxiety and depression. Current treatments include drugs that target serotonin and noradrenaline levels within the central nervous system, e.g., tricyclic antidepressants, serotonin noradrenaline reuptake inhibitors, and voltage-gated calcium channel subunit ligands, e.g., gabapentin and pregabalin. Investigation of a range of novel targets, such as melatoninergic, cannabinoid, dopamine, NMDA, angiotensin, orexin and opioid receptors, and ion channels, in addition revisiting bioamine modulation and subunits has provided efficacy outcomes that improve the health status of patients with FM. Nevertheless, modest and limited efficacy is often observed reflecting the heterogeneity of FM with existence of subpopulations of patients, the contribution of peripheral and central components to the pathophysiology, and the extensive range of accompanying co-morbidities. The complexity and multidimensional nature of FM is emphasized by the diversity of pharmacological targets gaining interest. Clues to underlying mechanisms which offer themselves as novel and potential targets for new medications are being provided by advances in the understanding of the pathophysiology of FM.
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Efficacy, acceptability and safety of guided imagery/hypnosis in fibromyalgia - A systematic review and meta-analysis of randomized controlled trials. Eur J Pain 2016; 21:217-227. [DOI: 10.1002/ejp.933] [Citation(s) in RCA: 62] [Impact Index Per Article: 6.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/19/2016] [Indexed: 12/23/2022]
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Lauche R, Spitzer J, Schwahn B, Ostermann T, Bernardy K, Cramer H, Dobos G, Langhorst J. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial. Sci Rep 2016; 6:37316. [PMID: 27853272 PMCID: PMC5112514 DOI: 10.1038/srep37316] [Citation(s) in RCA: 40] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/10/2016] [Accepted: 10/19/2016] [Indexed: 01/27/2023] Open
Abstract
This study aimed to test the efficacy of cupping therapy to improve symptoms and quality of life in patients diagnosed with the fibromyalgia syndrome. Participants were randomly assigned to cupping therapy, sham or usual care. Cupping was administered five times at twice weekly intervals on the upper and lower back. The primary outcome measure was pain intensity at day 18. Secondary outcomes included functional disability, quality of life, fatigue and sleep quality as well as pressure pain sensitivity, satisfaction and safety at day 18 and 6 months. Altogether 141 patients were included in this study (139 females, 55.8 ± 9.1 years). After 18 days patients reported significant less pain after cupping compared to usual care (difference −12.4; 95% CI: −18.9; −5.9, p < 0.001) but not compared to sham (difference −3.0; 95% CI: −9.9, 3.9, p = 0.396). Further effects were found for quality of life compared to usual care. Patients were mildly satisfied with cupping and sham cupping; and only minor side effects were observed. Despite cupping therapy being more effective than usual care to improve pain intensity and quality of life, effects of cupping therapy were small and comparable to those of a sham treatment, and as such cupping cannot be recommended for fibromyalgia at the current time.
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Affiliation(s)
- Romy Lauche
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany.,Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), University of Technology Sydney, Sydney, Australia
| | - Julia Spitzer
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
| | - Barbara Schwahn
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
| | - Thomas Ostermann
- Institute of Integrative Medicine, Department of Health, University of Witten/Herdecke, Herdecke, Germany
| | - Kathrin Bernardy
- Department of Anesthesiology, Berufsgenossenschaftliche Universitätsklinik Bergmannsheil, Bochum, Germany
| | - Holger Cramer
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany.,Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), University of Technology Sydney, Sydney, Australia
| | - Gustav Dobos
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
| | - Jost Langhorst
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
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Abstract
INTRODUCTION Fibromyalgia (FM) is a common, complex chronic widespread pain condition is characterized by fatigue, sleep disturbance and cognitive dysfunction. Treatment of FM is difficult, requiring both pharmacological and non-pharmacological approaches, with an empiric approach to drug therapy focused toward individual symptoms, particularly pain. The effectiveness of current medications is limited with many patients discontinuing use. AREAS COVERED A systemic database search has identified 26 molecular entities as potential emerging drug therapies. Advances in the understanding of the pathophysiology of FM provides clues to targets for new medications. Investigation of bioamine modulation and α2δ ligands and novel targets such as dopamine receptors, NMDA receptors, cannabinoid receptors, melatonin receptors and potassium channels has identified potential drug therapies. EXPERT OPINION Modest improvement of health status in patients with FM has been observed with drugs targeting a diverse range of molecular mechanisms. No single drug, however, offered substantial efficacy against all the symptoms characteristic of FM. Identification of new and improved therapies for FM needs to address the heterogeneity of the condition, which suggests existence of patient subgroups, the relationship of central and peripheral aspects of the pathophysiology and a requirement of combination therapy with drugs targeting multiple molecular mechanisms.
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Affiliation(s)
- Kim Lawson
- a Department of Biosciences and Chemistry, Biomolecular Sciences Research Centre, Faculty of Health and Wellbeing , Sheffield Hallam University , Sheffield , UK
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Abstract
BACKGROUND This review replaces part of an earlier review that evaluated oxycodone for both neuropathic pain and fibromyalgia, which has now been split into separate reviews for the two conditions. This review will consider pain in fibromyalgia only.Opioid drugs are commonly used to treat fibromyalgia, but they may not be beneficial for people with this condition. Most reviews have examined all opioids together. This review sought evidence specifically for oxycodone, at any dose, and by any route of administration. OBJECTIVES To assess the analgesic efficacy and adverse events of oxycodone for treating pain in fibromyalgia in adults. SEARCH METHODS We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE for randomised controlled trials from inception to 25 July 2016. We also searched the reference lists of retrieved studies and reviews, and searched online clinical trial registries. SELECTION CRITERIA We planned to include randomised, double-blind trials of eight weeks' duration or longer, comparing oxycodone (alone or in fixed-dose combination with naloxone) with placebo or another active treatment. We did not include observational studies. DATA COLLECTION AND ANALYSIS The plan was for two independent review authors to extract data and assess trial quality and potential bias. Where pooled analysis was possible, we planned to use dichotomous data to calculate risk ratio and numbers needed to treat for one additional event, using standard methods. MAIN RESULTS No study satisfied the inclusion criteria. Effects of interventions were not assessed as there were no included studies. We have only very low quality evidence and are very uncertain about estimates of benefit and harm. AUTHORS' CONCLUSIONS There is no randomised trial evidence to support or refute the suggestion that oxycodone, alone or in combination with naloxone, reduces pain in fibromyalgia.
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Affiliation(s)
- Helen Gaskell
- University of OxfordPain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics)OxfordOxfordshireUK
| | - R Andrew Moore
- University of OxfordPain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics)OxfordOxfordshireUK
| | - Sheena Derry
- University of OxfordPain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics)OxfordOxfordshireUK
| | - Cathy Stannard
- Frenchay HospitalPain Clinic, Macmillan CentreBristolUKBS16 1LE
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Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum 2016; 46:319-329. [PMID: 27916278 DOI: 10.1016/j.semarthrit.2016.08.012] [Citation(s) in RCA: 1147] [Impact Index Per Article: 127.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/22/2016] [Revised: 08/11/2016] [Accepted: 08/18/2016] [Indexed: 12/11/2022]
Abstract
OBJECTIVES The provisional criteria of the American College of Rheumatology (ACR) 2010 and the 2011 self-report modification for survey and clinical research are widely used for fibromyalgia diagnosis. To determine the validity, usefulness, potential problems, and modifications required for the criteria, we assessed multiple research reports published in 2010-2016 in order to provide a 2016 update to the criteria. METHODS We reviewed 14 validation studies that compared 2010/2011 criteria with ACR 1990 classification and clinical criteria, as well as epidemiology, clinical, and databank studies that addressed important criteria-level variables. Based on definitional differences between 1990 and 2010/2011 criteria, we interpreted 85% sensitivity and 90% specificity as excellent agreement. RESULTS Against 1990 and clinical criteria, the median sensitivity and specificity of the 2010/2011 criteria were 86% and 90%, respectively. The 2010/2011 criteria led to misclassification when applied to regional pain syndromes, but when a modified widespread pain criterion (the "generalized pain criterion") was added misclassification was eliminated. Based on the above data and clinic usage data, we developed a (2016) revision to the 2010/2011 fibromyalgia criteria. Fibromyalgia may now be diagnosed in adults when all of the following criteria are met: CONCLUSIONS: The fibromyalgia criteria have good sensitivity and specificity. This revision combines physician and questionnaire criteria, minimizes misclassification of regional pain disorders, and eliminates the previously confusing recommendation regarding diagnostic exclusions. The physician-based criteria are valid for individual patient diagnosis. The self-report version of the criteria is not valid for clinical diagnosis in individual patients but is valid for research studies. These changes allow the criteria to function as diagnostic criteria, while still being useful for classification.
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Affiliation(s)
- Frederick Wolfe
- National Data Bank for Rheumatic Diseases, 1035 N Emporia, Ste 288, Wichita, KS 67214; University of Kansas School of Medicine, Wichita, KS.
| | - Daniel J Clauw
- Chronic Pain and Fatigue Research Center, University of Michigan Medical School, Ann Arbor, MI
| | - Mary-Ann Fitzcharles
- Division of Rheumatology, McGill University Health Center, Montreal, Quebec, Canada
| | - Don L Goldenberg
- Oregon Health Science University, Portland, OR; Tufts University School of Medicine, Boston, MA
| | - Winfried Häuser
- Department Internal Medicine 1, Saarbrücken, Germany; Department Psychosomatic Medicine and Psychotherapy, Technische Universität München, München, Germany
| | | | - Philip J Mease
- Swedish Medical Center, Seattle, WA; University of Washington, Seattle, WA
| | - Anthony S Russell
- Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
| | | | - Brian Walitt
- National Institute of Nursing Research, National Institutes of Health, Bethesda, MD
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Goldenberg DL, Clauw DJ, Palmer RE, Clair AG. Opioid Use in Fibromyalgia: A Cautionary Tale. Mayo Clin Proc 2016; 91:640-8. [PMID: 26975749 DOI: 10.1016/j.mayocp.2016.02.002] [Citation(s) in RCA: 69] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/18/2015] [Revised: 01/27/2016] [Accepted: 02/02/2016] [Indexed: 01/10/2023]
Abstract
Multiple pharmacotherapies are available for the treatment of fibromyalgia (FM), including opioid analgesics. We postulate that the mechanism of action of traditional opioids predicts their lack of efficacy in FM. Literature searches of the MEDLINE and Cochrane Library databases were conducted using the search term opioid AND fibromyalgia to identify relevant articles, with no date limitations set. Citation lists in returned articles and personal archives of references were also examined for additional relevant items, and articles were selected based on the expert opinions of the authors. We found no evidence from clinical trials that opioids are effective for the treatment of FM. Observational studies have found that patients with FM receiving opioids have poorer outcomes than patients receiving nonopioids, and FM guidelines recommend against the use of opioid analgesics. Despite this, and despite the availability of alternative Food and Drug Administration-approved pharmacotherapies and the efficacy of nonpharmacologic therapies, opioids are commonly used in the treatment of FM. Factors associated with opioid use include female sex; geographic variation; psychological factors; a history of opioid use, misuse, or abuse; and patient or physician preference. The long-term use of opioid analgesics is of particular concern in the United States given the ongoing public health emergency relating to excess prescription opioid consumption. The continued use of opioids to treat FM despite a proven lack of efficacy, lack of support from treatment guidelines, and the availability of approved pharmacotherapy options provides a cautionary tale for their use in other chronic pain conditions.
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Affiliation(s)
- Don L Goldenberg
- Department of Medicine, Tufts University School of Medicine, Boston, MA.
| | - Daniel J Clauw
- Department of Anesthesiology, University of Michigan, Ann Arbor
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Fischer-White TG, Anderson JG, Taylor AG. An Integrated Methodology to Assess Compliance with Delphi Survey Key Components of Yoga Interventions for Musculoskeletal Conditions as Applied in a Systematic Review of Fibromyalgia Studies. Explore (NY) 2016; 12:100-12. [DOI: 10.1016/j.explore.2015.12.003] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/03/2015] [Indexed: 10/22/2022]
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Quintans-Júnior LJ, Araújo AA, Brito RG, Santos PL, Quintans JS, Menezes PP, Serafini MR, Silva GF, Carvalho FM, Brogden NK, Sluka KA. β-caryophyllene, a dietary cannabinoid, complexed with β-cyclodextrin produced anti-hyperalgesic effect involving the inhibition of Fos expression in superficial dorsal horn. Life Sci 2016; 149:34-41. [DOI: 10.1016/j.lfs.2016.02.049] [Citation(s) in RCA: 43] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2015] [Revised: 02/11/2016] [Accepted: 02/11/2016] [Indexed: 12/23/2022]
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Abstract
Fibromyalgia is a common illness characterized by chronic widespread pain, sleep problems (including unrefreshing sleep), physical exhaustion and cognitive difficulties. The definition, pathogenesis and treatment are controversial, and some even contest the existence of this disorder. In 1990, the American College of Rheumatology (ACR) defined classification criteria that required multiple tender points (areas of tenderness occurring in muscles and muscle-tendon junctions) and chronic widespread pain. In 2010, the ACR preliminary diagnostic criteria excluded tender points, allowed less extensive pain and placed reliance on patient-reported somatic symptoms and cognitive difficulties. Fibromyalgia occurs in all populations worldwide, and symptom prevalence ranges between 2% and 4% in the general population. The prevalence of people who are actually diagnosed with fibromyalgia ('administrative prevalence') is much lower. A model of fibromyalgia pathogenesis has been suggested in which biological and psychosocial variables interact to influence the predisposition, triggering and aggravation of a chronic disease, but the details are unclear. Diagnosis requires the history of a typical cluster of symptoms and the exclusion of a somatic disease that sufficiently explains the symptoms by medical examination. Current evidence-based guidelines emphasize the value of multimodal treatments, which encompass both non-pharmacological and selected pharmacological treatments tailored to individual symptoms, including pain, fatigue, sleep problems and mood problems. For an illustrated summary of this Primer, visit: http://go.nature.com/LIBdDX.
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Affiliation(s)
- Winfried Häuser
- Department of Internal Medicine 1, Klinikum Saarbrücken, Winterberg 1, D-66119 Saarbrücken, Germany.,Department Psychosomatic Medicine and Psychotherapy, Technische Universität München, Ismaninger Street 22, 81675 München, Germany
| | - Jacob Ablin
- Institute of Rheumatology, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | | | - Geoffrey Littlejohn
- Departments of Rheumatology and Medicine, Monash Health and Monash University, Clayton, Australia
| | - Juan V Luciano
- Teaching, Research and Innovation Unit, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Barcelona, Spain
| | - Chie Usui
- Department of Psychiatry, Juntendo University School of Medicine, Tokyo, Japan
| | - Brian Walitt
- National Center for Complementary and Integrative Health, and National Institute of Nursing Research, National Institutes of Health, Bethesda, Maryland, USA
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Effectiveness of different styles of massage therapy in fibromyalgia: A systematic review and meta-analysis. ACTA ACUST UNITED AC 2015; 20:257-64. [DOI: 10.1016/j.math.2014.09.003] [Citation(s) in RCA: 60] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/28/2014] [Revised: 09/21/2014] [Accepted: 09/29/2014] [Indexed: 11/23/2022]
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Kim SC, Landon JE, Lee YC. Patterns of health care utilization related to initiation of amitriptyline, duloxetine, gabapentin, or pregabalin in fibromyalgia. Arthritis Res Ther 2015; 17:18. [PMID: 25627453 PMCID: PMC4343277 DOI: 10.1186/s13075-015-0530-8] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2014] [Accepted: 01/19/2015] [Indexed: 11/21/2022] Open
Abstract
Introduction Several pharmacologic treatments are available for fibromyalgia, but little is known about the comparative effectiveness of these treatments on health care utilization. Methods Using US commercial insurance claims data (covering 2007 to 2009), we conducted a cohort study to examine the comparative effectiveness of amitriptyline, duloxetine, gabapentin, and pregabalin on health care utilization in patients with fibromyalgia. We measured patients’ medication adherence using the proportion of days covered (PDC) and estimated multivariable rate ratios (RRs) for outpatient visits, prescriptions, hospitalization, and emergency department (ED) visits in propensity score (PS)–matched cohorts. Results Cohorts of 8,269 amitriptyline, 9,941 duloxetine, and 18,613 gabapentin initiators were compared with their PS-matched pregabalin initiators. During the baseline 180-day period, patients had, on average, seven to nine physician visits, including six to eight specialist visits, and received eight prescription drugs. The mean PDC up to 180 days varied from 38.6% to 67.7%. The number of outpatient visits, prescriptions, and hospitalizations decreased slightly after initiating one of the study drugs, but the number of ED visits increased after treatment initiation. Compared to pregabalin, duloxetine was associated with decreased outpatient visits (RR, 0.94; 95% confidence interval (CI), 0.88 to 1.00), prescriptions (RR, 0.94; 95% CI, 0.90 to 0.98), hospitalizations (RR, 0.75; 95% CI, 0.68 to 0.83), and ED visits (RR, 0.85; 95% CI, 0.79 to 0.91). Little difference in health care utilization rates was noted among amitriptyline and gabapentin initiators compared to those who were started on pregabalin. Conclusions Fibromyalgia patients had high health care utilization before and after initiation of amitriptyline, duloxetine, gabapentin, or pregabalin. Medication adherence was suboptimal. Overall, fibromyalgia treatment had little impact on reducing health care utilization, but duloxetine initiators had less health care utilization than those started on pregabalin. Electronic supplementary material The online version of this article (doi:10.1186/s13075-015-0530-8) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Seoyoung C Kim
- Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St, Suite 3030, Boston, MA, 02120, USA.
| | - Joan E Landon
- Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St, Suite 3030, Boston, MA, 02120, USA.
| | - Yvonne C Lee
- Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St, Suite 3030, Boston, MA, 02120, USA.
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46
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Abstract
BACKGROUND This review is one of a series on drugs used to treat neuropathic pain and fibromyalgia. These conditions are estimated to affect 3 to 10% of adults, and are difficult to treat. Although they probably have different aetiologies, neuropathic pain and fibromyalgia can respond to the same therapies. There have been substantial changes in the standards of evidence considered necessary for assessment of interventions to treat chronic pain, to provide data that are more robust and clinically relevant. Oxycodone is a strong opioid agonist widely used to manage severe pain; this review assesses evidence for oxycodone using current standards of evidence designed to reduce bias. OBJECTIVES To assess the analgesic efficacy and adverse events of oxycodone for chronic neuropathic pain and fibromyalgia. SEARCH METHODS On 6 November 2013, we searched CENTRAL, MEDLINE and EMBASE databases. We reviewed the bibliographies of all included studies and of reviews, and also searched two clinical trial databases, ClinicalTrials.gov and the World Health Organisation (WHO) International Clinical Trials Registry Platform, to identify additional published or unpublished data. SELECTION CRITERIA We included randomised controlled trials (RCTs) with double-blind assessment of participant outcomes following two weeks of treatment or longer (although the emphasis of the review was on studies of eight weeks or longer) that used a placebo or active comparator. DATA COLLECTION AND ANALYSIS Two review authors independently extracted efficacy and adverse event data, examined issues of study quality, and assessed risk of bias. We performed analysis using three tiers of evidence. First tier evidence was derived from data meeting current best standards and subject to minimal risk of bias (outcome equivalent to substantial pain intensity reduction, intention-to-treat analysis without imputation for dropouts; at least 200 participants in the comparison, eight to 12 weeks duration, parallel design), second tier from data that failed to meet one or more of these criteria and were considered at some risk of bias but with adequate numbers in the comparison, and third tier from data involving small numbers of participants that was considered very likely to be biased or used outcomes of limited clinical utility, or both. MAIN RESULTS We included three studies with 254 participants; 204 had painful diabetic neuropathy and 50 postherpetic neuralgia. Study size ranged from 45 to 159 participants. Two studies used a cross-over design and one a parallel group design; study duration was four or six weeks. Controlled release oxycodone (oxycodone CR) was used in all three studies, with doses titrated up to a maximum of between 60 and 120 mg daily; mean doses achieved ranged between 37 and 45 mg daily. All studies used a placebo comparator, although in one study, an active placebo (benztropine) was used. All studies had one or more sources of potential major bias.No study reported the proportion of participants experiencing at least 50% pain relief or who were very much improved, while one reported the proportion with at least 30% pain relief, two reported at least moderate pain relief, and one reported the number of participants who considered treatment to be moderately effective. No study provided first or second tier evidence for an efficacy outcome. Third tier evidence indicated greater pain intensity reduction and better patient satisfaction with oxycodone than with placebo in all three studies, but such evidence was derived mainly from group mean data, with last observation carried forward (LOCF) imputation or completer analysis, in small studies lasting less than eight weeks (very low quality evidence).Adverse events were more common with oxycodone CR than with placebo. At least one adverse event was experienced by 86% of participants taking oxycodone CR and 63% taking placebo, and the number needed to treat for an additional harmful effect (NNH) was 4.3. The effect of oxycodone on serious adverse events reported was uncertain in comparison with placebo (oxycodone 3.4% versus placebo: 7.0%; RR 0.48 (95% confidence interval (CI) 0.18 to 1.23; very low quality evidence); one death was reported with oxycodone CR, but was not attributed to treatment. Adverse event withdrawals did not differ significantly between groups, occurring in 11% of participants with oxycodone CR and 6.4% with placebo (RR 1.69 (0.83 to 3.43); very low quality evidence). Withdrawals due to lack of efficacy were less frequent with oxycodone CR (1.1%) than placebo (11%), with an NNT to prevent one withdrawal of 10 (RR 0.12 (0.03 to 0.45); very low quality evidence).We found no relevant studies in chronic neuropathic pain conditions other than painful diabetic neuropathy or postherpetic neuralgia, or in fibromyalgia. AUTHORS' CONCLUSIONS No convincing, unbiased evidence suggests that oxycodone (as oxycodone CR) is of value in treating people with painful diabetic neuropathy or postherpetic neuralgia. There is no evidence at all for other neuropathic pain conditions, or for fibromyalgia. Adverse events typical of opioids appear to be common.
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Affiliation(s)
- Helen Gaskell
- Department of Clinical Geratology, Oxford University Hospitals NHS Trust, John Radcliffe Hospital, Headley Way, Oxford, Oxfordshire, UK, OX3 9DU
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Kim SC, Landon JE, Solomon DH. Clinical characteristics and medication uses among fibromyalgia patients newly prescribed amitriptyline, duloxetine, gabapentin, or pregabalin. Arthritis Care Res (Hoboken) 2014; 65:1813-9. [PMID: 23861291 DOI: 10.1002/acr.22071] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2013] [Revised: 05/20/2013] [Accepted: 06/21/2013] [Indexed: 11/10/2022]
Abstract
OBJECTIVE Fibromyalgia is a common chronic pain disorder with unclear etiology. No definitive treatment is available for fibromyalgia, and treatment with antidepressants or antiepileptics is often used for symptom management. METHODS Using US health care utilization data, a large population-based cohort study was conducted to describe clinical characteristics and medication use patterns in patients diagnosed with fibromyalgia who newly started amitriptyline, duloxetine, gabapentin, or pregabalin. RESULTS There were 13,404 amitriptyline starters, 18,420 duloxetine starters, 23,268 gabapentin starters, and 19,286 pregabalin starters. The mean age ranged from 48–51 years and 72–84% in each group were women. Back pain was the most frequent comorbidity in all 4 groups (range 48–64%) and hypertension, headache, depression, and sleep disorder were also common. The median daily dose at the start of followup was 25 mg for amitriptyline, 60 mg for duloxetine, 300 mg for gabapentin, and 75 mg for pregabalin, and >60% of patients remained on the same dose throughout the follow up period. Only one-fifth of patients continued the treatment started for ≥1 year. The mean number of different prescription drugs at baseline ranged from 8–10 across the groups. More than one-half of patients took opioids and one-third took benzodiazepines, sleep disorder drugs, and muscle relaxants. CONCLUSION Patients who started 1 of the 4 common drugs for fibromyalgia similarly had multiple comorbidities and other fibromyalgia-related medication use, but continued the treatment only for a short time. The dose of the 4 drugs was not increased in most patients during the followup period.
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48
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Häuser W, Walitt B, Fitzcharles MA, Sommer C. Review of pharmacological therapies in fibromyalgia syndrome. Arthritis Res Ther 2014; 16:201. [PMID: 24433463 PMCID: PMC3979124 DOI: 10.1186/ar4441] [Citation(s) in RCA: 103] [Impact Index Per Article: 9.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/11/2013] [Accepted: 01/09/2014] [Indexed: 12/16/2022] Open
Abstract
This review addresses the current status of drug therapy for the management of fibromyalgia syndrome (FMS) and is based on interdisciplinary FMS management guidelines, meta-analyses of drug trial data, and observational studies. In the absence of a single gold-standard medication, patients are treated with a variety of drugs from different categories, often with limited evidence. Drug therapy is not mandatory for the management of FMS. Pregabalin, duloxetine, milnacipran, and amitriptyline are the current first-line prescribed agents but have had a mostly modest effect. With only a minority of patients expected to experience substantial benefit, most will discontinue therapy because of either a lack of efficacy or tolerability problems. Many drug treatments have undergone limited study and have had negative results. It is unlikely that these failed pilot trials will undergo future study. However, medications, though imperfect, will continue to be a component of treatment strategy for these patients. Both the potential for medication therapy to relieve symptoms and the potential to cause harm should be carefully considered in their administration.
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Treatment of fibromyalgia syndrome: recommendations of recent evidence-based interdisciplinary guidelines with special emphasis on complementary and alternative therapies. EVIDENCE-BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE 2013; 2013:485272. [PMID: 24348701 PMCID: PMC3856149 DOI: 10.1155/2013/485272] [Citation(s) in RCA: 85] [Impact Index Per Article: 7.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 04/09/2013] [Accepted: 10/01/2013] [Indexed: 12/12/2022]
Abstract
Objective. Current evidence indicates that there is no single ideal treatment for fibromyalgia syndrome (FMS). First choice treatment options remain debatable, especially concerning the importance of complementary and alternative medicine (CAM) treatments. Methods. Three evidence-based interdisciplinary guidelines on FMS in Canada, Germany, and Israel were compared for their first choice and CAM-recommendations. Results. All three guidelines emphasized a patient-tailored approach according to the key symptoms. Aerobic exercise, cognitive behavioral therapy, and multicomponent therapy were first choice treatments. The guidelines differed in the grade of recommendation for drug treatment. Anticonvulsants (gabapentin, pregabalin) and serotonin noradrenaline reuptake inhibitors (duloxetine, milnacipran) were strongly recommended by the Canadian and the Israeli guidelines. These drugs received only a weak recommendation by the German guideline. In consideration of CAM-treatments, acupuncture, hypnosis/guided imagery, and Tai Chi were recommended by the German and Israeli guidelines. The Canadian guidelines did not recommend any CAM therapy. Discussion. Recent evidence-based interdisciplinary guidelines concur on the importance of treatment tailored to the individual patient and further emphasize the need of self-management strategies (exercise, and psychological techniques).
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Characteristics of patients with internal diseases who use relaxation techniques as a coping strategy. Complement Ther Med 2013; 21:481-6. [PMID: 24050583 DOI: 10.1016/j.ctim.2013.08.001] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/08/2013] [Revised: 07/29/2013] [Accepted: 08/06/2013] [Indexed: 11/21/2022] Open
Abstract
OBJECTIVES To assess sociodemographic, clinical, and psychological characteristics of patients with internal diseases who use relaxation techniques as a coping strategy. DESIGN Cross-sectional analysis among patients with internal diseases. SETTING Department of Internal and Integrative Medicine at an academic teaching hospital in Germany. MAIN OUTCOME MEASURES Prior use of relaxation techniques (e.g. meditation, autogenic training), perceived benefit, and perceived harm. Potential predictors of relaxation techniques use (sociodemographic characteristics, health behavior, internal medicine diagnosis, general health status, mental health, satisfaction, and health locus of control) were tested using multiple logistic regression analysis. RESULTS Of 2486 participants, 1075 (43.2%) reported to have used relaxation techniques, 648 (60.3%) reported benefits, and 11 (1.0%) reported harms. Use of relaxation techniques was independently associated with female gender (Odds ratio [OR]=1.43; 95% confidence interval [CI]=1.08-1.89), higher education (OR=1.32; 95%CI=1.03-1.71), fibromyalgia (OR=1.78; 95%CI=1.22-2.61), and internal health locus of control (OR=1.27; 95%CI=1.01-1.60). Use of relaxation techniques was negatively associated with age below 30 (OR=0.32; 95%CI=0.20-0.52) or above 64 (OR=0.65; 95%CI=0.49-0.88), full-time employment (OR=0.75; 95%CI=0.57-0.98), current smoking (OR=0.72; 95%CI=0.54-0.95), osteoarthritis (OR=0.51; 95%CI=0.34-0.77), rheumatic arthritis (OR=0.59; 95%CI=0.37-0.93), good to excellent health status (OR=0.70; 95%CI=0.52-0.96), and high life satisfaction (OR=0.78; 95%CI=0.62-0.98). CONCLUSION In a German sample of patients with internal diseases, relaxation techniques were used as a coping strategy by about 43%. Users were more likely to be middle-aged, female, well-educated, diagnosed with fibromyalgia, not smoking, not full-time employed, and not to have a good health status or high life satisfaction. A high internal health locus of control predicted relaxation techniques use. Considering health locus of control might improve adherence to relaxation techniques in internal medicine patients.
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