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Fang X, Wang X, Zheng W, Yin Y, Ge X. Effect of Acupuncture on Anxiety, Depression, and Quality of Life in Patients with Irritable Bowel Syndrome: A Meta-Analysis. Int J Behav Med 2025:10.1007/s12529-025-10348-z. [PMID: 39870963 DOI: 10.1007/s12529-025-10348-z] [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] [Accepted: 01/08/2025] [Indexed: 01/29/2025]
Abstract
BACKGROUND Irritable bowel syndrome (IBS) has been effectively treated with acupuncture, but the significance of quality of life, depression, and anxiety in the assessment of IBS patients has received little consideration. This study examined the impact of acupuncture on depression, anxiety, and quality of life in IBS patients. METHOD PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), EMBASE, China Science and Technology Journal Database (VIP), Chinese Biological Medical (CBM, SinoMed) Database, and the Wan Fang Database were among the electronic databases from which relevant randomized controlled trials (RCTs) were systematically retrieved between their inception and July 2023. The outcomes included adverse events, total response rate, anxiety, and symptoms of depression, as well as quality of life. In this study, the heterogeneity, publication bias, standardized mean difference (SMD), and risk ratios (RR) with 95% confidence intervals (CI) were estimated. RESULTS In this study, 29 RCTs including 3114 participants for analysis (treatment group, 1730; control group, 1384) were included. Compared to other therapies, acupuncture significantly improved the quality of life (SMD = 0.61, 95% CI = [0.26, 0.96], P < 0.001) and alleviated anxiety (SMD = - 0.72, 95% CI = [- 1.76, 0.32], P = 0.18) and depression (SMD = - 0.74, 95% CI = [- 1.18, - 0.3], P < 0.001) in IBS patients. A statistically significant improvement was recorded in their quality of life, and they also displayed fewer symptoms of depression. The total response rate (RR = 1.18, 95% CI = [1.12, 1.25], P < 0.001) indicated that acupuncture significantly affected IBS treatment in comparison to other methods. Subgroup analysis of primary outcome indicators revealed that acupuncture demonstrated better results regardless of the duration of intervention and was more effective than Western medicine or sham acupuncture. In addition to the total response rate (I2 = 0%), the other three outcome indicators showed significant heterogeneity (I2 > 50%). No publication bias was noted in RR (P < 0.05); however, a significant publication bias was observed in quality of life (P > 0.05). CONCLUSION Acupuncture can enhance the quality of life and relieve anxiety and depression in patients with IBS with apparent safety; however, a large number of high-quality RCTs are still needed.
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Affiliation(s)
- Xue Fang
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250011, Shandong Province, China
| | - XiaoYan Wang
- College of Acupuncture and Massage, Shandong University of Traditional Chinese Medicine, Jinan, 250355, Shandong Province, China
| | - WenJun Zheng
- Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan, 250117, Shandong Province, China
| | - Ying Yin
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250011, Shandong Province, China
| | - XiaoBin Ge
- Qilu Hospital of Shandong University, No. 107 Wen Hua Xi Road, Jinan, 250012, Shandong Province, China.
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Zhao J, Zheng H, Wang X, Wang X, Shi Y, Xie C, Tao Q, Li D, Sun J, Tian J, Gao J, Liu H, Shi S, Ni J, Xue R, Hu H, Chen M, Yu S, Li Z. Efficacy of acupuncture in refractory irritable bowel syndrome patients: a randomized controlled trial. Front Med 2024; 18:678-689. [PMID: 38958923 DOI: 10.1007/s11684-024-1073-7] [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: 10/09/2023] [Accepted: 02/08/2024] [Indexed: 07/04/2024]
Abstract
Previous studies have confirmed that acupuncture for irritable bowel syndrome (IBS) provided an additional benefit over usual care alone. Therefore, we performed a multicenter, randomized, sham-controlled trial to assess the efficacy and safety of acupuncture versus sham acupuncture for refractory IBS in patients in the context of conventional treatments. Patients in the acupuncture and sham acupuncture groups received real or sham acupuncture treatment in 3 sessions per week for a total of 12 sessions. The primary outcome was a change in the IBS-Symptom Severity Scale (IBS-SSS) score from baseline to week 4. A total of 521 participants were screened, and 170 patients (85 patients per group) were enrolled and included in the intention-to-treat analysis. Baseline characteristics were comparable across the two groups. From baseline to 4 weeks, the IBS-SSS total score decreased by 140.0 (95% CI: 126.0 to 153.9) in the acupuncture group and 64.4 (95% CI: 50.4 to 78.3) in the sham acupuncture group. The between-group difference was 75.6 (95% CI: 55.8 to 95.4). Acupuncture efficacy was maintained during the 4-week follow-up period. There were no serious adverse events. In conclusion, acupuncture provided benefits when combined with treatment as usual, providing more options for the treatment of refractory IBS.
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Affiliation(s)
- Jun Zhao
- School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China
- Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610044, China
| | - Hui Zheng
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, 610000, China
| | - Xin Wang
- Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China
| | - Xuefei Wang
- Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China
| | - Yunzhou Shi
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, 610000, China
| | - Chaorong Xie
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, 610000, China
| | - Qingfeng Tao
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, 610000, China
| | - Da Li
- Department of Acupuncture and Moxibustion, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China
| | - Jingwen Sun
- School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China
| | - Junjian Tian
- School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China
| | - Junxia Gao
- Department of Rehabilitation, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, 100029, China
| | - Huimin Liu
- Department of Rehabilitation, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, 100029, China
| | - Suhua Shi
- Department of Rehabilitation, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, 100029, China
| | - Jinxia Ni
- Department of Acupuncture and Moxibustion, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China
| | - Rongdan Xue
- Department of Acupuncture and Moxibustion, Dongfang Hospital Affiliated with Beijing University of Chinese Medicine, Beijing, 100078, China
| | - Hui Hu
- Department of Acupuncture and Moxibustion, Dongfang Hospital Affiliated with Beijing University of Chinese Medicine, Beijing, 100078, China
| | - Min Chen
- Anorectal Disease Department, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.
| | - Shuguang Yu
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, 610000, China.
| | - Zhigang Li
- School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.
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Kustra-Mulder A, Löwe B, Weigel A. Healthcare-related factors influencing symptom persistence, deterioration, or improvement in patients with persistent somatic symptoms: A scoping review of European studies. J Psychosom Res 2023; 174:111485. [PMID: 37716128 DOI: 10.1016/j.jpsychores.2023.111485] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/28/2023] [Revised: 08/30/2023] [Accepted: 09/04/2023] [Indexed: 09/18/2023]
Abstract
OBJECTIVE This scoping review explored healthcare-related factors associated with symptom persistence, deterioration, or improvement in patients with persistent somatic symptoms (PSS) across Europe. METHODS Articles were systematically searched in PubMed, Web of Science, Cochrane Library, and PsycINFO by combining terms of PSS and healthcare-related factors. Studies published in English, German, Polish, or Dutch between 2000 and 2022 were included. Healthcare-related factors associated with PSS symptom course were investigated, and study quality assessed (Center for Evidence-Based Medicine Checklist, Newcastle-Ottawa Scale). RESULTS Of 8386 identified studies, 56 were included in the analysis. A significant knowledge gap was evident, as most studies lacked comprehensive healthcare descriptions with particularly unclear definitions of "treatments as usual" in RCTs. The only extractable healthcare factor according to Andersen's Behavioral Model was the treatment setting. Rates of PSS improvement split by care-levels were 38% in primary, 44% in secondary, 25% in mixed, and 71% in specialized care. Persistence rates were 57%, 50%, 75%, and 29% respectively. Deterioration was observed in 5% of primary and 6% of secondary care studies. Studies were skewed toward the United Kingdom, Germany, and the Netherlands. CONCLUSIONS This scoping review shed light on the association between care levels and symptom outcomes in PSS patients. However, limited information in the current studies constrained our exploration of associations with other factors and symptom outcomes. Important aspects, like care availability, referral processes, and insurance coverage, are yet to be elucidated. Addressing these gaps is pivotal for developing targeted treatments across Europe, ultimately enhancing PSS patients' outcomes.
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Affiliation(s)
- Aleksandra Kustra-Mulder
- Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany.
| | - Bernd Löwe
- Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany
| | - Angelika Weigel
- Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany
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Gan Y, Huang SL, Luo MQ, Chen M, Zheng H. Acupuncture in addition to usual care for patients with irritable bowel syndrome: a component network meta-analysis. Acupunct Med 2022; 40:403-414. [PMID: 35437029 DOI: 10.1177/09645284221085280] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
OBJECTIVE The efficacy of acupuncture alone in the treatment of irritable bowel syndrome (IBS) is controversial, but the benefit of acupuncture added to usual care has rarely been studied. We aimed to examine the benefit of acupuncture added to usual care through network meta-analysis (NMA). METHODS PubMed, Embase, and the Cochrane Register of Controlled Trials (CENTRAL) were searched from their inception to 1 July 2021, without any language restriction. Randomized controlled trials (RCTs) testing the effect of acupuncture alone or acupuncture combined with usual care for IBS were included. The primary outcome was improvement of global IBS symptoms. Standard NMA was performed to compare differential combinations of acupuncture (including manual acupuncture (MA) and electroacupuncture (EA)), and component network meta-analysis (CNMA) was subsequently performed to determine whether acupuncture provided additional benefits to usual care. The effect size of an intervention was measured using relative ratio (RR). RESULTS We included 25 RCTs (n = 3041 participants) after screening 582 retrieved articles. Five RCTs were classified as low risk of bias. The results of standard NMA showed that MA combined with usual care ranked the most effective (sham acupuncture as common comparator; RR = 1.96 (95% confidence interval (CI) 1.23 to 3.12)). The results of CNMA showed that MA was the most effective component (RR = 1.38 (95% CI, 1.12 to 1.70)) when added to usual care. CONCLUSION Acupuncture provided additional benefits to usual care, and it might be considered as adjunctive therapy for patients who respond inadequately to usual care.
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Affiliation(s)
- Yu Gan
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Shi-Le Huang
- Department of Anorectal Diseases, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Meng-Qi Luo
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Min Chen
- Department of Anorectal Diseases, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Hui Zheng
- The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China
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Pei L, Geng H, Guo J, Yang G, Wang L, Shen R, Xia S, Ding M, Feng H, Lu J, Li J, Liu L, Shu Y, Fang X, Wu X, Wang X, Weng S, Ju L, Chen X, Shen H, Sun J. Effect of Acupuncture in Patients With Irritable Bowel Syndrome: A Randomized Controlled Trial. Mayo Clin Proc 2020; 95:1671-1683. [PMID: 32499125 DOI: 10.1016/j.mayocp.2020.01.042] [Citation(s) in RCA: 62] [Impact Index Per Article: 12.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/16/2019] [Revised: 01/27/2020] [Accepted: 01/31/2020] [Indexed: 12/19/2022]
Abstract
OBJECTIVE To evaluate the effect and safety of acupuncture for the treatment of irritable bowel syndrome (IBS) through comparisons with those of polyethylene glycol (PEG) 4000 and pinaverium bromide. PATIENTS AND METHODS This multicenter randomized controlled trial was conducted at 7 hospitals in China and enrolled participants who met the Rome III diagnostic criteria for IBS between May 3, 2015, and June 29, 2018. Participants were first stratified into constipation-predominant or diarrhea-predominant IBS group. Participants in each group were randomly assigned in a 2:1 ratio to receive acupuncture (18 sessions) or PEG 4000 (20 g/d, for IBS-C)/pinaverium bromide (150 mg/d, for IBS-D) over a 6-week period, followed by a 12-week follow-up. The primary outcome was change in total IBS-Symptom Severity Score from baseline to week 6. RESULTS Of 531 patients with IBS who were randomized, 519 (344 in the acupuncture group and 175 in the PEG 4000/ pinaverium bromide group) were included in the full analysis set. From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group. The between-group difference was 28.78 (95% CI, 16.84 to 40.72; P<.001). No participant experienced severe adverse effects. CONCLUSION Acupuncture may be more effective than PEG 4000 or pinaverium bromide for the treatment of IBS, with effects lasting up to 12 weeks. TRIAL REGISTRATION Chinese Clinical Trials Register, ChiCTR-IOR-15006259.
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Affiliation(s)
- Lixia Pei
- Jiangsu Province Hospital of Chinese Medicine, Nanjing, China
| | - Hao Geng
- Jiangsu Province Hospital of Chinese Medicine, Nanjing, China
| | - Jing Guo
- Nanjing University of Chinese Medicine, China
| | - Guohui Yang
- Shuyang Hospital of Traditional Chinese Medicine, China
| | - Lin Wang
- Shuyang Hospital of Traditional Chinese Medicine, China
| | - Rongrong Shen
- Nantong Hospital of Traditional Chinese Medicine, China
| | - Shuyu Xia
- Nantong Hospital of Traditional Chinese Medicine, China
| | - Min Ding
- Wuxi Hospital of Traditional Chinese Medicine, China
| | - Hua Feng
- Wuxi Hospital of Traditional Chinese Medicine, China
| | - Jin Lu
- Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine, China
| | - Jing Li
- Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine, China
| | - Lian Liu
- Affiliated Hospital of Jiangsu University, Zhenjiang, China
| | - Yanye Shu
- Affiliated Hospital of Jiangsu University, Zhenjiang, China
| | - Xiangdong Fang
- Affiliated Hospital of Jiangsu University, Zhenjiang, China; Kunshan Hospital of Traditional Chinese Medicine, China
| | - Xiaoliang Wu
- Jiangsu Province Hospital of Chinese Medicine, Nanjing, China
| | - Xiaoxiao Wang
- Jiangsu Province Hospital of Chinese Medicine, Nanjing, China
| | | | - Lu Ju
- Nanjing University of Chinese Medicine, China
| | - Xiao Chen
- Nanjing University of Chinese Medicine, China
| | - Hong Shen
- Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.
| | - Jianhua Sun
- Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.
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Shah MK, Ding Y, Wan J, Janyaro H, Tahir AH, Vodyanoy V, Ding MX. Electroacupuncture intervention of visceral hypersensitivity is involved in PAR-2-activation and CGRP-release in the spinal cord. Sci Rep 2020; 10:11188. [PMID: 32636402 PMCID: PMC7341736 DOI: 10.1038/s41598-020-67702-2] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2019] [Accepted: 05/16/2020] [Indexed: 01/02/2023] Open
Abstract
Electroacupuncture (EA) relieves visceral hypersensitivity (VH) with underlying inflammatory bowel diseases. However, the mechanism by which EA treats ileitis-induced VH is not clearly known. To assess the effects of EA on ileitis-induced VH and confirm whether EA attenuates VH through spinal PAR-2 activation and CGRP release, goats received an injection of 2,4,6-trinitro-benzenesulfonic-acid (TNBS) solution into the ileal wall. TNBS-injected goats were allocated into VH, Sham acupuncture (Sham-A) and EA groups, while goats treated with saline instead of TNBS solution were used as the control. Goats in EA group received EA at bilateral Hou-San-Li acupoints for 0.5 h at 7 days and thereafter repeated every 3 days for 6 times. Goats in the Sham-A group were inserted with needles for 0.5 h at the aforementioned acupoints without any hand manipulation and electric stimulation. Visceromotor responses to colorectal distension, an indicator of VH, were recorded by electromyography. The terminal ileum and thoracic spinal cord (T11) were sampled for evaluating ileitis at days 7 and 22, and distribution and expression-levels of PAR-2, CGRP and c-Fos on day 22. TNBS-treated-goats exhibited apparent transmural-ileitis on day 7, microscopically low-grade ileitis on day 22 and VH at days 7–22. Goats of Sham-A, VH or EA group showed higher (P < 0.01) VH at days 7–22 than the Control-goats. EA-treated goats exhibited lower (P < 0.01) VH as compared with Sham-A or VH group. Immunoreactive-cells and expression-levels of spinal PAR-2, CGRP and c-Fos in the EA group were greater (P < 0.01) than those in the Control group, but less (P < 0.01) than those in Sham-A and VH groups on day 22. Downregulation of spinal PAR-2 and CGRP levels by EA attenuates the ileitis and resultant VH.
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Affiliation(s)
- Manoj K Shah
- College of Veterinary Medicine, Huazhong Agricultural University, 1 Shizishan Street, Hongshan District, Wuhan, 430070, Hubei Province, People's Republic of China.,Department of Surgery and Pharmacology, Agriculture and Forestry University, Bharatpur, Nepal
| | - Yi Ding
- College of Veterinary Medicine, Huazhong Agricultural University, 1 Shizishan Street, Hongshan District, Wuhan, 430070, Hubei Province, People's Republic of China
| | - Juan Wan
- College of Veterinary Medicine, Huazhong Agricultural University, 1 Shizishan Street, Hongshan District, Wuhan, 430070, Hubei Province, People's Republic of China
| | - Habibullah Janyaro
- College of Veterinary Medicine, Huazhong Agricultural University, 1 Shizishan Street, Hongshan District, Wuhan, 430070, Hubei Province, People's Republic of China
| | - Adnan Hassan Tahir
- College of Veterinary Medicine, Huazhong Agricultural University, 1 Shizishan Street, Hongshan District, Wuhan, 430070, Hubei Province, People's Republic of China
| | - Vitaly Vodyanoy
- Department of Anatomy, Physiology and Pharmacology, Auburn University, Auburn, AL, USA
| | - Ming-Xing Ding
- College of Veterinary Medicine, Huazhong Agricultural University, 1 Shizishan Street, Hongshan District, Wuhan, 430070, Hubei Province, People's Republic of China.
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Abdelfatah MM, Beacham MC, Freedman M, Tillmann HL. Can Battlefield Acupuncture Improve Colonoscopy Experience? Med Acupunct 2018; 30:279-281. [PMID: 30377464 DOI: 10.1089/acu.2018.1289] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/22/2022] Open
Abstract
Background: Currently, patients undergoing colonoscopy receive sedation, but pain management with acupuncture could be a safer alternative. Cases: This article describes 3 cases for which Battlefield Acupuncture was applied during colonoscopy to avoid using opioids for sedation. One case was a patient with a life-threating morphine allergy, and 2 other cases avoided sedation completely. Results: Pain was reduced in all 3 cases to allow completion of colonoscopies without sedation. In Case 2, the patient also gained relief of preexisting mild joint pain. Conclusions: More data are needed, so potentially more patients can indeed avoid morphine/benzodiazepam-based sedation by use of acupuncture to make colonoscopies safer and more pleasant.
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Affiliation(s)
- Mohamed M Abdelfatah
- Greenville Veterans Administration Health Care Center, Greenville, NC.,Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, East Carolina University, Greenville, NC
| | | | - Michael Freedman
- Greenville Veterans Administration Health Care Center, Greenville, NC
| | - Hans L Tillmann
- Greenville Veterans Administration Health Care Center, Greenville, NC.,Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, East Carolina University, Greenville, NC
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Qin XR, Tan Y, Sun XN. Effect of retrograde colonic electrical stimulation on colonic transit and stress-induced visceral hypersensitivity in rats with irritable bowel syndrome. ASIAN PAC J TROP MED 2017; 10:827-832. [PMID: 28942833 DOI: 10.1016/j.apjtm.2017.07.017] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/06/2017] [Revised: 07/16/2017] [Accepted: 07/26/2017] [Indexed: 11/16/2022] Open
Abstract
OBJECTIVE To evaluate the effects of retrograde colonic electrical stimulation (RCES) with trains of short pulses and RCES with long pulses on colonic transit in irritable bowel syndrome (IBS) rats and to investigate whether stress-induced visceral hypersensitivity could be alleviated by RCES so as to find a valuable new approach for IBS treatment. METHODS A total of 48 male rats were randomly divided into model group and control group. Visceral hypersensitivity model was induced by a 6-day HIS protocol composed of two stressors, restraint stress for 40 min and forced swimming stress for 20 min. The extent of visceral hypersensitivity was quantified by electromyography and abdominal withdrawal reflex scores (AWRs) of colorectal distension (use a balloon) at different pressures. After the modeling, all rats were equipped with electrodes in descending colon for retrograde electrical stimulation and a PE tube for perfusing phenol red saline solution in the ileocecus. After recovering from surgery, RCES with long pulses, RCES with trains of short pulses, and sham RCES were performed in colonic serosa of rats for 40 min in six groups of 8 each, including three groups of visceral hypersensitivity rats and three groups of health rats. Colonic transit was assessed by calculating the output of phenol red from the anus every 10 min for 90 min. Finally, the extent of visceral hypersensitivity will be quantified again in model group. RESULTS After the 6-day HIS protocol, the HIS rats displayed an increased sensitivity to colorectal distention, compared to control group at different distention pressures (P < 0.01). CRES with trains of short pulses and long pulses significantly attenuated the hypersensitive responses to colorectal distention in the HIS rats compared with sham RCES group (P < 0.01). The effects of RCES on rats colon transmission: In the IBS rats, the colonic emptying were (77.4 ± 3.4)%, (74.8 ± 2.4)% and (64.2 ± 1.6)% in the sham RCES group, long pulses group and trains of short pulses group at 90 min; In healthy rats, The colonic emptying was (65.2 ± 3.5)%, (63.5 ± 4.0)% and (54.0 ± 2.5)% in the sham RCES group, long pulses group and trains of short pulses group at 90 min. CONCLUSION RCES with long pulses and RCES with trains of short pulses can significantly alleviate stress-induced visceral hypersensitivity. RCES with trains of short pulses has an inhibitory effect of colonic transit, both in visceral hypersensitivity rats and healthy rats.
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Affiliation(s)
- Xiao-Ri Qin
- Department of Gastroenterology, Hainan Provincial People's Hospital, Haikou 570311, China
| | - Yan Tan
- Department of Gastroenterology, The Affiliated Hospital of Hainan Medical College, Haikou 570102, China
| | - Xiao-Ning Sun
- Department of Gastroenterology, Hainan Provincial People's Hospital, Haikou 570311, China.
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9
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Evaluation of the Effectiveness of Acupuncture Therapy by Verbal Pain Scale in Patients with Abdominal Pain of Familial Mediterranean Fever. J Acupunct Meridian Stud 2016; 9:264-266. [PMID: 27776765 DOI: 10.1016/j.jams.2016.07.003] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/02/2016] [Revised: 07/07/2016] [Accepted: 07/18/2016] [Indexed: 12/14/2022] Open
Abstract
In this study, we evaluated the effectiveness of acupuncture therapy based on Verbal Pain Scale (VPS) scores in familial Mediterranean fever (FMF) patients admitted to the emergency department with attacks of abdominal pain. This observational study was conducted in Erzurum Regional Training and Research Hospital between August 2014 and December 2014. Twenty patients admitted to the emergency department with FMF attacks were included in the study. Acupuncture therapy was applied to three points including LI4 (Hegu), ST25 (Tianshu), and Ren12 (Zhongwan). The VPS test was applied to the patients before and after the treatment. Average VPS scores were found to be 8.45±0.75 before the treatment and 2.10±0.85 after the treatment. The difference of the VPS scores before and after treatment was statistically significant (p=0.001). To our knowledge, this is the first study evaluating the effectiveness of acupuncture therapy in the treatment of FMF attacks. Our results suggest that acupuncture therapy can be used as an effective treatment method in patients with FMF attacks.
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Hugh M, Altman DG, Hammerschlag R, Hammerschlag R, Li YP, Wu TX, White A, Moher D. [Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement (Chinese version)]. ACTA ACUST UNITED AC 2016; 8:804-18. [PMID: 20836969 DOI: 10.3736/jcim20100902] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Abstract
The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical", to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.
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Affiliation(s)
- Macpherson Hugh
- Department of Health Sciences, University of York, York, UK.
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11
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Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement. ACTA ACUST UNITED AC 2015. [DOI: 10.1016/j.arthe.2016.03.001] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022]
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Srinath A, Young E, Szigethy E. Pain management in patients with inflammatory bowel disease: translational approaches from bench to bedside. Inflamm Bowel Dis 2014; 20:2433-49. [PMID: 25208108 DOI: 10.1097/mib.0000000000000170] [Citation(s) in RCA: 65] [Impact Index Per Article: 5.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
Abdominal pain is a common symptom in patients with inflammatory bowel disease (IBD) that negatively affects quality of life and can lead to increased health-seeking behavior. Although abdominal pain has been traditionally attributed to inflammation, there is growing literature demonstrating the existence of functional abdominal pain in patients with IBD, of which there are a variety of potential causes. Thus, when approaching a patient with IBD who has abdominal pain, in addition to IBD-related complications (e.g., inflammation/stricture), it is important to screen for related contributors, including peripheral factors (visceral hypersensitivity, bacterial overgrowth, and bowel dysmotility) and centrally mediated neurobiological and psychosocial underpinnings. These central factors include psychological symptoms/diagnoses, sleep disturbance, and stress. Opioid-induced hyperalgesia (e.g., narcotic bowel syndrome) is also growing in recognition as a potential central source of abdominal pain. This review draws from clinical studies and animal models of colitis and abdominal pain to consider how knowledge of these potential etiologies can be used to individualize treatment of abdominal pain in patients with IBD, including consideration of potential novel treatment modalities for the future. Accurate assessment of the source(s) of pain in patients with IBD can help guide appropriate diagnostic workup and use of disease-modifying therapy.
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Affiliation(s)
- Arvind Srinath
- *Department of Pediatric Gastroenterology, Children's Hospital of UPMC, Pittsburgh, Pennsylvania; †Department of Anesthesiology, University of Pittsburgh, Pittsburgh, Pennsylvania; and ‡Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
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Sudhakaran P. Acupuncture for Irritable Bowel Syndrome. Med Acupunct 2013. [DOI: 10.1089/acu.2012.0931] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/27/2022] Open
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Zhou YY, Wanner NJ, Xiao Y, Shi XZ, Jiang XH, Gu JG, Xu GY. Electroacupuncture alleviates stress-induced visceral hypersensitivity through an opioid system in rats. World J Gastroenterol 2012; 18:7201-11. [PMID: 23326125 PMCID: PMC3544022 DOI: 10.3748/wjg.v18.i48.7201] [Citation(s) in RCA: 34] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/26/2012] [Revised: 09/10/2012] [Accepted: 10/16/2012] [Indexed: 02/06/2023] Open
Abstract
AIM: To investigate whether stress-induced visceral hypersensitivity could be alleviated by electroacupuncture (EA) and whether EA effect was mediated by endogenous opiates.
METHODS: Six to nine week-old male Sprague-Dawley rats were used in this study. Visceral hypersensitivity was induced by a 9-d heterotypic intermittent stress (HIS) protocol composed of 3 randomly stressors, which included cold restraint stress at 4 °C for 45 min, water avoidance stress for 60 min, and forced swimming stress for 20 min, in adult male rats. The extent of visceral hypersensitivity was quantified by electromyography or by abdominal withdrawal reflex (AWR) scores of colorectal distension at different distention pressures (20 mmHg, 40 mmHg, 60 mmHg and 80 mmHg). AWR scores either 0, 1, 2, 3 or 4 were obtained by a blinded observer. EA or sham EA was performed at classical acupoint ST-36 (Zu-San-Li) or BL-43 (Gao-Huang) in both hindlimbs of rats for 30 min. Naloxone (NLX) or NLX methiodide (m-NLX) was administered intraperitoneally to HIS rats in some experiments.
RESULTS: HIS rats displayed an increased sensitivity to colorectal distention, which started from 6 h (the first measurement), maintained for 24 h, and AWR scores returned to basal levels at 48 h and 7 d after HIS compared to pre-HIS baseline at different distention pressures. The AWR scores before HIS were 0.6 ± 0.2, 1.3 ± 0.2, 1.9 ± 0.2 and 2.3 ± 0.2 for 20 mmHg, 40 mmHg, 60 mmHg and 80 mmHg distention pressures, respectively. Six hours after termination of the last stressor, the AWR scores were 2.0 ± 0.1, 2.5 ± 0.1, 2.8 ± 0.2 and 3.5 ± 0.2 for 20 mmHg, 40 mmHg, 60 mmHg and 80 mmHg distention pressures, respectively. EA given at classical acupoint ST-36 in both hindlimbs for 30 min significantly attenuated the hypersensitive responses to colorectal distention in HIS rats compared with sham EA treatment [AWRs at 20 mmHg: 2.0 ± 0.2 vs 0.7 ± 0.1, P = 4.23 711 E-4; AWRs at 40 mmHg: 2.6 ± 0.2 vs 1.5 ± 0.2, P = 0.00 163; AWRs at 60 mmHg: 3.1 ± 0.2 vs 1.9 ± 0.1, P = 0.003; AWRs at 80 mmHg: 3.6 ± 0.1 vs 2.4 ± 0.2, P = 0.0023; electromyographic (EMG) at 20 mmHg: 24 ± 4.7 vs 13.8 ± 3.5; EMG at 40 mmHg: 60.2 ± 6.6 vs 30 ± 4.9, P = 0.00 523; EMG at 60 mmHg: 83 ± 10 vs 39.8 ± 5.9, P = 0.00 029; EMG at 80 mmHg: 94.3 ± 10.8 vs 49.6 ± 5.9, P = 0.00 021]. In addition, EA at the acupuncture point BL-43 with same parameters did not alleviate visceral hypersensitivity in HIS rats. EA in healthy rats also did not have any effect on AWR scores to colorectal distention at distention pressures of 20 and 40 mmHg. The EA-mediated analgesic effect was blocked by pretreatment with NLX in HIS rats [AWR scores pretreated with NLX vs normal saline (NS) were 2.0 vs 0.70 ± 0.20, 2.80 ± 0.12 vs 1.50 ± 0.27, 3 vs 2.00 ± 0.15 and 3.60 ± 0.18 vs 2.60 ± 0.18 for 20 mmHg, 40 mmHg, 60 mmHg and 80 mmHg; P = 0.0087, 0.0104, 0.0117 and 0.0188 for 20, 40, 60 and 80 mmHg, respectively]. Furthermore, EA-mediated analgesic effect was completely reversed by administration of m-NLX, a peripherally restricted opioid antagonist (EMG pretreated with m-NLX vs NS were 30.84 ± 4.39 vs 13.33 ± 3.88, 74.16 ± 9.04 vs 36.28 ± 8.01, 96.45 ± 11.80 vs 50.19 ± 8.28, and 111.59 ± 13.79 vs 56.42 ± 8.43 for 20 mmHg, 40 mmHg, 60 mmHg and 80 mmHg; P = 0.05 026, 0.00 034, 0.00 005, 0.000 007 for 20 mmHg, 40 mmHg, 60 mmHg and 80 mmHg, respectively).
CONCLUSION: EA given at classical acupoint ST-36 alleviates stress-induced visceral pain, which is most likely mediated by opioid pathways in the periphery.
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Peckham EJ, Relton C, Raw J, Walters C, Thomas K, Smith C. A protocol for a trial of homeopathic treatment for irritable bowel syndrome. Altern Ther Health Med 2012; 12:212. [PMID: 23131064 PMCID: PMC3517481 DOI: 10.1186/1472-6882-12-212] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2012] [Accepted: 10/25/2012] [Indexed: 02/08/2023]
Abstract
Background Irritable bowel syndrome is a chronic condition with no known cure. Many sufferers seek complementary and alternative medicine including homeopathic treatment. However there is much controversy as to the effectiveness of homeopathic treatment. This three-armed study seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with irritable bowel syndrome. Methods/design This is a three-armed pragmatic randomised controlled trial using the cohort multiple randomised trial methodology. Patients are recruited to an irritable bowel syndrome cohort from primary and secondary care using GP databases and consultants lists respectively. From this cohort patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. The primary clinical outcome is the Irritable Bowel Syndrome Symptom Severity at 26 weeks. From a power calculation, it is estimated that 33 people will be needed for the homeopathic treatment arm and 132 for the usual care arm, to detect a minimal clinical difference at 80 percent power and 5 percent significance allowing for loss to follow up. An unequal group size has been used for reasons of cost. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis. Discussion This trial has received NHS approval and results are expected in 2013. Trial registration Current Controlled Trials ISRCTN90651143
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Stuardi T, MacPherson H. Acupuncture for irritable bowel syndrome: diagnosis and treatment of patients in a pragmatic trial. J Altern Complement Med 2012; 18:1021-7. [PMID: 23102521 DOI: 10.1089/acm.2011.0670] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/14/2023] Open
Abstract
OBJECTIVE The aim of this study was to evaluate the treatments delivered during a pragmatic effectiveness study of acupuncture for irritable bowel syndrome (IBS) and to explore the roles of Traditional Chinese Medicine (TCM) diagnoses and preferences of the acupuncturists in treatment design. METHODS Patients allocated to an acupuncture arm of a study were offered up to ten sessions of acupuncture over 3 months. Acupuncturists followed a flexible treatment protocol that allowed for treatment individualization, use of additional therapies such as moxa, and provision of lifestyle advice. All treatments were recorded in logbooks and analyzed by content analysis. RESULTS Seven primary and eight secondary TCM patterns were identified among the 113 patients with IBS, and were combined in various ways to produce unique diagnoses for 84% patients. Liver Qi Stagnation and Damp Heat were the most commonly reported patterns. Of the 126 acupuncture points used, a distinct core and supporting group of points was associated with each primary pattern. Each practitioner also utilized a distinct core and supporting group of points that reflected his/her preferences. Use of additional therapies (e.g., moxa) and provision of lifestyle advice (e.g., diet) were generally consistent with a particular practitioner. CONCLUSIONS Data suggest that a patient's TCM diagnosis, the practitioner's preferences, and a patient's individual characteristics beyond his/her diagnosis influence treatment delivery. In particular, TCM diagnoses appear to influence the acupuncture (i.e., point selection) aspect of treatment more than the selection of additional therapies and lifestyle advice. From another perspective, the treatments incorporated pragmatic, individualized, and disease-specific approaches with combinations that produced both treatment commonalities and diversities.
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Affiliation(s)
- Tracy Stuardi
- Department of Health Sciences, University of York, York, United Kingdom.
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MacPherson H, Tilbrook H, Bland JM, Bloor K, Brabyn S, Cox H, Kang'ombe AR, Man MS, Stuardi T, Torgerson D, Watt I, Whorwell P. Acupuncture for irritable bowel syndrome: primary care based pragmatic randomised controlled trial. BMC Gastroenterol 2012; 12:150. [PMID: 23095376 PMCID: PMC3556159 DOI: 10.1186/1471-230x-12-150] [Citation(s) in RCA: 49] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/03/2012] [Accepted: 09/19/2012] [Indexed: 12/13/2022] Open
Abstract
Background Acupuncture is used by patients as a treatment for irritable bowel syndrome (IBS) but the evidence on effectiveness is limited. The purpose of the study was to evaluate the effectiveness of acupuncture for irritable bowel syndrome in primary care when provided as an adjunct to usual care. Methods Design: A two-arm pragmatic randomised controlled trial. Setting: Primary care in the United Kingdom. Patients: 233 patients had irritable bowel syndrome with average duration of 13 years and score of at least 100 on the IBS Symptom Severity Score (SSS). Interventions: 116 patients were offered 10 weekly individualised acupuncture sessions plus usual care, 117 patients continued with usual care alone. Measurements: Primary outcome was the IBS SSS at three months, with outcome data collected every three months to 12 months. Results There was a statistically significant difference between groups at three months favouring acupuncture with a reduction in IBS Symptom Severity Score of −27.43 (95% CI: –48.66 to −6.21, p = 0.012). The number needed to treat for successful treatment (≥50 point reduction in the IBS SSS) was six (95% CI: 3 to 17), based on 49% success in the acupuncture group vs. 31% in the control group, a difference between groups of 18% (95% CI: 6% to 31%). This benefit largely persisted at 6, 9 and 12 months. Conclusions Acupuncture for irritable bowel syndrome provided an additional benefit over usual care alone. The magnitude of the effect was sustained over the longer term. Acupuncture should be considered as a treatment option to be offered in primary care alongside other evidenced based treatments. Trial Registration Current Controlled Trials ISRCTN08827905
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Affiliation(s)
- Hugh MacPherson
- Department of Health Sciences, University of York, York, UK.
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Srinath AI, Walter C, Newara MC, Szigethy EM. Pain management in patients with inflammatory bowel disease: insights for the clinician. Therap Adv Gastroenterol 2012; 5:339-57. [PMID: 22973418 PMCID: PMC3437534 DOI: 10.1177/1756283x12446158] [Citation(s) in RCA: 83] [Impact Index Per Article: 6.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023] Open
Abstract
Abdominal pain is a common symptom in patients with inflammatory bowel disease (IBD) and has a profound negative impact on patients' lives. There are growing data suggesting that pain is variably related to the degree of active inflammation. Given the multifactorial etiologies underlying the pain, the treatment of abdominal pain in the IBD population is best accomplished by individualized plans. This review covers four clinically relevant categories of abdominal pain in patients with IBD, namely, inflammation, surgical complications, bacterial overgrowth, and neurobiological processes and how pain management can be addressed in each of these cases. The role of genetic factors, psychological factors, and psychosocial stress in pain perception and treatment will also be addressed. Lastly, psychosocial, pharmacological, and procedural pain management techniques will be discussed. An extensive review of the existing literature reveals a paucity of data regarding pain management specific to IBD. In addition, there is growing consensus suggesting a spectrum between IBD and irritable bowel syndrome (IBS) symptoms. Thus, this review for adult and pediatric clinicians also incorporates the literature for the treatment of functional abdominal pain and the clinical consensus from IBD and IBS experts on pharmacological, behavioral, and procedural methods to treat abdominal pain in this population.
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Affiliation(s)
- Arvind Iyengar Srinath
- Department of Pediatric Gastroenterology, Children's Hospital of Pittsburgh, Pittsburgh, PA, USA
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Manheimer E, Wieland LS, Cheng K, Li SM, Shen X, Berman BM, Lao L. Acupuncture for irritable bowel syndrome: systematic review and meta-analysis. Am J Gastroenterol 2012; 107:835-47; quiz 848. [PMID: 22488079 PMCID: PMC3671917 DOI: 10.1038/ajg.2012.66] [Citation(s) in RCA: 83] [Impact Index Per Article: 6.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
OBJECTIVES Evidence-based treatment guidelines have been unable to provide evidence-based guidance on the effects of acupuncture for irritable bowel syndrome (IBS) because the only previous systematic review included only small, heterogeneous, and methodologically unsound trials. We conducted a new systematic review and meta-analysis of randomized controlled trials (RCTs) to estimate the effects of acupuncture for treating IBS. METHODS MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, Cumulative Index to Nursing and Allied Health, and the Chinese databases Sino-Med, CNKI, and VIP were searched through November 2011. Eligible RCTs compared acupuncture with sham acupuncture, other active treatments, or no (specific) treatment, and evaluated acupuncture as an adjuvant to another treatment. Our outcomes were overall IBS symptom severity and health-related quality of life. Dichotomous data were pooled to provide a relative risk (RR) of substantial improvement after treatment, and continuous data were pooled to provide a standardized mean difference (SMD) in post-treatment scores between groups. RESULTS A total of 17 RCTs (N=1,806) were included. We found no evidence of an improvement with acupuncture relative to sham acupuncture on symptom severity (SMD=-0.11, 95% confidence interval (95% CI): -0.35 to 0.13; 4 RCTs) or quality of life (SMD=-0.03, 95% CI: -0.27 to 0.22; 3 RCTs). Because of the homogeneity of the results of the sham-controlled trials, results were unaffected by restriction to the four sham-controlled RCTs that used adequate randomization, blinding, and had few withdrawals/dropouts. Among RCTs that did not use a placebo control, acupuncture was more effective than pharmacological therapy (RR of symptom improvement=1.28, 95% CI: 1.12 to 1.45; 5 RCTs) and no (specific) treatment (RR = 2.11, 95% CI: 1.18 to 3.79; 2 RCTs). There was no difference between acupuncture and Bifidobacterium (RR=1.07, 95% CI: 0.90 to 1.27; 2 RCTs) or between acupuncture and psychotherapy (RR=1.05, 95% CI: 0.87 to 1.26; 1 RCT). Acupuncture as an adjuvant to another Chinese medicine treatment was statistically significantly better than the other treatment alone, in trials with a high risk of bias (RR=1.17, 95% CI: 1.02 to 1.33; 4 RCTs). CONCLUSIONS Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control on IBS symptom severity or IBS-related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from pharmacological therapies. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients' preferences for acupuncture or patients' greater expectations of improvement on acupuncture relative to drugs.
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Affiliation(s)
- Eric Manheimer
- Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, 21201, USA.
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Manheimer E, Cheng K, Wieland LS, Min LS, Shen X, Berman BM, Lao L. Acupuncture for treatment of irritable bowel syndrome. Cochrane Database Syst Rev 2012; 2012:CD005111. [PMID: 22592702 PMCID: PMC3718572 DOI: 10.1002/14651858.cd005111.pub3] [Citation(s) in RCA: 42] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND Irritable bowel syndrome (IBS) is a common, costly, and difficult to treat disorder that impairs health-related quality of life and work productivity. Evidence-based treatment guidelines have been unable to provide guidance on the effects of acupuncture for IBS because the only previous systematic review included only small, heterogeneous and methodologically unsound trials. OBJECTIVES The primary objectives were to assess the efficacy and safety of acupuncture for treating IBS. SEARCH METHODS MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the Cumulative Index to Nursing and Allied Health, and the Chinese databases Sino-Med, CNKI, and VIP were searched through November 2011. SELECTION CRITERIA Randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, other active treatments, or no (specific) treatment, and RCTs that evaluated acupuncture as an adjuvant to another treatment, in adults with IBS were included. DATA COLLECTION AND ANALYSIS Two authors independently assessed the risk of bias and extracted data. We extracted data for the outcomes overall IBS symptom severity and health-related quality of life. For dichotomous data (e.g. the IBS Adequate Relief Question), we calculated a pooled relative risk (RR) and 95% confidence interval (CI) for substantial improvement in symptom severity after treatment. For continuous data (e.g. the IBS Severity Scoring System), we calculated the standardized mean difference (SMD) and 95% CI in post-treatment scores between groups. MAIN RESULTS Seventeen RCTs (1806 participants) were included. Five RCTs compared acupuncture versus sham acupuncture. The risk of bias in these studies was low. We found no evidence of an improvement with acupuncture relative to sham (placebo) acupuncture for symptom severity (SMD -0.11, 95% CI -0.35 to 0.13; 4 RCTs; 281 patients) or quality of life (SMD = -0.03, 95% CI -0.27 to 0.22; 3 RCTs; 253 patients). Sensitivity analyses based on study quality did not change the results. A GRADE analysis indicated that the overall quality of the evidence for the primary outcomes in the sham controlled trials was moderate due to sparse data. The risk of bias in the four Chinese language comparative effectiveness trials that compared acupuncture with drug treatment was high due to lack of blinding. The risk of bias in the other studies that did not use a sham control was high due to lack of blinding or inadequate methods used for randomization and allocation concealment or both. Acupuncture was significantly more effective than pharmacological therapy and no specific treatment. Eighty-four per cent of patients in the acupuncture group had improvement in symptom severity compared to 63% of patients in the pharmacological treatment group (RR 1.28, 95% CI 1.12 to 1.45; 5 studies, 449 patients). A GRADE analysis indicated that the overall quality of the evidence for this outcome was low due to a high risk of bias (no blinding) and sparse data. Sixty-three per cent of patients in the acupuncture group had improvement in symptom severity compared to 34% of patients in the no specific therapy group (RR 2.11, 95% CI 1.18 to 3.79; 2 studies, 181 patients). There was no statistically significant difference between acupuncture and Bifidobacterium (RR 1.07, 95% CI 0.90 to 1.27; 2 studies; 181 patients) or between acupuncture and psychotherapy (RR 1.05, 95% CI 0.87 to 1.26; 1 study; 100 patients). Acupuncture as an adjuvant to another Chinese medicine treatment was significantly better than the other treatment alone. Ninety-three per cent of patients in the adjuvant acupuncture group improved compared to 79% of patients who received Chinese medicine alone (RR 1.17, 95% CI 1.02 to 1.33; 4 studies; 466 patients). There was one adverse event (i.e. acupuncture syncope) associated with acupuncture in the 9 trials that reported this outcome, although relatively small sample sizes limit the usefulness of these safety data. AUTHORS' CONCLUSIONS Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from two antispasmodic drugs (pinaverium bromide and trimebutine maleate), both of which have been shown to provide a modest benefit for IBS. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients' preferences for acupuncture or greater expectations of improvement on acupuncture relative to drug therapy.
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Affiliation(s)
- Eric Manheimer
- Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
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Manheimer E, Cheng K, Wieland LS, Min LS, Shen X, Berman BM, Lao L. Acupuncture for treatment of irritable bowel syndrome. THE COCHRANE DATABASE OF SYSTEMATIC REVIEWS 2012. [PMID: 22592702 DOI: 10.1002/14651858.cd005111] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND Irritable bowel syndrome (IBS) is a common, costly, and difficult to treat disorder that impairs health-related quality of life and work productivity. Evidence-based treatment guidelines have been unable to provide guidance on the effects of acupuncture for IBS because the only previous systematic review included only small, heterogeneous and methodologically unsound trials. OBJECTIVES The primary objectives were to assess the efficacy and safety of acupuncture for treating IBS. SEARCH METHODS MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the Cumulative Index to Nursing and Allied Health, and the Chinese databases Sino-Med, CNKI, and VIP were searched through November 2011. SELECTION CRITERIA Randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, other active treatments, or no (specific) treatment, and RCTs that evaluated acupuncture as an adjuvant to another treatment, in adults with IBS were included. DATA COLLECTION AND ANALYSIS Two authors independently assessed the risk of bias and extracted data. We extracted data for the outcomes overall IBS symptom severity and health-related quality of life. For dichotomous data (e.g. the IBS Adequate Relief Question), we calculated a pooled relative risk (RR) and 95% confidence interval (CI) for substantial improvement in symptom severity after treatment. For continuous data (e.g. the IBS Severity Scoring System), we calculated the standardized mean difference (SMD) and 95% CI in post-treatment scores between groups. MAIN RESULTS Seventeen RCTs (1806 participants) were included. Five RCTs compared acupuncture versus sham acupuncture. The risk of bias in these studies was low. We found no evidence of an improvement with acupuncture relative to sham (placebo) acupuncture for symptom severity (SMD -0.11, 95% CI -0.35 to 0.13; 4 RCTs; 281 patients) or quality of life (SMD = -0.03, 95% CI -0.27 to 0.22; 3 RCTs; 253 patients). Sensitivity analyses based on study quality did not change the results. A GRADE analysis indicated that the overall quality of the evidence for the primary outcomes in the sham controlled trials was moderate due to sparse data. The risk of bias in the four Chinese language comparative effectiveness trials that compared acupuncture with drug treatment was high due to lack of blinding. The risk of bias in the other studies that did not use a sham control was high due to lack of blinding or inadequate methods used for randomization and allocation concealment or both. Acupuncture was significantly more effective than pharmacological therapy and no specific treatment. Eighty-four per cent of patients in the acupuncture group had improvement in symptom severity compared to 63% of patients in the pharmacological treatment group (RR 1.28, 95% CI 1.12 to 1.45; 5 studies, 449 patients). A GRADE analysis indicated that the overall quality of the evidence for this outcome was low due to a high risk of bias (no blinding) and sparse data. Sixty-three per cent of patients in the acupuncture group had improvement in symptom severity compared to 34% of patients in the no specific therapy group (RR 2.11, 95% CI 1.18 to 3.79; 2 studies, 181 patients). There was no statistically significant difference between acupuncture and Bifidobacterium (RR 1.07, 95% CI 0.90 to 1.27; 2 studies; 181 patients) or between acupuncture and psychotherapy (RR 1.05, 95% CI 0.87 to 1.26; 1 study; 100 patients). Acupuncture as an adjuvant to another Chinese medicine treatment was significantly better than the other treatment alone. Ninety-three per cent of patients in the adjuvant acupuncture group improved compared to 79% of patients who received Chinese medicine alone (RR 1.17, 95% CI 1.02 to 1.33; 4 studies; 466 patients). There was one adverse event (i.e. acupuncture syncope) associated with acupuncture in the 9 trials that reported this outcome, although relatively small sample sizes limit the usefulness of these safety data. AUTHORS' CONCLUSIONS Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from two antispasmodic drugs (pinaverium bromide and trimebutine maleate), both of which have been shown to provide a modest benefit for IBS. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients' preferences for acupuncture or greater expectations of improvement on acupuncture relative to drug therapy.
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Affiliation(s)
- Eric Manheimer
- Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
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Manheimer E, Cheng K, Wieland LS, Min LS, Shen X, Berman BM, Lao L. Acupuncture for treatment of irritable bowel syndrome. THE COCHRANE DATABASE OF SYSTEMATIC REVIEWS 2012. [PMID: 22592702 DOI: 10.10002/14651858.cd005111.pub3] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND Irritable bowel syndrome (IBS) is a common, costly, and difficult to treat disorder that impairs health-related quality of life and work productivity. Evidence-based treatment guidelines have been unable to provide guidance on the effects of acupuncture for IBS because the only previous systematic review included only small, heterogeneous and methodologically unsound trials. OBJECTIVES The primary objectives were to assess the efficacy and safety of acupuncture for treating IBS. SEARCH METHODS MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the Cumulative Index to Nursing and Allied Health, and the Chinese databases Sino-Med, CNKI, and VIP were searched through November 2011. SELECTION CRITERIA Randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, other active treatments, or no (specific) treatment, and RCTs that evaluated acupuncture as an adjuvant to another treatment, in adults with IBS were included. DATA COLLECTION AND ANALYSIS Two authors independently assessed the risk of bias and extracted data. We extracted data for the outcomes overall IBS symptom severity and health-related quality of life. For dichotomous data (e.g. the IBS Adequate Relief Question), we calculated a pooled relative risk (RR) and 95% confidence interval (CI) for substantial improvement in symptom severity after treatment. For continuous data (e.g. the IBS Severity Scoring System), we calculated the standardized mean difference (SMD) and 95% CI in post-treatment scores between groups. MAIN RESULTS Seventeen RCTs (1806 participants) were included. Five RCTs compared acupuncture versus sham acupuncture. The risk of bias in these studies was low. We found no evidence of an improvement with acupuncture relative to sham (placebo) acupuncture for symptom severity (SMD -0.11, 95% CI -0.35 to 0.13; 4 RCTs; 281 patients) or quality of life (SMD = -0.03, 95% CI -0.27 to 0.22; 3 RCTs; 253 patients). Sensitivity analyses based on study quality did not change the results. A GRADE analysis indicated that the overall quality of the evidence for the primary outcomes in the sham controlled trials was moderate due to sparse data. The risk of bias in the four Chinese language comparative effectiveness trials that compared acupuncture with drug treatment was high due to lack of blinding. The risk of bias in the other studies that did not use a sham control was high due to lack of blinding or inadequate methods used for randomization and allocation concealment or both. Acupuncture was significantly more effective than pharmacological therapy and no specific treatment. Eighty-four per cent of patients in the acupuncture group had improvement in symptom severity compared to 63% of patients in the pharmacological treatment group (RR 1.28, 95% CI 1.12 to 1.45; 5 studies, 449 patients). A GRADE analysis indicated that the overall quality of the evidence for this outcome was low due to a high risk of bias (no blinding) and sparse data. Sixty-three per cent of patients in the acupuncture group had improvement in symptom severity compared to 34% of patients in the no specific therapy group (RR 2.11, 95% CI 1.18 to 3.79; 2 studies, 181 patients). There was no statistically significant difference between acupuncture and Bifidobacterium (RR 1.07, 95% CI 0.90 to 1.27; 2 studies; 181 patients) or between acupuncture and psychotherapy (RR 1.05, 95% CI 0.87 to 1.26; 1 study; 100 patients). Acupuncture as an adjuvant to another Chinese medicine treatment was significantly better than the other treatment alone. Ninety-three per cent of patients in the adjuvant acupuncture group improved compared to 79% of patients who received Chinese medicine alone (RR 1.17, 95% CI 1.02 to 1.33; 4 studies; 466 patients). There was one adverse event (i.e. acupuncture syncope) associated with acupuncture in the 9 trials that reported this outcome, although relatively small sample sizes limit the usefulness of these safety data. AUTHORS' CONCLUSIONS Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from two antispasmodic drugs (pinaverium bromide and trimebutine maleate), both of which have been shown to provide a modest benefit for IBS. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients' preferences for acupuncture or greater expectations of improvement on acupuncture relative to drug therapy.
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Affiliation(s)
- Eric Manheimer
- Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
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Hehir L, Williams S. A survey of health professionals’ views about integration of Traditional Chinese Medicine (TCM) Acupuncture into NHS Scotland. Eur J Integr Med 2012. [DOI: 10.1016/j.eujim.2011.11.002] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
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Anastasi JK, Capili B, Quinn J, McMahon DJ, Scully C. Irritable bowel syndrome subtype screening characteristics: constipation subtype patient profiles explored. GASTROENTEROLOGY INSIGHTS 2012; 4. [PMID: 29225760 PMCID: PMC5718377 DOI: 10.4081/gi.2012.e16] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
Irritable bowel syndrome (IBS), a chronic disorder, greatly impacts the lives of those affected. Approximately one quarter of the North American population suffers from this condition that includes abdominal pain, discomfort and alterations in normal bowel function. Constipation-subtype IBS (IBS-C) is often found to be a prevalent subtype; however, a lack of knowledge and effective treatment options remains surrounding this disorder. In the course of an ongoing study conducted by our research team on the use of acupuncture and moxibustion in the management of IBS symptoms, a considerable number of screened patients havemet the widely accepted Rome III criteria for IBS-C.
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Affiliation(s)
- Joyce K Anastasi
- Division of Special Studies in Symptom Management, New York University, New York, NY, USA
| | - Bernadette Capili
- Division of Special Studies in Symptom Management, New York University, New York, NY, USA
| | - Jessica Quinn
- Division of Special Studies in Symptom Management, New York University, New York, NY, USA
| | - Donald J McMahon
- Division of Special Studies in Symptom Management, New York University, New York, NY, USA
| | - Colin Scully
- Division of Special Studies in Symptom Management, New York University, New York, NY, USA
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Stuardi T, Cox H, Torgerson DJ. Database recruitment: a solution to poor recruitment in randomized trials? Fam Pract 2011; 28:329-33. [PMID: 21156752 DOI: 10.1093/fampra/cmq108] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/14/2022] Open
Abstract
BACKGROUND Achieving sample size is imperative to obtaining sufficient power to detect potential effects in health care research, yet many research studies are prone to under-recruitment. Not only does this create problems with power but also it contributes to research extensions, additional costs and delayed results. To combat this problem, one increasingly used technique is database recruitment, a method of searching the electronic medical records system for potential research participants. OBJECTIVE We discuss the advantages and disadvantages of identifying potential research participants using database recruitment with particular reference to primary care. CONCLUSION Database recruitment is a relatively simple and affordable means to recruit large numbers of patients in a timely manner; however, it is not without limitations.
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Affiliation(s)
- Tracy Stuardi
- Department of Health Sciences, University of York, York, UK.
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Shuai P, Zhou XH, Lao L, Li X. Issues of design and statistical analysis in controlled clinical acupuncture trials: an analysis of English-language reports from Western journals. Stat Med 2011; 31:606-18. [PMID: 21341295 DOI: 10.1002/sim.4034] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2010] [Accepted: 06/25/2010] [Indexed: 12/17/2022]
Abstract
OBJECTIVE To investigate major methods of design and statistical analysis in controlled clinical acupuncture trials published in the West during the past six years (2003-2009) and, based on this analysis, to provide recommendations that address methodological issues and challenges in clinical acupuncture research. METHOD PubMed was searched for acupuncture RCTs published in Western journals in English between 2003 and 2009. The keyword used was acupuncture. RESULTS One hundred and eight qualified reports of acupuncture trials that included more than 30 symptoms/conditions were identified, analyzed, and grouped into efficacy (explanatory), effectiveness (pragmatically beneficial), and other (unspecified) studies. All were randomized controlled clinical trials (RCTs). In spite of significant improvement in the quality of acupuncture RCTs in the last 30 years, these reports show that some methodological issues and shortcomings in design and analysis remain. Moreover, the quality of the efficacy studies was not superior to that of the other types of studies. Research design and reporting problems include unclear patient criteria and inadequate practitioner eligibility, inadequate randomization, and blinding, deficiencies in the selection of controls, and improper outcome measurements. The problems in statistical analysis included insufficient sample sizes and power calculations, inadequate handling of missing data and multiple comparisons, and inefficient methods for dealing with repeated measure and cluster data, baseline value adjustment, and confounding issues. CONCLUSION Despite recent advancements in acupuncture research, acupuncture RCTs can be improved, and more rigorous research methods should be carefully considered.
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Affiliation(s)
- Ping Shuai
- Department of Health Statistics, West China School of Public Health, Sichuan University, Chengdu, People's Republic of China
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Figueira HA, Figueira OA, Figueira AA, Figueira JA, Giani TS, Dantas EHM. Elderly quality of life impacted by traditional Chinese medicine techniques. Clin Interv Aging 2010; 5:301-5. [PMID: 21103400 PMCID: PMC2981102 DOI: 10.2147/cia.s10615] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/30/2010] [Indexed: 11/23/2022] Open
Abstract
BACKGROUND The shift in age structure is having a profound impact, suggesting that the aged should be consulted as reporters on the quality of their own lives. OBJECTIVES The aim of this research was to establish the possible impact of traditional Chinese medicine (TCM) techniques on the quality of life (QOL) of the elderly. SAMPLE Two non-selected, volunteer groups of Rio de Janeiro municipality inhabitants: a control group (36 individuals), not using TCM, and an experimental group (28 individuals), using TCM at ABACO/Sohaku-in Institute, Brazil. METHODS A questionnaire on elderly QOL devised by the World Health Organization, the WHOQOL-Old, was adopted and descriptive statistical techniques were used: mean and standard deviation. The Shapiro-Wilk test checked the normality of the distribution. Furthermore, based on its normality distribution for the intergroup comparison, the Student t test was applied to facets 2, 4, 5, 6, and total score, and the Mann-Whitney U rank test to facets 1 and 3, both tests aiming to analyze the P value between experimental and control groups. The significance level utilized was 95% (P < 0.05). RESULTS The experimental group reported the highest QOL for every facet and the total score. CONCLUSIONS The results suggest that TCM raises the level of QOL.
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MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement. J Altern Complement Med 2010; 16:ST1-14. [PMID: 20954957 DOI: 10.1089/acm.2010.1610] [Citation(s) in RCA: 115] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023] Open
Affiliation(s)
- Hugh MacPherson
- Department of Health Sciences, University of York, York, United Kingdom
| | - Douglas G. Altman
- Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
| | - Richard Hammerschlag
- Department of Research, Oregon College of Oriental Medicine, Portland, Oregon, United States of America
| | - Li Youping
- Chinese Cochrane Centre, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, China
| | - Wu Taixiang
- Chinese Cochrane Centre, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, China
| | - Adrian White
- Primary Care Research, Peninsula Medical School, Universities of Exeter and Plymouth, Plymouth, United Kingdom
| | - David Moher
- Ottawa Methods Centre, Ottawa Hospital Research Institute; Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Canada
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MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement. Med Acupunct 2010. [DOI: 10.1089/acu.2010.2023] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023] Open
Affiliation(s)
- Hugh MacPherson
- Department of Health Sciences, University of York, York, United Kingdom
| | - Douglas G. Altman
- Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
| | - Richard Hammerschlag
- Department of Research, Oregon College of Oriental Medicine, Portland, Oregon, United States of America
| | - Li Youping
- Chinese Cochrane Centre, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, China
| | - Wu Taixiang
- Chinese Cochrane Centre, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, China
| | - Adrian White
- Primary Care Research, Peninsula Medical School, Universities of Exeter and Plymouth, Plymouth, United Kingdom
| | - David Moher
- Ottawa Methods Centre, Ottawa Hospital Research Institute; Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Canada
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MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D, STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement. J Evid Based Med 2010; 3:140-55. [PMID: 21349059 DOI: 10.1111/j.1756-5391.2010.01086.x] [Citation(s) in RCA: 330] [Impact Index Per Article: 22.0] [Reference Citation Analysis] [Collaborators] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical," to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.
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Affiliation(s)
- Hugh MacPherson
- Department of Health Sciences, University of York, United Kingdom.
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Collaborators
Stephen Birch, Isabelle Boutron, Mark Bovey, Fei Yutong, Joel Gagnier, Sally Hopewell, Val Hopwood, Susanne Jena, Klaus Linde, Liu Jianping, Kien Trinh, Emma Veitch, Adrian White, Hitoshi Yamashita,
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MacPherson H, Bland M, Bloor K, Cox H, Geddes D, Kang'ombe A, Reynolds J, Stamuli E, Stuardi T, Tilbrook H, Torgerson D, Whorwell P. Acupuncture for irritable bowel syndrome: a protocol for a pragmatic randomised controlled trial. BMC Gastroenterol 2010; 10:63. [PMID: 20565790 PMCID: PMC2909152 DOI: 10.1186/1471-230x-10-63] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2010] [Accepted: 06/17/2010] [Indexed: 02/08/2023] Open
Abstract
BACKGROUND There is insufficient evidence on the effectiveness of acupuncture for irritable bowel syndrome (IBS) for conclusions to be drawn. Given the current interest in acupuncture by patients, it is in the public interest to establish more rigorous evidence. Building on the positive findings from a pilot study, in this paper we present the protocol for a fully-powered trial designed to establish whether or not acupuncture is effective and cost-effective. METHODS/DESIGN In this pragmatic randomised controlled trial we will randomise patients recruited directly from GP databases to either 10 sessions of acupuncture plus usual GP care or to usual GP care alone. The primary clinical outcome will be the IBS Symptom Severity Score (SSS) (maximum score 500) at three months, and at 12 month assessing whether there is an overall benefit. We estimate the sample size required to detect a minimum clinical difference at 90% power and 5% significance to be 188 patients. To allow for loss to follow up we will recruit 220 patients drawn from an estimated primary care population of 140 000. Analysis will be by intention-to-treat, and multiple imputation is to be used for missing data.In a nested qualitative study using in-depth interviews, we will explore how patients, acupuncturists, and GPs explain and subsequently understand acupuncture to work. We will use purposive sampling to identify patients and flexible topic guides for the interviews. The data analysis will lead to a thematic description of how patients and practitioners explain how acupuncture works, and whether or not the explanations influence treatment outcome and/or referrals.We will undertake a cost-effectiveness analysis at 12 months by comparing resource use in the two groups with any treatment benefit. We will use the EQ-5D to measure health-related quality of life and convert into quality adjusted life years (QALYs). We will generate cost effectiveness acceptability curves (CEACs) exploring the probability that acupuncture will produce an acceptable cost per QALY at different cost-effectiveness thresholds. DISCUSSION The trial has received NHS ethics approval and recruited 233 patients between November 2008 and June 2009. Results are expected in 2011. TRIAL REGISTRATION Current Controlled Trials ISRCTN08827905.
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Affiliation(s)
| | - Martin Bland
- Department of Health Sciences, University of York UK
| | - Karen Bloor
- Department of Health Sciences, University of York UK
| | - Helen Cox
- Department of Health Sciences, University of York UK
| | | | | | - Julie Reynolds
- College of Traditional Acupuncture, Hatton, Warwickshire, UK
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MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D, STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med 2010; 7:e1000261. [PMID: 20543992 PMCID: PMC2882429 DOI: 10.1371/journal.pmed.1000261] [Citation(s) in RCA: 619] [Impact Index Per Article: 41.3] [Reference Citation Analysis] [Collaborators] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/13/2023] Open
Abstract
Hugh MacPherson and colleagues present an updated reporting guideline called STRICTA, which stands for Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture.
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Affiliation(s)
- Hugh MacPherson
- Department of Health Sciences, University of York, York, United Kingdom.
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Collaborators
Anne Burton, Ann Hopton, Suzanne Jenna, Stephanie Prady, Tracy Stuardi, Doug Altman, David Moher, Hugh MacPherson, Richard Hammerschlag, Li Youping, Wu Taixiang, Mark Bovey, Val Hopwood, Adrian White, Joyce Anastasi, Stephen Birch, Joao Bosco, Claudia Citkovitz, Remy Coeytaux, Misha Cohen, Agatha Colbert, Helen Elden, Reginaldo de Carvalho Silva Filho, Alastair Forbes, Nadine Foster, Joel Gagnier, Mark Goldby, Marita Gronlund, Richard Harris, Dominik Irnich, Helene Langevin, Lao Lixing, Anna Lee, Lee Hyangsook, Lee Myeongsoo, Lee Sanghoon, George Lewith, Klaus Linde, Jianping Liu, Ryan Milley, Scott Mist, Dieter Melchart, Albrecht Molsberger, Vitaly Napadow, Richard Niemtzow, Park Jongbae, Mahmood Saghaei, Koosnadi Saputra, Rosa Schnyer, Charles Shang, Karen Sherman, Shin Byung-Cheul, Caroline Smith, Elisabet Stener-Victorin, Kien Trinh, Jorge Vas, Andrew Vickers, Peter White, Claudia Witt, Hitoshi Yamashita, Christopher Zaslawski, Stephen Birch, Isabelle Boutron, Mark Bovey, Fei Yutong, Joel Gagnier, Sally Hopewell, Val Hopwood, Susanne Jena, Klaus Linde, Liu Jianping, Kien Trinh, Emma Veitch, Adrian White, Hitoshi Yamashita,
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Stuardi T, Atkin K. How Acupuncturists Envision Treating Irritable Bowel Syndrome: A Pre-Trial Analysis. Med Acupunct 2010. [DOI: 10.1089/acu.2009.0726] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022] Open
Affiliation(s)
- Tracy Stuardi
- Department of Health Sciences, University of York, York, UK
| | - Karl Atkin
- Department of Health Sciences, University of York, York, UK
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MacPherson H, Altman DG, Hammerschlag R, Li Y, Wu T, White A, Moher D. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med 2010; 28:83-93. [PMID: 20615861 PMCID: PMC3002761 DOI: 10.1136/aim.2009.001370] [Citation(s) in RCA: 187] [Impact Index Per Article: 12.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023]
Abstract
The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word 'controlled' in STRICTA is replaced by 'clinical', to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.
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Affiliation(s)
- Hugh MacPherson
- Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.
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Xu GY, Winston JH, Chen JDZ. Electroacupuncture attenuates visceral hyperalgesia and inhibits the enhanced excitability of colon specific sensory neurons in a rat model of irritable bowel syndrome. Neurogastroenterol Motil 2009; 21:1302-e125. [PMID: 19558427 DOI: 10.1111/j.1365-2982.2009.01354.x] [Citation(s) in RCA: 48] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
The causes of irritable bowel syndrome remain elusive and there are few effective treatments for pain in this syndrome. Electroacupunture (EA) is used extensively for treatment of various painful conditions including chronic visceral hyperalgesia (CVH). However, mechanism of its analgesic effect remains unknown. This study was designed to investigate effect of EA on colon specific dorsal root ganglion (DRG) neurons in rats with CVH. CVH was induced by intracolonic injection of acetic acid (AA) in 10-day-old rats. Electromyography and patch clamp recordings were performed at age of 8-10 weeks. Colon DRG neurons were labelled by injection of DiI into the colon wall. EA was given at ST36 in both hindlimbs. As adults, neonatal AA-injected rats displayed an increased sensitivity to colorectal distension (CRD) and an enhanced excitability of colon DRG neurons. EA treatment for 40 min significantly attenuated the nociceptive responses to CRD in these rats; this attenuation was reversed by pretreatment with naloxone. EA treatment for 40 min per day for 5 days produced a prolonged analgesic effect and normalized the enhanced excitability of colon DRG neurons. Furthermore, in vitro application of [D-Ala(2), N-MePhe(4), Gly(5)-Ol] enkephalin (DAMGO) suppressed the enhanced excitability of colon neurons from rats with CVH. These findings suggest that EA produced-visceral analgesia, which might be mediated in a large part by endogenous opioids pathways, is associated with reversal of the enhanced excitability of colon DRG neurons in rats with CVH.
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Affiliation(s)
- G-Y Xu
- Division of Gastroenterology and Hepatology, University of Texas Medical Branch, Galveston, TX 77555-0655, USA
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Adeyemo MA, Chang L. New treatments for irritable bowel syndrome in women. WOMEN'S HEALTH (LONDON, ENGLAND) 2008; 4:605-22; quiz 623. [PMID: 19072463 PMCID: PMC2652519 DOI: 10.2217/17455057.4.6.605] [Citation(s) in RCA: 14] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
The estimated prevalence of irritable bowel syndrome (IBS) in Western countries is 7-15%, with a female:male ratio of 2-2.5:1 in IBS patients who seek healthcare services; however, the female predominance is lower in the general population. IBS has a significant impact on health-related quality of life and is associated with a significant healthcare and economic burden. Management of IBS is comprised of general measures and pharmacologic and nonpharmacologic treatment. However, there are ongoing efforts to find more effective therapeutic approaches. As advancements in the understanding of the pathophysiology of IBS continue to grow, new and effective treatments with novel mechanisms of action that have the potential to improve relief of IBS symptoms over current treatments are likely to be developed. This article provides an overview of current and emerging therapies for IBS and also highlights sex and gender differences in clinical trials and treatment response.
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Affiliation(s)
- Mopelola A Adeyemo
- Center for Neurobiology of Stress, Division of Digestive Diseases, David Geffen School of Medicine at UCLA, 11301 Wilshire Blvd, Building 115, Room 215, VA Greater Los Angeles Healthcare System, Los Angeles, CA 90073, USA, Tel:. +1 310 312 9276, Fax: +1 310 794 2864,
| | - Lin Chang
- Center for Neurobiology of Stress, Division of Digestive Diseases, David Geffen School of Medicine at UCLA, 11301 Wilshire Blvd, Building 115, Room 215, VA Greater Los Angeles Healthcare System, Los Angeles, CA 90073, USA, Tel:. +1 310 312 9276, Fax: +1 310 794 2864,
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