Published online Jun 18, 2023. doi: 10.5312/wjo.v14.i6.443
Peer-review started: March 6, 2023
First decision: March 24, 2023
Revised: April 19, 2023
Accepted: May 12, 2023
Article in press: May 12, 2023
Published online: June 18, 2023
Processing time: 104 Days and 10 Hours
High prevalence of osteoarthritis (OA) forces healthcare professionals to look for efficient and safe long-term treatment options. Combined oral treatment with glucosamine (GA) and chondroitin sulfate (CS) was shown to be efficient for pain relief and function improvement in OA patients with moderate to severe knee pain in clinical trials. There is still need in additional data regarding their effectiveness in routine clinical practice.
Considering high prevalence of OA and its frequent co-existence with concurrent diseases, as well as the absence of proven long-term disease-modifying treatment options, the authors aimed to evaluate the effectiveness and safety of long-term therapy of GA and CS in the framework of real clinical practice. One of the key questions was to assess the effectiveness of this therapy in the treatment of the two most common OA affected joints – knee and hip. It was important to assess the dynamics of OA symptoms, including patients who were using non-steroidal anti-inflammatory drugs (NSAIDs), and assessment of the following need of concomitant analgesic therapy.
The main objective of the study was to evaluate dynamics of pain syndrome, functions of living, quality of life and satisfaction of patient as well as of actual study product utilization by patients with OA for an observation period up to 64 wk. The study was also aimed to evaluate the HCP approach to the treatment and management of patients with OA to understand the place of the combination of GA and CS in their recommendations and formed the basis for the development of clinical practice guidelines.
An open-label multicenter non-interventional prospective cohort study enrolled patients with Hip or Knee OA stage I to III who started a treatment with combination of GA and CS to evaluate health status by physical examination and validated patient questionnaires for an observation period up to 64 wk. Patients visited clinical sites up to 4 study visits. During all visits data was collected by Investigators within the routine clinical practice. In addition, during each visit patient reported outcomes were generated, assessing Knee or Hip OA outcome, as well as a simple patient satisfaction questionnaire. Depending on the target joint, one of the questionnaires, either the Knee injury and Osteoarthritis Outcome Score (KOOS) or the Hip Osteoarthritis Outcome Score (HOOS) was used.
Mean improvement on Pain subscale in patients with knee and hip OA was 22.87 and 22.81 respectively, on the Symptoms subscales – 20.78 and 19.93, on the Physical Function subscale – 16.60 and 18.77, and on the Quality-of-Life subscale – 24.87 and 22.71 from baseline to the end of observation (up to 64 wk). Number of patients using any NSAIDs decreased from 43.1% to 13.5% by the end of the observation period. Treatment-related AEs were reported for 2.8% of patients and mainly included gastrointestinal disorders [25 AEs in 24 (2.2%) patients]. Most patients (78.1%) were satisfied with the treatment. Most patients (91.3%) generally complied with the recommended duration of treatment (not less than 3 mo per year).
This observational study showed that long-term oral treatment with GA + CS is associated with decrease of pain, improvements of joint function, quality of life and decrease of concomitant usage of NSAIDs in patients with knee and hip OA in routine clinical practice. Treatment with GA + CS combination showed low incidence of drug-related AEs, and high level of patients’ satisfaction with the treatment along with high compliance with long duration of the treatment.
In the long term perspective, this study will contribute to the enhancement of guidelines for the treatment of OA and improve the long-term outcomes for patients with OA. Authors believe, that application of the results of this study will help to reduce the medicinal load on the patient with analgesics and NSAIDs, which ultimately can reduce the number of concomitant adverse events and increase the safety profile of the therapy.