Efficacy of glucosamine plus diacerein versus monotherapy of glucosamine: a double-blind, parallel randomized clinical trial
Bibliographic record
Abstract
BACKGROUND: Patented crystalline glucosamine sulfate (pCGS) and diacerein monotherapy have been recommended for treatment of mild to moderate osteoarthritis (OA), but evidence of efficacy for combined treatments is lacking. Therefore, the aim of this study was to compare clinical outcomes (i.e., pain and Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] score) at 6 months as well as the safety profile of treatment with combined pCGS and diacerein versus pCGS alone. METHODS: A double-blind, parallel randomized controlled superiority trial was conducted between August 2013 and August 2014 at Ramathibodi Hospital, Bangkok, Thailand. A total of 148 patients (74 patients in each group) was randomly allocated to receive pCGS plus diacerein or pCGS plus placebo daily. Adult patients with OA were eligible if they had a Kellgren-Lawrence grade of 2-3. The primary outcomes were visual analogue scale score (VAS) for pain and WOMAC subscores measured at 24 weeks after receiving treatment, using the intention-to-treat principle (nonresponder imputation). RESULTS: , respectively. Mean VAS and minimal joint space width at baseline were 5.1 and 2.5 mm, respectively. The mean VAS values measured at 24 weeks were 2.97 and 2.88 in the pCGS plus diacerein and pCGS plus placebo groups, respectively. The estimated mean difference was 0.09 (95 % CI -0.75 to 0.94), which was not statistically significant (P = 0.710). In addition, the mean WOMAC total, pain, function, and stiffness scores for both groups were not significantly different, with corresponding means of 48.59, 12.02, 32.74, and 3.85 for the pCGS plus diacerein group and 48.69, 11.76, 32.47, and 4.16 for the pCGS plus placebo group. The risk of diarrhea and dyspepsia was very similar between the two groups, with risk ratios of 1.03 (95 % CI 0.56-1.89) and 0.91 (95 % CI 0.43-1.92), respectively. CONCLUSIONS: This study did not demonstrate that coadministration of diacerein with pCGS improves pain and WOMAC score compared with pCGS monotherapy in patients with mild to moderate OA of the knee. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01906801 . Registered on 20 July 2013.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".