Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a double-blinded, double-placebo, randomized controlled trial
Bibliographic record
Abstract
Abstract ObjectiveThe purpose of this study was to evaluate the difference of efficacy between moxibustion (experimental group) and local diclofenac sodium gel (control group) in the treatment of knee osteoarthritis (KOA).MethodsA multicenter, double-blinded, double-placebo, randomized controlled clinical trial was conducted in this research. 144 participants with knee osteoarthritis were randomly divided into two groups according to 1:1 ratio. The participants in the experimental group were treated with active Moxibustion plus placebo gel, whereas the control group was given diclofenac sodium gel plus placebo moxibustion. Moxibustion treatment was administrated at 3 acupoints (EX-LE4, ST35, ST36) for 4 weeks in 12 sessions. The entire trial cycle lasted 13 weeks, including 1 week at baseline, 4 weeks at treatment and 8 weeks at follow-up. Diclofenac sodium gel or placebo gel at a dose of 4 g per knee were applied three times per day for 4 weeks. The primary outcome measures were the changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures included changes in other subscales of WOMAC (pain, stiffness and function), visual analogue scale (VAS) and participant overall assessment (PGA).ResultsThe analysis showed that both the experimental group and the control group at 2 weeks, 4weeks, 8weeks and 12 weeks were statistically significant compared with baseline (P <0.05). There was no significant difference between the two groups in the first four weeks (P > 0.05). At 8 weeks, WOMAC total score (95% CI, 4.3 [0.5 to 8.1], P=0.03), pain score (95% CI, 1.0 [0.2 to 1.9], P=0.02) and functional score (95% CI, 3.0 [0.1 to 5.8], P=0.04) the control group are better than the experimental group (P < 0.05). At 12 weeks, there were no significant difference between the two groups (P > 0.05). ConclusionsDuring the treatment, moxibustion has the same therapeutic effect as local diclofenac sodium gel, which can alleviate the pain of KOA participants to different degrees, rigidity and dysfunction. The therapeutic effect of it can basically maintained until 2 months after treatment. Local diclofenac sodium gel was superior to moxibustion in relieving knee pain and knee dysfunction at 8 weeks.Trial registration number Clinical Trials.gov, NCT02769572.Date of trial registration May 2016＃These authors contributed equally to this work.
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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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.004 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
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".