Efficacy and Safety of Etodolac-Paracetamol Fixed Dose Combination in Patients With Knee Osteoarthritis Flare-up: A Randomized, Double-blind Comparative Evaluation
Bibliographic record
Abstract
OBJECTIVE: To evaluate the efficacy and safety of etodolac-paracetamol combination in comparison with etodolac alone in patients with knee osteoarthritis (OA) flare-up. METHODS: In this double-blind, double-dummy, randomized, comparative, multicentric, parallel group study, 220 patients of either sex in the age range of 40 to 70 years with an OA flare-up were randomized either to etodolac (300 mg)-paracetamol (500 mg) combination or etodolac (300 mg) alone twice a day for 10 days. Efficacy outcomes were an average daily pain intensity score on 11-point visual analog scale, Western Ontario and McMaster score (WOMAC), and Lequesne Severity Index; total pain relief score at 30 minutes, 1, 2, and 4 hours after first-dose administration; OA flare-up symptoms resolution; patient's and investigator's overall assessment of study treatments. RESULTS: Etodolac-paracetamol was significantly superior to etodolac alone in reducing pain intensity (P<0.001), achieving pain relief (P<0.05) during the first 4 hours after the study dose administration, and resolution of the clinical signs and symptoms of OA flare-up such as morning stiffness, swelling/inflammation, and erythema. The combination showed significantly greater improvement in WOMAC scores and Lequesne Severity Index (P<0.001) than in etodolac monotherapy. Peak pain intensity difference over a period of 10 days was also significantly (P<0.001) higher in combination-treated patients compared with monotherapy-treated patients. The combination had significantly better patient's and investigator's global efficacy assessment (P=0.001). Both treatments were well tolerated and safe in patients with OA flare-up. DISCUSSION: For the treatment of painful OA flare-ups, the etodolac-paracetamol combination can offer improved clinical outcomes by targeting multiple pain pathways. The results of the current study show that etodolac-paracetamol is more effective in the treatment of OA flare-up than etodolac alone.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.015 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".