<p>Clinical meaningfulness of duloxetine&#39;s effect in Chinese patients with chronic pain due to osteoarthritis: post hoc analyses of a phase 3 randomized trial</p>
Bibliographic record
Abstract
Purpose: To evaluate the analgesic effect of duloxetine in Chinese patients with osteoarthritis (OA) of the knee/hip at individual patient level and report the relationship between pain intensity reduction, overall improvement, and physical functioning. Patients and methods: Post hoc analysis of 13-week, phase 3, parallel-group, randomized, placebo-controlled study of duloxetine in Chinese patients with OA pain. Patients were randomized (1:1, computer-generated, interactive web-response system) to duloxetine (60 mg once daily, n=202) or placebo (n=207). Patients, investigators, and study staff were blinded throughout the study. Duloxetine’s efficacy was evaluated using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and the Osteoarthritis Research Society International and Outcome Measures in Rheumatology (OARSI-OMERACT) responder criteria. Analyses were conducted on all randomized patients with a baseline and at least one post-baseline observation. Results: At study endpoint, the percentage of patients experiencing ≥30% pain intensity reduction (30% responders) was significantly higher in the duloxetine group than in the placebo group (63.4% vs 49.7%; P =0.008). The percentage of patients experiencing ≥50% pain intensity reduction (50% responders) in the duloxetine group was numerically higher than in the placebo group (42.8% vs 34.5%; P =0.098). Most of the 30% and 50% responders to duloxetine treatment felt either “very much improved” or “much improved” on the Patient Global Impression-Improvement at endpoint. The 30% and 50% responders to duloxetine treatment also experienced greater improvements in the Western Ontario and McMaster Universities Osteoarthritis Index physical function scores at endpoint compared with non-responders. The overall percentage of OARSI-OMERACT responders was significantly higher in the duloxetine group vs the placebo group (70.1% vs 54.9%; P =0.003). Conclusion: Based on IMMPACT and OARSI-OMERACT criteria, the analgesic effect of duloxetine was associated with clinically relevant benefits in Chinese patients with OA of the knee/hip. ClinicalTrials.gov identifier: NCT01931475. Keywords: Chinese, chronic pain, duloxetine, clinical meaningfulness, efficacy, osteoarthritis
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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 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".