(211) A Placebo-Controlled Trial of Rofecoxib in the Treatment of Chronic Low Back Pain
Bibliographic record
Abstract
Objective: To evaluate the efficacy and safety of rofecoxib in the treatment of chronic low back pain. Study Design: Randomized, double-blind, placebo-controlled, parallel group, 4-week, multicenter study. Patients: Individuals with chronic low back pain (Quebec Task Force on Spinal Disorders Class 1 and 2) who were routine users of analgesic medications for their back pain. Interventions: Patients meeting pain worsening (flare) criteria upon discontinuation of prestudy analgesics were randomized 1:1:1 to rofecoxib 25 mg (n = 126), rofecoxib 50 mg (n = 126), or placebo (n = 128), administered orally once daily. Results: Patient baseline characteristics were similar in all treatment groups (mean age 52.5 years, 63.2% female, mean duration of back pain 11.8 years, prestudy analgesics: NSAID 82.9 %, non-NSAID 17.1%). Rofecoxib at both dose levels was superior to placebo as assessed by the Low Back Pain Intensity Scale (0- to 100-mm VAS), the prespecified primary endpoint. The least square mean difference from placebo was −15.27 mm and −14.36 mm for the rofecoxib 25 mg and 50 mg dose levels, respectively (p < 0.001). Both rofecoxib regimens were superior to placebo in additional prespecified secondary and other endpoints: Bothersomeness Scale, Roland Morris Disability Questionnaire, Patient and Investigator Global Assessment of Response to Therapy, and Patient Global Assessment of Disease Status (p < 0.001 for all comparisons). As measured by the Relief from Starting Pain endpoint, rofecoxib 25 mg and 50 mg both achieved superiority to placebo by bedtime after the first morning dose (p < 0.001). For all endpoints, the 25 mg and 50 mg dose levels were not statistically different from each other. Rofecoxib in both regimens was generally well tolerated. Conclusions: Rofecoxib administered once daily reduced chronic low back pain and was well tolerated. The 25 mg and 50 mg regimens had similar efficacy.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 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".