Tramadol (with or without acetaminophen) efficacy and harm
Bibliographic record
Abstract
OBJECTIVE: To evaluate the efficacy and safety of tramadol (with or without acetaminophen) in adult pain management compared with nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen alone. DATA SOURCES: Studies were identified through a search of the entire Ovid MEDLINE database, the Ovid MEDLINE Epub Ahead of Print database, Embase, and Evidence-Based Medicine Reviews (Cochrane Central Register of Controlled Trials) from 1946 to August 19, 2022. STUDY SELECTION: Included studies comprised double-blind, randomized controlled trials (RCTs) of oral tramadol (with or without acetaminophen) compared with opioids, NSAIDs, or acetaminophen for treatment of acute or chronic pain that reported at least 1 of 11 outcomes: total adverse events (AEs), fatal serious AEs (SAEs), nonfatal SAEs, patient withdrawals from the study due to AEs (WDAEs), total study withdrawals, measures of dependence or addiction, quality of life, functional improvement, 30% or more pain reduction, 50% or more pain reduction, and rescue medication use. Overall, 3184 articles were screened and 37 RCTs (21 opioid, 15 NSAID, 1 acetaminophen; N=7156; length 1 hour to 12 weeks) were included. Trials were critically appraised and assessed using the Cochrane risk of bias tool for randomized trials 1.0. Meta-analyzed outcomes were reported as risk ratios (with 95% confidence intervals [CIs]). SYNTHESIS: Compared with opioids, tramadol with or without acetaminophen did not significantly differ in efficacy based on 50% or more or 30% or more reduction in pain or in any harm outcomes (nonfatal SAEs [risk ratio (RR)=1.35, 95% CI 0.43 to 4.20]; WDAEs [RR=0.99, 95% CI 0.80 to 1.22]; total withdrawals [RR=0.93, 95% CI 0.78 to 1.11]; or total AEs [RR=0.97, 95% CI 0.89 to 1.05]). Compared with NSAIDs, tramadol with or without acetaminophen was less likely to achieve a 30% or more reduction in pain (RR=0.82, 95% CI 0.76 to 0.90), and was more likely to result in WDAEs (RR=2.86, 95% CI 2.23 to 3.66), total withdrawals (RR=1.68, 95% CI 1.47 to 1.93), and total AEs (RR=1.37, 95% CI 1.28 to 1.47). Evidence was insufficient for meta-analysis of fatal SAEs, drug dependence or addiction, quality of life, functional improvement, or use of rescue medications. CONCLUSION: Tramadol with or without acetaminophen did not differ significantly from other opioids, and was less effective and more poorly tolerated than NSAIDs. Short study duration, small sample size, extensive patient exclusion, and inconsistency in outcome reporting limit the scientific validity of conclusions.
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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 | 0.014 | 0.035 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.011 | 0.018 |
| Bibliometrics | 0.004 | 0.003 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".