Evaluation of Effectiveness and Safety of First-line Drugs Used in the Treatment of Peripheral Neuropathy Among Elderly Population—A Randomised, Open-label, Active Comparator Study
Bibliographic record
Abstract
Background Peripheral neuropathy is four times more common in geriatric age group patients compared to younger ones. Most of the trials have targeted adult population, and there is scarcity of data in the geriatric age group. Purpose A real-world study was planned on geriatric patients suffering from peripheral neuropathy to analyse the effectiveness and safety of first-line drugs used in the management of peripheral neuropathy. Methods It was a randomised, open-label, active comparator clinical trial in which first-line drugs for peripheral neuropathy were compared [amitriptyline (10 mg), duloxetine (30 mg), gabapentin (300 mg), pregabalin (75 mg)] for their effectiveness and safety. The trial duration was eight weeks. The modified Toronto Clinical Neuropathy Score (mTCNS), Verbal Rating Scale (VRS) and Geriatric Depression Scale (GDS) were used for effectiveness. Safety was assessed by monitoring adverse events. Multiple groups were compared with Kruskal–Wallis test, and post hoc analysis was performed with Dunn’s test. A p value <.05 was considered significant. Results A total of 80 patients were recruited (20 patients in each arm) with a mean age of 65.4 years, and 56.3% were male. Pregabalin was superior to amitriptyline ( p = .04) and duloxetine ( p = .02) in reducing mTCNS. Similarly, pregabalin was superior to amitriptyline ( p = .041 and duloxetine ( p = .009) in reducing GDS score. All drugs were comparable in reducing VRS ( p = .17). A total of 14 adverse events were observed, out of which constipation, sedation and dizziness were common. Maximum adverse events were observed in the duloxetine arm (6/14). Conclusion Pregabalin was superior to amitriptyline and duloxetine, whereas it was comparable to gabapentin in effectiveness. Constipation was the most common adverse event, but the central nervous system was the most involved in adverse events.
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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 | 0.007 | 0.006 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 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 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".