Trial reportDiabetes care2011
A comparative evaluation of amitriptyline and duloxetine in painful diabetic neuropathy: a randomized, double-blind, cross-over clinical trial.
Trial report in Diabetes care, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 108 citations in OpenAlex.
- Antidepressants for pain management in adults with chronic pain: a network meta-analysis.Health technology assessment (Winchester, England) · 2024Pooled it
- Amitriptyline for neuropathic pain in adults.The Cochrane database of systematic reviews · 2015Pooled it
- Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia.The Cochrane database of systematic reviews · 2014Pooled it
- Optimal pharmacotherapy pathway in adults with diabetic peripheral neuropathic pain: the OPTION-DM RCT.Health technology assessment (Winchester, England) · 2022Trial
- Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial.Lancet (London, England) · 2022Trial
- Duloxetine use in chronic painful conditions--individual patient data responder analysis.European journal of pain (London, England) · 2014Trial
- Trial
- LX9211, a rising star for relieving of diabetic peripheral neuropathic pain.Journal of diabetes investigation · 2025Article
- Effectiveness of Duloxetine versus Other Therapeutic Modalities in Patients with Diabetic Neuropathic Pain: A Systematic Review and Meta-Analysis.Pharmaceuticals (Basel, Switzerland) · 2024Review
- A systematic review and meta-analysis of randomized controlled head-to-head trials of recommended drugs for neuropathic pain.Pain reports · 2024Review
- Diabetic Neuropathy: An Overview of Molecular Pathways and Protective Mechanisms of Phytobioactives.Endocrine, metabolic & immune disorders drug targets · 2024Review
- Novel drugs affecting diabetic peripheral neuropathy.Iranian journal of basic medical sciences · 2024Review
- Pharmacological and Nonpharmacological Treatments for Painful Diabetic Peripheral Neuropathy.Diabetes & metabolism journal · 2023Review
- Issues and challenges in diabetic neuropathy management: A narrative review.World journal of diabetes · 2023Review
- Antidepressants for pain management in adults with chronic pain: a network meta-analysis.The Cochrane database of systematic reviews · 2023Review
- Prevention and Management Strategies for Diabetic Neuropathy.Life (Basel, Switzerland) · 2022Review
- Current Strategies for the Management of Painful Diabetic Neuropathy.Journal of diabetes science and technology · 2022Review
- Isolation of Thymol fromBioMed research international · 2022Article
- Pharmacotherapy of Painful Diabetic Neuropathy: A Clinical Update.Sisli Etfal Hastanesi tip bulteni · 2022Review
- Treatment of Painful Diabetic Neuropathy-A Narrative Review of Pharmacological and Interventional Approaches.Biomedicines · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare the efficacy and safety of duloxetine and amitriptyline in painful diabetic neuropathy (PDN). RESEARCH DESIGN AND
methodsIn this randomized, double-blind, cross-over, active-control trial, 58 patients received amitriptyline and duloxetine orally once daily at bedtime, each for 6 weeks with optional dose uptitration fortnightly. Single-blinded placebo washout was given for 2 weeks between the two treatments and a single-blinded placebo run-out phase of 4 weeks was given at the end of the treatment period. Pain relief was measured by the patient's global assessment of efficacy, using a visual analog scale (0-100) as a primary end point, and overall improvement and adverse events were assessed as secondary outcome measures. Median pain score reductions of >50%, 25-50%, and <25% were considered good, moderate, and mild responses, respectively.
resultsThere was a significant improvement in pain with both treatments compared with their baseline values (P < 0.001 for both). Good, moderate, and mild pain relief was achieved in 55, 24, and 15% of patients, respectively, on amitriptyline and 59, 21, and 9% of patients, respectively, on duloxetine. There were no significant differences in various other outcome measures between the groups. Of the reported adverse events, dry mouth was significantly more common with amitriptyline than duloxetine (55 vs. 24%; P < 0.01). Although, numerically, more patients preferred duloxetine, overall this was not statistically significant (48 vs. 36%; P = 0.18).
conclusionsBoth duloxetine and amitriptyline demonstrated similar efficacy in PDN. A large, multicentric clinical trial in other populations could possibly demonstrate the superiority of either drug.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.