Trial reportDaru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences2019
Comparing duloxetine and pregabalin for treatment of pain and depression in women with fibromyalgia: an open-label randomized clinical trial.
Trial report in Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 4 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
23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 64 citations in OpenAlex.
- Psychiatric Association of Türkiye Mood Disorders Section Depression Treatment Guideline - III: Treatment Approach for Depression Subtypes and Special Groups, Psychotherapies, and Psychosocial Interventions.Turk psikiyatri dergisi = Turkish journal of psychiatry · 2026Guideline
- Drug treatments for fibromyalgia: systematic review and network meta-analysis of randomised trials.BMJ medicine · 2026Pooled it
- Efficacy and safety of duloxetine in chronic musculoskeletal pain: a systematic review and meta-analysis.BMC musculoskeletal disorders · 2023Pooled it
- An Updated Systematic Review and Meta-analysis of Duloxetine for Knee Osteoarthritis Pain.The Clinical journal of pain · 2021Pooled it
- Transcutaneous Electrical Nerve Stimulation and Pain With Movement in People With Fibromyalgia: A Cluster Randomized Clinical Trial.JAMA network open · 2026Trial
- No effect of approved fibromyalgia drugs on the social pain (invalidation) contrary to physical pain: an open-label short-term randomized clinical trial.Clinical rheumatology · 2022Trial
- Serotonin-Norepinephrine Reuptake Inhibitors in Fibromyalgia Management: An Integrative Literature Review of Clinical Evidence.Clinics and practice · 2026Review
- Thermotolerant D-Hydantoinases for Efficient and Stereoselective Intermediate Synthesis of (R)-3-Isobutylglutaric Acid Monoamide, a Key Intermediate in Pregabalin Production.Microbial biotechnology · 2026Article
- Efficacy and Safety of Pregabalin-Tizanidine vs Pregabalin in Patients with Fibromyalgia: Study Protocol for a Multicenter, Prospective, Randomized, Controlled, Open-Label, Blinded Endpoint Trial.Journal of pain research · 2026Article
- Efficacy and safety of low-dose naltrexone (LDN) in fibromyalgia: a systematic review and meta-analysis.Annals of medicine and surgery (2012) · 2025Article
- Therapeutic approach to fibromyalgia: a consensus statement on pharmacological and non-pharmacological treatment from the neuropathic pain special interest group of the Italian neurological society.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Article
- Prescribing Patterns of Gabapentinoids in Chronic Pain Management: A Single Institution Retrospective Chart Review.Psychopharmacology bulletin · 2025Article
- Pharmacological Treatment of Fibromyalgia Syndrome: A Practice-Based Review.Current pain and headache reports · 2024Review
- Low Dose Pregabalin Improves Gastrointestinal Symptoms of Crohn's Disease.Case reports in gastrointestinal medicine · 2024Article
- Review
- Correlation between levels of perceived stress and depressive symptoms in the functional disability of patients with fibromyalgia.Revista da Associacao Medica Brasileira (1992) · 2023Article
- Thalamocortical bistable switch as a theoretical model of fibromyalgia pathogenesis inferred from a literature survey.Journal of computational neuroscience · 2022Article
- Review
- Association between descending pain modulatory system and cognitive impairment in fibromyalgia: A cross-sectional exploratory study.Frontiers in behavioral neuroscience · 2022Article
- Outcomes and Predictors of Response of Duloxetine for the Treatment of Persistent Idiopathic Dentoalveolar Pain: A Retrospective Multicenter Observational Study.Journal of pain research · 2022Article
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 4 institutions in 2 countries.
Funding
Abstract
backgroundDuloxetine and pregabalin are among the most widely used medications in the treatment of patients with fibromyalgia syndrome (FM).
objectivesTo add to the very few lines of evidence that exist on the comparative safety and efficacy of these two medications.
methodsIn this open-label randomized clinical trial, outpatient women, who were diagnosed with FM based on American College of Rheumatology 2010 criteria, and had an age range of 18-65 years old were assigned to either duloxetine 30-60 mg or pregabalin 75-150 mg per day for 4 weeks. Patients were excluded in cases of having used duloxetine, pregabalin, gabapentin, or antidepressants within 12 weeks prior to the study, having had a history of comorbid medical conditions that could provoke chronic pain, or having had comorbid neuropsychiatric disorders, except for major depressive/anxiety disorders. Primary outcomes were between-group differences in mean score changes from baseline to end point for Widespread Pain Index (WPI) and Beck Depression Inventory-II. Secondary outcomes were the same statistical estimates, but for Fibromyalgia Impact Questionnaire-Revised and 12-Item Short Form Survey. Descriptive statistics and independent samples t-test were the main methods of analysis. ( www.irct.ir ; IRCT2016030626935N1).
resultsAmong all the scales, only WPI scores improved with a statistically significant difference between the two treatment arms, favoring duloxetine (Mean difference in score change - 2.32, 95% CI, -4.46 to - 0.18; p = 0.034; Cohen's d 0.53 95% CI, 0.04 to 1.02). Drop out rate and cumulative incidence of nausea was significantly higher in the duloxetine arm compared to the pregabalin arm.
conclusionThis study provides further evidence on higher efficacy of duloxetine compared to pregabalin for the treatment of pain in patients with fibromyalgia. Future comprehensive pragmatic clinical trials are warranted.
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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.