Trial reportBMC musculoskeletal disorders2011
Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study.
Trial report in BMC musculoskeletal disorders, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00791739 (Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia), which is not on this map. Cited by 17 papers, 1 of them a synthesis 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.
Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia (Phase I) and Its Augmentation With Pregabalin in Trazodone Partial Responders (Phase II)
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.
- Combination pharmacotherapy for the treatment of fibromyalgia in adults.The Cochrane database of systematic reviews · 2018Pooled it
- Short-Term Magnesium Therapy Alleviates Moderate Stress in Patients with Fibromyalgia: A Randomized Double-Blind Clinical Trial.Nutrients · 2022Trial
- Quetiapine extended-release (Seroquel-XR) versus amitriptyline monotherapy for treating patients with fibromyalgia: a 16-week, randomized, flexible-dose, open-label trial.Psychopharmacology · 2014Trial
- Extended-Release Trazodone in Comorbid Major Depressive and Sedative-Hypnotic/Anxiolytic Use Disorders: A Real-World Preliminary Evaluation of Multidimensional Outcomes.Journal of clinical medicine · 2026Article
- Therapeutic and research frontiers in fibromyalgia: integrating pathophysiology with innovative drug repurposing.Inflammopharmacology · 2026Review
- Underuse of Pharmacologic Therapies for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Before Specialist Evaluation.Annals of family medicine · 2026Article
- Review of fibromyalgia treatment guidelines: part 2 - pharmacological treatment.Advances in rheumatology (London, England) · 2026Review
- Pharmacological Treatment of Fibromyalgia Syndrome: A Practice-Based Review.Current pain and headache reports · 2024Review
- Combination Drug Therapy for the Management of Chronic Neuropathic Pain.Biomolecules · 2023Review
- Pathogenesis, diagnosis and clinical management of diabetic sensorimotor peripheral neuropathy.Nature reviews. Endocrinology · 2021Review
- Review
- Psychotropic Drugs for the Management of Chronic Pain and Itch.Pharmaceuticals (Basel, Switzerland) · 2019Review
- Depression and chronic pain in the elderly: links and management challenges.Clinical interventions in aging · 2017Review
- Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease.Expert review of anti-infective therapy · 2014Review
- Milnacipran combined with pregabalin in fibromyalgia: a randomized, open-label study evaluating the safety and efficacy of adding milnacipran in patients with incomplete response to pregabalin.Therapeutic advances in musculoskeletal disease · 2013Article
- Monotherapy or combination therapy for fibromyalgia treatment?Current rheumatology reports · 2012Review
- What is the role of sedating antidepressants, antipsychotics, and anticonvulsants in the management of insomnia?Current psychiatry reports · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough trazodone is frequently used by fibromyalgia patients, its efficacy on this disease has not been adequately studied. If effective, pregabalin, whose beneficial effects on pain and sleep quality in fibromyalgia have been demonstrated, could complement the antidepressant and anxiolytic effects of trazodone. The aim of the present study was to assess the effectiveness of trazodone alone and in combination with pregabalin in the treatment of fibromyalgia.
methodsThis was an open-label uncontrolled study. Trazodone, flexibly dosed (50-300 mg/day), was administered to 66 fibromyalgia patients during 12 weeks; 41 patients who completed the treatment accepted to receive pregabalin, also flexibly dosed (75-450 mg/day), added to trazodone treatment for an additional 12-week period. Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients' Global Improvement scale (PGI). Emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test.
resultsTreatment with trazodone significantly improved global fibromyalgia severity, sleep quality, and depression, as well as pain interference with daily activities although without showing a direct effect on bodily pain. After pregabalin combination additional and significant improvements were seen on fibromyalgia severity, depression and pain interference with daily activities, and a decrease in bodily pain was also apparent. During the second phase of the study, only two patients dropped out due to side effects.
conclusionsTrazodone significantly improved fibromyalgia severity and associated symptomatology. Its combination with pregabalin potentiated this improvement and the tolerability of the drugs in association was good.
trial registrationClinicalTrials.gov: NCT00791739.
Indexed as
Identifiers
What OpenQuestion holds
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.