Trial reportPediatric rheumatology online journal2016
Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study.
Trial report in Pediatric rheumatology online journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 19 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.
A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia
A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia
Who cites it
19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Management of Juvenile Fibromyalgia: A Level I Evidence-Based Systematic Review.Medical sciences (Basel, Switzerland) · 2025Pooled it
- Effects of pharmacological and non-pharmacological interventions for the management of sleep problems in people with fibromyalgia: a multi-methods evidence synthesis.Health technology assessment (Winchester, England) · 2025Pooled it
- Pooled it
- Antiepileptic drugs for chronic non-cancer pain in children and adolescents.The Cochrane database of systematic reviews · 2017Pooled it
- Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a randomized controlled trial.Pediatric rheumatology online journal · 2019Trial
- Pharmacologic Management of Pain in Children: Balancing Evidence, Safety, and Clinical Challenges.Children (Basel, Switzerland) · 2026Review
- Juvenile Primary Fibromyalgia Syndrome: Advances in Etiopathogenesis, Clinical Assessment and Treatment: A Narrative Review.Biomedicines · 2025Review
- 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
- Mechanism-Based Pharmacological Treatment for Chronic Non-cancer Pain in Adolescents: Current Approaches and Future Directions.Paediatric drugs · 2022Review
- Association between the Use of Quantitative Sensory Testing and Conditioned Pain Modulation and the Prescription of Medication and Interventional Procedures in Children with Chronic Pain Conditions.Children (Basel, Switzerland) · 2022Article
- The Challenges of Identifying Fibromyalgia in Adolescents.Case reports in pediatrics · 2022Article
- Implications of Nerve Fiber Density on the Diagnosis and Treatment of Juvenile Fibromyalgia.Journal of pain research · 2022Review
- Therapeutic Effects of Ba-Duan-Jin versus Pregabalin for Fibromyalgia Treatment: Protocol for a Randomized Controlled Trial.Rheumatology and therapy · 2021Article
- Juvenile primary fibromyalgia syndrome: A Review- Treatment and Prognosis.Pediatric rheumatology online journal · 2021Review
- Beyond Amitriptyline: A Pediatric and Adolescent Oriented Narrative Review of the Analgesic Properties of Psychotropic Medications for the Treatment of Complex Pain and Headache Disorders.Children (Basel, Switzerland) · 2020Review
- American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain.Blood advances · 2020Article
- Medication use among pediatric patients with chronic musculoskeletal pain syndromes at initial pain clinic evaluation.Pain management · 2018Article
- Fibromyalgia: Treating Pain in the Juvenile Patient.Paediatric drugs · 2017Review
- [Definition, diagnostics and therapy of chronic widespread pain and the (so-called) fibromyalgia syndrome in children and adolescents : Updated guidelines 2017].Schmerz (Berlin, Germany) · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFibromyalgia (FM) is a common pain condition characterized by widespread musculoskeletal pain and tenderness. Pregabalin is an approved treatment for adults in the United States, but there are no approved treatments for adolescents with FM.
methodsThis was a 15-week, randomized, double-blind, placebo-controlled study and 6-month open-label safety trial of flexible-dose pregabalin (75-450 mg/day) for the treatment of adolescents (12-17 years) with FM. Primary outcome was change in mean pain score at endpoint (scored from 0-10, with 24-h recall). Secondary outcomes included global assessments and measures of pain, sleep, and FM impact.
resultsA total of 107 subjects were randomized to treatment (54 pregabalin, 53 placebo) and 80 completed the study (44 pregabalin, 36 placebo). Improvement in mean pain score at endpoint with pregabalin versus placebo was not statistically significant, treatment difference (95 % CI), -0.66 (-1.51, 0.18), P = 0.121. There were significant improvements with pregabalin versus placebo in secondary outcomes of change in pain score by week (P < 0.05 for 10 of 15 weeks); change in pain score at week 15 (1-week recall), treatment difference (95 % CI), -0.87 (-1.68, -0.05), P = 0.037; and patient global impression of change, 53.1 % versus 29.5 % very much or much improved (P = 0.013). Trends toward improvement with pregabalin in other secondary outcomes measuring pain, sleep, and FM impact were not significant. Safety was consistent with the known profile of pregabalin in adults with FM.
conclusionPregabalin did not significantly improve the mean pain score in adolescents with FM. There were significant improvements in secondary outcomes measuring pain and impression of change. TRIAL REGISTRATIONS: NCT01020474 ; NCT01020526 .
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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.