Objectives: To summarise and evaluate Cochrane reviews of pharmacological therapies for adults with fibromyalgia syndrome (FMS) pain.
Methods: Systematic search of Cochrane Database of Systematic Reviews to May 2024. Generic quality assessment used AMSTAR-2 criteria, validity checks of potentially critical factors in evaluation of analgesic efficacy, and assessment of susceptibility of results to publication bias. Pain outcomes were participant-reported pain relief of ≥ 30% or ≥ 50%, or PGIC much or very much improved.
Results: Twenty-one reviews (87 trials, 17,631 patients) were included. All rated moderate (15) or high-quality (6) using AMSTAR-2 and at least seven of eight critical pain criteria were met by 13 of 21 reviews. Diagnosis of FMS used recognised criteria. Seven reviews found no trials (carbamazepine, clonazepam, lamotrigine, phenytoin, oxycodone, topiramate, or valproate), seven had limited and inadequate data (antipsychotics, cannabinoids, combination therapy, gabapentin, lacosamide, monoamine oxidase inhibitors, NSAIDs), and two were subject to publication bias (amitriptyline, SSRI). Mirtazapine had moderate evidence of no effect. Duloxetine, milnacipran, and pregabalin had moderate/good evidence of substantial pain relief for 4-12 weeks in around 1 in 10 adults with moderate or severe FMS pain, without evidence of efficacy beyond six months. Serious adverse events were no more common than with placebo. There was no evidence about who might benefit or experience adverse events. There was no substantial efficacy evidence for other medicines.
Conclusions: Duloxetine, milnacipran, and pregabalin had good evidence that about 1 person in 10 with moderate or severe pain experienced pain intensity reduction by at least 50%.
Keywords: Fibromyalgia syndrome; duloxetine; milnacipran; pharmacological interventions; pregabalin; systematic overview; systematic reviews.
© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.