High?dose spironolactone lacks effectiveness in treatment of fibromyalgia (RCT)

Background Spironolactone (SPL) is a reversible mineralocorticoid receptor (MR) and androgen (AR) antagonist which attracts pharmacotherapeutic interest not only because of its beneficial effects in heart failure but also the pathogenetic roles MR AR activities neuropsychiatric diseases. Recently, rapid-onset SPL have been documented case series women with fibromyalgia syndrome (FMS). To reaffirm this observation, we performed double-blind placebo-controlled randomized clinical trial (RCT). Methods A total 69 patients were screened, 56 eligible to or placebo (each n = 28). Forty-three completed last visit (n 21 22). After run-in phase 50 100 mg/day, 200 mg/day applied between days 7 28. Primary outcome was change FIQ-G score (Fibromyalgia Impact Questionnaire, German version). Secondary parameters changes pain (numeric rating scale, NRS), mood (ADS), quality life (SF-36) FIQ scores 14 after end medication. Results did significantly either primary secondary points. evoked transient rise serum potassium fall GFR maximal 2 weeks, without relevance. Conclusions at does improve symptoms FMS, considered cause harm. Significance The spironolactone repeatedly tested for therapeutic effectivity against disorders. present RCT demonstrated that mg (FMS) adult women. Between 4 evokes decrease increase potassium. cannot be recommended treatment FMS.