Abstract
Background
Spironolactone (SPL) is a reversible mineralcorticoid‐receptor (MR) and androgen receptor (AR) antagonist which attracts pharmacotherapeutic interest not only because of its beneficial effects in heart failure, but also because of the pathogenetic roles of MR and AR activities in neuropsychiatric diseases. Recently, beneficial and rapid onset effects of SPL had been documented in a case series of women with fibromyalgia syndrome (FMS). To reaffirm this observation, we performed a double‐blind placebo controlled randomized clinical trial (RCT).
Methods
A total of 69 patients were screened, 56 patients were eligible and randomized to SPL or placebo (each n = 28). 43 patients completed the clinical trial to the last visit (n = 21 and n = 22). After a run‐in‐phase of 50 and 100 mg/d, 200 mg/d SPL or placebo were applied between day 7 and day 28. Primary outcome was the change of the FIQ‐G‐score (Fibromyalgia Impact Questionnaire, German version). Secondary outcome parameters were the changes of pain (numeric rating scala, NRS); mood (ADS); quality of life (SF‐36); and change of FIQ‐scores 14 days after the end of the medication.
Results
200 mg/d SPL did not change significantly either the primary nor the secondary endpoints. SPL evoked a transient rise in serum potassium and a transient fall in GFR maximal after 2 weeks, but without clinical relevance.
Conclusions
SPL at 200 mg/d does not improve symptoms in women with FMS, but was considered not to cause harm.
from Wiley: European Journal of Pain: Table of Contents https://ift.tt/3ulePjG
via IFTTT
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