{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T19:47:52Z","timestamp":1790624872476,"version":"4.1.0"},"reference-count":55,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2021,5,18]],"date-time":"2021-05-18T00:00:00Z","timestamp":1621296000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European Journal of Pain"],"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Spironolactone (SPL) is a reversible mineralocorticoid 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\u2010onset effects of SPL have been documented in a case series of women with fibromyalgia syndrome (FMS). To reaffirm this observation, we performed a double\u2010blind placebo\u2010controlled randomized clinical trial (RCT).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      A total of 69 patients were screened, 56 patients were eligible and randomized to SPL or placebo (each\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a028). Forty\u2010three patients completed the clinical trial to the last visit (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a021 and\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a022). After a run\u2010in phase of 50 and 100\u00a0mg\/day, 200\u00a0mg\/day SPL or placebo were applied between days 7 and 28. Primary outcome was the change in the FIQ\u2010G score (Fibromyalgia Impact Questionnaire, German version). Secondary outcome parameters were the changes in pain (numeric rating scale, NRS), mood (ADS), quality of life (SF\u201036) and change in FIQ scores 14\u00a0days after the end of the medication.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>SPL of 200\u00a0mg\/day did not change significantly either the primary or the secondary end points. SPL evoked a transient rise in serum potassium and a transient fall in GFR maximal after 2\u00a0weeks, but without clinical relevance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>SPL at 200\u00a0mg\/day does not improve symptoms in women with FMS, but was considered not to cause harm.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Significance<\/jats:title>\n                    <jats:p>The mineralocorticoid receptor and androgen receptor antagonist spironolactone is repeatedly tested for its therapeutic effectivity against neuropsychiatric disorders. The present RCT demonstrated that 200\u00a0mg spironolactone does not change the symptoms of the fibromyalgia syndrome (FMS) in adult women. Between 2 and 4\u00a0weeks, spironolactone evokes a transient decrease in GFR and increase in serum potassium. Spironolactone cannot be recommended for the treatment of FMS.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ejp.1784","type":"journal-article","created":{"date-parts":[[2021,4,28]],"date-time":"2021-04-28T13:44:07Z","timestamp":1619617447000},"page":"1739-1750","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["High\u2010dose spironolactone lacks effectiveness in treatment of fibromyalgia (RCT)"],"prefix":"10.1002","volume":"25","author":[{"given":"Ruwen","family":"B\u00f6hm","sequence":"first","affiliation":[{"name":"Institute for Experimental and Clinical Pharmacology University Medical Center Schleswig\u2010Holstein Kiel Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Westermann","sequence":"additional","affiliation":[{"name":"Clinic for Anesthesiology University Medical Center Schleswig\u2010Holstein Kiel 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