Efficacy of Spironolactone in Fibromyalgia
- Conditions
- M79.7Fibromyalgia
- Registration Number
- DRKS00008024
- Lead Sponsor
- niversitätsklinikum Schleswig-Holstein (UKSH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 56
Fibromyalgia, diagnosed according to ACR 2010
Blood test normal: creatinin, eGFR > 60 ml/min.
No known Diabetes mellitus, no known renal disease.
BMI > 18 kg/m²
No other serious pathological findings in patient history concerning cardio-vascular, renal, pulmonal, haematopoetic, hepatic, endocrin or neuronal functions
Written consent after education about course of events and risks of this study
Negative pregnancy test
Effective (Pearl Index < 1%) contraception measures (inhibitors of ovulation, heterosexual abstinence, menopause, vasectomized partner, bilateral tube occlusion, or combination of two less effective measures)
Known allergic reaction to the study medication (Aldactone® 50 (contains yellow-orange S) or Sinupret eXtract® placebos).
Hypotension (RR < 105/75 mmHg or MAD < 85 mmHg)
Hypovolemia
Blood test abnormal (as judged by the investigator): electrolytes (Na, K, Cl, Ca), liver function tests (ASAT, gGT), blood cell count.
Pregnancy / lactation period.
Expected noncompliance.
Differences between self-reported chronic medication usage and qualitative findings of medication usage in urine.
Contraindications to the study medication.
Concomitant use of ACE-inhibitors/ARB, potassium-sparing diuretics or potassium substitution.
Long-time (> 10 days) use of NSAID.
Other conditions that render the subject inapt for this study according to the investigator.
Concomitant participation in other clinical trials (self-reporting).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of FIQ-G-Scores (Fibromyalgia Impact Questionnaire, German version) after 4 weeks of treatment
- Secondary Outcome Measures
Name Time Method Reduction of pain (numeric rating scala, NRS) after 4 weeks<br>Improvement of mood (ADS) after 4 weeks<br>Improvement of quality of life (SF-36) after 4 weeks<br>Raise in Fibromyalgia Impact Questionnaire (FIQ) Scores after 6 weeks<br>Reduction of current analgetic comedication after 4 weeks<br>Assesment of variability of the plasmaconcentration of the active metabolite of spironolactone after 4 weeks, correlation with scores mentioned above