[Treatment of fibromyalgia syndrome with gamma-hydroxybutyrate : A randomized controlled study].
BACKGROUND
The etiology of fibromyalgia syndrome is not yet fully understood. Current hypotheses suggest a potential role of gamma-hydroxybutyrate (GHB) in influencing endocrinological abnormalities in patients with fibromyalgia.


OBJECTIVE
The aim of the study was to investigate whether low dose GHB as a growth-hormone releasing substance reduces pain intensity and improves depressive mood, physical impairment and sleep quality in outpatients with fibromyalgia. Additionally, adverse events were recorded.


METHODS
The pilot study was conducted in the outpatient clinic for pain at the clinic for anesthesiology and surgical intensive care of the Charité Universitätsmedizin Berlin. In the study 25 female patients with fibromyalgia according to the criteria of the American College of Rheumatology were randomized into 2 groups. Over 15 weeks patients of the intervention group received 25 mg/kg body weight oral GHB before going to bed and were compared with a placebo control group. In addition, all patients participated in operant behavioral pain treatment in a group setting. Dependent variables were pain intensity, depressive mood, physical impairment and quality of sleep.


RESULTS
There were no group differences in the course of pain intensity (p = 0.61), depressive mood (p = 0.16), physical impairment (p = 0.25) and quality of sleep (p = 0.44); however, all symptoms improved across the groups from pretherapy to posttherapy. Low dose GHB did not increase growth hormone blood concentrations. The number of adverse events that were reported more than two times was similar in both groups.


CONCLUSIONS
Administration of low dose GHB did not yield clinical improvements in female outpatients with fibromyalgia. General improvement in the course of treatment may have resulted from operant behavioral pain therapy. Future studies on GHB should control hypothetical risk factors for identification of non-responders.
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Schmerzambulanz, Campus Charité Mitte und Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Deutschland. eva.reuter@charite.de.
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Reuter
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Schmerzambulanz, Campus Charité Mitte und Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Deutschland.
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Tafelski
Institut für Medizinische Psychologie, Philipps-Universität Marburg, Marburg, Deutschland.
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Thieme
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Schmerzambulanz, Campus Charité Mitte und Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Deutschland.
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West
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Schmerzambulanz, Campus Charité Mitte und Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Deutschland.
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Haase
POLIKUM Charlottenburg, Berlin, Deutschland.
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Beck
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Schmerzambulanz, Campus Charité Mitte und Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Deutschland.
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Schäfer
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Schmerzambulanz, Campus Charité Mitte und Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Deutschland.
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Spies
D000284:Administration, Oral; D001521:Behavior Therapy; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy*; D006785:Hospitals, University; D006801:Humans; D008297:Male; D008875:Middle Aged; D010044:Outpatient Clinics, Hospital; D010147:Pain Measurement / Q000187:drug effects; D010865:Pilot Projects; D012978:Sodium Oxybate / Q000009:adverse effects / Q000627:therapeutic use*
D012978:Sodium Oxybate
Fibromyalgia; Gamma-hydroxybutyrate; Pain psychotherapy; Randomized controlled study; Treatment