Reuter E, Tafelski S, Thieme K, West C, Haase U, Beck L, Schäfer M, Spies C
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Schmerzambulanz, Campus Charité Mitte und Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Deutschland.
Institut für Medizinische Psychologie, Philipps-Universität Marburg, Marburg, Deutschland.
Schmerz. 2017 Apr;31(2):149-158. doi: 10.1007/s00482-016-0166-x.
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.
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.
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.
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.
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.
纤维肌痛综合征的病因尚未完全明确。目前的假说认为，γ-羟基丁酸（GHB）可能在影响纤维肌痛患者的内分泌异常方面发挥作用。
本研究旨在调查低剂量GHB作为一种生长激素释放物质，是否能减轻纤维肌痛门诊患者的疼痛强度，改善抑郁情绪、身体功能障碍和睡眠质量。此外，还记录了不良事件。
本前瞻性研究在柏林夏里特大学医学中心麻醉与外科重症监护门诊的疼痛门诊进行。根据美国风湿病学会的标准，将25例女性纤维肌痛患者随机分为2组。在15周的时间里，干预组患者在睡前口服25mg/kg体重的GHB，并与安慰剂对照组进行比较。此外，所有患者都参加了小组操作性行为疼痛治疗。因变量为疼痛强度、抑郁情绪、身体功能障碍和睡眠质量。
在疼痛强度（p = 0.61）、抑郁情绪（p = 0.16）、身体功能障碍（p = 0.25）和睡眠质量（p = 0.44）方面，两组之间没有差异；然而，从治疗前到治疗后，所有症状在两组中均有改善。低剂量GHB并未提高血液中生长激素的浓度。两组中报告次数超过两次的不良事件数量相似。
低剂量GHB对女性纤维肌痛门诊患者没有产生临床改善效果。治疗过程中的总体改善可能源于操作性行为疼痛治疗。未来关于GHB的研究应控制假设的风险因素，以识别无反应者。
