sodium-oxybate and Fatigue

The original European League Against Rheumatism recommendations for managing fibromyalgia assessed evidence up to 2005. The paucity of studies meant that most recommendations were 'expert opinion'.. A multidisciplinary group from 12 countries assessed evidence with a focus on systematic reviews and meta-analyses concerned with pharmacological/non-pharmacological management for fibromyalgia. A review, in May 2015, identified eligible publications and key outcomes assessed were pain, fatigue, sleep and daily functioning. The Grading of Recommendations Assessment, Development and Evaluation system was used for making recommendations.. 2979 titles were identified: from these 275 full papers were selected for review and 107 reviews (and/or meta-analyses) evaluated as eligible. Based on meta-analyses, the only 'strong for' therapy-based recommendation in the guidelines was exercise. Based on expert opinion, a graduated approach, the following four main stages are suggested underpinned by shared decision-making with patients. Initial management should involve patient education and focus on non-pharmacological therapies. In case of non-response, further therapies (all of which were evaluated as 'weak for' based on meta-analyses) should be tailored to the specific needs of the individual and may involve psychological therapies (for mood disorders and unhelpful coping strategies), pharmacotherapy (for severe pain or sleep disturbance) and/or a multimodal rehabilitation programme (for severe disability).. These recommendations are underpinned by high-quality reviews and meta-analyses. The size of effect for most treatments is relatively modest. We propose research priorities clarifying who will benefit from specific interventions, their effect in combination and organisation of healthcare systems to optimise outcome.

Topics: Activities of Daily Living; Acupuncture Therapy; Amitriptyline; Anti-Inflammatory Agents, Non-Steroidal; Anticonvulsants; Antidepressive Agents, Tricyclic; Biofeedback, Psychology; Capsaicin; Cognitive Behavioral Therapy; Europe; Evidence-Based Medicine; Exercise Therapy; Fatigue; Fibromyalgia; Human Growth Hormone; Humans; Hydrotherapy; Hypnosis; Manipulation, Chiropractic; Massage; Mind-Body Therapies; Mindfulness; Monoamine Oxidase Inhibitors; Pain; Practice Guidelines as Topic; S-Adenosylmethionine; Selective Serotonin Reuptake Inhibitors; Sensory System Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Sleep; Societies, Medical; Sodium Oxybate; Treatment Outcome

This 14-week, phase 3, double-blind, randomized, controlled trial evaluated sodium oxybate (SXB) 4.5 and 6g per night versus placebo in patients with fibromyalgia (FM). SXB is the sodium salt of γ-hydroxybutyrate (GHB). GHB is an endogenous compound, synthesized from γ-aminobutyric acid (GABA) and found broadly in the central nervous system and body. Among 548 randomized patients, a ≥30% reduction in pain was experienced by 54.2% and 58.5% of patients treated with SXB 4.5 and 6g, respectively, versus 35.2% for placebo with a 100-mm Visual Analog Scale (VAS) (P<0.001 for both comparisons). Relative to placebo, both SXB doses significantly reduced fatigue (with a 100-mm VAS; P<0.001) and sleep disturbance (with the Jenkins Sleep Scale; P<0.001), and resulted in significant improvements in function as measured by the FM Impact Questionnaire (P=0.003 and P=0.001 for 4.5 and 6 g per night, respectively). On the Short-Form 36 Health Survey, SXB-related improvement was significant on the Physical, but not the Mental, Component Scale. The proportion of patients who reported a global improvement of "much" or "very much" better on the Patient Global Impression of Change was significantly greater in both SXB groups versus placebo (P<0.001). Headache, nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis were the most commonly reported adverse events, with an incidence at least twice that of placebo. These results expand the evidence from previous clinical trials suggesting that SXB is effective and safe in FM.

Topics: Adjuvants, Anesthesia; Adult; Dose-Response Relationship, Drug; Double-Blind Method; Fatigue; Female; Fibromyalgia; Humans; Male; Middle Aged; Pain; Pain Measurement; Quality of Life; Sleep Wake Disorders; Sodium Oxybate; Treatment Outcome

To evaluate the effects of using a gamma-hydroxybutyrate (GHB) administered in divided doses at night in 11 patients previously diagnosed with fibromyalgia (FM).. Subjects completed daily diaries assessing their pain and fatigue levels and slept in the sleep laboratory before and one month after initiating GHB treatment. Polysomnographic recordings were evaluated for sleep stages, sleep efficiency and the presence of the alpha anomaly in non-REM sleep.. There was a significant improvement in both fatigue and pain, with an increase in slow wave sleep and a decrease in the severity of the alpha anomaly.. Further controlled studies are needed to characterize the clinical improvement and the polysomnographic changes we observed.

Topics: Adult; Fatigue; Female; Fibromyalgia; Humans; Male; Middle Aged; Pain; Pilot Projects; Polysomnography; Sleep Wake Disorders; Sodium Oxybate

Topics: Adjuvants, Anesthesia; Alpha Rhythm; Fatigue; Fibromyalgia; Humans; Pain; Sodium Oxybate