Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study.

Author: Elena CalandrePiedad Morillas-ArquesRocio Molina-BareaCarmen Rodriguez-lopezFernando Rico-Villademoros
Credits/Source: BMC Musculoskeletal Disorders 2011, 12:95

Although trazodone is frequently used by fibromyalgia patients, its efficacy on this disease has not been adequately studied. If effective, pregabalin, whose beneficial effects on pain and sleep quality in fibromyalgia have been demonstrated, could complement the antidepressant and anxiolytic effects of trazodone.
The aim of the present study was to assess the effectiveness of trazodone alone and in combination with pregabalin in the treatment of fibromyalgia.

Methods:
This was an open-label uncontrolled study.Trazodone, flexibly dosed (50-300 mg/day), was administered to 66 fibromyalgia patients during 12 weeks; 41 patients who completed the treatment accepted to receive pregabalin, also flexibly dosed (72-450 mg/day), added to trazodone treatment for an additional 12-week period. Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index (PSQI) the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients'Global Improvement scale (PGI).
Emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test.

Results:
Treatment with trazodone significantly improved global fibromyalgia severity, sleep quality, and depression, as well as pain interference with daily activities although without showing a direct effect on bodily pain.
After pregabalin combination additional and significant improvements were seen on fibromyalgia severity, depression and pain interference with daily activities, and a decrease in bodily pain was also apparent. During the second phase of the study, only two patients dropped out due to side effects.

Conclusions:
Trazodone significantly improved fibromyalgia severity and associated symptomatology.
Its combination with pregabalin potentiated this improvement and the tolerability of the drugs in association was good.Trial registration: This trial has been registered with ClinicalTrials.gov number NCT-00791739.

http://7thspace.com/headlines/382593/trazodone_plus_pregabalin_combination_in_the_treatment_of_fibromyalgia_a_two_phase_24_week_open_label_uncontrolled_study.html

European Medicines Agency decided against Xyrem (sodium oxybate)

Adrienne Dellwo, March 21, 2011
The European Medicines Agency has decided against recommending Xyrem (sodium oxybate) for treating fibromyalgia in adults. To date, the European Union doesn't have any medications approved for fibromyalgia.
Xyrem is approved in both the EU and the U.S. for narcolepsy and cataplexy (a narcolepsy symptom.) The U.S. FDA rejected this medication as a fibromyalgia treatment in October 2010, citing concerns over safety because it's similar to the date-rape drug GHB.
In clinical trials, Xyrem has been shown to improve the quality of stage-four sleep in fibromyalgia. Disrupted deep sleep is believed to be a primary contributor to symptoms of this illness and may play a role in its pathogenesis.
http://chronicfatigue.about.com/b/2011/03/21/eu-says-no-to-proposed-fibromyalgia-drug.htm

Dr. Ranchhodbhai Chaudhary, MD - Internal Medicine Physician

January 12, 2011

Q: What is the treatment for Fibromyalgia?

A: The goal of treatment for fibromyalgia is a multimodal approach to reduce fatigue and to allow appropriate sleep and activity routine. It includes both pharmacologic and non-pharmacologic treatments that are individualized for patients. Non-pharmacologic treatments are exercise, cognitive behavioral therapy, and psychotherapy. Educating patients that fibromyalgia is not a life-threatening disorder, not associated with deformity or with increased mortality or early death is critical to optimal management and improves the outcome. Light aerobic exercise appropriately titrated to an individual’s aerobic threshold, is as effective as any medication. Patients should stay away from narcotics to prevent further fatigue.