Summary
The current treatment alternatives for the fibromyalgia are limited by the sparse information regarding its etiology and natural history. Further scientific study is necessary to accurately define methods of treatment, which additionally may lead to insight into its cause. The recent study utilizing Sodium Oxybate is one investigation which has increased our knowledge regarding this troubling condition.
Analysis
Fibromyalgia is a debilitating condition which is manifested by pain, fatigue, stiffness and difficulty sleeping. Despite these easily identifiable symptoms, no definitive treatment modalities has emerged. As a result, studies which address fibromyalgia play an important role in understanding this disease. One such study includes the use of Sodium Oxybate.
Sodium Oxybate is a metabolite of GABA, an endogenous neurotransmitter of the central nervous system. The study involved two different doses of Sodium Oxybate and a placebo control in a rigorous Phase III double blind prospective randomized study. The results demonstrate a significant difference at the 4.5 g/night level. Specifically, 46.2% of patients taking the 4.5 g/night dose achieved at least 30% relief of symptoms based on a visual analog scale. Of those patients taking 6.0 g/night, 39.3 % achieved at least 30% relief. Interestingly, in the placebo group, 27.3% achieved at least 30% relief. The study concludes by stating that Sodium Oxybate can help relieve symptoms of fibromyalgia and likely does this by affecting the GABA receptor system of the central nervous system.
Questions which might be asked about the study include 1) why do almost 30% of patients get relief from placebo? my opinion is that there is a large psychosocial component to this condition in which a placebo "treatment" might play a role. 2) is a minimum of 30% pain relief an adequate criteria to measure effectiveness? are the risks of experiencing side effects worth the benefit of getting 30% relief of pain? 3) will the positive effects of the drug be long lasting? the study group underwent treatment for 14 weeks. With longer-term treatment, will there be up-regulation or alteration in the sensitivity of GABA receptors?
In summary, this study using Sodium Oxybate is a well-designed investigation of a potential treatment for fibromyalgia. It is useful. not only from a therapeutic standpoint, but also educational in terms of identifying possible causes at the central nervous system level and also stimulates further questions for scientific study.
