Abstract
BackgroundFibromyalgia is a prevalent chronic rheumatic disease of great clinical importance. Recent studies have found raised levels of glutamate in the insula, hippocampus and posterior cingulate cortex regions of the brains of fibromyalgia (FM) patients. This finding has led researchers to speculate about the usefulness of glutamate-blocking drugs such as memantine in the treatment of fibromyalgia. The hypothesis of this study is that the administration of memantine will reduce the glutamate levels, and futhermore, will decrease the perceived pain. The aim of this study is to evaluate the efficacy of memantine in the treatment of pain (pain perception). A secondary objective is to evaluate the efficacy of memantine in the treatment of other clinical symptoms of FM, and to evaluate the efficacy of memantine in reducing brain levels of glutamate, and its effects on the central nervous system as a whole.Method/DesignA double-blind parallel randomized controlled trial. Participants, Seventy patients diagnosed with FM will be recruited from primary health care centers in Zaragoza, Spain. Intervention. The subjects will be randomized in two groups: A) A treatment group (n = 35), which will receive 20 mg of memantine daily; B) A control group (n = 35), to which will be administered a placebo. There will be a six-month follow-up period (including a titration period of one month). Outcomes. The main efficacy variable of this study is pain (pain perception). The secondary efficacy variables are clinical symptoms (pain threshold, cognitive function, health status, anxiety, depression, clinical impression and quality of life) and glutamate levels in different regions of the brain, which will be assessed by magnetic resonance spectroscopy. Randomization and blinding. Randomization has been computer-generated, and the random allocation sequence will be implemented by telephone. Subjects of the study and the research assistants will be blinded to group assignment.DiscussionThere is a need for the development of innovative and more effective treatments for fibromyalgia. This clinical trial will determine whether memantine can be an effective pharmacological treatment for fibromyalgia patients.Trial registrationCurrent Controlled Trials http://ISRCTN45127327 EUDRACT 2011-006244-73
Highlights
Fibromyalgia is a prevalent chronic rheumatic disease of great clinical importance
There is a need for the development of innovative and more effective treatments for fibromyalgia
The neurophysiology of the phenomenon of pain has led to increased interest in employing different neuroimaging methods such as positron emission tomography (PET) [5], single photon emission computed tomography (SPECT) [6,7], functional magnetic resonance imaging and, more recently, magnetic resonance diffusion and diffusion tensor spectroscopy to identify the brain structures activated during episodes of pain in patients and controls [8]
Summary
This is the first randomized, controlled study of memantine for the treatment of fibromyalgia. Based on previous preliminary pilot studies (personal communication) a significant improvement in key clinical symptoms in fibromyalgia, such as depression, cognition and global function can be expected. Cognition is one of the most impairing symptoms in fibromyalgia [36] and is strongly correlated with depression [37] Cognition in these patients seems to be related to brain morphology changes that could be improved with memantine [38]. There is no clear hypothesis as to whether memantine is able to reduce glutamate levels in the affected brain areas, or, independent of this possibility, whether the drug will be an effective treatment for different clinical symptoms of fibromyalgia, in the cognitive domain. All authors have read and corrected draft versions and approved the final version
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