Abstract
BackgroundFibromyalgia is a common disorder characterized by chronic widespread pain, sleep disturbance, fatigue, depression, and cognitive dysfunction, resulting in substantial disability. As current analgesics provide incomplete relief and disabling side effects that aggravate fatigue and cognitive dysfunction, there is a need for new pain treatments with better efficacy and tolerability. Alpha-lipoic acid (ALA) is an antioxidant proven effective in painful diabetic neuropathy with minimal side effects.ObjectiveWe hypothesize that this agent will provide benefits in fibromyalgia because of several similarities with neuropathic pain and also because it does not cause sedation, fatigue, or mental-slowing. To test this, we have designed a clinical trial that will assess pain, side effects, and other outcomes in participants with fibromyalgia.MethodsUsing a crossover design, 24 adults with fibromyalgia will be randomly allocated to 1 of the 2 sequences of ALA and placebo. Participants will take capsules containing ALA or placebo for 4 weeks followed by a 1-week washout followed by a second 4-week treatment and 1-week washout period. ALA (or matching placebo) capsules will be titrated to 1800 mg/day over each 4-week period. The primary outcome will be mean daily pain intensity (0-10) during week 4 of each period. Secondary outcomes, assessed during week 4 of each period, will include global improvement, adverse events, mood, and quality of life.ResultsThis trial was registered in the International Standard Randomized Controlled Trial registry March 15, 2016 (Number ISRCTN58259979), and it attained ethics approval on December 3, 2016 (Queen’s University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board protocol number ANAE-287-15). The recruitment started in February 2017.ConclusionsThis trial will provide evidence for the efficacy of ALA in fibromyalgia.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 58259979; www.isrctn.com/ISRCTN58259979 (Archived by WebCite at http://www.webcitation.org/6og9JdiyZ)
Highlights
Fibromyalgia is a multisystem disorder characterized by chronic widespread pain, sleep disturbance, fatigue, irritable bowel syndrome, depressed mood, and cognitive dysfunction, that is reflected in functional disability and impaired quality of life [1,2]
Our primary hypothesis is that Alpha-lipoic acid (ALA) is safe and superior to placebo in treating pain in fibromyalgia
This trial has been funded by the Physicians’ Services Incorporated Foundation. It was registered in the International Standard Randomized Controlled Trial registry March 15, 2016 (Number ISRCTN58259979), and it attained ethics approval on December 3, 2016 (Queen’s University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board protocol number ANAE-287-15)
Summary
Fibromyalgia is a multisystem disorder characterized by chronic widespread pain, sleep disturbance, fatigue, irritable bowel syndrome, depressed mood, and cognitive dysfunction, that is reflected in functional disability and impaired quality of life [1,2]. In fibromyalgia (and most other chronic pain conditions), current drugs reduce pain by only 25-40% on average, and meaningful relief occurs in only 40-60% of the patients [9,11] This is in part due to incomplete efficacy and dose-limiting adverse events associated with these drugs (eg, sedation, cognitive dysfunction, and dizziness). It is perhaps not surprising that several treatments effective in neuropathic pain (eg, tricyclic antidepressants, selective norepinephrine reuptake inhibitor [SNRI] antidepressants, gabapentin, and pregabalin) are effective in fibromyalgia [10] These converging lines of evidence provide a sound rationale for evaluating new therapies for fibromyalgia that are known to be efficacious in neuropathic pain. JMIR Res Protoc 2017 | vol 6 | iss. 3 | e41 | p. 2 (page number not for citation purposes) dysfunction, we expect that ALA will have the added benefit of not exacerbating these fibromyalgia-related symptoms
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