Bad medicine: restless legs syndromeBMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f7615 (Published 19 December 2013) Cite this as: BMJ 2013;347:f7615
- Des Spence, general practitioner, Glasgow
All roads lead to neurology, today’s repository for the medically unexplained. Consider the rise of partial epilepsy, tremor, sleep disorders, atypical migraine, complex regional pain syndromes, and paraesthesia, for example. These conditions have limited pathological basis, few objective tests, and are based on symptoms that patients report themselves. The truth is that what we really know about the higher functioning of the brain can be written on the back of a large postage stamp.⇑
Restless legs syndrome (RLS) is deemed a common and serious neurological syndrome that affects 10% of the population,1 with 2-3% considerably affected,2 for which doctors are berated for underdiagnosis and undertreatment.3 The syndrome disturbs sleep and is characterised by restless movement and odd sensations in the legs. It is considered both a movement disorder and a sleep disorder, and various models of causation have been posited. But these symptoms are nebulous and unexplained biologically. In 20 years I have never had a patient present with these as primary symptoms in a consultation. So what I am being told does not reflect what I see.
The story of RLS is also a big pharma classic, with its fingerprints all over the research and even involvement in defining diagnostic criteria: “pharmaceutical companies attended the workshop and many of them made very helpful contributions.”4 This cosy group of elite international experts is steeped in direct payments from pharmaceutical companies and hence conflicts of interest.5
RLS research uses a classic trick: take soft, subjective symptoms that patients report themselves and then pseudoscientifically convert them to an illegitimate numerical rating.6 This can give statistically significant outcomes but with almost no discernible benefit for symptoms, sleep, and quality of life.7 8 There is also a massive unexplainable 40% placebo response in RLS.9 Indeed, rationally, placebos should be the treatment of choice. In addition the epidemiology describes a twofold difference among countries and between sexes.2
The biological basis of RLS is implausible, it is not one condition, and the benefit of treatment is marginal. But that hasn’t stopped the drug dealing, involving the usual suspects such as gabapentin derivatives (recently approved by the US Food and Drug Administration),10 strong opioids, and benzodiazepines.1 These psychoactive drugs are difficult to compare with placebo and are associated with dependence and rebound insomnia. Of course the big money is with RLS labelled as a chronic disease so that long term treatments can be peddled,11 despite a derelict research base and short duration of studies.12 RLS is medically unexplained yet the diagnosis is uncritically accepted. We risk overdiagnosis, overtreatment, and iatrogenic harm—classic bad medicine.
Cite this as: BMJ 2013;347:f7615
Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.
Provenance and peer review: Commissioned; not externally peer reviewed.
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