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Reserve drug therapy for the most severe cases of restless legs

The study

US researchers analysed data from 29 randomised controlled trials on pharmacological treatment for primary restless legs syndrome of at least four week’s duration. Treatment was either with dopaminergic drugs usually used in Parkinson’s disease (such as pramipexole, roitigotine or ropinirole) or the GABA analogues gababentin and pregabalin.

The findings

Patients who had long-term, high-moderate to severe symptoms found significant benefit from both classes of drug. Response - defined as 50% or greater reduction in symptoms from baseline – was 61% with the dopaminergic drugs compared to 41% with placebo. Similarly 61% of patients responded to gababentin or pregabalin compared to 37% with placebo. Significant improvements in sleep scores and quality of life was also seen. But treatment withdrawal rates were high - up to 57% with the dopaminergic drugs -  and there was little evidence to support the use of the drugs in patients with less severe symptoms.

What does it mean for GPs?

Previous UK primary care research has found a huge variation in the management of restless legs syndrome plus widespread use of unlicensed treatments- such as hypnotics and antidepressants – with no evidence-base. This review identifies a subset of the most severely affected patients who could benefit from a trial of treatment if self-help advice - such as improved sleep hygiene and stretching and massaging the affected leg - has not helped.

Expert comment

Dr Adrian Macdonald a GP and clinical assistant in neurology from Glasgow said: ‘Restless legs syndrome is a fairly common problem - up to 15% of the population in some studies – and good data on treatment options has been hard to find.

‘This study gives us an idea which patients could benefit from therapy- although it’s interesting to note how high the placebo response is in these trials.

‘We need to concentrate on accurate diagnosis and making sure exacerbating factors like poor sleep hygiene, smoking and caffeine use have been minimised. But after that I see no reason why GPs shouldn’t start a trial of a dopamine agonist in patient’s most severely affected – and refer if there is no response. Drugs like gabapentic aren’t licensed for restless legs in the UK’

JAMA Intern Med. 2013; (1):1-10

Readers' comments (1)

  • Vinci Ho

    Presumably there was some statistical analysis in the study ? Because the placebo response was high , you need a p value to reject a null hypothesis to confirm significant difference between treatment arms and placebo ?

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