Acupuncture for restless legs syndrome: Cochrane systematic review


Assessed as up to date: 2008/05/30


Restless legs syndrome (RLS) is a common movement disorder for which patients may seek treatment with acupuncture. However, the benefits of acupuncture in the treatment of RLS are unclear and have not been evaluated in a systematic review until now.


To evaluate the efficacy and safety of acupuncture therapy in patients with RLS.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2007), MEDLINE (January 1950 to February 2007), EMBASE (January 1980 to 2007 Week 8), Chinese Biomedical Database (CBM) (1978 to February 2007), China National Knowledge Infrastructure (CNKI) (1979 to February 2007), VIP Database (1989 to February 2007), Japana Centra Revuo Medicina (1983 to 2007) and Korean Medical Database (1986 to 2007). Four Chinese journals, relevant academic conference proceedings and reference lists of articles were handsearched.

Selection criteria

Randomized controlled trials and quasi-randomized trials comparing acupuncture with no intervention, placebo acupuncture, sham acupuncture, pharmacological treatments, or other non-acupuncture interventions for primary RLS were included. Trials comparing acupuncture plus non-acupuncture treatment with the same non-acupuncture treatment were also included. Trials that only compared different forms of acupuncture or different acupoints were excluded.

Data collection and analysis

Two authors independently identified potential articles, assessed methodological quality and extracted data. Relative risk (RR) was used for binary outcomes and weighted mean difference for continuous variables. Results were combined only in the absence of clinical heterogeneity.

Main results

Fourteen potentially relevant trials were identified initially, but twelve of them did not meet the selection criteria and were excluded. Only two trials with 170 patients met the inclusion criteria. No data could be combined due to clinical heterogeneity between trials. Both trials had methodological and/or reporting shortcomings. No significant difference was detected in remission of overall symptoms between acupuncture and medications in one trial (RR 0.97, 95% CI 0.76 to 1.24). Another trial found that dermal needle therapy used in combination with medications and massage was more effective than medications and massage alone, in terms of remission of unpleasant sensations in the legs (RR 1.36, 95% CI 1.06 to 1.75; WMD -0.61, 95% CI -0.96 to -0.26) and reduction of RLS frequency (WMD -3.44, 95% CI -5.15 to -1.73). However, there was no significant difference for the reduction in either the longest or the shortest duration of RLS (WMD -2.58, 95% CI -5.92 to 0.76; WMD -0.38, 95% CI -1.08 to 0.32).

Authors' conclusions

There is insufficient evidence to determine whether acupuncture is an efficacious and safe treatment for RLS. Further well-designed, large-scale clinical trials are needed.


Cui Ye, Wang Yin, Liu Zhishun


There is insufficient evidence to support the use of acupuncture for the symptomatic treatment of restless legs syndrome.

Restless legs syndrome (RLS) is a sensorimotor movement disorder characterized by uncomfortable sensations in the legs and an urge to move them. The syndrome is very common and its lifestyle impacts justify a search for more effective and acceptable interventions.

Acupuncture is an ancient Chinese therapeutic method. It regulates the function of internal organs and rebalances body energies by stimulating certain acupoints. As a non-pharmacological therapy, it would be of potential value in the treatment of RLS.

This review investigated the efficacy and adverse effects of acupuncture in treating RLS. The review did not find consistent evidence to determine whether acupuncture is effective and safe in the treatment of RLS, based on the two trials identified. More high quality trials are warranted before the routine use of acupuncture can be recommended for patients suffering from RLS.

Reviewer's Conclusions

Implications for practice

The belief that acupuncture is an effective treatment for RLS is not based on rigorous and comprehensive evidence. The hypotheses need to be validated by further high quality research before the routine use of acupuncture can be recommended for patients suffering from RLS.

Implications for research

Further high quality research is warranted to evaluate the efficacy and safety of acupuncture in the treatment of RLS. Here are some suggestions for future studies:

(1) statistical method of sample size calculations with at least 80% power of detecting a difference of clinical importance on a chosen outcome measure should be conducted to determine the minimum number of patients required;

(2) the method of randomization and allocation concealment should be rigorous and fully described to encourage confidence in the control of selection bias;

(3) although blinding of acupuncture practitioners is very unlikely, blinding of participants and outcome assessors should be attempted in order to minimize performance and detection biases;

(4) more sensitive and valid clinical outcomes such as PLMS index and quality of life should be used;

(5) a longer follow-up period is recommended to determine the long-term effects of acupuncture in the treatment of RLS;

(6) adverse effects of acupuncture should be critically assessed and reported; and

(7) it might also be worthwhile to examine the effectiveness of non-invasive acupressure therapy for RLS.

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