Acupuncture For Restless Legs Syndrome (Review) : Cui Y, Wang Y, Liu Z

Acupuncture for restless legs syndrome (Review)
Cui Y, Wang Y, Liu Z
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2008, Issue 4
http://www.thecochranelibrary.com
Acupuncture for restless legs syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Analysis 1.1. Comparison 1 Acupuncture versus no acupuncture, Outcome 1 Reduction in VAS score of unpleasant
sensations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Analysis 1.2. Comparison 1 Acupuncture versus no acupuncture, Outcome 2 Symptom remission. . . . . . . . 16
Analysis 1.3. Comparison 1 Acupuncture versus no acupuncture, Outcome 3 Reduction in RLS duration. . . . . 16
Analysis 1.4. Comparison 1 Acupuncture versus no acupuncture, Outcome 4 Reduction in RLS frequency. . . . . 17
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Acupuncture for restless legs syndrome (Review) i

[Intervention Review]
Acupuncture for restless legs syndrome
Ye Cui1 , Yin Wang2 , Zhishun Liu3
1 Department of Acupuncture and Moxibustion, Guang An Men Hospital - The China Academy of Chinese Medicine Science, Beijing,
China. 2 Department of Acupunture and Moxibustion, Guang An Men Hospital - The China Academy of Chinese Medicine Science,
Beijing, China. 3 Department of Acupuncture & Moxibustion, Guang An Men Hospital, China Academy of Traditional Chinese
Medicine, Beijing, China
Contact address: Ye Cui, Department of Acupuncture and Moxibustion, Guang An Men Hospital - The China Academy of Chinese
Medicine Science, Nº 5 Bei Xian Ge Street, Xuan Wu District, Beijing, 100053, China. [email protected].
Editorial group: Cochrane Movement Disorders Group.

Publication status and date: New, published in Issue 4, 2008.
Review content assessed as up-to-date: 29 May 2008.
Citation: Cui Y, Wang Y, Liu Z. Acupuncture for restless legs syndrome. Cochrane Database of Systematic Reviews 2008, Issue 4. Art.
No.: CD006457. DOI: 10.1002/14651858.CD006457.pub2.
ABSTRACT
Background
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.
Objectives
To evaluate the efficacy and safety of acupuncture therapy in patients with RLS.
Search strategy
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.
Acupuncture for restless legs syndrome (Review) 1
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.
PLAIN LANGUAGE SUMMARY
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.
BACKGROUND Racial and genetic factors may also play a role in such discrepan-
cies (Tison 2005).
Restless legs syndrome (RLS), a common sensorimotor movement
disorder first described in detail by Ekbom (Ekbom 1945), ranges In 1995, a uniform diagnosis of RLS was made possible world-
in severity from merely causing annoyance in the patient to af- wide, based on the criteria proposed by the International RLS
fecting sleep and quality of life severely enough to warrant med- Study Group (IRLSSG) (Walters 1995). According to the most
ical treatment (Allen 2005). Although its negative impact is be- recently revised diagnostic criteria (Allen 2003), the four clinical
yond doubt, RLS is still widely under-diagnosed and inadequately manifestations mandatory for the diagnosis are:
treated (Hogl 2005b).
(1) an urge to move the legs, accompanied or caused by uncom-
Remarkable differences in prevalence rates of RLS can be observed fortable and unpleasant sensations in the legs;
across countries and geographic regions. Epidemiological research (2) the urge to move or the unpleasant sensations begin or worsen
demonstrates that the prevalence of RLS in adults (18 years or during periods of rest or inactivity;
more) ranges from less than 1% (Tan 2001) in Singapore to ap-
proximately 10% in Europe and the United States (Hogl 2005a). (3) the urge to move or the unpleasant sensations are partially or
Such differences may be caused by variations in study methods. totally relieved by movement;
(4) the urge to move or the unpleasant sensations are worse in the patients with RLS, but rarely do these efforts completely eliminate
evening or night or only occur in the evening or night. symptoms (NINDS 2006).
Another associated sleep disorder, periodic leg movements during Acupuncture, an ancient Chinese medical therapy used in the pre-
sleep (PLMS), is observed in about 85% of patients with RLS ( vention and treatment of disease, is another useful method for
Wong 2006). PLMS are repetitive, stereotypical movements and treating RLS (Wang 2001). It involves inserting needles into spe-
include extension of the big toe with fanning of the small toes cific points (acupoints or Xue Wei) on the human body to bring
accompanied by flexion at the ankles, knees and thighs. They about its therapeutic effects. Conventional science suggests that
can cause significant disruption of sleep with decreased total sleep acupuncture works by neurological, neurohormonal as well as psy-
time and a consequent increase in daytime sleepiness (Schapira chological mechanisms (Smith 2006), and it is thought to confer
2004). Though not specific to RLS, PLMS can be supportive in an analgesic effect (Green 2006). Several kinds of acupuncture
its diagnosis (Allen 2003). methods, such as body acupuncture, auricular acupuncture, scalp
Etiology acupuncture, electro-acupuncture, laser acupuncture, acupressure,
acupoint injection therapy (injection of drugs into acupoints) or
The etiology of RLS is still not completely understood. Iron de- a combination of the approaches mentioned above, are used in
ficiency, renal failure and pregnancy may actually contribute to the treatment of RLS (Sun 2002; Wang 1994; Wen 2000; Zhao
RLS, which is then considered secondary RLS (Harrison’s 2001). 2005a).
Apart from the above established causes, there are no known phys-
ical abnormalities associated with the disorder (Hornyak 2006). A The mechanism of acupuncture treatment for RLS is still ill-de-
hypothesis of primary RLS etiology is associated with brain iron fined. According to our preliminary research, the current practice
homeostasis (Bogan 2006; Hogl 2005a). A study using magnetic of acupuncture for RLS is mainly based on principles of Traditional
resonance imaging has demonstrated reduced levels of iron in the Chinese Medicine (TCM) rather than conventional science. The
substantia nigra and putamen of patients with primary RLS (Allen traditional explanation, based on TCM theory, is that acupunc-
2001). Interestingly, iron is a co-factor for tyrosine hydroxylase, the ture restores the balance between Yin and Yang and regulates Qi
rate-limiting enzyme in dopamine production (Schapira 2004). (the essence) and blood so that integral unity can be maintained
and miscellaneous diseases cured (Yang 1997).
Although the exact role of dopamine in the pathogenesis of
RLS remains ill-defined (Lin 1998), positive results have been Some clinical trials have examined the efficacy of acupuncture in
demonstrated by several double-blind clinical trials, in which the the treatment of RLS and demonstrated that it was able to alleviate
dopamine precursor Levodopa (L-dopa) or dopamine agonists the clinical symptoms (Qiao 1997; Song 2004; Wang 2005). To
were applied (Allen 1998; Bogan 2006; Brodeur 1988; Montplaisir our knowledge, however, no systematic review has been published
1999; Walters 1988), thus implicating that both the dysfunction addressing the effectiveness and safety of acupuncture for relief of
of dopaminergic systems and brain iron homeostasis may cause RLS symptoms. Therefore, this review focused on investigating
the condition of RLS (Bogan 2006). the therapeutic efficacy and safety of acupuncture for RLS.
Treatment
A shift from L-dopa toward dopamine agonists as the first-line
treatment for RLS had been suggested by the Medical Advisory
OBJECTIVES
Board of the Restless Legs Syndrome Foundation (Silber 2004). The objectives of this systematic review are to evaluate the efficacy
Dopamine agonists are less likely to cause augmentation and re- and safety of acupuncture therapy in patients with RLS.
bound. Augmentation has been defined as an earlier onset of RLS
symptoms during the day, more rapid onset of symptoms when The following hypotheses are to be tested:
at rest, together with increased severity and shorter symptomatic
(1) acupuncture is more effective than placebo acupuncture, sham
relief from dopaminergic therapy (NINDS 2006; Schapira 2004).
acupuncture or no treatment in treating RLS;
Rebound is the appearance of RLS symptoms when the effects of
the drug are wearing off (Trenkwalder 2005). In 2005, ropinirole, (2) acupuncture is more effective than Western medicine or herbal
a nonergot-based dopamine agonist, became the only drug ap- medicine in treating RLS;
proved by the U.S. Food and Drug Administration specifically for
the treatment of moderate to severe RLS (Bogan 2006; NINDS (3) there are fewer adverse effects in the acupuncture group than
2006). in the Western medicine or herbal medicine group.
Apart from medications, certain lifestyle changes, decreased use of

caffeine, alcohol, and tobacco, maintaining a regular sleep pattern
and regular moderate exercise might also provide some relief for METHODS

Criteria for considering studies for this review (3) sleep disturbance measured on a scale (for example, sleep onset
latency (SOL));
(4) wakefulness after sleep onset (WASO) or by reported total sleep
Types of studies time;
(5) daytime functioning;
Randomized controlled trials (RCTs) and quasi-randomized trials (6) quality of life measures (e.g. SF-36);
(i.e., trials that used odd-even numbers or patient medical record (7) frequency and types of adverse effects.
numbers etc. as methods of allocation).
Studies were single or double blind or unblinded.
Search methods for identification of studies

Types of participants
(1) Electronic searches
Inclusion criteria
We searched the following electronic databases irrespective of lan-
We included patients with primary RLS consistent with the di-
guage and publication status: the Cochrane Central Register of
agnostic criteria defined by IRLSSG (Allen 2003; Walters 1995)
Controlled Trials (CENTRAL, The Cochrane Library, Issue 1,
irrespective of gender, race, age and setting.
2007), MEDLINE (January 1950 to February 2007), EMBASE
Exclusion criteria
(January 1980 to 2007 Week 8), Chinese Biomedical Database
We excluded patients with any signs of psychiatric or organic dis-
(CBM) (1978 to February 2007), China National Knowledge In-
orders.
frastructure (CNKI) (1979 to February 2007), and VIP Database
(1989 to February 2007). In addition, we checked Japana Centra
Revuo Medicina (http://www.jamas.gr.jp/) (1983 to 2007) and
Types of interventions
Korean Medical Database (http://kmbase.medric.or.kr/) (1986 to
We included trials evaluating all forms of acupuncture therapy in- 2007) for trials published in Japanese and Korean respectively.
cluding body acupuncture, auricular acupuncture, scalp acupunc- We also checked the reference lists of all included studies for other
ture, electro-acupuncture, laser acupuncture, dermal needle ther- potentially relevant publications.
apy, acupoint injection therapy, acupressure therapy and other CENTRAL (Ovid), MEDLINE (Ovid), EMBASE (Ovid)
acupuncture interventions. Search strategy to locate RLS:
The control interventions were: #1 restless legs syndrome
(1) no intervention, placebo acupuncture or sham acupuncture; #2 RLS
(2) pharmacological treatments (Western medicine or herbal #3 periodic leg movements
medicine or combination of them); #4 PLM or PLMS
(3) other non-acupuncture interventions. #5 Ekbom
We also included trials that compared acupuncture therapy plus #6 or/1-5
non-acupuncture treatment with the same non-acupuncture treat- Search Strategy to locate acupuncture interventions:
ment. #7 acupuncture
We excluded trials that only compared different forms of acupunc- #8 electroacupuncture
ture or different acupoints. #9 electro-acupuncture
#10 acupuncture points
#11 body acupuncture
Types of outcome measures #12 auricular acupuncture
Primary outcomes #13 ear acupuncture
#14 scalp acupuncture
(1) Unpleasant sensations of RLS measured by any type of vali- #15 laser acupuncture
dated scale (for example, visual analog scale (VAS)). #16 acupoint injection
#17 dermal needle
(2) Improvement of overall symptoms measured as a dichotomous #18 acupressure
outcome (remission versus no remission). #19 or/7-18
Secondary outcomes #20 6 and 19
We also considered the following outcome measures: The search strategy was translated accordingly for the databases in
(1) periodic leg movements during sleep (PLMS) index; Chinese, Japanese and Korean.
(2) absolute or percentage reduction in RLS frequency and dura- A record of the electronic searches conducted above was kept for
tion; future review.

(2) The following journals were handsearched from the first issue Two review authors (Cui and Wang) independently extracted data
to February 2007: Chinese Acupuncture & Moxibustion, Shanghai from included trials using a piloted data extraction form. The fol-
Journal of Acupuncture and Moxibustion, Acupuncture Research and lowing data were extracted from each included study: number of
Journal of Clinical Acupuncture and Moxibustion. participants, age and sex distribution, comparability of groups at
(3) We handsearched acupuncture and movement disorders con- baseline, inclusion and exclusion criteria, type, frequency and du-
ference abstracts over the past five years for further eligible studies. ration of treatment of acupuncture therapy, type of control treat-
(4) We contacted researchers in the field of acupuncture and movement, number of adverse events, duration of follow-up and num-
ment disorders for unpublished and ongoing studies. ber and reasons for dropouts.
(5) We consulted leading Chinese experts in RLS to ascertain that Extracted data were entered into RevMan by one review author
no trial was missed. (Cui) and then checked by another review author (Wang). Missing
data were obtained from trialists whenever possible.
Data analysis
We carried out the statistical analyses using RevMan 4.2. Data
Data collection and analysis were to be combined for meta-analysis if individual trials were
clinically homogeneous, otherwise a descriptive analysis was per-
Study identification
formed. We used relative risks (RR) with 95% confidence intervals
Two review authors (Cui and Wang) independently screened and
(CI) for binary outcomes and weighted mean difference (WMD)
identified all potentially relevant studies, and then selected the tri-
with 95% CI for continuous variables. We used the chi-square test
als that fulfilled the inclusion criteria. Disagreements between re-
for heterogeneity to assess statistical heterogeneity among trials.
view authors were resolved by consensus with the arbitrator (Liu).
We pooled results using a fixed-effect model in the absence of het-
Quality assessment
erogeneity. We used a random-effects model if heterogeneity was
Two review authors (Cui and Wang) independently assessed the
detected.
methodological quality of the included trials. Disagreements be-
Subgroup analysis
tween review authors were resolved by consensus with the arbitra-
We had pre-specified the following subgroup analyses:
tor (Liu).
(1) different types of acupuncture therapies;
According to the empirical evidence (Jadad 1996; Kjaergard 2001;
(2) different control interventions.
Moher 1998; Schulz 1995), we assessed the methodological qual-
Sensitivity analysis
ity of each trial based on the recommendations in the Cochrane
We planned to carry out sensitivity analyses to examine the effects
Handbook for Systematic Reviews of Interventions (Higgins 2005).
of including only those studies with adequate allocation conceal-
1. Method of randomization: A method to generate the sequence
ment or blinding of the outcome assessor.
of randomization was regarded as adequate (computer-generated
Publication bias
random numbers, table of random numbers etc.) if it allowed
We planned to investigate potential biases of publication using the
each study participant to have the same chance to receive each
funnel plot or other analytical methods, if sufficient trials were
intervention and the investigators could not predict which was the
identified (Egger 1997).
next treatment.
2. Allocation concealment: Adequate (central randomization; se-
rially numbered, opaque, sealed envelopes) or inadequate (open
list enrolment).
3. Blinding: The method of trials using blinding for outcome as- RESULTS
sessors alone or together with blinding for participants was con-
sidered as adequate, because it was unlikely for acupuncture prac-
titioners to be blinded.
4. Follow-up: Adequate (number and reasons for dropouts and
Description of studies
withdrawals described) or inadequate (number or reasons for See: Characteristics of included studies; Characteristics of excluded
dropouts and withdrawals not described). If there were no with- studies.
drawals, it should be stated in the article. Fourteen potentially relevant trials were identified from the initial
Based on the criteria above, the quality of a trial fell into one of searches. All of them were from the published literature. Of these,
the following three categories: two studies (Shi 2003; Zhou 2002) involving 170 patients in to-
A - Low risk of bias: all criteria met. tal met our inclusion criteria. Although there were no language
B - Moderate risk of bias: One or more criteria partly met or if it restrictions, both included studies were published in Chinese.
was unclear if all the criteria were met. Twelve trials were excluded for the following reasons:
C - High risk of bias: One or more criteria not met. (1) different forms of acupuncture were compared (Huang 1996;
Data extraction Tang 2003; Yang 1993);

(2) different acupoints were compared (Zhao 2005b); consecutively.
(3) patients suffered from other psychiatric or organic disorders ( The first trial (Shi 2003) described a follow-up period of six
Dai 2006; Gong 2004; Ma 2001); months, however, only the outcome immediately after treatment
(4) the four essential diagnostic criteria defined by IRLSSG were was reported. The second trial (Zhou 2002) followed participants
only partly met (Meng 2003; Zhang 2001); for one month, but the outcome measures used immediately after
(5) the non-acupuncture treatment used in the experimental group treatment were different from the outcome measures used in the
was not used in the control group (Tan 2005; Wang 1999; Zhang follow-up.
2006). Ordinal outcomes immediately following treatment were reported
The included studies used different acupuncture therapies as well by both studies. The first study (Shi 2003) used categories in-
as different comparators. The rationale for the style of acupunc- cluding ’cured’, ’marked effective’, ’improved’, and ’no effect’ to
ture used was stated in both trials. Participants in the first trial ( measure changes in overall symptoms. The second study (Zhou
Shi 2003) were diagnosed according to the criteria established by 2002) used ’cured’, ’effective’, and ’no effect’ to measure changes
IRLSSG (Walters 1995). Participants in the second trial (Zhou in unpleasant sensations in the legs. Both ordinal scales were made
2002) were diagnosed according to a similar set of criteria stated in into binary data by combining adjacent categories together. For
The Dictionary of Medical Syndromes (Lin 1994), which described the first study (Shi 2003), we combined ’cured’, ’marked effective’
all four clinical diagnostic criteria mandatory for RLS. The partic- and ’improved’ into ’remission’, and for the second study (Zhou
ipants of both studies were outpatients with primary RLS. Both 2002), we combined ’cured’ and ’effective’ into ’remission’.
trials excluded participants with other disorders. A fixed protocol The second study (Zhou 2002) also reported the means and stan-
of acupuncture prescription was used for the participants in both dard deviations for four continuous outcomes:
trials. (1) unpleasant sensations of RLS measured by VAS (baseline and
In the first trial (Shi 2003), 120 patients were assigned, according immediately after treatment);
to the entry sequence, into three groups to receive: (1) acupuncture (2) the longest duration of RLS symptoms before and after the
plus fuming and washing with herbs, or (2) Western medications, treatment (baseline and after one month);
or (3) acupuncture. However, the non-acupuncture treatment (i.e. (3) the shortest duration of RLS symptoms before and after the
fuming and washing with herbs) used in Group 1 was not used in treatment (baseline and after one month) ;
the other two groups, therefore, only Group 2 and Group 3 were (4) the frequency of RLS symptoms before and after the treatment
eligible for comparison. Patients in Group 2 were treated with (baseline and after one month).
Western medications for 30 days consecutively. Patients in Group Neither trial reported PLMS index, sleep disturbance, quality of
3 were treated with a combination of body and scalp acupunc- life or adverse effects.
ture. For body acupuncture, needles were inserted perpendicularly
into acupoints ST36, GB34, SP10, BL56 and BL57. For scalp
acupuncture, treatment zones consisted of MS5, the upper one
fifth of MS7, and MS8. The needle was first inserted obliquely at Risk of bias in included studies
an angle of 15 to 30 degrees with the scalp until its tip reached Included trials were either inadequately reported or had method-
subgaleal level, and then inserted transversely. Manipulation tech- ological flaws. Neither of the trials mentioned a sample size calcu-
niques called ’even supplementation and drainage’ were applied lation or any training of acupuncture practitioners. Neither trial
for both scalp and body acupuncture until the arrival of Qi had stated the specific data collection period. Both trials claimed that
been achieved. The needles were retained for 30 minutes, dur- baseline differences between groups were not significant. In the
ing which the same manipulation techniques were applied twice. first trial (Shi 2003), patients were allocated according to their
Acupuncture was administered daily over three treatment courses, entry sequence, therefore, quasi-randomized, and its approach to
each of which comprised of eight days in addition to a two-day allocation concealment was apparently inadequate. The second
interval. trial (Zhou 2002) did not describe how the randomization was
In the second trial (Zhou 2002), 90 patients were randomized to conducted, or report any concealment approach. Neither trial ex-
receive: (1) dermal needle therapy plus Western medications and plicitly described the use of blinding. There was no statement on
self massage of legs, or (2) Western medications and self massage dropouts or withdrawals in either trial, and both trials analyzed
of legs. The dermal needle is made of seven short needles mounted outcome data from the same number of patients allocated. There-
onto the end of a plastic handle. The practitioner held the handle fore, both included studies were classified as category B for their
and tapped vertically with an interval of 1cm. The leg portions methodological quality.
of four meridians, including the Stomach Meridian of Foot-Yang-
ming, the Spleen Meridian of Foot-Taiyin, the Bladder Meridian
of Foot-Taiyang and the Kidney Meridian of Foot-Shaoyin, were
tapped three times. Both groups received treatment for 30 days Effects of interventions

The included trials were extremely heterogeneous regarding allocation concealment in the second trial (Zhou 2002) may have
acupuncture and control interventions. Therefore, pooling of data led to selection bias. The possible lack of blinding of the outcome
was not performed. assessors may have introduced detection bias in both trials.
Due to the clinical heterogeneity in terms of the type of acupunc-

Scalp and body acupuncture versus medications
ture administered and the intervention of the control groups, no
In the first trial (Shi 2003), we only compared the outcome be-
pooling of data was possible and it was difficult to draw conclu-
tween Group 2 and Group 3, because Group 1 was not eligible for
sions for different types of acupuncture treatments.
comparison. Interestingly, acupuncture alone was not significantly
more effective than medications in remission of overall symptoms In the first trial (Shi 2003), no significant difference was detected
at the end of treatment (RR 0.97, 95% CI 0.76 to 1.24). in remission of overall symptoms between acupuncture and med-
Dermal needle plus medications and massage versus medica- ications. In the second trial (Zhou 2002), dermal needle therapy
tions and massage used in combination with medications and massage was demon-
In the second trial (Zhou 2002), acupuncture plus medications strated to be more effective than medications and massage alone,
and massage was slightly more effective for relief of unpleasant in terms of remission of unpleasant sensations in the legs and re-
sensations in the legs than medications and massage administrated duction of RLS frequency. This might suggest that some patients
alone. When remission of unpleasant sensations was analyzed as a with RLS are more likely to benefit from dermal needle treatment
dichotomous variable, the RR was 1.36 (95% CI 1.06 to 1.75) in for symptom management.
favor of the dermal needle group. For the reduction in VAS score
of unpleasant sensations, the WMD was -0.61 (95% CI -0.96 to The results above should be interpreted with extreme caution be-
-0.26), also in favor of the dermal needle group. There was no cause these comparisons involved only single studies. Addition-
significant difference between the two groups for the reduction in ally, both included trials enrolled small numbers of patients, which
either the longest or the shortest duration of RLS (WMD -2.58, might have limited statistical power. The small sample sizes to-
95% CI -5.92 to 0.76; WMD -0.38, 95% CI -1.08 to 0.32). How- gether with the wide confidence intervals also make it difficult
ever, there was a significant difference in favor of dermal needle to show a significant difference between acupuncture and control
therapy for the reduction in RLS frequency (WMD -3.44, 95% interventions should one exist. At the same time, it is necessary to
CI -5.15 to -1.73). point out that the ordinal outcomes of both included trials were
Neither trial reported the presence of harmful side effects. poorly defined and based on subjective evaluations, thus it is likely
We were unable to perform subgroup analysis, sensitivity analyses, that the results might have been overestimated as well.
or investigate potential biases of publication due to the lack of
available studies.
AUTHORS’ CONCLUSIONS
Implications for practice

DISCUSSION The belief that acupuncture is an effective treatment for RLS is
Despite the growing popularity of acupuncture around the world, not based on rigorous and comprehensive evidence. The hypothe-
there is still insufficient evidence to support the hypotheses that ses need to be validated by further high quality research before
acupuncture is more effective in the treatment of RLS than no the routine use of acupuncture can be recommended for patients
treatment or other therapies. Neither included trial reported data suffering from RLS.
on side effects, but we still cannot guarantee the safety of acupunc-
ture in treating RLS since the small sample sizes could have limited Implications for research
the power of detecting rare events. Further high quality research is warranted to evaluate the efficacy
This review is limited by the lack of well-designed randomized and safety of acupuncture in the treatment of RLS. Here are some
controlled trials. Only two trials with 170 patients were included. suggestions for future studies:
The quality of reporting was rather disappointing and did not
(1) statistical method of sample size calculations with at least 80%
meet the standards in the CONSORT statement (Begg 1996) and
power of detecting a difference of clinical importance on a chosen
STRICTA recommendations (MacPherson 2001). Although both
outcome measure should be conducted to determine the minimum
studies mentioned the use of randomization, it was apparent that
number of patients required;
patients were quasi-randomized in the first trial (Shi 2003), and it
was uncertain whether or not the patients in the second trial (Zhou (2) the method of randomization and allocation concealment
2002) were genuinely randomized. The inadequacy of allocation should be rigorous and fully described to encourage confidence in
concealment in the first trial (Shi 2003) and the possible lack of the control of selection bias;

(3) although blinding of acupuncture practitioners is very un-
likely, 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.
ACKNOWLEDGEMENTS
We would like to acknowledge the helpful comments of the panel
of experts who refereed the review. We are grateful to Ema Roque,
Movement Disorders Review Group Coordinator. We would also
like to thank Liu Jie and Dr. Zhang Wei for their assistance in the
preparation of the review.
REFERENCES
References to studies included in this review Ma 2001 {published data only}

Ma HX. Treatment of restless legs syndrome with acupuncture and
Shi 2003 {published data only} herbs in patients with diabetes mellitus. Journal of Shanxi College of
Shi YL, Wang YM. Observation on therapeutic effects of Traditional Chinese Medicine 2001;2(2):42–3.
acupuncture plus steaming washing with Chinese herbs for Meng 2003 {published data only}
treatment of 40 cases of restless legs syndrome. Chinese Acupuncture Meng XH. Treatment of 24 cases of restless legs syndrome with
& Moxibustion 2003;23(11):651–2. compound salvia acupoint injection. Guangxi Journal of Traditional
Zhou 2002 {published data only} Chinese Medicine 2003;26(1):24–5.
Zhou GY. Treatment of 48 cases of restless legs syndrome with Tan 2005 {published data only}
dermal needle therapy. Chinese Journal of Information on TCM Tan JY. Treatment of 38 cases of restless legs syndrome with
2002;9(10):63–4. electroacupuncture and massage. Journal of Practical Traditional
Chinese Medicine 2005;21(10):617.
References to studies excluded from this review Tang 2003 {published data only}
Tang SX, Xu ZH, Tang P. Clinical study on treating restless legs
Dai 2006 {published data only} syndrome by acupuncture. Chinese Journal of the Practical Chinese
Dai XY, Li Y, Song QZ, Han BJ. Observation on the efficacy of with Modern Medicine 2003;3(16):1430.
Biguan warming acupuncture for treating post-apoplectic restless
Wang 1999 {published data only}
legs syndrome. Shanghai Journal of Acupuncture and Moxibustion
Wang DJ, Wu ZY. Treatment of 40 cases of restless legs syndrome
2006;25(1):23–4.
with massage and herbs fumigation. Journal of Practical Traditional
Gong 2004 {published data only} Chinese Medicine 1999;15(8):8–9.
Gong CL, Zhang AQ. Treatment of 20 cases of restless legs Yang 1993 {published data only}
syndrome with acupoint injection. Modern Journal of Integrated Yang YD. Treatment of 108 cases of restless legs syndrome with
Traditional Chinese and Western Medicine 2004;13(8):1036. body and ear acupuncture. Chinese Acupuncture & Moxibustion
Huang 1996 {published data only} 1993, (3):13–4.
Huang W, Liu XQ. Treatment of restless legs syndrome with scalp Zhang 2001 {published data only}
acupuncture and warming acupuncture. Journal of Guiyang College Zhang ZY. Treatment of 32 cases of restless legs syndrome with
of Traditional Chinese Medicine 1996;18(4):34–5. acupuncture. Journal of Fujian College of TCM 2001;11(2):32.
Zhang 2006 {published data only} Systematic Reviews 2006, Issue 2.[Art. No.: CD003527. DOI:
Zhang H. Treatment of restless legs syndrome with acupoint 10.1002/14651858.CD003527]
injection and herbs. Hubei Journal of Traditional Chinese Medicine Harrison’s 2001
2006;28(8):47–8. Braunwald E, Fauci AS, Kasper DL, Hauser SL, Longo DL,
Zhao 2005b {published data only} Jameson JL, editors. Harrison’s Principles of Internal Medicine. 15th
Zhao W, Wang DH, Yang RK, Zhou H. Comparison of therapeutic Edition. The McGraw-Hill Companies, Inc, 2001.
effects of acupoints selected along different meridians on restless legs Higgins 2005
syndrome. Chinese Acupuncture & Moxibustion 2005;25(9):616–8. Higgins JPT, Green S, editors. Cochrane Handbook for Systematic
Reviews of Interventions 4.2.5 [updated May 2005]. In: The
Additional references
Cochrane Library [database on CDROM]. The Cochrane
Allen 1998 Collaboration, Chichester, UK: John Wiley & Sons Ltd; 2005,
Allen RP, Earley CJ, Hening WA, Walters AS, Yaffee J, Wagner ML. Issue 3.
Pergolide treatment of the restless legs syndrome: A double-blind Hogl 2005a
placebo-controlled study with objective assessment of leg Hogl B, Kiechl S, Willeit J, Saletu M, Frauscher B, Seppi KM, et
movements. Neurology 1998;50(4) (Suppl 4):A68–9. al.Restless legs syndrome: A community-based study of prevalence,
Allen 2001 severity, and risk factors. Neurology 2005;64(11):1920–4.
Allen RP, Barker PB, Wehrl F, Song HK, Earley CJ. MRI Hogl 2005b
measurement of brain iron in patients with restless legs syndrome. Hogl B, Poewe W. Restless legs syndrome. Current Opinion in
Neurology 2001;56:263–5. Neurology 2005;18(4):405–10.
Allen 2003 Hornyak 2006
Allen RP, Picchietti D, Hening W, Trenkwalder C, Walters AS, Hornyak M, Berner MM, Kriston L, Riemann D. Dopamine
Montplaisir J, et al.Restless legs syndrome: diagnostic criteria, agonists for restless legs syndrome. The Cochrane Database of
special considerations, and epidemiology: a report from the restless Systematic Reviews 2006, Issue 2.[Art. No.: CD006009. DOI:
legs syndrome diagnosis and epidemiology workshop at the 10.1002/14651858.CD006009]
National Institutes of Health. Sleep Medicine 2003;4:101–19. Jadad 1996
Allen 2005 Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ,
Allen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell TJ, Gavaghan DJ, et al.Assessing the quality of reports of randomized
et al.Restless legs syndrome prevalence and impact: REST general clinical trials: is blinding necessary?. Controlled Clinical Trials
population study. Archives of Internal Medicine 2005;165(11): 1996;17:1–12.
1286–92. Kjaergard 2001
Begg 1996 Kjaergard LL, Villumsen J, Gluud C. Reported methodologic
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et quality and discrepancies between large and small randomized trials
al.Improving the quality of reporting of randomized controlled in meta-analyses. Annals of Internal Medicine 2001;135(11):982–9.
trials: The CONSORT statement. JAMA 1996;276(8):637–9. Lin 1994
Bogan 2006 Lin LR, Lin WT, Yu MS, editors. The Dictionary of Medical
Bogan RK, Fry JM, Schmidt MH, Carson SW, Ritchie SY, for the Syndromes. 1st Edition. China Science and Technology Publishing
TREAT RLS US (Therapy with Ropinirole Efficacy And House, 1994.
Tolerability in RLS US) Study Group. Ropinirole in the treatment Lin 1998
of patients with restless legs syndrome: A US-based randomized, Lin SC, Kaplan J, Burger CD, Fredrickson PA. Effect of
double-blind, placebo-controlled clinical trial. Mayo Clinic pramipexole in treatment of resistant restless legs syndrome. Mayo
Proceedings 2006;81(1):17–27. Clinic Proceedings 1998;73(6):497–500.
Brodeur 1988 MacPherson 2001
Brodeur C, Montplaisir J, Godbout R, Marinier R. Treatment of MacPherson H, White A, Cummings M, Jobst K, Rose K,
restless legs syndrome and periodic movements during sleep with L- Niemtzow R. Standards for reporting interventions in controlled
dopa: a double-blind, controlled study. Neurology 1988;38: trials of acupuncture: the STRICTA recommendations.
1845–8. Complementary Therapies in Medicine 2001;9(4):246–9.
Egger 1997 Moher 1998
Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis Moher D, Pham B, Jones A, Cook DJ, Jadad A, Moher M, et
detected by a simple, graphical test. BMJ 1997;315:629–34. al.Does quality of reports of randomized trials affect estimates of
Ekbom 1945 intervention efficacy reported in meta-analysis. Lancet 1998;352:
Ekbom KA. Restless legs. Acta medica Scandinavica 1945;158: 609–13.
5–122. Montplaisir 1999
Green 2006 Montplaisir J, Nicolas A, Denesle R, Gomez-Mancilla B. Restless
Green S, Buchbinder R, Barnsley L, Hall S, White M, Smidt N, et legs syndrome improved by pramipexole: A double-blind
al.Acupuncture for lateral elbow pain. The Cochrane Database of randomized trial. Neurology 1999;52(5):938–43.

NINDS 2006 Trenkwalder 2005
National Institute of Neurological Disorders and Stroke. Restless Trenkwalder C, Paulus W, Walters AS. The restless legs syndrome.
Legs Syndrome Fact Sheet. http://www.ninds.nih.gov/disorders/ The Lancet Neurology 2005;4:465–75.
restless_legs/detail_restless_legs.htm (accessed 3 September 2006). Walters 1988
Qiao 1997 Walters AS, Hening WA, Kavey N, Chokroverty S, Gidro-Frank S.
Qiao HJ, Zhang LC. Treatment of restless legs syndrome with A double-blind randomized crossover trial of bromocriptine and
herbs and plum-blossom needle. Henan Traditional Chinese placebo in restless legs syndrome. Annals of Neurology 1988;24(3):
Medicine 1997;17(1):57. 455–8.
Schapira 2004 Walters 1995
Schapira AHV. Restless legs syndrome: An update on treatment Walters AS. The International Restless Legs Syndrome Study
options. Drugs 2004;64(2):149–58. Group. Toward a better definition of restless legs syndrome.
Movement Disorders 1995;10:634–42.
Schulz 1995
Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence Wang 1994
of bias: dimensions of methodological quality associated with Wang DY. Treatment of 30 cases of restless legs syndrome with
estimates of treatment effects in controlled trials. JAMA 1995;273: electro-acupuncture. Journal of Gansu College of Traditional Chinese
408–12. Medicine 1994;11(1):46.
Silber 2004 Wang 2001
Silber MH, Ehrenberg BL, Allen RP, Buchfuhrer MJ, Earley CJ, Wang CX. Recent developments in TCM treatment of restless legs
Hening WA, et al.for the Medical Advisory Board of the Restless syndrome. Shandong Journal of Traditional Chinese Medicine 2001;
Legs Syndrome Foundation. An algorithm for the management of 20(7):443–4.
restless legs syndrome. Mayo Clinic Proceedings 2004;79(7):916–22. Wang 2005
Smith 2006 Wang JZ, Zhou JD. Treatment of restless legs syndrome with
Smith CA, Hay PPJ. Acupuncture for depression. The Cochrane manipulation and acupoint injection therapy. Chinese
Database of Systematic Reviews 2006, Issue 2.[Art. No.: CD004046. Manipulation & Qi Gong therapy 2005;21(5):40.
DOI: 10.1002/14651858.CD004046.pub3] Wen 2000
Song 2004 Wen XL. Treatment of 75 cases of restless legs syndrome with body
Song BL, Pang XZ. Treatment of 37 cases of restless legs syndrome acupuncture and auricular acupuncture. Chinese Journal of
by puncturing BL57 exclusively. Hebei Journal of Traditional Traditional Medical Science and Technology 2000;7(4):264.
Chinese Medicine 2004;26(8):618. Wong 2006
Sun 2002 Wong KK, Dobbin CJ, Joffe D, March L. Interventions for
Sun ZT, Chen M. Treatment of 68 cases of restless legs syndrome dialysis-associated restless legs syndrome. The Cochrane Database of
by acupoint injection therapy. Henan Traditional Chinese Medicine Systematic Reviews 2006, Issue 2.[Art. No.: CD005018. DOI:
2002;22(6):43–4. 10.1002/14651858.CD005018.pub2]
Tan 2001 Yang 1997
Tan EK, Seah A, See SJ, Lim E, Wong MC. Restless legs syndrome Yang JS, Zhang J, Chen ZF, He SH, editors. Acupuncture and
in an Asian population: a study in Singapore. Movement Disorders Moxibustion. People’s Medical Publishing House, 1997.
2001;16:577–8. Zhao 2005a
Tison 2005 Zhao W. Treatment of restless legs syndrome with manipulation
Tison F, Crochard A, Leger D, Bousee S, Lainey E, El Hasnaoui A. and acupuncture. China Journal of Orthopaedics and Traumatology
Epidemiology of restless legs syndrome in French adults: A national 2005;18(8):506.
survey: The INSTANT Study. Neurology 2005;65(2):239–46. ∗
Indicates the major publication for the study

CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Shi 2003
Methods Quasi-randomized trial. Patients were allocated according to the entry sequence.
Blinding: The patients and acupuncture practitioners could not be blinded and it was unclear if the
outcome assessors were blinded.
Dropout/withdrawals: no statement.
Participants Setting: Hospital outpatient, China.

Demographics: aged 30 to 69 yrs; 64 male, 56 female.
Baseline comparability: Yes.
Diagnosis: Patients with primary RLS diagnosed according to the criteria established by IRLSSG.
Number of patients: 120 (40/40/40).
Interventions 3 arms:
Group 1: scalp and body acupuncture plus fuming and washing with herbs.
Group 2: oryzanol 20mg three times a day plus diazepam 5mg before bedtime.
Group 3: scalp and body acupuncture.
Comparison eligible: scalp and body acupuncture versus oryzanol and diazepam.
Acupuncture treatment:
(1) Acupuncture rationale: traditional Chinese medical theories and modern theories of cerebral cortical
function.
(2) Needle type: sterilised stainless steel, body acupuncture: 50 mm in length and 0.30 mm in diameter, 75
mm in length and 0.30 mm in diameter; scalp acupuncture: 50 mm in length and 0.35 mm in diameter.
(3) Acupuncture prescriptions: body acupoints: ST36, GB34, SP10, BL56 and BL57; scalp treatment
zones: MS5 (from GV20 to GV21), the upper 1/5th of MS7 (from GV20 to GB7) and MS8 (extending
for 1.5 Cun from BL7 along the Bladder Meridian of Foot-Taiyang).
(4) Depth of needle insertion: body acupuncture: 40 mm to 62.5 mm; scalp acupuncture: 40 mm.
Outcomes Only one outcome reported:

Ordinal outcome (immediately following treatment):
(a) Cured: disappearance of all symptoms;
Group 1: 27/40, Group 2: 18/40, Group 3: 19/40.
(b) Marked effective: most of the symptoms disappeared and sleep was occasionally disturbed by unpleasant
sensations and the urge to move the legs;
(c) Improved: symptoms were partially relieved, but sleep was often disturbed by unpleasant sensations
and the urge to move the legs;
(d) No effect: symptoms were unchanged after treatment.
Notes Author’s conclusion: Acupuncture plus fuming was significantly better than Western medications or
acupuncture. No significant difference was detected between Western medications and acupuncture alone.
Risk of bias

Shi 2003 (Continued)
Item Authors’ judgement Description
Allocation concealment? No C - Inadequate
Zhou 2002
Methods Randomized controlled trial. No details could be obtained from the author on how the allocation sequence
was generated.
Blinding: The patients and acupuncture practitioners could not be blinded and it was unclear if the
outcome assessors were blinded.
Dropout/withdrawals: no statement.
Participants Setting: Hospital outpatient, China.

Demographics: aged 27 to 52 yrs; 47 male, 43 female.
Baseline comparability: Yes.
Diagnosis: Patients with primary RLS diagnosed according to the criteria stated in The Dictionary of
Medical Syndromes, which described all four clinical diagnostic criteria mandatory for RLS.
Number of patients: 90 (48/42).
Interventions Group 1: dermal needle therapy.

Group 2: no acupuncture.
Both groups: dipyridamole 50mg three times a day + nicotinic acid 50mg three times a day + inositol 1g
before bedtime + self massage of legs before bedtime.
Acupuncture treatment:
(1) Acupuncture rationale: traditional Chinese medical theories and modern theories of neurology.
(2) Needle type: Dermal needle is made of seven short stainless needles mounted onto the end of a plastic
handle.
(3) Acupuncture prescriptions: The leg portions of four meridians (the Stomach Meridian of Foot-Yang-
ming, the Spleen Meridian of Foot-Taiyin, the Bladder Meridian of Foot-Taiyang and the Kidney Merid-
ian of Foot-Shaoyin) were tapped vertically with an interval of 1cm.
(4) Depth of needle insertion: the dermal needle was tapped superficially on the skin until slight bleeding
appeared.
Outcomes Five outcomes reported:

1. Ordinal outcome (immediately following treatment):
(a) Cured: disappearance of unpleasant sensations in the legs;
Group 1: 26/48, Group 2: 15/42.
(b) Effective: the unpleasant sensations were considerably relieved;
Group 1: 16/48, Group 2: 12/42.
(c) No effect: the unpleasant sensations were unchanged after treatment.
Group 1: 6/48, Group 2: 15/42.
2. Unpleasant sensations of RLS measured by VAS.
Baseline: Group 1: 8.86 ± 0.93, Group 2: 8.79 ± 0.95;
Immediately following treatment: Group 1: 7.54 ± 0.56, Group 2: 8.08 ± 0.73.
3. The longest duration of RLS symptoms in one month before and after the treatment.
After one month: Group 1: 23.71 ± 5.30, Group 2: 26.85 ± 7.12.
4. The shortest duration of RLS symptoms in one month before and after the treatment.

Zhou 2002 (Continued)

5. The frequency of RLS symptoms in one month before and after the treatment.
Notes Author’s conclusion: Acupuncture was significantly better.

We calculated the changes from baseline for the four continuous outcomes. The mean changes were
obtained by subtracting the final means from the baseline means. We imputed the standard deviations for
the change scores of both the experimental and control group by using an imputed correlation coefficient
of 0.5.
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear
Explanations for the two terms used in the description of the first trial (Shi 2003):
Manipulation techniques called ’even supplementation and drainage’ include lifting and thrusting of the needle performed with even
lifts and thrusts and/or rotation performed with even strength in both directions with a medium arc.
The arrival of Qi (De Qi in Chinese) means a sensation of soreness, numbness, distention or heaviness around the point.
Characteristics of excluded studies [ordered by study ID]
Dai 2006 All subjects had experienced cerebrovascular diseases.
Gong 2004 Subjects suffered from various psychiatric and organic disorders.
Huang 1996 Different forms of acupuncture were compared.
Ma 2001 All subjects suffered from type 2 diabetes mellitus (DM).
Meng 2003 The four essential diagnostic criteria defined by IRLSSG were only partly met.
Tan 2005 Electro-acupuncture plus massage were compared with Western medications.
Tang 2003 Different forms of acupuncture were compared.
Wang 1999 Acupressure plus massage and herbs fumigation were compared with Western medications.
Yang 1993 Different forms of acupuncture were compared.

(Continued)
Zhang 2001 The four essential diagnostic criteria defined by IRLSSG were only partly met.
Zhang 2006 Herbs plus acupoint injection of Vitamin B12 were compared with estazolam plus intramuscular injection of Vitamin
B1 and Vitamin B12.
Zhao 2005b Effects of different acupoints were compared.

DATA AND ANALYSES
Comparison 1. Acupuncture versus no acupuncture
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Reduction in VAS score of 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected
unpleasant sensations
2 Symptom remission 2 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected
2.1 Scalp and body 1 Risk Ratio (M-H, Fixed, 95% CI) Not estimable
acupuncture versus medications
2.2 Dermal needle plus 1 Risk Ratio (M-H, Fixed, 95% CI) Not estimable
medications and massage versus
medications and massage
3 Reduction in RLS duration 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected
3.1 Longest duration 1 Mean Difference (IV, Fixed, 95% CI) Not estimable
3.2 Shortest duration 1 Mean Difference (IV, Fixed, 95% CI) Not estimable
4 Reduction in RLS frequency 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected
Analysis 1.1. Comparison 1 Acupuncture versus no acupuncture, Outcome 1 Reduction in VAS score of
unpleasant sensations.
Review: Acupuncture for restless legs syndrome
Comparison: 1 Acupuncture versus no acupuncture
Outcome: 1 Reduction in VAS score of unpleasant sensations
Study or subgroup acupuncture no acupuncture Mean Difference Mean Difference

N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI
Zhou 2002 48 -1.32 (0.81) 42 -0.71 (0.86) -0.61 [ -0.96, -0.26 ]
-10 -5 0 5 10
Favours acup Favours no acup

Analysis 1.2. Comparison 1 Acupuncture versus no acupuncture, Outcome 2 Symptom remission.
Outcome: 2 Symptom remission
Study or subgroup acupuncture no acupuncture Risk Ratio Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
1 Scalp and body acupuncture versus medications

Shi 2003 30/40 31/40 0.97 [ 0.76, 1.24 ]
2 Dermal needle plus medications and massage versus medications and massage
Zhou 2002 42/48 27/42 1.36 [ 1.06, 1.75 ]
0.1 0.2 0.5 1 2 5 10

Favours no acup Favours acup
Analysis 1.3. Comparison 1 Acupuncture versus no acupuncture, Outcome 3 Reduction in RLS duration.
Outcome: 3 Reduction in RLS duration

1 Longest duration
Zhou 2002 48 -6.88 (7.63) 42 -4.3 (8.42) -2.58 [ -5.92, 0.76 ]
2 Shortest duration
Zhou 2002 48 -1.27 (1.71) 42 -0.89 (1.65) -0.38 [ -1.08, 0.32 ]
-10 -5 0 5 10

Analysis 1.4. Comparison 1 Acupuncture versus no acupuncture, Outcome 4 Reduction in RLS frequency.
Outcome: 4 Reduction in RLS frequency

Zhou 2002 48 -4.55 (4.15) 42 -1.11 (4.13) -3.44 [ -5.15, -1.73 ]
-10 -5 0 5 10
WHAT’S NEW
Last assessed as up-to-date: 29 May 2008.
30 May 2008 Amended Converted to new review format.
HISTORY
Protocol first published: Issue 2, 2007
Review first published: Issue 4, 2008
30 May 2008 Amended Substantive amendment
CONTRIBUTIONS OF AUTHORS
Ye Cui wrote the protocol and was responsible for study identification, methodological quality assessment, data extraction and data
analysis.
Yin Wang contributed to protocol development, study identification, quality assessment and data extraction.
Zhishun Liu contributed to protocol development and worked as the arbitrator in the process of study selection and quality assessment.

DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
• Department of Acupuncture and Moxibustion, Guang An Men Hospital, The China Academy of Chinese Medicine Science,
China.
• Beijing University of Chinese Medicine, China.
External sources
• No sources of support supplied
INDEX TERMS
Medical Subject Headings (MeSH)

Acupuncture Therapy [∗ methods]; Randomized Controlled Trials as Topic; Restless Legs Syndrome [∗ therapy]
MeSH check words

Humans


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Acupuncture for restless legs syndrome (Review)

Cui Y, Wang Y, Liu Z

Acupuncture for restless legs syndrome (Review)

Acupuncture for restless legs syndrome (Review) i

Acupuncture for restless legs syndrome

Ye Cui1 , Yin Wang2 , Zhishun Liu3

Editorial group: Cochrane Movement Disorders Group.

Data collection and analysis

PLAIN LANGUAGE SUMMARY

Apart from medications, certain lifestyle changes, decreased use of

Acupuncture for restless legs syndrome (Review) 3

Search methods for identification of studies

Acupuncture for restless legs syndrome (Review) 4

Acupuncture for restless legs syndrome (Review) 5

Acupuncture for restless legs syndrome (Review) 6

Due to the clinical heterogeneity in terms of the type of acupunc-

Implications for practice

Acupuncture for restless legs syndrome (Review) 7

References to studies included in this review Ma 2001 {published data only}

Acupuncture for restless legs syndrome (Review) 9

Acupuncture for restless legs syndrome (Review) 10

Characteristics of included studies [ordered by study ID]

Participants Setting: Hospital outpatient, China.

Outcomes Only one outcome reported:

Acupuncture for restless legs syndrome (Review) 11

Item Authors’ judgement Description

Allocation concealment? No C - Inadequate

Participants Setting: Hospital outpatient, China.

Interventions Group 1: dermal needle therapy.

Outcomes Five outcomes reported:

Acupuncture for restless legs syndrome (Review) 12

Baseline: Group 1: 6.84 ± 1.95, Group 2: 6.72 ± 1.88;

Notes Author’s conclusion: Acupuncture was significantly better.

Item Authors’ judgement Description

Allocation concealment? Unclear B - Unclear

Characteristics of excluded studies [ordered by study ID]

Dai 2006 All subjects had experienced cerebrovascular diseases.

Huang 1996 Different forms of acupuncture were compared.

Ma 2001 All subjects suffered from type 2 diabetes mellitus (DM).

Tang 2003 Different forms of acupuncture were compared.

Yang 1993 Different forms of acupuncture were compared.

Acupuncture for restless legs syndrome (Review) 13

Zhao 2005b Effects of different acupoints were compared.

Acupuncture for restless legs syndrome (Review) 14

Comparison 1. Acupuncture versus no acupuncture

Review: Acupuncture for restless legs syndrome

Comparison: 1 Acupuncture versus no acupuncture

Outcome: 1 Reduction in VAS score of unpleasant sensations

Study or subgroup acupuncture no acupuncture Mean Difference Mean Difference

Zhou 2002 48 -1.32 (0.81) 42 -0.71 (0.86) -0.61 [ -0.96, -0.26 ]

Acupuncture for restless legs syndrome (Review) 15

Review: Acupuncture for restless legs syndrome

Comparison: 1 Acupuncture versus no acupuncture

Outcome: 2 Symptom remission

Study or subgroup acupuncture no acupuncture Risk Ratio Risk Ratio

1 Scalp and body acupuncture versus medications

0.1 0.2 0.5 1 2 5 10

Review: Acupuncture for restless legs syndrome

Comparison: 1 Acupuncture versus no acupuncture