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Journal of Alternative and Complementary Medicine logoLink to Journal of Alternative and Complementary Medicine
. 2009 Nov;15(11):1171–1186. doi: 10.1089/acm.2009.0041

Acupuncture for Treatment of Insomnia: A Systematic Review of Randomized Controlled Trials

Huijuan Cao 1, Xingfang Pan 1, Hua Li 1, Jianping Liu 1,✉
PMCID: PMC3156618  PMID: 19922248

Abstract

Background

Acupuncture is commonly used in treating insomnia in China, and clinical studies have shown that acupuncture may have a beneficial effect on insomnia compared with Western medication.

Methods

We included randomized controlled trials on acupuncture for insomnia. We searched PubMed, the Cochrane Library (2008 Issue 3), China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Wan Fang Database. All searches ended in December 2008. Two authors extracted data and assessed the trials' quality independently. RevMan 5.0.17 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI).

Results

Forty-six (46) randomized trials involving 3811 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding, and intention-to-treat analysis. Meta-analyses showed a beneficial effect of acupuncture compared with no treatment (MD −3.28, 95% CI −6.10 to −0.46, p = 0.02; 4 trials) and real acupressure compared with sham acupressure (MD −2.94, 95% CI −5.77 to −0.11, p = 0.04; 2 trials) on total scores of Pittsburgh Sleep Quality Index. Acupuncture was superior to medications regarding the number of patients with total sleep duration increased for >3 hours (RR 1.53, 95% CI 1.24–1.88, p < 0.0001). However, there was no difference between acupuncture and medications in average sleep duration (MD −0.06, 95% CI −0.30–0.18, p = 0.63). Acupuncture plus medications showed better effect than medications alone on total sleep duration (MD 1.09, 95% CI 0.56–1.61, p < 0.0001). Similarly, acupuncture plus herbs was significantly better than herbs alone on increase of sleep rates (RR 1.67, 95% CI 1.12–2.50, p = 0.01). There were no serious adverse effects with related to acupuncture treatment in the included trials.

Conclusions

Acupuncture appears to be effective in treatment of insomnia. However, further large, rigorous designed trials are warranted.

Introduction

Insomnia is one of the most common sleep disorders, with a prevalence of 40% in adults. It is generally believed that 10%–15% of the adult population suffers from chronic insomnia, and an additional 25%–35% have transient or occasional insomnia.1 The symptoms of insomnia may be difficult falling asleep, sleep latency more than 30 minutes, or sleep efficiency less than 85%, which usually happened more than 4 nights a week and occurred at least 3 weeks.2 Patients with insomnia may feel tired, tense, lazy, or have delayed reactions, distraction, or headache. The serious consequence of insomnia can be mental illness, and the worst mental illness is schizophrenia.

Insomnia can be treated with medications, herbal therapy, and psychologic or physical therapy. The commonly used medications include hypnotic sedative agents, such as zaleplon and benzodiazepines, but they may cause adverse effects such as damage of memory, drug resistance, dependency, and addiction.3 Nondrug therapy including acupuncture is commonly used by patients with insomnia. The mechanism of acupuncture treatment may be regulating yin and yang to reinforce health and eliminate the pathogenic, thus improving sleep.4 In modern medicine, acupuncture can increase the content of γ-amino butyric acid, and then enhance sleep quality.5 We performed this systematic review to evaluate the beneficial and harmful effects of acupuncture for treatment of insomnia in randomized trials.

Methods

Inclusion criteria

Parallel randomized controlled trials (RCTs) of acupuncture compared with no treatment, placebo, or basic medical therapy in patients with insomnia were included. Combined therapy of acupuncture and other interventions compared with other interventions in RCTs was also included. Outcome measures include duration and quality of sleep, such as total sleep duration and increased sleep duration, Pittsburgh Sleep Quality Index (PSQI) scores, Index of Severity of Insomnia, Sleep Quality, and other validated scores, as well as adverse effects. Multiple publications reporting the same groups of participants were excluded. There was no limitation on language and publication type.

Identification and selection of studies

We searched China Network Knowledge Infrastructure (1979–2008), Chinese Scientific Journal Database VIP (1989–2008), Wan Fang Database (1985–2008), PubMed (1966–2008), and the Cochrane Library (Issue 3, 2008). All of the searches ended at December 2008. The search terms included “acupuncture,” “acupressure,” “acupoint,” “electroacupuncture,” or “meridian” combined with “insomnia,” “sleepless,” or “dysomnia.” Two authors (H.J. Cao and H. Li) selected studies for eligibility and checked against the inclusion criteria independently.

Data extraction and quality assessment

Two authors (H.J. Cao and H. Li) extracted the data from the included trials independently. Quality of the included trials was evaluated according to the following categories6: Category A (good): studies have the least biases and their results are considered valid. These studies are likely to consist of (1) clear description of the population, setting, interventions, and comparison groups; (2) appropriate measurement of outcomes; (3) appropriate statistical and analytical methods; (4) no reporting errors; (5) less than 20% dropouts; (6) clear reporting of dropouts; and (7) appropriate consideration and adjustment for potential confounders. Category B (fair): studies are susceptible to some degrees of biases that are not sufficient to invalidate the results. These studies may have suboptimal adjustments for potential confounders and may also lack certain information that is needed to assess limitations and potential problems. Category C (poor): studies have significant biases that may invalidate the results. These studies either do not consider potential confounders or do not make adjustments for them appropriately. These studies may have critical flaw in design, analysis, and/or reporting, missing information, and/or discrepancies in reporting.

Data analysis

Data were summarized using relative risk (RR) with 95% confidence intervals (CI) for binary outcomes or mean difference (MD) with 95% CI for continuous outcomes. Revman5.0.17 software was used for data analyses. Meta-analysis was used if the trials had a good homogeneity on study design, participants, interventions, control, and outcome measures. Publication bias was explored by funnel plot analysis.

Results

Description of studies

After primary searches from seven databases, 1956 citations were identified, and the majority were excluded due to obvious ineligibility, and full text papers of 67 studies were retrieved. Forty-six (46) RCTs were included in this review (Fig. 1),7–47 and among them, five trials were unpublished and were from graduate student dissertations.* There were 21 studies including 16 RCTs excluded from this review due to multiple publications, non-RCT design, data unavailable, or not meeting one of the inclusion criteria.48–68 The characteristics of included trials are listed in Table 1, and the reasons for excluded studies are listed in Table 2.

FIG. 1.

FIG. 1.

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The process of study selection. RCTs, randomized controlled trials.

Table 1.

Characteristics of Included Studies

 
 Number of patients
  
  
  
  
  
  
Study Treatment M/F Control M/F Age (mean or range) Diagnostic criteria Acupuncture (no. of points used) Control group Duration of treatment (day) Outcome measure
Chen M 19997 28 28 79 Pittsburgh Sleep Quality Index (PSQI) Real acupressure (5) 15 min per session, 5 sessions per week for 3 weeks 1) Sham acupressure at nonacupressure points 15 min per session, 5 sessions per week for 3 weeks 21 PSQI
  28 28     Real acupressure (5) 15 min per session, 5 sessions per week for 3 weeks 2) Conversation only    
Chen X 20038 17/23 19/21 50 Government guideline in China Electroacupuncture (3 + x)a plus auricular acupuncture (8), 25 min, once daily; estazolam 2 mg once per night Estazolam 2 mg once per night 36 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Chen F 20079 18/22 17/23 18–64 Unavailable Electroacupuncture (2), 30 min, once daily Diazepam 2.5 mg plus oryzanol 20 mg and VB1 20 mg 3 times a day 14 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to sleeping efficacy
Cui R 200110 34/26 28/32 27–67 Government criteria in China Body acupuncture (8) once daily plus estazolam 1–2 mg once per night Estazolam 1–2 mg once per night 30 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to sleeping efficacy
Ding D 200811 13/19 11/13 20–71 CCMD-2 Body acupuncture (7 + x)a 30 min/3 hours once daily Estazolam 1 mg once per night 28 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Ding W 200612 44/40 16/16 13–75 Unavailable Body acupuncture (2 + x)a Diazepam 5 mg 3 times a day 7–14 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Du M 200713 12/22 7/13 20–82 Unavailable Body acupuncture (5 + x)a 30–60 min every 2 days plus herbal medicine twice a day Herbal medicine 200 mL twice a day 20 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to sleeping efficacy
Fan D 200614 17/23 12/16 19–65 CCMD-2 Body acupuncture (5) 30 min once daily Diazepam 5 mg once per night plus oryzanol 10 mg 3 times a day 22 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to sleeping efficacy
Hong Y 200515 30 30 22–76 ICD-10/CCMD-3 Electroacupuncture (2 + x)a 45 min once daily Trazodone 50 mg–100 mg once per night 28 Self-rating Depression Scale (SDS) and Self-rating Anxiety Scale (SAS) AsbergRating Scale (ARS)
Huang X 2000 40 36 18–65 Government criteria in China Body acupuncture (17 + x)a 30 min once daily Estazolam 2 mg once per night 21 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to sleeping efficacy; PSQI
Huang L 200716 38/52 34/56 Unavailable ICD-10 Rolling acupuncture 15–20 min once daily Clonazepam 4–6 mg once per night 28 PSQI
Jian J 200517 50 30 29–76 Hollister Body acupuncture (9)a 40 min once daily plus Ciwujia injection 60 mL once daily Ciwujia injection 60 mL once daily 25 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to sleeping efficacy
Kang F 200618 36/42 14/16 18–61 CCMD-3 Body acupuncture (3 + x)a 30 min once daily plus auricular therapy (7) Diazepam 5 mg once per night plus oryzanol 20 mg 3 times a day 12 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Kim 200419 15 15 67 Insomnia Severity Index (ISI) Acupuncture (4) 2 days Placebo (sham) acupuncture 2 days 2 MQ (morning questionnaire), ISI
Kou J 2003 14/16 15/15 18–70 CCMD-2 Body acupuncture (17) 30 min once daily Stilnox 10 mg once per night 28 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Li Q 200520 10/16 9/15 31–80 Unavailable Electroacupuncture (3) 45 min every 2 days plus Prozac 20 mg once daily Prozac 20 mg once daily 28 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Li X 200721 53/80 21/27 17–65 Government guideline in China Body acupuncture (6 + x)a 30 min every 2 days plus auricular therapy (4 + x) Estazolam 2 mg once per night 20 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to sleeping efficacy
Li T 200722 18/14 17/15 68 Unavailable Body acupuncture (7) 20–30 min once daily plus auricular therapy (1) Diazepam 2.5 mg once per night or estazolam 1 mg once per night 28 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Liu Y 200123 56 30 56–82 Unavailable Body acupuncture (4 + x)a 40 min once daily plus Ciwujia injection 60 mL once daily Ciwujia injection 60 mL once daily 25 Significant as “cured,” “improved,” “ineffective” according to improvement of symptom
Liu Q 200024 36 36 18–70 Unavailable Body acupuncture (4 + x)a once daily plus auricular therapy (4) Estazolam 2 mg once per night 32–51 Significant as “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Liu J 200625 15/17 15/15 68 Unavailable Body acupuncture (8) 30 min once daily plus auricular therapy (1) Diazepam 2.5 mg once per night or estazolam 1 mg once per night 28 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Liu Z 200726 34/36 35/45 49 CCMD-3 Scalp acupuncture 6 hours once daily Clonazepam 4 mg once per night 28 Significant as “cured,” “improved,” “ineffective” according to improvement of symptom
Lu W 199827 14/21 10/13 16–60 Government criteria in China Body acupuncture (2) 30 min once daily plus Qiye Anshen tablet 100 mg 3 times a day Qiye Anshen tablet 100 mg 3 times a day 30 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to sleeping efficacy
Luo L 2005 13/19 15/17 41 CCMD-3 Rolling acupuncture 10–15 min once daily/every 2 days plus clonazepam 2 mg once per night Clonazepam 2 mg once per night 28 Significant as “cured,” “improved,” “ineffective” according to improvement of symptom; PSQI; Visual Analogue Scale (VAS)
Luo W 2006 33 32 21–64 CCMD-3 Body acupuncture (8) 30 min once daily Trazodone 50–150 mg once per night 28 PSQI; SDS; Asberg Rating Scale (ARS); Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Lv Y 200728 13/21 11/23 18–70 ICD-10 Electroacupuncture (10 + x)a 20 min once daily and auricular therapy (5) plus Suanzaoren decoction once daily Suanzaoren decoction 300 mL once daily 30 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Ma X 200629 4/26 5/25 17–75 Unavailable Body acupuncture (6 + x)a 30 min once daily plus alprazolam 0.4–0.8 mg once per night and antipsychotic drug Alprazolam 0.4–0.8 mg plus antipsychotic drug 21–32 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Ma Z 200630 11/20 16/15 17–72 CCMD-3 Electroacupuncture (5 + x)a 60 min once daily Clonazepam 2 mg once per night plus oryzanol 20 mg 3 times a day 30 Sleep Dysfunction Rating Scale (SDRS); Self-rating Sleep Dysfunction Scale (SSDS); Hamilton Anxiety Scale (HAMA)
Pan Q 200531 22/34 20/36 15–70 CCMD-2 Body acupuncture (more than 5) 30 min once daily Estazolam 1 mg once per night 36 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Qiu R 199932 53 36 Unavailable Unavailable Acupressure once per night plus herbal medicine once daily Estazolam 2 mg once per night plus herbal medicine once daily 23 Significant as “markedly effective,” “improved,” “ineffective” according to improvement of symptom
Tang W 200733 16/24 18/22 47–84 Unavailable Auricular therapy (7) plus Tuina and acupressure No treatment 21 Significant as “excellent,” “good,” “fair,” “ineffective” according to improvement of symptom
Tian H 200634 39 39 35–70 Government criteria in China Body acupuncture (6)a 30 min once daily plus herbal medicine once daily Herbal medicine once daily 25 Significant as “cured,” “improved,” “ineffective” according to improvement of symptom
Tsay S 200335 35 31 55.52 PSQI Real acupressure (3) 14 min 3 days per week Usual care 28 Medical Outcome Study–Short Form 36 (SF-36)
  35 32   Real acupressure (3) 14 min 3 days per week Sham acupressure (3) 14 min 3 days per week    
Tsay S 200436 35 35 58.16 PSQI Acupressure (4) 15 min 3 times a week Usual care 30 Piper Fatigue Scale (PFS); PSQI; Beck Depression Inventory (BDI)
    36 35   Transcutaneous electrical acupoint stimulation Usual care    
Wang M 200337 22/38 19/36 16–70 CCMD-2 Body acupuncture (7) 30 min once daily Diazepam 5 mg once per night 22 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom  
Wang Q 200338 17/23 17/23 19–65 Unavailable Electroacupuncture (4) 30 min once daily plus acupoint injection with Ciwujia injection (2) 4 mL once daily Diazepam 2.5 mg 3 times a day plus oryzanol 20 mg 3 times a day and VB120 mg 3 times a day 14 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to sleeping efficacy  
Wang X 200839 21 23 22–56 CCMD-3 Abdominal acupuncture (12) once daily for the first 3 days and once every 3 days for the remaining 11 days plus placebo pill once daily Estazolam once daily plus sham acupuncture once daily for the first three days and once every three days for the remaining 11 days 14 Leeds Sleep Evaluation Questionnaire (LSEQ)  
Wang Y 200440 22/12 17/13 41–70.5 Unavailable Scalp acupuncture with electrical stimulation plus auricular therapy (1) and body acupuncture (5) 20–30 min 5 times a week Diazepam 2.5 mg once per night plus clozapine 25 mg once per night 28 PSQI; Hamilton Rating Scale for Depression (HRSD)  
Xuan Y 200741 11/13 10/12 49 ICD-10 Body acupuncture (5) 30 min once daily Estazolam 1 mg every two night 30 PSQI  
Ye T 200842 10 12 29–67 Diagnostic and Statistical Manual of Mental Disorders 4th ed. (DSM-IV) Abdominal acupuncture (12) 30 min once daily 5 times a week plus estazolam 2 mg once per night Estazolam 2 mg once per night 14 PSQI  
Zhang H 200343 55/82 25/20 16–62 CCMD-3/SRSS Body acupuncture (8 + x)a 30–60 min once daily Clonazepam 2 mg once per night 28 Self-Rating Sleep Scale (SRSS)  
Zhang X 200544 10/35 14/31 23–70 Unavailable Body acupuncture (3 + x)a 45 min once daily Estazolam 2 mg once per night plus oryzanol 20 mg 3 times a day 25 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom  
Zhang Q 2006 18/20 20/17 18–64 ICD-10/CCMD-3 Body acupuncture (10 + x)a 1 hour once daily Estazolam 2 mg once per night 20 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to sleeping efficacy  
Zhong Z 200845 15/17 12/14 40 CCMD-3 Body acupuncture (7 + x)a 30 min once per night and massage of sole once daily plus alprazolam 0.4–0.8 mg once per night Alprazolam 0.4–0.8 mg once per night 40 PSQI, SDS, SAS, significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom  
Zhu Z 200446 50/0 50/0 18–47 ICD-10 Electroacupuncture (6) 20 min 3 times a week No treatment 40 Scores evaluated by patients  
Zou Y 200847 28/32 30/28 18–68 Government criteria in China Electroacupuncture (8 + x)a 30 min once daily Alprazolam 0.4 mg once per night 20 Significant as “cured,” “markedly effective,” “improved,” “ineffective” according to improvement of symptom  
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CCMD, Chinese Classification of Mental Disease; CCMD-2, second version of CCMD; CCMD-3, third version of CCMD; ICD-10, 10th version of International Classification of Disease.

a

The selection of the acupoints according to syndrome differentiation.

Table 2.

Excluded Studies with Reasons

Study Reason for exclusion
Chen Z 200248 Randomized controlled trial but data were not available for analysis due to inadequate reporting
Chen Z 200249 Randomized controlled trial that was a replicated publication of Chen Z 200253
Chen X 200350 Randomized controlled trial that was a replicated publication of Chen X 20038
Chen H 200451 Randomized controlled trial but data were not available for analysis due to inadequate reporting
Cui G 200052 Randomized controlled trial but data were not available for analysis due to inadequate reporting
Cui R 200353 Randomized controlled trial that was a replicated publication of Cui R 200310
Dai M 200254 Randomized controlled trial but data were not available for analysis due to inadequate reporting
Gao H 200155 Randomized controlled trial but data were not available for analysis due to inadequate reporting
Hou C 200556 Randomized controlled trial but data were not available for analysis due to inadequate reporting
Li Z 200657 Quasi-randomized trial that did not meet the include criteria of this review
Luo L 200658 Randomized controlled trial that was a replicated publication of Luo L 200530
Sjoling M 200859 Quasi-randomized trial that did not match the included criteria of this review
Su X 200560 Randomized controlled trial but data were not available for analysis due to inadequate reporting
Tsay S 200361 Randomized controlled trial that was a replicated publication of Tsay 200339
Wang J 200462 Randomized controlled trial but data were not available for analysis due to inadequate reporting
Wang J 200663 Quasi-randomized trial that did not match the include criteria of this review
Wang C 199264 Retrospective study that did not match the include criteria of this review
Huang L 200716 Randomized controlled trial that was a replicated publication of Huang L 200716
Weng M 200766 Randomized controlled trial but data were not available for analysis due to inadequate reporting
Yang Z 200867 Prospective cohort study that did not match the included criteria of this review
Zhu H 200268 Randomized controlled trial but data were not available for analysis due to inadequate reporting
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The 46 trials involved a total of 3811 patients with insomnia, of whom 2882 were patients with primary insomnia, 220 were insomnia patients with poststroke, 179 with depression, 60 in remittent stage with schizophrenia, 166 with cervical spondylosis, 100 with drug addiction, and 204 with end-stage renal disease. There was a wide variation in the age of subjects (13–85 years) and disease duration (10 days–40 years). Thirty-three (33) trials specified six diagnostic criteria, including four national criteria in China, one criterion from the United States, and one international classification of disease (ICD). The interventions included acupuncture (body, auricular acupuncture, electroacupuncture, acupressure, and acupoint injection), acupuncture plus conventional medication, or herbal medicine. The controls included no treatment, sham acupuncture, medication, or herbal medicine. The acupoints used were not fixed, the number of acupoints selected ranged from 2 to 20, and the total treatment duration ranged from 2 days to 10 weeks. The top 10 commonly used body acupoints and top 5 auricular acupoints are presented in Figures 2 and 3 Ten (10) of the 46 trials used the scores (PSQI) as the outcome measure and 12 kinds of scores were used for sleep measurement. Thirty-three (33) trials used four classes to evaluate treatment effects including cure, markedly effective, effective, and ineffective according to the degree of overall symptom improvement.

FIG. 2.

FIG. 2.

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Top 10 points used for meridian acupuncture treatment.

FIG. 3.

FIG. 3.

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Top five points for auricular acupuncture treatment.

Methodological quality

The majority of the included trials were assessed to be of generally fair methodological quality. According to our predefined quality assessment criteria, seven trials (15.22%) were evaluated as good (A), and the remaining as fair (B). The sample size varied from 22 to 182 participants, with an average of 35 patients in each group. Only 1 of the 46 trials40 reported sample size calculation that used Sample Power software, essential for ensuring adequate statistical power of 82%. Fourteen (14) trials described the randomization procedure, using random number table, drawing, or coin tossing. Three trials37,41 (Luo L 2005, unpublished data) used envelope as the method for allocation concealment. Eight trials7,27,35,39,42 (Huang X 2000; Kou J 2003; Zhang Q 2006, unpublished data) employed a blinding procedure: four of them used patient blinding, three used assessor blinding, and one trial provide no information on blinding. There was high potential to have bias caused by belief of the subjects and the measurers in the remaining 38 trials. Nine (9) of the 46 trials reported the number of dropouts7,15,17,27,35,36,41 (Kou J 2003; Luo L 2005, unpublished data), six trials7,8,16,35,36,40 (Huang X 2000, unpublished data) mentioned follow-up, and none of them used intention to treat method. The reporting quality of 46 trials according to Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) varied among different trials (Table 3).

Table 3.

Reporting Quality of 46 Randomized Controlled Trials According to Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA)

Intervention   Description of item No. trials eligible to the principle Percentage
(1) Acupuncture rationale 1 1a) Style of acupuncture 46 100.00%
    1b) Rationale for treatment (e.g., syndrome patterns, segmental levels, trigger points) and individualization if used 46 100.00%
    1c) Literature sources to justify rationale 33 71.74%
(2) Needling details 2 2a) Points used (uni/bilateral) 46 100.00%
    2b) Numbers of needles inserted 24 52.17%
    2c) Depths of insertion (e.g., cun or tissue level) 21 45.65%
    2d) Responses elicited (e.g., de qi or twitch response) 21 45.65%
    2e) Needle stimulation (e.g., manual or electrical) 27 58.70%
    2f) Needle retention time 46 100.00%
    2g) Needle type (gauge, length, and manufacturer or material) 25 54.35%
(3) Treatment regimen 3 3a) Number of treatment sessions 46 100.00%
    3b) Frequency of treatment 46 100.00%
(4) Co-interventions 4 4a) Other interventions (e.g., moxibustion, cupping, herbs, exercises, lifestyle advice) 46 100.00%
(5) Practitioner background 5 5a) Duration of relevant training 2 4.35%
    5b) Length of clinical experience 2 4.35%
    5c) Expertise in specific condition 3 6.52%
(6) Control intervention(s) 6 6a) Intended effect of control intervention and its appropriateness to research question and, if appropriate, blinding of participants (e.g., active comparison, minimally active penetrating or nonpenetrating sham, inert) 11 23.91%
    6b) Explanations given to patients of treatment and control interventions 7 15.22%
    6c) Details of control intervention (precise description, as for item 2 above, and other items if different) 12 26.09%
    6d) Sources that justify choice of control 7 15.22%
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Effect estimates (Table 4)

Table 4.

Effect Estimates of Acupuncture Treatment in 46 Included Trials

Study Comparisons Effect estimate (95% CI) p value
Acupuncture/auricular/acupressure/TEAS versus no treatment
1 No. patients with total sleeping time increased >3 hours
 Tang W 200733 Auricular therapy plus Tuina and acupressure versus no treatment RR 1.81 (1.19, 2.77) 0.006
2 Quality scores of sleeping evaluated by patients
 Zhu Z 200446 Electroacupuncture versus no treatment MD −2.16 (−2.80, −1.52) <0.0001
3 Total scores of PSQI
 Chen M 19997 Acupressure versus conversation −6.32 (−7.47, −5.17)  
 Tsay 200335 Acupressure versus usual care −3.78 (−5.98, −1.58)  
 Tsay 200436 Acupressure versus usual care −1.20 (−3.91, 1.51)  
 Tsay 200436 Transcutaneous electrical acupoint stimulation versus usual care −1.45 (−4.06, 1.16)  
Meta-analysis   MD −3.28 (−6.10, −0.46) 0.02
Real acupuncture/acupressure versus sham acupuncture/acupressure
1 Total scores of PSQI
 Chen M 19997 Real acupressure versus sham acupressure −4.25 (−5.49, −3.01)  
 Tsay 200335 Real acupressure versus sham acupressure −1.35 (−3.49, 0.79)  
Meta-analysis   MD −2.94 (−5.77, −0.11) 0.04
2 Total sleeping duration (hours)
 Kim 200419 Real acupuncture versus sham acupuncture MD 74.00 (15.61, 132.39) 0.01
3 Quality of sleeping (scores)
 Kim 200419 Real acupuncture versus sham acupuncture MD 34.00 (19.30, 48.70) <0.0001
Acupuncture/auricular/acupressure versus Western medicine
1 No. patients with total sleeping time increased >3 hours
 Ding D 200811 Body acupuncture versus estazolam 1.01 (0.73, 1.42)  
 Huang X 2000 Body acupuncture versus estazolam 1.50 (1.03, 2.18)  
 Kang F 200518 Body acupuncture plus auricular therapy versus diazepam and oryzanol 3.91 (1.89, 8.08)  
 Kou J 2003 Body acupuncture versus stilnox 1.80 (1.23, 2.62)  
 Liu J 200625 Body plus auricular acupuncture versus diazepam or estazolam 2.25 (1.31, 3.88)  
 Liu Z 200726 Scalp acupuncture versus clonazepam 0.97 (0.68, 1.39)  
 Luo W 2006 Body acupuncture versus trazodone 1.55 (1.02, 2.37)  
 Wang M 200337 Body acupuncture versus diazepam 1.64 (1.26, 2.15)  
 Wang Y 200440 Scalp with electrical stimulation plus body acupuncture and auricular therapy versus diazepam and clonzapine 2.03 (1.16, 3.54)  
 Zhang X 200544 Body acupuncture versus estazolam plus oryzanol 1.20 (0.94, 1.54)  
Meta-analysis   RR 1.53 (1.24, 1.88) <0.0001
2 No. patients with total sleeping time increased >2 hours
 Liu Q 200024 Body plus auricular acupuncture versus estazolam 0.78 (0.46, 1.31)  
 Qiu R 199932 Acupressure plus herbal medicine versus estazolam plus herbal medicine 0.79 (0.50, 1.26)  
 Zou Y 200847 Electroacupuncture versus alprazolam 1.25 (1.08, 1.44)  
Meta-analysis   RR 0.95 (0.61, 1.50) 0.84
3 No. patients with total sleeping time >4 hours
 Ding W 200612 Body acupuncture versus diazepam 1.58 (1.18, 2.12)  
 Pan Q 200531 Body acupuncture versus estazolam 1.48 (1.17, 1.89)  
Meta-analysis   RR 1.53 (1.27, 1.84) <0.00001
4 Total scores of PSQI
 Huang X 2000 Body acupuncture versus estazolam 1.50 (1.03, 2.18)  
 Kou J 2003 Body acupuncture versus stilnox 1.80 (1.23, 2.62)  
 Li T 200722 Body plus auricular acupuncture versus diazepam or estazolam −2.66 (−4.91, −0.41)  
 Liu J 200625 Body plus auricular acupuncture versus diazepam or estazolam 2.25 (1.31, 3.88)  
 Liu Z 200726 Scalp acupuncture versus clonazepam 0.97 (0.68, 1.39)  
 Luo W 2006 Body acupuncture versus trazodone 1.55 (1.02, 2.37)  
 Wang Y 200440 Scalp with electrical stimulation plus body acupuncture and auricular therapy versus diazepam and clonzapine −5.48 (−8.16, −2.80)  
Meta-analysis   MD −2.83 (−4.47, −1.19) 0.0007
5 Scores of sleep time evaluated by patients
 Huang L 200716 Rolling acupuncture versus clonazepam −0.15 (−0.42, 0.12)  
 Xuan Y 200741 Body acupuncture versus estazolam 0.32 (−0.24, 0.88)  
Meta-analysis   MD −0.06 (−0.30, 0.18) 0.63
6 No. patients with sleep rates >65%
 Chen F 20079 Electroacupuncture versus diazepam plus oryzanol and VitB1 1.36 (1.04, 1.79)  
 Fan D 200614 Body acupuncture versus diazepam plus oryzanol 1.28 (0.91, 1.80)  
 Li X 200721 Body plus auricular acupuncture versus diazepam or estazolam 1.33 (0.99, 1.78)  
 Wang Q 200338 Electroacupuncture plus acupoint injection versus diazepam plus oryzanol and VitB1 1.46 (1.10, 1.93)  
 Zhang Q 2006 Body acupuncture versus estazolam 0.79 (0.45, 1.41)  
Meta-analysis   RR 1.28 (1.11, 1.48) 0.001
7 Total scores of SDS
 Hong Y 200515 Electroacupuncture versus trazodone −0.06 (−5.91, 5.79)  
 Luo W 2006 Body acupuncture versus trazodone −0.02 (−0.34, 0.30)  
Meta-analysis   MD −0.02 (−0.34, 0.30) 0.9
8 Total scores of SQ
 Hong Y 200515 Electroacupuncture versus trazodone MD −19.01 (−21.65, −16.37) <0.00001
9 Total scores of ASR
 Hong Y 200515 Electroacupuncture versus trazodone −4.00 (−5.19, −2.81)  
 Luo W 2006 Body acupuncture versus trazodone −2.16 (−3.58, −0.74)  
Meta-analysis   MD −3.12 (−4.92, −1.32) 0.0007
10 Total scores of LSEQ
 Wang X 200839 Abdominal acupuncture plus placebo pill versus estazolam plus sham acupuncture MD −18.78 (−29.81, −7.76) <0.01
11 Total scores of SRSS
 Zhang H 200343 Body acupuncture versus clonazepam MD −3.00 (−4.41, −1.59) <0.0001
12 Total scores of HAMA
 Ma ZX 200630 Electroacupuncture versus clonazepam MD −1.55 (−4.25, 1.15) 0.26
Acupuncture/auricular plus Chinese medicine versus Chinese medicine
1 No. patients with total sleeping time increased >3 hours
 Lv Y 200728 Electroacupuncture plus auricular acupuncture and Suanzaoren decoction versus Suanzaoren decoction RR 1.30 (0.93, 1.82) 0.13
2 No. patients with total sleeping time >4 hours
 Tian H 200634 Body acupuncture plus herbal medicine versus herbal medicine RR 1.71 (1.26, 2.32) 0.0005
3 Total sleeping duration (hour)
 Lv Y 200728 Electroacupuncture plus auricular therapy and Suanzaoren decoction versus Suanzaoren decoction MD 1.25 (1.13, 1.37) <0.00001
4 No. patients with sleep rates >60%
 Du M 200713 Body acupuncture plus herbal medicine versus herbal medicine 1.41 (0.87, 2.30)  
 Lu W 199827 Body acupuncture plus Qiyeanshen tablet versus Qiyeanshen tablet 2.07 (1.06, 4.03)  
Meta-analysis   RR 1.67 (1.12, 2.50) 0.01
Acupuncture/auricular plus Western medicine versus Western medicine
1 Total sleeping duration (hour)
 Chen X 20038 Body plus auricular acupuncture and estazolam versus estazolam 1.01 (0.31, 1.71)  
 Li Q 200520 Electroacupuncture plus Prozac versus Prozac 1.18 (0.40, 1.96)  
Meta-analysis   MD 1.09 (0.56, 1.61) <0.0001
2 Total scores of PSQI
 Luo L 2005 Rolling acupuncture plus clonazepam versus clonazepam −1.00 (−4.00, 2.00)  
 Ye T 200842 Abdominal acupuncture plus estazolam versus estazolam −2.08 (−3.77, −0.39)  
 Zhong Z 200845 Body acupuncture and massage of sole plus alprazolam versus alprazolam −2.10 (−3.03, −1.17)  
Meta-analysis   −2.02 (−2.81, −1.24) <0.00001
3 No. patients with total sleeping time increased >3 hours
 Chen X 20038 Body plus auricular acupuncture and estazolam versus estazolam 1.01 (0.31, 1.71)  
 Li Q 200520 Electroacupuncture plus Prozac versus Prozac 1.28 (0.82, 2.00)  
 Luo L 2005 Rolling acupuncture plus clonazepam versus clonazepam 1.18 (0.40, 1.96)  
 Ma X 200629 Body acupuncture plus alprazolam and antipsychotic drug versus alprazolam plus antipsychotic drug 1.73 (1.18, 2.55)  
Meta-analysis   RR 1.33 (1.03, 1.71) 0.03
4 No. patients with total sleeping time increased >2 hours
 Liu Y 200123 Body acupuncture plus Ciwujia injection versus Ciwujia injection RR 1.48 (1.06, 2.07) 0.02
5 No. patients with sleep rates >55%
 Jian J 200517 Body acupuncture plus Ciwujia injection versus Ciwujia injection RR 2.00 (1.47, 2.73) <0.0001
6 No. patients with sleep rates increased >10%
Cui R 200110 Body acupuncture plus estazolam versus estazolam RR 1.79 (1.33, 2.39) 0.0001
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TEAS, transcutaneous electrical acupoint stimulation; CI, confidence interval; PSQI, Pittsburgh Sleep Quality Index; MD, mean difference; RR, relative risk; SDS, Self-rating Depression Scale; SQ, sleep quality; ARS, Asberg Rating Scale; LSEQ, Leeds Sleep Evaluation Questionnaire; SRSS, Self-Rating Sleep Scale; HAMA, Hamilton Anxiety Scale.

Acupuncture versus no treatment

Five (5) trials7,33,35,36,46 compared acupuncture with no treatment. Data from the no-treatment group was divided in half when compared with the other two interventional groups to avoid duplicated use in a three-arm trial40 in the meta-analysis. The result showed that acupressure was significantly better than no treatment on improving the total scores of PSQI (MD −3.28, 95% CI −6.10 to −0.46, p = 0.02).

Real acupuncture versus sham acupuncture

Three trials7,19,35 compared real versus sham acupuncture or acupressure, respectively. The result of meta-analysis showed that real acupuncture was more effective than sham acupuncture on improving total scores of PSQI (MD −2.94, 95% CI −5.77 to −0.11, p = 0.04).

Acupuncture versus Western medication

Twenty-six (26) trials compared acupuncture with Western medications. Most meta-analyses showed positive effect of acupuncture in treatment of insomnia, but one meta-analysis16,41 reported no difference between acupuncture and drugs on improving sleep duration evaluated by patients (MD −0.06, 95% CI −0.30 to 0.18, p = 0.63), one pooled results15 (Luo W 2006, unpublished data) showed no difference between acupuncture and trazodone on improving total scores of the Self-rating depression scale (SDS; MD −0.02, 95% CI −0.34 to 0.30, p = 0.90), and also another one trial30 reported no significant difference (MD −1.55, 95% CI −4.25 to 1.15, p = 0.26) between electroacupuncture and clonazepam on improving the scores of Hamilton Anxiety Scale.

Acupuncture plus other interventions versus other interventions

Seven trials compared acupuncture plus Western medications versus medications. Meta-analysis of two trials8,20 showed significant difference between acupuncture plus medications compared with the same medications on increasing the total sleep duration by hour (MD 1.09, 95% CI 0.56–1.61, p < 0.0001). Other results of meta-analysis were consistent that acupuncture plus medications had a much more therapeutic effect than medications alone.

Four trials13,27,28,34 compared acupuncture plus herbal medicine with herbal medicine. Only one trial28 showed there was no significant difference between the combination therapy and herbal group on increasing the numbers of patients whose total sleeping time increased for more than 3 hours (RR 1.30, 95% CI 0.93–1.82, p = 0.13). However, the meta-analyses showed a positive effect of acupuncture plus herbal medicine compared with herbal medicine on increasing the numbers of patients with sleep rates that increased by more than 60% (RR 1.67, 95% CI 1.12–2.50, p = 0.01).

Meta-analysis of 10 trials showed a better effect of acupuncture than medications for the outcome of the number of patients whose total sleep duration increased for more than 3 hours (RR 1.53; 95% CI 1.24–1.88; p < 0.0001; 10 trials).

A funnel plot analysis of the 10 trials was generated, and it showed a significant asymmetry (Fig. 4).

FIG. 4.

FIG. 4.

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Funnel plot of 10 randomized controlled trials for the outcome of number of patients with sleeping time increased over 3 hours. SE, standard error; RR, relative risk.

Adverse effect

Outcome of adverse effect with relation to acupuncture was described in 12 trials; only 3 of them reported minor adverse effect in the acupuncture group. Two (2) trials16 (Kou J, 2003, unpublished data) reported no adverse effect observed in the acupuncture group. Another trial15 reported mild headache (1 case), and lassitude (1 case) in the acupuncture group (n = 28), whereas there was dizziness (3 cases), constipation (3 cases), dry mouth (2 cases), palpitation (1 case), and oscitation (1 case) in the trazodone group (n = 27).

Two (2) trials15,28 evaluated the scores of the adverse effect rating scale. The result showed that acupuncture was safer than trazodone (MD −3.12, 95% CI −4.92 to −1.32, p = 0.0007).

Discussion

Based on the results of meta-analyses, the majority showed that compared with no treatment, sham acupuncture, or medications, acupuncture was significantly better on improving parameters in sleep quality and duration, and the combination of acupuncture and other interventions appears more effective than those interventions alone, though it was possible that the beneficial effect from acupuncture is overvalued because of the small sample size, flawed methodology of the included trials and the short follow-up duration.

There are several limitations in this review. First, the quality of the included studies is generally fair, which means the existence of moderate risk of bias. Because of inadequate reporting of randomization and blinding in the majority of trials, it was possible that there was performance bias and detection bias due to patients and researchers being aware of the therapeutic interventions for the subjective outcome measures. Intention-to-treat analysis was not applied in data analyses in the trials. The funnel plot asymmetry suggests the possibility of publication bias and small, low-quality trials. In addition, there is probably language bias because 43 of 46 included trials were published in Chinese, and 3 were published in English, but conducted in Taiwan and Korea. Vickers69 found that some Asian countries including China publish unusually high proportions of positive results, for which publication bias is a possible explanation. Second, 22 trials used Chinese diagnostic criteria of insomnia, 1 trial used U.S. criterion, and 6 trials used an ICD, but there were no specified diagnostic criteria for insomnia in the remaining trials. The participants are quite heterogeneous in terms of type of insomnia, such as in elderly with an average age of 81 years, or in heroin addicts with dyssomnia after detoxification. Third, there were different acupunctures used in the trials, which included acupuncture as a unique treatment in 18 trials, and acupuncture combined with other treatments in 28 trials. Twenty (20) trials selected the acupoints according to syndrome differentiation based on Chinese medicine theory, and 26 trials used fixed acupoints throughout the treatment. According to STRICTA, all of the 46 trials reported the style of acupuncture, rationale for treatment, points used, number of treatment sessions, frequency of treatment, and other interventions, but only about 50% of trials reported needling techniques such as the depth of insertion, responses elicited, needle stimulation and needle type, and less than 30% of trials mentioned the details of control intervention and practitioner's background. Controls were also heterogeneous in these trials, including Western medications, no treatment, sham acupuncture, acupressure, or herbal medicine. The treatment duration varied from 2 days to 10 weeks. Fourth, the use of composite outcome measures in 34 trials to evaluate overall improvement of symptoms limits the generalization of the findings. The classification of cure—markedly effective, effective, or ineffective—is not internationally recognized, and it is hard to interpret the effect. We suggest future trials to comply with international standards in the evaluation of treatment effect. Although there is no major statistical heterogeneity among the data analyses, we realized that the clinical heterogeneity would be very significant due to the variations in study quality, participants, intervention, control, and outcome measures. The interpretation of the positive findings from the meta-analyses needs to be incorporated with the clinical characteristics of the included trials and evidence strength. Therefore, the conclusion of the beneficial effect of acupuncture for insomnia needs to be confirmed in large and rigorously designed RCTs.

Our latest searches identified three systematic reviews of acupuncture for insomnia. One (1) Cochrane review published in 2007 included only 7 randomized trials published in English, and it concluded that current evidence was not sufficient to support the use of any form of acupuncture for the treatment of insomnia.70 Another systematic review published in Chinese in 2005 included only 6 Chinese trials with low quality, and had a similar conclusion.71 The most recent review published in 200972 included 12 clinical trials (including 3 randomized trials) and 18 case series. However, the authors were not able to access Chinese databases and quite a lot of studies published in Chinese were missed. This review by Huang and colleagues described the TCM diagnosis for insomnia and acupuncture treatment, which is considered relevant to clinical practice. We conducted comprehensive searches in both English and Chinese databases, and included 46 randomized trials. Our review suggests that acupuncture improves sleep quality and increases sleep duration. However, the beneficial findings of this systematic review still are not conclusive due to the limitations of the methodological quality of the included trials. Further rigorous trials are warranted.

Most of the existing trials are small and there is a moderate risk of bias. Further high-quality studies with larger sample size are needed to confirm the effectiveness of acupuncture in treating insomnia. Randomization methods need to be clearly described and fully reported. Although blinding of the acupuncturists might be very difficult, blinding of patients and outcome assessors should be attempted as far as possible to minimize performance and assessment biases. Analysis of outcomes based on intention-to-treat principle is important. Since insomnia is a highly heterogeneous disease with different etiology and severity, acupuncture is likely to have different effects on different subgroups of patients. Therefore, future clinical trials should be focused on particular subgroups or include a very large sample size to delineate the effect of acupuncture on different types of patients or different treatment techniques. In addition, well-defined diagnostic or classified criteria such as ICD-10 or the third version of Chinese Classification of Mental Disease should be employed to make a precise clinical diagnosis of insomnia, and hence increase the comparability between trials. Reporting of trials should follow the Consolidated Standards of Reporting Trials73 to explicitly explain the process of the treatment, so that the clinicians or other researchers can possibly use this process. Because the acupuncturist's technical competence may influence the therapeutic effect, we suggest that researchers describe the detailed treatment and that trials be conducted by qualified, well-trained acupuncturist in future studies according to STRICTA.74 Since insomnia may wax and wane with or without treatment, a longer follow-up period with serial measurement of outcomes is important to determine the effectiveness and long-term effect of acupuncture.

Footnotes

*

Huang XQ, Dong GR. Clinical study of acupuncture with combining Yin-Yang or Qi-Blood points on treatment of insomnia [in Chinese]. Dissertation for the master degree from Heilongjiang University of Traditional Chinese Medicine. 2000;

Kou JY, Sun YZ. Clinical observation of effect of acupuncture with Tiaozang Anshen method on Treatment of Insomnia [in Chinese]. Dissertation for the master degree from Heilongjiang University of Traditional Chinese Medicine. 2003;

Luo L, Yu SG. Effect of rolling acupuncture on treatment of insomnia [in Chinese]. Dissertation for the master degree from Chengdu University of Traditional Chinese Medicine. 2005;

Luo WZ, Lai XS. Clinical study of therapeutic effect of acupuncture with Jieyutiaoshen method on treatment of insomnia with depressive disorder [in Chinese]. Dissertation for the master degree from Guangzhou University of Traditional Chinese Medicine. 2006;

Zhang Q, Dong GR. Study of therapeutic effect of acupuncture with combining Yin-Yang or Qi-Blood points method on treatment of insomnia and its effect on polysomnography [in Chinese]. Dissertation for the master degree from Heilongjiang University of Traditional Chinese Medicine. 2006;

Acknowledgments

H.J. Cao and J.P. Liu were supported by a grant from the National Basic Research Program of China (“973” Program, no. 2006CB504602) and the 111 Project (B08006). J.P. Liu was supported in part by grant number R24 AT001293 from the National Center for Complementary and Alternative Medicine (NCCAM) of the U.S. National Institutes of Health. We also thank medical student Zhanguo Xie for his help in identifying articles for this review.

Disclosure Statement

No competing financial interests exist.

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