| Background:Primary Insomnia (Insomnia) is a clinically common disease, seriously affecting the quality of life of patients and imposing a heavy burden on patients and society. Currently, the main use of primary insomnia is sedative medication, but these drugs are easy to induce tolerance and withdrawal as well as other adverse reactions. Acupuncture treatment of primary insomnia has been used for thousands of years, although many literature reported its clinical effectiveness and safety, but because of poor quality research literature, clinical study design factors such as irrationality, therefore, the lack of evidence for efficacy and safety of acupuncture is still a problem.Objective:To collect at home and abroad before the end of March 2010 all published and unpublished, acupuncture treatment of primary insomnia randomized controlled study in English (RCT) documents, in accordance with the evaluation of evidence-based medicine approach to acupuncture treatment of primary efficacy and safety of insomnia, so as to acupuncture treatment of primary insomnia in the clinical application of evidence to provide evidence-based medicine, and clinical in-depth study to provide new ideas.Materials and Methods:strict inclusion and exclusion criteria, comprehensive search Cochrane Library (2010, Issuel), Medline or Pubmed (1980-2010), Ovid Evidence-based medicine databases (Cochrane DSR, ACP Journal Club, DARE, and CCTR.1991-2010), Embase CD-ROM database (1978 to 2010), Chinese Biomedical CD Database (CBM disc) (1978 a 2010), China Academic Journal (CNKI Web: www.cnki.net) (1994 a 2010), VIP Chinese Science and Technology Periodical Database (1959 a 2010), Articles Resources Database (1975 to 2010); hand searched from January to March 2010 published in "Traditional Chinese Medicine", "Chinese Acupuncture", "Shanghai Journal of Acupuncture", "Journal of Clinical Acupuncture "" Acupuncture Research,"" Modern Medicine"," Journal of Traditional Chinese Medicine "and" new medicine "and other 9 kinds of magazines, and in http://www.google.cn/, http://www. controlled-trials.com, http://www.clinicaltrials.gov and other network resources and conference literature database (CMCC) and the gray literature database to supplement search. Will get published and unpublished literature, by two researchers independently met the inclusion criteria of randomized controlled trials, data extraction and quality assessment, if any differences through discussion or by a third of researchers to solve. Finally, the research into the literature of the quality assessment and data synthesis. Number of patients using valid and invalid, PSQI total score, and sleep evaluation factors as indicators of the efficacy of acupuncture treatment of primary insomnia. Statistical analysis provided by Cochrane Collaboration RevMan5.1.21 software, count data, calculate the odds ratio (OR) or relative risk (Relative Risk, RR) and 95% confidence interval (confidence interval, Cl); measurement data, weighted mean difference (weighted mean difference, WMD) or standardized mean difference (standardized mean difference, SMD) and 95% confidence interval.Results:A total of 307 retrieved documents, which, by reading the title and abstract screening, removal and related research in this study does not 117, by reading the full text of this study was not associated with the removal of 169, and ultimately into the 21 met the inclusion criteria of clinical trials in English and Chinese patients were enrolled a total of 1728 cases of systematic reviews. The 21 included trials methodological quality was mixed, and generally low, mainly in:random allocation scheme is imperfect, do not use allocation concealment; the proper use of a small blind test; no sample size estimation; did not say withdrawal and exit the situation, without making the intention of the analysis; very small number of test subjects after the end of treatment were followed up, and several other aspects. Extracted data, the Meta-analysis or descriptive analysis. (1) Efficiency:Acupuncture better than western medicine [Peto OR 2.16,95% CI (1.58,2.97), P<0.00001]; acupuncture in combination with other therapies are better than western medicine [OR 3.17,95% CI (1.54,6.55), P=0.002]. However, sensitivity analysis, excluding concealment or blinding, or unclear implementation of the experimental error, regardless of acupuncture (OR 1.93,95% CI 0.94-3.96, P=0.07) or acupuncture in combination with other therapies (OR 1.91,95% 0.30-21.10, P=0.49) than simply not the sedative and hypnotic class of medicine has more advantages, this is not the same as the general trend; (2) PSQI score:Acupuncture is superior to western medicine [MD1.27,95% CI (0.90,1.63), P<0.00001]; acupuncture in combination with other therapies are better than western medicine [MD 3.12,95% CI (1.94,4.31), P<0.00001]; but data can not prove that acupuncture needles are more than comfort superiority (MD-0.10,95% CI-1.46-1.26, P<0.00001). Consistent with the overall results of sensitivity analysis; (3) sleep-related factors:Effects of acupuncture on sleep quality in patients with primary insomnia (MD 0.43,95% CI 0.27-0.59, P <0.00001), sleep disorders (MD 0.30,95% CI 0.19-0.41, P<0.00001), daytime function (MD 1.01,95% CI 0.37-1.65, P<0.0001) compared with the three aspects of medicine were excellent, the sensitivity analysis also showed the same results; and The available evidence does not confirm the time of acupuncture on sleep (MD 0.16,95% CI (-0.03,0.35), P=0.10), sleep time (MD 0.03,95% CI (-0.14,0.20), P=0.74) is has the advantage of sensitivity analysis results are consistent with the general trend; acupuncture effect on the use of sleeping pills are not as good as medicine acupuncture showed a trend (MD-0.89,95% CI (-1.08,-0.69), P<0.00001), sensitivity analysis consistent with the general trend; the impact of acupuncture on sleep efficiency, due to the presence of heterogeneity of the defects and test methodology, the results differ, therefore, can not suggest acupuncture and sedative hypnotic class greater impact on some of its drugs. Conclusion:The current evidence suggests that acupuncture treatment of primary insomnia clinical trial quality was generally low, there are several methodological flaws, especially not truly randomized and blinded assessment. In terms of efficiency, can not come to acupuncture or acupuncture in combination with other therapies is better than the pure western conclusions; in PSQI total score, the acupuncture and acupuncture with other therapies and better than the only western, but the existing evidence can not be that acupuncture and placebo acupuncture, and who is better; factors on sleep, the acupuncture or acupuncture in conjunction with other therapy on sleep quality, sleep disturbance, daytime function has advantages, while the sleep time, sleep time, sleep disorders, sleeping pills can not confirm whether there is advantage, but because of poor quality literature, this result should be carefully treated. Further research necessary to conduct high-quality, large sample of RCT to further clarify the efficacy of acupuncture treatment of primary insomnia and safety.
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