The protocol was performed in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement[19, 20]. Meanwhile, it has been registered with PROSPERO with registration number
Criteria for including studies in this review
Types of studies
Randomized controlled trials in English and Chinese will be included; reviews, systematic evaluations, case reports, expert experience, conference proceedings, animal experiments, duplicate publications, or similar literature will be excluded.
Types of patients
Patients diagnosed with primary insomnia according to internationally recognized criteria such as the International Classification of Diseases (10th edition) (ICD-10), International Classification of Sleep Disorders, 3rd edition (ICSD-3), Chinese Classification and Diagnostic Criteria for Mental Disorders, 3rd edition (CCMD-3), Diagnostic and Statistical Manual of Mental Disorders, 4th and 5th editions (DSM-IV, DSM-V), or accepted diagnostic standards will be included in this study. The inclusion criteria are not restricted by gender, race, economic status, ethnicity, or the severity of primary insomnia. However, patients with insomnia caused by other mental disorders, physical illnesses, substance abuse, or other specific sleep disorders, as well as those with primary insomnia coexisting with other disorders, will be excluded from the study.
Types of interventions
In the experimental group, the treatment will solely consist of body acupuncture without any combined pharmacologic or non-pharmacologic therapies. There will be no limitations placed on the selection of specific acupoints, the number of acupoints used, the frequency or duration of treatments, or the overall course of treatment. However, specialized acupuncture interventions such as auricular acupuncture, eye acupuncture, electroacupuncture, acupoint injections, acupressure, intradermal needling, and moxibustion will be excluded from the study.
Types of control groups
Treatments in the control groups will include oral Western or Chinese medicine, with no restriction on specific drugs.
Types of outcome measures
Studies that report one or more of the below-mentioned outcomes will be included. Otherwise, the trial will be excluded.
Primary outcomes
This study focuses on the effectiveness of body acupuncture over medication in the treatment of primary insomnia. Therefore, the change in the Pittsburgh Sleep Index(PSQI) and the Clinical effectiveness rate will be used to measure treatment efficacy.
Secondary outcomes
The secondary outcomes will include adverse events measured by Treatment Symptom Scale(TESS)or the incidence of adverse events.
Search methods for identification of studies
Electronics searches
The following eight electronic databases including Cochrane Library, MEDLINE (via PubMed), Embase, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Database, and Chinese Biomedical Literature Database (CBM) will be searched from their inception to 1 March 2024. Gray literature should also be searched. All randomized controlled trials reported in English or Chinese will be included. In addition, qualified research conference abstracts, reference lists of manuscripts and trial registry database (WHO International Clinical Trials Registry Platform and Clinical Trials. gov) will be retrieved to identify additional studies. The search strategy con- sists of Medical Subject Headings (MeSH) and free-text terms. The proposed detailed search strategy for PubMed is presented in Table 1.Detailed information on the full search strategies for all data- bases is available in the online Supplemental appendix 1.
Table 1
search strategy in PubMed database
No
|
Search Items
|
#1
|
Sleep Initiation and Maintenance Disorders.Mesh
|
#2
|
Disorders of Initiating and Maintaining Sleep.ti.ab
|
#3
|
Early Awakening.ti.ab
|
#4
|
Nonorganic Insomnia.ti.ab
|
#5
|
Primary Insomnia.ti.ab
|
#6
|
Rebound Insomnia.ti.ab
|
#7
|
Sleep Initiation Dysfunction.ti.ab
|
#8
|
Sleeplessness.ti.ab
|
#9
|
Insomnia Disorder.ti.ab
|
#10
|
Insomnia Disorders.ti.ab
|
#11
|
Insomnia.ti.ab
|
#12
|
Insomnias.ti.ab
|
#13
|
Chronic Insomnia.ti.ab
|
#14
|
Awakening, Early.ti.ab
|
#15
|
Insomnia, Nonorganic.ti.ab
|
#16
|
Insomnia, Primary.ti.ab
|
#17
|
Insomnia, Rebound.ti.ab
|
#18
|
Dysfunction, Sleep Initiation.ti.ab
|
#19
|
Dysfunctions, Sleep Initiation.ti.ab
|
#20
|
Sleep Initiation Dysfunctions.ti.ab
|
#21
|
Insomnia, Chronic.ti.ab
|
#22
|
1 or 2–21
|
#23
|
Acupuncture.Mesh
|
#24
|
Acupuncture therapy.ti.ab
|
#25
|
Body acupuncture.ti.ab
|
#26
|
acupuncture point.ti.ab
|
#27
|
23 or 24–26
|
#28
|
Randomized Controlled Trial.Publication Type
|
#29
|
Randomized.ti.ab
|
#30
|
placebo.ti.ab
|
#31
|
28 or 29–30
|
#32
|
#22 and #27 and #31
|
Selection of studies
Studies obtained through database searches will be imported into the Endnote21 software and duplicates will be removed. The remaining studies will be screened by 2 researchers(DL and SW) based on inclusion and exclusion criteria by reading the titles, abstracts, and full text of relevant studies to finalize the literature for inclusion. For unspecified studies, the authors will be contacted for detailed information to determine if the study will be included. Any analysis of the article will be resolved through discussion or reviewed by a third researcher(SL) until consensus is reached. An outline of the study selection process will be presented in the Preferred Reporting Items for Systematic Evaluation and Meta-Analysis flowchart Fig. 1.
Data extra action and management
Based on self-designed data acquisition forms, 2 researchers(YC and SP) will independently extract the following information from eligible studies: (1) general information (country, first author, year of publication, sample size, and study design); (2) patient information (age, sex, race); (3) interventions and comparisons (treatment duration, treatment frequency, total number of treatments, and medications); (4) outcome indicators (type of outcome indicator, data and time of each measurement); (5) adverse events; for unclear or incomplete data, the corresponding author will be contacted by phone or e-mail to obtain complete information. Disagreements, if any, will be resolved by discussion or involvement of a third researcher(SW). Finally, the data will be imported into RevMan 5.4 software.
Quality assessment
2 researchers(DZ and XW) will independently conduct a quality evaluation of the included studies according to the Cochrane Risk of Bias Evaluation Tool. The evaluation includes the following 6 aspects: (1) selection bias (method of generating randomized sequences and concealment of allocation); (2) implementation bias (blinding of investigators and subjects); (3) measurement bias (blinding of outcome evaluators); (4) follow-up bias (completeness of the outcome metrics); (5) reporting bias (selective reporting of study results); and (6) other bias (other sources of bias). The results of the risk of bias evaluation of the two investigators will be checked, and in case of disagreement, the decision will be made by a third investigator(DL). A risk of bias map will be made of the evaluation results of the included studies using RevMan 5.4 software.
Statistical analysis
Meta-analysis of the included studies will be performed using RevMan 5.4 with publication bias, heterogeneity test and sensitivity analysis. Relative risk (RR) will be used as the efficacy analysis statistic for count data, and Mean Difference (MD) will be used as the efficacy analysis statistic for count data, and each effect size will be expressed as 95% confidence interval (95% Cl). (1) Heterogeneity test: if P < 0.1 and I2 > 50%, it suggests that there is a large heterogeneity among studies, and a random effect model will be used; if P > = 0.1 and I2 < = 50%, it suggests that there is no significant heterogeneity among studies, and a fixed effect model will be used. (2) Publication bias test: the funnel plot will be used to evaluate the publication bias of the included studies. (3) Sensitivity analysis: The studies to be included will be excluded one by one for Meta-analysis to analyze the impact of the excluded studies on the combined effect size. If there will be no substantial change in the results, the results will be considered credible; if the conclusions will be changed, it will suggest that there will be some potential factors for the effect of the intervention.
Ethics and consents
No ethics approval is required since this systematic review and meta-analysis do not collect confidential personal data and do not perform interventions in treating patients. Besides, the findings will be disseminated through a peer-reviewed journal.