Abstract
Aim To assess the reporting quality of randomized controlled trials (RCTs) on acupuncture for primary insomnia (PI). Methods Seven Chinese and English databases were searched for publication reporting RCTs on acupuncture for PI from the inception of the databases to August 6, 2021. The internationally recognized Consolidated Standards of Reporting Trials (CONSORT) statement and the International Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines were used to evaluate the reporting quality. The agreement between two researchers was calculated by Cohen's kappa. Results A total of 102 eligible RCTs were assessed. According to the CONSORT statement (2017), the positive reporting rates of items such as “abstract,” “background,” “participants,” and “numbers analyzed” were above 80%. However, the positive reporting rates of items such as “sample size,” “randomization implementation,” “Outcomes and estimation,” “Ancillary analyses,” and “Registration” were below 20%. According to STRICTA guidelines, the positive reporting rates of items such as “style of acupuncture,” “reasons for acupuncture treatment,” “Number of needles inserted,” “Needle retention time,” “Treatment regimen,” and “precise description of the control intervention” were above 80%. However, the positive reporting rates of items such as “setting and context of treatment” and “practitioner background” were below 20%. Conclusion It is essential to advocate the endorsement of the CONSORT statement and STRICTA guidelines to improve the quality of acupuncture RCT reports.
Highlights
Primary insomnia (PI) is characterized by difficulty in falling asleep or staying asleep, with the exclusion of insomnia caused by various secondary factors including mental, physical, and neurological disorders, alcohol, or drugs [1].e overall prevalence of insomnia was 5%–10% worldwide [2], while the incidence rate of insomnia in females is higher than that in males [3]
All the following criteria were met: (1) confirmed diagnosis of PI; (2) randomized controlled trials (RCTs) of acupuncture to treat PI; and (3) the intervention measures of the experimental group were acupuncture or acupuncture combined with traditional Chinese medicine (TCM) nondrug therapy other than acupuncture; the control group was treated with Western medicine or sham acupuncture or acupuncture at nonmeridian and nonacupoints
One of the following criteria was met: (1) not in accordance with the inclusion criteria; (2) no confirmed diagnosis of PI in the RCT; (3) in addition to acupuncture, the intervention measures in the experimental group included drug treatment; (4) the control group was treated with routine acupuncture; (5) if the content of conference paper and periodical paper or Chinese paper and English paper were similar, the one with higher quality were chosen; (6) if the papers were about the same RCT, the one published later was chosen; (7) the paper was about research protocol; and (8) full-text paper not available
Summary
Primary insomnia (PI) is characterized by difficulty in falling asleep or staying asleep, with the exclusion of insomnia caused by various secondary factors including mental, physical, and neurological disorders, alcohol, or drugs [1].e overall prevalence of insomnia was 5%–10% worldwide [2], while the incidence rate of insomnia in females is higher than that in males [3]. Primary insomnia (PI) is characterized by difficulty in falling asleep or staying asleep, with the exclusion of insomnia caused by various secondary factors including mental, physical, and neurological disorders, alcohol, or drugs [1]. The treatments of insomnia mainly include cognitive behavioral therapy (CBT), drug therapy, physical therapy, and complementary and alternative medicine (CAM) [5]. The short-term efficacy of drugs in the treatment of insomnia has been confirmed, it has been reported that there are side effects such as hangover, drug resistance, and drug dependence [5]. E efficacy of physical therapy (such as transcranial magnetic stimulation and Evidence-Based Complementary and Alternative Medicine phototherapy) is not certain yet [4, 7]. Structured abstract including trial design, methods, results, and conclusions. Important changes to methods after trial commencement (such as eligibility criteria), with reasons
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