Clinical effectiveness of Tui Na for insomnia compared with estazolam: A systematic review and meta-analysis of randomized controlled trials.

The purpose of this systematic review (SR) is to evaluate the effectiveness and safety of Tui Na therapy for insomnia. Two authors separately searched PubMed, the Cochrane Library, EMBASE, SinoMed Database, China National Knowledge Infrastructure (CNKI), Wanfang Database, China Science Technology Journal Database, related SR and published protocols at the same time to find randomized controlled trials (RCTs), which compared Tui Na therapy with estazolam therapy for insomnia, from their inception to January1st 2019. Screening documents, data extraction, quality assessment of methodology and quality assessment of evidence were also conducted by two authors separately at the same time. We used Cochrane Risk of Bias tool to assess the methodological quality of included RCTs. The results of meta-analysis were made via RevMan software (5.3). The quality of evidence was assessed by on-line GRADEpro. The primary outcome: Pittsburgh Sleep Quality Index (PSQI) score, the secondary outcome: clinical effectiveness rate and the safety index: adverse events. The clinical effectiveness of these included RCTs all focused on the improvement of patients' satisfaction with sleep time and sleep quality. We included 22 RCTs(1,999 participants), meeting the inclusion and exclusion criteria. The assessment of methodological quality was not satisfied, in which "high risk", "unclear risk" and "low risk" all existed. The results of meta-analysis demonstrated that (1)for primary outcome, the PSQI score of Tui Na therapy was lower than that of estazolam therapy after treatment in subgroup1(Head)(MD-2.39,95%CI[-3.79,-0.98],I2 = 82%,n = 291,3 trials) and subgroup4(Abdomen)(MD-1.7,95%CI[-2.53,-0.87],I2 = 0%,n = 120,2 trials);while there was no significant difference between Tui Na therapy and estazolam therapy in subgroup2(Head and trunk)(MD-1.39,95%CI[-3.03,0.24],I2 = 90%,n = 200, 2 trials) and subgroup3(Head, trunk and extremities)(MD-0.51,95%CI[-1.53,0.5],I2 = 30%,n = 126,2 trials).(2) for secondary outcomes(the clinical effectiveness rate and safety index),the clinical effectiveness rate of Tui Na therapy was higher than that of estazolam therapy after treatment in subgroup1(Head)(RR1.21,95%CI[1.05,1.39],I2 = 26%,n = 239,3 trials), subgroup2(Head and trunk)(RR1.15,95%CI[1.08,1.23],I2 = 33%,n = 1024,10 trials) and subgroup4(Abdomen)(RR1.12,95%CI[1.01,1.23],I2 = 0%,n = 180,3 trials); while there was no significant difference between Tui Na therapy and estazolam therapy in subgroup3(Head, trunk and extremities)(RR1.03,95%CI[0.94,1.13],I2 = 28%,n = 346,4 trials).Safety index, 5 RCTs reported adverse events. Among them, only 1 RCT reported adverse event in Tui Na therapy, which was daytime drowsiness; all 5 RCTs reported adverse events in estazolam therapy, which were dry mouth, dizziness, daytime drowsiness etc. The evidence quality was generally low to very low. Tui Na therapy appeared to be superior to estazolam therapy in treating areas(head; abdomen), while there was no significant difference between Tui Na therapy and estazolam therapy in treating areas(head and trunk; head, trunk and extremities). No serious adverse event was reported in Tui Na therapy. However the methodological quality and evidence quality were not satisfied. Therefore we could not make a convincing conclusion on the effectiveness and safety of Tui Na therapy for insomnia. Practitioners should combine their experience, evidence of our review and patients' preferences to make a proper treatment. And more high quality RCTs and well-designed protocols of Tui Na therapy for insomnia are needed in the future.

Feng G ，Han M ，Li X ，Geng L ，Miao Y ... -  《-》

Pediatric Tui Na for acute diarrhea in children under 5 years old: A systematic review and meta-analysis of randomized clinical trials.

To evaluate the benefits and harms of pediatric Tui Na as a non-pharmaceutical Chinese medicine therapy for acute diarrhea in children under 5 years of age. Systematic review and meta-analysis of randomized clinical trials. We searched seven major English and Chinese databases from their inception to January 2018 for randomized clinical trials (RCTs) comparing pediatric Tui Na therapy with conventional medicine (montmorillonite/diosmectite or probiotics used alone or in combination). Two authors extracted data and assessed the Cochrane risk of bias, independently. The primary outcomes are clinical cure rate and diarrhea duration from admission to the cessation of diarrhea. 'Clinical cure' is defined as the frequency, timing and character of stool back to normal status, as well as disappearance of diarrhea symptoms. We present dichotomous data as risk ratio (RR), and continuous data as mean difference (MD) with their 95% confidence interval (CI). We used the Cochrane's Revman software (v.5.3) for data analysis. Trial sequential analysis (TSA) was applied to calculate the required sample size in a meta-analysis and detect the robustness of the results. The GRADEpro was used to generate a summary of finding table. Totally 26 RCTs were included, involving 2410 children with acute diarrhea. Most of the included trials had high or unclear risk of bias in terms of random sequence generation, blinding, and incomplete outcome reporting. The pooled results demonstrated that pediatric Tui Na was superior to montmorillonite after three-session treatment (RR 1.45, 95% CI 1.29-1.62, n = 772, 10 trials), and also superior to montmorillonite combined with probiotics after three-session treatment (RR 2.04, 95% CI 1.49-2.78, n = 533, 7 trials) and after six-session treatment (RR 1.52, 95% CI 1.34-1.73, n = 631, 5 trials) in improving clinical cure rate. Pediatric Tui Na significantly decreased the duration of acute diarrhea (hrs) (MD -0.40 h, 95% CI -15.31 to -5.48 h, n = 410, 6 trials) and daily stool frequency (MD -1.71times, 95% CI -2.37 to -1.04, n = 217, 3 trials, after three-session treatment). No adverse event related to pediatric Tui Na was reported in the included trials. The quality of evidence of included trials was generally moderate to low. TSA for cure rate demonstrated that the pooled data reached a sufficient power regarding both numbers of trials and participants. This review shows pediatric Tui Na appears to be effective and safe in improving clinical cure rate and shortening diarrhea duration in childhood aged less than five years of age with acute diarrhea. However, rigorously designed well-reported RCTs are warranted to confirm the findings.

Lai BY ，Liang N ，Cao HJ ，Yang GY ，Jia LY ，Hu RX ，Lu CL ，Zhao NQ ，Fang SN ，Liu XH ，Zhang YJ ，Fei YT ，Wu DR ，Liu JP ... -  《-》

Acupuncture for Primary Insomnia: An Updated Systematic Review of Randomized Controlled Trials.

Cao HJ ，Yu ML ，Wang LQ ，Fei YT ，Xu H ，Liu JP ... -  《-》

Acupuncture for cancer-related insomnia: A systematic review and meta-analysis.

Cancer-related insomnia is a highly prevalent complaint in cancer patients. However, there is no meta-analytic synthesis explored the efficacy of acupuncture for cancer-related insomnia among cancer patients undergoing active cancer treatments. This systematic review and meta-analysis were performed to explore the efficacy and safety of acupuncture for insomnia in people diagnosed with cancer. Systematic review and meta-analysis of existing randomized controlled trials on acupuncture in the treatment of cancer-related insomnia. According to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, we identified and extracted the trials through November 2021 from ten databases and two trials record platforms (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PUBMED, Web of Science, PsycINFO, Allied and Complementary Medicine, Cumulative Index to Nursing and Allied Health Literature, China National Knowledge Infrastructure, Wanfang Digital Journals, ClinicalTrials, World Health Organization International Clinical Trials Registry Platform). The quality of the trials was assessed using Jadad score and Risk of Bias (2.0). A meta-analysis was synthesized using the random-effects model if the included studies were in high methodological quality. A total of 690 studies were identified, with 22 were included in the review, and 6 of them were included in the quantitative synthesis. Studies were highly heterogeneous in terms of participant characteristics and study methodologies. Most studies recruited patients diagnosed with a specific cancer type, and breast cancer patients were the subgroup most represented. The qualitative review of available evidence suggested a beneficial efficacy of acupuncture on sleep without serious adverse events in several studies (55%). The meta-analysis revealed that acupuncture produced a significant improvement in the total Pittsburgh Sleep Quality Index (PSQI) score relative to the wait-list control among breast cancer patients undergoing active cancer treatments (MD -1.92, 95% CI -3.25 to -0.59, p = 0.005). Similar improvement of real and sham acupuncture on PSQI score change post-intervention was found (MD: -0.68, 95% CI: -2.44 to 1.07, p = 0.44). Manual acupuncture had similar effective rate as compared to estazolam immediately post-intervention (RR: 0.94, 95% CI: 0.87 to 1.01, p = 0.09), and had significantly better effective rate than estazolam at 1-week post-intervention follow-up (RR: 1.25, 95% CI: 1.10 to 1.43, p = 0.0009). All reported acupuncture related adverse events were mild or moderate in severity. Acupuncture has great potential to be used to manage cancer-related insomnia for cancer patients or survivors. More studies with rigorous designs and larger sample size are warranted to verify the efficacy and safety of acupuncture for insomnia among people diagnosed with cancer, in particular among those with clinically significant insomnia. PROSPERO (ID: CRD42021285844).

Zhang J ，Zhang Z ，Huang S ，Qiu X ，Lao L ，Huang Y ，Zhang ZJ ... -  《-》

A comprehensive insight on cognitive behavioral therapy for insomnia in pregnant women: A systematic review and meta-analysis.

Cognitive behavioral therapy for insomnia (CBT-I) as a first-line treatment may improve insomnia in pregnant women. The efficacy of the components, modalities, doses, and effectiveness of CBT-I in pregnant women at follow-up remains unclear. To assess the effectiveness of CBT-I in pregnant women and identify effective intervention components, modalities, and doses. Systematic review and meta-analysis. Six English databases (PubMed, Embase, Cochrane Library, Web of Science, PsycINFO, CINAHL) and four Chinese databases (CNKI, WanFang Data, SinoMed, and CQVIP) were searched from inception to 10 January 2023. Randomized controlled trials (RCTs) on CBT-I in pregnant women with outcomes of insomnia severity measured by Insomnia Severity Index (ISI) or sleep quality measured by Pittsburgh Sleep Quality Index (PSQI). Two reviewers independently completed records selection, data extraction, and study quality assessment. The fixed-effect or random-effect model was used for pooled analyses. Subgroup analyses were conducted based on different delivery types and intervention duration. The GRADE approach was used to evaluate the certainty of the evidence. Narrative analyses were used when meta-analysis was not appropriate. Mean differences with 95% CIs of insomnia severity and sleep quality scores were the main outcomes (greater scores indicating greater severity). Nine RCTs (N = 978) meeting the inclusion criteria were included. These trials included individual- (n = 6) or group-based (n = 3) interventions, which were conducted via face-to-face (n = 5), digital (n = 3) or telephone and e-mail (n = 1) formats. Six studies stated intervention components specific to pregnant women. CBT-I improved insomnia severity (MD = -2.69, 95% CI: -3.41 to -1.96, P ＜ 0.001, high quality evidence; MD = -3.69, 95% CI: -5.91 to -1.47, P = 0.001, moderate quality evidence) and sleep quality (MD = -2.85, 95% CI: -4.73 to -0.97, P = 0.003, moderate quality evidence; MD = -1.88, 95% CI: -2.89 to -0.88, P ＜ 0.001, moderate quality evidence) immediately after intervention (＜1-month) and at short-term (≥1 month to ＜6 months) follow-up, respectively. Two RCTs reported no effectiveness on insomnia severity at medium-term (≥6 months to＜12 months) follow-up. Only 1 RCT showed reduced insomnia severity at long-term (≥12 months) follow-up. One RCT reported no effectiveness in sleep quality at medium-term follow-up and effectiveness at long-term follow-up was not reported. Pregnant women may benefit from CBT-I to improve short-term insomnia, but long-term effectiveness is unclear. Rigorous RCTs with long-term follow-ups are warranted.

Shang X ，Ye L ，Wang MP ，Lam TH ，Lai AYK ... -  《-》