The reporting checklist for Chinese patent medicine guidelines: RIGHT for CPM.

Existing reporting checklists lack the necessary level of detail and comprehensiveness to be used in guidelines on Chinese patent medicines (CPM). This study aims to develop a reporting guidance for CPM guidelines based on the Reporting Items of Practice Guidelines in Healthcare (RIGHT) statement. We extracted information from CPM guidelines, existing reporting standards for traditional Chinese medicine (TCM), and the RIGHT statement and its extensions to form the initial pool of reporting items for CPM guidelines. Seventeen experts from diverse disciplines participated in two rounds of Delphi process to refine and clarify the items. Finally, 18 authoritative consultants in the field of TCM and reporting guidelines reviewed and approved the RIGHT for CPM checklist. We added 16 new items and modified two items of the original RIGHT statement to form the RIGHT for CPM checklist, which contains 51 items grouped into seven sections and 23 topics. The new and revised items are distributed across four sections (Basic information, Background, Evidence, and Recommendations) and seven topics: title/subtitle (one new and one revised item), Registration information (one new item), Brief description of the health problem (four new items), Guideline development groups (one revised item), Health care questions (two new items), Recommendations (two new items), and Rationale/explanation for recommendations (six new items). The RIGHT for CPM checklist is committed to providing users with guidance for detailed, comprehensive and transparent reporting, and help practitioners better understand and implement CPM guidelines.

Efficacy of cupping therapy on pain outcomes: an evidence-mapping study.

Objective: Cupping therapy is an ancient technique of healing used to treat a variety of ailments. An evidence-mapping study was conducted to summarize the existing evidence of cupping therapy for pain-related outcomes and indicate the effect and the quality of evidence to provide a comprehensive view of what is known. Methods: PubMed, Cochrane Library, Embase, and Web of Science were searched to collect the meta-analyses investigating the association between cupping therapy and pain-related outcomes. The methodological quality was assessed by using the AMSTAR 2 tool. Significant outcomes (p < 0.05) were assessed using the GRADE system. The summary of evidence is presented by bubble plots and human evidence mapping. Results: Fourteen meta-analyses covering five distinct pain-related conditions were identified and assessed for methodological quality using the AMSTAR 2, which categorized the quality as critically low (36%), low (50.0%), moderate (7%), and high (7%). In accordance with the GRADE system, no high-quality evidence was found that demonstrates the efficacy of cupping therapy for pain-related outcomes. Specifically, for neck pain, there were two moderate-quality, four low-quality, and two very low-quality evidence, while only one very low-quality evidence supports its efficacy in treating herpes zoster and one low-quality evidence for chronic back pain. Additionally, for low back pain, there were two moderate-quality, one low-quality, and four very low-quality evidence, and for knee osteoarthritis, three moderate-quality evidence suggest that cupping therapy may alleviate pain score. Conclusion: The available evidence of very low-to-moderate quality suggests that cupping therapy is effective in managing chronic pain, knee osteoarthritis, low back pain, neck pain, chronic back pain, and herpes zoster. Moreover, it represents a promising, safe, and effective non-pharmacological therapy that warrants wider application and promotion.Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021255879, identifier: CRD42021255879.

Effect of acupuncture with donepezil based on syndrome differentiation on cognitive function in patients with mild-to-moderate Alzheimer's disease: a study protocol for a multicenter randomized controlled trial.

BACKGROUND: There has been a rapid increase in the worldwide prevalence of Alzheimer's disease (AD). Previous studies have shown that acupuncture can improve neurological and cognitive function; however, the utility of applying acupuncture in patients with AD remains unclear. This study protocol describes a clinical trial for evaluating the efficacy and safety of acupuncture based on syndrome differentiation with donepezil hydrochloride on cognitive function in patients with AD. METHODS/DESIGN: This multicenter randomized controlled trial commenced on February 1, 2019, at the Shanghai Longhua Hospital of TCM, Shanghai Huashan Hospital of Fudan University, and Shanghai Mental Health Center, and will conclude on June 30, 2022. The study will recruit 184 patients randomly divided into an acupuncture group or a control group at a 1:1 ratio. All participants will receive donepezil hydrochloride (5 mg/day), and those in the acupuncture group will receive acupuncture based on syndrome differentiation with donepezil for 12 weeks. The primary outcome will be the post-treatment change in the Alzheimer's Disease Assessment Scale-cognition score at 12 weeks. The secondary outcomes will be the efficacy scores of the Minimum Mental State Examination, Alzheimer's Disease Cooperative Research Activity-Daily Life, and Quality of Life-Alzheimer's Disease. All assessments will be performed at baseline, after treatment (week 12), and at follow-up (weeks 24 and 36). DISCUSSION: This trial may provide high-quality evidence for the efficacy of acupuncture in the treatment of AD. The results of this study will be published in peer-reviewed journals. TRIAL REGISTRATION: ClinicalTrials.gov NCT03810794 . Registered on 17 January 2019.

Modulation of Brain Activity and Functional Connectivity by Acupuncture Combined With Donepezil on Mild-to-Moderate Alzheimer's Disease: A Neuroimaging Pilot Study.

Background: Functional brain imaging changes have been proven as potential pathophysiological targets in early-stage AD. Current longitudinal neuroimaging studies of AD treated by acupuncture, which is one of the growingly acknowledged non-pharmacological interventions, have neither adopted comprehensive acupuncture protocols, nor explored the changes after a complete treatment duration. Thus, the mechanisms of acupuncture effects remain not fully investigated. Objective: This study aimed to investigate the changes in spontaneous brain activity and functional connectivity and provide evidence for central mechanism of a 12-week acupuncture program on mild-to-moderate AD. Methods: A total of forty-four patients with mild-to-moderate AD and twenty-two age- and education-level-matched healthy subjects were enrolled in this study. The forty-four patients with AD received a 12-week intervention of either acupuncture combined with Donepezil (the treatment group) or Donepezil alone (the control group). The two groups received two functional magnetic resonance imaging (fMRI) scans before and after treatment. The healthy subject group underwent no intervention, and only one fMRI scan was performed after enrollment. The fractional amplitude of low-frequency fluctuation (fALFF) and functional connectivity (FC) were applied to analyze the imaging data. The correlations between the imaging indicators and the changed score of Alzheimer's Disease Assessment Scale-Cognitive Section (ADAS-cog) were also explored. Results: After the 12-week intervention, compared to those in the control group, patients with AD in the treatment group scored significantly lower on ADAS-cog value. Moreover, compared to healthy subjects, the areas where the fALFF value decreased in patients with AD were mainly located in the right inferior temporal gyrus, middle/inferior frontal gyrus, middle occipital gyrus, left precuneus, and bilateral superior temporal gyrus. Compared with the control group, the right precuneus demonstrated the greatest changed value of fALFF after the intervention in the treatment group. The difference in ADAS-cog after interventions was positively correlated with the difference in fALFF value in the left temporal lobe. Right precuneus-based FC analysis showed that the altered FC by the treatment group compared to the control group was mainly located in the bilateral middle temporal gyrus. Conclusion: The study revealed the key role of precuneus in the effect of the combination of acupuncture and Donepezil on mild-to-moderate AD for cognitive function, as well as its connection with middle temporal gyrus, which provided a potential treating target for AD. Trial Registration Number: NCT03810794 (http://www.clinicaltrials.gov).

Acupuncture for migraine prophylaxis: A protocol for systematic review and Bayesian network meta-analysis.

BACKGROUND: Migraine causes health problems in 1 billion people worldwide and imposes a huge social burden. Acupuncture therapy has a good clinical effect in migraine prophylaxis and is recommended by authoritative journals. We plan to conduct a Bayesian network meta-analysis to compare the efficacies of different acupuncture therapies. METHODS: We will search PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure, VIP database for Chinese technical periodicals, Chinese biological medical database, WanFang Data, Cochrane register of controlled trials, Chinese Clinical Trial Register, and ClinicalTrials.gov from their inception to July 1, 2022, for randomized controlled trials that studied different acupuncture therapies and other therapies for the preventive treatment of migraine. Migraine episodes, migraine days, headache intensity, and adverse events will be counted as outcomes. Two reviewers will independently complete the study selection, data extraction, and risk of bias assessment of all filtered trials. Pairwise meta-analysis and Bayesian network meta-analysis will be performed (if applicable) through Review Manager 5.3 and the "gemtc" and "rjags" packages of the R software. Confidence in Network Meta-Analysis will be used to evaluate the quality and credibility of the evidence for each outcome. RESULTS: The protocol will compare the efficacies of different acupuncture therapies for migraine prophylaxis. CONCLUSION: This study aims to help clinicians develop an effective and safe treatment plan for migraine prophylaxis.

Overview of Meta-Analyses of Five Non-pharmacological Interventions for Alzheimer's Disease.

Background: Alzheimer's disease (AD) is a neurodegenerative disease characterized by progressive memory deficits, cognitive decline, and spatial disorientation. Non-pharmacological interventions to treat AD have been reported in many meta-analyses (MAs), but robust conclusions have not been made because of variations in the scope, quality, and findings of these reviews. Objective: This work aimed to review existing MAs to provide an overview of existing evidence on the effects of five non-pharmacological interventions in AD patients on three outcomes: Mini-Mental State Examination (MMSE), activities of daily living (ADL), and Alzheimer's Disease Assessment Scale-cognitive section (ADAS-cog). Methods: The databases PubMed, Cochrane Library, Embase, and Web of Science were searched to collect MAs of non-pharmacological interventions for AD. Two reviewers independently conducted literature screening, data extraction, and quality assessment. We assessed the quality of MAs with the Measurement Tool to Assess Systematic Reviews (AMSTAR) 2 and assessed the evidence quality for significant outcomes using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Results: We found 10 eligible MAs, which included between three (133 patients) and 15 randomized trials (1,217 patients), and five non-pharmacological interventions, namely, acupuncture therapy (40%), exercise intervention (30%), music therapy (10%), cognitive intervention (10%), and repetitive transcranial magnetic stimulation (rTMS) (10%). All the included MAs were critically low to low quality by AMSTAR 2. Acupuncture therapy and exercise intervention showed the preliminary potential to improve ADL and MMSE. rTMS and acupuncture therapy show benefits in decreasing ADAS-cog, and there were some evidence of improved MMSE with cognitive intervention. All these outcomes scored very low quality to moderate quality of evidence on the GRADE system. Conclusions: Non-pharmacological therapy shows promise for the treatment of AD, but there is still a lack of high-quality evidence. In the future, the quality of the original research needs to be improved, and strictly designed MAs should be carried out following methodological requirements.

Earlier Acupuncture Enhancing Long-Term Effects on Motor Dysfunction in Acute Ischemic Stroke: Retrospective Cohort Study.

Stroke is the leading fatal disease in China. This retrospective study aimed to explore the optimal acupuncture intervention time for long-term efficacy on motor dysfunction in patients suffering from acute ischemic stroke through 1-year of follow-up. Three hundred and nine patients collected at Longhua Hospital from January 2016 to December 2017 were classified into 3 groups based on the acupuncture intervention time, including groups A (within 2 days), B (within 3-7 days) and C (within 8-14 days). All patients had received standard treatment combined with acupuncture therapy. Specifically, acupuncture was performed at the acupoints including LI4 (Hegu), ST40 (Fenglong), DU20 (Baihui), and motor area of the scalp, followed by 2 electroacupuncture protocols based on different muscle tensions once a day for 5 days consecutively. The time-effect relationship was assessed using both the Fugl-Meyer Assessment (FMA) and the modified Barthel index (MBI) on the 90th day and 1st year, respectively. Meanwhile, the modified Rankin scale (mRS), high-sensitivity C-reactive protein (hs-CRP), and fibrinogen (FIB) were also measured during the 1-year follow-up. The favorable outcome rate was 74.4%. One-way univariate analysis of variance (ANOVA) revealed significant differences in FMA and MBI on the 90th day among the 3 groups ([Formula: see text] < 0.05), while no significant differences were observed in FMA, MBI or mRS at the 1st year between groups A and B. The levels of hs-CRP and FIB ([Formula: see text] < 0.05) were markedly reduced. Binary logistic regression analysis suggested that patients with atrial fibrillation (AF) (odds ratio (OR): 3.156), chronic kidney disease (CKD) (OR: 2.563), diabetes mellitus (DM) (OR: 2.174) or stroke history (OR: 1.883) were more inclined to recover poorly from nerve function deficit ([Formula: see text] < 0.05). Earlier acupuncture intervention may have a better long-term effect on motor dysfunction and inflammation during the 1-year follow-up. Moreover, acupuncture within 2 days is probably the optimal treatment time for early recovery on the 90th day.

Acupuncture therapy for Alzheimer's disease: A protocol for an overview of systematic reviews.

BACKGROUND: Alzheimer's disease (AD) is the fifth-leading cause of death in people more than 65 years old. Acupuncture therapy has been traditionally used to treat various kinds of health problems including AD. This protocol aims to summarize the available evidence from current systematic reviews (SRs) for the efficacy of acupuncture therapy for AD. METHODS: Seven databases will be searched: PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), Wanfang Data, Chongqing VIP (CQVIP), and Chinese Biomedical Literature Database (CBM). SRs/meta-analyses (MAs) of acupuncture therapy for AD which were reported in Chinese or English will be included. Study selection, data extraction, and assessment of the study quality will be performed independently by 2 or more reviewers. And the methodological quality, report quality and evidence quality will be evaluated by Assessment of Multiple Systematic Reviews-2 (AMSTAR-2) tool, Preferred Reporting Items for Systematic Reviews and Meta Analyses Statement (PRISMA) checklist and Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, respectively. RESULTS: The article in this overview will be submitted for publication in a peer-reviewed journal. CONCLUSION: We expect to compile evidence from multiple systematic reviews of acupuncture therapy in AD patients in an accessible and useful document.Registration number: INPLASY202040035.

Acupuncture for Obstructive Sleep Apnea (OSA) in Adults: A Systematic Review and Meta-Analysis.

OBJECTIVE: Our aim was to assess the efficacy and safety of acupuncture for OSA patients with various severities of the disorder. METHODS: Eight databases including PubMed, Cochrane Library, EMBASE, Web of Science, China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), Wanfang Data, and Chinese Biomedical Literature Database (CBM) were comprehensively searched till July 2019. Randomized controlled trials (RCTs) testing acupuncture in the treatment of OSA were eligible for inclusion. Studies were selected for inclusion, and data were extracted by two authors independently. The Cochrane Collaboration's Risk of Bias Assessment Tool and RevMan software (version 5.3) were used to evaluate the quality of studies and conduct statistical analysis. RESULTS: Nine RCTs with 584 participants were included. The trials covered acupuncture and electropuncture. Acupuncture caused clinically significant reductions in AHI (MD: -6.18; 95% CI: -9.58 to -2.78; Z = 3.56, P = 0.0004) as well as in ESS (MD: -2.84; 95% CI: -4.80 to -0.16, Z = 2.09, P = 0.04). AHI was reduced more in the subgroup analysis of moderate OSA patients (MD: -9.44; 95% CI: -12.44 to -6.45; Z = 6.18, P < 0.00001) and severe OSA patients (MD: -10.09; 95% CI: -12.47 to -7.71; Z = 8.31, P < 0.00001). ESS was also reduced more in the subgroup analysis of moderate OSA patients (MD: -2.40; 95% CI: -3.63 to -1.17; Z = 3.83, P = 0.0001) and severe OSA patients (MD: -4.64; 95% CI: -5.35 to -3.92; Z = 12.72, P < 0.00001). Besides, acupuncture had a beneficial effect on LSaO2 (MD: 5.29; 95% CI: 2.61 to 7.97; Z = 3.86, P = 0.0001). The outcome of AHI and LSaO2 yielded consistent results after sensitivity analysis, but the direction of the outcome of ESS was reversed. And the quality of evidence was mainly low to very low. CONCLUSIONS: Acupuncture therapy is effective for OSA patients in reducing AHI and ESS and in improving the LSaO2 of various severities, especially in moderate and severe OSA patients. High-quality trials are urgently needed.