Extending the Grading of Recommendations Assessment, Development and Evaluation (GRADE) in Traditional Chinese Medicine (TCM): The GRADE-TCM.

AIM: To extend and form the "Grading of Recommendations Assessment, Development and Evaluation in Traditional Chinese Medicine" (GRADE-TCM). METHODS: Methodologies were systematically reviewed and analyzed concerning evidence-based TCM guidelines worldwide. A survey questionnaire was developed based on the literature review and open-end expert interviews. Then, we performed expert consensus, discussion meeting, opinion collection, external examination, and the GRADE-TCM was formed eventually. RESULTS: 265 Chinese and English TCM guidelines were included and analyzed. Five experts completed the open-end interviews. Ten methodological entries were summarized, screened and selected. One round of consensus was conducted, including a total of 22 experts and 220 valid questionnaire entries, concerning 1) selection of the GRADE, 2) GRADE-TCM upgrading criteria, 3) GRADE-TCM evaluation standard, 4) principles of consensus and recommendation, and 5) presentation of the GRADE-TCM and recommendation. Finally, consensus was reached on the above 10 entries, and the results were of high importance (with voting percentages ranging from 50 % to 81.82 % for "very important" rating) and strong reliability (with the Cr ranging from 0.93 to 0.99). Expert discussion meeting (with 40 experts), opinion collection (in two online platforms) and external examination (with 14 third-party experts) were conducted, and the GRADE-TCM was established eventually. CONCLUSION: GRADE-TCM provides a new extended evidence-based evaluation standard for TCM guidelines. In GRADE-TCM, international evidence-based norms, characteristics of TCM intervention, and inheritance of TCM culture were combined organically and followed. This is helpful for localization of the GRADE in TCM and internationalization of TCM guidelines.

Efficacy and safety of traditional Chinese medicine nasal irrigation on chronic rhinosinusitis recovery after endoscopic sinus surgery: A protocol for a systematic review and meta-analysis.

BACKGROUND: Continuous comprehensive treatment is still needed after endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) to promote the recovery of sinus mucosal morphology and function. Traditional Chinese medicine (TCM) nasal irrigation is a promising external treatment of TCM, but at present, the application of TCM nasal irrigation after ESS for CRS has not been recommended by the guidelines. Therefore, this article aims to develop a systematic overview and meta-analysis protocol to assess the effectiveness and safety of Chinese herbal nasal rinse for CRS recovery after ESS. METHODS: Seven databases shall be retrieved from their inception until December 2021. Eligible randomized controlled trials will be covered in the study. The outcome indicators of the survey will consist of efficacy, visual analogue scale score, Lund-Kennedy score for nasal endoscopy, Lund-Mackay score for sinus computed tomography and other secondary outcome indicators. The selection of literature, extraction of data, and methodological quality evaluation of literature shall be conducted by two researchers separately. If there is any dispute, it can be discussed and solved by a third researcher. Review Manager 5.3 software will be applied to data analysis. RESULTS: The article will make a detailed research programme to explore the efficacy and safety of TCM nasal irrigation on CRS recovery after ESS. CONCLUSION: This protocol is suitable for evaluating the effectiveness and safety of TCM nasal rinse for CRS recovery after ESS, and can provide corresponding evidence-based medical evidence. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework Registration DOI: 10.17605/OSF.IO/ZV73Q.

Yu ping feng san for pediatric allergic rhinitis: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The potential treatment effects and safety of Yu ping feng san (YPFS) for pediatric allergic rhinitis (PAR) patients have yet to be studied systematically. OBJECTIVES: To assess the effects and safety of YPFS for treat pediatric patients, allergic rhinitis. METHODS: We systematically searched PubMed, EMBASE (Excerpta Medical Database), Cochrane library, Chinese Cochrane Centre's Controlled Trials Register platform, Wanfang Chinese Digital Periodical and Conference Database, China National Knowledge Infrastructure Database, and VIP Chinese Science, from inception dates to November 1, 2019. Randomized controlled trials (RCTs) were included. The risk of bias in the trials was assessed in accordance with the Cochrane Handbook, version 5.1.0. RevMan 5.3 software was used to perform a meta-analysis. Grading of Recommendations Assessment, Development and Evaluation methodology was applied to evaluate the evidence quality for each outcome. The quality of evidence for each outcome measurement was low for 4 outcomes and very low for 5 outcomes. RESULTS: A total of 10 RCTs involving 1069 participants (3-15 years old) fulfilled the inclusion criteria. After exclusion, 8 RCTs were pooled for efficacy assessment. The overall efficacy evaluation result did not show benefit for the experimental group (relative risk 0.32, CI 95% 0.24-0.45; P = .98;) Investigation of variation of serum IgA, immunoglobulin E, IgG in three studies in 2 groups returned no statistical significance. YPFS gave relatively better safety (relative risk 0.29, CI 95% 0.14-0.58; P = .0005; Fig. S8, http://links.lww.com/MD/F751) and lower recurrence rates than did Western medical therapy. CONCLUSIONS: Current evidence cannot support the routine use of YPFS for treatment of PAR. This may be due to poor-quality study-design limitations of the included YPFS studies. Our data showed that the use of YPFS for PAR is relatively safe compared to Western medical therapy, but a conclusion could not be drawn because only 5 studies were analyzed. Every study suffered from some methodological limitation. Therefore, further large, rigorously-designed studies are necessary to determine conclusively the utility of YPFS in PAR.

Effectiveness and safety of acupuncture for treatment of tinnitus: A protocol for systematic review and meta-analysis.

BACKGROUND: Tinnitus is a common disease in otolaryngology. In China, acupuncture has been used as a promising treatment for tinnitus. Yet, the specific effect and safety of acupuncture are still disputable. The ultimate goal of this paper is to formulate a protocol for systematic review and meta-analysis, which can be employed in assessing the benefits and safety of acupuncture on tinnitus. METHODS: Seven databases should be retrieved from their establishment until June 2020, including PubMed, Cochrane Central Register of Controlled Trials, Excerpt Medical Database, Chinese Biomedical Literature Database, Chinese Science and Technology Periodical Database, China National Knowledge Infrastructure and Wan Fang Database. Randomized controlled trials of acupuncture treatment of tinnitus will be included. The experimental group is acupuncture or combined with additional treatment measures, and the control group is a placebo, sham acupuncture, Cognitive Behavioral Therapy, sound therapy, conventional medication, or same additional treatment. The clinical efficacy rate, Tinnitus Handicap Inventory, Tinnitus Questionnaire, visual analogue scale or other indicators are all concerned in the systematic evaluation of the program. Data collection, selection and extraction should be made separately by different researchers. The quality of the literature will be evaluated by the bias analysis table in the Cochrane Handbook, and Review Manager 5.3 software shall be applied to data analysis. RESULTS: This protocol has made a concrete plan to evaluate whether acupuncture is effective and safe in curing tinnitus. CONCLUSION: This protocol is suitable for evaluating the effectiveness and safety of acupuncture in curing tinnitus, and is helpful for subsequent evaluation.Open Science Framework Registration DOI: 10.17605/OSF.IO/85FCS.

Clinical effects and safety of electroacupuncture for the treatment of allergic rhinitis: A protocol for systematic review.

BACKGROUND: As the therapy of acupuncture continues to expand, electroacupuncture is increasing used in allergic rhinitis prevention and therapy, and many studies have published that it is effective in the treatment of allergic rhinitis. However, it is unclear if electroacupuncture provides an evidence-based clinical benefit in the allergic rhinitis population. METHODS/DESIGN: We will conduct a systematic review of electroacupuncture and health-related outcomes in allergic rhinitis patients according to the Preferred Reporting Items for Systematic Reviews. The primary objective is to assess the impact of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines on clinical outcomes relevant to allergic rhinitis patients, such as effective rate, life-quality evaluation, and adverse events. The Cochrane Risk Assessment Tool will be used to assess the quality of eligible studies according to the Cochrane handbook. RESULTS: We will perform a meta-analysis using standard techniques for the outcomes. CONCLUSION: The results of this systematic review may highlight the gaps in our knowledge of the relevance of electroacupuncture after treatment or after follow-ups.PROSPERO registration number: PROSPERO CRD42018104080. (https://www.crd.york.ac.uk/PROSPERO/#recordDetails).

Traditional Chinese medicine foot bath combined with acupoint massage for the treatment of diabetic peripheral neuropathy: A systematic review and meta-analysis of 31 RCTs.

In this study, we aim to evaluate the efficiency and safety of traditional Chinese medicine foot bath combined with acupoint massage for the treatment of diabetic peripheral neuropathy. A total of eight online databases were searched to collect studies published up to February 2019. Study quality of each included article was evaluated by the Cochrane Collaboration risk of bias tool. Systematic reviews and meta-analyses were conducted based on the Cochrane systematic review method by using the RevMan 5.3 software. Traditional Chinese medicine foot bath combined with acupoint massage was the main therapy in experimental group. Interventions in control groups include western medicine, oral traditional Chinese medicine, other symptomatic treatment of western medicine, and blank control. Primary outcomes in this study include sensory nerve conduction velocity (SNCV), motor nerve conduction velocity (MNCV), total effective rate, and neuropathic syndrome score. Finally, 31 trials involving 3284 participants were included. The results of systematic reviews and meta-analyses showed that traditional Chinese medicine foot bath combined with acupoint massage was significantly better compared with the control groups in terms of the total effective rate, SNCV, MNCV, and neuropathic syndrome score. No case of adverse effect was reported. These findings show that traditional Chinese medicine foot bath combined with acupoint massage may be safer and more effective for the treatment of DPN. However, due to the low methodological quality, further research with randomized controlled trials (RCTs) of higher quality is required to prove its efficacy and better evidence for clinical treatment.

The effectiveness of catgut implantation at acupoints for allergic rhinitis: A protocol for a systematic review and meta-analysis.

BACKGROUND: Catgut implantation at acupoint (CIAA) is increasing used in allergic rhinitis therapy, and many studies have published that it is effective in the treatment of allergic rhinitis. However, it is controversy if CIAA can provide an evidence-based clinical benefit in the allergic rhinitis population. METHODS: We will go through 8 databases, and conduct a systematic review of CIAA and health-related outcomes in allergic rhinitis patients according to the Preferred Reporting Items for Systematic Reviews. The primary objective is to assess the impact of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines on clinical outcomes relevant to allergic rhinitis patients, such as effective rate, life-quality evaluation, and adverse events. Cochrane Risk Assessment Tool will be used to assess the quality of eligible studies according to the Cochrane handbook. RESULTS: The results of this systematic review will provide a synthesis of current evidence of CIAA and we have a specific opportunity to determine the efficacy and safety of it. CONCLUSION: This study will explore whether or not CIAA can be used as one of the nondrug therapies to prevent or treat allergic rhinitis.PROSPERO registration number: CRD42018095074 (https://www.crd.york.ac.uk/PROSPERO/#recordDetails).

Effectiveness of Acupuncturing at the Sphenopalatine Ganglion Acupoint Alone for Treatment of Allergic Rhinitis: A Systematic Review and Meta-Analysis.

AIMS: To evaluate the efficiency of acupuncturing at the sphenopalatine ganglion acupoint alone for treatment of allergic rhinitis. DESIGN: A total of ten online databases were searched to find studies published up to Jan. 2018. Primary outcome measures include the TNSS, the RQLQ score, the VAS score, total effective rate, score for signs and symptoms, and the improvement of disease classification. Study quality of each included article was evaluated by the Cochrane Collaboration risk of bias tool. A meta-analysis was conducted based on the Cochrane systematic review method by using RevMan 5.3 software. INTERVENTIONS: Acupuncturing SGA alone was the only therapy in experimental group. Interventions in control groups includes sham acupuncture, acupuncturing other regular acupoints, and western medicine. Specific techniques included manual acupuncture and electroacupuncture only. PRIMARY OUTCOMES: They include TNSS, RQLQ, VAS score, total effective rate, the improvement of disease classification. RESULTS: Ten studies of eight articles involving 1004 participants were included. Result of meta-analysis showed that acupuncturing sphenopalatine ganglion acupoints alone was more effective than control groups. However, several adverse effects were reported. CONCLUSION: These findings show that acupuncturing the sphenopalatine ganglion acupoint alone has a potential role in alleviating nasal symptoms, improving quality of life for patients, and the effectiveness of acupuncture in the treatment of allergic rhinitis, suggesting it as a considerable therapy for allergic rhinitis. However, more studies are needed to execute a subgroup analysis of various variables and to evaluate the publication bias of the study.