Chinese herbal medicine for COVID-19: Current evidence with systematic review and meta-analysis

BackgroundThere is currently no drug or therapy that cures COVID-19, a highly contagious and life-threatening disease.ObjectiveThis systematic review and meta-analysis summarized contemporary studies that report the use of Chinese herbal medicine (CHM) to treat COVID-19.Search strategySix electronic databases (PubMed/MEDLINE, Cochrane Library, ScienceDirect, Google Scholar, Wanfang Data and China National Knowledge Infrastructure) were searched from their beginning to May 15, 2020 with the following search terms: traditional Chinese medicine, Chinese medicine, Chinese herbal medicine, COVID-19, new coronavirus pneumonia, SARS-CoV-2, and randomized controlled trial.Inclusion criteriaRandomized controlled trials (RCTs) from peer-reviewed journals and non-reviewed publications were included. Further, included RCTs had a control group that was given standard care (SC; such as conventional Western medicine treatments or routine medical care), and a treatment group that was given SC plus CHM.Data extraction and analysisTwo evaluators screened and collected literature independently; information on participants, study design, interventions, follow-up and adverse events were extracted, and risk of bias was assessed. The primary outcomes included scores that represented changes in symptoms and signs over the course of treatment. Secondary outcomes included the level of inflammatory markers, improvement of pneumonia confirmed by computed tomography (CT), and adverse events. Dichotomous data were expressed as risk ratio or hazard ratio with 95% confidence interval (CI); where time-to-event analysis was used, outcomes were expressed as odds ratio with 95% CI. Continuous data were expressed as difference in means (MD) with 95% CI, and standardized mean difference (SMD) was used when different outcome scales were pooled.ResultsSeven original studies, comprising a total of 732 adults, were included in this meta-analysis. Compared to SC alone, CHM plus SC had a superior effect on the change of symptom and sign score (−1.30 by SMD, 95% CI [−2.43, −0.16]; 3 studies; n = 261, P = 0.03), on inflammatory marker C-reactive protein (CRP, mg/L; −11.82 by MD, 95% CI [−17.95, −5.69]; 5 studies; n = 325, P = 0.0002), on number of patients with improved lung CT scans (1.34 by risk ratio, 95% CI [1.19, 1.51]; 4 studies; n = 489, P < 0.00001). No significant adverse events were recorded in the included RCTs.ConclusionCurrent evidence shows that CHM, as an adjunct treatment with standard care, helps to improve treatment outcomes in COVID-19 cases.     

Cupping therapy for patients with chronic urticaria: A systematic review and meta-analysis

BackgroundChronic urticaria (CU) is a common skin disease, which has a negative effect on quality of life. Current treatments do not fully control the symptoms of urticaria for many CU patients, thus effective and safe treatments for CU are still needed.ObjectiveThis review aims to evaluate the effectiveness and safety of cupping therapy in patients with CU.Search strategyThe search strategy looked for the presence of related keywords, such as “chronic urticaria” and “cupping therapy,” in the title and abstract of research articles indexed in major databases. Randomized controlled trials (RCTs) were selected after querying nine electronic databases from their inception to May 2019 with the above search terms.Inclusion criteriaRCTs were included if they recruited patients with CU who were intervened with dry or wet cupping. Publications could be written in Chinese or English.Data extraction and analysisData were extracted, and the studies were assessed for the quality of their methodological design and risk of bias. Meta-analyses of the RCT data were conducted to assess the total effective rate of the treatment as the primary outcome. Skin disease quality of life index score, recurrence rate, and adverse events were assessed as secondary outcomes. Subgroup analyses were conducted based on different interventions.ResultsThirteen comparisons from 12 RCTs involving 842 participants were included. There were no significant differences between wet cupping and medications in total effective rate (n = 372; risk ratio [RR] = 1.10, 95% confidence interval [CI] 0.97 to 1.25; P = 0.14) or recurrence rate (n = 240; RR = 0.56, 95% CI 0.23 to 1.36; P = 0.20). Cupping therapy, in combination with antihistamine treatment was more efficacious than antihistamines alone, with a greater total effective rate (n = 342; RR = 1.18, 95% CI 1.01 to 1.39; P = 0.03) and lower recurrence rate (n = 342; RR = 0.52, 95% CI 0.32 to 0.84; P = 0.007). Cupping therapy combined with acupuncture was more effective than acupuncture alone (n = 156; RR = 1.25, 95% CI 1.07 to 1.46; P = 0.006). No serious adverse events were reported.ConclusionWet cupping may be as effective as treatment with antihistamines. When cupping therapy is used as an adjuvant therapy to antihistamines or acupuncture, it may enhance the efficacy. Results drawn from these studies should be interpreted with caution and applied with care to clinical practice, because of the poor quality among the studies that were reviewed.Systematic review registrationPROSPERO, CRD42019137451.     

Association between metabolic syndrome and body constitution of traditional Chinese medicine: A systematic review and meta-analysis

BackgroundThe constitution theory of traditional Chinese medicine (TCM) states that body constitution and disease are associated; therefore, the identification of body constitution can provide reference for disease prevention and treatment. A series of clinical studies evaluating the association between TCM constitution and metabolic syndrome (MetS) have been conducted in recent years. The aim of this systematic review is to summarize and evaluate the clinical evidence of the relationship between constitution and MetS.MethodsThe PubMed, Embase, China National Knowledge Infrastructure (CNKI), Chongqing VIP, and Wanfang Data electronic databases were searched from April 2009 to July 2020. The search terms included “metabolic syndrome,” “constitution,” and “Chinese medicine.” Observational studies evaluating the relationship between body constitution of TCM and MetS were included. The primary outcome included the distribution of constitutional types in the MetS population, and odds ratio (OR) or relative risk (RR) between constitution and MetS. Effect size was expressed as proportion or OR with 95% confidence interval (CI). Methodological quality of included studies was evaluated by the Newcastle–Ottawa Scale (NOS) or the American Agency for Healthcare Research and Quality (AHRQ) criteria.ResultsThree case–control and 26 cross-sectional studies involving 30 435 cases were included. Phlegm-dampness, qi-deficiency, and damp-heat were the main constitution types in patients with MetS, accounting for 29% (22%–39%), 18% (13%–24%), and 12% (9%–17%) of the population, respectively; the risk of MetS in people with phlegm-dampness and qi-deficiency constitution was 1.74 [1.27, 2.38] and 1.29 [1.01, 1.65] times higher than that in those with other constitutions. There were sex- and age-related differences in the distribution of TCM constitution in patients with MetS.ConclusionPhlegm-dampness and qi-deficiency were associated with the occurrence of MetS. Well-designed cohort and case–control studies are needed to provide evidence for the use of TCM to prevent and treat MetS.     

2019—2021年中医药治疗绝经过渡期随机对照试验结局指标文献分析

[目的] 评价目前中医药治疗绝经过渡期随机对照试验结局指标的现状,为未来核心指标集研究提供依据和基础。[方法] 检索2019年1月—2021年12月中国知网（CNKI）、万方数据库（WanFang）、维普数据库（VIP）、PubMed、Embase和Cochranelibrary数据库,收集中医药治疗绝经过渡期的随机对照试验。按照预先设定的纳入排除标准由2名评价员独立筛选文献和进行资料提取,描述纳入的随机对照试验结局指标的使用情况。[结果] 最终纳入47篇随机对照试验,共使用了38个疗效指标,排在前5位的分别是临床疗效30篇（64%）、雌激素水平26篇（55%）、改良Kupperman指数评分18篇（38%）、中医症状评分15篇（32%）、匹兹堡睡眠质量指数14篇（30%）。35篇研究采用全局疗效评价指标,68%的研究评价时间点为治疗前后两次,85%的研究随访时间在3个月之内。[结论] 中医药治疗绝经过渡期的随机对照试验在结局指标的选择、测量和报告方面存在较大异质性,应该进行核心指标集的研究,并建立健全符合中医药特色的患者报告和医生报告疗效指标评价体系。     

Traditional Chinese medicine for acute mountain sickness prevention: A systematic review and meta-analysis of randomized controlled trials

ObjectiveTo evaluate the efficacy of traditional Chinese medicine (TCM) for preventing acute mountain sickness (AMS).MethodsWe included randomized controlled trials (RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6 major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals (CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0 (RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation (GRADE) approach.ResultsTwenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies (15/20) was of some concerns. In terms of the AMS incidence, Rhodiola rosea (R. rosea, Hong Jing Tian) and Ginkgo biloba (G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR (95% CI): 0.66 (0.43–1.01), 0.82 (0.63–1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR (95% CI): 2.92 (1.69–5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD (95% CI): -0.98 (-1.71, -0.25), -2.05 (-3.14, -0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.ConclusionR. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.     

Modified Zhibai Dihuang pill,a traditional Chinese medicine formula,on steroid withdrawal in systemic lupus erythematosus: A systematic review and meta-analysis

BackgroundZhibai Dihuang pill (ZBDH), a Chinese herbal formula, has been widely used as an adjunctive therapy to help reduce the patient’s steroid dose and maintain low disease activity in systemic lupus erythematosus (SLE).ObjectiveThis systematic review evaluates the therapeutic effect of modified ZBDH in reducing steroid use in patients with SLE.Search strategyA systematic literature search was carried out using seven databases, including PubMed, Embase, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure, Chinese VIP Information and Wanfang Database, from their inception to June 1st, 2019. The search terms included “systemic lupus erythematosus,” “Chinese medicine” and “clinical trial,” and their synonyms. Subject headings matching the above terms were also used.Inclusion criteriaThis meta-analysis included randomized controlled trials that evaluated the reduction of steroid dose in patients with SLE. Traditional Chinese medicine (TCM) formulas in experimental group should be prescribed based on ZBDH and used as adjunctive therapy and the comparator should contain steroids.Data extraction and analysisTwo authors independently conducted database search, study selection, data extraction and quality assessment. The extracted information contained study design, sample size, recruitment mode, diagnostic criteria, inclusion and exclusion criteria, participant characteristics, TCM patterns, TCM formulas and treatment outcomes. The primary outcome was the change of steroid dose. Secondary outcomes included SLE Disease Activity Index (SLEDAI), biomarkers of disease activity and clinical response rate. STATA 15.0 was used to analyze the pooled effects reported as weighted mean difference (WMD) or odds ratio, with a 95% confidence interval (CI).ResultsIn total, 20 trials involving 1470 SLE patients were included. The pooled result showed that modified ZBDH taken in combination with standard care led to a larger reduction in steroid dose, compared to standard care alone (WMD: 3.79; 95% CI: 2.58–5.01; P < 0.001). Favorable outcomes were also seen in secondary outcome criteria, such as SLEDAI and complement 3. The modified ZBDH treatments were well tolerated without increasing adverse effects.ConclusionThe systematic review provided preliminary evidence supporting the use of ZBDH as a co-therapy to aid steroid dose reduction in patients with SLE. However, more rigorous studies should be conducted to validate these findings, and explore the mechanisms of ZBDH’s relevant bioactive constituents.     

中药治疗肺癌临床试验结局指标文献研究＊

目的 分析中药治疗肺癌随机对照试验的结局指标，为构建肺癌临床试验的核心指标集提供基础。方法 计算机检索8个数据库。以2009、2014、2018及2019年发表的临床随机对照试验为样本，由2位作者严格按照纳入与排除标准独立筛选文献、提取资料，如有分歧通过讨论解决。结果 纳入654个RCT研究中共包含55024位患者，共采用116个结局指标。单个研究指标数量最少为１个，最多达10个，平均每个研究结局指标的数量为3.1个。654个RCT研究普遍存在结局指标不规范、临床重要性低、测量工具不一致等问题。结论 中药治疗肺癌临床试验结局指标存在较多问题，需要开展核心指标集研究。     

Traditional Oriental Herbal Medicine and Natural Killer Cells for Cancer Patients: A Systematic Review and Meta‐analysis

Traditional oriental herbal medicine (HM) is used by cancer patients to improve immunity. Natural killer (NK) cells are associated with development and progression of tumor and survival of cancer patients. This literature review examined randomized controlled trials (RCTs) in four electronic databases until October 2015 to evaluate the effects of oral HM on NK cells in cancer patients. Data were pooled and computed in a meta‐analysis. The methodological quality was assessed according to the Cochrane risk of bias tool. Sixteen RCTs involving 1326 cancer patients were identified. Combination of HM and conventional treatment was associated with significantly higher level of NK cells compared with conventional cancer treatments (standardized mean difference, 1.218; 95% confidence interval 0.719–1.717; p < 0.001). Eight RCTs reported statistically significant improvements in the proportions or activity of NK cells in patient groups who received both HM and conventional treatment compared with patients who received conventional treatment alone, while eight RCTs reported no statistically significant differences between the two groups. Studies (n = 16) included in this review had insufficient quality of evidence with unclear (n = 1) and high (n = 15) values of the risk of bias. Although traditional oriental HM may have the positive effects on preserving the level of NK cells in cancer patients receiving conventional treatments, current evidence is inconclusive because of lack of high‐quality evidence. Copyright © 2017 John Wiley & Sons, Ltd.     

Women’s preconception health patterns in traditional Chinese medicine as a predictor of fertility outcomes

ObjectiveTo examine the association between traditional Chinese medicine (TCM), preconception health patterns and fertility outcomes.MethodsA community-based prospective cohort study was conducted in China. A total of 3012 newly married women who were willing to conceive within 2 years were enrolled in the study and took National Free Prepregnancy Checkups (NFPC). A reliably structured self-rating scale was used to measure the TCM preconception health patterns of the enrolled women. A 3-year follow-up was conducted to obtain the fertility outcomes, including pregnancy rate, time to pregnancy, spontaneous miscarriage and newborn status. Statistical analyses were conducted using Chi-square or Fisher’s exact tests, logistic regression models, general linear models and the Cox proportional hazard model.ResultsThe fertility outcomes showed no statistic correlations to the terms of NFPC in this population. Approximately a half of the women (46.66%) had unhealthy patterns. Women with qi & blood-deficiency (odds ratio [OR] = 35.19, 95% confidence interval [CI] = 1.55–801.15) or qi-stagnation (OR = 4.55, 95% CI = 0.90–23.06) pattern took a longer time to get pregnant, and those with qi-stagnation (OR = 2.05, 95% CI = 1.1–3.82) or yang-deficiency (OR = 1.91, 95% CI = 1.12–3.25) pattern had a higher risk of spontaneous miscarriage.ConclusionThree unhealthy TCM patterns during the preconception period might be risk factors for low fecundity or poor pregnancy outcomes. The TCM preconception pattern identification may provide a convenient and effective way to screen for potential pregnancy risks beyond the NFPC. Further, appropriate interventions based on the TCM preconception health patterns are needed to improve quality in women’s fecundability and birth outcomes.     

中医辨证论治联合化疗治疗晚期非小细胞肺癌的Meta分析

目的:系统评价中医辨证论治联合化疗方案治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的临床效果以及安全性。方法:计算机检索The Cochrane Library,Pubmed,Embase,中国科技期刊全文数据库(VIP),万方数据库,中国期刊全文数据库(CNKI),中国生物医学文献数据库(CBM)等,检索时间限定为建库至2015年7月5日,检索所有中医辨证论治联合化疗方案治疗晚期非小细胞肺癌的随机对照试验(randomized controlled trials,RCTs),并追索纳入研究的参考文献。由两位评价者独立对纳入研究的质量进行严格评价和资料提取后,采用Rev Man 5.3软件进行Meta分析。结果:最终纳入12项RCT,共1 341例患者。Meta分析结果显示:与单纯化疗相比,中医辨证论治联合化疗方案可有效提高临床近期疗效[OR=1.58,95%CI(1.03,2.42),P=0.03],改善患者生存质量[OR=4.38,95%CI(3.17,6.05),P0.000 01]。不良反应方面,中医辨证论治联合化疗方案能减少化疗引起的骨髓抑制:白细胞下降[OR=0.21,95%CI(0.10,0.44),P0.000 1],血红蛋白下降[OR=0.29,95%CI(0.13,0.68),P=0.004],血小板下降[OR=0.26,95%CI(0.10,0.69),P=0.007],减少消化道不良反应[OR=0.23,95%CI(0.09,0.63),P=0.004],但在减少肝功能损害[OR=0.37,95%CI(0.08,1.66),P=0.19],肾功能损害[OR=0.51,95%CI(0.23,1.14),P=0.10]方面两组差异均无统计学意义。结论:中医辨证论治联合化疗方案治疗晚期非小细胞肺癌能有效提高临床近期疗效和改善患者生存质量,减少化疗引起的严重骨髓抑制和消化道不良反应,但在减少肝肾功能损害方面和单纯使用化疗方案相比无显著性差异。鉴于本研究纳入RCTs数量和质量有限,中医辨证论治联合化疗方案治疗晚期非小细胞肺癌的临床疗效以及安全性仍需要严格的、大样本的随机双盲试验加以验证。     

中医药治疗乳腺癌随机对照试验结局指标分析

[目的] 分析近5年发表的中医药治疗乳腺癌随机对照试验的结局指标,为乳腺癌临床试验的核心指标集构建奠定基础。[方法] 检索Cochrane Library、Pubmed、Embase、Web of Science、SinoMed、万方数据和中国知网（CNKI）数据库,收集中医药干预乳腺癌的随机对照试验（RCT）。检索时间为2014年1月—2019年10月。由两名研究者严格根据纳入排除标准独立进行文献筛选、资料提取,如有分歧,经第3方讨论决定。[结果] 共纳入112篇RCT,包含9 430位患者,共涉及61个结局指标。单个研究采用的指标数为1~7个,平均为3个。指标使用频次排前15位的依次为：临床疗效、不良反应、生活质量、肿瘤标志物、生存情况、免疫功能指标、安全性评价、复发转移情况、中医证候积分、中医证候疗效、中医症状积分、血管生成指标、体力状况、骨髓抑制、睡眠质量。指标存在问题主要包括：终点指标过少、缺乏对指标长期效应的测量、指标组合过于随意、指标测量时间与方法差异性大、指标表达不规范,缺少经济学指标等。[结论] 中医药治疗乳腺癌RCT在指标选择、指标测量和表达等方面存在差异大、不规范等问题,需要开展乳腺癌核心指标集研究,以提高相关临床研究的价值。     

Chinese herbal medicine for incomplete immune reconstruction in patients with AIDS undergoing antiretroviral treatment: A systematic review of randomized trials

ObjectiveTo evaluate the effectiveness and safety of Chinese herbal medicines (CHMs) for incomplete immune reconstruction in patients with HIV/AIDS.MethodsEight electronic databases were searched for randomized controlled trials (RCTs) on the use of CHM for patients with HIV/AIDS with incomplete immune reconstruction. Outcomes included CD4⁺ cell count, quality of life, and adverse events/effects. The Cochrane Risk of Bias was employed to evaluate the methodological quality of the included RCTs.ResultsWe identified 13 eligible RCTs, with an overall high risk of bias, on 10 different CHMs. There was a significant increase in CD4⁺ cell count after the use of Jianpi Yiqi medicinal paste for 3 months; tripterygium glycosides tablets (TGTs) for 3 months (mean difference [MD] 52.63 cells/μL, 95% confidence interval [CI, 46.98, 58.28]), 6, 9, and 12 months; Wenshen Jianpi granules for 6 months; Shenling Fuzheng capsules for 6 months (MD 49.53 cells/μL, 95% CI [8.45, 90.61]) and 12 months; Aikeqing granules for 9 months (MD 61.51 cells/μL, 95% CI [16.25, 106.77]) and 12 months; Guipi decoction for 12 months; Mianyi No.2 granules (JT) for 12 and 18 months; and Chinese medicine granules for 18 months. The increase in the mean difference of CD4⁺ cell count from 6 to 18 months was larger in Chinese medicine granules and Mianyi No.2 granules (JT). Guipi decoction and Jianpi Qushi decoction improved the Karnofsky score. Four RCTs reported the outcome of adverse events/effects, while four cases of minor adverse effects were reported in the TGTs group.ConclusionJianpi Yiqi medicinal paste, Wenshen Jianpi granules, Shenling Fuzheng capsules, Aikeqing granules, Guipi decoction, and TGTs may be effective in increasing CD4⁺ within 12 months, and Mianyi No.2 granules (JT) and Chinese medicine granules may show long-term effects. High-quality large RCTs on the effectiveness and safety of CHMs are still warranted.     

Searching for the emotional roots of breast cancer: A cross-disciplinary analysis integrating psychology,Chinese medicine,and oncology biomarkers

Objective: We employed a multidisciplinary approach incorporating theoretical ideas, clinical experience,psychology, physiology, traditional Chinese medicine(CM), modern practice of CM, and oncology to explore the effect of patients’ repression of negative emotions and traumatic events on breast cancer(BC) pathogenesis.Methods: BC female patients, older than 18 years of age, with available pathology reports who were treated at Rabin Medical Center were recruited. All participants completed questionnaires regarding medical history, behavioral tendencies, negative emotions, trauma, symptoms, and pathology(from a CM perspective). Data on tumor characteristics were collected from the pathology reports. The associations were examined using hierarchical binary logistic regressions.Results: A total of 155 BC patients were enrolled. The median age was 52 years, with a range of 26–79;95% were mothers;28% had estrogen receptor(ER)-negative BC, 52% had progesterone receptor(PR)-negative BC, 48% had human epidermal growth factor receptor 2-negative BC, and antigen Ki-67 ≥ 20%was reported for 52% of tumors. Statistically significant associations were found between the emotional markers(sense of motherhood failure, and lack of self-fulfillment), avoidance behavior, and physical symptoms that are related to emotional repression based on CM. Significant associations were also found between variables associated with physical symptoms of emotional repression, which involves the production and accumulation of non-substantial phlegm(i.e., ‘‘high-lipid Qi-like microscopic phlegm"),avoidance behavior which unconsciously uses ‘‘high-lipid Qi-like microscopic phlegm" in order to achieve emotional repression, and tumor parameters including tumor grade, PR status, and Ki-67.Patients with higher levels of ‘‘high-lipid Qi-like microscopic phlegm" were more likely to have tumors with worse prognosis(PR-negative, higher grade, and higher Ki-67).Conclusion: We demonstrated a relationship between emotional parameters, behavioral tendencies, CM parameters, and oncologic parameters in BC. Additional research is warranted to explore these associations and their relevance to clinical practice.     

Traditional Chinese medicine treatment for COVID-19: An overview of systematic reviews and meta-analyses

BackgroundCoronavirus disease 2019 (COVID-19) is a rapidly spreading disease that has caused an extensive burden to the world. Consequently, a large number of clinical trials have examined the efficacy of traditional Chinese medicine (TCM) for treating and preventing COVID-19, with coinciding proliferation of reviews summarizing these studies.ObjectiveThis study aimed to evaluate the methodological quality and evidence quality of systematic reviews and meta-analyses on the efficacy of TCM.Search strategySeven electronic databases, including PubMed, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Chongqing VIP, Wanfang Data and SinoMed, were searched for systematic reviews and meta-analyses in October 2021. Search terms such as “Chinese medicine,” “Lianhua Qingwen” and “COVID-19” were used.Inclusion criteriaSystematic reviews and meta-analyses of randomized controlled trials that evaluated the efficacy of TCM treatment of COVID-19 were included.Data extraction and analysisA Measurement Tool to Assess Systematic Reviews Version 2.0 (AMSTAR 2) was used to evaluate the methodological quality. The quality of evidence was graded using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Data extraction and analysis were performed by two reviewers independently.ResultsThere were 17 meta-analyses included in our overview. The intervention group was defined as TCM combined with Western medicine, while the control group was Western medicine alone. The methodological quality of all the included studies was moderate to poor. A total of 89 outcome indicators were evaluated, of which, 8 were rated as moderate quality, 39 as low quality, and 41 as very low quality. Only one outcome measure was graded as being of high quality. The moderate quality of evidence indicated that, for the treatment of COVID-19, the clinical efficacy of TCM in combination with Western medicine was better, in terms of lung recovery, rate of conversion to severe/critical cases, symptom scores, duration of symptoms, mortality, and length of hospital stay.ConclusionEvidence from the included studies shows that, compared with conventional Western medical therapy alone, the addition of TCM to COVID-19 treatment may improve clinical outcomes. Overall, the quality of evidence of TCM for COVID-19 was moderate to poor. Meta-analyses of the use of TCM in the treatment of COVID-19 can be used for clinical decision making by accounting for the experiences of clinical experts, medical policies, and other factors.     

中药治疗卒中后认知障碍疗效和安全性的系统评价

目的:评价中药治疗卒中后认知障碍(PSCI)的疗效与安全性。方法:计算机检索中国知网数据库,万方数据库,维普数据库,中国生物医学文献数据库,PubMed,The Cochrane library和ClinicalTrials.gov共7个数据库,纳入中药治疗PSCI的随机对照试验(RCT)。使用Cochrane偏倚风险评估工具对纳入研究的方法学质量进行评价,并对纳入研究进行描述性分析,应用RevMan 5.3软件进行Meta定量分析。结果:共纳入16项RCT,1296例受试者,干预组649例,对照组647例。研究结果显示中药联合西药组和中药组干预在改善PSCI患者蒙特利尔认知评估量表,简易精神状态检查量表,Barthel指数评定量表,日常生活能力量表,中国脑卒中临床神经功能缺损程度评分量表和美国国立卫生研究院卒中量表的评分上均优于西药组,且未见严重的不良反应。结论:中药在改善PSCI患者的认知功能水平方面具有潜在优势,对改善日常生活能力及神经功能缺损症状也有一定疗效,并未观察到严重不良事件。本文纳入研究的方法学质量不高,建议后续开展高质量的RCT来研究中药治疗PSCI的疗效和安全性,为该疾病的临床诊疗提供决策依据。     

中药注射剂治疗非小细胞肺癌临床试验结局指标文献研究

[目的]分析中药注射剂治疗非小细胞肺癌随机对照试验(RCT)的结局指标,为构建肺癌临床试验的核心指标集提供基础。[方法]计算机检索中国知网数据库(CNKI),万方数据(WanFang),维普数据库(VIP),中国生物医学文献服务系统(SinoMed),Embase,Cochrane library,Web of Science和PubMed 8个数据库。以2018年发表的文献为样本,由2位作者严格按照纳入与排除标准独立筛选文献、提取资料,如有分歧,经讨论解决。[结果]纳入94个RCT研究中共包含8450位患者,共采用64种结局指标。单个研究指标数量最少为1个,最多达10个,平均每个研究结局指标的数量为3.3个。使用频次排前10位的结局指标依次为:临床疗效、不良反应、生活质量、免疫功能、肿瘤标志物水平、卡氏(KPS)评分、毒副作用、T细胞亚群变化、中医证候积分、总生存期。94个RCT研究普遍存在结局指标临床相关性差、缺少中医药特色指标、指标组合随意、指标测量时点多样、时间跨度较大、指标测量工具不一致等问题。[结论]中医药治疗非小细胞肺癌临床试验结局指标存在较多问题,需要建立核心指标集提高相关临床研究质量。     

Effects of l-arginine supplementation on glycemic profile: Evidence from a systematic review and meta-analysis of clinical trials

BackgroundThe effects of l-arginine supplementation on indices of glycemic control and the role of many factors influencing this intervention have been controversial in clinical trials.ObjectiveThis meta-analysis was performed to assess the effects of l-arginine supplementation on indices of glycemic control, including fasting blood glucose (FBG), hemoglobin A1c (HbA1c), serum insulin and homeostatic model assessment of insulin resistance (HOMA-IR) levels in randomized controlled trials (RCTs).Search strategyThis study conducted a systematic review of RCTs published in PubMed, Scopus, Web of Science, Cochrane Library and Embase, up to 5 May, 2018.Inclusion criteriaStudies were included in this meta-analysis if they were RCTs with parallel design and reported sufficient data on participants before and after intervention, and outcomes of glycemic profile parameters in both the arginine supplementation and control groups.Data extraction and analysisThe screening of titles and abstracts was performed independently by two reviewers. Selected articles were considered if they met the study’s inclusion criteria. The quality of included studies was assessed by using the Cochrane Collaboration modified tool. From 710 articles retrieved in the initial search, only 10 trials were suitable for pooling the effects of arginine supplementation on serum glucose, insulin, HOMA-IR and HbA1c levels, with effect sizes of nine, eight, five and five, respectively.ResultsPooled random-effect analysis revealed that l-arginine supplementation could significantly decrease FBG level (weighted mean difference [WMD]: 3.35 mg/dL; 95% confidence interval [CI] = [−6.55, −0.16]; P = 0.04) and serum insulin level (WMD: −2.19 μIU/mL; 95% CI = [−3.70, −0.67]; P = 0.005). However, the effects of l-arginine supplementation on HOMA-IR and HbA1c were not significant. Results of subgroup analysis showed that supplementation with l-arginine could significantly decrease serum insulin levels when the dosage of l-arginine is > 6.5 g/d (WMD: −3.49 μIU/mL; 95% CI = [−5.59, −1.38]; P = 0.001), when the duration of supplementation is ≤ 12.8 weeks (WMD: −3.76; 95% CI = [−6.50, −0.98]; P = 0.008), when the participants are not diabetic patients (WMD: −2.54 μIU/mL; 95% CI = [−4.50, −0.50]; P = 0.01) and when the baseline serum level of insulin was > 20 μIU/mL (WMD: −3.98; 95% CI = [−6.31, −1.65]; P = 0.001).ConclusionAlthough the results of this study confirmed that supplementation with l-arginine could have significant effects on some glycemic profile indices of participants in clinical trials, the clinical importance of this reduction may not be meaningful.     

中药干预肿瘤患者化疗后并发心律失常的系统评价和网状Meta分析

目的 旨在评价现有文献中中药联合化疗药改善肿瘤患者化疗后心律失常的有效性及安全性,评估文献中是否存在多种偏倚因素,并对结局指标进行量化,为临床应用中药防治肿瘤患者化疗后心律失常提供可靠的证据支撑。方法 计算机检索PubMed、Cochrane Library、中国知网（CNKI）、万方等数据库,并辅以手工检索获得相关临床随机对照试验,检索时限均从建库至2023年5月。由2位评价员独立进行文献筛选、数据提取和研究质量评估。使用RevMan 5.4和Stata 17软件进行网状Meta分析。结果 共纳入16项临床随机对照试验,1380例肿瘤化疗后并发心律失常患者,11个中药处方（稳心颗粒、复方斑蝥、参麦注射液、参芪扶正注射液、参松养心胶囊、丹红注射液、生脉散、通络宁心汤、通脉四逆汤、心脉隆注射液和益心补气方）。传统Meta分析显示,与常规化疗药物相比,中药联合常规化疗药物可有效降低患者化疗后心律失常的发生率[OR=0.31, 95%CI (0.24, 0.40), P<0.000 01],减少心动过速、室性早搏、房性早搏发以及其他心律失常发生次数[OR=0.40, 95%CI (0....     

Systematic review and meta-analysis of the therapeutic effect on functional dyspepsia treated with acupuncture and electroacupuncture: 针刺和电针治疗功能性消化不良疗效的系统评价和 meta 分析

ObjectiveTo review systematically the therapeutic effect and safety of acupuncture or electroacupuncture (EA) on functional dyspepsia (FD).MethodsUsing computer, the randomized controlled trials (RCTs) of FD treated with acupuncture or EA were retrieved from the databases, i.e. Cochrane Library, PubMed, EMbase and Web of science, from the date of database establishment to June 1, 2020. Using the assessment tool of risk of bias in Cochrane Handbook for systematic reviews of interventions, 5.1.0, the quality of the included RCTs were evaluated in methodology. Meta-analysis was performed by RevMan 5.3 software.ResultsA total of 10 articles were included, with 1202 cases involved. In this study, the effectiveness of EA or acupuncture on FD was analyzed in comparison with the treatment with sham-acupuncture, sham-EA or western medication. The results indicated that compared with sham-acupuncture or sham-EA, acupuncture or EA greatly relieved the clinical symptoms of FD (SMD = ?3.03, 95% CI [?3.56, ?2.50], P < 0.00001) and obtained a higher clinical response rate (OR = 5.09, 95% CI [3.30, 7.86], P < 0.00001), but the difference was not significant statistically in gastric electrical activity (P > 0.05). Compared with gastric prokinetics, acupuncture or EA more effectively reduced the symptom score (MD = ?3.03, 95%CI [?3.56, ?2.50], P = 0.02), but the differences were not significant in the aspects of the improvement of clinical effective rate (OR = 1.33, 95% CI [0.70, 2.52], P = 0.39), the promotion of gastric half-emptying (MD = 0.23, 95% CI [?1.94, 2.40], I²=0%, P = 0.83), the promotion of motilin secretion (SMD = ?0.06, 95% CI [?0.23, 0.11], I² = 0%, P = 0.50) and the increase of gastric electrical activity (MD = ?0.01, 95% CI [?0.03, 0.01], I² = 0%, P = 0.41). The three RCT studies with adverse events reported indicated that the difference in the incidence of the adverse events was not significant statistically in comparison of acupuncture with sham-acupuncture or gastric prokinetic agent (P < 0.05).ConclusionRegarding the improvement in the symptoms of FD, the effect of EA or acupuncture is superior to the sham-acupuncture group or the western medication group. Simultaneously, the clinical response rate in the treatment with EA or acupuncture is higher than the sham-acupuncture group. During the treatment with EA, some adverse reactions happened in treatment of FD with acupuncture or western medication. Even though there are the limitations in quality and quantity of the included trials, EA and acupuncture still deserve to be promoted in treatment of FD. However, more studies of RCTs with large-scale sample, high quality and multiple centers are required for a further verification of the therapeutic effect.     

Effects of traditional Chinese exercises and general aerobic exercises on older adults with sleep disorders: A systematic review and meta-analysis

BackgroundSleep disorders are common in older adults and have a negative influence on their physical and mental health. General aerobic exercises (GAEs) have long been used in the treatment of sleep disorders as a non-pharmacological measure. However, there is no consensus on the efficacy of traditional Chinese exercises (TCEs) for treating sleep disorders in older adults and the difference between TCEs and GAEs.ObjectiveThis study assessed the effects of TCEs and GAEs on the sleep quality of older adults and the differences between these two interventions.Search strategyPubMed, Embase, Cochrane Library, Web of Science, China Biology Medicine disc, China National Knowledge Infrastructure, China Science Journal Database and Wanfang Data were searched from their inception to August 2020.Inclusion criteriaRandomized controlled trials (RCTs) that evaluated the effects of TCEs and GAEs on older adults with sleep disorders were included.Data extraction and analysisData were extracted by two researchers working independently. The risk bias of included studies was assessed using the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 and the quality of evidence was assessed using the Grades of Recommendation, Assessment, Development and Evaluation approach. The Pittsburgh Sleep Quality Index (PSQI) was used to estimate sleep quality. Meta-analyses were performed to assess the total PSQI score of the exercise intervention as the primary outcome, and the scores of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunction were assessed as secondary outcomes. Subgroup, sensitivity, and meta-regression analyses were conducted to assess the contribution of covariables to heterogeneity.ResultsA total of 22 RCTs (including 1747 participants) were included in the meta-analysis. The results indicated that TCEs (weighted mean difference [WMD] = −2.14, 95% confidence interval [CI] [−2.82, −1.46], P < 0.001; heterogeneity: P < 0.001, I² = 82%; 15 studies, n = 1063) and GAEs (WMD = −2.88, 95% CI [−5.22, −0.55], P < 0.001; heterogeneity: P < 0.001, I² = 98%; 5 studies, n = 500) significantly improved total sleep quality, having favorable effects on subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunction. Subgroup analysis showed that TCEs demonstrated superiority after 12 weeks (WMD = −2.77, 95% CI [−4.26, −1.28], P < 0.001; heterogeneity: P < 0.001, I² = 85%; 5 studies, n = 420) and Qigong had a greater intervention effect for improving the sleep quality of older adults than Tai Chi (WMD = −3.37, 95% CI [−4.38, −2.35], P < 0.001; heterogeneity: P = 0.04, I² = 63%; 4 studies, n = 321). Meta-regression revealed that the year of publication, sample size, mean age of participants, and percentage of females in the primary studies did not account for the overall heterogeneity.ConclusionCurrent evidence shows that both TCEs and GAEs, as complementary and non-pharmacological approaches, help to improve the sleep quality in older adults with potentially clinical implications; however, there was not enough evidence to conclude the difference between them. More rigorous and high-quality RCTs are needed to arrive at reliable conclusions.