Objective To compare the effectiveness of integrated traditional Chinese medicine (TCM) with Western medicine and Western medicine alone for acute episodes of withdrawal in alcoholism. Methods According to the criteria of alcohol dependence and acute alcochol withdrawal syndrome of Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-Ⅳ) , 62 consecutive patients were divided into two groups: 31 patients with odd numbers were allocated to the treatment group (4 patients were excluded because they left hospital early), 31 patients with even numbers were allocated to the control group. According to the four diagnostic methods of TCM, all patients in the treatment group were further divided into 4 types. The treatment group received valium, tiopronin, transfusion therapy and herbs (potion per day). The control group received the same therapy as the treatment group did but without oral herbs. Results Liver function, especially the difference between before and after treatment of GOT and γ-GT,the treatment group showed more improvement than the control group (P=0.046 and 0.001). The scores of anxiety and depression test, especially the HAMD, the treatment group showed more improvement than the control group (t=3.165, P=0.003). The treatment group used significantly less time than the control group (P=0.01), but no statistically significant difference was seen in the dosage of valium between the two groups (P=0.434). Conclusions The efficacy of integrated TCM with Western medicine is better than Western medicine alone for acute episodes of withdrawal in alcoholism.
Objective To evaluate the methodological quality of clinical trials on traditional Chinese medicine (TCM) nursing in recent six years.Methods Such databases as CNKI, VIP, WanFang Data and CBM were searched for collecting clinical trials on TCM nursing published from January 2006 to September 2011, and domestic primary nursing journals were also searched from January 2010 and September 2011. Methodological quality of included studies was assessed using quality assessment criteria of the Cochrane systematic review guideline. Results A total of 854 clinical trials were retrieved, including 706 (82.7%) randomized controlled trials (RCTs), 108 (12.6%) quasi-randomized controlled trials and 40 (4.7%) non-randomized controlled trials. In the methodological quality analysis, the comparability of baseline was mentioned in 784 trials (91.8%), a total of 498 (58.3%) reported definite diagnosis criteria. 178 (20.8%) reported exclusive criteria. 831 studies (97.3%) applied relevant statistical methods properly. However, only 55 trials (6.4%) mentioned the method of randomization sequence. 10 studies (1.2%) described the method of randomiztion assignment. Blinding was mentioned in 22 studies (2.6%). 98 trials (11.5%) did prospective follow-up. 93 trials (10.9%) had safety description. 20 trials (2.3%) reported lost and with drawl cases, but only 2 conducted intention-to-treat analysis. It was hard to determine whether there was selective reporting bias or not because all the studies did not have protocols. Only 21 studies (2.5%) mentioned the lack of outcome indicators which could be the evidence for existing of bias. By annual analysis, there were 81 trials which conformed to at least 2 low risk criteria. 10 trials (12.3%) was published in 2009, 26 trials (32.1%) published in 2010, and 27 trials published by September 2011, indicated an uptrend. Conclusions According to the Cochrane Collaboration’s tool for assessing risk of bias, the overall quality of clinical trials on TCM nursing is low with defects in different degrees, but it rises gradually over years.
Objective To assess the reporting quality of noninferiority and equivalence randomized controlled trials (RCTs) related to Traditional Chinese Medicine (TCM). Methods The noninferiority and equivalence RCTs related to TCM were searched, and the quality of the included RCTs was identified in accordance with the extended version of CONSORT statement which refers to the reporting standard of noninferiority and equivalence RCTs. Results A total of 13 noninferiority and equivalence RCTs were included. Except for the common questions of RCTs in reporting quality, some contents related to noninferiority and equivalence trials in reporting were not enough: a) The title of RCTs did not reflect the most important content of the literature; b) The introduction of background was quite simple. The rationale about noninferiority and equivalence trials, and the effectiveness of positive control were not clearly defined; c) All literatures did not indicate whether the subjects, interventions and outcomes in the noninferiority and equivalence trials were identical or similar to those in previous trials of defining the effectiveness of control treatment; d) Most literatures did not define the critical value of noninferiority and equivalence, and did not estimate the sample size; e) Only half of literature described the statistical methods of noninferiority test and equivalence test; and f) Some literature had mistakes in noninferiority and equivalence conclusion. Conclusion The researchers still need deeper understanding of the theoretical basis of noninferiority and equivalence trials. The reference to the extended version of CONSORT statement, which refers to the reporting standard of noninferiority and equivalence RCTs, is helpful for researchers to identify the key points of the design, performance and reporting of the noninferiority and equivalence RCTs, to lay stress on the related contents of noninferiority and equivalence trial reporting, and to radically improve the reporting quality of such clinical trials.
Objective To assess the efficacy and safety of Chinese medicinal herbs for asymptomatic hepatitis B virus(HBV) infection. Data Source The trials registers of the Cochrane Hepato-Biliary Group, the Cochrane Library and the Cochrane Complementary Medicine Field were searched in combination with MEDLINE, EMBASE, and handsearches of Chinese journals and conference proceedings. Data Selection Randomized clinical trials with 3 months follow-up comparing Chinese medicinal herbs versus placebo, no intervention, non-specific treatment, or interferon treatment for asymptomatic HBV carriers were included. No language and blinding limitations were applied. Data Extraction Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment. Results Three randomized clinical trials (307 patients) with low methodological quality following patients for three months or more after the end of treatment were included. Herbal compound Jianpi Wenshen recipe showed significant effects on clearance of HBV markers compared to interferon: relative risk 2.40 (95 % CI 1.01 to 5.72) for clearance of serum HBsAg, and 2.54 (1.13 to 5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomized clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers. No serious adverse event was observed. Conclusions There is insufficient evidence for treatment of asymptomatic HBVcarriers using Chinese medicinal herbs due to the low quality of the trials. Further randomized, double blind, placebo-controlled trials are needed.
Objective To investigate the effectiveness of teaching morning handover in clinical teaching of traditional Chinese medicine (TCM) in general hospitals. Methods A retrospective study was conducted at the Institute of Integrated Traditional Chinese and Western Medicine, West China Hospital of Sichuan University from April 2023 to March 2024, involving a total of 220 participants including interns, postgraduates/standardized training students, and residents/refresher students. The control group consisted of trainees who studied from April to September 2023, while the observation group included those who studied from October 2023 to March 2024. Teaching morning handover was added to the clinical morning report for the observation group, while the control group only conducted the conventional clinical morning report. Due to the differences in basic knowledge and clinical positioning, trainees except interns were classified as clinical residents. A questionnaire survey including satisfaction of teaching content, teaching methods, teaching ability and teaching management and graduation assessment including total score, theoretical assessment score, clinical process score and participation in teaching activities were compared between the two groups. Results Compared with those of the interns (n=57) and clinical residents (n=49) in the control group respectively, there was no statistically significant difference in satisfaction of teaching content, teaching methods or teaching ability of the interns (n=78) and clinical residents (n=36) in the observation group (P>0.05); however, teaching management satisfaction was significantly improved (interns P=0.002, clinical residents P=0.022). Both the interns and clinical residents in the observation group had a significantly higher total score as well as theoretical assessment score and increased participation in teaching activities (P values for interns were <0.001, 0.001, and <0.001, respectively, and for clinical residents were <0.001, 0.013, and <0.001, respectively). However, there was no significant difference observed between groups regarding clinical process score (P>0.05). Conclusion Teaching morning handover is helpful in improving the quality of TCM teaching in general hospitals and is an effective model for clinical teaching of TCM.
ObjectiveTo systematically review the research status of therapeutic drug monitoring (TDM) for traditional Chinese medicine. MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM, VIP databases, official websites of governments and societies associated with TDM were electronically searched to collect studies on TDM for traditional Chinese medicine from inception to January, 2022. Two reviewers independently screened literature and extracted data. Then, a qualitative systematic review was conducted. ResultsA total of 13 studies were included, all of which came from China and were small sample size studies. The studied population consisted mainly of healthy volunteers (85%), followed by patients of coronary artery disease with blood stasis pattern (31%), patients of rheumatoid arthritis (8%), and patients of acquired immune deficiency syndrome (8%). There were two types of medicine, including proprietary Chinese medicine (69%) and Chinese herbal pieces (31%). The research topics were all theoretical research of TDM, mainly concentration detection methods (77%), followed by influence factors of blood drug concentration (15%), the selection of specimen (15%), the selection of monitoring object (8%) and the concentration reference range (8%). There was no clinical practice study on TDM of traditional Chinese medicine. ConclusionTDM of traditional Chinese medicine is still in the exploratory stage in China. Published studies are mainly on the theoretical research of TDM, and no relevant studies is on clinical practice of TDM of traditional Chinese medicine.
ObjectivesTo analyze the active areas of real world studies on traditional Chinese medicine in China.MethodsCBM, CNKI, WanFang Data, PubMed and EMbase databases were electronically searched to collect real world studies on traditional Chinese medicine in China from inception to 26th April, 2018. The main research contents (research direction, data sources, and research methods) by Excel were extracted, together with the primary information by BICOMS-2 software and production of the network figures by NetDraw 2.084 software.ResultsEventually, 373 real world studies in traditional Chinese medicine were included, in which the initial one was punished in 2008. The top three ranking of authors involved in real world studies on traditional Chinese were Xie Yanming, Zhuang Yan, Yang Wei, and the top three ranking of institutions were Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences, School of Statistics of Renmin University of China, and the PLA Navy General Hospital. The amount of related studies in Beijing accounted for 74.26%. It was found that the active areas involve real world, hospital information system, real world study, drug combination, and propensity score method. In terms of the main studied contents on the use of traditional Chinese medicine in the real world, in which the top three were Fufang Kushen injection, Dengzhanxixin injection, and Shuxuetong injection. Digestive system disease, nervous system disease and cardiovascular disease received the highest attention rate, specifically stroke, coronary heart disease, virus hepatitis and hypertension. 58.18% studies were retrospective studies, 49.60% of the information were from the hospital information system, and 56.30% studies used data mining to carry out statistical analysis.ConclusionsMost real world studies on traditional Chinese medicine are based on HIS, and use data mining to study Chinese medicine preparations. The research attention on Chinese medicine is higher than that of the method of diagnosis and treatment, similarly the Chinese medicine preparations is higher than traditional Chinese medicine. In future, attention should be paid to traditional Chinese medicine, prescription and traditional methods of diagnosis and treatment, such as moxibustion and scraping.
Objective To assess the efficacy and safety of Chinese medicinal herbs for treating endometriosis. Methods We searched Cochrane Library, MEDLINE, EMBASE, CBM (from establishment to 2003). Randomized controlled trials (RCTs) and quasi-randomized controlled trials of patients with endometriosis were included. The quality of included studies such as randomization, blinding, allocation concealment and loss of follow up were evaluated and meta-analysis was performed by RevMan 4.3 software. Results Ten RCTs or quasi-RCTs involving 1 120 patients were included. Because of different therapies in the treatment and control groups, the results of outcome were described separately. Most of included studies suggested that the effects of traditional Chinese medicine (TCM) on general effect, pregnancy rate improvement and alleviating dysmenorrhoea were similar to Danazol or Tamoxifen, only a few studies showed better effects. There was no evidence to support that TCM was more effective than western medicine in reducing the size of endometriotic cysts. Only one study mentioned the recurrence rate and showed that TCM enema had lower recurrence rate than oral Tamoxifen with OR 0.17, 95%CI 0.04 to 0.67. Five studies mentioned adverse reactions and showed TCM had fewer adverse effects than western medicine. Conclusions Chinese medicinal herbs are effective in treating endometriosis with fewer adverse effects. The evidence is not b enough because of low quality of the included studies. Therefore, more high quality randomized controlled trials are required.
Objective To conduct a scoping review on the clinical research evidence for the treatment of coronavirus disease 2019 (COVID-19) with traditional Chinese medicine, identify relevant problems in the literature, and provide ideas for the follow-up research. Methods PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, Wanfang Digital Journal Full-text Database, and China Biomedical Literature Database were searched from inception to July 21st, 2022. The clinical research evidence for the treatment of COVID-19 with traditional Chinese medicine was included, the data information was sorted out, and the results were descriptively analyzed. Results A total of 132 studies were included, including 53 randomized controlled trials, 17 non-randomized controlled trials, and 62 retrospective cohort studies, all of which were published between 2020 and 2022. The clinical studies were carried out in 19 provincial level regions, among which Hubei province had the largest number of studies (49.2%, 65/132). The sample sizes of the studies were mostly between 50 and 100 cases (43.2%, 57/132). Most of the studies had a treatment course of 0-14 days (50.0%, 66/132). The most compared intervention measures were traditional Chinese medicine + conventional western medicine treatment vs. conventional western medicine treatment, accounting for 75.0% (99/132) of the studies. The COVID-19 patients included in the studies were mainly mild and moderate. Outcome indicators included changes in symptoms/signs, laboratory indicators, CT indicators, clinical outcomes, safety indicators, functional scales, etc. The main adverse reactions/events in intervention/exposure groups were gastrointestinal reactions. Conclusions There has been a lot of clinical research evidence on the treatment of COVID-19 by traditional Chinese medicine. To provide strong evidence support for the treatment of COVID-19 by traditional Chinese medicine, more clinical trials with large samples and international collaboration are needed in the future.
Objective To assess the benefits and harms of traditional Chinese medicine in the treatment of postmenopausal osteoporosis. Methods We electronically searched MEDLINE (1966-2003), EMBASE (1974-2003), Controlled Trials Register and The National Research Register, The Cochrane Library Issue 4, 2003, CBM disc, VIP, CNKI, and CMCC. We also handsearched some related journals. The search was conducted in Nov., 2003. The quality of included randomized controlled trials was evaluated and meta-analysis was conducted by RevMan 4.2.2. Results We identified 33 studies including 2 337 patients and 27 traditional Chinese medicines. Some traditional Chinese medicines alone or integrated Chinese and Western medicine may be effective for improving patients’ bone mineral density, serum oestradiol and serum calcium. For example, Compared with placebo, Bushen Yigu soft extraction with WMD 0.76, 95% confidence interval 0.65 to 0.87, Bushen Qianggu capsule with WMD 39.94, 95% confidence interval 35.12 to 44.76 were effective for improving the level of serum oestradiol.There were no confirmed results of the other traditional Chinese medicines because of the small number of studies or inconsistent conclusions among studies. We didn’t find obvious side effects. Conclusions Some traditional Chinese medicines may be effective for treating postmenopausal osteoporosis. Due to the limited evidence identified, we can not draw a firm conclusion. More randomised controlled trials of high quality are needed for ber evidence.
