ABSTRACT
Objective To evaluate the quality of the clinical trial literatures published on the treatment of COVID-19 with TCM, find out the shortcomings and put forward corresponding suggestions, in order to promote TCM against COVID-19. Methods "COVID-19", "New Coronavirus Pneumonia", "TCM", "Chinese Medicine", "Clinical Trial", "Lianhua Qingwen", "Huoxiang Zhengqi", "Jinhua Qinggan", and other keywords were used to search relevant literatures in CNKI and PubMed database. Among the all the screened relevant literatures on the treatment of COVID-19 with TCM, the literature quality was assessed according to evaluation criteria of clinical trial literatures. Results A total of 463 papers related to the treatment of COVID-19 with TCM were obtained. 440 papers on theoretical research on the network pharmacology mechanism of Chinese medicine treatment of COVID-19 were excluded. Among the 23 articles included in the quality analysis, there are 3 randomized controlled studies, 1 multi-center prospective randomized controlled trial, 2 disease case report trials, and 5 uncontrolled single arm studies, 5 controlled trials and 7 retrospective studies. In the period of more than half a year, although many clinical trial documents of TCM for the treatment of COVID-19 have been published, the clinical trial design reflected in most TCM clinical trials were not standardized. There are problems in "randomness and rationality", such as no control group, no randomization design, only case studies, no blinding method in controlling bias, and insufficient objectivity in the evaluation criteria of efficacy. All of these need to be improved. Conclusion The treatment of new coronavirus pneumonia with TCM still requires more and standardized clinical trial verifications and publications to generate strong evidence-based results, such as adding control groups, increasing sample size, and using blinding methods to increase the credibility of clinical trials.
ABSTRACT
Objective To assess the quality of literature on randomized or semirandomized clinical controlled trials of fire needling treatment for rheumatoid arthritis.Method Acomputer search assisted by a manual search was conducted of CBM (1979—2015), CNKI (1979—2015), VIP (1989—2015),Wanfang digital periodical group(1998—2015), PubMed (1966—2015), EMbase (1980—2015) and Cochrane Library (Issue4, 2015).Randomizedor semir and omized clinical controlled trials were included.Two reviewers extracted data independently and checked them each other.The methodological quality of research design, diagnostic and inclusion/exclusion criteria, intervening measures for fire needling/control group,efficacy evaluation criteriaand observation time points, and adverse reaction reporting were assessed according toCochrane Reviewers' Handbook 4.2.8.Ameta-analysis was made of homogeneity studies.The GRADE approach ratedsystem outcomes.ResultA total of sevenr and omized controlled trialswere included.Four included studies made a comparison between fire needling andmedication (analgesic+ antirheumatic) groups andthere was no statistically significant difference in the efficacy rate [RR=1.22, 95%CI(0.97, 1.52)].GRADE ratingwas very low.Internationally accepted diagnostic criteria and general evaluation methodswere still not used universally.Conclusion The current clinical reports show that fire needling treatment has some effect on rheumatoid arthritis, but it still needs related evidence support.
ABSTRACT
Acupuncture treatment of insomnia has been reported for many years,but its validity remains controversial up to now.In the present review,the authors took "Acupuncture","Insomnia" as the key words to do a literature search from databases in both Chinese and English via computer retrieval system and also conducted a hand-made retrieval from journals of Chinese medicine as Chinese Acu-moxibustion,and collections of theses of the related academic conferences.Then,they made a systemic evaluation on the original articles from methodology,diagnosis,criteria for the enlisted and excluded patients,intervention methods of acupuncture and control groups,standards for assessing the curative efficacy,follow-up visit,etc.Of the retrieved 80 clinical articles,20 are RCT(randomized controlled trails) composed of 1907 cases,including 4 high-quality trails and 16 lower-quality trails.Regarding the assessment of the therapeutic effect,measuring scales are often adopted in overseas studies,while in domestic researches,self-drawn standards are frequently used.In conclusion,there have had no high-quality clinical trails about acupuncture treatment of primary insomnia in China at the present,and the related evaluating methods could not definitely confirm the efficacy of acupuncture in relieving insomnia.Therefore,a strict and scientific clinical trail scheme being in line with evidence-based medicine is urgently needed in the coming studies on acupuncture treatment of primary insomnia.