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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.
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OBJECTIVE： To investigate current status and quality of domestic pharmacoeconomic literatures， and to provide reference for the standardization of pharmacoeconomic research. METHODS： Retrieved from CNKI， Wanfang， VIP and other database， the pharmacoeconomic literatures published from Jan. 2017 to May 2018 were collected. The qualities of literatures were evaluated with Guidelines for Quality Evaluation of Pharmacoeconomics Evaluation Reports （“PEERs” for short）. RESULTS： Totally 160 domestic pharmacoeconomic research literatures were included. The results of PEERs evaluation showed of which the coincidence rate was 32.5％ （52/160）. The literatureswhich were in full compliance （the report had a certain reference value） accounted for 1.3％ （2/160）， which were in basic compliance （the report had certain reference value after being revised） accounted for 31.3％（50/160），which were in non-conformity （the report did not had reference value） accounted for 67.5％（108/160）. Domestic pharmacoeconomic researches were of high quality in terms of research object， evaluation method and content，research purpose， research design and design type， etc.； but the researches were of low quality in terms of research angle， incremental cost/incremental output analysis， sensitivity analysis and other aspects， and there was no explanation or unclear elaboration. CONCLUSIONS： The quality of domestic pharmacoeconomic research literatures are uneven， and their research quality needs to be further improved. It is recommended to standardize the evaluation of pharmacoeconomics， making the evaluation of pharmacoeconomics more scientific and objective.
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The internationally-accepted Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) were applied to evaluate the literature quality of randomized controlled trials (RCTs) regarding acupuncture for chronic neck pain in past 10 years. The literature of RCTs regarding acupuncture for chronic neck pain was searched by computer; the English literature was searched in PubMed and EMbase, while the Chinese literature was searched in CNKI, Wanfang database, VIP database and China Biomedical Literature Database. The literature published from January 2008 to January 2018 was searched. As a result, 29 Chinese articles and 10 English articles were included. According to CONSORT, among Chinese articles, 28 articles (96.6%) described baseline data, 23 articles (79.3%) described randomization, 0 articles (0.0%) described allocation concealment, 3 articles (10.3%) described blind method; among English articles, 6 articles (60.0%) described baseline data, 8 articles (80.0%) described randomization, 8 articles (80.0%) described allocation concealment, and 7 articles (70.0%) described blind method. According to STRICTA, among Chinese articles, 8 articles (27.6%) described needle instrument selection, 18 articles (62.1%) described needle depth, 24 articles (82.8%) described needling sensation, and 0 articles (0.0%) described acupuncturist' qualifications; among English articles, 5 articles (50.0%) described needle instrument selection, 8 articles (80.0%) described needle depth, 3 articles (30.0%) described needling sensation, and 4 articles (40.0%) described acupuncturist' qualifications. In conclusion, the reporting of acupuncture details in Chinese literature is superior to that in English literature, while the reporting of trial design in English literature is slightly superior to that in Chinese literature. Moreover, both Chinese and English literature need to further improve clinical trial design to improve the reporting quality of clinical evidence based on CONSORT and STRICTA.
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Humans , Acupuncture Therapy , China , Neck Pain , Therapeutics , PubMed , Publications , Randomized Controlled Trials as TopicABSTRACT
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.
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Objective To explore the quality of clinical trial papers published in medical SCI-tech journal.Methods A total of 1201 original research projects were published in 6 medical journals from Mar.2012 to Mar.2014 in China.Fifty-four of them were selected according to the key words randomizedcontrolled,and they were evaluated using 2010 CONSORT statement.Results In 54 articles,the section of background and abstract were described clearly and standardize.Fifty-one (94.44 ％)papers described intervention method in details.Thirty-five (64.81％) papers described the experimental design method.Thirty-one (57.41％) papers defined the primary and secondary outcome indicators,only 3 (5.56％)of them described distribution order,and the method of blindness.Four (7.41％) papers provides the information on sample size calculation.The using of flow chart accounted for 7.41％.Ten (18.52％) papers described the reason of drop out.Two (3.70％) papers evaluated the effect and accuracy,and the trial results were explained clearly and consider other evidences.Only 18 (33.33％) papers wrote the limitation of the studies.For other information of the studies,5 (9.26％) of them was registered somewhere,the information on funding support was on 20 (37.04％)papers.Conclusions The description on most RCT papers were clear and complete,but close attention should be paid to the method of blindness and sample size determine.
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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.
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Objective:To evaluate quality of clinical trials about acupuncture and moxibustion treatment of hyperthyrodism in China. Methods:Literature of clinical trials of acupuncture and moxibustion treatment of hyperthyroidism were attained by computer and manual retrieval,and randomization,control,selection of study objects,comparability between groups,amount of samples, description and control of source of samples,criteria for diagnosis,application of blind method,criteria for assessment of therapeutic effects,statistical method,adverse effects,follow-up,and others in the literature were analyzed and evaluated by the randomized controlled test criteria and the clinical assessing method in Cochrane handbook of international Cochrane cooperation net.Results:In 63 papers,clinical randomized controlled tests of acupuncture and moxibustion treatment of hyperthyroidism only accounted for 22.2%,but with increasing tend year by year in recent years.Conclusion:Though acupuncture and moxibustion have been widely applied in prevention and treatment of hyperthyroidism,it could not provide evidences of higher reliability for clinical treatment due to less clinical randomized controlled tests and lower quality,which severely hinder testing and verifying of clinical therapeutic effects of acupuncture and moxibustion.It is proposed that multiple central and randomized controlled test should be made,so as to search for feasible acupuncture and moxibustion methods with definite therapeutic effect for hyperthyroidism,and provide basis for further systematical evaluation of acupuncture and moxibustion treatment of hyperthyroidism.