The reporting quality, scientific rigor, and ethics of randomized placebo-controlled trials of traditional Chinese medicine compound formulations and the differences between Chinese and non-Chinese trials

Zhong, Yunqing; Fu, Juanjuan; Liu, Xuemei; Diao, Xiang; Mao, Bing; Fan, Tao; Yang, Hongmei; Liu, Guanjian; Zhang, Wenbin

doi:10.1016/j.curtheres.2010.02.001

Cited by 35 publications

(22 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…While this trend does reflect editorial interest of higher ranking journals on conventional care (Turner et al, 2013) and possibility concerns over quality of primary studies (Shang et al, 2007;Wang et al, 2007;Zhong et al, 2010Zhong et al, , 2011, methodological shortcomings among the included MA could be another reason for their lower IF (Fleming et al, 2014). While it is acknowledged that IF is only one of the indicators reflecting research quality, our results demonstrated that MA on CHM trials should improve in these areas: first, protocol of non-Cochrane MA should be registered and published in PROSPERO, such that editors, peer reviewers and users of MA can directly assess the possibility of reporting bias (Booth et al, 2012).…”

Section: Table 4bmentioning

confidence: 96%

Are meta-analyses of Chinese herbal medicine trials trustworthy and clinically applicable? A cross-sectional study

Chung

et al. 2015

Journal of Ethnopharmacology

View full text Add to dashboard Cite

Section: Table 4bmentioning

confidence: 96%

Are meta-analyses of Chinese herbal medicine trials trustworthy and clinically applicable? A cross-sectional study

Chung

et al. 2015

Journal of Ethnopharmacology

View full text Add to dashboard Cite

“…Chinese herbal medicine has been widely used to treat colds in China for a long time and has gradually been accepted and applied in many other countries. However, evidence-based efficacy and safety data on Chinese herbs are limited, because the studies have used small sample sizes or are of poor quality [26]. …”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial

Wang

Jiang

et al. 2017

Trials

Self Cite

View full text Add to dashboard Cite

BackgroundThe common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, based on the theory of traditional Chinese medicine (TCM), with the objective of evaluating the efficacy and safety of Lian-Ju-Gan-Mao capsules (LJGMC), a Chinese patent medicine, compared with placebo in patients suffering from the common cold with wind-heat syndrome (CCWHS).Methods/designThis is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. A total of 240 patients will be recruited and randomly assigned to a high-dose group, medium-dose group, low-dose group, and placebo-matched group in a 1:1:1:1 ratio. The treatment course is 3 consecutive days, with a 5-day follow-up. The primary outcome is time to all symptoms’ clearance. Secondary outcomes include time to the disappearance of primary symptoms and each secondary symptom, time to fever relief, time to fever clearance, and change in TCM symptom and sign scores.DiscussionThis trial is a well-designed study according to principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high-quality evidence on the efficacy and safety of LJGMC in treating CCWHS and help to optimize the dose for the next phase III clinical trial. Moreover, the protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM.Trial registrationChinese Clinical Trial Registry, ChiCTR-IPR-15006504. Registered on 4 June 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1747-9) contains supplementary material, which is available to authorized users.

show abstract

“…An unregulated landscape can be seen in traditional Chinese medicine (TCM) clinical trials, where over 60% of studies did not adhere to the standard Consolidated Standard of Reporting Trials requirements [28]. Training on proper record keeping and informed consent processes must therefore be rigorous and strictly implemented in order for Chinese hospitals and CROs to be competitive for domestic and international drug development.…”

Section: Scientific and Technical Considerations In Research And Clinmentioning

confidence: 99%

Challenges in orphan drug development and regulatory policy in China

Cheng

Xie

2017

Orphanet J Rare Dis

View full text Add to dashboard Cite

While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements have begun to support rare disease patients and facilitate drug discovery through research. Recently, the Chinese FDA set new regulatory guidelines for drugs being developed in China, including an expedited review process for life-saving treatments. In this review, we discuss the effects of these new policy changes on and suggest potential solutions to innovate orphan drug development in China.

show abstract

The reporting quality, scientific rigor, and ethics of randomized placebo-controlled trials of traditional Chinese medicine compound formulations and the differences between Chinese and non-Chinese trials

Cited by 35 publications

References 27 publications

Are meta-analyses of Chinese herbal medicine trials trustworthy and clinically applicable? A cross-sectional study

Are meta-analyses of Chinese herbal medicine trials trustworthy and clinically applicable? A cross-sectional study

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial

Challenges in orphan drug development and regulatory policy in China

Contact Info

Product

Resources

About