Article type
Year
Abstract
Background: Randomized Controlled Trials (RCTs) of traditional Chinese medicine (TCM) have been produced in large numbers. But the epidemiological characteristics, reporting detail, scientific validity is unknown.
Objectives: To provide the comprehensive information and guide the development of RCTs on TCM in China.
Methods: Chinese Biomedicine Literature Database, Chinese Scientific Journal Full-text Database and Chinese Journal Full-text Database were searched to December 2010. Search terms included 'stomach neoplasms', 'Traditional Chinese Medicine’ and 'RCTs' etc (MESH or EMTREE). Data were collected using an Excel form designed to examine the epidemiological and reporting detail. The CONSORT checklist was used to appraise the reporting quality.
Results: A total of 102 randomized controlled trials (RCTs) published in 72 periodicals were included. Only 41.67% were published in specialty journals, 21.57% were included in Chinese Science Citation Database as cited by journals. Two studies reported informed consent. Two studies stated 'randomization’ in title. 52.94% and 11.76% of trials reported the specific inclusion and exclusion criteria respectively. None of the studies stated the method of sample size calculation. Only 17 trials reported how the random allocation sequence was generated. A participant flow chart was not described in any of the trial reports. Only two articles stated the limitations of the study. None of the studies reported registration and protocol. Fund sources were not reported in 82.35% trials.
Conclusions: A large number of RCTs were published in China, but the reporting information was insufficient and the scientific validity worrying. We suggest three measures to improve the quality of clinical trials in China. Firstly, enhancing the clinical trials registration policy. Secondly, the Chinese Medical Journal should endorse the CONSORT statement in their 'Instructions to authors'. Finally, medical schools should introduce a registration policy and reporting guidelines as soon as possible.
Objectives: To provide the comprehensive information and guide the development of RCTs on TCM in China.
Methods: Chinese Biomedicine Literature Database, Chinese Scientific Journal Full-text Database and Chinese Journal Full-text Database were searched to December 2010. Search terms included 'stomach neoplasms', 'Traditional Chinese Medicine’ and 'RCTs' etc (MESH or EMTREE). Data were collected using an Excel form designed to examine the epidemiological and reporting detail. The CONSORT checklist was used to appraise the reporting quality.
Results: A total of 102 randomized controlled trials (RCTs) published in 72 periodicals were included. Only 41.67% were published in specialty journals, 21.57% were included in Chinese Science Citation Database as cited by journals. Two studies reported informed consent. Two studies stated 'randomization’ in title. 52.94% and 11.76% of trials reported the specific inclusion and exclusion criteria respectively. None of the studies stated the method of sample size calculation. Only 17 trials reported how the random allocation sequence was generated. A participant flow chart was not described in any of the trial reports. Only two articles stated the limitations of the study. None of the studies reported registration and protocol. Fund sources were not reported in 82.35% trials.
Conclusions: A large number of RCTs were published in China, but the reporting information was insufficient and the scientific validity worrying. We suggest three measures to improve the quality of clinical trials in China. Firstly, enhancing the clinical trials registration policy. Secondly, the Chinese Medical Journal should endorse the CONSORT statement in their 'Instructions to authors'. Finally, medical schools should introduce a registration policy and reporting guidelines as soon as possible.