Article type
Year
Abstract
Background:
Trial registration is considered to be an important measure to improve the quality of clinical trials, as well as promote the transparency. There is growing recognition that the quality of trials of traditional Chinese medicine (TCM) has become a focus internationally, but the registered status of trials is unclear to date.
Objectives:
To describe and summarize the current status of and existing problems with registered trials of TCM on the Chinese Clinical Trial Registry (ChiCTR).
Methods:
All trials on ChiCTR were searched and screened on 17 December 2013. The most extracted information included study design, date of releasing the registration number, registration status, sources of funding, target disease and type of interventions.
Results:
Trials of TCM made up 15.46% (558/3610) of all registered trials on ChiCTR. The number increased from eight in 2007 to 193 in 2013. Prospective registration accounted for 79.57% (444/558). Registered trials of TCM focused on cardiovascular and cerebrovascular diseases (118, 21.15%), digestive system disease (61, 10.93%), musculoskeletal diseases (55, 9.86%), respiratory problems (53, 9.50%), metabolic/endocrine diseases (39, 6.99%) and gynecological diseases (39, 6.99%). There were 449 randomized controlled trials (RCTs), and interventions were mainly TCM taken by oral administration (253, 45.34%), non-pharmaceutical therapies including acupuncture, massage and moxibustion (140, 25.09%), and TCM injection (28, 1.43%). The majority of trials were funded by government departments such as the Ministry of Science and Technology and Finance (207, 37.10%).
Conclusions:
The number of registered trials of TCM has increased with more funding from the government. However, this number is far less than the number of randomized controlled trials published in China. Full implementation of clinical trial registration will require more collaboration from participants in trials of TCM. Sufficient attention has been paid to chronic non-communicable diseases, which is the dominant therapeutic area of TCM.
Trial registration is considered to be an important measure to improve the quality of clinical trials, as well as promote the transparency. There is growing recognition that the quality of trials of traditional Chinese medicine (TCM) has become a focus internationally, but the registered status of trials is unclear to date.
Objectives:
To describe and summarize the current status of and existing problems with registered trials of TCM on the Chinese Clinical Trial Registry (ChiCTR).
Methods:
All trials on ChiCTR were searched and screened on 17 December 2013. The most extracted information included study design, date of releasing the registration number, registration status, sources of funding, target disease and type of interventions.
Results:
Trials of TCM made up 15.46% (558/3610) of all registered trials on ChiCTR. The number increased from eight in 2007 to 193 in 2013. Prospective registration accounted for 79.57% (444/558). Registered trials of TCM focused on cardiovascular and cerebrovascular diseases (118, 21.15%), digestive system disease (61, 10.93%), musculoskeletal diseases (55, 9.86%), respiratory problems (53, 9.50%), metabolic/endocrine diseases (39, 6.99%) and gynecological diseases (39, 6.99%). There were 449 randomized controlled trials (RCTs), and interventions were mainly TCM taken by oral administration (253, 45.34%), non-pharmaceutical therapies including acupuncture, massage and moxibustion (140, 25.09%), and TCM injection (28, 1.43%). The majority of trials were funded by government departments such as the Ministry of Science and Technology and Finance (207, 37.10%).
Conclusions:
The number of registered trials of TCM has increased with more funding from the government. However, this number is far less than the number of randomized controlled trials published in China. Full implementation of clinical trial registration will require more collaboration from participants in trials of TCM. Sufficient attention has been paid to chronic non-communicable diseases, which is the dominant therapeutic area of TCM.