Article type
Year
Abstract
Background: Randomized controlled trials (RCTs) of gastric cancer treated with traditional Chinese medicine (TCM) have become increasingly popular in China and have been published in large numbers. However, the quality of reporting in these RCTs was unknown.
Objectives: To assess the reporting quality of RCTs of gastric cancer treated with TCM.
Methods: We searched the Chinese Biomedicine Literature Database (CBM), Chinese Scientific Journal Full-text Database (CSJD), Chinese Journal Full-text Database (CJFD), and Wangfa database to the end of June 2010. The search terms included 'Traditional Chinese Medicine’ and 'Chinese herbs' (MESH or EMTREE), 'Gastric Cancer’, 'Stomach Cancer’ and 'Stomach Neoplasms' (MESH or EMTREE). We also searched using the Google search engine using the snowballing method. The reporting quality of included studies was evaluated based on the CONSORT 2010 statement.
Results: A total of 102 RCTs were included. Only 12 (11.8 %) RCTs included studies that reported specific inclusion and exclusion criteria. Some important methodological components of RCTs, such as: sample size calculation (0 %), randomization sequence (16.7 %), allocation concealment (0.0 %) and blinding (2.0 %), were incompletely reported. Only half of the trials (54.9 %) defined the criteria of subjective measures, and none of them registered in any clinical trials registry platform or agency.
Conclusions: Although many such RCTs have been published, the reporting quality is troubling. As a potential key source of information for clinicians and researchers, not only were many of these RCTs incomplete, some contained mistakes or were misleading. Focusing on improving the quality of RCTs of TCM, rather than continuing to publish them in great quantity, is urgently needed in order to increase the value of these studies.
Objectives: To assess the reporting quality of RCTs of gastric cancer treated with TCM.
Methods: We searched the Chinese Biomedicine Literature Database (CBM), Chinese Scientific Journal Full-text Database (CSJD), Chinese Journal Full-text Database (CJFD), and Wangfa database to the end of June 2010. The search terms included 'Traditional Chinese Medicine’ and 'Chinese herbs' (MESH or EMTREE), 'Gastric Cancer’, 'Stomach Cancer’ and 'Stomach Neoplasms' (MESH or EMTREE). We also searched using the Google search engine using the snowballing method. The reporting quality of included studies was evaluated based on the CONSORT 2010 statement.
Results: A total of 102 RCTs were included. Only 12 (11.8 %) RCTs included studies that reported specific inclusion and exclusion criteria. Some important methodological components of RCTs, such as: sample size calculation (0 %), randomization sequence (16.7 %), allocation concealment (0.0 %) and blinding (2.0 %), were incompletely reported. Only half of the trials (54.9 %) defined the criteria of subjective measures, and none of them registered in any clinical trials registry platform or agency.
Conclusions: Although many such RCTs have been published, the reporting quality is troubling. As a potential key source of information for clinicians and researchers, not only were many of these RCTs incomplete, some contained mistakes or were misleading. Focusing on improving the quality of RCTs of TCM, rather than continuing to publish them in great quantity, is urgently needed in order to increase the value of these studies.