Article type
Year
Abstract
Objective: To find out randomized controlled trials (RCTs) from clinical trials on infectious diseases published in "Chinese Journal of Infectious Diseases" in 1983-1997, so as to establish baseline data in this fields in China.
Methods: Page by page handsearching was used in identifying RCTs amongst clinical trials from start publication (Jan., 1983) to Dec., 1997 of "Chinese Journal of Infectious Diseases", which amounted to 60 issues and 15 volumes. The definitions of RCT and controlled clinical trial (CCT) were strictly based on "The Cochrane Collaboration Handbook (version 3.0.2, Sep., 1997)".
Results: 48 RCTs were identified from 101 clinical trials, with a percentage of 47.5. Among 48 RCTs, 5 were double-blinded. The percentage of RCTs was varied by every five-year period, ie. 40.9% (9/22) in 1983-1987, 38.2% (13/34) with 2 double-blind in 1988-1992, and 57.8% (26/45) with 3 double-blind in 1993-1997. The major infectious diseases studied in 48 RCTs included 16 viral hepatitis, 9 hemorrhagic fever with renal syndrome, 5 typhoid fever, 4 bacterial infection, 3 bacillary dysentery, 3 epidemic encephalitis and 3 clonorchiasis sinensis.
Discussion: The quality of clinical trials on infectious diseases in China still has to be improved. More RCT and double-blind method should be used in design of clinical trial.
Methods: Page by page handsearching was used in identifying RCTs amongst clinical trials from start publication (Jan., 1983) to Dec., 1997 of "Chinese Journal of Infectious Diseases", which amounted to 60 issues and 15 volumes. The definitions of RCT and controlled clinical trial (CCT) were strictly based on "The Cochrane Collaboration Handbook (version 3.0.2, Sep., 1997)".
Results: 48 RCTs were identified from 101 clinical trials, with a percentage of 47.5. Among 48 RCTs, 5 were double-blinded. The percentage of RCTs was varied by every five-year period, ie. 40.9% (9/22) in 1983-1987, 38.2% (13/34) with 2 double-blind in 1988-1992, and 57.8% (26/45) with 3 double-blind in 1993-1997. The major infectious diseases studied in 48 RCTs included 16 viral hepatitis, 9 hemorrhagic fever with renal syndrome, 5 typhoid fever, 4 bacterial infection, 3 bacillary dysentery, 3 epidemic encephalitis and 3 clonorchiasis sinensis.
Discussion: The quality of clinical trials on infectious diseases in China still has to be improved. More RCT and double-blind method should be used in design of clinical trial.