Article type
Year
Abstract
Introduction/Objective: To establish baseline data about randomized controlled trials (RCTs) relevant to viral hepatitis in China in the past 20 years.
Methods: Page by page handsearching was used in identifying RCT in controlled trials published in 9 Chinese journals from 1978-1997. The definitions of RCT and CCT were strictly based on "The Cochrane Collaboration Handbook (1997)".
Results: 178 RCTs was collected from 454 controlled trials, identified in total 1123 issues of 134 volumes. The proportion of RCTs was 39.2%, among which double blind trials accounted for 10.1% (18/178). Since 1978, the proportion was progressively increased every five years, which were 15.4% (2/13) in 1978-1982, 26.2% (11/42) in 1983-1987, 40.4% (46/114) in 1988-1992 and 41.8% (119/285) in 1993-1997 respectively. The viral hepatitis studied included hepatitis A (5 pieces), B(105), C(10), D(l), E(2) and the rest untyped (59). Clinical types contained acute (18), chronic (119), severe (10) hepatitis, HBV carriers (5), cholestatic hepatitis (2), liver cirrhosis associated with hepatitis (7) and untyped. The medicines on trial consisted of traditional Chinese medicines (48.3%), western medicines (28.1%) and integrated traditional & western medicines (23.6%).
Discussion: Although the quality of clinical trials in viral hepatitis has improved with the spread of clinical epidemiology, more efforts should be made in the management of viral hepatitis so as to explore effective ones from traditional Chinese medicines and pharmacology.
Methods: Page by page handsearching was used in identifying RCT in controlled trials published in 9 Chinese journals from 1978-1997. The definitions of RCT and CCT were strictly based on "The Cochrane Collaboration Handbook (1997)".
Results: 178 RCTs was collected from 454 controlled trials, identified in total 1123 issues of 134 volumes. The proportion of RCTs was 39.2%, among which double blind trials accounted for 10.1% (18/178). Since 1978, the proportion was progressively increased every five years, which were 15.4% (2/13) in 1978-1982, 26.2% (11/42) in 1983-1987, 40.4% (46/114) in 1988-1992 and 41.8% (119/285) in 1993-1997 respectively. The viral hepatitis studied included hepatitis A (5 pieces), B(105), C(10), D(l), E(2) and the rest untyped (59). Clinical types contained acute (18), chronic (119), severe (10) hepatitis, HBV carriers (5), cholestatic hepatitis (2), liver cirrhosis associated with hepatitis (7) and untyped. The medicines on trial consisted of traditional Chinese medicines (48.3%), western medicines (28.1%) and integrated traditional & western medicines (23.6%).
Discussion: Although the quality of clinical trials in viral hepatitis has improved with the spread of clinical epidemiology, more efforts should be made in the management of viral hepatitis so as to explore effective ones from traditional Chinese medicines and pharmacology.