Article type
Year
Abstract
Objective: To assess the quality of clinical trials relevant to Diabetes Mellitus and it's complications published in Chinese Medical Journal to provide scientific basis in the benefit of improvement of clinical works.
Methods: Seven Chinese Key Medical Journal in the years of 1990-1999 were hand-searched and 95 clinical trails for Diabetes Mellitus and it's complications were identified from 536 issues of 56 volumes. The journal included: Chinese Journal of Endocrinology and Metabolism; Chinese Journal of Internal Medicine; Chinese Journal of Nephrology; Chinese Journal of Geriatrics; Chinese Journal of Ophthalmology; Chinese Journal of Pediatrics; National Medical Journal of China. The numbers of the literature of each year distribution are: 1990(7), 1991(10), 1992(10), 1993(8), 1994(4), 1995(11), 1996(14), 1997(6), 1998(16), 1999(9). The investigation content: Design type of clinical trials; Diagnosis criteria; Therapeutic effectively criteria; Follow-up; Drug adverse reaction.
Results: In the recently 10 years, 95 issues of clinical trials of Diabetes mellitus have published in seven keys Chinese Medical Journal. Among the 95 trials were 38.9% RCT (Randomized Controlled Trial) and 16.8% Non-RCT, and 16.8% No-controlled-trial. Among the RCT there were only 4 issues described the method for randomized allocation; Blindness and Double blindness were 9 and 5 issues respectively. 50.6% have diagnosis criteria, 62.1% were with explicit inclusion criteria for subject selection and 8.4% with exclusion criteria. 55.8% clinical trials set up the controlled group. Among there were with 37.7% drug controlled group and 24.5% with placebo. Almost 96.8% evaluation criteria for therapeutic effect were not used National or WHO criteria. There were 44.2% trials reported drug adverse reaction or drug side effect, and 15.8% did follow-up.
Conclusion: The quality of clinical trials especial RCTs is not high as placebo controlled and blindness were seldom used and adequate randomization and it's concealment were not used correctly and rigorously. Therefore, clinicians should be used correctly RCTs method in order to improve the quality of clinical trials, after that we can make the evaluation for drug and medical apply on the right way.
Methods: Seven Chinese Key Medical Journal in the years of 1990-1999 were hand-searched and 95 clinical trails for Diabetes Mellitus and it's complications were identified from 536 issues of 56 volumes. The journal included: Chinese Journal of Endocrinology and Metabolism; Chinese Journal of Internal Medicine; Chinese Journal of Nephrology; Chinese Journal of Geriatrics; Chinese Journal of Ophthalmology; Chinese Journal of Pediatrics; National Medical Journal of China. The numbers of the literature of each year distribution are: 1990(7), 1991(10), 1992(10), 1993(8), 1994(4), 1995(11), 1996(14), 1997(6), 1998(16), 1999(9). The investigation content: Design type of clinical trials; Diagnosis criteria; Therapeutic effectively criteria; Follow-up; Drug adverse reaction.
Results: In the recently 10 years, 95 issues of clinical trials of Diabetes mellitus have published in seven keys Chinese Medical Journal. Among the 95 trials were 38.9% RCT (Randomized Controlled Trial) and 16.8% Non-RCT, and 16.8% No-controlled-trial. Among the RCT there were only 4 issues described the method for randomized allocation; Blindness and Double blindness were 9 and 5 issues respectively. 50.6% have diagnosis criteria, 62.1% were with explicit inclusion criteria for subject selection and 8.4% with exclusion criteria. 55.8% clinical trials set up the controlled group. Among there were with 37.7% drug controlled group and 24.5% with placebo. Almost 96.8% evaluation criteria for therapeutic effect were not used National or WHO criteria. There were 44.2% trials reported drug adverse reaction or drug side effect, and 15.8% did follow-up.
Conclusion: The quality of clinical trials especial RCTs is not high as placebo controlled and blindness were seldom used and adequate randomization and it's concealment were not used correctly and rigorously. Therefore, clinicians should be used correctly RCTs method in order to improve the quality of clinical trials, after that we can make the evaluation for drug and medical apply on the right way.