Article type
Year
Abstract
Background: To assess the quality of Randomized controlled trials (RCTs) relevant to diabetes mellitus and it's complication Published in Chinese medical journal to provide scientific basis in the benefit of improvement of clinical works.
Methods: Six Chinese medical journals in the years of 1995-1999 were hand searched and 94 RCTs for Diabetes mellitus and it's complications were identified from 250 issues of 30 volumes, the Journals included Chin Journal of Diabetes; Chin J of new drugs and clinical Remedies; Chin J of endocrine and metabolic; Chin J integrated Trad western Med; Chin J Internal Med on emergency treatment.
Results: In the recent 6 years. The numbers of RCTs were increased. Among the 94 trials 55.3% were with explicit inclusion criteria for subject selection 23.4% with exclusion criteria. Only 9 RCTs described the method for randomized allocation and no one trial had randomized concealment. Blindness and placebo control were used in 9 and 2 RCTs respectively. The average sample Sizes of Intervention group and control group were 32.3 1(11-669)cases and 28.7 1.05(6-707) cases separately statistical management was mainly assessed on the basis through X2 or t test clinical outcome assessment was made by the normalization of biochemical indicates , elimination of symptoms and sighs but none of them used relative risk reduction(RRR) ,absolute risk reduction (ARR),number needed to treat(NNT) or intention-to-treat analysis to evaluate treatment effects . Only one trial accounted for compliance of patients, and of 43% trials; the side effects or adverse drug reaction was observed, and none of them had follow-up.
Conclusions: More and More RCT for Diabetes mellitus and it's complication with small Mediate sample size were published in Chinese Medical literatures. But the quality of the RCTs is not high as placebo controlled and blinding was seldom used and adequate randomization and its concealment was not used correctly and rigorously. However, pseudo and quasi-randomization should be avoided. Therefore, clinicians should be further trained on clinical epidemiology in order to improve the quality of clinical trial, and the nation-wide and world-wide trials with multi -um centers? large-scale and long-term collaboration even with abroad should be made. Key words: Diabetes mellitus complication, Methodological Evaluation, Clinical trials.
Methods: Six Chinese medical journals in the years of 1995-1999 were hand searched and 94 RCTs for Diabetes mellitus and it's complications were identified from 250 issues of 30 volumes, the Journals included Chin Journal of Diabetes; Chin J of new drugs and clinical Remedies; Chin J of endocrine and metabolic; Chin J integrated Trad western Med; Chin J Internal Med on emergency treatment.
Results: In the recent 6 years. The numbers of RCTs were increased. Among the 94 trials 55.3% were with explicit inclusion criteria for subject selection 23.4% with exclusion criteria. Only 9 RCTs described the method for randomized allocation and no one trial had randomized concealment. Blindness and placebo control were used in 9 and 2 RCTs respectively. The average sample Sizes of Intervention group and control group were 32.3 1(11-669)cases and 28.7 1.05(6-707) cases separately statistical management was mainly assessed on the basis through X2 or t test clinical outcome assessment was made by the normalization of biochemical indicates , elimination of symptoms and sighs but none of them used relative risk reduction(RRR) ,absolute risk reduction (ARR),number needed to treat(NNT) or intention-to-treat analysis to evaluate treatment effects . Only one trial accounted for compliance of patients, and of 43% trials; the side effects or adverse drug reaction was observed, and none of them had follow-up.
Conclusions: More and More RCT for Diabetes mellitus and it's complication with small Mediate sample size were published in Chinese Medical literatures. But the quality of the RCTs is not high as placebo controlled and blinding was seldom used and adequate randomization and its concealment was not used correctly and rigorously. However, pseudo and quasi-randomization should be avoided. Therefore, clinicians should be further trained on clinical epidemiology in order to improve the quality of clinical trial, and the nation-wide and world-wide trials with multi -um centers? large-scale and long-term collaboration even with abroad should be made. Key words: Diabetes mellitus complication, Methodological Evaluation, Clinical trials.