梁传余 1 , 陈娜 2 , 龚允 2
  • LIANG Chuan-yu1; CHENG Na2; GONG Yun2;
1. Department of Otorhinolaryngology; West China Hospital; SiChuan University; Chengdu 610041; China2. Department oj Otnrhinolaryngalogy; The People s Hospital oj Sichuan Province; China
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Objective 　To evaluate the quality of randomized controlled trials in otorhinolaryngology in China and provide to comprehend the possibility of its contribution in providing reliable, evidence in clinical practice; thus providing evidence to elevate the clinical treatment level.
Methods 　Five Chinese clinical otorhinolaryngology journals were searched and randomized controlled trials were identified and analyzed according to the standards of evidence-based medicine.
Results 　Two hundred and eighty seven issues were referred to and eighty-one randomized controlled trials were identified and analyzed. Of these randomized controlled trials, 34.57% (28/81) had definite diagnostic standards, 38.27% (31/81) had inclusion standards and 33.33% (27/81) had exclusion standards; only 1.23% (1/81) got the approval of the participants; 40.74% (33/81) had moderate sample size; 3.70% (3/81) had large sample size and no one mentioned sample size estimation; 81.48% (66/81) didn’t report the method of randomization and 38.27% (31/81) had baseline comparison; 18.52% (15/81) didn’t define the control interventions and 8.64% (7/81) even didn’t explicate the experimental interventions; 32.10% (26/81) used blank comparison; 86.42% (70/81) didn’t use blindness; 37.04% (30/81) didn’t mention the adverse effects; 23.46% (19/81) used accredited standards to evaluate the outcomes; l l.11% (9/81) mentioned the loss of participants and only 1.23% (1/81) treated the loss with statistics methods.
Conclusions 　The quantity and quality of the otorbinolaryngologic randomized controlled trials in present review can not meet the clinical need. Higher quality of randomized controlled trials are required to improve the level of prevention and the treatment of otorhinolaryngologic diseases.

Citation： 梁传余,陈娜,龚允. Analysis of randomized controlled trials on otorhinolaryngologic diseases in China. Chinese Journal of Evidence-Based Medicine, 2001, 01(3): 158-163. doi: Copy

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