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[Analysis of randomized controlled trials on otorhinolaryngological diseases in China]
1Department of Otorhinolaryngology, West China Hospital, Sichuan University, Chengdu 610041, China. lcyj@mail.sc.cninfo.net
Objective:
To evaluate the quality of randomized controlled trials (RCT) in otorhinolaryngology in China and offer evidence for the improvement of RCT.
Methods:
Five kinds of Chinese journals of clinical otorhinolaryngology were searched, and RCTs 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 RCTs were finally identified and analyzed. Of these RCTs, 34.57% (28/81) had definite diagnostic standards, 38.27% (31/81) had including standards and 33.33% (27/81) had excluding 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 non of them 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 intervention; 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; 11.11% (9/81) mentioned the loss of following-up and only 1.23% (1/81) treated the loss with statistics methods.
Conclusion:
The quantity and quality of otorhinolaryngological RCTs couldn't meet the clinical need. More high quality RCTs are required to improve the level of prevention and cure of otorhinolaryngologic diseases.