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.
Objective To assess the effects and safety of vasodilators for sudden sensorineurial hearing loss (SSHL). Search strategy Electronic databases: MEDLINE from 1966, EMBASE from 1974, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database from 1989. Hand search: Five kinds of Chinese otolaryngology journals were searched. Literature references were checked intensively. Selection criteria Randomized controlled trials comparing vasodilators with placebo or other drugs in patients with SSHL. Data collection and analysis At least two reviewers independently assessed trials quality and extracted data. Main results Thirteen trials with 1 155 patients were eligible and included in the systematic review. Ten of the trials were from developed countries and them were from P. R. China. None of the four trials showed that the effects of vasodilators were better than placebo for SSHL. None of the seven trials showed that the effects of one kind of vasodilators were better than that of the other vasodilators. Two trials showed that other drugs, such as batroxobin and hypaque,were probably better than some vasodilators (dextran, papaverine, 654-2, danshen). Eight trials reported the side effects of vasodilators, such as pruritus, allergy, etc. Reviewers’ conclusions Base on the systematic review of current eligible randomized controlled trials, there is no evidence to prove that vasodilator therapy is better than placebo or other therapies for SSHL, or the effects of one kind of vasodilator are better than that of the other vasodilators. We can’t draw a reliable conclusion about the effects of vasodilators for SSHL at the moment. And we must pay attention to their potential adverse reactions.