11种地方性中医药期刊1995～2000年临床研究文献质量的初步分析

A Brief Study on the Quality of Clinical Trials in 11 Medical Journals of Traditional Chinese Medicine From 1995 to 2000

目的 对 1 1种地方性中医药期刊 1 995～ 2 0 0 0年中所发表的临床研究类文献进行分析 ,以了解中医药临床研究的现状和存在的问题。 方法 对 1 995～ 2 0 0 0年发表在《湖南中医杂志》等 1 1种地方性中医药期刊 (共 6 6卷、390期 )上的全部文章 ,采用手工逐期逐页鉴定 ,筛选出临床研究类文献 ,而后对其试验设计、随机方法、盲法、组间可比性描述、纳入排除标准、诊断标准、疗效判定指标明确与否 ,以及样本含量、统计方法、主要结果与不良结果的描述、随访和结论推荐与否等进行分析。 结果 该 1 1种期刊 6年间共发表了2 2 739篇临床研究 ,其中随机对照试验 (RCT) 1 4 1 6篇 (双盲 2 4篇 ,占RCT总数 1 6 9% ) ,占论文总数 6 2 3% ;非随机的对照试验 (CCT) 1 4 1篇 ,占论文总数 0 6 2 % ;RCT数量呈逐年上升趋势 ,并以消化系统疾病研究最多。在 1 4 1 6篇RCT中 ,对随机方法进行了描述的有 38篇 ,占 2 6 8% ;1 2 2 0篇有明确疗效判定指标 ,占86 1 6 % ;1 2 0 3篇有统计学方法描述 ,占 84 96 % ;设有可比性对照研究的共 934篇 ,占 6 5 96 % ;描述了诊断标准的有 82 8篇 ,占 5 8 4 7% ;1 97篇有纳入和排除标准 ,占RCT总数的 1 3 91 % ,仅有 89篇报告了不良反应 ,占RCT总数的 6 2 9%。

Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems.MethodsEleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method,described outcome, side effects, and follow up etc. were analyzed. ResultsIn the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method,934 (65.96%) had baseline comparison,828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria,finally only 89 (6.29%) reported side effects.ConclusionAlthough the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.