Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China.
J Ethnopharmacol. 2012 Apr 10;140(3):555-67. doi: 10.1016/j.jep.2012.01.031. Epub 2012 Feb 9.
The clinical use of Chinese herbal medicine granules is gradually increasing. However, there is still no systematic review comparing the effectiveness and safety of granules with the more traditional method of herbal decoctions.
A literature search was conducted using China National Knowledge Infrastructure Databases (CNKI), Chinese Science and Technology Periodical Database (VIP), China Biomedical Database web (CBM), Wanfang Database, PubMed, and the Cochrane Library until March 10, 2011. Clinical controlled trials (CCTs) including randomized trials (RCTs) comparing the effectiveness and safety between Chinese herbal medicine granules and decoction were included. Two authors conducted the literature searches, and extracted data independently. The assessment of methodological quality of RCTs was based on the risk of bias from the Cochrane Handbook, and the main outcome data of trials were analyzed by using RevMan 5.0 software. Risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) were used as effect measure.
56 clinical trials (n=9748) including 42 RCTs and 14 CCTs were included, and all trials were conducted in China and published in Chinese literature. 40 types of diseases and 15 syndromes of traditional Chinese medicine (TCM) were reported. Granules were provided by pharmaceutical companies in 13 trials. The included RCTs were of generally low methodological quality: 7 trials reported adequate randomization methods, and 2 of these reported allocation concealment. 10 trials used blinding, of which 5 trials used placebo which were delivered double blind (blinded participants and practitioners). 98.2% (55/56) of studies showed that there was no significant statistical difference between granules and decoctions of Chinese herbal medicine for their effectiveness. No severe adverse effects in either group were reported.
Due to the poor methodological quality of most of the included trials, it is not possible to reach a definitive conclusion whether both Chinese herbal medicine granules and decoctions have the same degree of effectiveness and safety in clinical practice, but this preliminary evidence supports the continued use of granules in clinical practice and research. Standardization of granules and further more rigorous pharmacological, toxicological and clinical studies are needed to demonstrate the equivalence with decoctions.
中草药颗粒的临床应用正在逐渐增多。然而，目前仍然没有系统评价比较颗粒剂与传统草药煎剂的疗效和安全性。
检索中国期刊全文数据库（CNKI）、中文科技期刊全文数据库（VIP）、中国生物医学文献数据库（CBM）、万方数据库、PubMed 和 Cochrane 图书馆，检索时间截止到 2011 年 3 月 10 日，收集比较中草药颗粒剂与煎剂疗效和安全性的临床对照试验（CCT），包括随机对照试验（RCT）。由 2 位作者独立筛选文献、提取资料并评价纳入研究的方法学质量。采用 RevMan 5.0 软件进行统计分析，二分类变量采用风险比（RR）作为效应指标，连续性变量采用均数差（MD）作为效应指标，各效应量均给出 95%可信区间（CI）。
共纳入 56 个临床试验（n=9748），其中 42 个 RCT 和 14 个 CCT。试验均在中国进行，且均为中文发表。涉及疾病 40 种，中医证候 15 种。13 个试验的颗粒剂由制药公司提供。纳入的 RCT 方法学质量总体较低：7 个试验报道了随机分组方法，但仅 2 个试验报道了分配隐藏；10 个试验采用了盲法，其中 5 个试验采用了安慰剂双盲（盲法对象和实施者）。56 个研究中 98.2%（55/56）的研究报道颗粒剂与中药煎剂的疗效无显著统计学差异。两组均未报道严重不良反应。
由于大多数纳入研究的方法学质量较低，目前尚不能确定中草药颗粒剂与煎剂在临床实践中是否具有相同的疗效和安全性，但这一初步证据支持颗粒剂在临床实践和研究中的继续应用。需要对颗粒剂进行标准化，并开展更严格的药理学、毒理学和临床研究，以证明其与煎剂等效。
