Li Guanhong, Cai Linli, Jiang Hongli, Dong Shoujin, Fan Tao, Liu Wei, Xie Li, Mao Bing
Altern Ther Health Med. 2015 Nov-Dec;21(6):48-57.
The common cold is one of the most frequent acute illnesses of the respiratory tract, affecting all age groups. The compound formulas of traditional Chinese medicine (TCM) are frequently used to treat the common cold in China and other parts of the world. Until now, however, the efficacy and safety of compound formulas of TCM for the common cold, studied in comparison with placebos, have not been systematically reviewed.
This literature review intended to assess existing evidence of the effectiveness and safety of compound formulas of TCM for the common cold.
Randomized, controlled trials (RCTs) comparing compound formulas of TCM with placebos in treating the common cold were included, regardless of publication status. The research team searched the Cochrane Library, PubMed, Embase, the Chinese Biomedical Literature Database, the Chinese Scientific and Technological Periodical Database, the Chinese National Knowledge Infrastructure and the Wangfang Database from their inceptions to December 2013. The team also searched Web sites listing ongoing trials and contacted experts in the field and relevant pharmaceutical companies to locate unpublished materials.
Two review authors independently extracted data and assessed the methodological quality of included studies, using the Cochrane risk of bias tool.
A total of 6 randomized, double-blind, placebo-controlled trials involving 1502 participants were included. Most trials had a low risk of bias. Five were conducted in mainland China and 1 in Hong Kong; 5 were multicenter clinical trials and 1 was a single-center trial; 4 were published in Chinese and 2 were published in English. Compound formulas of TCM were superior to placebos in reducing disease symptoms, inducing recovery from a TCM syndrome, and increasing quality of life. In addition, the formulas were superior in shortening the duration of the main symptoms, the amount of time for a decline in temperature of at least 0.5°C to occur, and the duration of any fever. The team did not perform a summary meta-analysis due to clinical heterogeneity. No serious adverse event (AE) occurred in either the treatment or the control groups.
This systematic review indicated that compound formulas of TCM, compared with placebo, can provide benefits to patients with the common cold, with no serious side effects having been identified in the included trials. However, due to the small number of included studies and of participants and the unclear risk of some biases in the included studies, more high-quality, large-scale RCTs are still warranted to clarify fully the effectiveness and safety of compound formulas of TCM in treating the common cold.
普通感冒是呼吸道最常见的急性疾病之一，影响所有年龄组。中药复方在中国和世界其他地区常用于治疗普通感冒。然而，迄今为止，与安慰剂相比，中药复方治疗普通感冒的疗效和安全性尚未得到系统评价。
本综述旨在评估中药复方治疗普通感冒有效性和安全性的现有证据。
纳入比较中药复方与安慰剂治疗普通感冒的随机对照试验（RCT），无论其发表状态如何。研究团队检索了考克兰图书馆、PubMed、Embase、中国生物医学文献数据库、中国科技期刊数据库、中国知网和万方数据库，检索时间从建库至2013年12月。该团队还检索了列出正在进行试验的网站，并联系了该领域的专家和相关制药公司以查找未发表的资料。
两位综述作者独立提取数据，并使用考克兰偏倚风险工具评估纳入研究的方法学质量。
共纳入6项随机、双盲、安慰剂对照试验，涉及1502名参与者。大多数试验的偏倚风险较低。5项试验在中国大陆进行，1项在香港进行；5项为多中心临床试验，1项为单中心试验；4项以中文发表，2项以英文发表。中药复方在减轻疾病症状、促使中医证候恢复以及提高生活质量方面优于安慰剂。此外，该复方在缩短主要症状持续时间、体温至少下降0.5°C所需时间以及任何发热的持续时间方面更具优势。由于临床异质性，研究团队未进行汇总Meta分析。治疗组和对照组均未发生严重不良事件。
本系统评价表明，与安慰剂相比，中药复方可为普通感冒患者带来益处，纳入试验中未发现严重副作用。然而，由于纳入研究和参与者数量较少，且纳入研究中一些偏倚风险不明确，仍需要更多高质量、大规模的RCT来充分阐明中药复方治疗普通感冒的有效性和安全性。
