Wong W C W, Lee A, Lam A T, Li K T, Leung C Y M, Leung P C, Wong E L Y, Tang J L
Department of Community and Family Medicine, the Chinese University of Hong Kong, Hong Kong SAR, China.
Cough. 2006 Jun 22;2:5. doi: 10.1186/1745-9974-2-5.
Rigorous scientific and well-designed clinical trials to evaluate the effect of traditional Chinese medicine (TCM) is lacking. We, therefore, designed this study to evaluate the effectiveness of a commonly used TCM preparation in treating acute cough of uncomplicated URTI in adults and to search for a safe, effective and affordable alternative treatment for this common condition.
A randomised, double-blinded, placebo-control study comparing this TCM preparation with a placebo was conducted in 82 patients who attended the Family Medicine Training Centre, Prince of Wales Hospital, Hong Kong between November and December, 2003. The TCM herbal preparation includes nine commonly used TCM herbs for cough such as chuanbei, fangfeng, jiegeng, gancao and baibu (see Table 1). The treatment lasted for 5 days and patients were followed-up for another 6 days. Patients were asked to fill in a cough score and validated Leicester cough questionnaire (LCQ).
62 patients (75.6%) had completed the trial and no adverse effects were reported. Both intervened and control groups had improved in cough score and LCQ in the follow-up period, despite no overall statistical significance was observed in the differences of scores between the two groups. Women taking TCM had significantly fewer problems with sputum production (p = 0.03) and older subjects (>35 years of age) reported a significant improvement in hoarseness (p = 0.05) when compared to those using placebo.
TCM was well-tolerated and received among the Hong Kong Chinese population. This TCM preparation appeared to have some benefits in the treatment of cough. Future research on TCM should concentrate more on commonly encountered conditions such as UTRI and cough. Our experience on the sensitivity of assessment tools used in detecting subtle differences in an otherwise self-limiting illness and clinical trial methodology when applying the underlying theory of how TCM works in disease management was invaluable.
缺乏严格科学且设计良好的临床试验来评估中药的疗效。因此，我们设计了本研究，以评估一种常用中药制剂治疗成人单纯上呼吸道感染所致急性咳嗽的有效性，并为这一常见病症寻找一种安全、有效且经济实惠的替代疗法。
2003年11月至12月期间，在香港威尔士亲王医院家庭医学培训中心就诊的82例患者中，开展了一项将这种中药制剂与安慰剂进行比较的随机、双盲、安慰剂对照研究。该中药草药制剂包含九种常用的止咳中药，如川贝、防风、桔梗、甘草和百部（见表1）。治疗持续5天，并对患者进行另外6天的随访。要求患者填写咳嗽评分表和经过验证的莱斯特咳嗽问卷（LCQ）。
62例患者（75.6%）完成了试验，且未报告不良反应。尽管两组之间的评分差异未观察到总体统计学意义，但在随访期间，干预组和对照组的咳嗽评分和LCQ均有所改善。与使用安慰剂的患者相比，服用中药的女性咳痰问题明显较少（p = 0.03），年龄较大的受试者（>35岁）声音嘶哑有显著改善（p = 0.05）。
香港华人对中药耐受性良好且接受度较高。这种中药制剂在治疗咳嗽方面似乎有一些益处。未来对中药的研究应更多地集中在诸如上呼吸道感染和咳嗽等常见病症上。我们在检测自限性疾病细微差异时所用评估工具的敏感性以及在应用中药治疗疾病的基础理论时的临床试验方法方面的经验非常宝贵。
