美国国立健康研究院(NIH)资助的针灸临床研究内容与特点

近年来,美国国立健康研究院(National Institute of Health)对不少针灸临床研究进行了资助。在所资助的60项针灸临床研究中,美国本土的研究有39项,加拿大2项,欧洲7项,中东4项,东南亚8项,中国大陆的复旦大学有2项。有些与手术后或化疗后的病症有关,如幻肢痛,结肠切除术后、化疗后的慢性疲乏、防止放疗后的口腔干燥,减轻手术后的伤口疼,减轻放疗或化疗后的恶心呕吐,减轻手术后的肠梗阻等;有些与疼痛有关,如关节炎、癌症、手术后的疼痛管理等;有与心理精神疾病相关的,如儿童的孤独症,成人的药物滥用等;也有与妇女疾病有关的,如痛经、非周期性乳腺疼痛、生产过程中的生产延迟、生产后会阴修补术引起的疼痛、乳腺炎、妇女更年期以及乳腺癌后的潮热等都纳入了针灸临床研究的范围。与早期只注重于疼痛管理或癌症后的胃肠道反应相比,这些研究项目更深入更广泛。NIH资助的针灸临床研究有以下特点:①规模较小。国内的许多针灸临床往往规模较美国的研究要大。但近年来一些欧洲国家的临床研究参与的病例数就超过了国内一些临床研究项目。②设计严谨。由于NIH的针灸临床研究的研究对象是针灸疗法,在研究的报告中很少提及所用穴位或穴位配合。但大部分的研究都会在纳入或排除标准中注明受试者没有接触过针灸,因为往往在安慰组或假针灸组里,采用假刺或仅仅浅刺,受试者不可能有类似针灸得气的感觉。NIH研究设计的一个优点是随访周期可长达数月甚至数年。③立题新颖。总的来讲,NIH的针灸临床研究项目肯定没有国内的多和广,但它所涉及的领域,有些在国内还是空白。④实用性强。西方人往往是在常规或传统的治疗方法无效的情况下才会想到使用针灸的,在许多疾病如疼痛、癌症、艾滋病、糖尿病或吸毒(药物滥用),会求助于替代医学中的针灸疗法。因而,NIH只会选择那些实用性很强,能切实帮助解决问题的研究进行资助。⑤着重安全。美国NIH对于所有医学治疗的态度可能与国内有所不同,安全性是一个首要的而且是决定性的因素。几乎所有的针灸临床研究都需经过预试验(pilot),设立纳入或排除标准时一定要按照常规医疗的规范来进行,可以避免许多法律上的麻烦。

Acupuncture Clinical Trails of NIH

Background： Recently, there are more and more acupuncture clinical trails be supported by National Institute Health. Purpose： Through the analysis of acupuncture clinical trails which are supported by NIH, we can know the general condition of international acupuncture clinical research. Methods： A cross-database searched the word ＂acupuncture＂ in the website of NIH, and analyzed the relative reports and medical articles. Result： Till to August 2007, there are 60 items related with acupuncture in http：//clinicaltrials, gov which belongs to National Institute Health. Among those items, most studies are currently recruiting patients, 8 of them are not yet recruiting. There are 39 studies made in United States, and 2 in Canada, 7 in Europe, 4 in Middle East, and 8 in Southeastincluding universities of Taiwan or Hong Kong, but only 2 in China mainland. The top lists of the states which have studies are New York （8）, Pennsylvanian （6）, Maryland （5） and California （4）. The enrolled diseases are pare syndromes （like phantom limb pain, chronic low back pain, myofascial pain and post-surgical wound）, related syndromes or symptoms with cancer （hot flush caused by breast cancer, Radiation-Induced Xerostomia, chronic fatigue and so on）, HIV and related syndromes, Elevated Intraocular Pressure, Urinary Incontinence, Hypertension, diabetes, drug or alcohol abuse and diseases ot women＇s like pelvic pain, timely delivery, mastitis, breast cancer and so on. Conclusion.- In general, the enrollment of the acupuncture trails of NIH is smaller compare with trails in China, but almost of them with strict design, especially pay more attentior to the safety and effects of acupuncture clinical research. All the clinical trails using sham acupuncture （no needle insertion or ver shallow insertion） as a placebo, so in the criteria ＂no experience of needling/acupuncture＂ is required, and people who are gotten acupuncture would not have the feeling of Deqi. Of course it is impossible in china, b