Exploration of the Methodology in the Evaluation of Safety of Non-pharmaceutical Therapy

Abstract

Abstract: Non -pharmaceutical therapies play a major role in traditional medicine. However, the reporting of their safety is not paid enough attention. This paper focused on safety issues of non-pharmaceutical therapies, introduced several Methods including randomized clinical trials, cohort study, case report, questionnaire, and qualitative method, respectively. Based on findings of above research methods, we introduced method of research synthesis so to provide references for clinical researches in non-pharmaceutical therapies.

Key words: non-pharmaceutical therapy, safety, adverse event, evaluation methods

CLC Number:

R954

CAO Hui –juan, LI Xun ,LIU Jian –ping. Exploration of the Methodology in the Evaluation of Safety of Non-pharmaceutical Therapy [J]. Chinese Journal of Pharmacovigilance, 2010, 7(10): 595-597.

References

[1] E thgen M, Boutron I, Baron G, Giraudeau B, et al. Reporting of harm in randomized controlled trials of nonpharmacologic treatment for rheumatic disease[J]. Ann Intern Med, 2005, 143:20-25.
[2] 洪永波,朱韪,姚卫海.电针与曲唑酮治疗失眠症患者临床疗效对照研究[J].医学研究通讯,2005,34(1):72-74.
[3] 罗文政,赖新生.解郁调神针刺法治疗失眠伴抑郁障碍的临床研究.广州中医药大学博士学位论文,2006.
[4] Witt C M, Pach D, Brinkhaus B,et al.. Safety of acupuncture: results of a prospective observational study with 229230 patients
and introduction of a medical information and consent form [J]. Forsch Komplementmed, 2009, 16:91-97.
[5] Vincent C. The safety of acupuncture: acupuncture is safe in the hands of competent practitioners[J]. BMJ, 2001, 323:467-468.
[6] White A, Hayhoe S, Hart A, et al. Adverse events following acupuncture: prospective survey of 32 000 consultations with doctors and physiotherapists[J]. BMJ, 2001,323:485-486.
[7] Macpherson H, Thomas K, Walters S, Fitter M.A prospective survey of adverse events and treatment reactions following 34000 consultations with professional acupuncturists [J]. Acupunct Med, 2001, 19(2): 93-102.
[8] 曹卉娟,费宇彤,孙瑛,刘建平.定性研究在药物安全性研究中的应用（一）[J].中国药物警戒, 2010,7（7）：410-413.
[9] 刘建平主编.循证中医药定性研究方法学[M].北京:人民卫生出版社,2009.
[10] LaoL X, Hamilton G R, Fu J,et al. Is acupuncture safe? A systematic review of case reports[J]. Altern Ther Health Med, 2003,9 (1): 72-83.
[11] Ernst E. The safety of massage therapy[J]. Rheumatology, 2003, 42: 1101-1106.
[12] CaoH J, LiuJ P, Lewith G T. Traditional Chinese Medicine for Treatment of Fibromyalgia:A Systematic Review of Randomized Controlled Trials[J]. JACM, 2010, 16(4): 397-409.
[13] Assefi N P, ShermanK J, Jacobsen C, et al.A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia[
J].J Rehabil Med, 2008,40(7):582-588.
[14]傅红卫,金毓丽,洪景.疏肝解郁活血通络方治疗纤维肌痛综合征 21例[J].浙江中医杂志, 2006,41(4):204-205.
[15]高冠民,蒋莉,刘升云,等.骨碎补总黄酮治疗纤维肌痛综合征的随机对照研究[J].中国新药与临床杂志, 2007,26(11):837-840.
[16]蒋峰,刘坚白.纤维肌痛综合征疼痛症状临床疗效观察[J].中华风湿病学杂志, 2004,8(12):750-752.
[17]李安林,王振亮,平阳.定痛汤配合针刺治疗原发性纤维肌痛综合征临床观察[J].中华现代临床医学杂志, 2004,2(9A):1387-1388.
[18]李俊,于海波,余阗.针刺加电脑中频治疗纤维肌痛综合征疗效观察[J].中国现代医药杂志, 2005,7(1):42-44.
[19]刘建中,刘艳芳,刘建俊.正清风痛宁治疗原发性纤维肌痛综合征的临床观察[J].中国中西医结合杂志, 2002,22(4):316.
[20] TarginoR A, Imamura M, Kaziyama H H, et al.A randomized controlled trial of acupuncture added to usual treatment for fibromyalgia[J]. J Rehabil Med, 2008,40:582-588.
[21]杨焕彪.逍遥羌活除湿汤联合酸枣木瓜三七酒治疗纤维肌痛综合征38例疗效观察[J].临床和实验医学杂志,2008,7(10):146-147.