Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2005, Vol. 3 ›› Issue (6): 421-425.doi: 10.3736/jcim20050601

• Expert Forum •     Next Articles

Evaluating the effects of acupuncture on knee osteoarthritis: A stepwise approach to research, University of Maryland experience

Li-xing Lao,Brian Berman   

  1. Center for Integrative Medicine, School of Medicine, University of Maryland, Third Floor, James Kernan Hospital Mansion, 2200 Kernan Drive, Baltimore, Maryland 21207, USA
  • Received:2005-08-16 Online:2005-11-20 Published:2005-11-20
  • Contact: Lixing Lao, Ph.D.

Conventional treatments for osteoarthritis (OA), the most common form of arthritis, are associated with unpleasant adverse effects and often ineffective. Acupuncture and traditional Chinese medicine (TCM) have been used for thousands of years to treat pain and other dysfunctions. However, the scientific evidence on the efficacy of acupuncture and TCM is equivocal, and adapting the Western biomedical model to assess them is a great challenge. By adopting a systematic, step-by-step approach, the research team at the University of Maryland has been carefully evaluating the effectiveness of acupuncture on knee OA over the past 10 years. Their successful experience may be a useful model for future acupuncture and TCM research.

Key words: Osteoarthritis, Knee, Randomized controlled clinical trials, Outcome assess, Acupuncture therapy

CLC Number: 

  • R245.31


类型 主要特点
Ⅰ期 药物作用、合适剂量、安全性的预初研究。采用典型的非随机化的人体初步试验,通常不设对照组。
Ⅱ期 疗效评价的预初研究,进一步研究药物的剂量和安全性。试验可以是随机化的。比Ⅰ期的研究规模大,
Ⅲ期 评估剂量效应,评价长期使用的安全性和有效性。试验是随机化的。治疗必须显示良好的风险/效益比。


[1] Somerville K, Faulkner G, Langman M . Non-steroidal anti-inflammatory drugs and bleeding peptic ulcer[J]. Lancet, 1986,1(8479):462-464
[2] Brooks PM, Potter SR, Buchanan WW . NSAID and osteoarthritis--help or hindrance?[J]. J Rheumatol, 1982,9(1):3-5
[3] Perneger TV, Whelton PK, Klag MJ . Risk of kidney failure associated with the use of acetaminophen, aspirin, and nonsteroidal antiinflammatory drugs[J]. N Engl J Med, 1994,331(25):1675-1679
doi: 10.1056/NEJM199412223312502
[4] Buffum M, Buffum JC . Nonsteroidal anti-inflammatory drugs in the elderly[J]. Pain Manag Nurs, 2000,1(2):40-50
doi: 10.1053/jpmn.2000.7779
[5] Stiel D . Exploring the link between gastrointestinal complications and over-the-counter analgesics: current issues and considerations[J]. Am J Ther, 2000,7(2):91-98
doi: 10.1097/00045391-200007020-00006
[6] Davies NM, Jamali F . COX-2 selective inhibitors cardiac toxicity: getting to the heart of the matter[J]. J Pharm Pharm Sci, 2004,7(3):332-336
[7] NIH Consensus Conference . Acupuncture[J]. JAMA, 1998,280(17):1518-1524
doi: 10.1001/jama.280.17.1518
[8] Berman BM, Lao L, Langenberg P , et al. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial[J]. Ann Intern Med, 2004,141(12):901-910
doi: 10.7326/0003-4819-141-12-200412210-00006
[9] Ernst E . Acupuncture as a symptomatic treatment of osteoarthritis. A systematic review[J]. Scand J Rheumatol, 1997,26(6):444-447
doi: 10.3109/03009749709065717
[10] Ezzo J, Hadhazy V, Birch S , et al. Acupuncture for osteoarthritis of the knee: a systematic review[J]. Arthritis Rheum, 2001,44(4):819-825
doi: 10.1002/(ISSN)1529-0131
[11] Lao L, Ezzo J, Berman B , et al. Assessing clinical efficacy of acupuncture: Considerations for the future design of clinical trials in acupuncture[A]. In: Stux G, Hammerschlag R (Eds.). Scientific basis of acupuncture[M]. Berlin: Springer-Verlag, 2000. 187-209
[12] FDA. CDER Handbook[M/OL]. 2005.
[13] Niebuhr B. Handbook of clinical trial and epidemiological research designs[M/OL]. 2000.
[14] Cheng X. Chinese acupuncture and moxibustion(1st ed)[M]. Beijing: Beijing Foreign Languages Press .,1987,(1st ed):
[15] O'Connor J , Bensky D.Acupuncture-A comprehensive text(1st ed)[M]. Chicago: Eastland Press.,1981,(1st ed):
[16] Berman BM, Singh BB, Lao L , et al. A randomized trial of acupuncture as an adjunctive therapy in osteoarthritis of the knee[J]. Rheumatology (Oxford), 1999,38(4):346-354
doi: 10.1093/rheumatology/38.4.346
[17] Berman B, Lao L, Greene M , et al. Efficacy of traditional Chinese acupuncture in the treatment of symptomatic knee osteoarthritis: a pilot study[J]. Osteoarthritis Cartilage, 1995,3(2):139-142
doi: 10.1016/S1063-4584(05)80046-9
[18] Lao L, Bergman S, Hamilton GR , et al. Evaluation of acupuncture for pain control after oral surgery: a placebo-controlled trial[J]. Arch Otolaryngol Head Neck Surg, 1999,125(5):567-572
doi: 10.1001/archotol.125.5.567
[19] Lao L, Zhang RX, Zhang G , et al. A parametric study of electroacupuncture on persistent hyperalgesia and Fos protein expression in rats[J]. Brain Res, 2004,1020(1-2):18-29
doi: 10.1016/j.brainres.2004.01.092
[20] Zhang RX, Lao L, Wang L , et al. Involvement of opioid receptors in electroacupuncture-produced anti-hyperalgesia in rats with peripheral inflammation[J]. Brain Res, 2004,1020(1-2):12-17
doi: 10.1016/j.brainres.2004.05.067
[21] Zhang RX, Lao L, Wang X , et al. Electroacupuncture combined with indomethacin enhances antihyperalgesia in inflammatory rats[J]. Pharmacol Biochem Behav, 2004,78(4):793-797
doi: 10.1016/j.pbb.2004.05.010
[1] Katy Andrade Monteiro Zacaron, Nélia da Silva Mendes, Yuri Cotta e Silva, Giancarlo Lucchetti. Effects of laying on of hands with and without a spiritual context on pain and functionality of older women with knee osteoarthritis: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2018, 16(2): 106-112.
[2] Fabiana de Almeida Andrade, Caio Fabio Schlechta Portella. Research methods in complementary and alternative medicine: An integrative review. Journal of Integrative Medicine, 2018, 16(1): 6-13.
[3] Kyeong Mee Park, Tae Hwan Cho. Therapeutic effect of acupuncture point injection with placental extract in knee osteoarthritis. Journal of Integrative Medicine, 2017, 15(2): 135-141.
[4] Steven H. Stumpf, Kory Ward-Cook, Clifford R. Carr. Comparing outcomes from the two most recognized acupuncturist workforce surveys. Journal of Integrative Medicine, 2017, 15(1): 37-43.
[5] Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
[6] Paulo AraujoDias, André Brito Bastos Guimarães, Andrea de Oliveira Albuquerque, Karoline Lucasde Oliveira, Maria Luzete CostaCavalcante, Sergio BotelhoGuimarães. Short-term complementary and alternative medicine on quality of life in women with fibromyalgia. Journal of Integrative Medicine, 2016, 14(1): 29-35.
[7] Bosch Peggy, van den Noort Maurits, Yeo Sujung, Lim Sabina, Coenen Anton, van Luijtelaar Gilles. The effect of acupuncture on mood and working memory in patients with depression and schizophrenia. Journal of Integrative Medicine, 2015, 13(6): 380-390.
[8] Arthur Yin Fan. The methodology flaws in Hinman’s acupuncture clinical trial, Part III: Sample size calculation. Journal of Integrative Medicine, 2015, 13(4): 209-211.
[9] Sung Min Lim, Sook-Hyun Lee. Effectiveness of bee venom acupuncture in alleviating post-stroke shoulder pain: A systematic review and meta-analysis. Journal of Integrative Medicine, 2015, 13(4): 241-247.
[10] Arthur Yin Fan. The methodology flaws in Hinman’s acupuncture clinical trial, Part II: Zelen design and effectiveness dilutions. Journal of Integrative Medicine, 2015, 13(3): 136-139.
[11] Arthur Yin Fan. The methodology flaws in Hinman’s acupuncture clinical trial, Part I: Design and results interpretation. Journal of Integrative Medicine, 2015, 13(2): 65-68.
[12] Marco Gemma, Elisa Nicelli, Luigi Gioia, Elena Moizo, Luigi Beretta, Maria Rosa Calvi. Acupuncture accelerates recovery after general anesthesia: A prospective randomized controlled trial. Journal of Integrative Medicine, 2015, 13(2): 99-104.
[13] Kwan Leung Chia. Symptomatic Tarlov cyst and electroacupuncture: More studies required. Journal of Integrative Medicine, 2015, 13(1): 58-60.
[14] Dagmar Ehling. Integrative techniques using acupuncture, Chinese herbal medicine, diet, and supplements for polycystic ovary syndrome: A case report. Journal of Chinese Integrative Medicine, 2013, 11(6): 422-427.
[15] Feng-bin Liu, Zheng-kun Hou, Yun-ying Yang, Pei-wu Li, Qian-wen Li, Nelson Xie, Jing-wei Li, Xiang-jing Zeng. Literature review and analysis of the application of health outcome assessment instruments in Chinese medicine. Journal of Chinese Integrative Medicine, 2013, 11(3): 157-167.
Full text



[1] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[2] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[3] Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022
[4] Wei Xu, Meng Shi, Jian-gang Liu, Cheng-long Wang . Collagen protein expressions in ischemic myocardium of rats with acute myocardial infarction and effects of qi-tonifying, yin-tonifying and blood-activating herbs and detoxifying and blood-activating herbs. Journal of Chinese Integrative Medicine, 2010, 8(11): 1041-1047
[5] Bing Hu , Hong-mei An , Ke-ping Shen , Qin Du. Senescence-inducing effects of Chinese herbal medicine Tenglong Buzhong Decoction on human colon carcinoma LS-174-T cells and the mechanism. Journal of Chinese Integrative Medicine, 2010, 8(11): 1048-1052
[6] Ya-hui Liang , Ping Li, Jing-xia Zhao, Xin Liu, Qi-fu Huang. Acetyl-11-keto-beta-boswellic acid and arsenic trioxide regulate the productions and activities of matrix metalloproteinases in human skin fibroblasts and human leukemia cell line THP-1. Journal of Chinese Integrative Medicine, 2010, 8(11): 1060-1069
[7] Zhi-mei Wang, Bin Zhang. A study on translation of ellipses in Huangdi Neijing from perspective of hermeneutic theory. Journal of Chinese Integrative Medicine, 2010, 8(11): 1097-1100
[8] Hui-min Liu, Xian-bo Wang, Yu-juan Chang, Li-li Gu. Systematic review and meta-analysis of randomized controlled trials of integrative medicine therapy for treatment of chronic severe hepatitis. Journal of Chinese Integrative Medicine, 2012, 10(11): 1211-1228
[9] Pedro Saganha João, Doenitz Christoph, Greten Tobias, Efferth Thomas, J. Greten Henry. Qigong therapy for physiotherapists suffering from burnout: a preliminary study. Journal of Chinese Integrative Medicine, 2012, 10(11): 1233-1239
[10] Nian-hong Wang , Jun-tao Yan , Wu-quan Sun , Yong-shan Hu , Jun Xia , Li-cheng Wei , Jie Jia , Gui-lin Ouyang , Yong He , Yan-ming Guo , Jie Xu . Effects of early application of Tuina treatment on quadriceps surface myoelectricity in patients after total knee arthroplasty: a randomized controlled trial. Journal of Chinese Integrative Medicine, 2012, 10(11): 1247-1253