SUBSCRIBE
Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (8): 847-852.doi: 10.3736/jcim20120803

Previous Articles     Next Articles

Adequate application of quantitative and qualitative statistic analytic methods in acupuncture clinical trials

Ming T. Tan1, Jian-ping Liu2, Lixing Lao3,4()   

  1. 1. Division of Biostatistics and Bioinformatics, University of Maryland School of Medicine, Baltimore 21201, Maryland, USA
    2. Center for Evidence-based Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
    3. Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore 21201, Maryland, USA
    4. Institute of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2012-06-13 Accepted:2012-07-08 Online:2012-08-20 Published:2018-08-15
  • Contact: Lixing Lao E-mail:LLao@compmed.umm.edu

RichHTML

3

PDF (PC)

34

Like

Recently, proper use of the statistical methods in traditional Chinese medicine (TCM) randomized controlled trials (RCTs) has received increased attention. Statistical inference based on hypothesis testing is the foundation of clinical trials and evidence-based medicine. In this article, the authors described the methodological differences between literature published in Chinese and Western journals in the design and analysis of acupuncture RCTs and the application of basic statistical principles. In China, qualitative analysis method has been widely used in acupuncture and TCM clinical trials, while the between-group quantitative analysis methods on clinical symptom scores are commonly used in the West. The evidence for and against these analytical differences were discussed based on the data of RCTs assessing acupuncture for pain relief. The authors concluded that although both methods have their unique advantages, quantitative analysis should be used as the primary analysis while qualitative analysis can be a secondary criterion for analysis. The purpose of this paper is to inspire further discussion of such special issues in clinical research design and thus contribute to the increased scientific rigor of TCM research.

Key words: acupuncture therapy, randomized controlled trial, statistics, medical, qualitative analysis, quantitative analysis

Table 1

Primary outcome measure for observed VAS scores and changes in VAS scores (cm) from baseline at each time point in ITT analyses (n=169)[7]"

Characteristic Acupuncture (n=56) Sham acupuncture 1 (n=56) Sham acupuncture 2 (n=57) Pvalue
Observed VAS scores (cm)
0.5 hour after treatment 5.0 (4.0, 5.5) 4.6 (3.0, 5.7) 5.5 (3.0, 6.0) 0.103
1 hour after treatment 4.9 (6.7, 5.1) 4.8 (4.0, 5.5) 5.2 (3.0, 6.0) 0.166
2 hours after treatment 4.0 (3.1, 5.0) 4.5 (4.0, 5.1) 5.0 (3.0, 6.0) 0.032*
4 hours after treatment 4.0 (2.0, 4.9) 4.2 (3.0, 5.3) 5.0 (3.0, 5.8) 0.028*
Changes in VAS scores from baseline (cm)
0.5 hour after treatment 0.0 (–0.3, 0.0) 0.0 (–0.2, 0.0) 0.0 (–0.1, 0.0) 0.471
1 hour after treatment –0.4 (–1.0, 0.0)? –0.2 (–0.5, 0.1) 0.0 (–0.5, 0.0) 0.063
2 hours after treatment –0.7 (–1.5, –0.1)? –0.3 (–0.8, 0.2)? –0.2 (–0.7, 0.0)? 0.006*
4 hours after treatment –1.0 (–2.1, 0.0)? –0.5 (–1.2, 0.1)?? –0.1 (1.0, 0.0)??a 0.012*

Table 2

Comparing effectiveness of acupuncture to a control in treating migraine"

组别 n 基本恢复 显效 有效 无效 有效率（%）
治疗组 20 5 (25) 10 (50) 3 (15) 2 (10) 901)
对照组 20 2 (10) 5 (25) 8 (40) 5 (25) 75
[1] Meinert CL. Clinical trials: design, conduct and analysis. New York: Oxford University Press, Inc. 1986.
doi: 10.1001/jama.1987.03390090119041
[2] Coeytaux RR, Kaufman JS, Kaptchuk TJ, Chen W, Miller WC, Callahan LF, Mann JD . A randomized, controlled trial of acupuncture for chronic daily headache[J]. Headache, 2005,45(9):1113-1123
doi: 10.1111/j.1526-4610.2005.00235.x pmid: 16178942
[3] Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K . Acupuncture in patients with tension-type headache: randomised controlled trial[J]. BMJ, 2005,331(7513):376-382
doi: 10.1136/bmj.38512.405440.8F pmid: 16055451
[4] Vickers AJ, Rees RW, Zollman CE , McCarney R, Smith CM, Ellis N, Fisher P, Van Haselen R.Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial[J]. BMJ, 2004,328(7442):744
doi: 10.1136/bmj.38029.421863.EB pmid: 15023828
[5] Vickers AJ, Rees RW, Zollman CE, McCarney R, Smith CM, Ellis N, Fisher P, Van Haselen R, Wonderling D, Grieve R.Acupuncture of chronic headache disorders in primary care: randomised controlled trial and economic analysis[J].Health Technol Assess , 2004, 8(48): iii, 1-35
[6] Facco E, Liguori A, Petti F, Zanette G, Coluzzi F, De Nardin M, Mattia C . Traditional acupuncture in migraine: a controlled, randomized study[J]. Headache, 2008,48(3):398-407
doi: 10.1111/j.1526-4610.2007.00916.x pmid: 17868354
[7] Li Y, Liang F, Yang X, Tian X, Yan J, Sun G, Chang X, Tang Y, Ma T, Zhou L, Lan L, Yao W, Zou R . Acupuncture for treating acute attacks of migraine: a randomized controlled trial[J]. Headache, 2009,49(6):805-816
doi: 10.1111/j.1526-4610.2009.01424.x pmid: 19438740
[8] Li Y . Acupuncture on “Siguan” points for 32 patients with migraine[J]. Shanghai Zhen Jiu Za Zhi, 2010,29(11):733
doi: 10.3969/j.issn.1005-0957.2010.11.733
李悦 . 针刺四关穴治疗偏头痛32例[J]. 上海针灸杂志, 2010,29(11):733
doi: 10.3969/j.issn.1005-0957.2010.11.733
[9] Wang LQ . Acupuncture treatment for 83 patients with migraine[J]. Gansu Zhong Yi Xue Yuan Xue Bao, 2010,27(1):48-49
王立群 . 针刺治疗偏头痛83例疗效观察[J]. 甘肃中医学院学报, 2010,27(1):48-49
[10] Zhou Y . Acupuncture combined with bloodletting treatment for 30 patients with migraine[J]. Henan Zhong Yi, 2010,30(6):603-604
周莹 . 针刺配合放血疗法治疗偏头痛30例[J]. 河南中医, 2010,30(6):603-604
[11] Ai M, Chang YJ, Zhang Y, Ma L, Zhao LG, Cheng WP, Pang YH . Effect of acupuncture on bilateral Taiyang and Fengchi(GB20) for migraine and its influence on 5-HT in plasma[J]. Zhong Yi Yao Xin Xi, 2011,28(5):98-99
[12] Cbet HM. 在整形外科中应用干燥保存的组织移植法对战伤机能障碍的疗效[J]. 人民军医, 1951,( 4):17-21
doi: 10.3969/j.issn.1002-2406.2011.05.044
艾民, 常亚娟, 张洋, 马莉, 赵立刚, 程为平, 庞有慧 . 针刺双侧“太阳”、“风池”穴治疗偏头痛的疗效及对血浆5-HT含量的影响[J]. 中医药信息, 2011,28(5):98-99
doi: 10.3969/j.issn.1002-2406.2011.05.044
Cbet HM . Application of dryly preserved tissue transplantation for dysfunction due to war injury in plastic surgery[J]. Ren Min Jun Yi, 1951,( 4):17-21
[13] Li YQ . Summary report of acupuncture for neurvous system diseases[J]. Zhong Yi Za Zhi, 1955,( 9):44-45
李一泉 . 针灸治疗神经系疾病的总结报告[J]. 中医杂志, 1955,( 9):44-45
[14] Zhang DX . Observation of effect of blood refrigeration therapy in dermatology[J]. Ren Min Jun Yi, 1953,( 6):447-449
张德祥 . 冷藏血液疗法在皮肤科临床疗效之观察[J]. 人民军医, 1953,( 6):447-449
[15] Fei XM, Liu LY . Integrative acupuncture therapy for 40 patients with migraine[J]. Shanghai Zhen Jiu Za Zhi, 2011,30(4):258-259
费新明, 刘丽艳 . 综合针刺疗法治疗偏头痛40例[J]. 上海针灸杂志, 2011,30(4):258-259
[16] Wang J, Zhao JP, Dai JZ . Immediate curative effect of needling singly in Jing point in patient with migraine[J]. Beijing Zhong Yi Yao Da Xue Xue Bao Zhong Yi Lin Chuang Ban, 2010,17(6):14-16
doi: 10.3969/j.issn.1672-2205.2010.06.005
王军, 赵吉平, 戴京璋 . 针刺井穴治疗偏头痛即时疗效观察[J]. 北京中医药大学学报(中医临床版), 2010,17(6):14-16
doi: 10.3969/j.issn.1672-2205.2010.06.005
[17] Wang JF . One hundred and twenty cases of migraine treated by acupuncture on Zulinqi(GB41) and bloodletting therapy on Ashi points[J]. Shi Jie Zhen Jiu Za Zhi, 2010,20(3):54-55, 65
王俊富 . 针刺足临泣配阿是穴放血治疗偏头痛120例[J]. 世界针灸杂志, 2010,20(3):54-55, 65
[18] Dai M, Jin M, Shen WN . Observations on the curative effect of acupuncture on migraine and its influence on cerebral blood flow[J]. Shanghai Zhen Jiu Za Zhi, 2007,26(9):3-5
doi: 10.3969/j.issn.1005-0957.2007.09.002
戴明, 靳淼, 沈维娜 . 针刺治疗偏头痛患者疗效观察及对脑血流的影响[J]. 上海针灸杂志, 2007,26(9):3-5
doi: 10.3969/j.issn.1005-0957.2007.09.002
[19] Vickers A, Goyal N, Harland R, Rees R . Do certain countries produce only positive results? A systematic review of controlled trials[J]. Control Clin Trials, 1998,19(2):159-166
doi: 10.1016/S0197-2456(97)00150-5 pmid: 9551280
[20] Lao LL . Recommendations for enhancing the quality of traditional Chinese medicine clinical research reporting[J]. J Chin Integr Med, 2004,2(6):402-406
劳力行 . 提高中医药临床研究报道质量的建议[J]. 中西医结合学报, 2004,2(6):402-406
[21] White P, Lewith G, Prescott P, Conway J . Acupuncture versus placebo for the treatment of chronic mechanical neck pain: a randomized, controlled trial[J]. Ann Intern Med, 2004,141(12):911-919
doi: 10.7326/0003-4819-141-12-200412210-00007
[22] Warms CA, Turner JA, Marshall HM, Cardenas DD . Treatments for chronic pain associated with spinal cord injuries: many are tried, few are helpful[J]. Clin J Pain, 2002,18(3):154-163
doi: 10.1097/00002508-200205000-00004
[23] Diggle PJ, Heagerty P, Liang KY, Zeger SL. Analysis of longitudinal data. 2nd ed. New York: Oxford University Press, Inc. 2002.
[24] Lao L, Huang Y, Feng C, Berman BM, Tan MT . Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial[J]. Stat Med, 2012,31(7):619-627
doi: 10.1002/sim.4003
[25] Tan M, Qu Y, Mascha E, Schubert A . A Bayesian hierarchical model for multi-level repeated ordinal data: analysis of oral practice examinations in a large anaesthesiology training programme[J]. Stat Med, 1999,18(15):1983-1992
doi: 10.1002/(ISSN)1097-0258
[26] Li Y, Li Y, Liu LA, Zhao L, Hu KM, Wu X, Chen XQ, Li GP, Mang LL, Qi QH . Acupuncture and moxibustion for peripheral facial palsy at different stages: multicentral large sample randomized controlled trial[J]. Zhongguo Zhen Jiu, 2011,31(4):289-293
doi: 10.3321/j.issn:1673-8225.2005.33.044
李瑛, 李妍, 刘立安, 赵凌, 胡卡明, 吴曦, 陈晓琴, 李桂平, 邙玲玲, 戚其华 . 针灸择期治疗周围性面瘫多中心大样本随机对照试验[J]. 中国针灸, 2011,31(4):289-293
doi: 10.3321/j.issn:1673-8225.2005.33.044
[27] Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A , White AR .Acupuncture for migraine prophylaxis[J].Cochrane Database Syst Rev, 2009,(1):CD001218
[28] Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A , White AR .Acupuncture for tension-type headache[J].Cochrane Database Syst Rev, 2009,( 1):CD007587
[29] Li DP, Ji FY, Liu P, Tao CC, Shi Y . Clinical observation of combination of acupuncture with ear acupressure with bead for migraine[J]. Zhen Jiu Lin Chuang Za Zhi, 2011,27(6):25-26
李道丕, 姬锋养, 刘鹏, 陶春潮, 石瑛 . 针刺结合磁珠压耳治疗偏头痛临床观察[J]. 针灸临床杂志, 2011,27(6):25-26
[30] Li GM, Yan W, Yin JQ . Observations on the therapeutic effect of acupuncture on the acute migraine attack[J]. Shanghai Zhen Jiu Za Zhi, 2010,29(7):439-441
李桂敏, 严伟, 殷建权 . 针刺治疗偏头痛急性发作疗效观察[J]. 上海针灸杂志, 2010,29(7):439-441
[31] Wu JP, Gu SZ . Randomized controlled clinical trials for acupuncture treatment of aura-absence migraine patients[J]. Zhen Ci Yan Jiu, 2011,36(2):128-131, 149
吴家萍, 谷世喆 . 针刺治疗无先兆偏头痛临床随机对照观察[J]. 针刺研究, 2011,36(2):128-131, 149
[32] Zheng XY. The guide for clinical trials of new drugs of Chinese medicine. Beijing: Chinese Medical Science and Technology Press. 2002. Chinese.
郑筱萸 . 中药新药临床研究指导原则. 北京: 中国医药科技出版社. 2002.
[1] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[2] Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[3] Lena Grönblom Lundström, Ulrika Aasa, Yan Zhang, Tobias Sundberg. Health care in light of different theories of health—A proposed framework for integrating a social humanistic perspective into health care. Journal of Integrative Medicine, 2019, 17(5): 321-327.
[4] Mohammad Hossein Ayati, Ata Pourabbasi, Nazli Namazi, Arman Zargaran, Zahra Kheiry, Amir Hooman Kazemi, Bagher Larijani. The necessity for integrating traditional, complementary, and alternative medicine into medical education curricula in Iran. Journal of Integrative Medicine, 2019, 17(4): 296-301.
[5] Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[6] Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[7] Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[8] J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[9] Bellavite Paolo, Marzotto Marta, Bonafini Clara. Arnica montana experimental studies: Confounders and biases?. Journal of Integrative Medicine, 2018, 16(2): 72-76.
[10] Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
[11] Zahra Hajmohammadi, Mojtaba Heydari, Majid Nimrouzi, Pouya Faridi, Mohammad Javad Zibaeenezhad, Gholamhossein Ranjbar Omrani, Mesbah Shams . Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: A double-blind placebo-controlled randomized clinical trial. Journal of Integrative Medicine, 2018, 16(1): 45-50.
[12] Saswati Mahapatra, Anjali Bhagra, Bisrat Fekadu, Zhuo Li, Brent A. Bauer, Dietlind L. Wahner-Roedler. Incorporation of integrative medicine education into undergraduate medical education: A longitudinal study. Journal of Integrative Medicine, 2017, 15(6): 442-449.
[13] Laura Belland, Laura Rivera-Reyes, Ula Hwang. Using music to reduce anxiety among older adults in the emergency department: A randomized pilot study. Journal of Integrative Medicine, 2017, 15(6): 450-455.
[14] Hilal Yuksel, Yasemin Cayir, Zahide Kosan, Kenan Tastan. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: A randomized controlled trial. Journal of Integrative Medicine, 2017, 15(6): 456-461.
[15] Salvatore Chirumbolo, Geir Bjørklund. Homeopathic potencies of Arnica montana L. change gene expression in a Tamm-Horsfall protein-1 cell line in vitro model: The role of ethanol as a possible confounder and statistical bias. Journal of Integrative Medicine, 2017, 15(4): 255-264.
Viewed
Full text


Abstract

Cited
  Shared   
  Discussed   
[1] Jun Hu, Jian-ping Liu. Non-invasive physical treatments for chronic/recurrent headache. Journal of Chinese Integrative Medicine, 2008, 6(1): 31
[2] Li Zhou, Hong-xing Zhang, Ling-guang Liu, Wen-jun Wan. Effect of electro-acupuncture at Fenglong (GV 16) on nitric oxide and endothelin in rats with hyperlipidemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 89-92
[3] Xin-jun Wang, Ling-ling Wang . A mechanism of endogenous opioid peptides for rapid onset of acupuncture effect in treatment of depression. Journal of Chinese Integrative Medicine, 2010, 8(11): 1014-1017
[4] Jing-yuan Mao, Chang-xiao Liu, Heng-he Wang, Guang-li Wei , Zhen-peng Zhang, Jie Xing, Wang Xian liang , Ying-fei Bi . Effects of Shenmai Injection on serum concentration and pharmacokinetics of digoxin in dogs with heart failure. Journal of Chinese Integrative Medicine, 2010, 8(11): 1070-1074
[5] Gui Yu, Jie Wang. Thinking on building the network cardiovasology of Chinese medicine. Journal of Chinese Integrative Medicine, 2012, 10(11): 1206-1210
[6] 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
[7] Ming-qing Wei , Jin-zhou Tian , Jing Shi , Fu-yun Ma , Ying-chun Miao , Yong-yan Wang. Effects of Chinese medicine for promoting blood circulation and removing blood stasis in treating patients with mild to moderate vascular dementia: a randomized, double-blind and parallel-controlled trial. Journal of Chinese Integrative Medicine, 2012, 10(11): 1240-1246
[8] Ying Xu , Chang-chun Zeng , Xiu-yu Cai , Rong-ping Guo , Guang Nie , Ying Jin. Chromaticity and optical spectrum colorimetry of the tongue color in different syndromes of primary hepatic carcinoma. Journal of Chinese Integrative Medicine, 2012, 10(11): 1263-1271
[9] Zhao-guo Li , Rui-qiang Liu. Comparative study on WHO Western Pacific Region and World Federation of Chinese Medicine Societies international standard terminologies on traditional medicine: Diseases in Internal Medicine (Part 7). Journal of Chinese Integrative Medicine, 2012, 10(11): 1310-1315
[10] Ji Chen, Qin Pan, Li-shuang Ye, Jia-ling Huang. English translation of cultural aspects of the titles of traditional Chinese medicine classics based on the skopos theory. Journal of Chinese Integrative Medicine, 2012, 10(11): 1316-1320
Journal of Integrative Medicine, ISSN: 2095-4964 CN 31-2083/R
Copyright © Journal of Integrative Medicine
Powered by Beijing Magtech Co. Ltd
沪公网安备31010602003416号      沪ICP备18017633号-3