Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (12): 1133-1146.doi: 10.3736/jcim20101205

• Systematic Review • Previous Articles     Next Articles

Clinical critical qualitative evaluation of the selected randomized controlled trials in current acupuncture researches for low back pain

Yong Miao Edwin   

  1. M. Modern Traditional Chinese Medical Clinic, Ring wood, Victoria 3134, AustraliaM. Modern Traditional Chinese Medical Clinic, Ring wood, Victoria 3134, Australia
  • Received:2010-08-15 Accepted:2010-09-25 Online:2010-12-20 Published:2010-12-15
  • Contact: Yong Miao Edwin


Many randomized controlled trials (RCTs) and reviews concluded that acupuncture is not an effective treatment for low back pain (LBP) and there is no difference between real acupuncture and sham acupuncture in the treatment of LBP.


This study aims to evaluate the most recently published RCTs and reviews from the clinical protocol, which is used by professional acupuncturists.Data sources and synthesis: English-language studies were identified through searches of The Cochrane Library, PubMed/MEDLINE and EMBASE, limited to those published between January 2007 and January 2010. Eighteen trials studying conditions related to LBP conditions treated by acupuncture or acupuncture as one of the co-interventions were eligible.Study appraisal methods: A critical clinical qualitative evaluation is the core methodology of this study. The study design employs daily used clinical skills and knowledge with supplementary statistical concepts to evaluate the quality and reliability of the selected RCTs and reviews. Five evaluation criteria were established for the assessment of the selected RCTs and reviews. By implementing the evaluation criteria, which are similar to the inclusion and exclusion criteria used in RCTs, the weaknesses, limitations or errors of RCTs and reviews can be identified, despite the strength of internal validity produced by statistical calculations.


Various terms are used when describing LBP conditions. However, 16 RCTs or 88% of the trials did not establish a medical diagnosis. No trials had objective measurements as a clinical standard for assessing outcomes. Furthermore, significant variation existed due to the numerous treatment methods or therapists used in the RCTs included in the study. Various co-interventions were used in 10 or 55% of the trials, among them, 6 or 33% of the trials used non-steroidal anti-inflammatory drugs (NSAID) or analgesics. Due to the lack of diagnostic status, the accuracy of the external validity was put into question. No logistic regression models were used in any of the selected RCTs and reviews to resolve the degree of heterogeneity.


All selected RCTs either partially met the evaluation criteria or did not fulfill the evaluation criteria while being compared. The major problem existing in all RCTs was the lack of accurate medical diagnosis and a lack of objective measurements to judge the clinical outcomes, which in turn, created incorrect eligibility criteria, improper matches and inaccuracies in data recording before entry into statistical calculations. As a consequence of the subjective nature of measurements, conclusions of RCTs and RCT-based reviews were biased due to overgeneralized or cross-generalized estimations, which infer that alternative explanations cannot be excluded. In addition, the range of variables created in the treatment procedure was difficult to control or estimate, in turn, threatening the reliability of RCTs’ estimations. For these reasons, creating appropriate diagnostic criteria before randomization and constructing a related objective outcome measurement, which are more relevant to clinical practice, should be considered in future RCTs and systematic review studies.

Key words: Low back pain, Soft tissue injuries, Acupuncture therapy, Randomized controlled trials, Reviews, Evaluation studies

Figure 1

Flow diagram of literature retrieval and selectionThe critical evaluation criterion contains two components, clinical evaluation, criteria 1 and 2, and methodological evaluation, criteria 3 to 5."


Figure 2

Suggested flow chart of the selection criteria for future LBP research"

[1] Du YH, Xiong J, Huang W, Li B, Shi L . Medical conditions treated by acupuncture: a preliminary review of randomised controlled trials. Med Acupunct. 2009 ; 21(3):207-213.
doi: 10.1089/acu.2009.0681
[2] Niemtzow RC, Burns SM, Cooper J, Libretto S, Walter JAG, Baxter J . Acupuncture clinical trial in a military medical center: outcomes. Med Acupunct. 2008; 20(4) : 255-261.
doi: 10.1089/acu.2008.0594
[3] Miao EY . Acupuncture treatment for subacute non-specific low back pain: a retrospective cohort study in the role of the back exercise in acupuncture services for low back pain sufferers.[J] Acupunct Tuina Sci. 2007 ; 5(6):372-376.
doi: 10.1007/s11726-007-0372-2
[4] Lin JG, Chen WL . Review: acupuncture analgesia in clinical trials. Am[J] Chin Med. 2009; 37(1):1-18.
doi: 10.1142/S0192415X09006679
[5] van Tulder MW, Cherkin DC, Berman B, Lao L , Koes BW . Acupuncture for low back pain. Cochrane Database Syst Rev. 2000; (2): CD001351.
[6] Furlan AD, van Tulder MW, Cherkin DC, Tsukayama H, Lao L, Koes BW, Berman BM.Acupuncture and dry-needling for low back pain. Cochrane Database Syst Rev. 2005; ( 1) : CD001351.
[7] Madsen MV, Gotzsche PC, Hrobjartsson A . Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009; 338:a3115.
doi: 10.1136/bmj.a3115
[8] Moffet HH . Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials.[J] Altern Complement Med. 2009; 15(3):213-216.
doi: 10.1089/acm.2008.0356
[9] Polgar S, Thomas SA. Interview techniques and the analysis of interview data. In: Polgar S, Thomas SA. Introduction to research in the health sciences. 3rd ed. Melbourne: Churchill Livingstone. 1995 : 137-147.
[10] Brinkhaus B, Witt CM, Jena S, Linde K, Streng A, Wagenpfeil S, Irnich D, Walther HU, Melchart D, Willich SN . Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med. 2006; 166(4) : 450-457.
[11] Molsberger AF, Mau J, Pawelec DB, Winkler J . Does acupuncture improve the orthopedic management of chronic low back pain — a randomized, blinded, controlled trial with 3 months follow up. Pain. 2002; 99(3):579-587.
doi: 10.1016/S0304-3959(02)00269-5
[12] Leibing E, Leonhardt U, Koster G, Goerlitz A, Rosenfeldt JA, Hilgers R, Ramadori G . Acupuncture treatment of chronic low-back pain — a randomized, blinded, placebo-controlled trial with 9-month follow-up. Pain. 2002; 96(1-2) : 189-196.
doi: 10.1016/S0304-3959(01)00444-4
[13] Cherkin DC, Sherman KJ, Avins AL , Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009; 169(9) : 858-866.
doi: 10.1001/archinternmed.2009.65
[14] Yuan J, Purepong N, Hunter RF, Kerr DP, Park J, Bradbury I , McDonough S. Different frequencies of acupuncture treatment for chronic low back pain: an assessor-blinded pilot randomised controlled trial. Complement Ther Med. 2009; 17(3):131-140.
doi: 10.1016/j.ctim.2008.10.003
[15] Haake M, Muller HH, Schade-Brittinger C, Basler HD, Schafer H, Maier C, Endres HG, Trampisch HJ , Molsberger A. German Acupuncture Trials ( GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007; 167(17):1892-1898.
doi: 10.1001/Archinte.167.17.1892
[16] Schlesselman JJ, Stolley PD. Research strategies. In: Schlesselman JJ, Stolley PD. Case-control studies: design, conduct, analysis. New York: Oxford University Press. 1982: 8, 20-72.
[17] Nagel T. Mortal questions. Cambridge: Cambridge University Press. 1979: 147.
[18] Einstein A, Calaprice A. The expanded quotable Einstein. Princeton: Princeton University Press. 2000 : 232.
[19] Cook TD, Campbell DT. Quasi-experimentation : design and analysis issues for field settings. Chicago: Rand McNally College Publishing Company. 1979: 59-85.
[20] MacPherson H, White A, Cummings M, Jobst KA, Rose K, Niemtzow RC; STRICTA Group . Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations.[J] Altern Complement Med . 2002; 8(1):85-89.
doi: 10.1089/107555302753507212
[21] Wood L, Egger M, Gluud LL, Schulz KF, Juni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA . Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ . 2008; 336(7644):601-605.
[22] Sterne JA, Jiini P, Schulz KF, Altman DG, Bartlett C, Egger M . Statistical methods for assessing the influence of study characteristics on treatment effects in ameta- epidemiological” research . Stat Med. 2002; 21(11):1513-1524.
doi: 10.1002/sim.v21:11
[23] Carlsson CP, Sjolund BH . Acupuncture for chronic low back pain: a randomized placebo-controlled study with long-term follow-up. Clin[J] Pain. 2001 ; 17(4):296-305.
[24] Meng CF, Wang D, Ngeow J, Lao L, Peterson M, Paget S . Acupuncture for chronic low back pain in older patients: a randomized, controlled trial. Rheumatology (Oxford). 2003; 42(12):1508-1517.
doi: 10.1093/rheumatology/keg405
[25] Ceccherelli F, Rigoni MT, Gagliardi G, Ruzzante L . Comparison of superficial and deep acupuncture in the treatment of lumbar myofascial pain: a double-blind randomized controlled study. Clin[J] Pain. 2002; 18(3):149-153.
[26] Garvey TA, Marks MR, Wiesel SW . A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain. Spine. 1989; 14(9):962-964.
doi: 10.1097/00007632-198909000-00008
[27] Inoue M, Kitakouji H, Ikeuchi R, Katayama K, Ochi H. Randomized controlled pilot study comparing manual acupuncture with sham acupuncture for lumbago ( 2nd report ) . J Jpn Soc Acupunct Moxibust. 2001 ; 51(3): 412. Japanese.
[28] Tsukayama H, Yamashita H, Amagai H, Tanno Y . Randomised controlled trial comparing the effectiveness of electroacupuncture and TENS for low back pain: a preliminary study for a pragmatic trial. Acupunct Med. 2002; 20(4) : 175-180.
doi: 10.1136/aim.20.4.175
[29] Yeung CK, Leung MC, Chow DH . The use of electroacupuncture in conjunction with exercise for the treatment of chronic low-back pain.[J] Altern Complement Med. 2003; 9(4) : 479-490.
doi: 10.1089/107555303322284767
[30] Araki S, Kawamura O, Mataka T , Fujioka H. Randomized controlled trial comparing the effect of manual acupuncture with sham acupuncture for acute low back pain. J Jpn Soc Acupunct Moxibust. 2001 ; 51(3): 382 . Japanese.
[31] Inoue M, Kitakouji H, Ikeuchi R, Katayama K , Ochi H. Randomized controlled pilot study comparing acupuncture with sham acupuncture for lumbago. J Jpn Soc Acupunct Moxibust. 2000; 50(2): 356 . Japanese.
[32] Kittang G, Melvaer T, Baerheim A . Acupuncture contra antiphlogistics in acute lumbago. Tidsskr Nor Laege- foren. 2001; 121(10):1207-1210.
[33] Sakai T, Tsutani K, Tsukayama H, Nakamura T, Ikeuchi T, Kawamoto M , Kasuya D. Multi-center randomized controlled trial of acupuncture with electric stimulation and acupuncture-like transcutaneous electrical nerve stimulation for lumbago. J Jpn Soc Acupunct Moxibust. 2001 ; 51(2) : 175-184. Japanese with abstract in English.
[34] Cherkin DC, Eisenberg D, Sherman KJ, Barlow W, Kaptchuk TJ, Street J, Deyo RA . Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain. Arch Intern Med. 2001; 161(8) : 1081-1088.
doi: 10.1001/archinte.161.8.1081
[35] Victoria WorkCover Authority . Guidelines for the management of employees with compensable low back pain. Melbourne: Victorian Government Publisher. 1996: 5-7.
[36] Broder J, Snarski JT . Back pain in the elderly. Clin Geriatr Med. 2007; 23(2):271-289.
doi: 10.1016/j.cger.2007.01.011
[37] Mooney V . The classification of low back pain. Ann Med. 1989; 21(5):321-325.
doi: 10.3109/07853898909149215
[38] Hanley EN Jr . Distinguish the specific from non-specific low back pain. Bull Hosp Jt Dis. 1996; 55(4) : 195-196.
[39] Davies RA, Maher CG, Hancock MJ . A systematic review of paracetamol for non-specific low back pain. Eur Spine J . 2008; 17(11):1423-1430.
doi: 10.1007/s00586-008-0783-x
[40] Roelofs PD, Deyo RA, Koes BW, Scholten RJ , van Tulder MW. Non-steroidal anti-inflammatory drugs for low back pain. Cochrane Database Syst Rev. 2008; (1): CD000396.
[41] Yang JZ. Great achievement in acupuncture and moxi- bustion. 2nd ed. Beijing: People ’ s Medical Publishing House. 1994: 327. Chinese.
杨继洲 . 针灸大成. 第2版. 北京: 人民卫生出版社. 1994: 327.
[42] Wu YC, Zhang BM, Wang CM, Zhang JF, Shao P, Liu GZ . Observations on the short-term and long-term effects of point Houxi (SI3) electroacupuncture on acute lumbar sprain. J Acupunct Tuina Sci. 2006; 4(6):356-359.
doi: 10.1007/s11726-006-0356-7
[43] Hsieh JC, Tu CH, Chen FP, Chen MC, Yeh TC, Cheng HC, Wu YT, Liu RS, Ho LT . Activation of the hypothalamus characterizes the acupuncture stimulation at the analgesic point in human: a positron emission tomography study. Neurosci Lett. 2001 ; 307(2):105-108.
doi: 10.1016/S0304-3940(01)01952-8
[44] Hui KK, Liu J, Makris N, Gollub RL, Chen AJ, Moore Cl, Kennedy DN, Rosen BR, Kwong KK . Acupuncture modulates the limbic system and subcortical gray structures of the human brain: evidence from fMRI studies in normal subjects. Hum Brain Mapp. 2000 ; 9(1) : 13-25.
doi: 10.1002/(ISSN)1097-0193
[45] Qiu PR, Chen HP. Newly organized Chinese acupuncture and moxibustion. Shanghai: Shanghai Scientific and Technical Publishers. 1992: 440-790. Chinese.
裘沛然, 陈汉平 . 新编中国针灸学.上海: 上海科学技术出版社. 1992: 440-790.
[46] Chou R,Qaseem A,Snow V,Casey D,Cross JT Jr,Shekelle P,Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 ; 147(7) : 478-491.
doi: 10.7326/0003-4819-147-7-200710020-00006
[47] Staud R, Price DD . Mechanisms of acupuncture analgesia for clinical and experimental pain. Expert Rev Neurother. 2006; 6(5) : 661-667.
doi: 10.1586/14737175.6.5.661
[48] Cochran WG . The combination of estimates from different experiments. Biometrics. 1954 ; 10(1) : 101-129.
doi: 10.2307/3001666
[49] Cooper H, Hedges LV . The handbook of research synthesis. New York: Russell Sage Foundation. 1994.
[50] Higgins JP, Thompson SG . Quantifying heterogeneity in a meta-analysis. Stat Med. 2002; 21(11):1539-1558.
doi: 10.1002/(ISSN)1097-0258
[51] Higgins JP, Thompson SG, Deeks JJ, Altman DG . Measuring inconsistency in meta-analyses. BMJ. 2003; 327(7414) : 557-560.
doi: 10.1136/bmj.327.7414.557
[1] Bin Zhao, Yong Chen, Shi-min Liao, Jian-ying Zheng, Shi-hua Yan, Dong-shu Zhang. Successfully treated recalcitrant atopic eczema with acupoint autohemotherapy: A case report and hypothesized mechanism of the therapy. Journal of Integrative Medicine, 2022, 20(2): 182-186.
[2] Luciana Aikawa, Alexandre Massao Yoshizumi, Mirian Matsura Shirassu, Marcia Kiyomi Koike. Rapid acupuncture for musculoskeletal pain in the emergency room of the Hospital Servidor Publico Estadual, Brazil: A quasi-experimental study. Journal of Integrative Medicine, 2020, 18(4): 313-318.
[3] 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.
[4] 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.
[5] 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.
[6] Nouran A. Aleyeidi, Khaled S. Aseri, Shadia M. Matbouli, Albaraa A. Sulaiamani, Sumayyah A. Kobeisy. Effects of wet-cupping on blood pressure in hypertensive patients: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(6): 391-399.
[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] 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.
[9] 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.
[10] Kwan Leung Chia. Symptomatic Tarlov cyst and electroacupuncture: More studies required. Journal of Integrative Medicine, 2015, 13(1): 58-60.
[11] Vamsi Reddy, Arvind Sridhar, Roberto F. Machado, Jiwang Chen. High sodium causes hypertension: Evidence from clinical trials and animal experiments. Journal of Integrative Medicine, 2015, 13(1): 1-8.
[12] Atefeh Arabzadeh, Mehdi Ajdari Tafti, Mohammad M. Zarshenas. The very early textbook of pediatrics: Tadbir-Al-Sebyān. Journal of Integrative Medicine, 2014, 12(6): 531-532.
[13] Hui-ling Wang, Nan-mei Liu, Rui Li . Role of adult resident renal progenitor cells in tubular repair after acute kidney injury. Journal of Integrative Medicine, 2014, 12(6): 469-475.
[14] Chang-qing Zhao, Yang Zhou, Jian Ping, Lie-ming Xu. Traditional Chinese medicine for treatment of liver diseases: Progress, challenges and opportunities. Journal of Integrative Medicine, 2014, 12(5): 401-408.
[15] Zhong-liang Liu, Wei-rong Zhu, Wen-chao Zhou, Hai-feng Ying, Lan Zheng, Yuan-biao Guo, Jing-xian Chen, Xiao-heng Shen. Traditional Chinese medicinal herbs combined with epidermal growth factor receptor tyrosine kinase inhibitor for advanced non-small cell lung cancer: A systematic review and meta-analysis. Journal of Integrative Medicine, 2014, 12(4): 346-358.
Full text



[1] Jin-rong Fu. Establishment of multivariate diagnosis and treatment system of modern gynecology of traditional Chinese medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 22-24
[2] Hao Li, Ming-jiang Yao, Wen-ming Zhao, Jie Guan, Lin-lin Cai, Ling Cui. A randomized, controlled, double-blind trial of Huannao Yicong capsule in senile patients with mild cognitive impairment. Journal of Chinese Integrative Medicine, 2008, 6(1): 25-31
[3] Zhi-chun Jin. Problems in establishing clinical guideline for integrated traditional Chinese and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 5-8
[4] SUN Ming-yu, ZUO Jian, DUAN Ji-feng, HAN Jun, FAN Shi-ming, ZHANG Wei, ZHU Li-fang, YAO Ming-hui. Antitumor activities of kushen flavonoids in vivo and in vitro. Journal of Chinese Integrative Medicine, 2008, 6(1): 51-59
[5] Min Cheng, Qiong Feng, Shu-wen Qian, Hui Gao, Cui-qing Zhu. Preliminary assay of p-amyloid binding elements in heart-beneficial recipe. Journal of Chinese Integrative Medicine, 2008, 6(1): 68-72
[6] Ning-qun Wang, Liang-duo Jiang, Zong-xing Li. Research progress in asthma-related quality of life. Journal of Chinese Integrative Medicine, 2008, 6(1): 93-97
[7] 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
[8] 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
[9] Gui Yu, Jie Wang. Thinking on building the network cardiovasology of Chinese medicine. Journal of Chinese Integrative Medicine, 2012, 10(11): 1206-1210
[10] 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