下腰背部疼痛的针刺随机对照试验的临床定性评估

doi:10.3736/jcim20101205

Abstract

Background

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.

Objective

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.

Results

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.

Conclusion

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

Yong Miao Edwin. Clinical critical qualitative evaluation of the selected randomized controlled trials in current acupuncture researches for low back pain. Journal of Chinese Integrative Medicine, 2010, 8(12): 1133-1146.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20101205

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[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

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

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