Development and validation of an index of the adequacy of the control technique for acupuncture studies
Keywords:
acupuncture, placebo, research methodology.Abstract
ABSTRACTBackground: unspecific effects of a technique may occur for several different reasons and play an important role when defining its efficacy. There is no information on any study in the Western world that has created or validated a scale that evaluates the possibility of the control technique exerting physiological effects and, therefore, underestimating the effect of acupuncture. Methods: a literature review was performed, and the most important items concerning the control technique that might exert a physiological effect were listed and scored according to their importance, based on the Jadad scale. Three experienced acupuncturists evaluated the index, suggested modifications or enhancements, and tested it. Results: score ranges from 0 to 10, from items 1 to 4, adding up to a total; next, such total is multiplied according to the importance attributed to it, on item 5, ranging the corrected total from 0 to 20. Despite the index's objectiveness, the specialists made some mistakes when using it, making the Friedman test non-significant. Discussion: the index was developed so that, the higher the score, the higher the probability of the control technique exerting a physiological effect. Despite the difference of scores among evaluators, these mistakes are rarely attributable to inter-rater subjectivity or uncertainties to items, as all of them are quite objective. Only one item in 145 scored showed diverging opinions. Conclusion: we have created an index of control adequacy (placebo or sham) for acupuncture studies that may be used with great objectivity by specialists and non-specialists.
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References
Fletcher RH, Fletcher SW, Wagner EH. Epidemiologia clínica: elementos essenciais. 3ª ed. Porto Alegre: Artes Médicas; 1996.
Benedetti F. Mechanisms of placebo and placebo-related effects across diseases and treatments. Annu Rev Pharmacol Toxicol. 2008; 48:33-60.
Pariente J, White P, Frackowiak RSJ, Lewith G. Expectancy and belief modulate the neuronal substrates of pain treated by acupuncture. Neuroimage. 2005; 25:1161-7.
Wallach H. The efficacy paradox in randomized controlled trials of CAM and elsewhere: beware of the placebo trap. J Altern Complement Med. 2001; 7(3):213-8.
MacPherson H, Green G, Nevado A, Lythgoe MF, Lewith G, Devlin R, et al. Brain imaging of acupuncture: comparing superficial with deep needling. Neurosci Lett. 2008; 434:144-9.
Moher D, Jadad AR, Nichol G, Pernman M, Tugwell P, Walsh S. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials. 1995; 16:62-73.
Birch S. Clinical research on acupuncture: part 2. Controlled clinical trials, an overview of their methods. J Altern Complement Med. 2004; 10(3):481-98.
Birch S. Issues to consider in determining an adequate treatment in a clinical trial of acupuncture. Complement Ther Med. 1997; 5:8-12.
Claraco AE, Fargas-Bablak A, Hanna SE. The Reporting of clinical acupunture research: what do clinicians need to know? J Altern Complementa Med. 2003; 9(1):143-9.
Hammerschlag R. Methodological and ethical issues in clinical trials of Acupuncture. The Journal of Alternative and Complementary Medicine, 1998; 4(2):159-71.
MacPherson H, White A, Cummings M, Jobst J, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med. 2001; 9:246-9.
Bensky D, O'Connor J; Shanghai College of Traditional Medicine. Acupuntura: um texto compreensível. São Paulo: Roca; 1996.
Maciocia G. Os Fundamentos da medicina chinesa: um texto abrangente para acupunturistas e fitoterapeutas. 2ª ed. São Paulo: Roca; 2007.
Birch S. Systematic reviews of acupuncture – are there problems with these? Clin Acupunct Oriental Med. 2001; 2:17-22.
MacPherson H, White A, Cummings M, Jobst J, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med. 2001; 9:246-9.
Asghar AUR, Green G, Lythgoe MF, Lewith G, MacPherson H. Acupuncture needling sensation: The neural correlates of deqi using fMRI. Brain Res. 2010; 1315:111-8.
Bäcker M, Hammes MG, Valet M, Deppe M, Conrad B, Tölle TR, Dobos G. Different modes of manual acupuncture stimulation differentially modulate cerebral blood flow velocity, arterial blood pressure and heart rate in human subjects. Neurosci Lett. 2002; 333:203-6.
Hamza MA, Ghoname EA, White PF, Craig WF, Ahmed HE, Gajraj NM, et al. Effect of the duration of electrical stimulation on the analgesic response in patients with low back pain. Anesthesiology. 1999;91:1622-7.
Kong J, MA L, Gollub RL, Wei J, Yang X, Li D, et al. A pilot study of functional magnetic resonance imaging of the brain during manual and electroacupuncture stimulation of acupuncture point LI-4 Hegu) in normal subjects reveals differential brain activation between methods. J Altern Complement Med. 2002; 8(4):411-9.
Napadow V, Dhond R, Park K, Kim J, Makris N, Kwong KK, et al. Time-variant fMRI activity in the brainstem and higher structures in response to acupuncture. Neuroimage. 2009; 47:289-301.
Zhang WT, Zhen J, Luo F, Zhang L, Zeng YW, Han JS. Evidence from brain imaging with fMRI supporting functional specificity of acupoints in humans. Neurosci Lett. 2004; 354:50-3.
Birch S. A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert. J Altern Complement Med. 2006; 12(3):303-10.
Chae Y, Lee H, Kim H, Sohn H, Park JH, Park HJ. The neural substrates of verum acupuncture compared to non-penetrating placebo needle: An fMRI study. Neurosci Lett. 2009; 450:80-4.
Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on μ-opioid receptors (MORs). Neuroimage. 2009; 47:1077-85.
Hróbjartsson A, Gotzsche PC. Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment. J Intern Med. 2004; 256:91-100.
Lai X, Zhang G, Huang Y, Tang C, Yang J, Wang S, et al. A cerebral functional imaging study by positron emission tomography in healthy volunteers receiving true or sham acupuncture needling. Neurosci Lett. 2009; 452:194-9.
Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med, 2002; 136:471-6.
Wood R, Lewith G. The credibility of placebo controls in acupuncture studies. Complem Ther Med. 1998;6:79-82.
Jadad AR, Moore A, Carrol D, Jenkinson C, Reynolds DJM, Cavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clinical Trials, 1996;17:1-12.
Aird M, Cobbin DM, Rogers C. A study of the relative precision of acupoint location methods. J Altern Complementary Med. 2002; 8(5):635-42.
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