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== Research methodology and challenges == === Sham acupuncture and research === It is difficult but not impossible to design rigorous research trials for acupuncture.<ref name=White2001/><ref>{{cite journal | vauthors = Witt CM, Aickin M, Baca T, Cherkin D, Haan MN, Hammerschlag R, Hao JJ, Kaplan GA, Lao L, McKay T, Pierce B, Riley D, Ritenbaugh C, Thorpe K, Tunis S, Weissberg J, Berman BM | title = Effectiveness Guidance Document (EGD) for acupuncture research β a consensus document for conducting trials | journal = BMC Complementary and Alternative Medicine | volume = 12 | issue = 1 | pages = 148 | date = September 2012 | pmid = 22953730 | pmc = 3495216 | doi = 10.1186/1472-6882-12-148 | doi-access = free }}</ref> Due to acupuncture's invasive nature, one of the major challenges in [[Efficacy#Medicine|efficacy]] research is in the design of an appropriate placebo [[control group]].<ref name=Ersnt-2007/><ref name=Johnson2006>{{cite journal | vauthors = Johnson MI | title = The clinical effectiveness of acupuncture for pain relief β you can be certain of uncertainty | journal = Acupuncture in Medicine | volume = 24 | issue = 2 | pages = 71β79 | date = June 2006 | pmid = 16783282 | doi = 10.1136/aim.24.2.71 | s2cid = 23222288 }}</ref> For efficacy studies to determine whether acupuncture has specific effects, "sham" forms of acupuncture where the patient, practitioner, and analyst are [[Blind experiment|blinded]] seem the most acceptable approach.<ref name=White2001>{{cite journal | vauthors = White AR, Filshie J, Cummings TM | title = Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding | journal = Complementary Therapies in Medicine | volume = 9 | issue = 4 | pages = 237β45 | date = December 2001 | pmid = 12184353 | doi = 10.1054/ctim.2001.0489 | author4 = International Acupuncture Research Forum | s2cid = 4479335 }}</ref> Sham acupuncture uses non-penetrating needles or needling at non-acupuncture points,<ref>{{harvnb|Madsen|2009|page=a3115}}</ref> e.g. inserting needles on meridians not related to the specific condition being studied, or in places not associated with meridians.<ref name=Urruela2012>{{cite journal | vauthors = Amezaga Urruela M, Suarez-Almazor ME | title = Acupuncture in the treatment of rheumatic diseases | journal = Current Rheumatology Reports | volume = 14 | issue = 6 | pages = 589β97 | date = December 2012 | pmid = 23055010 | pmc = 3691014 | doi = 10.1007/s11926-012-0295-x }}</ref> The under-performance of acupuncture in such trials may indicate that therapeutic effects are due entirely to non-specific effects, or that the sham treatments are not inert, or that systematic protocols yield less than optimal treatment.<ref name=Langevin2011/><ref>{{cite journal | vauthors = Paterson C, Dieppe P | title = Characteristic and incidental (placebo) effects in complex interventions such as acupuncture | journal = BMJ | volume = 330 | issue = 7501 | pages = 1202β05 | date = May 2005 | pmid = 15905259 | pmc = 558023 | doi = 10.1136/bmj.330.7501.1202 }}</ref> A 2014 [[review article|review]] in ''[[Nature Reviews Cancer]]'' found that "contrary to the claimed mechanism of redirecting the flow of ''qi'' through meridians, researchers usually find that it generally does not matter where the needles are inserted, how often (that is, no dose-response effect is observed), or even if needles are actually inserted. In other words, "sham" or "placebo" acupuncture generally produces the same effects as "real" acupuncture and, in some cases, does better."<ref name=Gorski2014/> A 2013 meta-analysis found little evidence that the effectiveness of acupuncture on pain (compared to sham) was modified by the location of the needles, the number of needles used, the experience or technique of the practitioner, or by the circumstances of the sessions.<ref name=MacPherson2013/> The same analysis also suggested that the number of needles and sessions is important, as greater numbers improved the outcomes of acupuncture compared to non-acupuncture controls.<ref name=MacPherson2013>{{cite journal | vauthors = MacPherson H, Maschino AC, Lewith G, Foster NE, Witt CM, Witt C, Vickers AJ | title = Characteristics of acupuncture treatment associated with outcome: an individual patient meta-analysis of 17,922 patients with chronic pain in randomised controlled trials | journal = PLOS ONE | volume = 8 | issue = 10 | pages = e77438 | year = 2013 | pmid = 24146995 | pmc = 3795671 | doi = 10.1371/journal.pone.0077438 | editor1-last = Eldabe | author7 = Acupuncture Trialists' Collaboration | editor1-first = Sam | bibcode = 2013PLoSO...877438M | doi-access = free }}</ref> There has been little systematic investigation of which components of an acupuncture session may be important for any therapeutic effect, including needle placement and depth, type and intensity of stimulation, and number of needles used.<ref name=Langevin2011>{{cite journal | vauthors = Langevin HM, Wayne PM, Macpherson H, Schnyer R, Milley RM, Napadow V, Lao L, Park J, Harris RE, Cohen M, Sherman KJ, Haramati A, Hammerschlag R | title = Paradoxes in acupuncture research: strategies for moving forward | journal = Evidence-Based Complementary and Alternative Medicine | volume = 2011 | pages = 1β11 | year = 2011 | pmid = 20976074 | pmc = 2957136 | doi = 10.1155/2011/180805 | doi-access = free }}</ref> The research seems to suggest that needles do not need to stimulate the traditionally specified acupuncture points or penetrate the skin to attain an anticipated effect (e.g. psychosocial factors).<ref name=Berman2010/> A response to "sham" acupuncture in [[osteoarthritis]] may be used in the elderly, but placebos have usually been regarded as deception and thus unethical.<ref name=Cherniack2010/> However, some physicians and ethicists have suggested circumstances for applicable uses for placebos such as it might present a theoretical advantage of an inexpensive treatment without adverse reactions or interactions with drugs or other medications.<ref name=Cherniack2010>{{cite journal | vauthors = Cherniack EP | title = Would the elderly be better off if they were given more placebos? | journal = Geriatrics & Gerontology International | volume = 10 | issue = 2 | pages = 131β37 | date = April 2010 | pmid = 20100289 | doi = 10.1111/j.1447-0594.2009.00580.x | s2cid = 36539535 | doi-access = free }}</ref> As the evidence for most types of alternative medicine such as acupuncture is far from strong, the use of alternative medicine in regular healthcare can present an ethical question.<ref name=Posadzki2012>{{cite journal | vauthors = Posadzki P, Alotaibi A, Ernst E | title = Prevalence of use of complementary and alternative medicine (CAM) by physicians in the UK: a systematic review of surveys | journal = Clinical Medicine | volume = 12 | issue = 6 | pages = 505β12 | date = December 2012 | pmid = 23342401 | pmc = 5922587 | doi = 10.7861/clinmedicine.12-6-505 }}</ref> Using the principles of [[evidence-based medicine]] to research acupuncture is controversial, and has produced different results.<ref name=Ersnt-2007>{{cite journal | vauthors = Ernst E, Pittler MH, Wider B, Boddy K | s2cid = 40080937 | title = Acupuncture: its evidence-base is changing | journal = The American Journal of Chinese Medicine | volume = 35 | issue = 1 | pages = 21β25 | year = 2007 | pmid = 17265547 | doi = 10.1142/S0192415X07004588 }}</ref> Some research suggests acupuncture can alleviate pain but the majority of research suggests that acupuncture's effects are mainly due to placebo.<ref name=Ernst2006/> Evidence suggests that any benefits of acupuncture are short-lasting.<ref name=Wang-2008>{{cite journal | vauthors = Wang SM, Kain ZN, White PF | s2cid = 24912939 | title = Acupuncture analgesia: II. Clinical considerations | journal = Anesthesia and Analgesia | volume = 106 | issue = 2 | pages = 611β21, table of contents | date = February 2008 | pmid = 18227323 | doi = 10.1213/ane.0b013e318160644d | doi-access = free }}</ref> There is insufficient evidence to support use of acupuncture compared to [[medicine|mainstream medical treatments]].<ref name=GoldmanSchafer2015>{{cite book| first1 = Lee | last1 = Goldman | first2 = Andrew I. | last2 = Schafer | name-list-style = vanc |title=Goldman-Cecil Medicine: Expert Consult β Online|url=https://books.google.com/books?id=40Z9CAAAQBAJ&pg=PA98-IA61|date=21 April 2015|publisher=Elsevier Health Sciences|isbn=978-0-323-32285-0|page=98}}</ref> Acupuncture is not better than mainstream treatment in the long term.<ref name=Urruela2012/> The use of acupuncture has been criticized owing to there being little scientific evidence for explicit effects, or the mechanisms for its supposed effectiveness, for any condition that is discernible from placebo.<ref name=Gorski2014>{{cite journal | vauthors = Gorski DH | title = Integrative oncology: really the best of both worlds? | journal = Nature Reviews. Cancer | volume = 14 | issue = 10 | pages = 692β700 | date = October 2014 | pmid = 25230880 | doi = 10.1038/nrc3822 | s2cid = 33539406 }}</ref> Acupuncture has been called "theatrical placebo",<ref name=Colquhoun2013/> and [[David Gorski]] argues that when acupuncture proponents advocate "harnessing of placebo effects" or work on developing "meaningful placebos", they essentially concede it is little more than that.<ref name=Gorski2014/> === Publication bias === [[Publication bias]] is cited as a concern in the reviews of [[randomized controlled trial]]s of acupuncture.<ref name=Colquhoun2013/><ref name=Lee2006>{{cite journal | vauthors = Lee A, Copas JB, Henmi M, Gin T, Chung RC | title = Publication bias affected the estimate of postoperative nausea in an acupoint stimulation systematic review | journal = Journal of Clinical Epidemiology | volume = 59 | issue = 9 | pages = 980β83 | date = September 2006 | pmid = 16895822 | doi = 10.1016/j.jclinepi.2006.02.003 }}</ref><ref name=Tang1999>{{cite journal | vauthors = Tang JL, Zhan SY, Ernst E | title = Review of randomised controlled trials of traditional Chinese medicine | journal = BMJ | volume = 319 | issue = 7203 | pages = 160β61 | date = July 1999 | pmid = 10406751 | pmc = 28166 | doi = 10.1136/bmj.319.7203.160 }}</ref> A 1998 review of studies on acupuncture found that trials originating in China, Japan, Hong Kong, and Taiwan were uniformly favourable to acupuncture, as were ten out of eleven studies conducted in Russia.<ref name=Vickers1998>{{cite journal | vauthors = Vickers A, Goyal N, Harland R, Rees R | title = Do certain countries produce only positive results? A systematic review of controlled trials | journal = Controlled Clinical Trials | volume = 19 | issue = 2 | pages = 159β66 | date = April 1998 | pmid = 9551280 | doi = 10.1016/S0197-2456(97)00150-5 | s2cid = 18860471 }}</ref> A 2011 assessment of the quality of randomized controlled trials on traditional Chinese medicine, including acupuncture, concluded that the methodological quality of most such trials (including randomization, experimental control, and blinding) was generally poor, particularly for trials published in Chinese journals (though the quality of acupuncture trials was better than the trials testing traditional Chinese medicine remedies).<ref name=He-2011/> The study also found that trials published in non-Chinese journals tended to be of higher quality.<ref name=He-2011>{{cite journal | vauthors = He J, Du L, Liu G, Fu J, He X, Yu J, Shang L | title = Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews | journal = Trials | volume = 12 | issue = 1 | pages = 122 | date = May 2011 | pmid = 21569452 | pmc = 3114769 | doi = 10.1186/1745-6215-12-122 | doi-access = free }}</ref> Chinese authors use more Chinese studies, which have been demonstrated to be uniformly positive.<ref name=Ernst2012>{{cite journal | vauthors = Ernst E | title = Acupuncture: what does the most reliable evidence tell us? An update | journal = Journal of Pain and Symptom Management | volume = 43 | issue = 2 | pages = e11β13 | date = February 2012 | pmid = 22248792 | doi = 10.1016/j.jpainsymman.2011.11.001 | doi-access = free }}</ref> A 2012 review of 88 systematic reviews of acupuncture published in Chinese journals found that less than half of these reviews reported testing for publication bias, and that the majority of these reviews were published in journals with [[impact factor]]s of zero.<ref>{{cite journal | vauthors = Ma B, Qi GQ, Lin XT, Wang T, Chen ZM, Yang KH | title = Epidemiology, quality, and reporting characteristics of systematic reviews of acupuncture interventions published in Chinese journals | journal = Journal of Alternative and Complementary Medicine | volume = 18 | issue = 9 | pages = 813β17 | date = September 2012 | pmid = 22924413 | doi = 10.1089/acm.2011.0274 }}</ref> A 2015 study comparing pre-registered records of acupuncture trials with their published results found that it was uncommon for such trials to be registered before the trial began. This study also found that selective reporting of results and changing outcome measures to obtain statistically significant results was common in this literature.<ref>{{cite journal | vauthors = Su CX, Han M, Ren J, Li WY, Yue SJ, Hao YF, Liu JP | title = Empirical evidence for outcome reporting bias in randomized clinical trials of acupuncture: comparison of registered records and subsequent publications | journal = Trials | volume = 16 | issue = 1 | pages = 28 | date = January 2015 | pmid = 25626862 | pmc = 4320495 | doi = 10.1186/s13063-014-0545-5 | doi-access = free }}</ref> Scientist [[Steven Salzberg]] identifies acupuncture and Chinese medicine generally as a focus for "fake medical journals" such as the ''[[Journal of Acupuncture and Meridian Studies]]'' and ''[[Acupuncture in Medicine]]''.<ref>{{cite web|url=https://www.forbes.com/sites/stevensalzberg/2017/01/03/fake-medical-journals-are-spreading-and-they-are-filled-with-bad-science/|title=Fake Medical Journals Are Spreading, And They Are Filled With Bad Science|first=Steven|last=Salzberg|website=[[Forbes]]|access-date=21 August 2017|archive-date=24 August 2017|archive-url=https://web.archive.org/web/20170824113043/https://www.forbes.com/sites/stevensalzberg/2017/01/03/fake-medical-journals-are-spreading-and-they-are-filled-with-bad-science/|url-status=live}}</ref>
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