Guest guest Posted July 18, 2006 Report Share Posted July 18, 2006 <http://www.acubriefs.com/> Acubriefs News June 2006 <http://www.acubriefs.com/newcitations.htm> Many thanks to our renewing Institutional Sponsor TCMtests.com. Please support them at TCMtests.com <http://www.tcmtests.com/?acubriefs=1> In this issue, we are including a review from Acubriefs Editor James K. Rotchford MD MPH on Pragmatic Trials in acupuncture research (below, and at http://www.acubriefs.com/newcitations.htm ). Our free citation list at http://www.acubriefs.com/newcitations.htm includes 56 Randomized Controlled Trials (and Abstracts of RCTs). 26 of these are sent to us each month from our researcher in Beijing, who retrieves them from the National Library for us. English Abstracts are available to Acubriefs members/rs. Our June 2006 Members New Citations page is now available to rs, with 250 citations, including 56 Randomized Controlled Trials (and abstracts of RCTs) and 37 Reviews. 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You may sign up using our secure server at: http://www.bestbothworlds.org/amember/signup.php Dr. Rotchford's Review: Dear Acubriefs readers, My availability to write further reviews of current acupuncture literature is under financial constraints. Nonetheless, those of you have read my previous reviews know that I'm a strong of advocate of what are now being termed Pragmatic Trials. A recent one demonstrated benefit to those Germans who received acupuncture for osteoarthritis of the knee and/or hip. Acupuncture for osteoarthritic pain: an observational study in routine care. (Linde,K. et al) Rheumatology (Oxford) 2006, Vol. 45(2) p. 222-7. Publisher's <http://rheumatology.oxfordjournals.org/cgi/content/abstract/45/2/222> Abstract online Albeit an important study, I'm most interested in commenting on the review done by Edzard Ernst. Testing acupuncture for osteoarthritis: pragmatic trials or efficacy studies? Rheumatology (Oxford) 2006, Vol. 45(2) p. 125, Publisher's <http://rheumatology.oxfordjournals.org/cgi/content/full/45/2/125> Full text online Dr. Ernst appears to be coming around to seeing the value of Pragmatic Trials.Although there are clear limitations to the conclusions that one can reach as the result of these trials, their limitations are likewise often overstated. In his review Dr. Ernst wrote: " It is important to understand this background [knowledge by participants that further funding of acupuncture was contingent upon results of the study] because it has the potential to impact significantly on the findings of this study. Linde et al. state that 'the minimal interference of the study with routine practice makes it likely that the findings reflect current practice in Germany' [1 <http://rheumatology.oxfordjournals.org/cgi/content/abstract/45/2/222> ] . I am not convinced that this is true. The treatment may well reflect current practice but the socio-economic situation surely did not. Participating doctors as well as patients knew that the results of these evaluations would determine whether or not acupuncture would be refunded in future. It is, I think, unlikely that their judgments regarding the effects of acupuncture were not influenced by this knowledge. " Unlike an efficacy trial, a pragmatic trial doesn't answer the research question of why an outcome was observed. Rather, it is like a rather large " observational " study that may or may not have controls. All good science begins with close observation of what occurs. Why something occurs is a whole other issue and can be thorny to tease out especially in " real life " situations. Dr. Ernst argues that possibly the results are based on the socio-economic issues pertinent to the study. He also later gives other possible explanations: " The positive outcome could be due to placebo or Hawthorn effects, to concomitant therapies, to regression towards the mean or simply to patients trying to please their doctors. " Yes, yes, these are all possibilities and further testing is needed to eliminate or confirm some of them. And yes, the study design doesn't try to answer the question, Did the Acupuncture' cause the effect? It just states what was observed in this large number of German patients who received acupuncture for their osteoarthritis. The question remains - Is it reasonable to assume a beneficial effect of having acupuncture in a standard clinical setting based on this study? I maintain that the answer is currently yes. Given the robustness of the data, I consider it wiser to take the stance of innocent until proven guilty rather than the position guilty until proven innocent. The most damning criticism of Dr. Ernst is his contention that the findings are tenuous because they can't be generalized entirely to " real life " situations. What good is a clinical trial if there is no possibility of it being generalized to a larger population? Dr. Ernst contends that because " under the very special conditions that existed at the time in Germany and that are unlikely to ever be re-created " , it is unwise to generalize the results. If one takes that stance to an extreme, you can never be satisfied with the value of a clinical trial because once you start to formally study something you clearly create an effect that goes beyond the " real life " situation. Besides, as Dr. Ernst points out, " real life " is constantly changing. My question/retort for Dr. Ernst would be simply this: Compared to other clinical designs/studies, how well does this design reflect " real life " ? In my opinion pragmatic trials, whether controlled and/or randomized, have the best external validity of current clinical trial designs.[2 <http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Retrieve & dopt=A bstract & list_uids=9472515> ] But I don't want to come down too hard on Dr. Ernst for I respect his work in the field and what's more, in the last paragraph of the review he appears to be migrating to my position regarding pragmatic trials when he asks and states: " But how should we explain the finding that the long-term results were positive in the observational study [1 <http://rheumatology.oxfordjournals.org/cgi/content/abstract/45/2/222> ] while they were negative in the randomized trial [3 <http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Retrieve & dopt=A bstract & list_uids=16005336> ]? 'Give me an efficacy study any time.', I am tempted to exclaim at this point. But this would probably be quite wrong. The question rarely is whether we need pragmatic or efficacy trials. They are not like fire and water, but trials move on a continuum from the strictly controlled conditions of the laboratory to the confounded situations of real life. Therefore they answer different research questions and, in an ideal world, we should have both to guide our decisions. The study by Linde et al.[1 <http://rheumatology.oxfordjournals.org/cgi/content/abstract/45/2/222> ] does generate a host of fascinating results. What seems crucial, however, is to interpret its results correctly. We should commend Linde and colleagues for repeatedly pointing out that the interpretation of their data requires great caution. " When Dr. Ernst gets to 'Give me a pragmatic trial first' he will clearly be in my camp. Lastly, whether the results are positive or negative regarding acupuncture I think it is prudent to interpret the data of any clinical trial involving acupuncture with great caution. As I have stated elsewhere, even defining acupuncture is problematic. [4 <http://www.medicalacupuncture.org/aama_marf/journal/vol13_3/article5.html> ] James K. Rotchford, MD MPH, Acubriefs Editor References 1.Linde K, Weidenhammer W, Streng A, Hoppe A et al. Acupuncture for osteoarthritic pain. Rheumatology(Oxford) 2006;45:2227.Publishers <http://rheumatology.oxfordjournals.org/cgi/content/abstract/45/2/222> Abstract 2.Roland M, Torgerson DJ. What are pragmatic trials? BMJ 1998;31:285.[PubMed <http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Retrieve & dopt=A bstract & list_uids=9472515> Citation ] 3.Witt C, Brinkhaus B, Jena S et al . Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet 2005;366:13643. [PubMed <http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Retrieve & dopt=A bstract & list_uids=16005336> Abstract] 4.Rotchford JK, Kobrin L, A modern and comprehensive definition for acupuncture in clinical research: Preliminary perspectives Med Acup 2002 Vol. 13(3) p. 38-40; Full <http://www.medicalacupuncture.org/aama_marf/journal/vol13_3/article5.html> text online Acubriefs Membership Services include: 1. Access to the most complete list of current Citations, updated at least weekly, using our new web-based search engine (coming very soon!). 2. Newsletter with Links and specifics of new citations. 3. Online Acupuncture Manual 4. 10% Discount on Library Services. 5. 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