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AN Australian expert has welcomed a call to shift the focus in acupuncture research from efficacy to comparative effectiveness.
A German study, published in the Annals of Internal Medicine, found that acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use after 8 weeks of treatment compared with sham acupuncture and with rescue medication (the antihistamine cetirizine). However, the researchers said the clinical significance of the findings remained uncertain. (1)
The study involved 422 people with seasonal allergic rhinitis who were randomly allocated to receive acupuncture plus cetirizine (n = 212), sham acupuncture plus cetirizine (n = 102) or cetirizine alone (n = 108).
An accompanying editorial questioned why acupuncture, which had undergone extensive study with large, sham-controlled clinical trials, was not directly compared with other potentially therapeutic protocols. (2)
“There is precedence for evaluating the comparative effectiveness of a given intervention without first having demonstrated superiority over a sham intervention; for example, ample head-to-head studies have compared angioplasty with medical management in the treatment of coronary artery disease or cognitive behavior therapy with medical management for general anxiety”, the editorial said.
Professor Charlie Xue, chair of the Chinese Medicine Board of Australia, said the research was an exciting development.
He said that given the challenges in devising a real placebo for acupuncture, comparative effectiveness studies were more appropriate for this type of intervention.
“We all need to be open-minded about [new research approaches]. When looking into manual therapies or surgical procedures, we need to focus on the effectiveness rather than keep talking about how we are going to devise a real placebo, which is almost impossible”, said Professor Xue, who is also the head of the School of Health Sciences at Melbourne’s RMIT University.
The editorial said sham-controlled trials were an important tool in the evaluation of acupuncture’s potential efficacy, “but it may be time to prioritize studies that directly compare a specified acupuncture protocol with potentially therapeutic alternatives”.
“The argument to consider conducting fewer efficacy and more effectiveness trials of acupuncture may be especially timely given current interest in patient-centred outcomes and comparative effectiveness research”, it said.
Professor Paul Komesaroff, director of the Monash Centre for Ethics in Medicine and Society, said studies into the efficacy of complementary therapies, such as acupuncture, were important.
“It’s necessary for the same reason it’s necessary to conduct research on any treatment or proposed treatment and that is, essentially, to see if they work”, he said.
However, it was crucial to look beyond efficacy, and consider factors such as side effects, safety, cost, convenience and comfort to patients, he said. “If the treatment happens to be one that potentially attracts public subsidy, we want to know that we are spending the public money wisely.”
Professor Komesaroff said this study was a good example of how to design a research protocol in an area where there was much clinical and scientific uncertainty. However, it also raised questions about whether the effects of acupuncture in seasonal allergic rhinitis were clinically significant and compared favourably with other treatment possibilities.
He acknowledged the challenges associated with conducting clinical trials into acupuncture saying the main difficulty was standardising the treatment and building in an effective control process.
“This particular study used sham acupuncture which was needle acupuncture using points that are thought not to be relevant to seasonal allergic rhinitis. But there’s an argument, for which there seems to be quite reasonable evidence, that any kind of acupuncture may be active”, Professor Komesaroff said.
“So there may not be any inactive placebo, so to speak. If you stick a needle in somewhere, you always evoke whatever the acupuncture response is and because we don’t know what the exact physiological mechanisms are, we can’t measure them.”
Professor Xue said acceptance of acupuncture had been growing in Australia in the past couple of decades, with research showing that almost 10% of the Australian population used acupuncture in a 12-month period. (3)
Compulsory registration of Chinese medicine practitioners, including acupuncturists, with the Chinese Medicine Board of Australia, was introduced in July last year.
– Nicole MacKee
1. Ann Intern Med 2013; 158: 225-234
2. Ann Intern Med 2013; 158: 287-288
3. J Alternative Comp Med 2007; 13: 643-650
Posted 25 February 2013
Anonymous – iontophoresis has some application in the treatment of hyperhidrosis through its effect on eccrine sweat glands, and as a way of giving transdermal medication. Are you proposing its effect in other areas? One of the hallmarks of a scam is the proposal that a therapy, using one mechanism, is effective across a spectrum of conditions of different pathology and aetiology.
‘Amanda’, in your response you cite iontophoresis as an example of (unproven) placebo. Surely this is an error you would like to retract.
http://www.ncbi.nlm.nih.gov/pubmed/?term=iontophoresis
http://www.ncbi.nlm.nih.gov/pubmed/?term=iontophoresis+hyperhidrosis
Hi “younger doctor” – as I said above, since there is reasonable evidence about some effect of acupuncture in pain perception, why don’t its proponents argue to restrict it to that use until further positive evidence emerges. We all need to be wary of any therapy that claims to treat conditions across the scope of pathology types – that is just not feasible. So far as the intentional use of placebo is concerned, this is no considered paternalistic and unethical amongst the medical commmunity. The problem with CAMs used as placebo is that the purveyors are not honest about it. One law for all would make sense. At least trained doctors using placebo could also use effective medicine where it was necessary.
I wonder if age might be a factor in some of the opinions here.
During my (recent) medical school education we were taught the Gate Control Theory of Pain – which explains the basis for why TENS (transcutaneous electrical nerve stimulation) and acupuncture work to relieve pain.
There may be other physiological effects of nerve stimulation apart from pain relief as well, as there are also likely to be some bogus claims about the utility of acupuncture for various diseases.
But I suggest some of the critics here do some CME on the issue.
The placebo effect can be very powerful, as many studies of pain management show, and there is plenty of evidence out there to back this up. I agree it is important to test therapies against placebo, to protect our patients (and health system) from treatments which may cost a lot, or cause harm, whilst performing no better than placebo.
The trouble with this focus, though, is that we can sometimes lose sight of the power of the placebo effect. In addition, every time the evidence shows a therapy does not out-perform placebo, we lose another (potentially relatively safe) placebo, which may actually help some of our patients! Our patients then gravitate to the next untested placebo out there in the marketplace.
Often in my daily (general) practice I find myself wishing for more safe placebos that I can enthusiastically encourage my patients to try (hopefully further boosting the placebo effect). I was so disappointed when large trials of glucosamine in osteoarthritis did not show superiority to placebo.
I want my patients to feel better. Sometimes placebo is able to do this safely when western medicine fails us or causes side effects for patients. I am sure that many of the GPs who embrace acupuncture or other unproven (but safe-ish) treatments such as iontophoresis, TENS, or their own special cough linctus, do this in an attempt to provide our patients with the at times powerful benefits of placebo. Studies comparing acupuncture to established therapies (rather than placebo) may just provide me with the evidence I need to help my patients in the search for effective placebos.
With regard to expensive vs cheap placebos, some studies suggest that expensive ones provide a stronger placebo effect than cheap ones. With tablets, some colours outperform others and big ones tend to do better than small ones!
A personal comment. I recently developed diabetic amyotrophy, an unpleasant painful and muscle wasting condition. The pain was continuous in proximal leg muscles with exacerbations worse at night. It requuired 6 nurofen and 8/10 panadol daily to manage.
Medical practitioner suggested acupuncture. Although skeptical attended a registered AP practitioner and within 24 hours pain lessened considerably, analgesic intake decreased, could sleep at night. 2 further treatments have helped reduce pain levels further. I have now become a believer in its efectiveness. Weakness remains.
As the underlying cause for amyotrophy is unknown and AP therapy is speculative the 2 combined very well.
I continue to be gobsmacked at the completely unscientific way that supposed proponents of evidence based medicine assess evidence that doesn’t suit their belief system….. I am talking about the extremely well documented neurophysiological effects (in animals as well as humans) of needle insertion for a starter which are described in a recent textbook of pain medicine….one doesn’t have to conjure up Qi or meridians to understand acupuncture mechanisms…how sad that people such as R Gordon continue on their crusade in such ignorance.
Tabula Rasa – you say “People who criticise AP and other modalities, which they have no or little experience with or no learned knowledge of it, are biased, judgmental and short sighted, closed to any idea they do not wish to understand.” Personally, I do wish to understand, which is why I have read studies cited by acupuncture practitioners as supporting efficacy. Outside the area of pain relief, the well-conducted studies just don’t show what you claim. IF acupuncture is a good pain relief modality, then let’s reserve it for that (with guidelines to mitigate against the risks – such as needle placement site and depth). IF the effect is via placebo – then let’s acknowledge that, and have the debate about whether the use of placebo is ethical for all health practitioners. I suspect the general population would not favour medical practice going back to “saline injections”.
Tabula Rasa, the main concern I have is that even if acupuncture is for whatever reason associated with someone feeling happier about something, there is no justification in having “registration” at public expense. The nonscientific practitioners can “regulate” themselves. Conferring this legitimacy is only of benefit to the practitioner who with a 4 year degree from Endeavour College emphasising the mythical “qi” they are not safe to perform health assessments as solo practitioners though legally permitted to do so. The stated aim of the AHPRA is to support the Boards in “protecting the public” (ref: website) and the false legitimisation of such practices actually endangers the public. AHPRA should not register osteopaths, chiropractors or chinese “medicine” – cut them loose and let “patients” pay for their indulgences and fairy tales any way they please.
Tabula Rasa, doctors are doing acupuncture the favour of treating it the same as they would any of their other treatments. The problem for acupuncturists is that they are not doing doctors the same favour, and that their favourite treatment is simply not coming up to scratch once all possible sources of bias are removed.
In scientific medicine (which is constributed to by researchers all over the world btw) you stop using something if it is not shown to be any better than a placebo or a cheaper, safer treatment. I’ve never seen an acupuncture proponent recommend that it should not be used for treatment X because their study was negative. They usually call for more research when they should be more homest and say that there is no reason to htink it works based on all the negatiove studies.
Most “scientifically proven” therapies work only on certain percentage of patients. What is the definition of “placebo” when it makes people better? Why is that comical? Are the sceptics laughing at people whose health improves with acupuncture (AP) treatment regime, which is not accepted by these sceptics? AP treatment is improving something in the homeostasis of the body, otherwise the patient would not feel and function better. It is not just “in the mind”. Not all AP point work equally successfully for different ailments. AP has been extensively researched for many decades. There are several scientific theories how acupuncture works. If we do not understand fully how something alleviates symptoms, it does not mean it is “magic or fairy dust”. If the Asian and other population has used the same treatment system successfully for hundreds or thousands of years, it does seem to be a proof of its effectiveness. People who criticise AP and other modalities, which they have no or little experience with or no learned knowledge of it, are biased, judgemental and short sighted, closed to any idea they do not wish to understand. AP does work well in veterinary practice, on all animals – this means it cannot be “magical fairy dust” and “only placebo”. Many Western trained doctors,vets and well trained TCM practitioners help large number of patients with acupuncture, who did not improve with our Western therapies or AP in conjunction with Western therapies enhances improvement. It is a misconception that it is expensive. To see a GP for 21 minute consultation of Item 36 (no treatment in it) can cost $155 in Sydney, and one does not come out better from the GP. While for 60 minutes consultation and AP treatment the patient at the university clinic pays $25 and feels better after. A healing method that has improved the wellbeing of hundreds of millions or billions of people over long historical time cannot be a “sham”. Just use common sense…
Wow. Such strong sentiments. Has anyone actually read the article or are these sentiments based on preconceived opinions? The scientific process doesn’t work this way either.
Couldn’t agree more with the above 3 posts except to say that acupuncture should go the way of homeopathy. Acupuncture is an elaborate and expensive placebo. There are cheaper placebos available.
The question is a complex one, does acupuncture work because it is a placebo is still relevant. If it turns out that just sticking pins into you is effective in reducing allergic rhinitis symptoms, the public need to know that, because it is not necessary to be a registered chinese medicine practitioner in order to stick pins into someone. Nobody has ever isolated a single bottle of Qi though acupuncturists seem to swear by it. “We don’t know why it works, it just does” is comical, is no longer scientifically valid and does not justify the lofty process of registration and official recognition misguidedly conferred by AHPRA. A “registered chinese medicine practitioner” certainly is no safer than an “unregistered” one, and given placebos also work, is obviously no more effective than an unregistered one, so why register any of them?
Accepting that complications are minimal, I’m happy to see well-conducted controlled comparative effectiveness studies of acupuncture. Once they are done, though, the use of acupuncture should be restricted to those conditions in which the effectiveness has been shown. (The best evidence I’ve seen is in the area of pain control). It’s just not feasible that a single modality could be effective against the full range of illness and injury mechanisms.
Great. Accupuncture cannot stand up to higher quality placebo, controlled, double blinded studies, so let’s lower the bar and see what type of studies it does seem to show positive results for. A modality that depends on hitherto undetectable fields of qui needs to get over the bar of scientific plausibility before such studies are done. If fairy dust don’t work, no point comparing it to leprichaun pots of gold.