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
Posted 25 February 2013