What if Sydney University’s complementary medicine research shows it’s useless?

Simon Chapman, University of Sydney

The Faculty of Medicine at the University of Sydney has just announced A$1.3 of funding from Blackmores, the complementary medicine manufacturer, for a Chair in Integrative Medicine (a blending of evidence-based conventional and complementary medicine). It will be named after the company’s owner, Maurice Blackmore.

The Dean of the Faculty, Bruce Robinson, has given a coherent and persuasive account of why research in this area is of importance to modern medical practice. Nearly a quarter of Australians with chronic health problems use complementary and alternative medicine (CAM) and the bewildering range and often changing nature of these products are often of unknown efficacy, and may have important adverse or beneficial interactions with prescribed medicines. Still, more of the “worried well” regularly use unnecessary vitamins and other dietary supplements, often achieving little other than the generation of expensive urine in consumers and handsome profits in manufacturers.

Robinson is correct in arguing that medical practitioners and students know little about what a significant proportion of their patients are using and about whether these preparations help, harm, generate only placebo effects or simply waste patients’ money. And he is absolutely correct in making it clear from the beginning that the relationship will be at “arm’s length”, with Blackmores having no say in the research projects selected, in vetting the results produced, or in any post-publication researcher communications about those results. But there is already a great deal of evidence about a large number of complementary and alternative medicine preparations being useless, and about how faith in their magical properties can too often cause people with serious health problems to stay away from “conventional” evidence-based treatments of known effectiveness.

Complementary and alternative medicine manufacturers continue to produce and promote many of these substances, paying no heed to the evidence for their uselessness. Conventional medicines (so-called “ethical pharmaceuticals”) have to pass through onerous regulatory hurdles to prove both safety and efficacy. With the exception of the United States and New Zealand, prescribed medicines cannot be advertised directly to consumers. While the complementary and alternative medicine industry has to satisfy concerns about safety and toxicity, it does not have to satisfy standards of efficacy and can promote useless products in often quasi-mystical and vague language.

The University of Sydney needs to be extremely careful that its association with Blackmores does not turn into a “CAM-wash” exercise, where any adverse research findings on efficacy or interactions are ignored by the company, with the products not being withdrawn or the promotional language unchanged. There are social and financial costs in the mass consumption of unnecessary and ineffective “medicines”. The pages of medical journals routinely expose such drugs in the conventional medicines area. Many are highly sceptical that far too many players in the complementary and alternative medicine industry are the historical siblings of snake-oil medicine. For the Blackmores-University of Sydney association to repudiate that concern, it will be important to see evidence that the evidence-based and ethical principles at the heart of medical research are both shared and acted upon by the company.

In view of the sensitivities involved over potential reputational damage, the Faculty would do well to appoint an external audit committee to periodically review the relationship and to provide the Faculty with a report on the impact of the research program on the way Blackmores responds to the research it will have supported.

Editor’s note: please ensure your comments are courteous and on-topic.

Simon Chapman is Professor of Public Health at University of Sydney.

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

Still no good evidence that most complementary medicine works

Ian Musgrave

The complementary medicine industry has been quick to respond to an opinion piece by Cassandra Wilkinson in The Australian newspaper on the lack of evidence for many complementary medicines, and particularly complementary medicines for children.

Alan Bensoussan of the National Institute of Complementary Medicine claimed in a follow-up letter to the Australian that complementary medicines included many well-established medicines (scroll down for the letter). He claimed that these well-established complementary medicines include medicines that prevent spina bifida in newborns, osteoporosis in the elderly, macular degeneration, cognitive decline, and childhood bronchitis.

Except, well, they don’t. You can search for clinical trials of complementary medicines for the above complaints that show them to be “well-established” and you will come up empty handed. You will find one or two studies suggesting that there might be a beneficial effect of some complementary medicine (see here for the inconsistent evidence for Ginkgo and macular degeneration), but nothing “well-established”.

Similarly, a search of systematic reviews, which look at the overall evidence from multiple studies, turns up nothing, although one treatment for osteoarthritis (not osteoporosis) glucosamine, might be beneficial in some patients. This is hardly “well-established” though.

If you go to the web site of the National Center for Complementary and Alternative Medicine and look up “bronchitis” you get the following “There is not enough evidence to support the use of any complementary health practices for the relief of asthma”. If you look up cognitive decline, you get a page that shows all current complementary therapies either do not help (and this includes the favoured herb, Gingko) or have not enough evidence.

So where does Alan Benoussan’s claim come from? Some clarification comes from an article in Pharmacy News, where Steve Scarff, regulatory and scientific affairs director of the Australian Self Medication Industry, also claimed that there is a growing evidence base to support the use of complementary medicines. Mr Scarff used as examples of clinically-supported complementary medicines “calcium and vitamin D for osteoporosis, omega-3 fish oil for heart disease, folate for pregnant women in preventing spina bifida, iron supplementation for anaemia, and evidence to support St John’s Wort for depression”.

One problem here, all but one (St. John’s Wort) of these are conventional medicine, not complementary medicine. It was conventional medicine that researched the physiology, did the clinical trials and developed the therapies and approaches, not complementary medicine (calcium and vitamin D for osteoporosis (note that this is not “one size fits all” medication), omega-3 fish oil for heart disease, folate for pregnant women in preventing spina bifida). Just because you sell vitamin pills doesn’t mean you get to appropriate the hard work of medical researchers and clinicians.

“Complementary” use of vitamins is usually use of high dose vitamins, such as high dose vitamin C for colds and flu’s (which doesn’t really work) or high dose antioxidant vitamins (high dose fat soluble antioxidant vitamin are actually associated with slightly worse outcomes and in some cases a slight increase in death). And vitamin supplementation of healthy, non-vitamin deficient people also has no benefit.

St. John’s Wort does have a modest anti-depressant effect (although very variable due to wide differences in composition). It also has significant side effects and very serious interactions with conventional medicines, so is not recommended for therapy. People have died because of it. Information on the side effects of St. John’s Wort from points of sale are generally very poor and most consumers will be unaware of them (see also here)

The claims from the National Institute of Complementary Medicine and the Australian Self Medication Industry does nothing to address the issues brought up in the opinion piece, namely that there is no evidence that complementary medicine works for children and that between 70-90% of complementary medicines surveyed did not meet regulatory requirements (71% had manufacturing or quality problems). As well, complementary medicine sponsors drag their feet when asked to remove non-compliant medicines (see here and here).

This is what the National Institute of Complementary Medicine and the Australian Self Medication Industry should be dealing with, not claiming the work of conventional medicine as complementary medicine.

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

2014, a Bad Year for Homoeopathy

By Ian Musgrave

This has been a bad year for homoeopathy, first there was the Draft Information Paper on Homoeopathy from the NHMRC, which concluded there was no reliable evidence for the use of homoeopathy in the treatment of the 61 health conditions looked at. Then a homoeopathic remedy manufacturer left the North American market due to law suites over the ineffectiveness of their products, then the Federal Court has found that Homeopathy Plus! was engaged in misleading conduct over its homoeopathic “vaccines”

Quoting from the ACCC website “…[Homeopathy Plus!] engaged in misleading and deceptive conduct and made false and misleading representations to the effect that there was an adequate foundation in medical science for the statement that homoeopathic treatments are a safe and effective alternative to the whooping cough vaccine, when in fact no such foundation exists..”

However, this is not a one-way street. Complementary Medicines Australia has claimed, 6 months after the public consultation process had closed, that the NHMRC process was flawed. In the august publication Food Navigator Asia it was claimed to be “fatally flawed”.

What coffee diluted homeopathically looks like. Ian Musgrave

Before we examine these claims, let me remind you that homoeopathy is based on two principles “like cures like” and extreme dilution, in most cases to levels so dilute that there is almost no chance of a single remaining molecule of original compound being present in the remedy. Thus caffeine diluted 1 in a hundred 30 times is used to treat insomnia and Uranium nitrate diluted 1 in a hundred 30 times is used to treat diabetes.

In the latter case it is fortunate at no uranium will actually be present, as uranium nitrate causes kidney failure. In uranium nitrate-induced kidney failure some glucose turns up in the urine, as the kidneys ability to reabsorb it is damaged. This is completely unlike what happens in diabetes, where high blood glucose overwhelms the kidneys capacity to reabsorb it (in uranium nitrate toxicity blood glucose is not elevated so it is not “like” diabetes at all). Thus the rationale for homoeopathic treatment is flawed at many levels.

But back to the draft report of the NHMRC’s review of homoeopathy. This represents the largest and most extensive recent review of homoeopathy research. The review looked at both systematic reviews of the use of homoeopathy in 61 heath conditions and submissions on behalf of interested parties, which contained a mix of systematic reviews and individual randomised controlled trials. All submissions and papers were carefully evaluated against strict criteria recognised internationally for this type of review. The Australasian Cochrane Centre independently reviewed the overview report to ensure that it was valid and high quality.

To remind you, the review found there was no good evidence that homeopathy was effective for any of the 61 medical conditions considered. In some cases, there was clear evidence that homoeopathy was ineffective; in others the evidence base was too weak to give a clear result. These findings are in concert with other large reviews of homoeopathy. Let’s look at the claimed “flaws”.

There was no adequate explanation of why randomised controlled trials (RCTs) were excluded.

They were not excluded. The main review focused on systematic reviews, which included randomised controlled trials (and other types of high level evidence). This is the best way to compare multiple studies. Randomised controlled trials are considered the highest level of evidence, but the results of a single randomised controlled trial may be misleading for many reasons.

Chance is one, if a therapy has no actual effect,by chance alone you will find some studies that appear to show an effect.

Thus it is far better to compare as many high quality trials as possible to get a clearer picture. Randomised trials were not excluded, but an integral part of the evidence through systematic reviews. Randomised controlled trials submitted by stakeholders that were not already part of systematic reviews were considered as well.

While there are limitations to this approach (specifically the most recent research may be excluded), it is widely used in making clinical decisions and in no way invalidates the findings of the report. One of the biggest limitations is that negative findings tend to be under-reported, so that systematic reviews tend to overestimate the effectiveness of a therapy. That homoeopathy cannot pass muster under these conditions is telling.

Three academics invited to comment on the review all broadly agreed there was no high quality evidence recommending homoeopathy for any disorder.

The review excluded too many studies.

Of the 1367 publications considered in the main review, only 60 were finally considered. Not because of anything sinister, but because only those met the review criteria. 374 were duplicate citations, 729 were the wrong study type (not peer-reveiwed, not systematic reviews or metaanalyses, or not looking at controlled trials or high level evidence) or were not looking at the conditions considered in the review or did not report the outcomes (etc. etc.) (see the main review for details).

Of the reports submitted by stakeholders, only a few passed the inclusion criteria or were not already included. Pro tip, if the NHMRC asks you for peer-reviewed systematic reviews and randomised controlled trials in humans, don’t submit books on the life of Hahneman and studies of frogs exposed to thyroxine (yes, I went through the papers).

The review did not consider any publication not in English.

While this excludes some studies, most high quality studies are published in the English language press. As well, the practicalities of translating foreign language papers to ensure there are no complicating errors in translation are avoided. Overall, the impact of this decision on the reliability of the report is marginal at best.

The NHMRC had not appointed a homeopathic expert to the panel.

Assoc Prof Evelin Tiralongo on the NHMRC panel is trained in homeopathic remedies.

The review did not consider animal studies.

These homoeopathic preparations are already in use in humans, so the appropriate studies are ones in humans in the first place. As well, the studies in animals suffer the same flaws as those in humans, too many are of poor quality and many are unable to be interpreted or make claims that cannot be supported. For example, one study submitted to the review that claimed to demonstrate that homoeopathic treatments kill breast cancer cells actually shows that the ethanol diluent is the lethal factor.

Summary

Overall, while there are some limitations to the study, this is a wide ranging, carefully interpreted study. While overall the broad conclusion is that there is no good evidence the homoeopathy being effective in the 61 studied conditions, in at least 13 studies there was good evidence that homoeopathy was ineffective (asthma for example). The results of this study are in broad agreement with previous studies of homoeopathy (see also this, and before you bring up the “Swiss Report” see here and here).

The NHMRC study conclusion that “…the assessment of the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered” cannot be ignored or dismissed.

This article was originally published on The Conversation. (Reblogged with permission). Read the original article.