UK doctor-scientist leading the debate on alternative modalities

Is there evidence for complementary-alternative modalities? Some say there’s been no good research done on CAM and dismiss it out of hand, others say it cannot be tested by using the scientific process and embrace it out of hand. Both sides use their respective reasonings to explain why no evidence exists to support CAM.

According to Dr. Edzard Ernst, M.D., Ph.D., FRCP, FRCPEd, they’re both wrong and the truth is much more complex. Writing in the current issue of the British Medical Journal Clinical Evidence, he says the topic of CAM cannot be ignored any longer as it’s everywhere in popular media, including on some 40 million websites, and increasingly entering into traditional medicine and even into government-sponsored initiatives. As the country’s first and only professor of complementary medicine, he’s devoted the past 15 years to putting alternative modalities under rigorous scrutiny to find out what works and what doesn’t.

When Dr. Edzard came to establish and chair the department of complementary medicine at the University of Exeter in 1993, he left a revered position as head of the physical medicine and rehabilitation department at the University of Vienna, Austria, and professor at Hanover Medical School in Germany. As one of the world’s most respected scientists with an impressive career, his peers found his decision to head into what they considered superstition and folklore unexpected. But his first love was research and he valued the study of medicine for the right reasons, rather than “about power, money and status.” As he told the Guardian in 2003: “People mistakenly think I must be a promoter of complementary medicine - that I should have an allegiance to the camp. I don't. My allegiance is firstly to the patient — I feel that very strongly as an ex-clinician — and secondly to science.”

Sadly, many consumers are intentionally confused and believe that the evidence proving CAM is stronger than it is, or that the evidence against certain claims are more equivocable than it really is. What he’s found most disquieting after years of study is that reliable information about CAM is not reaching the public and patients are the biggest losers.

Actually, CAM has been extensively researched. “There are now thousands of clinical trials of various forms of CM and hundreds of systematic reviews,” he writes. And the “knee-jerk reaction that ‘they are all rubbish’ is also incorrect. Indeed, on average, they compare very well in terms of methodological quality with trials in conventional medicine.”

BUT, the fact that credible studies exist does not mean that CAM is efficacious, he cautions. “ [Y]es, there is now plenty of evidence, and much of the recent research is reasonably sound, but by no means does all the evidence demonstrate that the treatment under investigation generates more good than harm.”

The second attitude that he finds disturbing is the claim that “scientific evidence cannot be applied to CAM.” This “tends to be used by proponents of CM whenever the data fail to show what they had hoped for,” he wrote. Homeopaths would only celebrate a randomized clinical trial of homeopathy, for example, if it showed it worked, he said. Otherwise “they are likely to ridicule the ‘tunnel vision’ of scientists and call for a ‘paradigm shift.’ Wanting to have cake and eat it may be all too human, but when applied to medicine, it badly misleads the public.” Putting it more forcefully, he added:

Many enthusiasts claim that the standard of evidence in CM must be different from that in mainstream health care, and they use a range of arguments to support their view: “My therapy is holistic, individualised, complex, etc; conventional outcome measures do not capture the subtle effects generated by CM; randomisation has detrimental effects that neutralise those of my treatment; and clinical trials tell us nothing about individuals”, for example. On closer inspection, these notions turn out to be pseudo-arguments, and it is tedious to argue against them (although a full discussion has been published). Suffice to say that, after years of debate, I have reached the conclusion that those who hold such views are either deliberately trying to mislead, or are not fully informed as to what a clinical trial can and cannot achieve.

Legacy of patient advocacy

While Dr. Ernst has been in the news abundantly this past week (more on that in a minute), he has more than a thousand papers in peer-reviewed publications, in addition to dozens of books and frequently consulted for consumer publications. His focus on the safety and welfare of patients has long been evident in his work. In August 2004, for instance, he warned consumers to be especially wary of websites claiming to offer cures for cancer and not place too much faith in complementary medicine’s ability to cure. Most claims for these modalities, he said, are unproven. He studied 32 of the most popular cancer websites and described his findings as “quite an eye opener and pretty scary stuff.”

“A lot of unproven stuff is being recommended to cancer patients,” he said. “Cancer patients, particularly those who are seriously ill, are desperate patients, and desperate patients will cling to any claim and promise that is being made to them. Therefore, I think bogus claims for alternative cancer cures are very, very dangerous.”

Especially worrisome, were the websites advising people to stop taking their regular cancer drugs. Dr. Ernst said there must be some people who have come to an earlier than expected death as a result of following that advice. Similarly concerning, is that some alternative products undermine the effectiveness of crucial life-saving drugs, he said. For example, St. John’s Wort undermines the effectiveness of Warfarin, leaving patients at a higher risk for having a heart attack. He reminded readers that these therapies were unregulated and to be sure to tell their doctors about any alternative therapies they’re using.

In the October 9, 2005 issue of Focus on Alternative Complementary Therapies, he reviewed the value of chiropractic, one of the only two CAM professions that are regulated in the UK (the other is osteopathy). “Hundreds of thousands of citizens consult chiropractors each year,” he wrote. “Therefore the question of the therapeutic value of chiropractic spinal manipulation is important for public health and we should evaluate it in more detail.”

He took issue with national clinical guidelines saying that “guidelines are well known to be influenced by the people who serve on the panel that develops them.” So, just like problems seen in official guidelines for traditional medicine, “chiropractors’ views on their very own treatment might not be entirely free of conflicts of interest.” On the other hand, independent research, such as that conducted by the Cochrane Collaboration, is considered to be objective and rigorous. It is “designed to be transparent, reproducible, fair and of the highest possible standard,” he wrote.

In the best interests of the public’s health, it’s essential to evaluate any treatment using the best available evidence. If something claims to work for a condition, it can be tested and shown to be effective or not. Nothing mysterious about that. Concerning spinal manipulations, he said there have been four Cochrane reviews of clinical trials to date:

The Cochrane review of spinal manipulation for back pain summarised 39 clinical trials. The authors’ conclusions were very clear: ‘There is no evidence that spinal manipulative therapy is superior to other standard treatments for patients with acute or chronic low back pain.’

A Cochrane review of spinal manipulation and mobilisation for mechanical neck disorders evaluated 33 clinical trials... ‘the evidence did not favour manipulation and/or mobilisation done alone or in combination with various other physical medicine agents; when compared to one another, neither was superior.’

Another Cochrane review summarised the available trials of chiropractic treatment for asthma. The authors found only two such studies and ‘neither trial found significant differences between chiropractic spinal manipulation and a sham manoeuvre on any of the outcomes measured.’

Finally, a Cochrane review assessed five trials of spinal manipulation for dysmenorrhoea. The authors concluded that ‘there is no evidence to suggest that spinal manipulation is effective in the treatment’ of this condition.

Of course, any consideration of therapeutic benefits also have to weigh any adverse effects. “Most chiropractors recognize that manipulation of the upper spine may lead to a stroke, which can be fatal,” he wrote. “However, they are adamant that such dramatic complications are extremely rare.” No Cochrane review is available that specifically addresses the safety of spinal manipulation, he wrote. However, “an authoritative (non-Cochrane) systematic review of this area included 295 complications after spinal manipulation.”

In the crosshairs: Foundation for Integrated Health

Dr. Ernst has taken particular issue with the Prince of Wales’ Foundation for Integrated Health and wrote a letter to the editor in The Times this week, along with science writer, Simon Singh, which has sparked a flurry of controversy. In it, they called upon the Foundation to withdraw two publications (Complementary Health Care: A Guide for Patients and the Smallwood report) for containing “numerous misleading and inaccurate claims concerning the supposed benefits of alternative medicine.” They noted that in 2000, the Prince had identified “rigorous scientific evidence as one of the keys to the medical establishment’s acceptance of non-conventional approaches,” yet there have been well over 4,000 research studies into alternative medicine since then and “the majority of alternative therapies appear to be clinically ineffective, and many are downright dangerous.” They conclude: “The nation cannot be served by promoting ineffective and sometimes dangerous alternative treatments.”

For those unfamiliar with the Foundation’s guide to complementary care, each entry includes an uncritical appraisal of each alternative modality without mentions of precautions, ineffectiveness or risks. A few examples:

“Homeopathy is most often used to treat chronic conditions such as asthma; eczema; arthritis; fatigue disorders like ME; headache and migraine; menstrual and menopausal problems; irritable bowel syndrome; Crohn’s disease; allergies; repeated ear, nose, throat and chest infections or urine infections; depression and anxiety...Your homeopath or pharmacist can advise you on the use of these remedies to treat first aid problems such as cuts, stings, minor burns, bruises and minor ailments.”

“Chinese herbal medicine is part of traditional Chinese medicine, which includes acupuncture, massage, tai chi (exercise using controlled movement) and qi gong (breathing exercises)... Traditional Chinese medicine is based on the theory that energy (known as qi, pronounced chee) flows through pathways in the body. Qi consists of equal and opposite qualities - yin and yang - and when these become unbalanced, illness may result. Practitioners usually prescribe a particular mixture of herbs for each patient, aimed at putting the balance right and improving the patient’s health... Herbal medicine practitioners treat a wide range of conditions including anxiety and depression; arthritis; chronic fatigue syndrome; eczema and other skin problems; fibromyalgia; hay fever; headaches and migraine; insomnia; digestive problems including irritable bowel syndrome; menstrual and menopausal problems.”

“Research suggests that yoga may be helpful for hypertension, asthma and reducing joint stiffness in osteoarthritis. There is also some evidence to suggest that it may be useful in epilepsy (Sahaja yoga), some kinds of irritable bowel syndrome, for reducing cholesterol levels and for mild depression. There are yoga therapy classes for a wide range of conditions including arthritis, asthma, back pain, cancer, diabetes, depression, digestive problems, fatigue, hypertension, heart disease, HIV & AIDS, ME, menstrual problems, multiple sclerosis, respiratory problems and stress.”

Thursday, The Times science editor, Mark Henderson, reported the response of a Foundation spokesperson, who told the paper: “We entirely reject the accusation that our online publication Complementary Healthcare: A Guide contains any misleading or inaccurate claims about the benefits of complementary therapies. On the contrary, it treats people as adults and takes a responsible approach by encouraging people to look at reliable sources of information... so that they can make informed decisions. The foundation does not promote complementary therapies.”

The paper then listed a few of the claims made in the Foundation’s guide and Dr. Ernst’s counter arguments, for example:

Chiropractic

The Guide: used in disorders of musculoskeletal system such as spine, neck, shoulder problems. It may also be used for asthma

Ernst: no good evidence for anything other than back pain

Acupuncture

The Guide: increasingly used in trying to overcome addictions to alcohol, drugs and smoking.

Ernst: The reliable evidence suggests it does not work for addictions

Cranial therapists

The Guide: the conditions they treat range from acute to chronic health problems

Ernst: No good evidence for any of this

Homoeopathy

The Guide: most often used to treat chronic conditions such as asthma; eczema; fatigue disorders; migraine; menopausal problems; irritable bowel syndrome; Crohn’s disease; allergies; repeated infections; depression.

Ernst: Data do not show homoeopathic remedies to be more than placebos

Reiki

The Guide: used for physical, mental and emotional conditions

Ernst: There is no good evidence that Reiki is effective for any condition

Evidence-based medicine

Dr. Ernst and Simon Singh have compiled their reviews of the thousands of studies on alternative modalities into a new book, Trick or treatment? Alternative medicine on trial, which is due out next month. This, no doubt, also partly explains the abundance of recent articles in the press, such as the one by Singh in this morning’s Guardian in honor of Chiropractic Awareness Week. Their book promises to reveal what works, what doesn’t and which alternative modalities are safe and which ones are dangerous.

In advance of the book’s release, they wrote a hard-hitting article in the Daily Mail last week describing the approach they took to put the alternative modalities to the test: “evidence-based medicine.”

As they wrote:

[E]vidence-based medicine has revolutionised medical practice, transforming it from an industry of charlatans and incompetents into a system of healthcare that can deliver such miracles as transplanting kidneys, removing cataracts, combating childhood diseases, eradicating smallpox and saving millions of lives each year. Evidence-based medicine is about using the current best evidence — gathered through clinical trials and other scientific investigations — to make medical decisions. Alternative medicine claims to be able to treat the same illnesses and diseases that conventional medicine tries to tackle. We set out to establish the truth of these claims by using the principles of evidence-based medicine.

Some people will be suspicious of this, perceiving evidence-based medicine as a strategy for allowing the medical establishment to defend its own members and treatment, while excluding outsiders who offer alternative treatments. In fact, the opposite is often true — evidence-based medicine actually allows outsiders to be heard; it endorses any treatment that turns out to be effective, however strange it may seem. In the 18th century, for instance, lemon juice as a treatment for scurvy was regarded as implausible but the establishment had to accept it because it was backed up by evidence from trials. We had no axe to grind - indeed Professor Ernst even practised as a homeopath for many years (as well as receiving treatment as a patient) — and we came to our conclusions based on a fair, thorough and scientific assessment of the evidence. So what did we find?

While some modalities were found to offer some benefit, they found, “most have nothing to offer.”

“Many popular therapies are ‘effective’ only because they are good at eliciting a placebo response; making the patient feel better simply because they believe the treatment will help,” they wrote. They took issue with those who believed that the placebo effect justifies promoting these modalities, arguing “any treatment that relies on the placebo effect is essentially a bogus treatment.” And they’re far from cheap, costing individuals 1.6 billion pounds a year. The National Health Service also spends 500 million pounds per year on alternatives — money that could have been spent on 20,000 more nurses.

“If alternative practitioners are making unproven, disproven or vastly exaggerated claims, and if their treatments carry risks, then we are being swindled at the expense of our own good health,” they wrote, adding:

[The public is being misled over and over again, often by misguided therapists; sometimes by exploitative charlatans. It is time for the tricks to stop, and for the real treatments to take priority. The same scientific standards, evaluation and regulation should be applied to all types of medicine. If this doesn't happen, then homeopaths, acupuncturists, chiropractors, herbalists and many other alternative therapists will continue to prey on the most vulnerable — raiding their wallets, offering false hope and even endangering their health.

Their article goes on to describe a number of alternative modalities and claims, and answer the question “Does it work?” They explain the research evidence of effectiveness and risks for everything from the Alexander technique to osteopathy and the findings will probably surprise a lot of traditional medical professionals and CAM proponents. It really does not read as a hatchet job against alternative modalities, but carefully acknowledges when a modality may offer some benefit and when it can’t. They urge readers, in conclusion, to “look before you leap:”

Consult and inform your GP — the treatment might interfere with any ongoing conventional therapies. • Do not stop your conventional treatment unless your doctor advises that this is sensible. • Alternative therapies can be expensive, so make sure there is evidence to support the efficacy of a therapy before spending huge sums of money. • Every treatment carries risks, so make sure the risks are outweighed by the benefits.