Evidence Based Medicine and complementary therapies – can they work together?

Evidence based medicine and complementary therapies may seem uneasy bedfellows, but this does not mean we should not explore how they may be effectively used together. In Asian cultures, such as China and India, it is accepted that their ancient medical knowledge can be successfully combined with more recently introduced western medical practice. Here in Australia many of our patients also embrace both, backing their medical treatment up with a variety of complementary therapies.

Professors Djulebgovic and Guyatt, proponents of EBM since its inception, have recently written an honest and comprehensive review of the progress in EBM over 25 years. In summarising they say that:

“EBMs enduring contribution to clinical medicine include placing the practice of medicine on a solid scientific basis, the development of more sophisticated hierarchies of evidence, the recognition of the crucial role of patient values and preferences in clinical decision making, and the development of the methodology for generating trustworthy recommendations.” (1)

As physicians, it is difficult to offer patient-centred holistic care, if we do not accept our patients’ values and preferences and their management choices, and support them in their decision making.

The use of Evidence Based Medicine

Since I started my medical training, now 50 years ago this year, the approach to medical care has been revolutionised by Evidence Based Medicine (EBM). Gone are the days when the medical text books we learned from, enormous as they were, could contain all we needed to learn. For us doctors coming to the other end of our careers, it has not been only a matter of learning the new but of letting go some of the old. The root of the word medicine may be in docere, teacher, but we are in fact for-ever students. While the miracle of the human body remains the same, medicine as a science is dynamic, ever changing and should always be open to challenge.

It is our role as clinicians to assimilate EBM, combine it with our clinical expertise, and use the art that is medicine to work with each unique patient to help them make informed decisions about their care. In general practice, where the variety of clinical encounters is so broad, we rely heavily on others to assess the validity of research evidence. In this we are supported by clinical guidelines and medical literature which synthesise research evidence into a useable tool in a clinical setting. In supporting patients’ decisions, we can use decision aids such as those developed by the Cochrane Institute which offer the patient up to date research to support their decision making process. (2)

How then are we able to assess the validity of complementary therapies and safely incorporate them into our medical practice, unless we encourage research?

Randomised Controlled Trials

Randomised controlled trials have for the last 70 years been the mainstay of clinical research, particularly for pharmaceuticals (3).

Introduced in the 1940s, they have been re-evaluated repeatedly to ensure the highest ethical standards and reliability. The original proponent of RCTs, Austen Bradford Hill stated that:

“Physicians should be particularly careful in accepting drugs purely on the basis of the manufacturer’s evidence or on the basis of testimonials provided to the manufacturer. They should demand clear, unbiased, well studied and adequately controlled evidence produced and interpreted by reliable observers.”(3)

It was the tragedy of thalidomide in the early 1960’s, causing phocomelia, which caused governments across the globe to mandate reliable research evidence for all pharmaceuticals and that mandate still stands today.

Evidence based medicine has grown more reliable and perhaps more realistic since its inception. The adage stands that the quality of evidence is only as reliable as the quality of the scientists and their research, and ensuring the integrity of medical research remains intact is of paramount importance to both physicians and patients.

“Critics have become increasingly adept at ferreting out flaws in RCTs, forcing trialists to be more vigilant in their designs. From a historical perspective, the RCT is not a single or stable technique, but an approach that has evolved as physicians have revised and refined clinical research.”(3)

It was at the instigation of several present and past editors of reputable medical journals that medical research and scientific journals were challenged to ensure that this work is of the highest possible calibre. The reality is that our patients’ health and even lives are at stake if this is not so.

In 2005 Richard Smith, a past editor of the BMJ, wrote an article entitled “Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies” detailing how trials could be designed to give the funding bodies the results that they want.(4)

Despite an awareness of the problems with pharmaceutical trials since Bradford Hills comments over 70 years ago, a recent study reported in the BMJ concluded that:

“Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.” (5)

In 2015 Richard Horton, then editor of the Lancet stated that:

“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.”

As one participant put it: “poor methods get results”. Horton concluded his editorial by saying:

“The good news is that science is beginning to take some of its worst failings very seriously. The bad news is that nobody is ready to take the first step to clean up the system.” (6)

Djulebgovic and Guyatt describe possible approaches to addressing flaws in medical research which affect the quality of EBM. These include the registering of research projects and the publication of all outcomes even though they may not be the ones the research funders were looking for. The pharmaceutical industry in particular is heavily invested in the outcomes of research that they fund, possibly raising questions of reliability and emphasising the need for effective control and monitoring of research, and of its publication.

It is not only our patients but also our doctors who are sceptical about undue influence on medical research – it is not perfect and it is imperative that we ensure that EBM is of the highest standard possible. We cannot point fingers at the lack of scientific research in complementary therapies until we attempt to address our own issues.

Applying evidence base to complementary therapies

The longer one works in medicine, the more you are made aware of gaps in our ability to control symptoms, let alone to cure all diseases. Often, we feel we have not truly reached the core of the problem, recognising the complexity of causative factors from epigenetics and life style choices to the mind-body connection.

A 2016 review of studies of the usage of Complementary Therapies (CT) in Australia has shown the high utilisation of CT by Australians ­– estimated to be the second highest in the world. (7)

The review found that the same patients who utilise complementary and alternative therapies are also frequent users of western medicine, in other words combining treatments. The reasons for using CT are complex, and although they do include dissatisfaction with the treatment they have received, distrust of pharmaceuticals and western medicine procedures, they may also be about feeling cared for more holistically, being given more time and having more of a sense of being in control of their lifestyle and treatment choices. These are all factors which we as western medicine practitioners should learn from. CT clients tend to be middle aged, women, educated and suffering from serious or chronic disease.

As doctors, we are polarised in our consideration of complementary therapies. I recently listened again to an ABC interview discussing these opposing view-points.(8)

Some doctors, seeing gaps in the effectiveness of western medical care, embrace complementary therapies, integrating them into their own clinical practice, working together in their clinics with practitioners of various natural therapy modalities. Others believe that scientifically unproven therapies have no place in medical care, should not be taught at universities and should not in any way be funded by Medicare or by insurance companies supported by government. In the middle are those who would embrace complementary therapies if they were validated.

Our patients will ultimately decide on their own management. I acknowledge the frustration we may feel as doctors when our patients choose alternative therapies, when western medicine may offer a cure for severe disease and we witness them deteriorating. It is important to ensure we have supported our patients to make informed decisions, addressing their fears and reservations about western medicine with honesty and sharing evidence based findings in ways which they fully understand. Often educated and informed people, we need to give our patients credit for judging the modality they choose by the effect on their own body and wellbeing.

As a profession, while having a suspicion of snake oil treatments (I know I draw the bottom line at coffee enemas), we have always been open to innovative ideas, that is after all how the science of medicine progresses. At what point did we decide that leeches were ineffectual, that bleeding patients was more likely to kill than cure? At what point did medicine embrace salicylates that are still used in modern medicine but which were medicinal herbs used from the time of ancient Egypt; or digitalis, found in foxgloves and long used in herbal medicine to treat “dropsy”?

We are aware of areas in which medical care is currently inadequate and it would be arrogant of us to dismiss out-of-hand therapies from which our patients report they are gaining benefit. Is it not time that we supported and encouraged the research of those complementary therapies that are open to scientific rigour? We have learned much from our pursuit of high standards in evidence based medicine, including the fact that controlled clinical observations provide more trustworthy evidence than do uncontrolled observations, biological experiments and individual clinicians experiences.(1) However, the authors agree that while regarded as lower levels of evidence, there is still a place for the older methods such as case series and case reports. In fact, in some fields of western medicine such as psychotherapy and surgery, RCTs have not been found to be as useful a tool.(3) This may also be so for some complementary medicine modalities.

When complementary therapies are validated, doctors are quick to embrace them, as seen with fish oil in cardiology and a surge of interest in gut organism health among gastroenterologists. Even if some of these therapies cannot be scientifically proven, we should perhaps look carefully at the so called “placebo effect” which may suggest that given time and compassionate care, the well-being of a patient will improve.

Our patients are embracing different complementary therapies, whether we approve of them or not. If our patients do not feel they can talk to us about what they are using, and what is helping, we are unaware of any deleterious interactions with what we are prescribing. Is there not a place for us to work together, to encourage research, to identify both positive and negative effects and to offer our patients more holistic care?

References:

1. Djulebgovic B & Guyatt G, Progress in evidence-based medicine: a quarter century on.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31592-6/fulltext

2. Cochrane. org

http://www.cochrane.org/evidence

3. Bothwell LE et al, Assessing the Gold Standard — Lessons from the History of RCTs

https://www.nejm.org/doi/full/10.1056/NEJMms1604593

4. Smith, Richard, Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies

http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020138

5. Ahn R et al, Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

https://www.bmj.com/content/356/bmj.i6770

6. Horton R, Offline: What is medicine’s 5 sigma? – The Lancet

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60696-1/fulltext

7. Reid, R et al, Complementary medicine use by the Australian population: a critical mixed studies systematic review of utilisation, perceptions and factors associated with use

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4902999/

8. Radio National morning show interview

http://mpegmedia.abc.net.au/rn/podcast/2012/01/bst_20120130_0805.mp3