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International Clinical Trials

Yes, we CAM

Opinions about complementary and alternative medicine (CAM) vary widely, from uncritical enthusiasm to uninformed scepticism. However, what cannot be disputed is that these unconventional treatments are gaining in popularity. As a result, in many parts of the world, politicians, health professionals and the public are raising questions about security, effectiveness, quality, availability, prevention and the future of healthcare based on CAM.

One of the first skills that medical students have to acquire is how to assess a patient’s medical history, including identifying what medicines they are currently taking. With the growth of CAM, physicians should be even more aware of the risk of side-effects and interactions between various drugs in the body, particularly if the patient participates in a clinical study.

Areas of Concern

Interactions between alternative treatments and the product undergoing tests may result in a false positive outcome, potentially leading to the registration of an ineffective drug, or the registration of a drug with harmful side-effects, not reported when both treatments are used concurrently (1,2).

People worldwide are increasingly disillusioned with conventional healthcare and often turn to CAM. At the same time, patients are more aware of clinical trials and take part in them in growing numbers. Unfortunately, this is not accompanied by greater awareness that CAM therapies may have a positive or negative impact on the final assessment of the safety and effectiveness of the product undergoing a clinical trial.

CAM Definition

The US National Center for Complementary and Alternative Medicine (NCCAM) defines CAM as a set of healthcare systems, practices and products that are not generally accepted – so rejected or only partly accepted – by practitioners of conventional, science-based medicine (1). According to another defi nition, adopted by the World Health Organization (WHO), CAM is a set of healthcare practices that are not part of that country’s own tradition and are not integrated into the dominant healthcare system. Other terms associated with this defi nition include ‘natural medicine’, ‘unconventional medicine’ and ‘holistic medicine’ (2).

Traditional medicine, on the other hand, is defined by the WHO as the sum total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness (3,4).

Strictly speaking, complementary medicine is used alongside conventional medicine, while alternative treatments replace it, although often these two terms are used interchangeably.

NCCAM distinguishes between the following four categories of CAM (5):
  • Practices based on the interaction of biological processes
  • Energy therapies
  • Methods based on the body and on manipulation
  • Mind-body medicine
Worldwide Use

It is often believed that CAM is used more often in Asia than in the West, due in part to the uptake of Indian Ayurveda and traditional Chinese medicine. This is true to an extent – WHO studies show the proportion of patients who use alternative medicine is high in Asian and African countries and other developing nations, but those same studies also indicate that CAM use is signifi cant in the US, Australia and Europe.

Certainly, alternative medicine is practised on a huge scale in Asia. For example, in China, traditional Chinese medicine has its own medical schools, hospitals and research institutes, as well as its own department in the Ministry of Health, which subsidises it.

But that is not to say its use in Western nations is low. In the US, for instance, NCCAM reports that approximately one in three adult Americans uses CAM, and that each year the number of visits to CAM medical practitioners exceeds the number of visits to primary care physicians (6).

Overall, the most common therapies include: massage, vitamins, healthy food (including dietary supplements), acupressure and Kampō (a traditional Japanese medicine). Others are steadily growing in use, such as Korean oriental medicine, which uses herbs, animal secretions and therapy-based diets.

That said, there are still more patients who visit doctors practising Western medicine than those who choose traditional Chinese medicine. Patients much more often use alternative medicine to maintain a satisfactory state of health than to treat diseases. Many of these patients do not inform their family doctors and specialists about it, fearing a negative reaction and disapproval.

Patient-Physician Interaction

Due to the significant role played by CAM in many societies, including those of highly developed countries, a small survey on this topic was undertaken among doctors.

The purpose of the study was to investigate the attitudes, prevalent among physicians-investigators, towards CAM as a therapy often associated with conventional treatment. It also sought to ascertain the extent to which physicians who treat patients in clinical trials are aware of the use of alternative medicine and its possible correlation with the use of the products being tested.

Carried out between 22 November 2012 and 1 March 2013, the online survey gained feedback from 23 respondents – medical doctors of any specialism involved in clinical trials either as principal investigators or sub-investigators.

The responses were analysed to evaluate the use of CAM patients during trials, and investigators’ awareness of the possible interaction between the products being tested and the alternative methods.

Survey Analysis

All of the questionnaire respondents had been or were currently involved in clinical trials as physicians-investigators. Respondents included neurologists (30 per cent), oncologists (25 per cent), internists (20 per cent) and cardiologists (15 per cent).

One question asked was if they enquire about patients using alternative medicines when assessing medical histories before clinical trials? Of the 18 respondents who answered, 13 said yes and five said no – indicating that about three-quarters make this check.

Another question was whether their patients in clinical trials use alternative medicine when taking part in the study? Based on feedback from the nine respondents who answered, 50 per cent of all patients said they do. Four respondents did not know what specific alternative therapies their patients were using.

It is recommended to investigate further if alternative medicines are being used by patients in trials, particularly those relating to pharmacological therapies or investigational products.

Supplement Information

A further question asked what alternative medicine therapies are used by patients who also participate in a clinical trial?

Feedback from the 12 respondents who answered indicated that vitamin and mineral supplements were the most popularly used. This is perhaps unsurprising as these forms of alternative medicine are arguably the most readily available and cheapest of those listed.

It should be noted that very few patients/trial participants are aware that the use of such widely available vitamins and minerals is classified as an alternative therapeutic treatment. Indeed, the author’s own experience indicates that few patients realise that, when their medical history is being taken, they should inform the physician conducting a trial of their use of such supplements. In addition, there may often be incorrect reporting of concurrent medicines by physicians-investigators.

Physician Attitudes

As mentioned, a specific aim of the survey was to identify physicians’ awareness of the use of alternative medicine by participating patients and its possible correlation with the use of the products being tested in the trial. The following list shows the percentage of respondents who agreed with particular statements:
  • I carefully note the use of alternative medicine in source documentation – 63 per cent
  • As a physician, I am aware of the correlation between active substances and the products under investigation in the trial – 56 per cent
  • I do not oppose the patient’s choice, but I inform the study participant of a possible correlation and the unknown effect of alternative methods on the safety and efficacy of the active substance under investigation in the trial – 44 per cent
  • I do not oppose the patient’s choice, but at the same time I inform them that conventional medical treatment should be continued – 25 per cent
  • I reject alternative methods and recommend that their use be discontinued – 19 per cent
  • I do not oppose the patient’s choice and leave it without further comment – 13 per cent
The results indicate that physicians record the fact that alternative medicine is being used in source documentation, and are aware of the possible correlation between active substances and the products under investigation in the clinical trial. However, investigators are equally likely not to recommend that patients discontinue the use of alternative medicine, or to leave the decision to them.

Further Analysis

Clearly, this subject area requires further research and investigation, but the small survey outlined here does provide intriguing findings and raises some interesting issues for debate.

In particular, the survey suggests that physicians are aware of possible interactions between the product undergoing tests and the use of alternative medicine, and record the use of CAM in source documentation.

However, this does not match the authors' own experiences. Similarly, conversations with professionals familiar with the problem indicate that physicians rarely, if ever, note down information about alternative medicine therapies potentially used by patients.

It should also be noted that the design of clinical trial protocols and case report forms (CRFs) do not mention alternative methods directly, although the documents do feature questions concerning concurrent treatment. It is recommended that CRFs be developed further to request information about concurrent alternative treatment.

Future research needs to take into account the regional diversity of the use and role of CAM. Furthermore, at this stage it is difficult to unambiguously define and classify certain products and therapies used in various types of alternative medicine. The authors intend to undertake an analyse of the problem from the perspective of investigators who monitor clinical trials.

1. National Center for Complementary and Alternative Medicine. Visit:
2. General guidelines for methodologies on research and evaluation of traditional medicine (WHO/EDM/TRM/2000.1), WHO, 2000
3. Visit: nitions/en
4. WHO Traditional Medicine Strategy 2002-2005
5. Guidance for industry on complementary and alternative medicine products and their regulation by the Food and Drug Administration, FDA, December 2006
6. Institute of Medicine, Complementary and alternative medicine in the United States, pp34-35, 2005

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Marcin Stefanowicz PhD, MSc, BSc has over seven years of experience in clinical research, including three years in the laboratory focusing on cardiosurgery, oncology and vascular surgery indications. He is the owner of Trial-Med, responsible for good clinical practice and research training for investigators. Marcin is a member of the Polish Association of Good Clinical Practice and lectures in clinical research at the Pharmacy Department of Jagiellonian University.

Martyna Stefanowicz PhD, MSc has more than 10 years of experience in dentistry. Previously a General Oral Clinical Manager, she currently owns a small CRO focusing on clinical trials in the oral and cardiology areas. She has also authored several publications.
Marcin Stefanowicz
Martyna Stefanowicz
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