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Is There a Place for Integrative Medicine Approaches in Clinical Trials?

Adopting a patient-centric approach to clinical research and healthcare has fast become best practice for many — and aspirational for plenty others. This approach requires putting patients first, granting them greater autonomy in their treatment journey and treating the whole person.

It’s regarding the last point in particular that integrative medicine (IM) and complementary and alternative medicine (CAM) have become important components of better patient care. Even with opinions far from unanimous about the efficacy of these types of treatment, practitioners (and more so their patients), believe that relying solely on conventional medicine for holistic treatment no longer seems sufficient.

In this post we explore what IM and CAM mean in the clinical environment, how valid they are considered to be and how valuable they can be to patients.

Defining Integrative Medicine

The American Board of Integrative Medicine and the Consortium of Academic Health Centers for Integrative Medicine define integrative medicine as the practice of medicine that focuses on the importance of the practitioner-patient relationship, using a variety of healthcare approaches and disciplines to treat the whole person.

Defined this way, integrative medicine includes complementary health treatments such as mind and body practices, dietary supplements and medicinal herbs and botanicals, explains Bette Weinstein Kaplan at Oncology Nurse Advisor.

It’s not hard to understand why people look to any possible treatment to make themselves or their loved ones healthier. This is probably even truer when parents are seeking treatment for their child suffering from a terminal illness. While the motivation may be pure, Kaplan notes the treatment may not always be suitable and indeed many IM and CAM approaches are not necessarily effective. For example, a study into children with anxiety undergoing hematopoietic stem cell transplantation were treated with aromatherapy by way of bergamot essential oil, which actually increased their anxiety and nausea compared with the control group.

However, dismissing these IM and CAM approaches out of hand is not prudent either. Kaplan explains that parents of children with cancer have effectively used massage techniques to help manage the pain associated with their children’s condition.

The Popularity of Plants

Plants remain a useful means of treating patients. In fact, as many as 80 percent of the world’s population use them, explain researchers Neha Arora Chugh, Shreya Bali and Ashwani Koul in their article published in the journal of Integrative Medicine Research.

Between 70 and 95 percent of people in Africa, Asia, Latin America and the Middle East rely on some form of traditional medicine as their first line of treatment. Traditional Chinese medicine (TCM) has been used to control acute respiratory distress syndrome, while in Africa, traditional herbal medicine was used to alleviate HIV symptoms.

The researchers say the international market for herbal supplements and remedies will be worth $115 billion by 2020.

Studies Into the Efficacy of CAM

Many regard plants and other alternative or complementary therapies as effective, but to determine medical efficacy, we need to consult studies. According to the NIH, various studies have shown the efficacy or failings of CAM. These include:

  • Effective. Chiropractic care is as effective as conventional medical treatment for moderate relief from low-back pain.
  • Effective. Acupuncture significantly reduced osteoarthritis knee pain when used to complement conventional therapy.
  • Possibly Effective. People with fibromyalgia may benefit from tai chi.
  • Not Effective. The dietary supplement Ginkgo biloba does not reduce the development of dementia and Alzheimer’s disease in older people.

portrait of doctor in front of traditional chinese medicine cabinet - integrative medicine

Traditional Chinese Medicine for Fractures

TCM has been used to treat patients with osteoporosis by reducing the likelihood of fractures. According to a study by Yu-Chi Wang, Jen-Huai Chiang, Hsin-Cheng Hsu and Chun-Hao Tsai published by the journal of BMC Complementary and Alternative Medicine, patients that received TCM experienced a lower incidence of fracture events than patients without TCM treatment.

The study also showed that the length of treatment was important: The longer patients underwent treatment using traditional Chinese medicine, the lower the fracture rate, and concluded that TCM may have a positive impact on osteoporotic fracture prevention.

Three Spheres of Integrative Treatment

Integrative medicine has been used to treat colorectal cancer by relying on three spheres of intervention — lifestyle, biology, and conventional treatment.

The lifestyle sphere refers to nutrition, biobehavioral strategies with circadian interventions, and physical care modalities, explain Keith I. Block, M.D., Penny B. Block, Ph.D., and Charlotte Gyllenhaal of Block Center Integrative Cancer Treatment.

Biology refers to the patient’s internal biochemical environment, including inflammation, glycemia, immune dysregulation and coagulopathy, among others. Conventional treatment includes lifestyle advice and supplements and drugs to make that treatment more tolerable or effective.

Healthcare providers can use all three spheres to treat patients with colorectal cancer and provide individualized care. However, Block et al argue that while studies show credibility behind integrative care, more research is required.

The Research Value of Prostate Cancer

Because many patients with prostate cancer often survive for long periods living with the disease, makes it a valuable study tool. It affords time to research how the way these men eat, exercise and live can be changed and how those changes affect their condition, writes integrative oncologist Donald I. Abrams in his study “An Integrative Approach to Prostate Cancer.”

When treating prostate cancer, conventional medicine can often be delayed, and when it is used, side-effects of surgery, radiation or androgen deprivation therapy can be treated with complementary therapies, Abrams says. Under the study, patients consumed a plant-based diet rich in antioxidants and high in marine omega 3 fatty acids. They were also administered supplements for vitamin D3, omega 3 and other nutraceutical-based preparations.

These interventions, along with exercise such as yoga positively impacted patients, the latter having a salutogenic effect for both patients and caregivers, Abrams explains.

Too Few Opportunities to Learn

While there is definitely a demand for and from clinical researchers and oncology providers to learn about integrative oncology, few opportunities exist, researchers note in a commentary published in The Journal of Alternative and Complementary Medicine.

Patients request complementary or alternative therapies but their healthcare providers are unaware of how to advise them or implement it into treatment plans.

Serious smart scientists doing a research together - integrative medicine

Integrative Medicine as Quackery

Some healthcare practitioners regard integrative medicine unfavorably. Surgical oncologist David Gorski at Science-Based Medicine calls it mysticism quackery and pseudoscience. He argues that integrative medicine stretches its scope too broadly and allows homeopathy and acupuncture, as examples, to be integrated with science-based medicine.

The result is that integrative medicine co-opts diet, exercise and lifestyle interventions rather than consider them part of a conventional medicine approach, which Gorski says they always have been.

Research Challenges With CAM and IM Therapies

So far, there are three categories of support for CAM therapies: those based on clinical outcomes in controlled clinical trials; physiological evidence; and traditional use over century-long periods. Yet researching CAM and IM in a clinical setting presents challenges not encountered when studying conventional treatments, explains internist Dr. Denise Millstine.

For a start, therapies are often not standardized. That means acupuncture practices may differ  between practitioners and plant extracts might be dependent on plant species and climate. Equally, diagnoses may not be standardized as many CAM therapies are designed to meet a patient’s unique characteristics or experiences rather than disease or disorder.

It’s difficult to employ double or single-blinding, Millstine says. Patients know they are meditating or practicing Tai Chi, for example. Likewise, determining the effect of placebos is a challenge as massage therapy, for instance, could be effective based on touch itself, the specific area of the body massaged, the particular massage technique used, the length of the massage or a combination thereof.

Nevertheless, Millstine says there are many high-quality studies of CAM therapies such as acupuncture and homeopathy.

An IM Case Study

When confronted by a patient with high cholesterol, cardiologist Dr. Shaista Malik prescribed more than medication. She advised the patient to eat a plant-based, vegan diet and take herbal supplements for heart health. The results were that within six months the patient no longer needed cholesterol medication.

This approach is becoming increasingly common and Malik calls it integrative health 2.0. Treatment relied on conventional approaches such as diagnostics and genetic testing. The lifestyle and dietary treatment helped make the conventional medicine work better.

Malik is executive director at the Susan Samueli Integrative Health Institute in California, which has long used the approach of seeing a patient as a whole person, combining conventional treatment with mind, body, spirit and emotional wellbeing. Hard clinical evidence of the efficacy of certain aspects of integrated health is sparse, however, the notion of treating the whole person to improve patient outcomes is powerful.

Until such time that IM and CAM are able to stand up to the rigorous testing standards required by clinical trials (or the testing processes themselves are changed to accomodate integrative medicine and complementary and alternative medicine), patients will do well to temper their enthusiasm about these treatment approaches. The clinical research community must be able to investigate these therapies thoroughly and prove or disprove their efficacy, before healthcare providers can prescribe them with confidence.

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