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Is Evidence-based Medicine in Palliative Care Doing More Harm than Good?

By Friends of Science in Medicine

Stringent regulations govern what is administered to us in the prime of our lives, but different values seem to apply when it comes to the terminally ill and the dying.

Clinicians use evidence-based practices in most medical specialities to give their patients the best possible treatment. When it comes to palliative care, however, the literature is bombarded with articles about the challenges of obtaining quality evidence in this important aspect of medicine. Those challenges stem from a multitude of factors: problems with project design, recruitment, attrition, ethical issues and funding. In fairness, these difficulties affect clinical research in all medical disciplines, but they seem to be more prominent in treating the most vulnerable and physically impaired patients – those who are terminally ill.

A principal aim of palliative care involves prescribing pharmacological interventions to provide relief from symptoms and increase the quality of life for patients with incurable conditions. However, several drugs used in palliative care are not listed on the Pharmaceutical Benefits Scheme for use in palliative patients. This is largely because there is a lack of appropriately designed clinical trials providing evidence of efficacy and efficiency of the drugs used in palliative care.

What is more alarming is the use of pharmaceutical drugs designed for other purposes, where the benefit-risk ratio for palliative care patients is unclear. For example ketamine is commonly used to treat pain related to cancer, but it has been associated with increased rates of toxicity and a lack of net clinical benefit to many palliative care patients who receive it.

Haloperidol is another drug commonly prescribed to treat the debilitating symptom of nausea in terminally ill patients, but the evidence for its efficacy as an anti-emetic in a palliative population is lacking. One study showed that only 24% of palliative care cancer patients will report complete response after treatment with haloperidol, yet it is still prescribed to patients with life-limiting illnesses.

Ethical considerations also play their part. The research culture in palliative care is growing, but some in the medical community still argue against evidence-based research in this area. In clinical research, randomised controlled trials provide the gold standard for comparing and evaluating treatment modalities. These involve the possibility of being randomly assigned either a placebo or the active trial drug. The possibility of a terminally ill patient being given a placebo instead of active treatment has led to interesting ethical debates. Some physicians believe it is unethical to give a dying patient a placebo instead of active drug treatment that may bring them relief. On the other hand, clinical researchers argue that it is unethical to prescribe a medication to a patient without it having been properly tested in a randomised controlled trial.

Ultimately, whether to participate in a clinical trial is the patient’s and their family’s decision, but in the last stages of life, when fear and pain may be constant factors, patients and their families are very dependent on advice, and the treating physician’s views on clinical research play a huge role in whether a patient consents to be involved in any type of research study.

Much publicity is given to the public about the importance of medical research in our society, and the focus is primarily on preventing and curing disease. But Australia is an ageing country, and death from a life-threatening disease is, or will be, a reality for many. Improving the quality of life in terminally ill patients through clinical research, and applying evidence-based palliative care, should be embraced, not avoided.

It is not surprising that the literature lacks randomised controlled clinical drug trials in palliative care when funding is scarce, public appeals focus on particular diseases, and ethical arguments complicate considerations about research in this sensitive field of medicine, but our focus should be on improving education about the appropriate treatment of the dying and in promoting the importance of evidence-based research into how to do that best.

This starts with the medical professionals who make decisions that about our health, even when that health may be fragile and waning.

Dr Natalie Cutri is a clinical researcher who worked as the recruitment project officer for the Palliative Care Clinical Studies Collaborative at Flinders University.