Two out of three Australians use complementary medicines to boost their nutrition, alleviate various symptoms and improve their overall health and well-being. There are around 10,000 products to choose from and they’re not cheap – the industry generates around $1.2 billion in sales each year.
Despite the availability and common use of these vitamins, minerals, herbal remedies, aromatherapy and homeopathic products, consumers can’t always be sure how effective they are.
While pharmaceutical companies are required to prove the quality, safety and efficacy of prescription drugs and over-the-counter medicines to the Therapeutic Goods Administration (TGA) before they’re “registered”, complementary medicines aren’t required to live up to the claims on their packaging.
Rather, complementary medicines are “listed” by the TGA after being reviewed for safety and quality only.
The quality requirement means the medicine is produced by a licensed manufacturer and adheres to the Good Manufacturing Principles. The safety requirement is important because the components and content of active ingredients can vary, particularly among herbal products.
The difference between registered and listed products, and whether they’ve proved their efficacy, is often not clear to the consumer. And as we saw with Ken Harvey’s recent battle with Sensaslim over allegations of false and misleading advertising, consumers can’t always believe the claims made by manufacturers about the efficacy of complementary medicines.
The public backlash after the Pharmacy Guild announced its (now defunct) plan to recommend Blackmores products to patients filling a prescription for four common ailments also shows consumers feel confused and misled about the efficacy of complementary products.
The TGA is expected to address this problem in the coming weeks by announcing that complementary medicines will soon have to carry a “not tested” label.
But labels alone wouldn’t provide enough information to consumers, who want to know whether the medicine works. For that, testing is required.
So how should these therapies be tested? And should the same rules that are applied to prescription and over-the-counter medicines be applied to complementary medicines?
Pharmaceuticals are subjected to a series of randomised controlled studies to demonstrate their effectiveness. And while some complementary medicines have undergone similar rigorous reviews to demonstrate their efficacy, the idea of such evidence-based testing is problematic for many complementary and alternative medicine practitioners.
Practitioners of complementary medicines work in many different ways and their patients have varied goals.
Some complementary therapies, such as homeopathy and acupuncture, are based on the assumption that the human body has an energy level, with therapies having a physiological impact via the energy level. How could this be tested?
As Wainwright Churchill noted in an article in the Journal of Chinese Medicine, in order to test the efficacy of complementary medicines, you would first need to address some difficult questions:
Should the treatment that is researched be individualised for each patient?
Does it involve the personal relationship between the treating health professional and patient?
Does it involve the patient’s expectations, conscious or unconscious, of the treatment?
This leads us to the role of the placebo: Is the placebo effect a valid healing modality?
Sceptics deride the placebo. And yet, the placebo effect is powerful in all therapeutic relationships, in allopathic and complementary medicine. To be effective, placebos don’t even require conscious belief in a particular treatment.
In determining a process by which complementary medicines should be evaluated, regulators should look to Switzerland for some lessons on what to avoid.
In the late 1990s, the Swiss government began a Program for Evaluating Complementary Medicine (PEK – Programm Evaluation Komplementärmedizin).
The findings of the evaluation were inconclusive but six years later, five complementary therapies were removed from the list of services covered by the national health insurance scheme. This occurred before all parts of the review had been completed and the process was far from transparent.
Recently, the Swiss government decided that from 2012 the five complementary therapies that had been removed from the health insurance scheme will be included again, at least for another six years. During that time, the organisations representing the five therapies will have to prove their effectiveness.
In Australia, consumers need reliable information about the effectiveness of all medicines, complementary or otherwise. The TGA’s plans to slap an “untested” label on complementary medicines simply isn’t enough.
It’s clear, however, that this world-first style of regulation won’t be easy. Regulators need to find testing methods that are acceptable to the majority of stakeholders – I’m not going to hold my breath but I hope we can one day achieve this goal.
Should complementary medicines be tested for efficacy? Share your comments below.