A growing understanding of how a person's genetic makeup affects their response to treatment demands a redesign of randomised controlled clinical trials (RCTs), which would also help integrate Asian and Western medicine for more effective and personalised treatments, say Liang Liu and colleagues.
RCTs are the 'gold standard' of testing the safety and efficacy of new drugs in Western medicine. This method relies on the concept of the average patient selected according to shared clinical and biological characteristics. "Yet such a patient does not really exist," say the authors.
Asian medicine, on the other hand, considers disease symptoms as a pattern specific to each person, with prescriptions tailored accordingly and revised during the course of treatment. "Such complexity and changeability has been difficult, if not impossible, to assess through the current standard method [of RCTs]," say the authors.
The current design of RCTs is also challenged by new understanding of pharmacogenomics (molecular or genotype-based therapies tailored to individuals). For example, the lung-cancer drug gefitinib was found to benefit patients with a specific gene mutation that encodes epidermal growth factor receptor, but only after initial negative results were probed by testing the drug on patient subgroups.
New types of clinical trials have been designed to integrate the principles of pharmacogenomics by selecting patients according to their genotype — and because such personalised medicine has similarities with methods used in Asian approaches to diagnosis, this type of trial would also work well for testing traditional medicines, argue the authors.
They recommend moving towards integrating Asian and Western medicine through a review of how trial outcomes are assessed, and by considering alternative inclusion and exclusion criteria for RCTs. The two styles of healing "can be developed together into an integrated form of personalised medicine," they conclude.