Topic / Research News

Prof Jelinek publishes new paper showing the difficulty of lifestyle-related research

Critics often say there should be more research into MS lifestyle-based therapies; this study shows just how hard randomized controlled trials can be.

It is common to hear criticism of studies such as Swank's landmark research on the basis that the research wasn't a randomized controlled trial, or to hear calls for more controlled trials on the effect of retreats for MS or cancer. Many of these critics have never attempted such trials.

Randomized controlled trials are particularly well suited to assessing drug therapy; giving a placebo to one group and an active drug to the other, and assessing the difference is comparatively easy.

Doing a similar study for lifestyle-based therapies, such as diet, exercise, and meditation, is methodologically much more difficult. For a start, asking people to commit to such changes is not nearly as easy as asking them to take a drug.

Drop outs are common. And it is not unusual for many people in the 'placebo' or standard care group to take up the lifestyle changes, contaminating the randomization.

Earlier this year, Professor Jelinek was set to embark on an ambitious research study comparing a comprehensive lifestyle intervention essentially identical to the OMS approach for people with type 2 diabetes, a chronic disease that doctors everywhere accept is caused by lifestyle factors including obesity, poor diet, lack of exercise, and so on.

This was planned to be delivered via a five day residential retreat at the Gawler Foundation, very similar to the OMS retreats that are currently held four times a year

The study unfortunately was not able to proceed, simply because essentially no-one with diabetes was interested, despite widespread advertising and attempted recruitment through a hospital emergency department, diabetes clinic, general practices and via the internet.

There are important lessons to be learnt from this failure, but probably most importantly, that a lack of randomised controlled trials of lifestyle-based treatment for chronic diseases doesn't mean that this approach doesn't work, but rather that there is immense difficulty in conducting this kind of research and in accumulating the appropriate evidence that might convince critics.