Almost three years ago, one of the British Medical Journal – one of the top rated medical journals in the world - published an amusing article with an extremely serious sting in the tail. The article, entitled "Parachute use to prevent death and major trauma due to gravitational challenge," highlighted some of the absurdity surrounding the constant demand for scientific validation using only one set of criteria.
The authors pointed out that - as with many interventions intended to prevent ill health - there had been no randomized controlled trials of parachutes in preventing the major trauma that may be caused by gravity!! Yet we would hope that nobody would consider exiting a plane in flight without first equipping himself or herself with a parachute.
Advocates of evidence-based medicine have criticized the adoption of interventions that have only been evaluated by using observational data.
The authors therefore said that, “We think that everyone might benefit if the most radical protagonists of evidence based medicine organized and participated in a double blind, randomized, placebo controlled, crossover trial of the parachute.”
They used the lack of randomized controlled trials in testing parachutes to show that situations still exist where such trials are not only unnecessary, but also dangerous.
Anyone who has spent 30 seconds on this blog knows that I’m firmly committed to the rational analysis of data. But I am just as certain that there are many valid types of evidence.
There is an important article in this week’s issue of the British Medical Journal that lies at the heart of Integrated Medicine, and the research that we’ve been facilitating. The article suggests that waiting for the results of randomized trials of public health interventions can cost hundreds of lives, especially in poor countries with great need and potential to benefit. If the science is good, we should act before the trials are done.
The article argues that the “parachute approach,” where practice and policies are based on good science but without randomized trials, is often more suitable in resource poor settings. They go on to consider three areas of critical importance, in which there are real ethical, moral and logistical problems if we wait for the results of randomized controlled trials.
They use the three examples of:
- Oral rehydration therapy
- Male circumcision to prevent HIV infection
- Misoprostol for postpartum hemorrhage
We have constantly run into the same kinds of problems with alternative, complementary and now Integrated Medicine. In most of theses fields there is precious little in the way of randomized controlled trials, but a wealth of clinical reports and case series. The problem with unorthodox medicine is that much of it does not fulfill one of the criteria for the parachute approach: to be “based on good science.” This is one of the reasons for expending so much energy on finding common ground between conventional and Integrated Medicine, and for investigating several advances in the basic sciences that may help us square the circle.
It is also why we have adopted a second criterion: the potential for a therapy to do harm. Clearly the level of evidence for risk and benefit is quite different for a potentially risky surgical procedure, compared with, say, crystal therapy. The biggest risk with crystal therapy is that it might get used inappropriately in place of a treatment that has been shown to work.
But above all else, when we are dealing with sick and suffering people, we have to take action. Safe action, action that has a good chance of helping, and action that is fully explained to the individual. Honestly and straightforwardly, and without false optimism.
“A man's best friends are his ten fingers.”--Robert Collier (American Writer and Publisher, 1885-1950)