25/03/2008

The Best of Both Worlds

Seth Roberts links to a story about an alcoholic curing his disease by self-experimentation:
The last time Olivier Ameisen formally practiced medicine was in the early summer of 1997. After two decades in the field, the French-born physician (...) abruptly rang up his secretary one morning and told her to clear his schedule. (...) He was ill, he told her; he was an alcoholic (...).
He tried pretty much everything to kick his habit, but nothing worked.
Finally (...) he read about a study of a muscle relaxant that had stifled the cravings of a cocaine addict. The drug, baclofen, had also shown efficacy against anxiety and depression. Eager to try it, he prescribed a high dosage for himself. Within a few weeks of starting the regimen, his craving for drink evaporated. Eleven months into his self-experiment, he published a case study of his self-treatment in the journal Alcohol and Alcoholism, and he is now writing a book called The End of My Addiction, chronicling his successful journey.

(...) But, contrary to Ameisen's experience, a recent double-blind study of 80 alcoholics at the University of North Carolina School of Medicine in Chapel Hill found no difference in outcome between those taking baclofen or a placebo.
Does that mean he is an anomaly? No.
Ameisen points out (...) that the dosage of 30 milligrams a day given to study participants was far lower than his up to 270-milligram daily dose, which studies had shown people could tolerate without displaying side effects (...).
That's an interesting contrast. I don't follow the medical literature, but from what I've read and heard, here's what medical researchers do when they want to determine the efficacy of a drug. In what they call a randomized controlled trial (RCT), participants are randomly assigned either to the control or the treatment group. Members of the control group receive a placebo. Members in the treatment group receive a fixed dosage of the drug in question.

Meanwhile, self experimenters, as well as doctors, will play around with the dosage if the first thing doesn't work (or try a different treatment altogether). Which makes sense given that people differ from each other. In medication, there's no one-size-fits-all.

I first thought about this when I read a short exchange between Andrew Gelman and, incidentally, Seth Roberts about the latter's hunger-reduction technique, which he calls The Shangri-La Diet*. (This must have been either on Andrew's or Seth's blog; I can't re-find it.) Andrew argued that the Shangri-La Diet should be tested in an RCT. Seth objected on the grounds that people, some of which post on his forums, were still experimenting with how to do the diet best (see below). Andrew replied proposing a certain specific regimen to be tested.

But why not combine the two methods? Instead of comparing a placebo group with a treatment group that practices the Shangri-La Diet in a specific way, you could compare the control group with a treatment group that you tell about the Shangri-La Diet and different ways to practice it and then instruct them to look for the way it works best for them. This would not test a specific regimen, but rather the diet as a whole.

Likewise, in the baclofen study, one could have tried increasing the dosage up to the amount which is deemed safe with patients for whom the initial results were not satisfactory.

Or is this thing already done in RCTs? If so, how common is it?

*For those not in the know, a very short description of the Shangri-La Diet:

The theory behind the diet is based on the notion that there is a body-weight set point. The set point is what the brain wants the body to weigh. The mechanism with which the body signals this is hunger (or lack thereof). To illustrate, if you are ten kilos below your set point, you'll be hungry pretty much all of the time.

Roberts argues that the set-point has a default tendency to slowly decrease over time. However, it will rise if you experience taste sensations that your brain associates with calories - if you eat familiar-tasting food.

The idea behind the Shangri-La diet is to lower the set point by giving the body calories from food that does not come with familiar tastes. Methods include: 1. Drinking extra light (!) olive oil (which is nearly tasteless) between meals. The between-meals bit is important so that the oil's calories won't get associated with the taste of the meals. For the same reason, the consumption of the oil must not go with any other tastes (cigarettes, gum, etc.). 2. "Crazy spicing": When you have a meal, use a random selection of spices to flavour it, so that the taste of the food is unusual every time. (This doesn't sound particularly attractive to me.) 3. Nose-clipping during meals. This reduces the taste sensation and thus the flavour-calorie association.

For more, go here.

As alluded to above, it's never been tested scientifically, and I've personally never tried it (I don't want to lose weight), but it seems to work at least for some people, as can be seen on his forums.


Addendum: More on baclofen dosages, also from Seth Roberts.

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