- Diet, exercise, and behavioral modification were not standardized
among treatment centers.
- Using the last observations carried forward method assumes that the
individual data at the time of drop-out is representative of the data
at the end of the study if the participant had completed it. In most
cases, when treatment improves the condition over time, this method
is a conservative bias in which the drop-out value is not as good as
if the person had completed the study. However in this study, the effect
of Orlistat is more substantial in the beginning but weakens as time
goes on; by using the last observation carried forward method, it might
have led to a better outcome especially if the drop out rate was during
the beginning of the study.
- Although the results were statistically significant, one may argue
that the treatment effects from Orlistat were modest (decrease of 2.61
kg in weight and 0.86 in BMI from the placebo participants over 1 year)
and may not be substantial enough to sustain treatment in adolescents.
On the other hand, slowing weight gain can have benefits such as delaying
the development of obesity-related complications such as type 2 diabetes.
- Patient population was highly selective which may affect the generalizability
of these results.
- Study duration was one year and longer follow-up studies are needed
to allow assessment of efficacy and safety beyond one year.
JP, Hampl S, Jensen C, Boldrin M, Hauptman J. Effect of Orlistat on
weight and body composition in obese adolescents: A randomized controlled
trial. JAMA 2005; 293:2873-83.