Randomized double blind placebo-controlled clinical trial. Polycystic ovary syndrome (PCOS)
is a frequent endocrinopathy, affecting more than 10% of women of reproductive age. It is
associated with a higher prevalence of obesity and insulin resistance, with a higher risk for
diabetes, dyslipidemia and hypertension. Topiramate is a drug used in the treatment of
epilepsy and migraine prophylaxis since the 1990s and several studies show an association
with weight loss. This medicine is administered in combination with phentermine in other
countries, with variable weight loss. Despite evidence of the benefit of topiramate for
weight loss, there is still no record of studies evaluating this drug in patients with PCOS
for the treatment of obesity. The objective of this project is to evaluate the results of
treatment with topiramate in terms of weight reduction, reduction of serum androgens and
changes in body composition, in patients with PCOS and obese, associated with a low-calorie
diet, over a period of six months. Eighty patients with PCOS (18 to 40 years old) seen at the
HCPA Endocrinology Service outpatient clinic who are overweight with a BMI> or = 27 kg / m2
associated with at least one comorbidity or obesity (BMI 30-40) will be included. Patients
will be randomized to 2 groups: Topiramate and Placebo and the 2 groups will receive a
low-calorie diet.
Anthropometric, clinical, hormonal, nutritional and body composition assessment will be
performed before, during and after treatments. It is expected to determine whether the
addition of topiramate to dietary treatment can improve metabolic, hormonal and weight loss
outcomes in women with PCOS.
Research Objective: General objective: To evaluate the results of treatment with topiramate
in patients with PCOS and obese, associated with a low-calorie diet, in six months of
treatment.
Specific objectives: To evaluate the response to the proposed treatment in terms of weight
reduction and body mass index (BMI), reduction of serum androgens, changes in body
composition, in addition to assessing minor psychiatric disorders possibly associated through
the Self-Reporting screening questionnaire. Questionnaire (SRQ-20).
Assessment of Risks and Benefits: The risks of the project are mainly related to the use of
the drug topiramate. This drug has an extensive list of adverse effects, in addition to the
side effect on appetite and weight, the most common are paresthesias, drowsiness, lethargy,
attention disorder, mood disorders, depression, taste changes and psychomotor disorders.
However, studies show that the majority of adverse reactions were mild to moderate in
severity. Other risks inherent to the study are the absence of previous studies in the target
population and discomfort in relation to the number of visits, additional tests and blood
samples for an extended period of 6 months. The benefits of the study are related to the
acquisition of knowledge and the likely positive results may benefit future patients.