We hypothesized that metformin (MET)-diet would improve signs-symptoms of idiopathic intracranial hypertension (IIH) in women who also had polycystic ovary syndrome (PCOS) or hyperinsulinemia without PCOS. We prospectively assessed changes in weight, papilledema, headache, visual fields, and life status on 2.25 g MET-diet or diet alone for > 4 months in 75 women with IIH, 43 also having PCOS. Life status was graded by a self-reported 1-5 scale (1-well; 2-unwell, usual activities; 3-poor, usual activities; 4-poor, no usual activities; 5-totally disabled). Conventional Rx for IIH was maintained unchanged during MET-diet Rx. The diet was hypocaloric (1,500 cal/day if BMI $ 25, 2000 cal/day if BMI < 25), high protein (26% of calories), low-carbohydrate (44%). Of the 43 PCOS cases, 31 received MET-diet, 12 diet only (not tolerate MET). Of the 32 cases without PCOS, 15 were hyperinsulinemic and received MET-diet, and 17 received diet alone. (*p < .05,**< .01 vs baseline, within group).
The greatest % weight loss occurred in diet-MET groups. MET (p = .012) and baseline BMI (p = .019) were predictors for weight loss. Papilledema improved in all 4 groups. The most marked improvement in life status (p = .004) was seen in the 31 women with PCOS on diet-MET. Since Å50% of women with IIH have PCOS, and since weight loss is central to IIH treatment, diet-MET is a novel approach to treat IIH in women with concurrent PCOS or hyperinsulinemia without PCOS.