Clinical Trials

Randomized, double blind placebo-controlled trial: effects of myo-inositol on ovarian function and metabolic factors in women with PCOS

S Gerli, E Papaleo, A Ferrari, G C Di Renzo

The aim of our study was to use a double-blind, placebo-controlled approach with detailed assessment of ovarian activity (two blood samples per week) to assess the validity of this therapeutic approach in this group of women. Of the 92 patients randomized, 47 received 400 mcg folic acid as placebo, and 45 received myo-inositol plus folic acid (4 g myo-inositol plus 400 mcg folic acid). The ovulation frequency assessed by the ratio of luteal phase weeks to observa-tion weeks was significantly (P < 0.01) higher in the treated group (25%) compared with the placebo (15%), and the time to first ovulation was significantly (P < 0.05) shorter [24.5 d; 95% confidence interval (CI), 18, 31; compared with 40.5 d; 95% CI, 27, 54].

 

Efficacy of myo-inositol in the treatment of cutaneous disorders in young women with polycystic ovary syndrome

Martino Maria Zacchè, Luigi Caputo, Susanna Filippis, Gabrio Zacchè, Moreno Dindelli, Augusto Ferrari

Fifty patients with PCOS were enrolled in the study. BMI, LH, FSH, insulin, HOMA index, androstenedione, testosterone, free testosterone, hirsutism and acne were evaluated at the baseline and after receiving MYO therapy for 6 months. After 3 months of MYO administration, plasma LH, testosterone, free testosterone, insulin and HOMA index resulted significantly reduced; no significant changes were observed in plasma FSH and androstenedione levels. Both hirsutism and acne decreased after 6 months of therapy.

 

Endocrine and clinical effects of myo-inositol administration in polycystic ovary syndrome. A randomized study

P G Artini , O M Di Berardino, F Papini, A D Genazzani, G Simi, M Ruggiero, V Cela

To evaluate the effects the administration of myo-inositol (MYO) on hormonal parameters in a group of polycystic ovary syndrome (PCOS) patients. After 12 weeks of MYO administration plasma LH, PRL, T, insulin levels and LH/FSH resulted significantly reduced. Insulin sensitivity, expressed as glucose-to-insulin ratio and HOMA index resulted significantly improved after 12 weeks of treatment. Menstrual cyclicity was restored in all amenorrheic and oligomenorrheic subjects. No changes occurred in the patients treated with folic acid.

 

Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial

D Costantino , G Minozzi, E Minozzi, C Guaraldi

Forty-two women with PCOS were treated in a double-blind trial with Myo-inositol plus folic acid or folic acid alone as placebo. In the group treated with Myo-inositol the serum total testosterone decreased from 99.5 +/- 7 to 34.8 +/- 4.3 ng/dl (placebo group: from 116.8 +/- 15 to 109 +/- 7.5 ng/dl; P = 0.003), and serum free testosterone from 0.85 +/- 0.1 to 0.24 +/- 0.33 ng/dl (placebo group: from 0.89 +/- 0.12 to 0.85 +/- 0.13 ng/dl; P = 0.01). Plasma triglycerides decreased from 195 +/- 20 to 95 +/- 17 mg/dl (placebo group: from 166 +/- 21 to 148 +/- 19 mg/dl; P = 0.001). Systolic blood pressure decreased from 131 +/- 2 to 127 +/- 2 mmHg (placebo group: from 128 +/- 1 to 130 +/-1 mmHg; P = 0.002). Diastolic blood pressure decreased from 88 +/- 1 to 82 +/- 3 mmHg (placebo group: from 86 +/- 1 to 90 +/- 1 mmHg; P = 0.001). The area under the plasma insulin curve after oral administration of glucose decreased from 8.54 +/- 1.149 to 5.535 +/- 1.792 microU/ml/min (placebo group: from 8.903 +/- 1.276 to 9.1 +/- 1.162 microU/ml/min; P = 0.03). The index of composite whole body insulin sensitivity (ISI comp) increased from 2.80 +/- 0.35 to 5.05 +/- 0.59 mg(-2)/dl(-2) (placebo group: from 3.23 +/- 0.48 to 2.81 +/- 0.54 mg(-2)/dl(-2); P < 0.002). 16 out of 23 women of Myo-inositol group ovulated (4 out of 19 in placebo group). Treatment of PCOS patients with Myo-inositol provided a decreasing of circulating insulin and serum total testosterone as well as an improvement in metabolic factors.

 

Chromium picolinate reduces insulin resistance in polycystic ovary syndrome: Randomized controlled trial

Sherif Ashoush, Amgad Abou-Gamrah, Hassan Bayoumy, Noura Othman 

To investigate the effect of chromium picolinate (CrP) on insulin resistance (IR) in polycystic ovary syndrome (PCOS). There were no significant differences between women of both groups regarding pretreatment levels of FBS, FSI, FGIR, and serum testosterone. Use of CrP for 6 months was associated with significant reduction of BMI (P < 0.001) and FSI (P = 0.007), and significant rise in FGIR (P = 0.045). CrP significantly increased the chances of ovulation (P = 0.011) and regular menstruation (P = 0.002) by almost twofold after the fifth month of treatment.

 

Chromium picolinate improves insulin sensitivity in obese subjects with polycystic ovary syndrome

Michael L Lydic , Margaret McNurlan, Shirley Bembo, Lina Mitchell, Eugene Komaroff, Marie Gelato

Trivalent chromium (1000 microg), as chromium picolinate, given without change in diet or activity level, caused a 38% mean improvement in glucose disposal rate in five obese subjects with polycystic ovary syndrome who were tested with a euglycemic hyperinsulinemic clamp technique. This suggests that chromium picolinate, an over-the-counter dietary product, may be useful as an insulin sensitizer in the treatment of polycystic ovary syndrome.