Effects of Inositol(s) in Women with PCOS: A Systematic Review of Randomized Controlled Trials

Table 1

Eligible RCTs where myo-inositol and/or D-chiro-inositol have been evaluated for the treatment of PCOS patients.

Ref	Study design	Duration	Treatment	Number of subjects	Inclusion criteria	Exclusion criteria	Assessment of the response
[20]	Randomized,; controlled	12 weeks	Treated group: Myo-Ins 2 g + FA 200 µg/d; Control group: FA 200 µg/d	Number = 20; Treated: 10; Control: 10	PCOS, oligo/amenorrhea, normal PRL levels (range 5–25 ng/mL), and mild to severe hirsutism and/or acne	Hormone treatments in the last 24 weeks; adrenal enzymatic deficiency and/or other endocrine diseases	LH, FSH, PRL, E2, A, 17OHP, T, insulin, cortisol, OGTT for insulin, glucose, C-peptide determinations, vaginal ultrasound examination Ferriman-Gallwey score, BMI, and HOMA index
[21]	Double-blind,; randomized,; controlled	12–16 weeks	Treated group: Myo-Ins 4 g + FA 400 µg/d; Control group: FA 400 µg/d	Number = 42; Treated: 23; Control: 19	Age: <40 years; PCOS, oligomenorrhea, and; high serum-free T and/or hirsutism	Not described	Systolic/diastolic blood pressure, triglycerides, cholesterol, BMI, WHR, plasma glucose and insulin sensitivity, total/free T, DHEAS, SHBG, A, and progesterone peak value
[10]	Double-blind,; randomized,; controlled	16 weeks	Treated group: Myo-Ins 200 mg + FA 800 µg/d; Control group: matching placebo	Number = 283; Treated: 136; Control: 147	Age: <35 years; PCOS according to Adams et al. criteria,; oligo/amenorrhea	Hyperprolactinemia,; abnormal thyroid function tests, and congenital adrenal; hyperplasia	E2, P and LH, BMI, ovulation frequency, inhibin-b, fasting glucose, fasting insulin, or insulin AUC, VLDL, LDL, HDL, total cholesterol, and triglycerides
[11]	Double-blind,; randomized,; controlled	16 weeks	Treated group: Myo-Ins 4 g + FA 400 µg/d; Control group: FA 400 µg/d	Number = 92; Treated: 45; Control: 47	Age: <35 years; PCOS according to Adams et al. criteria,; oligo/amenorrhea	Hyperprolactinemia,; abnormal thyroid function tests, and congenital adrenal hyperplasia	E2, P and LH, ratio of luteal phase weeks to observation weeks; inhibin-b, fasting glucose, fasting insulin, or insulin AUC, VLDL, LDL, HDL, total cholesterol, BMI, and triglycerides
[22]	Randomized; controlled	24 weeks	Treated group: Myo-Ins 1.1 g + D-chiro-Ins 27.6 mg/d; Control group: Myo-Ins 4 g/d	Number = 50; Treated: 26; Control: 24	Age: <41 years, BMI >27 kg/m^2, and; PCOS according to Rotterdam criteria	Diabetic subjects,; smokers, and alcohol users	Blood pressure, BMI, WHR, SHBG, serum steroids and lipid profile levels, OGTT, plasma glucose insulin, HOMA, and P
[23]	Randomized controlled	24 weeks	Treated group: Myo-Ins 1.1 g + D-chiro-Ins 27.6 mg + FA 400 μg/d; Control group: FA 400 μg/d	Number = 46; Treated: 21; Control: 25	Age: <35 years, BMI >30 kg/m^2, and; PCOS according to Rotterdam criteria	Diabetic subjects,; smokers, and alcohol users	FSH, LH, E2, SHBG, A, free T, DHEA-S, HOMA index, and fasting glucose and insulin

Myo-Ins, myo-inositol; D-chiro-Ins, D-chiro-inositol; FA, folic acid; PCOS, polycystic ovary syndrome; PRL, prolactin; E2, oestradiol; A, androstenedione; 17OHP, 17-hydroxyprogesterone; T, testosterone; P, progesterone; OGTT, oral glucose tolerance; BMI, body mass index; LH, luteinizing hormone; FSH, follicle stimulating hormone; DHEAS, dehydroepiandrosterone; SHBG, sex hormone binding globulin; AUC, area under the curve of OGTT; VLDL, very-low-density lipoprotein; LDL, low-density lipoprotein; HDL, high-density lipoprotein; WHR, waist-to-hip ratio.
OGTT performed sampling 15 minutes before and 30, 60, 90, 120, and 240 minutes after the oral assumption of 75 g of glucose.
Adams et al. [24].