International Journal of Endocrinology / 2016 / Article / Tab 1

Review Article

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.

RefStudy designDurationTreatmentNumber of subjectsInclusion criteriaExclusion criteriaAssessment of the response

[20]Randomized,
controlled
12 weeksTreated 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 acneHormone treatments in the last 24 weeks; adrenal enzymatic deficiency and/or other endocrine diseasesLH, 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 weeksTreated 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 describedSystolic/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 weeksTreated 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 weeksTreated 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 weeksTreated 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/m2, 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 controlled24 weeksTreated 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/m2, 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].

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