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

Abstract

Objective: To evaluate the effects the administration of myo-inositol (MYO) on hormonal parameters in a group of polycystic ovary syndrome (PCOS) patients.

Design: Controlled clinical study.

Setting: PCOS patients in a clinical research environment.

Patients: 50 overweight PCOS patients were enrolled after informed consent.

Interventions: All patients underwent hormonal evaluations and an oral glucose tolerance test (OGTT) before and after 12 weeks of therapy (Group A (n¼10): MYO 2?g plus folic acid 200?mg every day; Group B (n¼10): folic acid 200?mg every day). Ultrasound examinations and Ferriman–Gallwey score were also performed.

Main outcome measures: Plasma LH, FSH, PRL, E2, 17OHP, A, T, glucose, insulin, C peptide concentrations, BMI, HOMA index and glucose-to-insulin ratio.

Results: 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.

Conclusions: MYO administration improves reproductive axis functioning in PCOS patients reducing the hyperinsulinemic state that affects LH secretion.     

Myo-inositol administration positively affects hyperinsulinemia and hormonal parameters in overweight patients with polycystic ovary syndrome.

OBJECTIVE: To evaluate the effects the administration of myo-inositol (MYO) on hormonal parameters in a group of PCOS patients. DESIGN: Controlled clinical study. SETTING: PCOS patients in a clinical research environment. PATIENTS: 20 overweight PCOS patients were enrolled after informed consent. INTERVENTIONS: All patients underwent hormonal evaluations and an oral glucose tollerance test (OGTT) before and after 12 weeks of therapy (Group A (n = 10): myo-inositol 2 gr. plus folic acid 200 mug every day; Group B (n = 10): folic acid 200 mug every day). Ultrasound examinations and Ferriman-Gallwey score were also performed. MAIN OUTCOME MEASURES: Plasma LH, FSH, PRL, E2, 17OHP, A, T, glucose, insulin, C peptide concentrations, BMI, HOMA index and glucose-to-insulin ratio. RESULTS: 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. CONCLUSIONS: Myo-inositol administration improves reproductive axis functioning in PCOS patients reducing the hyperinsulinemic state that affects LH secretion.     

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

Background.?Polycystic ovary syndrome (PCOS) is the most common endocrine cause of hirsutism, acne and pattern alopecia, often characterised by ovulation disorders (usually manifested as oligo- or amenorrhea). In addition, 30–40% of women with PCOS have impaired glucose tolerance, and a defect in the insulin signalling pathway seems to be implicated in the pathogenesis of insulin resistance. For this reason, insulin-lowering medications represent novel approach in women with PCOS. The aim of this study was to evaluate the effects of myo-inositol (MYO), an isoform of inositol, belonging to the vitamin B complex, in the treatment of cutaneous disorders like hirsutism and acne.

Methods.?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.

Results.?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.

Discussion.?MYO administration is a simple and safe treatment that ameliorates the metabolic profile of patients with PCOS, reducing hirsutism and acne.     

Differential insulin response to myo-inositol administration in obese polycystic ovary syndrome patients

Polycystic ovary syndrome (PCOS) is characterized by hyperandrogenism, chronic anovulation, polycystic ovaries at ultrasound evaluation, and quite frequently by insulin resistance or compensatory hyperinsulinemia. Attention has been given to the role of inositol-phosphoglycan (IPG) mediators of insulin action and growing evidences suggest that a deficiency of d-chiro-inositol (DCI) containing IPG might be at the basis of insulin resistance, frequent in PCOS patients. On such basis, we investigated the efficacy on insulin sensitivity and hormonal parameters of 8 weeks treatment with myo-inositol (MYO) (Inofert, ItalPharmaco, Milano, Italy) at the dosage of 2 g day in a group (n = 42) of obese PCOS patients,. After the treatment interval body mass index (BMI) and insulin resistance decreased together with luteinizing hormone (LH), LH/FSH and insulin. When subdividing the patients according to their fasting insulin levels, Group A (n = 15) insulin below 12 µU/ml and Group B (n = 27) insulin above 12 µU/ml, MYO treatment induced similar changes in both groups but only patients of Group B showed the significant decrease of both fasting insulin plasma levels (from 20.3 ± 1.8 to 12.9 ± 1.8 µU/ml, p < 0.00001) and of area under the curve (AUC) of insulin under oral glucose tolerance test (OGTT). In conclusion, our study supports the hypothesis that MYO administration is more effective in obese patients with high fasting insulin plasma levels.     

Myo-inositol administration positively effects ovulation induction and intrauterine insemination in patients with polycystic ovary syndrome: a prospective,controlled, randomized trial

Object?ve: The aim of the study is to investigate the effect of myo-inositol (MYO) on pregnancy rates of patients diagnosed with polycystic ovary syndrome (PCOS) who undergone controlled ovulation induction and intrauterine insemination (IUI).

Methods: A total of 196 infertile patients diagnosed with PCOS and admitted to Dokuz Eylul University Faculty of Medicine were included in the study between March 2013 and May 2016. The patients in group 1 (n?=?98) were given 4?g MYO and 400?μg folic acid before and during ovulation induction. The patients undergone controlled ovarian hyperstimulation (COH) with recombinant FSH and IUI. The patients in group 2 (n?=?98), were given recombinant FSH directly and 400?μg folic acid. The primary outcome measure of this study was the clinical pregnancy rate.

Results: In group 1, 9 patients conceived spontaneous pregnancy. During COH?+?IUI treatment three cycles were canceled in group 1 and 8 cycles in group 2. Total rFSH dose and cycle duration were significantly lower and clinical pregnancy rates were higher in group 1. The pregnancy rate for group 1 was %18.6 and for group 2 was %12.2.

Conclus?ons: This study shows that MYO should be considered in the treatment of infertile PCOS patients. MYO administration increases clinical pregnancy rates, lowers total rFSH dose and the duration of the ovulation induction.     

Comparison between effects of myo-inositol and d-chiro-inositol on ovarian function and metabolic factors in women with PCOS

Myo-inositol and d-chiro-inositol are capable of improving the ovarian function and metabolism of polycystic ovary syndrome (PCOS) patients. The aim of this work is to compare the effects of myo-inositol and d-chiro-inositol in PCOS. We enrolled 50 patients, with homogeneous bio-physical features, affected by PCOS and menstrual irregularities, and we randomly divided them into two groups: 25 were treated with 4?g of myo-inositol/die plus 400?mcg of folic acid/die orally for six months, 25 with 1?g of d-chiro-inositol/die plus 400?mcg of folic acid/die orally for six months. We analyzed in both groups pre-treatment and post-treatment BMI, systolic and diastolic blood pressure, Ferriman–Gallwey score, Cremoncini score, serum LH, LH/FSH ratio, total and free testosterone, dehydroepiandrosterone sulfate (DHEA-S), Δ-4-androstenedione, SHBG, prolactin, glucose/immunoreactive insulin (IRI) ratio, homeostatic model assessment (HOMA) index, and the resumption of regular menstrual cycles. Both the isoforms of inositol were effective in improving ovarian function and metabolism in patients with PCOS, although myo-inositol showed the most marked effect on the metabolic profile, whereas d-chiro-inositol reduced hyperandrogenism better.     

Metformin administration was associated with a modification of LH,prolactin and insulin secretion dynamics in women with polycystic ovarian syndrome

Aim. To elucidate the dynamics of FSH, LH, prolactin (PRL), TSH and insulin secretion in women with polycystic ovarian syndrome (PCOS) treated with metformin (MET).

Patients and methods. In a prospective, controlled and randomised trial, 32 women with PCOS and 32 with normal cycle were recruited to receive MET (850 mg b.i.d.) or placebo (n: 16 for each subgroup) for an average of 40 days. Pituitary function and insulin secretion were assessed before and after intervention by GnRH-TRH tests and oral glucose tolerance test induced insulin response.

Results. Basal and area under the response curve (AURC) LH values were higher in PCOS than in normal controls before MET and declined following treatment in the former group (P < 0.05). Ovulatory PCOS responders had lower basal LH, AURC_LH and AURC_PRL values during MET than anovulatory cases (P < 0.05 for all) and AURCins was lower in ovulatory than anovulatory PCOS before and on MET (P < 0.02–P < 0.05), with a rise of QUICKY index in the former group during MET treatment (P < 0.05). FSH and TSH were similar.

Conclusions. MET administration lowered LH activity in all PCOS women and in ovulatory responders and also compromised PRL stimulated secretion in the latter cases. These findings were indicative of an effect of MET on pituitary activity.     

The effect of myoinositol on ovarian blood flows in women with polycystic ovary syndrome

To evaluate whether 4 gram myoinositol and 400?mcg folic acid(MYO) therapy has any effects on ovarian stromal blood flow by using pulsed and color Doppler at 3?months follow-up period in polycystic ovary syndrome (PCOS). One-hundred eighty patients were designed into six groups; Group 1: PCOS patients that received OCP containing 30?mcg ethinyl estradiol (EE) plus 3?mg drospirenone (DRP); Group 2: PCOS patients that received MYO; Group 3: PCOS patients that received no medication. Group 4: Healthy patients that received OCP; Group 5: Healthy patients that received MYO; Group 6: Healthy patients that received no medication. Resistance index (RI) and pulsatility index (PI) of both ovaries were assessed. There was a significant increase in RI and PI of both ovarian stromal blood flow women with PCOS who received OCP (Group 1, p?<?.001) and MYO (Group 2, p?<?.001). The rate of increment in both RI and PI values were similar for OCP users (Group 1) and MYO users(Group2) in PCOS patients. MYO therapy reduced ovarian vascularization in both PCOS and healthy users after 3?months and this decrease is especially noticeable in women with PCOS compared to healthy women. OCP therapy also reduced ovarian vascularization just like MYO therapy.     

Metformin administration restores allopregnanolone response to adrenocorticotropic hormone (ACTH) stimulation in overweight hyperinsulinemic patients with PCOS

Objective.?To investigate the adrenal response in terms of allopregnanolone secretion in a group of hyperinsulinemic patients with polycystic ovary syndrome (PCOS).

Design.?Controlled clinical study.

Setting.?Patients with PCOS in a clinical research environment.

Patients.?Twenty-two overweight patients with PCOS with hyperinsulinism were enrolled after informed consent.

Interventions.?All patients underwent hormonal evaluations, oral glucose tolerance test (OGTT) and adrenocorticotropic hormone (ACTH) test before and after 4 months of metformin administration (500 mg p.o. bi-daily). Ultrasound examinations and Ferriman-Gallway score were also performed. Main outcome measures. plasma luteinizing hormone (LH), follicle stimulating hormone (FSH), prolactin (PRL), estradiol, 17-hydroxy-progesterone (17OHP), androstenedione (A), testosterone (T), allopregnanolone, glucose, insulin, C peptide concentrations, body mass index (BMI).

Results.?Metformin administration reduced significantly LH, A, T, insulin and BMI, while allopregnanolone was significantly increased with no change in progesterone plasma levels. Insulin response to OGTT decreased and allopregnanolone response to ACTH stimulation before while this was restored after the treatment interval. The Ferriman-Gallway score as well as the ovarian volume was significantly decreased after 4 months of metformin therapy.

Conclusions.?In overweight patients with PCOS with hyperinsulinism, allopregnanolone secretion is impaired and metformin administration restored normal allopregnanolone concentrations modulating both steroid syntheses from the ovaries and from adrenal gland.     

The role of serum PRL bioactivity evaluation in hyperprolactinaemic women with different menstrual disorders

Objective.?The objective of the study was to characterize the bioactivity of prolactin (PRL) in hyperprolactinaemic patients with prolactinomas, irregular menstrual cycles, regular menstrual cycles and PCOS.

Methods.?Serum PRL, biological activity of PRL (after polyethylene glycol (PEG) precipitation) and serum follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), testosterone (T), thyroid-stimulating hormone (TSH) concentrations were measured in all hyperprolactinaemic patients and control group (healthy subjects). Correlations between active PRL (PRL-PEG) and serum FSH, LH, E2, T, TSH concentrations were also evaluated.

Results.?Prolactinoma is characterized by high serum PRL levels and its high biological activity. Hyperprolactinaemic patients with irregular cycles were characterized by high biological activity of PRL. Patients with hyperprolactinaemia and regular cycles had low biological activity of PRL.

Conclusions.?Diagnosis of hyperprolactinaemia should be associated with estimation of PRL biological activity because it is important for type of hyperprolactinaemia management. Low biological activity of PRL does not impair FSH and LH secretion and does not cause hypoestrogenism.     

The effect of different hormone therapies on anti-müllerian hormone serum levels in anovulatory women of reproductive age

Objective.?To investigate the effect of oral contraceptives (OC), metformin and ovulation induction with gonadotropins on circulating anti-müllerian hormone (AMH).

Design.?Prospective clinical study.

Patients.?Thirty patients with PCOS (Group 1), 15 normogonadotropic anovulatory infertile women (WHO 2) (Group 2) and 15 normoovulatory control women (Group 3). Patients in Group 1 received OC (n?=?12), metformin (n?=?11) or no-treatment (n?=?7) for 6 months. Ovulation induction with FSH or hMG was used in Group 2.

Main outcome measures.?Total follicle number (TFN) and hormonal (fasting insulin and glucose, testosterone, SHBG, LH, androstenedione and AMH) measurements at baseline and during therapy.

Results.?Basal AMH and TFN were higher in Groups 1 and 2 than in controls. Only TFN was significantly related to AMH level in Groups 1 and 2. AMH level was significantly reduced during OC treatment, and there was a trend for AMH decrease during metformin therapy. No significant changes in AMH level were observed during ovulation induction. TFN was the only parameter showing a significant positive correlation with circulating AMH over the 6-month treatment period in patients in Group 2.

Conclusions.?AMH is an accurate marker of the antral follicle pool in WHO-2/PCOS women but the measurement of AMH is not likely to be helpful in the management of those patients.     

Evaluation of dopaminergic activity of the hypothalamus in patients with polycystic ovarian syndrome]

To evaluate the hypothalamic dopaminergic activity in patients with polycystic ovary syndrome (PCOS), we studied the PRL, TSH, LH and FSH responses to i.m. administration of sulpiride in five euthyroid women affected by PCOS and in five normal women. The mean basal PRL and TSH plasma levels resulted significantly higher (p less than 0.01) in PCOS subjects with respect to normal subjects. The incremental area under PRL and TSH profiles, after sulpiride administration, were significantly lower (p less than 0.05) in PCOS patients than in the control group; no significant variation of LH and FSH plasma levels resulted. Our data suggest a decrease dopaminergic activity in PCOS.     

The value of anti-Mullerian hormone in the management of polycystic ovary syndrome in adolescents

Abstract

A prospective study was carried out in 110 adolescents (13–19 years), 90 patients with polycystic ovary syndrome (PCOS) (study group) and 20 healthy adolescents (control group). The study group was divided into two: Group I – patients without insulin resistance (n?=?30) and Group II – patients with insulin resistance (n?=?60). Group I was treated with oral contraceptives (OCs), while Group II was divided into treatment subgroups of 20 patients each: Subgroup A received OCs; Subgroup B ? myo-inositol; subgroup C – OCs + myo-inositol. Data were analyzed at baseline, 3 and 6 months of treatment. Results showed average anti-Mullerian hormone (AMH) levels were significantly higher in PCOS patients (11.8?±?5.3?ng/ml) than in controls (2.98?±?4.5?ng/ml). After treatment, in Group I and Group II Subgroup A: AMH, luteinizing hormone (LH), free testosterone (FT), total testosterone (T), Ov/v, antral follicle count (AFC), and Ferriman–Gallwey modified scale (mFG) significantly decreased, homeostatic model assessment-insulin resistance (HOMA-IR), body mass index (BMI) did not change significantly. In Group II Subgroup B only HOMA-IR and BMI significantly decreased; in Subgroup C all the parameters decreased significantly. The correlation between AMH and hormonal, morphological characteristics of ovaries were established. The results indicate that AMH could possibly be a valuable marker for the diagnosis of PCOS in adolescents, and for the assessment of treatment efficacy as well.     

Metformin administration modulates and restores luteinizing hormone spontaneous episodic secretion and ovarian function in nonobese patients with polycystic ovary syndrome

OBJECTIVE: To evaluate the effects of metformin administration on spontaneous LH episodic release in a group of nonobese polycystic ovary (PCOS) patients. DESIGN: Controlled clinical study. SETTING: PCOS patients in a clinical research environment. PATIENT(S): Twenty nonobese PCOS patients were enrolled after informed consent. INTERVENTION(S): All patients underwent hormonal evaluations and a pulsatility study (sampling every 10 minutes for 4 hours) before and at the sixth month of therapy (metformin, 500 mg, p.o. b.i.d.). Ultrasound examinations and Ferriman-Gallwey scoring were also performed. MAIN OUTCOME MEASURE(S): Measurements of plasma LH, FSH, estradiol (E(2)), androstenedione (A), 17-hydroxy-progesterone (17-OHP), and testosterone (T), glucose, insulin, and C-peptide concentrations. RESULT(S): After 6 months of metformin administration, the plasma LH, 17-OHP, A, and T levels and LH/FSH ratio were significantly reduced. Insulin sensitivity, expressed as the glucose-to-insulin ratio, was significantly improved under glucose load after 6 months of treatment. Spontaneous LH episodic release showed a significant reduction in pulse amplitude with no changes in pulse frequency. Menstrual cyclicity was restored in all amenorrheic and oligomenorrheic women. The ovarian volume and Ferriman-Gallwey scores also were significantly reduced. CONCLUSION(S): Metformin administration improves reproductive axis functioning in hyperandrogenic nonobese PCOS patients. By acting on the ovary and restoring normal ovarian activity, metformin positively modulates the reproductive axis (namely GnRH-LH episodic release).     

Effect of myo-inositol and melatonin versus myo-inositol,in a randomized controlled trial,for improving in vitro fertilization of patients with polycystic ovarian syndrome

Polycystic ovarian syndrome (PCOS) induces anovulation in women of reproductive age, and is one of the pathological factors involved in the failure of in vitro fertilization (IVF). Indeed, PCOS women are characterized by poor quality oocytes. Therefore, a treatment for enhancing oocyte quality becomes crucial for these patients. Myo-Inositol and melatonin proved to be efficient predictors for positive IVF outcomes, correlating with high oocyte quality. We tested the synergistic effect of myo-inositol and melatonin in IVF protocols with PCOS patients in a randomized, controlled, double-blind trial. Five-hundred twenty-six PCOS women were divided into three groups: Controls (only folic acid: 400?mcg), Group A (Inofolic® plus, a daily dose of myo-inositol: 4000?mg, folic acid: 400?mcg, and melatonin: 3?mg), and Group B (Inofolic®, a daily dose of myo-inositol: 4000?mg, and folic acid: 400?mcg). The main outcome measures were oocyte and embryo quality, clinical pregnancy and implantation rates. The treatment lasted from the first day of the cycle until 14 days after embryo transfer. Myo-inositol and melatonin have shown to enhance, synergistically, oocyte and embryo quality. In consideration of the beneficial effect observed in our trial and on the bases of previous studies, we decided to integrate routinely MI and M supplementation in the IVF protocols. The same treatment should be taken carefully in consideration in all procedures of this kind.     

Preptin in women with polycystic ovary syndrome

Introduction: Polycystic ovary syndrome (PCOS) patients, frequently develop metabolic complications, such as insulin resistance (IR), impaired carbohydrate metabolism, dyslipidemia, obesity. Among the new markers responsible for metabolic disorders, preptin seems to be of great significance.

Material: One hundred and thirty-four women aged 17–45 were enrolled. PCOS was diagnosed in 73 women on the basis of ESHRE-ASRM criteria. Non-PCOS group consisted of 61 women with regular menstruation matched for nutritional status.

Methods: All women underwent anamnesis, physical examination, anthropometric measurements, the abdominal ultrasound examination, and dual energy X-ray absorptiometry (DXA). Serum adropin levels were determined by ELISA. Biochemical and hormonal (testosterone, androstenedione, LH, FSH, estradiol) measurements were also performed. Insulin resistance indices (HOMA, QUICKI, Matsuda) and free androgen index (FAI) were calculated with the test results according to the standard formula. For all comparisons, statistical significance was defined by p?≤?.05.

Results: Serum preptin levels were significantly higher in the PCOS group. No significant correlations between preptin level and metabolic and hormonal markers were observed. The logistic regression analysis demonstrated that serum preptin level was an independent factor differentiating the two groups.

Conclusions: Serum preptin levels were significantly higher in women with PCOS compared with controls. This peptide might be an independent predictor of PCOS in the future.     

Elevated serum interferon γ-inducible protein-10 in women with polycystic ovary syndrome

Background: Interferon γ-induced protein 10?kDa (IP10/CXCL10) is a chemokine related to endocrine disorders; however, the serum concentrations of IP10 in women with polycystic ovary syndrome (PCOS) have not yet been reported. Therefore, we investigated whether IP10 is increased in PCOS patients and its potential clinical value in PCOS patients.

Methods: For this research, the serum IP10, glucose, insulin, high sensitivity C-reactive protein (hs-CRP), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and total testosterone (TT) concentrations were measured in 60 women with PCOS and healthy controls.

Results: The median IP10 concentration was 45.60?pg/mL [interquartile range (IQR):29.75, 79.69], which was significantly higher than that of the body mass index (BMI)-matched controls (median: 36.46?pg/mL; IQR:28.98, 45.80). In the multivariate linear regression analysis, hs-CRP and the homeostasis model assessment of insulin resistance index (HOMA2-IR) were independent predictors of the IP10 values, while FSH was inversely associated with the IP10.No significant association was observed between the IP10 and BMI, glucose, LH and TT.

Conclusions: The serum IP10 concentrations increase in women with PCOS, moreover, IP10 appears to be correlated with the inflammatory and IR statuses of PCOS. IP10 may be a potential biomarker to estimate the disease activity of PCOS.     

Ameliorative effect of myo-inositol on red blood cell alterations in polycystic ovary syndrome: in vitro study

Polycystic ovary syndrome (PCOS)is a gynecological endocrine disorder which is associated with systemic inflammatory status inducing red blood cells (RBC) membrane alterations related to insulin resistance and testosterone levels which could be greatly improved by myo-inositol (MYO) uptake. In this study we aim to evaluate the effect of MYO in reducing oxidative-related alterations through in vitro study on PCOS RBC. Blood samples from two groups of volunteers, control group (CG, n?=?12) and PCOS patient group (PG, n?=?12), were analyzed for band 3 tyrosine phosphorylation (Tyr-P), high molecular weight aggregate (HMWA), IgG in RBC membranes, and glutathione (GSH) in cytosol, following O/N incubation in the presence or absence of MYO. PCOS RBC underwent oxidative stress as indicated by higher band 3 Tyr-P and HMWA and increased membrane bound autologous IgG. Twenty four hours (but not shorter time) MYO incubation, significantly improved both Tyr-P level and HMWA formation and concomitant membrane IgG binding. However, no relevant modification of GSH content was detected. PCOS RBC membranes are characterized by increased oxidized level and enhanced sensitivity to oxidative injuries leading to potential premature RBC removal. MYO treatment is effective in reducing oxidative related abnormalities in PCOS patients probably restoring the inositol phospholipid pools of the membranes.     

Comparison of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in women with polycystic ovary syndrome: a randomized,double-blind,placebo-controlled trial

Introduction: Data on comparison of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in subjects with polycystic ovary syndrome (PCOS) are scarce. This purpose of this study was to compare of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in subjects with PCOS.

Methods: This randomized controlled trial was conducted among 60 subjects diagnosed with PCOS according to the Rotterdam criteria. Subjects were randomly assigned into two groups to intake either myo-inositol (n?=?30) or metformin (n?=?30) for 12?weeks. Parameters of mental health were recorded at baseline and after the 12-week intervention. Fasting blood samples were obtained at baseline and the end of the study to determine biomarkers of biomarkers of oxidative stress.

Results: After the 12-week intervention, changes in beck depression inventory total score (?1.0?±?1.7 vs. ?0.3?±?0.7, p?=?0.03), general health questionnaire scores (?1.7?±?2.9 vs. ?0.5?±?1.2, p?=?0.02), depression anxiety and stress scale scores (?3.9?±?6.4 vs. ?0.9?±?1.9, p?=?0.01) and plasma total antioxidant capacity (TAC) concentrations (+106.1?±?69.6 vs. +2.1?±?132.4?mmol/L, p?<?0.001) in the myo-inositol group were significantly different from the changes in these indicators in the metformin group. Myo-inositol supplementation for 12?weeks among patients with PCOS did not affect plasma glutathione and malondialdehyde levels.

Conclusions: Overall, our data supported that myo-inositol supplementation for 12?weeks among patients with PCOS had favorable effects on parameters of mental health and plasma TAC levels.     

Myo-inositol in patients with polycystic ovary syndrome: A novel method for ovulation induction

Background. Polycystic ovary syndrome (PCOS) is often characterized by chronic oligo- or anovulation (usually manifested as oligo- or amenorrhea), and hyperandrogenism. In addition, 30–40% of PCOS women have impaired glucose tolerance, and a defect in the insulin signaling pathway (inositol-containing phosphoglycan mediators) seems to be implicated in the pathogenesis of insulin resistance. PCOS patients are subfertile as a consequence of such ovulatory disorders and often need drugs, such as clomiphene citrate or follicle-stimulating hormone, for ovulation induction, which increases the risk of multiple pregnancy and ovarian hyperstimulation syndrome. We hypothesized that the administration of an isoform of inositol (myo-inositol), belonging to the vitamin B complex, would improve the insulin-receptor activity, restoring normal ovulatory function.

Materials and methods. Twenty-five PCOS women of childbearing age with oligo- or amenorrhea were enrolled in the study. Ovulatory disorder due to PCOS was apparently the only cause of infertility; no tubal defect or deficiency of male semen parameters was found. Myo-inositol combined with folic acid (Inofolic®) 2 g twice a day was administered continuously. During an observation period of 6 months, ovulatory activity was monitored with ultrasound scan and hormonal profile, and the numbers of spontaneous menstrual cycles and eventually pregnancies were assessed.

Results. Twenty-two out of the 25 (88%) patients restored at least one spontaneous menstrual cycle during treatment, of whom 18 (72%) maintained normal ovulatory activity during the follow-up period. A total of 10 singleton pregnancies (40% of patients) were obtained. Nine clinical pregnancies were assessed with fetal heart beat at ultrasound scan. Two pregnancies evolved in spontaneous abortion.

Conclusion. Myo-inositol is a simple and safe treatment that is capable of restoring spontaneous ovarian activity and consequently fertility in most patients with PCOS. This therapy did not cause multiple pregnancy.