The information on this page is for the use of healthcare professionals.
Inofolic® is a combination of myo-inositol and folic acid presented in packs of 30 sachets, each sachet containing 2g myo-inositol and 200mcg folic acid.
The recommended daily dose is 1 sachet twice a day dissolved in a small glass of water.
Inofolic has been available in Italy for about 15 years. Over the last 2 years, Inofolic has been marketed in the UK by Pharmasure Ltd. Pharmasure has started to promote Inofolic to fertility specialists, obstetricians, gynaecologists and endocrinologists.
Myo-inositol is present in every living cell and has many important functions. One important role is being part of the ‘second messenger’ system for Insulin1. Myo-inositol is involved in the signal of insulin from the insulin receptor – particularly important for patients with insulin resistance.
Inofolic has a variety of roles in PCOS, spanning fertility2,3,4,5 and IVF1,6,7,8. Inofolic corrects menstrual cycle disturbances9, reduces obesity4 and androgenic symptoms, such as hirsutism and acne10. Inofolic achieves ovulation 70% of PCOS patients9. It is associated with improved oocyte and embryo quality in those patients undergoing assisted reproductive technologies (ART), such as IVF1,6,7,8.
Between 65- 80% of patients with PCOS have insulin resistance11, where the response to insulin is sub-optimal. This condition is thought to contribute to a number of other issues related to PCOS, such as metabolic syndrome, hormonal imbalance, androgenic symptoms and diabetes in pregnancy.
PCOS patients have a higher risk than normal of developing the metabolic syndrome12 ; a mix of conditions including weight gain, type 2 diabetes and dyslipidaemia. Approximately one third to one half of all women and adolescent girls with PCOS has the metabolic syndrome13. A recent RCOG ‘green top’ guideline advises doctors to inform patients with PCOS of such long term health consequences12. Such patients have considerable long term health risks and the evidence for using Inofolic in these patients is compelling.
Postmenopausal patients with metabolic syndrome treated with Inofolic plus diet for 6 months showed significant improvements diastolic blood pressure
(-11%) , HOMA index (-75%), serum triglycerides (-20%) and an improvement in high-density lipoprotein cholesterol (22%), compared with the control group (diet plus placebo)14. Indeed, of a cohort of 80 postmenopausal women with metabolic syndrome was split into 40 receiving Inofolic® + diet and 40 receiving placebo + diet for one year; the Inofolic group showed improvement in every parameter, save BMI and waist circumference, and at the end of the study, only 8 (20%) of the Inofolic group had metabolic syndrome, whereas only one woman in the control group no longer had the syndrome15. Similar improvements in HOMA-IR, reductions in insulin levels and improvements in lipid profile were also shown in the placebo controlled study by Capasso et al16, 2013.
PCOS patients also have a much higher incidence of developing diabetes in pregnancy, in fact 30% of PCOS patients develop gestational diabetes mellitus (GDM)17. A retrospective study in PCOS women showed a reduction in risk od GDM of 17.4% in the Inofolic group compared to 54% in the control group17. In patients with GDM, a prospective randomised controlled study showed that Inofolic improved insulin resistance compared to controls18. A prospective RCT in women with a high risk of developing GDM showed a significantly lower prevalence of GDM in the Inofolic arm compared to controls (P<0.001), less requirement for insulin, a late gestational age, smaller babies with fewer neonatal hypoglycaemia19. Inofolic has also been shown to reduce the rate of GDM in pregnant women at risk of developing GDM, due to a family history of type 2 diabetes; a 2-year prospective, randomised, open-label, placebo controlled study showed that the Inofolic arm showed a reduced incidence of GDM (P<0.04) and statistically significantly less macrosomia20.
|There is now hope that Inofolic will be effective at reducing the incidence of GDM in normal patients in order to reduce the general incidence of GDM.|
- Results from the International Consensus Conference on myo-inositol and D-chiro-inositol in Obstetrics and Gynaecology – assisted reproduction technology. Bevilacqua, Carlomagno et alGynecol Endocrinol, 2015; Early online: 1-6
- Effects of myo-inositol in women with PCOS: a systematic review of randomised controlled trials Gynecological Endocrinology, 2012; Early Online 1–7
- Contribution of myo-inositol to reproduction, Papaleo et al, European Journal of Obstetrics & Gynecology and Reproductive Biology 147 (2009) 120–123
- Effects of myo-inositol on ovarian function and metabolic factors in women with PCOS: a randomized double blind placebo-controlled trial, Gerli et al, European Review for Medical and Pharmacological Sciences, 2003; 7: 151-159
- Ovulation induction with myo-inositol alone and in combination with clomiphene citrate in polycystic ovarian syndrome patients with insulin resistance,Kamenov et al, Gynecological Endocrinology 2015, Vol 31, – Issue 2, pp131-135
- Effects of myo-Inositol supplementation on oocyte’s quality in PCOS patients: a double blind trial, Ciotta et al, European Review for Medical and Pharmacological Sciences, 2011; 15: 509-514
- Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Chiu et al, Hum Rep 2002, vol17, No 6, pp 1591 – 1596,
- Pretreatment with myo-inositol in non-polycystic ovary syndrome patients undergoing multiple follicular stimulation for IVF: a pilot study, Lisi et al, Reproductive Biology and Endocrinology 2012,10:52
- Myo-inositol in patients with polycystic ovary syndrome: A novel method for ovulation induction, Papaleo et al, Gynecological Endocrinology, December 2007; 23(12): 700–703
- Efficacy of myo-inositol in the treatment of cutaneous disorders in young women with polycystic ovary syndrome, Zacche et al, Gynecological Endocrinology, 2009; 25(8); 508-513
- Long Term Consequences of Polycystic Ovary Syndrome, RCOG Green-top Guideline No 33, November 2014
- Metabolic syndrome and polycystic ovary syndrome… and vice versa, Kandaraki et al, Arq Bras Endocrinol Metab. 2009; 53/2
- The metabolic syndrome in polycystic ovary syndrome. Essah PA1, Wickham EP, Nestler JE. Clin Obstet Gynecol.2007 Mar;50(1):205-25.
- Effects of Myoinositol Supplementation in Postmenopausal Women with Metabolic Syndrome: A Prospective, Randomized, Placebo controlled Study, Giordano et al, Menopause, 2011;18(1):102-104.
- One year effects of myo-inositol supplementation in postmenopausal women with metabolic syndrome, Santamaria et al, Climacteric, 2012; 15;490-495
- Combination of inositol and alpha lipoic acid in metabolic syndrome-affected women: a randomized placebo-controlled trial, Capaaso et al, Trials 2013,14:273
- Myo-inositol may prevent gestational diabetes in PCOS women, D’Anna et al, Gynecological Endocrinology, 2012; 28(6): 440-442
- The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes, Corrado et al, Diabetic Medicine, 2011, 972-975
- Effect of dietary myo-inositol supplementation in pregnancy on the incidence of maternal gestational diabetes mellitus and fetal outcomes: a randomized controlled trial, Matarrelli et al, J Matern Fetal Neonatal Med, 2013, Early Online: 1–6
- Myo-Inositol Supplementation and Onset of Gestational Diabetes Mellitus in Pregnant Women With a Family History of Type 2 Diabetes, Diabetes Care, Vol 36, April 2013