Resolution of subchorionic hematoma and symptoms of threatened miscarriage using vaginal alpha lipoic acid or progesterone: clinical evidences.

OBJECTIVE: Alpha Lipoic Acid (ALA) is a safe natural molecule that exerts a selective immunomodulating activity with antioxidant and anti-inflammatory properties. This randomized controlled clinical trial (RCT) tested the effect of the vaginal administration with ALA or Progesterone, in subchorionic hematoma resorption in women with threatened miscarriage. PATIENTS AND METHODS: 400 mg of vaginal Progesterone or 10 mg of vaginal ALA were administered to sixty-two pregnant women, in the first trimester of gestation with threatened miscarriage and subchorionic hematoma. Controls were patients who chose not to receive any treatment. RESULTS: In the ALA group the subchorionic hematoma was reabsorbed more quickly in comparison with the progression detected in Progesterone group (p ≤ 0.05). The other parameters checked (pelvic pain and vaginal bleeding) did not show any significant difference and a smaller number of miscarriages was recorded in the ALA group, compared to Progesterone group. CONCLUSIONS: Our data provides the first evidence of the efficacy of ALA, administered by vaginal route, in the healing process of patients with threatened miscarriage, thus supporting the normal course of pregnancy. CLINICAL TRIAL REGISTRATION NUMBER: NCT02601898 (ClinicalTrials.gov registry).

[Counseling about folate intake during pregnancy]. / Counseling per l'utilizzo di folati nella gravidanza.

AIM: In gynecology, the importance of an adequate folate intake in the periconceptional period and during pregnancy is widely accepted. Its purpose is to decrease the risk of maternal and fetal diseases, such as neural tube defects (NTD), so that Italy strongly recommends that women who are pregnant or are planning to become pregnant receive folate supplementation (i.e. 0.4 or 4-5 mg per day, as needed). Despite that, recent studies show women's low awareness of the importance of folate supplementation, above all during the periconceptional period. Basing on these considerations, we surveyed pregnant women to investigate their awareness and the real use of folate. METHODS: From January to October 2014 we surveyed 650 pregnant women. We used a questionnaire with closed and semi-closed questions. RESULTS: The mean age of the enrolled women was 32.8 (±2.9). The survey showed that a significant proportion of women knew folate benefits in pregnancy (about 70%) and they used it during gestational period (89.8%), whereas folate supplementation during periconceptional period was inadequate, used by only the 16.9% of women and often at a lower than recommended amount. CONCLUSION: Awareness and use of folate can be promoted through informational campaigns among general practitioners and obstetricians/gynecologists, through preconceptional and prenatal counseling, and through a risk assessment addressed to choose the appropriate folate type and dosage.

[Use of alpha-lipoic acid and omega-3 in postpartum pain treatment]. / [Acido alfa-lipoico e omega-3 nel trattamento del dolore nel postpartum.

Postpartum pain is a frequent condition that negatively affects women's quality of life, interferring with everyday life. Analgesic drugs and surgery are often contraindicated in pregnancy and during breast feeding. This review of the literature aims to evaluate the rational of the association of lipoic acid and omega-3 employ in the management of postpartum pain. Lipoic acid is a cofactor essential in mitochondrial metabolism with antioxidant and anti-inflammatory activity. Lipoic acid has been shown to be effective in neuropatic pain treatment in patients with sciatica, carpal tunnel syndrome and diabetic neuropathy. Omega-3 are known for their anti-inflammatory and neurotrophic activity. The peripheral and central activity of both substances allows to act on neuroinflammation mechanisms thus reducing cronicization of pain and also determining a potential improvement of women's emotional status. The preliminary data here presented confirm the positive effect of this association on the treatment of postpartum perineal pain. The supplementation of lipoic acid in association with omega-3 seems effective and safe for the treatment of chronic postpartum pain, allowing a pathogenetic approach to neuroinflammation, thus reducing the consumption of analgesic drugs, often contraindicated during breast-feeding.

Hyaluronic acid and vitamins are effective in reducing vaginal atrophy in women receiving radiotherapy.

AIM: During the last decades, therapies targeting cervical cancer have been considerably improved. Surgery and radiotherapy (RT) represent the main common therapeutic approach in cervical cancer. In order to minimize the side effects of radiotherapy approach, several protocols have been developed such as brachytherapy (BRT). Among the side effects associated with RT, the vaginal atrophy is the most important and common one. Vaginal atrophy, in turn, leads to additional alterations like inflammation, associated to relevant symptoms such as itching, burning and dyspareunia. All these alterations heavily affect the quality of women's life. The aim of our study was to evaluate the toxicity induced by RT on vaginal mucosa, and the adjuvant action of a product containing LMWHA, vitamin A, and Vitamin E (Santes®, Lo.Li. Pharma, Rome, Italy). The introduction of adjuvant therapies may have likely had a relevant place in providing that result. METHODS: A prospective randomized study was designed. From October 2006 to October 2008, 45 women with a mean age 38 ± 6 years were enrolled. After surgery, all patients were treated with 4 weeks of RT and 4 weeks of BRT, concomitantly with chemiotherapy. They were randomly assigned in two groups: 23 women were treated with two suppositories (Santes®) per day for 4 months. For the first two months the preventive treatment was simultaneous to RT and BRT. Instead the control groups for composed by 22 patients and they did not undergo any treatment during RT. To evaluate the efficacy of Santes® treatment three biopsies were performed. RESULTS: At the second biopsy, after the BRT therapy, the treated group showed a statistically significant improvement (P<0.05 vs. control) on inflammation, cell atypia, fibrosis, mucositis and bleeding. At the third biopsy, two months after BRT, further statistically improvement were observed for all RT/BRT associated side effects. The treatment showed an efficacy also in terms of pain severity. CONCLUSION: Our data suggest that low molecular weight HA shows good performances in treating RT-damaged tissue and plays a key role in all steps of the healing process. Indeed the results shows that women exposed to RT treatments and simultaneously treated with Santes®, had an optimal resolution of vaginal atrophy and related symptoms.

Peripheral neuropathy in obstetrics: efficacy and safety of α-lipoic acid supplementation.

OBJECTIVE: Neuropathic pain during pregnancy is a common condition due to the physical changes and compression around pregnancy and childbirth that make pregnant women more prone to develop several medical conditions such as carpal tunnel syndrome, sciatica, meralgia paraesthetica and other nerve entrapment syndromes. Most of the treatments usually performed to counteract neuropathic pain are contraindicated in pregnancy so that, the management of these highly invalidating conditions remains an issue in the clinical practice. We aimed to review the efficacy and safety of alpha lipoic acid supplementation in the treatment of neuropathic pain. DISCUSSION: Lipoic acid is a co-factor essential in the regulation of mitochondrial energy. It has been demonstrated that lipoic acid supplementation is involved in several biochemical processes and actions, exerting important antioxidant and anti-inflammatory activity and significantly improving pain and paraesthesia in patients with sciatica, carpal tunnel syndrome and diabetic neuropathy. CONCLUSIONS: Efficacy of lipoic acid is combined with a high safety profile, making this molecule a novel candidate for the management of several diseases. Data reported so far are promising and dietary supplementation with lipoic acid seems a useful tool to contrast neuropathic pain during pregnancy.

[Role of D-chiro-inositol in glucidic metabolism alterations during pregnancy]. / Ruolo del D-chiro inositolo nelle alterazioni del metabolismo glucidico in gravidanza.

The recent epidemiological explosion of diabetes amplified the problems regarding the various complications related to the disease and its complex healthcare management. Among these, those relating to the pregnancy of women with diabetes are highly significant from the point of view of social health, for the consequences of the disease on the unborn child, but also in the mother. It is possible that diabetes exists before pregnancy (pregestational diabetes), but much more often it can appear during pregnancy in women unaware of the disease (gestational diabetes). The mainstay of therapy for diabetes and gestational diabetes resides in diet, therapy with oral hypoglycemic agents or insulin, but the appearance on the market of supplements consisting of substances such as D-chiro-Inositol (DCI) arousing considerable interest, as it seems to be able to help in the glycemic control in this type of disease but, of course, its effectiveness must be proved. The data of our study seem to show that the DCI supplement has a role in the regulation of glucose metabolism and insulin sensitivity, and is able to act on the metabolism of pregnant women at risk of developing gestational diabetes, who probably have a basic alteration of insulin and glucose metabolism. It acts improving insulin sensitivity and reducing the onset of gestational diabetes in pregnant women at risk, decreasing the weight gain and nocturnal hypoglycemia responsible for the attacks of hunger at night. Further studies would be desirable to clarify the mechanism of action of DCI at the cellular level in glucose metabolism during pregnancy, and clinical data must be confirmed with wider studies.

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

To investigate the effects of treatment with Myo-inositol (an insulin sensitizing drug), on circulating insulin, glucose tolerance, ovulation and serum androgens concentrations in women with the Polycystic Ovary Syndrome (PCOS). 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.

[Preliminary evaluation of a vaginal cream containing lactoferrin in the treatment of vulvovaginal candidosis]. / Studio preliminare sull'utilizzo di una crema contenente Lattoferrina nel trattamento della vulvovaginite acuta da candida.

AIM: The objective of the study is to verify the clinical effectiveness of a cream containing lactoferrin in the treatment of acute vulvovagininal candidiasis. METHODS: The study enrolled 34 patients aged 25-45 years and preenting signs and symptoms of acute vulvovaginal candidiasis. The patients have been treated with a cream containing lactoferrin 4%, 5 g of cream in vagina and 2 cm applied on the vulva twice a day for 7 days. At the end of the treatment the patients a clinical and microscopical examination was performed in order to evaluate the effectiveness of the therapy. RESULTS: The results obtained showed that 27 women completely recovered, 5 showed a good improvement and only 2 women were still suffering from vulvovaginitis at the end of treatment. CONCLUSION: From the data of our study, a cream containing lactoferrin seems to be clinically effective in the treatment of acute vulvovaginal candidiasis, with a good response on all the characteristic symptoms of this infection.

Effectiveness and safety of vaginal suppositories for the treatment of the vaginal atrophy in postmenopausal women: an open, non-controlled clinical trial.

Menopause, due to the physiological decrease in the estrogens levels, is often associated with many symptoms related to vaginal atrophy such vaginal dryness, dyspareunia, burning, itching, decreasing in libido and therefore a worsening of the quality of life and in particular of the sexual activity. There are many pharmacological remedies to solve these events, first of all hormone replacement therapy (HRT) that up to the 90s was the therapy of choice for the care of the menopause symptoms. This hormonal therapy, however, has been re-considered due to its side effects. As alternative, a clinical trial has been performed to investigate the efficacy and safety, in postmenopausal women with urogenital atrophy, of the use of suppositories for vaginal use, containing hyaluronic acid, vitamin E and vitamin A. The trial, according to a open, non-controlled design, was performed on 150 postmenopausal women, 1 vaginal suppository per day, for the first 14 days and then a vaginal suppository, day in and day out, for other 14 days. The primary endpoint was the evaluation of vaginal dryness assessed by a Visual Analogue Scale (VAS) both by the investigator and the patient. The secondary endpoints were the evaluation of all the other symptoms and signs associated with the vaginal atrophy (itching, burning, dyspareunia, vaginal inflammation or swelling, irritation, assessed by a 4-point scale, presence of vaginal abrasions and irritation), and the recording of the adverse events occurring during the trial. The patients have not reported adverse effects during the treatment, and the results in terms of effectiveness on the vaginal atrophy symptoms were markedly positive. A high level of compliance was registered. The product tested can therefore be considered a safe and effective alternative for the treatment of vaginal atrophy symptoms in postmenopausal women, especially when HRT is not recommended.