Vitamin E as alternative local treatment in genitourinary syndrome of menopause: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: Genitourinary syndrome of menopause is a major health concern in postmenopausal women. This study was aimed at comparing the effect of a vitamin E vaginal suppository with that of conjugated estrogen vaginal cream on sexual function in postmenopausal women with genitourinary syndrome of menopause. METHODS: This survey was carried out on 52 postmenopausal women aged 40-65 years who had been referred to gynecology clinics in Mashhad city, during 2013-2014. Keeping ß = 0.1, the power was calculated to be 90%. The patients were randomly divided into two groups: vitamin E vaginal suppository and conjugated estrogen vaginal cream. Participants used the medications for 12 weeks. They were visited at the 4th, 8th, and 12th weeks. Validated Abbreviated Sexual Function Questionnaire (ASFQ), as the primary outcome measure, and a demographic information questionnaire, were used to collect data at each visit. Data were analyzed using SPSS and p < 0.05 was considered statistically significant. RESULTS: Mean overall scores of the ASFQ were increased significantly in both groups during the course of the study, compared with baseline (p < 0.001). However, the mean ASFQ scores of the two treatments did not differ significantly. CONCLUSION: Improved scores of ASFQ after the 12th week showed that the treatment was successful in both groups. Therefore, a vitamin E vaginal suppository may be an alternative to vaginal estrogen in relieving the symptoms of vaginal atrophy in postmenopausal women, especially those not able to use hormone therapy or have low compliance.

Controlled release of betamethasone from vitamin E-loaded silicone-based soft contact lenses.

CONTEXT: Betamethasone (BMZ) is an effective drug which is commonly used as an eye drop for the management of ophthalmic inflammations. Due to low ocular bioavailability, it is necessary to prepare and optimize an ocular drug delivery system for BMZ. OBJECTIVE: In this study we tried to use vitamin E diffusion barrier for sustaining BMZ release. MATERIALS AND METHODS: Three commercial contact lenses were soaked in vitamin E solutions and swelling percentage, diameter, transmittance, binding capacity and release amount and time were evaluated in comparison with non-vitamin E-loaded pure lenses. RESULTS: The results showed that vitamin E significantly decreased water content of contact lenses whereas, increased the lens diameter in both dry and wet states. It effectively blocked UV radiation which is harmful for the eye surface while had no significant effect on visible transmittance. BMZ loading capacity enhanced and release rate remarkably decreased after using vitamin E as a hydrophobic diffusion barrier. DISCUSSION AND CONCLUSIONS: This study revealed that vitamin E can be applied as a hydrophobic diffusion barrier for controlling and sustaining BMZ release from silicone-based soft contact lenses into the lachrymal fluid. It can also protect eye tissues as an antioxidant by blocking the UV radiation.

Effect of a functional food (vegetable soup) on blood rheology in patients with polycythemia.

OBJECTIVE: Key hemorheological variables are associated with several life-threatening diseases including cardio-cerebro-vascular diseases. A diet can influence the blood rheological variables. To compare the effectiveness of a vegetable soup on blood viscosity (BV), hematocrit (Hct), plasma fibrinogen, lipid profile, fasting blood sugar (FBS), and blood osmolarity in patients with polycythemia in comparison to a control group. MATERIALS AND METHODS: This randomized controlled trial study was conducted at Isar health clinics in Mashhad, Iran, during a 7-month period. Forty male participants (35 to 60 years old) with polycythemia, but without underlying diseases, were included. They randomly assigned to two groups and either received diet/phlebotomy or phlebotomy alone, for 6 weeks. The data were analyzed by SPSS version 16 using parametric tests. RESULTS: A significant reduction in BV at 30s (p ≤ 0.001), BV at 40s (p ≤ 0.001), BV at 50s (p ≤ 0.001), Hct (p ≤ 0.001), plasma fibrinogen (p ≤ 0.001), total cholesterol (p<0.01), LDL-cholesterol (p<0.01), VLDL-cholesterol (p ≤ 0.001), HDL-cholesterol (p ≤ 0.01), osmolarity (p ≤ 0.001), and FBS (p ≤ 0.001) was observed in diet recipients. Following the intervention, there was a significant decrease in triglyceride (intervention group, p<0.05; control group, p<0.05), in both groups. CONCLUSION: This trial showed that the plant-based food used in this study could improve blood rheology.

Nasal immunization studies using liposomes loaded with tetanus toxoid and CpG-ODN.

To increase the systemic and mucosal immune responses against the nasally administered tetanus toxoid, liposomes as a drug delivery system and CpG-ODN as an adjuvant were evaluated. Rabbits were nasally immunized with entrapped tetanus toxoid (TT) and CpG-ODN in neutral liposomes and systemic and mucosal immune responses were determined. Liposomes containing TT and CpG-ODN were prepared by dehydration-rehydration method. The volume mean diameter of liposomes was 2.3+/-0.6 microm. Encapsulation efficiency of TT and CpG-ODN was determined as 54.0+/-8.8 and 60.1+/-7.4, respectively. The leakage of the encapsulated TT from liposomes reached 7.38% after 3 months. Encapsulated TT kept its intact structure, and its immunoreactivity was also completely preserved, as shown by SDS-PAGE and ELISA methods. The highest serum IgG and antitoxin titers were observed in groups immunized with solution formulations (P < 0.001). However the highest mucosal sIgA titers were achieved by liposomes encapsulated with TT. CpG-ODN as an adjuvant was able to increase the serum IgG and antitoxin titers when co-administered with TT solution (P < 0.05) or co-encapsulated with TT in liposomes (P < 0.01), but failed to increase the sIgA titers in nasal lavages. No hemolysis occurred on incubation of liposomes and human RBCs. Also after nasal administration of plain liposomes to human volunteers, no local irritation was seen. Intranasal administration of liposomes encapsulated with vaccines showed to be an effective way for inducing the mucosal immune responses.

Crocin, the main active saffron constituent, as an adjunctive treatment in major depressive disorder: a randomized, double-blind, placebo-controlled, pilot clinical trial.

OBJECTIVE: Herbal remedies play an important role in treatment of psychiatric disorders. The aim of this study was to assess the efficacy of crocin, the main active constituent of saffron, as an adjunctive treatment in major depressive disorder (MDD). METHOD: This study was a randomized, double-blind, placebo-controlled, pilot clinical trial. It was carried out during 4 weeks in two groups (placebo and treatment) on 40 MDD patients between 24 and 50 years old in Ibn-e-Sina psychiatric hospital, Mashhad, Iran, from March 2013 to December 2013. The crocin group (n=20) was given one selective serotonin reuptake inhibitor (SSRI) drug (fluoxetine 20mg/day or sertraline 50mg/day or citalopram 20mg/day) plus crocin tablets (30mg/day; 15mg BID) and placebo group (n=20) was administered one SSRI (fluoxetine 20mg/day or sertraline 50mg/day or citalopram 20mg/day) plus placebo (two placebo tablets per day) for 4 weeks. Both groups filled beck depression inventory (BDI), beck anxiety inventory (BAI), general health questionnaire (GHQ), the mood disorder questionnaire (MDQ), side effect evaluation questionnaire, and demographic questionnaire before and after one month intervention. RESULTS: The crocin group showed significantly improved scores on BDI, BAI and GHQ compared to placebo group (Pvalue<0.0001). The averages of decrease in BDI, BAI and GHQ scores in placebo group were 6.15, 2.6 and 10.3 respectively, whereas the values in crocin group were 17.6, 12.7 and 17.2 after 4 weeks trial. LIMITATIONS: Poor patient compliance with medications and short trial period, small sample size and self-report assessments were the major limitations of this study. CONCLUSION: These results demonstrated the effect of crocin in depression and could be administered in treatment of MDD patients.

Brimonidine Imprinted Hydrogels and Evaluation of Their Binding and Releasing Properties as New Ocular Drug Delivery Systems.

Molecular imprinting is a technique for preparation of specific polymeric receptors for recognition and selective binding of chemicals. Recently, molecularly imprinted soft contact lenses have been studied as novel ocular drug delivery systems. The aim of this work was to prepare, for the first time, a brimonidine (BRN) imprinted soft contact lens material and study of its binding and releasing properties in aqueous media. The hydrogels were prepared using hydroxyethyl methacrylate (HEMA) as a backbone monomer, methacrylic acid (MAA), methacrylamide (MAAM) and 4-vinylpyridine (4VP) as the functional monomers and ethylene glycol dimethacrylate (EGDMA) as a cross linker monomer. Different BRN: MAA molar ratios were also applied in feed composition of monomers to study the influence of molecular imprinting technique on their binding properties. The hydrogels were characterized by determination of their swelling and binding properties in water. Their loading and release properties were also studied using Korsmeyer-Peppas equation in normal saline (NaCl 0.9%) and artificial tear solution. Poly (HEMA-co-MAA) showed superior binding properties compared to other copolymers. Also molecular imprinting technique significantly increased the hydrogel affinity to drug. It was found that all molecularly imprinted polymers (MIPs) had higher affinity to BRN in comparison with nonimprinted polymers (NIPs). The optimized MIP hydrogel with BRN: MAA molar ratio of 1: 8 showed greater ability to drug loading and controlled release compared to other MIPs. The results of the present work indicated that molecular imprinting technique had a significant effect on improving loading capacity and sustaining drug release from hydrogels.

Antioxidant Activity of Pistacia vera Fruits, Leaves and Gum Extracts.

The side effects of synthetic antioxidants have been considered in different studies. Accordingly, there is an increasing interest toward the use of natural substances instead of the synthetic ones. In this study, the aqueous and ethanolic extracts of Pistacia vera leaves and fruits as well as hydroalcoholic extract of gum were tested for a possible antioxidant activity using in vitro methods. Deoxyribose assay, erythrocyte membrane lipid peroxidation and liver misrosomal non- enzymatic lipid peroxidation tests were used as an in-vitro model for determination antioxidant activity. The extract were evaluated at different concentratios: 25,100, 250, 500 and 1000 µg/mL. In all procedures, all extracts showed free radical scavenging activity. The effect of ethanolic extract of P. vera fruit at 1000 µg/mL was quite similar to positive control (DMSO 20 mM) in deoxyribose method. In two other tests, the ethanolic extracts of fruits and leaves were more effective than the aqueous extracts to inhibit malondialdehyde generation. Phytochemical tests showed the presence of flavonoids and tannins in Pistocia vera extracts. The present study showed that extracts of different part of P. vera have antioxidant activity in different in vitro methods. The ethanolic extracts of leaves and fruits showed more roles for antioxidant properties and gum hydroalcoholic extract demonstrated less antioxidant effect.