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INTRODUCTION: Low testosterone is usually associated with erectile dysfunction (ED). SA3X (Spilanthes acmella) has proven to be effective in alleviating symptoms of ED, which could be due to an alteration in serum testosterone levels. This study was carried out to evaluate the change in testosterone levels in participants with ED supplemented with SA3X for three months. MATERIALS AND METHODS: A group of 326 sexually active men aged 25-60 years was investigated from November 2021 to May 2022 in Hyderabad. The participants were subjected to supplementation with SA3X capsules for three months, and a follow-up was done at the end of six months with serum testosterone assessment in each visit. The change in testosterone level was assessed using a mixed model repeated measures analysis. RESULTS: A significant increase was observed in the mean serum testosterone levels by the end of the second month (323.91 ± 13.76 ng/dL vs. 309.84 ± 14.11 ng/dL; p=0.03) and third month (332.27 ± 12.85 ng/dL vs. 309.84 ± 14.11 ng/dL; p<0.01) of SA3X therapy. The adjusted mean change in testosterone levels was found to be 22.43 ng/dL at the end of the three-month therapy. It was also observed that the change in testosterone levels was significantly lower in participants having diabetes mellitus, hypercholesterolemia, and a history of substance abuse. However, participants on phosphodiesterase-5 inhibitors had an increased change in testosterone levels. CONCLUSION: Supplementation with SA3X capsules for three months increases the serum testosterone levels. However, causality cannot be ascertained owing to the longitudinal nature of the study, and further controlled trials are required for the same.
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Introduction Spilanthes acmella has been used as an aphrodisiac in India and other countries. However, studies concerning humans have been limited. This randomized controlled trial was carried out to evaluate the effect of SA3X capsules containing 500 mg of S. acmella on sexual function domain scores in sexually active men with symptoms of erectile dysfunction (ED) using the Men's Sexual Health Questionnaire (MSHQ). Materials and methods This triple-blind, placebo-controlled, parallel-group was conducted at two centres in Hyderabad and Secunderabad from May to December 2021. Patients were randomized 1:1 to SA3X therapy or placebo for one month along with an observational cohort. The change of MSHQ score and its subdomains from baseline to month 1 (primary endpoint) and one-month post-treatment (secondary outcome) was assessed using a mixed model repeated measures analysis. Additional secondary outcomes measured were the change in the International Index of Erectile Function (IIEF) and duration of penile erection. Safety was evaluated. Results The intention-to-treat population included 448 patients (152 - SA3X therapy; 146 - placebo; 150 - observational cohort). A significant increase was observed with SA3X therapy versus placebo on the total MSHQ score (17.24 vs 4.72; SE: 2.11, 1.98; P<0.001) along with the sub-domains at the end of one month of therapy. At one-month post-treatment, the increase in MSHQ score with SA3X therapy was significant (18.48 vs 3.78; SE 2.81, 1.39; P<0.001). The IIEF scores and duration of penile erection also increased significantly in the SA3X therapy group. Dysgeusia (3.94%) was the most common drug-related adverse effect. No serious adverse effects were noted. Conclusion SA3X was concluded to be safe and effective as a potential treatment for ED.
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Objectives:To determine whether SA3X (Spilanthes acmella) supplementation improves serum testosterone levels, in comparison with placebo, in participants with erectile dysfunction (ED) and low testosterone levels. Material and methods:This double-blind placebo-controlled parallel-group was conducted in Hyderabad, India, among male participants who were randomized to SA3X therapy or placebo (1:1) for three months. The change of serum testosterone levels from baseline to months 1, 2, 3 and 6 (three months after completion of the intervention) were assessed using a mixed model repeated measures analysis. Additional secondary outcomes were the change in the Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF) and the duration of penile erection. Stratifying the effect of SA3X on testosterone levels was done to account for potential confounders and effect modifiers. Safety was evaluated. Results:The intention-to-treat population included 215 patients (105 - SA3X therapy; 110 - placebo). SA3X intervention increased the testosterone levels significantly (21.85 vs. 1.89 ng/dL; P<0.001) at the end of month 3. The elevated testosterone levels were maintained at month 6 (18.69 vs. 1.79; P<0.001) even after discontinuation of the intervention. The MSHQ scores, IIEF scores, and duration of penile erection also increased significantly in the SA3X group. Sensitivity analysis showed that the effect of SA3X on testosterone significantly differed by BMI, presence of comorbid conditions and intake of phosphodiesterase-5 inhibitors. Dysgeusia (7.61%) was the significant drug-related adverse effect. Conclusion:Supplementation with SA3X for people with ED and low testosterone is a safe option as it significantly increases testosterone levels along with erectile function.
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AIM: To determine whether wearing a face mask for more than three to six hours/day leads to the new onset of symptoms or worsening of pre-existing dry eye disease (DED) in healthcare workers (HCWs) of our institute. METHODOLOGY: An observational cross-sectional study, where 114 HCWs using face masks regularly participated voluntarily in the study. A survey with a modified Ocular Surface Disease Index (OSDI) questionnaire was completed by participants. They were divided into groups based on their sex, age, how long they had been wearing face masks, and whether they had a history of DED. RESULTS: We found that for HCWs who had previously experienced DED and who were under the age of 40, wearing a face mask for more than three to six hours/day could contribute to or worsen symptoms of DED. Also, we observed that the N-95 mask has a higher chance of causing DED than surgical masks. CONCLUSION: Medical professionals need to be aware of any potential dry eye symptoms related to the prolonged use of a face mask. Additional consideration should be given to patients who already have DED. The possible concerns that incorrectly fitted facemasks may cause to the health of their ocular surface should be discussed with patients by ophthalmologists. Future research involving larger populations will shed light on the prevalence and scope of the mask-associated dry eye problem.
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Corona virus infection (COVID-19) is increasing exponentially globally. It is also affecting pregnant women among others. Complications arising during pregnancy because of COVID-19 must be considered a health issue. The objective of the study was to analyse symptoms of pregnant women affected with COVID-19 based on the available literature. The articles were searched from Medline/PubMed, Scopus which were published till June 2020 and reviewed for the determined outcomes. The review demonstrated that common symptoms were fever, cough, nausea and myalgia. Vertical transmission of Corona virus infection was not found in any of the articles reviewed. Multicenter studies are important to better understand the pathogenesis and treatment planning for COVID-19 affected pregnant women.
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INTRODUCTION: Spilanthol, an active metabolite of the herb Spilanthes acmella, has many biological and pharmacological effects with limited studies on humans. OBJECTIVES: To determine the extent of increase/decrease in muscle mass and sexual frequency over a period of 3 weeks and 2 months in participants consuming SA3X capsules (containing 500 mg of Spilanthes acmella extract, standardized to 3.5% spilanthol delivering 17.5 mg spilanthol). MATERIALS AND METHODS: The study is longitudinal in nature and is conducted among 240 male participants consuming SA3X capsules at three points - first at recruitment, second at the end of 3 weeks, and lastly at the end of 2 months in Hyderabad and Secunderabad who were assessed for muscle gain by measuring mid upper-arm circumference (MUAC), chest circumference (CC), thigh circumference (TC), and for sexual activity by a change in frequency of sexual activity and duration of penile erection. The nutrient intake was assessed by 24-h dietary recall method at each visit along with the daily activity. RESULTS: A significant increase in the MUAC, (P = 0.050), frequency of sexual intercourse (P = 0.028), and duration of penile erection (P = 0.032) were observed at the end of 3 weeks; however, no changes were observed in CC and TC. At the end of 2 months, a significant increase in the parameters MUAC (P = 0.031), frequency of sexual intercourse (P < 0.001), duration of penile erection (P = 0.029) along with significant increase in CC; (P = 0.048) and TC; (P = 0.036) was observed. CONCLUSION: The study reflects the herb Spilanthes acmella to be a potent muscle gainer and aphrodisiac. However, further studies on humans need to be carried out to establish the temporality of the association of spilanthol with its claimed benefits.
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AIM: To study the effect of increased maternal BMI on fetal outcome. MATERIALS AND METHODS: The present descriptive cross-sectional study entitled was conducted in the Department of Obstetrics and Gynecology. The study includes 100 subjects who have taken antenatal care at the hospital. Descriptive statistics included computation of percentages, means and standard deviations were calculated using SPSS version 20. RESULTS: Mean age was 27.21 years, mean BMI (kg/m2) was 27.49 and mean weight gain was 7.14 kgs. Most common neonatal complication was Low Birth Weight (7%) followed by Meconium Aspiration Syndrome (6%), Sepsis (6%). Neonatal death was observed among 5% subjects and still birth was reported among 4%. CONCLUSION: Present study confirmed that maternal obesity is associated with an increased risk of neonatal complications like Low Birth Weight, Meconium Aspiration Syndrome and Sepsis.
