Understanding the need for developing a structured competency-based curriculum for health policy and programs among community medicine postgraduates: A grounded theory approach.

Introduction: Many plans and policy changes about health outcomes have evolved, but none of them have ever given a definite shape to the postgraduate (PG) curriculum so as to make it more intensive and integrative, which needs to be so structured and tailored that it is more patient, community centric, and less knowledge based. Objectives: The objective of this study was to identify the gap in existing curriculum in learning of health policy and program among PGs of community medicine and recommend a structured model for the same. Materials and Methods: A qualitative study (grounded theory approach) with all PGs of community medicine in one teaching institute in South India (8 PG students) was taken up. Results: PGs felt that they never had any day-to-day update. They wanted to understand the working pattern and ground reality of policy and program which was unavailable to them. People who came to postgraduation after being medical officers felt that the monitoring and evaluation done by inexperienced MD Community Medicine students was never accepted by state public health because they did not understand the implementation problems and so could not rightly critically evaluate the programmatic challenges. Conclusion: With the shift in medical education patterns and expectations of residents, it becomes important to justify the need of developing a structured based curriculum, more so for policy and programs, which will make them capable enough by polishing their managerial and financial skill set. The evaluation technique should focus more on practical aspects on field instead of their theory examination.

Evaluation of Serum Testosterone Levels Following Three Months of SA3X (Spilanthes acmella) Supplementation.

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.

Randomized, Triple-Blinded, Placebo-Controlled Trial of SA3X (Spilanthes acmella) for the Management of Erectile Dysfunction.

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.

Effect of SA3X (Spilanthes acmella) Supplementation on Serum Testosterone Levels in Males with Erectile Dysfunction - A Parallel Double-Blind Randomized Controlled Trial.

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.

Evaluation of effects of Spilanthes acmella extract on muscle mass and sexual potency in males: A population-based study.

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.

Association between mid-upper arm circumference and body mass index in pregnant women to assess their nutritional status.

BACKGROUND: Underweight/ Undernourished is a state when the body mass index (BMI) falls below 18.5 kg/m2 and as per National Family and Health Survey-4, 22.9% of women in the reproductive age group fall into this category. Despite being considered as an important anthropometry marker, it is not measured in most of the healthcare facilities across India due to lack of basic amenities and resources. In such instances, how helpful other indicators like mid-upper arm circumference (MUAC) can be to measure the undernourished status of pregnant needs to be determined. OBJECTIVES: To estimate the prevalence of undernutrition in pregnant women (PW) based on baseline BMI and MUAC and to determine the association between them. MATERIALS AND METHODS: A cross-sectional study was conducted in Tangi Block of Odisha among 440 PW (in the first trimester) from July 2018 to November 2018 using a pre-tested, validated questionnaire and anthropometric instruments. RESULTS: PW having BMI <18.5 kg/m2 were found to be 16.6% and having MUAC <23.5 cm were 19.5%. A significant association was found between BMI and MUAC [aOR 7.91 (4.27-14.65)]. Also, a moderate correlation was established between the indicators (r = 0.57). CONCLUSION: MUAC can be used instead of BMI as it is easier to measure, cheaper, does not require any training or calculations, and insensitive to changes during the period of gestation unlike BMI. This can be beneficial to the healthcare workers at primary level who are in resource-limited settings.

Maternal Nutrition and Inadequate Gestational Weight Gain in Relation to Birth Weight: Results from a Prospective Cohort Study in India.

Inadequate/excessive gestational weight gain (GWG) can cause adverse pregnancy outcomes and only few studies have described patterns of weight gain in Indian women. Also, studies pertaining to dietary intake throughout gestation are insufficient. This prospective cohort study was conducted to evaluate GWG and nutrient intake in all trimesters of pregnancy and investigate the relationship between themselves along with that of birth weight (BW). Our study was carried out in a population-based prospective birth cohort in Odisha, India. The 418 pregnant women were followed till delivery with measurements of maternal weight, weight gain throughout gestation, and BW. Macronutrients were assessed based on a 24-hour dietary recall method in each trimester. Women characterized by under-weight pre-pregnancy body mass index (BMI) were 16.20%, and a total of 6.45% did not comply with current weight gain recommendations. Particularly, overweight and obese women gained more weight than recommended. In a multivariate analysis GWG correlated significantly with BMI (p = 0.03), total calorie intake (p < 0.001) and fat intake (p < 0.001), while BW of newborns correlated significantly with adequacy of weight gain and fat intake (p < 0.001). Though measures are taken by health workers to record the weight but nutritional counseling is not being provided regularly. A high priority should be given to increase awareness among general population regarding the importance of diet in pregnancy and how to adhere to the balanced diet for optimal growth of child.