Does Coronavirus Disease 2019 Kill More Elderly Men than Women Due to Different Hormonal Milieu.

Preliminary data depicts a much greater prevalence and high case-fatality rate in advanced age males as compared to age-matched women with severe acute respiratory syndrome-coronavirus-2 infections with high morbidity, mortality, high referral, and admission to intensive care unit with severe sequelae. However, the literature search revealed both for and against studies in this context. Thus, at present, in light of the mixed studies, it cannot be established whether low testosterone levels in aging hypogonadal males create a permissive environment for severe response to coronavirus disease 2019 (COVID-19) infection and can it increase the morbidity or mortality, or on the contrary if the virus inhibits androgen formation. Hence, it is highly warranted to establish the said hypothesis by conducting large statistically powered clinical studies in future. Further, it is highly indicated that impact of sex hormones and gender on the incidence and case fatality of the disease and hormones as a treatment according to sex and gender for COVID requires further scientific research by the research community before it is actually recommended to mitigate the COVID-19 disease course among elderly men and women at large.

Menopause and Sleep Disorders.

Women are likely to suffer from sleep disorders more in comparison to men during menopause and with advancing age. The incidence of sleep disorders ranges from 16% to 47% at peri-menopause and 35%-60% at postmenopause. Insomnia with or without associated anxiety or low lying depression and Mood disorder is most common associated manifestations. Sleep disorders and insomnia largely remain a clinical diagnosis based on the subjective complaints of patients. Benzodiazepines remain the mainstay of the treatment in majority of the sleep disorders including chronic or acute insomnia. Treatment of associated anxiety, depression, or psychosis is most important. Tricyclic antidepressant, Selective Serotonin Reuptake Inhibitors (SSRI), Melatonin, Duloxetine, Fluoxetine, Imipramine, Nortriptyline or Amitriptyline and other drugs such as Eszopiclone, Escitalopram, Gabapentin, Quiteiapine, Citalopram, Mirtazapine followed by long-acting Melatonin and Ramelteon, also are very useful for the management of various sleep disorders. Hormone replacement therapy presently lacks concrete evidence to be used in menopausal women for sleep disorder. Sleep hygiene practices, self-hypnosis, meditation, and exercise play a very important role.

Cardiovascular and Osteoporosis Protection at Menopause with Lycopene: A Placebo-Controlled Double-Blind Randomized Clinical Trial.

Objective: The effect of lycopene (LycoRed) supplementation was evaluated in healthy postmenopausal women by biochemical markers for cardiovascular protection and osteoporosis protection. Study Settings and Design: This was a multi-centric placebo-controlled double-blind randomized clinical trial that screened 198 postmenopausal women at 21 centers across 12 cities in India. Levels of lycopene, lipid profile, high-risk C-reactive protein, and bone turnover markers: amino-terminal propeptide of Type I collagen (P1NP) and C-terminal telopeptide of Type I collagen (ß-CTx) were measured at baseline and 6 months postsupplementation with LycoRed or placebo. Interventions: The study was completed with 57 of the 100 women on LycoRed 8 mg (antioxidant potency is equivalent to 24 mg of lycopene) and 43 placebos for 6 months by randomization. Main Outcome Measures: Rise in serum lycopene and effect of serum lycopene on surrogate markers of cardiovascular health and bone health. Results: LycoRed supplementation increases lycopene levels and P1NP and nonsignificant fall in ß-CTx levels in healthy postmenopausal women. Conclusions: Lycopene supplementation in Indian menopausal women may confer protection from osteoporosis as shown by the directional change in the surrogate biochemical markers. This study can form a basis for larger studies with different doses to understand the effect of lycopene to prevent and act as adjuvant treatment on clinical endpoints for cardiovascular disease (CVD) and bone health.

Polycystic Ovarian Syndrome and Menopause in Forty Plus Women.

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age group, but it affects women's health and quality of life across the life course. During different stages of life, the PCOS phenotype can change, which requires a personalized diagnostic approach and treatment. With increasing age, the syndrome evolves from a reproductive disease to a more metabolic disorder. Along with various metabolic disturbances like insulin resistance and abnormalities of energy expenditure, PCOS is recognized as a major risk factor for the development of type 2 diabetes and cardiovascular disease (CVD) in later life. The aim of the current review was to conduct a nonsystematic review of published literature and research that has been presented so far regarding menopausal women with PCOS as well as the associated changes in hormone profile, their lipid profile, and various metabolic changes that occur. The current review may also contribute to raise awareness about the risk of hypertension and CVDs in postmenopausal women with PCOS.

Comparative Efficacy and Safety of Clonazepam versus Nortrptilline on Menopausal Symptom among Forty Plus Women: A Prospective, Open-Label Randomized Study.

AIMS AND OBJECTIVES: The aim of this study is to compare the effect of clonazepam and nortryptiline on menopausal symptoms in above 40 years women. MATERIALS AND METHODS: A prospective, randomized, open-label comparative study was conducted in a tertiary care teaching hospital for 1 year. Patients were randomized into two groups. Both the groups had 60 patients, out of which Group A had 39 menopausal patients and Group B had 31 menopausal patients, respectively. Group 1 received tablet clonazepam 0.5 mg bed time orally daily. Group 2 received tablet nortryptiline 25 mg bed time orally daily. The primary efficacy end points were effect on menopausal symptoms evaluated by at 0, 4, and 8 weeks. RESULTS: Mean age since menopause was 45 ± 4.06 years, and the mean number of years since menopause was 9.18 ± 7.59 years clonazepam and nortryptiline recorded statistically comparable effect with numerical superiority of nortryptiline both at 4 and 8 weeks on mean Menopausal Symptom Score, thereby indicating that both the drugs may have directly/indirectly improved the mean menopausal symptoms equally. Improvement in the clonazepam group was numerically and statistically more than nortryptiline group at 4 and 8 weeks on mean Vasomotor Symptom Score with P < 0.01 in clonazepam group and P < 0.05 in nortryptiline group both at 4 and 8 weeks. Both the drugs showed comparable results on psychosocial symptom score both at 4 and 8 weeks with numerical superiority in nortryptiline group. Clonazepam group showed more improvement on mean physical score than nortryptiline group numerically and statistically. Both the drugs showed comparable results on mean sexual symptom score at 4 weeks, but nortryptiline proved to be statistically better at 8 weeks P < 0.01 versus P < 0.05 in clonazepam group. CONCLUSION: Clonazepam and nortryptiline recorded statistically comparable effect at 4 and 8 weeks on mean menopausal symptom. Both the drugs were equally safe and did not recorded any serious Adverse Drug Reaction (ADRs).

Comparative Efficacy and Safety of Clonazepam versus Nortriptyline in Restless Leg Syndrome among Forty Plus Women: A Prospective, Open-Label Randomized Study.

AIMS AND OBJECTIVES: The aim of this study is to compare the effect of clonazepam and nortriptyline on rate, frequency, and severity of restless leg syndrome (RLS) in above 40 years women suffering from RLS. MATERIALS AND METHODS: A prospective, randomized, open-label comparative study was conducted at a tertiary care teaching hospital for 1 year. Restless legs syndrome (RLS) diagnosis was based on four essential clinical criteria established by the International RLS Study Group in 2003. Patients were randomized into two groups. Group 1 received tablet clonazepam 0.5 mg bedtime orally daily. Group 2 received tablet nortriptyline 25 mg bedtime orally daily. The primary efficacy endpoints by the International Restless leg Syndrome Scale (IRLS) were evaluated at 0, 4, and 8 weeks. Adverse drug events and safety assessment for vital signs such as blood pressure, pulse, heart rate, waist circumference, and body mass index were compared between two groups. RESULTS: Effect on mean IRLSS was statistically more in clonazepam group in comparison to nortriptyline group with comparable results at 8 weeks (P < 0.001), but at 4 weeks, nortriptyline showed less improvement (P < 0.01) versus P < 0.001 in nortriptyline group. Thus, nortriptyline reported relatively more improvement on IRLSS numerically in comparison to clonazepam. Nortriptyline proved to be statistically better in improving the frequency of RLS with comparison to clonazepam, whereas the results were comparable with regard to rate and the severity of RLS. Both the groups were relatively safe and did not produce any change in biochemical parameters and were free from any serious or severe adverse events and overall, both the treatments were well tolerated. CONCLUSION: Both the drugs provided clinically and statistical significant effect on RLS when compared with their respective baselines. However, nortriptyline proved to be statistically better in improving the frequency of RLS in comparison to clonazepam, whereas the results were comparable with regard to rate and the severity of RLS on intergroup comparison. Both the drugs were well tolerated.

A Prospective, Randomized, Open-Label Study Comparing the Efficacy and Safety of Clonazepam versus Nortriptyline on Quality of Life in 40+ Years old Women Presenting with Restless Leg Syndrome.

INTRODUCTION: Restless legs syndrome (RLS) is a neurological disorder characterized by an urge to move the legs usually accompanied by unpleasant leg sensations. RLS also impacts health related quality of life (QOL) in patients suffering from it. Further, it affects women more than men. Although a voluminous literature of studies is available evaluating the role of benzodiazepines (clonazepam and antidepressant (nortriptyline) in the treatment of RLS, but to the best of our knowledge, no comparative study is available comparing both of these drugs for efficacy and safety for the treatment of RLS QoL among 40 + years old women. MATERIALS AND METHODS: A prospective, randomized, open label comparative study was conducted in Postgraduate Department of Pharmacology in collaboration with the Department of General Medicine, Government Medical College, Jammu, a tertiary care teaching hospital for 1 year. CONCLUSION: Clonazepam proved to be significantly better in improving RLSQoL score. Difference between respective baselines of both groups was statistically insignificant.

Zidovudine-induced nail hyper-pigmentation in 45-year-old women prescribed for HIV/tuberculosis co-infection.

Zidovudine is an important component of first-line antiretroviral treatment regimens used to manage HIV and tuberculosis (TB) co-infection. Nail pigmentation is documented both in adult as well as pediatric HIV patients, but to the best of our knowledge, it has not been reported in 45-year-old women of HIV/TB co-infection. Such an adverse drugs reactions (ADR), although is harmless and reversible, psychological aspects of such ADR may be immense to the extent that it can negatively affect the compliance and result in therapeutic failure. Thus, it is worth reporting.

Prescribing Pattern of Oral Antihyperglycaemic Drugs, Rationality and Adherence to American Diabetes Association (ADA) Treatment Guidelines among Type 2 Diabetes Mellitus (T2DM) Postmenopausal Women.

INTRODUCTION: Oral antihyperglycaemic prescription trends keep on changing and thus the drug prescription trend study may prove to be powerful exploratory tool for health care providers. AIM: To investigate trends in prescriptions of oral antihyperglycaemic drugs (OHDs) among postmenopausal women suffering from T2DM in India and evaluate the rationality and adherence to ADA treatment guidelines. MATERIALS AND METHODS: An observational, cross-sectional descriptive prescription audit (n=500) was carried. Postmenopausal women were interviewed in their local language using pre-tested pre validated questionnaire after verbal informed consent at a teaching tertiary care hospital of north India. Oral antihyperglycaemic drugs (OHDs) drugs were categorized as per the pharmacological classification. Adherence to available clinical practice guidelines/recommendations issued under American Diabetes Association (ADA) 2015 Guidelines as well as rationality of these prescriptions were assessed using WHO Guide to Good Prescribing. RESULTS: Mean age of the study population was 58.14±12.86. Mean duration since menopause was 5.3 years and of T2DM was 9.5 years. A 93.4% of the prescriptions had only OHDs whereas 6.6% of the prescriptions had various insulin preprations + OHDs (p<0.0001). Biguanides followed by sulfonylureas, thiazolidinediones, DPP-inhibitors and alpha-glucosidases inhibitor were prescribed in 85.6%, 59.8%, 26.6%, 26% and 12.2% respectively as monotherapy or in combination. Among biguanides, metformin was the most frequently prescribed OHDs. In spite of black box warning on pioglitazone, it was prescribed in 26.6% as FDC. However, clear increase use of vidagliptine was noticed upto 26%. Among combinations most frequent was metformin plus glimipride followed by voglibose plus metformin, whereas, among FDC, metformin plus glimipride followed by metformin plus vidagliptine were most frequently prescribed. CONCLUSION: Metformin was the most common OHDs to be prescribed followed by glimepiride. Although pioglitazone still continues to be prescribed after safety alert but apparently it appears that the share of pioglitazone has been shifted to vidagliptin or combinations like metformin plus glimipride. Polypharmacy, high use of FDC, & prescription by brand names were some of the irrationalities. Relatively low adherence to ADA treatment guidelines was observed.

A Study Evaluating Adherence and Compliance of Anti-rheumatic Drugs in Women Suffering from Rheumatoid Arthritis.

BACKGROUND: Treatment of Rheumatoid arthritis (RA) has always remained challenging, complex and associated with high level of non adherence, noncompliance in clinical practice. AIM: To evaluate the satisfaction/adherence/compliance rates of most commonly prescribed anti-rheumatic drugs among Indian women. MATERIALS AND METHODS: A cross-sectional descriptive obser-vational study was undertaken to evaluate the adherence/compliance rates of most commonly prescribed anti-rheumatic drugs among women in a tertiary care teaching hospital in North India. Hundred women on anti rheumatic treatment for rheumatoid arthritis diagnosed by American College of Rheumatology (ACR) criteria were evaluated at one point analysis for adherence/compliance/satisfaction. RESULTS: Dissatisfaction rate with the anti rheumatic treatment was significantly high p<0.0001 among 68% of the women. Non compliance/ non adherence rate was also recorded very high among 52% and interrupted compliance rate was noticed among 6% of the women suffering from RA. Switch over rate to other treatment or doctors was also significantly (p<0.0001) very high among 66% of the women. Switch over to alternative treatment, treatment under quacks and intermittent self medication was recorded by 12%, 4% & 16% respectively. Among the self medication 12% of the women took corticosteroids and 4% preferred taking intermittent NSAIDs. CONCLUSION: Treatment compliance is not very good with anti-rheumatic drugs among women patients of RA due to multi-factorial reasons.

Menopausal symptoms and its effect on quality of life in urban versus rural women: A cross-sectional study.

AIM AND OBJECTIVE: To analyze the menopause-related symptoms and its impact on quality of life in post-menopausal women from urban and rural area. MATERIALS AND METHODS: A cross-sectional 1-year study was carried among women of urban (n = 490) and rural (n = 380) areas, attending the outpatient department in the urban area and a house-to-house survey in rural areas, by interviews with the help of a pretested semi-structured standard questionnaire. For assessment of the menopausal symptoms menopause rating scale (MRS) and for quality of life, World Health Organization Quality of Life Scale (WHO QOL-BREF) questionnaire was used. RESULTS: There was a significant difference between the MRS total scores of the urban (14.67 ± 6.64) and rural (16.08 ± 7.65) group. The somatic, psychological, and urogenital symptoms were high in rural women than in urban women. The results were not significant for urogenital subscale. The mean raw scores of physical health, psychological, social relationships, and environmental domains was more in urban than in rural women. The mean transformed scores (4-20) of physical health, psychological, social relationships, and environmental domains was more in urban than in rural women. The mean transformed scores (0-100) including the physical health, psychological, social relationships, and environmental domains was more in urban than in rural women. The result was not significant for physical health. CONCLUSION: The high proportions and the scores of MRS were observed in both rural and the urban women. The severity of symptoms was found more distressing for rural women. The quality of life in urban society was average and better than in rural women.

Bisphosphonate drug holidays: Can we recommend currently?

Bisphosphonates (BP) are the mainstay of treatment for osteoporosis. Subtrochanteric or diaphyseal fractures have been reported with long term use of BP, which raised world-wide debate on two aspects, i.e., for how long the BP is to be given and potential advantages/role of BP drug holidays. BP accumulates in bone with some persistent protective effect after therapy is stopped endorses the concept. Theoretically, a drug holiday may be a considerable option to decrease risks of BP, which continuing the protection from fractures but the level of evidence and data supporting the concept of drug holidays is a week. Hence, no specific recommendations are available on BP drug holidays from major available treatment guidelines on postmenopausal osteoporosis. Hence, before it is recommended it requires more robust research in this field.

Prevalence of vitamin d deficiency among Indian menopausal women and its correlation with diabetes: A first Indian cross sectional data.

AIM AND OBJECTIVE: To evaluate prevalence of Vitamin D deficiency and establish any correlation between diabetes and vitamin D deficiency among postmenopausal women. MATERIALS AND METHODS: The 25-hydroxy vitamin D [25 (OH) D] concentrations were measured by competitive in-vitro quantitative immunoassay. The subjects were classified as vitamin D-deficient, insufficient or sufficient on the basis of 25 (OH) D concentrations of < 20 ng/mL, 20-30 ng/mL or > 30 ng/mL respectively. The apparently normal postmenopausal women (PMW) were subjected to fasting blood sugar levels to analyse any correlation between vitamin D deficiency and diabetes. RESULTS: Vitamin D deficiency was observed in 53.35% of the population, 19.48% had insufficiency and 26.83% had adequate Vitamin D levels. In 12.14% of the study population fasting blood glucose was > 110 mg/dl and rest of the subjects were between the normal range which is 70-110mg/dl. Correlation between raised blood sugar levels and Vitamin D deficiency among PMW was non-significant (P = 0.324). CONCLUSION: High prevalence of vitamin D deficiency exists among apparently healthy Indian PMW. However, the current study failed to show any statistical correlation between vitamin D deficiency and existence of diabetes, which may be due to small sample size.

Antihypertensive drug prescription patterns, rationality, and adherence to Joint National Committee-7 hypertension treatment guidelines among Indian postmenopausal women.

AIM OF STUDY: The aim of this study is to evaluate antihypertensive drug prescription patterns, rationality and adherence to Joint National Committee (JNC-7) hypertension (HT) treatment recommendations among Indian postmenopausal women (PMW). MATERIALS AND METHODS: An observational and cross-sectional prospective prescription audit study was carried over a period of 1 year. A total of 500 prescriptions prescribed to PMW for diagnosed HT, were identified for one point analysis. Drug prescription patterns/trends, and their adherence to JNC-7 report as well as rationality using WHO guide to good prescribing was assessed. RESULTS: In the monotherapy, category angiotensin receptor blockers (ARBs) accounted (24.8%), calcium channel blockers (CCBs) (19.4%), angiotensin converting enzyme inhibitors (ACEIs) (11%), beta blockers (BBs) (2.8%), and diuretics (2%) of the total prescription. Individually, amlodipine was maximally prescribed in 16.4%. 31.6% had double combination, whereas 2.2% and 1% had triple and four drug combinations, respectively. About 3.6% of the prescription contained antihypertensive combination along with other class of drug. ARBs + diuretic were observed in 11%, CCBs + BB 10% and ACEI + diuretic in 2.6% of the total prescriptions. Among the combination therapy amlodipine + atenolol (8.4%), telmisartan + hydrochlorothiazide (6%) and losartan + hydrochlorothiazide (4.4%) were maximally prescribed. 84.21% (P < 0.001) of the prescription showed nonadherence as per recommendations for pre-HT. 100% and 43.25% adherence rates were noticed for Stage 1 HT (P < 0.001) and Stage 2 HT (P > 0.05) patients. CONCLUSION: Antihypertensive prescription trends largely adhere to existing guidelines and are rational except polypharmacy, generic and fixed dose combinations prescribing, were some of the common pharmacologically considered irrationality noticed.