Assessing the Effectiveness of Panchatikta Ghrita, a Classical Ayurvedic Formulation as Add-on Therapy to Vitamin D3 and Calcium Supplements in Patients with Osteopenia: A Randomized, Open-Labeled, Comparative, Controlled Clinical Study.

Objectives: To assess the change in the bone mineral density (BMD) score, bone-specific biomarkers (serum vitamin D3, tartrate-resistant acid phosphatase 5b [TRAP-5b], and osteocalcin), quality of life, Ayurvedic symptoms (Asthikshaya Lakshanas), and fracture risk assessment tool (FRAX) scores following treatment with Panchatikta Ghrita (PG), a classical herbal formulation as add-on therapy to calcium and vitamin D3 supplements. Study design: Randomized, open-labeled, comparative, controlled clinical study. Location: TN Medical College and BYL Nair Hospital, Mumbai, India. Study participants: Eighty adult patients, aged between 40 and 75 years, diagnosed to have osteopenia (BMD T-score between -1 and -2.5 in at least two of the three joints tested-lumbar spine L1-L4, left femur-neck, left forearm-radius total). Study intervention: Treatment group received two tablespoons of PG (10 mL in lukewarm milk) along with calcium and vitamin D3 supplements twice a day, whereas control group received only calcium and vitamin D3 supplements twice a day for a period of 12 months. Outcome measures: BMD, bone-specific biomarkers (vitamin D3, TRAP-5b, and osteocalcin), quality of life, Ayurvedic symptoms, and FRAX scores were evaluated before and at 6 and 12 months. Results: Eighty patients were enrolled; of which, 65 patients completed the study while 15 patients dropped out. Improvement in the BMD scores was observed at 6 and 12 months with the maximum benefit in the lumbar spine region. Significant improvement in the bone-specific biomarkers, namely serum vitamin D3 (p < 0.001), osteocalcin (p < 0.001), and TRAP-5b (p < 0.05), was observed in the PG-treated group compared with the standard treatment group. Improvement in the quality of life, Ayurvedic symptoms scores, and risk reduction in FRAX scores of major osteoporotic fracture risk and hip fracture risk was greater with PG, although not statistically significant. Conclusions: The study findings demonstrate that PG slows down the bone degeneration processes by its stabilizing effect on the bone-specific biomarkers, indicating its potential usefulness as preventive therapy in osteopenia. The positive improvement noted in this study needs to be confirmed in studies with a larger sample size and longer duration.

A case of hypersensitivity to soluble and isophane insulins but not to insulin glargine.

Insulin is an important agent for the treatment of diabetes mellitus (DM). Allergic reactions to insulin therapy, although rare, have been evident since animal insulin became available for the treatment of DM in 1922. Hypersensitivity to insulin has considerably been reduced with the introduction of human insulin produced by recombinant deoxyribonucleic acid technology. Here, we present a case of Type 2 DM who demonstrated immediate (Type 1) hypersensitivity reaction on the sites of subcutaneous injection of soluble and isophane insulin but insulin glargine was tolerated well and provided good glycemic control.

Prevalence, clinical and biochemical profile of subclinical hypothyroidism in normal population in Mumbai.

BACKGROUND: Subclinical Hypothyroidism (ScHt) affects 3-15% of the adult population. It's clinical and biochemical profile is not well defined, especially in Indian scenario. Our study aimed at screening normal population to define normative ranges of thyroid hormones and Serum thyroid stimulating hormone (S.TSH) and prevalence of ScHt and thyroid autoimmunity. MATERIALS AND METHODS: Two-hundred thirty-seven normal subjects without family history of thyroid disease were evaluated for symptoms and laboratory tests for thyroid dysfunction and autoimmunity. RESULTS: The thyroid function tests were as follows: EUTHYROID GROUP: MEAN VALUES WERE: T3: 1.79 ± 0.42 ng/mL, T4: 10.23 ± 2.25 µg/dL, FT3: 1.88 ± 0.19 pg/mL, FT4: 1.12 ± 0.21 ng/dL, S.TSH: 2.22 ± 1.06 µlu/mL. 10.2% of euthyroid subjects had antimicrosomal antibodies (AMA) +ve (mean titer 1:918) and 23.6% were anti-thyroid peroxidase autoantibody (anti-TPO) +ve (mean titer 15.06 Au/mL). The euthyroid outlier range for S.TSH was 0.3-4.6 µlu/mL. The values were comparable in both the sexes. Those with S.TSH ≥ 5 µlu/mL were defined to have ScHt. SCHT GROUP: Prevalence of ScHt was 11.3% (M:F ratio 1:3.7). 74% belonged to 35-54 years age group and prevalence increased with age (post-menopausal females: prevalence 20%). S.TSH was 9.8 ± 7.22 µlu/mL, mean S.AMA was 1:5079 (40.7% positivity) and mean S.anti-TPO was 260 Au/mL (47.6% positivity). Majority were agoitrous (74%), and stage I goiter was seen in 26% of this population. Symptom score of 5-8 was seen in 55% ScHt subjects versus 35% normal subjects. CONCLUSION: Mean S.TSH in our population was 2.22 µlu/mL (euthyroid outliers: 0.3-4.6 µlu/mL); hence, S.TSH above 4.6 µlu/mL should be considered as abnormal. The prevalence of thyroid autoimmunity increases after age of 35 years. ScHt presents mainly in agoitrous form and with positive antibodies, suggesting autoimmunity as the cause.

A study of the prevalence of diabetes, insulin resistance, lipid abnormalities, and cardiovascular risk factors in patients with chronic plaque psoriasis.

BACKGROUND: The association between psoriasis, diabetes, and cardiovascular disease remains largely unelucidated in the Indian population. AIMS: To study the prevalence of diabetes, insulin resistance, lipid abnormalities, and cardiovascular risk factors in patients with chronic plaque psoriasis. MATERIALS AND METHODS: Seventy-seven patients of chronic plaque psoriasis and ninety two age- and sex-matched controls were enrolled in the study over a period of one year. Clinical and biometric data were noted and fasting venous blood samples were collected. Nondiabetic patients were subjected to an oral glucose tolerance test with 75 g glucose and postprandial venous blood samples collected at 120 mins. The fasting glucose, insulin, lipid levels, postprandial glucose and postprandial insulin levels were measured in samples from nondiabetic patients whereas fasting lipid levels only were measured in diabetic patients. RESULTS: The prevalence of impaired fasting glucose, impaired glucose tolerance, and diabetes mellitus in psoriatics was 5.2%, 9.1%, and 32.5%, respectively, as compared to 6.5%, 3.3%, and 15.2%, respectively, in the controls. The difference was statistically significant. The odds ratio of having an abnormal glucose metabolism in psoriasis was 2.63. Smoking had a positive association with insulin resistance in psoriatic cases. The serum cholesterol levels were elevated in 29 (37.7%) cases with a mean of 186.27 ± 43.18 and 34 (37%) controls with a mean of 194.38 ± 57.20. The serum HDL-cholesterol levels were reduced in 50 (64.9%) cases with a mean of 53.29 ± 15.90 as compared to 71 (74.7%) in controls with a mean of 48.76 ± 12.85. The serum LDL-cholesterol levels were elevated in 38 (49.4%) cases with a mean of 102.56 ± 44.02 and 36 controls with a mean of 115.62 ± 54.37. The serum triglyceride levels were elevated in 25 (32.5%) cases with a mean of 129.99 ± 61.32 and 38 (41.3%) controls with a mean of 141.04 ± 80.10. The differences between the two groups were not statistically significant. The two groups did not differ with respect to other cardiovascular risk factors such as increased body mass index, increased waist size, increased waist-to-hip ratio, and hypertension. CONCLUSION: There is a positive association between insulin resistance and psoriasis. No association between psoriasis and dyslipidemia has been found in this study.

Performance of plasma fractionated free metanephrines by enzyme immunoassay in the diagnosis of pheochromocytoma and paraganglioma.

OBJECTIVE: To study the performance of measuring plasma fractionated free metanephrines by enzyme immunoassay (EIA) in the diagnosis of pheochromocytoma and catecholamine-secreting paraganglioma. METHODS: Consecutive patients attending the endocrine clinic at King Edward Memorial Hospital, Mumbai, India, for suspicion of catecholamine-secreting tumors were included. Plasma fractionated free metanephrines were measured by EIA, and computed tomography of the neck, chest, abdomen, and pelvis was performed. Those with tumor identified by imaging underwent 131I m-iodobenzylguanidine scintigraphy. All patients with adrenal masses larger than 3 cm and patients with secretory tumors, irrespective of their size, underwent tumor excision. The rest were followed up for 6 to 12 months. RESULTS: One hundred patients with a clinical suspicion of pheochromocytoma or paraganglioma were included. Plasma free normetanephrine alone had a sensitivity of 94.1% (cutoff: 180 ng/mL), while plasma free metanephrine had a sensitivity of 14.7% (cutoff: 90 pg/mL). Both had 96.9% specificity. When combined (either test positive), the sensitivity was 94.1% with a specificity of 93.75%. Thirty-four patients had a histopathologically proven pheochromocytoma or paraganglioma. It was concluded that 66 patients did not harbor a pheochromocytoma or catecholamine-secreting paraganglioma. CONCLUSION: Plasma fractionated free metanephrines measured by EIA have good sensitivity and specificity in the diagnosis of pheochromocytoma and catecholamine-secreting paraganglioma.