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Background: A prospective, randomized controlled study with parallel treatment groups carried out to assess efficacy and tolerability of atorvastatin in escalating doses (10 mg, 20 mg, 40 mg and 80 mg) in modulating the lipid profile in patients of coronary artery disease in eastern Indian population and whether “Rule of six” commonly referred to in context of low-density lipoprotein (LDL) reduction by statins stands true in our population. Methods: Patients randomly allocated into four groups (n=632) as per selection criteria. Groups A, B, C, D received atorvastatin 10 mg, 20 mg, 40 mg and 80 mg, respectively once daily at bedtime, for 24 weeks after which evaluation of efficacy and tolerability was done. Comparison between groups performed with one-way ANOVA; p<0.05 considered to be statistically significant. Results: There was a significant reduction in cholesterol, LDL and triglycerides in all the groups, but between group comparisons did not reveal any significant reduction in lipid parameters between Groups C and D. “Rule of six” was not observed at higher doses of atorvastatin (40, 80 mg). Further, there was significant reduction of high-density lipoprotein (HDL) in Groups C and D, which is not accepted especially in Indian context where it is already low at baseline. Conclusion: In Indian perspective, where HDL is low, and the LDL values are not very high, escalating dose of atorvastatin does not give additional clinical benefit. On the contrary, reduction of HDL itself predicts an adverse cardiovascular outcome. Increased adverse events and burden of cost must be taken into account, while prescribing atorvastatin.
ABSTRACT
Background: Quantitative measurement of valproate and lithium induced tremor using hand steadiness tester and their comparison in bipolar disorder. Methods: 200 newly diagnosed patients of bipolar disorder were randomly allocated into two equal groups receiving lithium (300mg twice daily) and sodium valproate (500 mg twice daily) after they fulfilled the inclusion / exclusion criteria of the study. 87 patients from Lithium group and 93 from Valproate completed the study. Hand Tremor was assessed quantitatively at 0, 6, 12, 18 and 24 weeks using hand steadiness tester. Anxiety level of the study subjects was assessed to be insignificant using a standardized anxiety scale. Final data was assessed after 24 weeks by using Stat Calc and Z test. P value <0.05 was considered to be significant. Results: No significant difference was found in terms of the development and transition of tremor induced by valproate and lithium (p=0.22). However more men developed tremor with lithium when compared with females (p<0.05) and the mean age of patients who developed tremor appeared to be significantly higher in lithium group (54.7±3.9) than valproate (39.6±5.1). Conclusions: Tremor of hands is a common side effect of lithium and valproate treatment. Timely, objective assessment of onset and extent of tremor has always remained a challenge to the clinicians. Hand Steadiness tester is a simple, portable, inexpensive, non-invasive instrument that can be used to ascertain the development and transition of tremor in a quantitative manner. This would guide the clinicians as when to intervene for better management of such tremors.
ABSTRACT
Background: The abundant resource of drugs and its beneficial properties are hidden in our natural and Indigenous sources, which are under constant evaluation by man. Cholesterol lowering ability of ethanol extract of garlic was evaluated in comparison to atorvastatin, the most frequently used lipid lowering agent in rabbits. Methods: Hypercholesterolemia was induced to the animals with cholesterol powder (50mg/kg) for the study duration (16 weeks). At the end of 4 weeks, they were randomly selected and divided into 3 groups (n=6). Group II received Cholesterol + atorvastatin 10 mg daily; Group III received Cholesterol + 0.1g garlic extract kg b. w. daily while Group I continued with cholesterol powder (to serve as control) for the rest study period. Serum cholesterol, LDL, HDL and Triglycerides were estimated using the enzymatic method at 0, 4, 8, 12, 16 weeks in all the groups. The results were tabulated and analyzed statistically using one way ANOVA test. Results: The results indicate that both atorvastatin and garlic extract have a definite role in retarding the rate of weight gain as a consequence to high cholesterol diet in rabbits. Also, there is fewer rises in all the lipid parameters in both the treatment groups when compared to the control group. Conclusion: Though atorvastatin is definitely more effective in reducing the lipid parameters but it also significantly lowers HDL where as Garlic shows promising results when compared to placebo and also has a favourable effect on HDL. Garlic can be recommended as a dietary supplement for long term use without toxic effects for its wide range of medicinal properties in general and therapeutic potential inpatients with CAD in particular.
ABSTRACT
The rhizomes of Nardostachysjatamansi, the plant commonly known as Jatamansi have been described in Ayurveda for their soothing and sedative action on the central nervous system. In the present study, the anti-stress effect of hydroethanolic extract (70%) of N. jatamansi (NJE) was evaluated in reference to its antioxidant property. Wistar rats were divided into four groups: naive, stressed, and T-200 and T-500 stressed with oral pre-treatment of NJE 200 and 500 mg/kg, respectively. Restraint of rats in metallic chambers for 4 h at 4 degreesC was followed by sacrifice and assessment of stress-induced alterations in biochemical parameters, incidence and severity of ulcers. Lipid peroxidation (LPO) and NO levels in stomach and LPO, NO levels and catalase activity in brain, plasma corticosterone level and adrenal ascorbic acid were measured. In vitro antioxidant activity of NJE was studied by measuring the free radical scavenging activity. NJE showed potent antioxidant activity and significantly reversed the stress-induced elevation of LPO and NO levels and decrease in catalase activity in the brain. It inhibited the incidence of gastric ulcerations and reversed the alterations in biochemical parameters/markers of stress-induced gastric ulceration. NJE also significantly altered stress-induced increase in adrenal and spleen weights and decrease in level of ascorbic acid in adrenal gland. Elevation of plasma corticosterone level was negated dose- dependently. The findings suggest that the NJE possesses significant anti-stress activity, which may be due to its antioxidant activity.