Impact of recent regulatory notifications on an institutional ethics committee.

The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court’s orders and a Parliamentary Standing Committee’s report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee’s (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants’ safety and well-being.

Efficacy and safety of a polyherbal formulation in hemorrhoids.

Background: The medical management of hemorrhoids should include an integrated approach. This integrated approach can be achieved by polyherbal formulations containing anti-inflammatory, styptics, analgesics, and laxative effect which reduce inflammation, pain, and bleeding, and increase gastro-intestinal motility and soften stools. One such polyherbal kit is “Arshkeyt™, a 7 day kit,” which consists of oral tablets and powder along with topical cream. Objective: Efficacy and safety of Arshkeyt™, a 7 day kit, a marketed polyherbal formulation was evaluated in comparison with conventional therapy practiced in surgery outpatient departments. Materials and Methods: Patients (n = 90) with hemorrhoids were randomly allocated to receive either Arshkeyt™ or standard therapy (combination of oral Isabgul powder and 2% lidocaine gel) for 14 days. Assessment on the basis of rectal symptoms and proctoscopic examination was done on day 0, 7, and 14 to derive a “composite score” which ranged from 0 to 25 by a blinded evaluator. The primary endpoint was number of patients achieving composite score 0 at the end of therapy (day 14). Inter-group analysis was done using Chi-square test. Results: On day 14, the composite score of 0 was achieved in 15 patients of Arshkeyt™ group versus 6 patients receiving standard therapy. The symptoms and signs which showed significant improvement in Arshkeyt™ group compared to standard treatment group were the tenesmus (visual analog score) score (P = 0.047), anal sphincter spasm (P = 0.0495) and a decrease in the grade of hemorrhoids (P = 0.0205) on day 14. Arshkeyt™ was also more beneficial in case of bleeding hemorrhoids as compared to nonbleeding hemorrhoids (P < 0.05). The incidence of adverse drug reactions in both groups was comparable and no patient required any treatment for the same. Conclusion: “Arshkeyt™, a 7 day kit,” was effective in the treatment of hemorrhoids and had a good safety profile.

Evaluation Of Antidepressant Activity Of Statins Alone And In Combination With Fluoxetine In Acute And Chronic Behavioural Models Of Depression.

Context: To study the role of statins (Atorvastatin, Simvastatin, and Pravastatin) as novel pharmacological option in treatment of depression. Aim: To evaluate antidepressant activity of statins (HMG-CoA reductase inhibitor) in combination with Fluoxetine in acute and chronic forced swim test in rats. Design: An experimental animal study. Materials and methods : Male albino wistar rats of either sex with weight range 150-250 grams were used. Part 1 is Dose finding study in acute forced swim test with three doses of Atorvastatin (2.5 mg/kg, 5 mg/ kg, 10 mg/kg), Simvastatin (2.5 mg/kg, 5 mg/kg, 10 mg/kg), and Pravastatin (10 mg/kg, 20 mg/kg, 40 mg/ kg) each were done. Part 2 was conducted to study the effects of statins (Atorvastatin, Simvastatin, and Pravastatin) and Fluoxetine (10 mg/kg) per se and in combination, on immobility of rats in acute forced swim test were compared. In part 3 effects of statins (Atorvastatin, Simvastatin, and Pravastatin) and Fluoxetine per se and in combination on immobility of rats in chronic forced swim test were compared. Open field test was performed to discriminate between the general behavioural stimulation (false positives) and antidepressant effect of study drugs. All study drugs were given orally. In Part 2 & 3 maximum effective dose of statin from part 1 was utilised. Statistics: ANOVA with post-hoc Tukeys test, significant effects were analyzed further using post hoc Newman-Keuls tests. Results: In part 1 of dose finding study most effective doses for Atorvastatin, Simvastatin and Pravastatin were 10 mg/kg, 10 mg/kg and 40 mg/kg respectively. In this part acute forced swim test showed, no statistically significant reduction in duration of immobility by any of the statins (Atorvastatin, Simvastatin, and Pravastatin) as compared to control. In Part 2 acute forced swim test, When combined with Fluoxetine, Atorvastatin (157.83 ± 10.51) and Simvastatin (167.66 ± 7.71) showed significant reduction in duration of