Study on the Comparative Efficacy and Safety of Intellan, Poly Herbal Product (Test Group) with Vinpocetine (Control Group) to Treat Dementia

Abstract

This study aimed to compare the efficacy and safety of Polyherbal product Intellan with Vinpocetine in managing dementia and subject them to analysis by Mini metal state examination (MMSE) score, which is the most broadly perceived formal intellectual test. The MMSE was a 30-point test. This study was conducted at the Department of Medicine, Civil Hospital, Karachi, for six months. Patients were dispensed to get the test drug Intellan or controlled drug Vinpocetine. Keeping in consideration for 20% dropout in the test drug arm, with full appliance in the vinpocetine treatment arm, 150 subjects were in each arm. A total of 300 patients of both genders aged between 30 and 75 years who met the inclusion criteria participated in the study. The patients were evaluated prospectively for 24 weeks. The patients were advised follow-up visits weekly. Data were entered and analyzed using SPSS 12.0 (statistical software). The study groups were compared with the baseline characteristic, clinical presentation and history. Mean comparison was done by independent t-test and dependent t-test as appropriate, p≤0.05 was considered significant. No such study can be found that compare these drugs for treating dementia. In our study, mean MMSE before treatment, at 3 months and at 6 months was 8.91±4.12, 10.78±4.41, 13.54±4.54, respectively, while in group B, mean MMSE before treatment, at 3 months and at 6 months was 8.61±4.00, 10.74±4.18, 13.24±4.63, respectively. We found significant mean difference of MMSE before treatment with MMSE at 3 months, MMSE before treatment with MMSE at 6 months and MMSE at 3 months with MMSE at 6 months for both groups. An insignificant mean difference of MMSE at the 6th month s with study group (p=0.572) was found. Mean comparison was also done according to the study group s for stratified categories of gender, age, socio-economic status, education status, family history of dementia, living area, Alzheimer, epilepsy, diabetes mellitus, hypertension and body mass index.