|Date: 06-15-2017||HC# 111653-570|
Kumar N, Abichandani LG, Thawani V, Gharpure KJ, Naidu MUR, Venkat Ramana G. Efficacy of standardized extract of Bacopa monnieri (Bacognize®) on cognitive functions of medical students: A six-week, randomized placebo-controlled trial. Evid Based Complement Alternat Med. October 10, 2016;2016:4103423. doi: 10.1155/2016/4103423.
Bacopa (Bacopa monnieri, Plantaginaceae) aerial plant extract, also known as Brahmi, has been used in Ayurvedic medicine for hundreds of years to treat neurological conditions and anxiety and to improve cognitive function. Research shows that bacopa improves learning and memory in rodent models of Alzheimer's disease and in a preliminary, open-label, clinical study of patients with Alzheimer's disease. There are also several studies in healthy, normal subjects that suggest that bacopa improves memory. The authors state that no studies have evaluated bacopa in healthy, normal people with high intellect. Hence, the purpose of this randomized, double-blind, placebo-controlled study was to evaluate the effect of bacopa on improving cognition in people with an already high cognitive function. [Note: Not mentioned here is the fact that there are really no drugs or supplements (other than psychostimulants) that can enhance cognition in normal subjects—a very difficult task.]
Male and female medical students (n = 60, aged 19-22 years) from Government Medical College in Nagpur, India, were recruited for this study. Study dates were not indicated. Included subjects had basic computer literacy and exposure to computerized tests. Exclusion criteria included use of any memory-improving medicine, alcohol, tobacco (Nicotiana tabacum, Solanaceae), or any other substance acting on the central nervous system (CNS); history of allergy; chronic disease (including hypertension, ischemic heart disease, diabetes, psychiatric disorder, or CNS disorders) or abnormal findings on a physical exam; participation in any clinical trial or blood donation in the past month; and use of bacopa in any form (e.g., hair oil).
Subjects received either 300 mg bacopa per day (Bacognize®; M/s Pharmanza Herbal Pvt. Ltd.; Gujarat, India), in 2 doses of 150 mg, or placebo for 45 days. The extraction process and high-performance liquid chromatography (HPLC)-analyzed constituents are described in the paper. Subjects were followed for an additional 15 days after stopping the treatment. The following battery of tests were conducted at baseline and after 45 days: digit span memory task, paired associate task, logical memory test (story recall), memory span for nonsense syllables, finger tapping test, simple reaction test, choice reaction test, choice discrimination test, and digit picture substitution test. Blood was drawn at baseline and day 45 to measure calcium, serum total cholesterol, serum high-density lipoprotein (HDL) cholesterol, serum triglycerides, and serum low-density lipoprotein cholesterol.
Demographics were similar between groups. Two students were dropped for noncompliance during the study, while others did not participate in post-treatment testing or did not have 2 usable blood samples due to hemolysis. Final numbers were thereby reduced much more in the placebo group (n = 14 for memory tests, n = 18 for blood tests) than in the bacopa group (n = 28 for memory tests, n = 26 for blood tests). The bacopa group had significant increases in calcium (P < 0.05), but the levels were still within the normal range. Also, the bacopa group had a significant decrease in total cholesterol (P < 0.05) and increase in HDL (P < 0.05) compared to baseline; however, these changes were not significantly different from placebo. Of all of the neuropsychological tests, only digit span backwards and logical memory test were significantly better in the bacopa group compared with placebo (P < 0.05 for both); in the former, mostly explainable by declining performance in the placebo group. Adverse events were not reported. The subjects were followed 15 days after stopping treatment; no relevant observations were reported.
The bacopa-induced improvement in the digit span backwards test suggests an improvement in attention, distractibility, and working memory. However, the lack of significant effect on the digit span forward test suggests that bacopa's principal effect is not on distractibility. The bacopa-induced improvement in the logical memory test suggests an improvement in immediate recall and language comprehension. The authors conclude that bacopa improves some components of memory in intelligent normal subjects; however, longer studies are needed. A limitation of the study is the statistical analysis. The authors conducted many analyses but used only a Student's t-test. They did not conduct a correction for multiple comparisons. P-values of significant results were stated only to be < 0.05. If statistical corrections for multiple comparisons had been conducted, it is likely that none of the between-group differences would be statistically significant. Therefore, the significance of the results is questionable. The authors report no conflict of interest; treatments were provided free by M/s Pharmanza Herbal Pvt. Ltd., but the authors state that the company did not receive data or results.—Heather S. Oliff, PhD