Interact J Med Res. 2022 May 25. doi: 10.2196/38542. Online ahead of print.
ABSTRACT
BACKGROUND: Bacopa monnieri, a herb used extensively, has shown neuroprotective effects in animal and invitro studies; human studies on patients with Alzheimer’s Disease (AD) have been inconclusive.
OBJECTIVE: The primary objective was to determine the clinical efficacy and safety of Bacopa monnieri (Brahmi) in persons with mild, moderate or severe dementia due to Alzheimer’s disease and Mild Cognitive Impairment-Alzheimer’s disease (MCI-AD).
METHODS: We searched PubMed, Excerpta Medica dataBASE (EMBASE), Cochrane library, clinical trial registries (WHO, Aus-New Zealand, US and SA clinical registry), metaRegister of Controlled Trials (mRCT) and Cumulative Index to Nursing and Allied Health Literature (CINAHL). We intended to include ll randomized and quasi-randomized controlled trials that compared Bacopa monnieri, its extract or active ingredients (at any dosage) with placebo or one of the Cholinesterase inhibitors among adults with dementia due to AD and MCI-AD.
RESULTS: Our comprehensive search yielded five eligible studies. Three studies used Bacopa in combination with herbal extracts while remaining two used Bacopa extracts only. Two studies compared Bacopa with Donepezil while others used placebo as control. There was considerable variation in dose of bacopa used (ranging between 125 mg to 500 mg twice daily) and heterogeneity in treatment durations, follow up and outcomes. The major outcomes were Mini-mental status examination reported in three trials, Alzheimer’s disease assessment scale – Cognitive (ADAS-Cog) in one and a battery of cognitive tests in two studies. Using Cochrane risk of bias tool, overall, we judged all five studies to be at high risk of bias. While all studies reported statistically significant difference between Bacopa and comparator in at least one outcome, we rated overall quality of evidence for ADAS-Cog, PGI memory scale, Mini-Mental State Examination (MMSE) and Weschler memory scale to be very low because of downgrading by two levels for high risk of bias and one more level for impreciseness consequent to small sample sizes and wide confidence intervals.
CONCLUSIONS: There is no difference between Bacopa and placebo or Donepezil in treatment of AD based on very low certainty evidence. No major safety issues were reported in the included trials. Future Randomized Controlled Trials (RCTs) must aim to recruit more participants and report clinically meaningful outcomes.
CLINICALTRIAL: Crd42020169421.
PMID:35612544 | DOI:10.2196/38542
