Brahmi (Bacopa Monnieri) for dementia due to Alzheimer's disease: Systematic review and meta‐analysis protocol: Human/Human trials: Nutraceuticals and non‐pharmacological interventions. (7th December 2020)

• Record Type: Journal Article
• Authors: Vishnu, Venugopalan Y.; Padma, Vasantha; Basheer, Aneesh; Gupta, Anu; Kirubakaran, Richard
• Is Part Of: Alzheimer's & dementia. Volume 16(2020)Supplement 9
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-12-07
• Subjects: Alzheimer's disease -- Periodicals; Alzheimer Disease -- Periodicals; Dementia -- Periodicals; Démence; Maladie d'Alzheimer; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.83
• DOI: 10.1002/alz.037003
• Languages: English
• ISSNs: 1552-5260

Abstract

Abstract: Background: Bacopa Monnieri or Brahmi is a herb belonging to plant family Scrophulariaceae whose medicinal properties have been reported in Indian traditional medicine (Ayurveda) literature for treatment of anxiety, intellect and memory disorders. Even though there is good quality preclinical evidence on utility of Brahmi, peer‐reviewed published data on the use of the Brahmi in Alzheimer's disease (AD) and MCI‐AD is limited. Most of the research on Brahmi are methodologically weak in design and a systematic review of the existing literature will give us the best available evidence to undertake future research including a multicentre randomised controlled trial comparing Brahmi and Choline‐esterase inhibitors. Method: Primary objective is to determine the clinical efficacy and safety of Brahmi in people with mild, moderate or severe dementia due to AD and MCI‐AD. Secondary objective is to compare the efficacy and safety of different doses of Brahmi. We will include RCTs and quasi‐RCTs, regardless of publication status or language, that have compared Brahmi with placebo or a choline esterase inhibitor in persons with AD and MCI‐AD, irrespective of any duration of intervention including cross‐over trials. We will include individuals diagnosed with dementia due to AD or MCI‐AD according to ICD‐10, DSM IV/DSM V, NINCDS‐ADRDA or Duboi's criteria. Brahmi of any formulation and dose given for any duration will be the intervention. Placebo or any Choline esterase inhibitor at standard doses given for AD and MCI‐AD will be the comparator. Result: The outcomes that will be assessed are 1) Cognitive function (2) Activities of daily living 3) Behavioural disturbance 4) Clinical global impression 4) Quality of life 5) Dependency 6) Death 7) Acceptability of treatment as measured by withdrawal from trial 8) Safety as measured by the incidence of adverse effects leading to withdrawal 9) Safety as measured by the overall incidence of adverse effects. Subgroup analysis include 1) Mild, moderate and severe dementia, and those with MCI‐AD 2)Duration of intervention 3) Different doses of Bacopa Conclusion: This systematic review and meta‐analysis will bring out the current best available evidence regarding efficacy and safety of Brahmi in treatment of AD and MCI‐AD