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Accepted for/Published in: Interactive Journal of Medical Research

Date Submitted: Apr 6, 2022
Date Accepted: May 25, 2022
Date Submitted to PubMed: May 25, 2022

The final, peer-reviewed published version of this preprint can be found here:

Use of Bacopa monnieri in the Treatment of Dementia Due to Alzheimer Disease: Systematic Review of Randomized Controlled Trials

Basheer A, Agarwal A, Misra B, Gupta A, Srivastava P, Kirubakaran R, Vishnu V

Use of Bacopa monnieri in the Treatment of Dementia Due to Alzheimer Disease: Systematic Review of Randomized Controlled Trials

Interact J Med Res 2022;11(2):e38542

DOI: 10.2196/38542

PMID: 35612544

PMCID: 9379783

Bacopa monnieri in the treatment of dementia due to Alzheimer’s disease: A systematic review of randomised controlled trials

  • Aneesh Basheer; 
  • Ayush Agarwal; 
  • Biswamohan Misra; 
  • Anu Gupta; 
  • Padma Srivastava; 
  • Richard Kirubakaran; 
  • Venugopalan Vishnu

ABSTRACT

Background:

Alzheimer’s disease (AD), the commonest cause of dementia is currently treated with acetylcholinesterase inhibitors like donepezil. Search for effective and safe treatments has led to research on Bacopa monnieri, a herb mentioned and used for centuries in Ayurveda for improving cognition. Human studies using Bacopa have conflicting results and investigated predominantly on healthy adults.

Objective:

Our objective was to determine the efficacy and safety of Bacopa monnieri in persons with mild, moderate and severe dementia due to AD and mild cognitive impairment-Alzheimer’s disease (MCI-AD).

Methods:

We performed a systematic review of literature in MEDLINE, EMBASE, Cochrane Library, clinical trial registries and metaRegister of Controlled Trials from inception to January 2021. We reported results as per Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Randomized and quasi-randomized controlled trials comparing Bacopa with placebo or an acetylcholinesterase inhibitor among adults with dementia due to AD and MCI-AD were included if they reported any outcome including cognitive function, clinician rated global impression tests, behavioural symptoms, safety, dependency or death. Following search, articles were screened, and data extracted independently by two review authors using standardized data extraction forms. Risk of bias was determined using Cochrane risk-of-bias tool for RCT. Data was not pooled as none of the outcomes were reported commonly across studies.

Results:

Of the 164 studies identified, five RCTs were found eligible. All five studies were at low risk of bias for random sequence generation, while Raghav et al was judged as having some concerns for allocation concealment. All five studies were double-blinded although only three described how blinding was done and ensured during the study. Despite use of an intention to treat analysis, the loss to follow up was considerable in Prabhakar et al to judge it as high risk of bias. For missing outcome data, all studies were at high risk of bias except Cicero et al. Besides, none of the trials were registered (except Prabhakar et al which was registered retrospectively). However, all five RCT reported outcomes stated in their methods. Overall, the RCTs were judged as having high risk of bias. None of the studies described the effects of Bacopa in patients with varying severity of AD; different doses were also not tested in any study. Prabhakar et al and Sadhu et al found no significant changes in cognitive function at 12 months while Cicero et al, Raghav et al and Barbhaiya et al found significant changes in cognitive function using MMSE, Wechsler Memory scale and tests for attention respectively.

Conclusions:

Very low certainty evidence from five RCT suggests that there is no difference between Bacopa monnieri and placebo or donepezil in treatment of AD or MCI-AD. Clinical Trial: The protocol was registered on PROSPERO (CRD42020169421).


 Citation

Please cite as:

Basheer A, Agarwal A, Misra B, Gupta A, Srivastava P, Kirubakaran R, Vishnu V

Use of Bacopa monnieri in the Treatment of Dementia Due to Alzheimer Disease: Systematic Review of Randomized Controlled Trials

Interact J Med Res 2022;11(2):e38542

DOI: 10.2196/38542

PMID: 35612544

PMCID: 9379783

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