Background: Bacopa monnieri (BM), a commonly used herb, has shown neuroprotective effects in animal and in vitro studies; but human studies on patients with Alzheimer’s Disease (AD) have been inconclusive. Further high-quality trials are required to conclusively state the utility of BM in AD and other neurodegenerative dementias.
Methods: In the present study, we did a narrative review of the current challenges in designing clinical trials of BM in dementia and their evidence-based recommendations.
Results: Many facets of the BM trials need improvement, especially effect size and sample size estimation. Current assessment and outcomes measures need a more holistic approach and newer scales for diagnosing and monitoring prodromal AD. The stringent guidelines in CONSORT and STROBE are often considered difficult to implement for clinical trials in ayurvedic medications like BM. However, adherence to these guidelines will undoubtedly improve the quality of evidence and go a long way in assessing whether BM is efficacious in treating AD/prodromal AD patients and other neurodegenerative dementias.
Conclusion: Future studies on BM should implement more randomized controlled trials (RCTs) with an appropriate sample size of accurately diagnosed AD/prodromal AD patients, administering a recommended dosage of BM and for a pre-specified time calculated to achieve adequate power for the study. Researchers should also develop and validate more sensitive cognitive scales, especially for prodromal AD. BM should be evaluated in accordance with the same rigorous standards as conventional drugs to generate the best quality evidence.
1. Introduction
Ayurveda is an ancient system of medicine that originated in India over 3,000 years ago. It has recently gained popularity, especially as more people seek natural and holistic approaches to health and wellness. Despite the growing popularity of Ayurveda, it still faces many challenges in establishing its place as a mainstream form of medicine. One of the key obstacles is the lack of high-quality evidence to support its effectiveness. This is because many clinical trials of Ayurvedic treatments have not been conducted to rigorous standards, making it difficult to determine their safety and efficacy.
Some of the issues facing clinical trials of Ayurveda include:
• Lack of standardization: There is a lack of standardization in the manufacturing process and formulation of Ayurvedic medicines, leading to difficulties in reproducibility and consistency in clinical trials.
• Determining efficacy: Ayurvedic treatments are often complex and involve multiple ingredients, making it challenging to determine the specific component responsible for the therapeutic effect.
• Placebo effects: Patients in Ayurvedic trials often expect a positive outcome, leading to a high placebo response rate that can impact the interpretation of trial results.
• Regulatory challenges: Ayurvedic treatments are often not regulated as drugs, and there is a lack of clear guidelines for conducting clinical trials, making it difficult to obtain regulatory approval.
• Cultural and language barriers: Ayurvedic treatments are often deeply rooted in Indian culture and language, making it challenging for Western researchers to understand and conduct trials.
These challenges make it difficult to determine the safety and efficacy of Ayurvedic treatments and to establish their place in modern medicine. It is important to note that these challenges are not limited to one particular herb or treatment, but are present across the field of Ayurveda. In order to establish the place of Ayurveda in modern medicine and ensure its safe and effective use, it is necessary to bring more standardization, clarity, and scientific rigor to its practices. This can be achieved through continuous research and the development of rigorous and well-designed clinical trials, which will help to understand the mechanisms of action better and determine the safety and efficacy of Ayurvedic treatments. Additionally, regulatory bodies can play a crucial role in establishing standards and guidelines for the practice of Ayurveda, and ensuring that patients receive safe and effective treatments (Rastogi, 2010, 2011, 2018).