Evaluation of clinical trials for natural products used in diabetes

Abstract

Background relevance: A plethora of literature is available regarding the clinical trials for natural products however; no information is available for critical assessments of the quality of these clinical trials. Aim of study: This is a first time report to critically evaluate the efficacy, safety and large scale applications of up-to-date clinical trials for diabetes, based on the three scales of Jadad, Delphi, and Cochrane. Methodology: An in-depth and extensive literature review was performed using various databases, journals, and books. The keywords searched included, “clinical trials,” “clinical trial in diabetes,” “diabetes,” “natural products in diabetes,” “ethnopharmacological relevance of natural products in diabetes,” etc. Results: Based on eligibility criteria, 16 plants with 74 clinical trials were found and evaluated. Major drawbacks observed were; “non-randomization and blindness of the studies,” “non-blindness of patients/healthcare/outcome assessors,” “lack of patient compliance and co-intervention reports,” “missing information regarding drop-out/withdrawal procedures,” and “inappropriate baseline characteristics.” Principal component analysis and Pearson correlation revealed four components with %variability; PC1: 23.12, PC2: 15.83, PC3: 13.11, and PC4: 11.38 ( P ≤ .000). According to descriptive statistics, “non-blinding of outcome assessors” was the major drawback (82%) whereas, “not mentioning the timing of outcome assessment” was observed lowest (6.8%). An in-house quality grading (scale 0–24) classified these clinical trials as; poor (67.6%), acceptable (19.9%), and good quality trials (13.5%). Conclusion: Proper measures in terms of more strict regulations with pharmacovigilance of plants are utmost needed in order to achieve quality compliance of clinical trials.

A comprehensive in-vitro/in-vivo screening toolbox for the elucidation of glucose homeostasis modulating properties of plant extracts (from roots) and its bioactives

“…These methods are not only applied in animal models, but also find their implementation in human studies ( Rijkelijkhuizen et al, 2009 ; Ajala et al, 2012 ; Besser et al, 2012 ; Lian et al, 2014 ; Vitetta et al, 2020 ). Clinical trials with plant extracts indicate that a variety of different parameters may reflect an antihyperglycemic activity in humans including HbA1c (glycated haemoglobin A1c) values, postprandial levels of glucose, insulin or C-peptide or the HOMA-IR (homeostasis model assessment of insulin resistance) index ( Ahmad R. et al, 2021 ; Lim et al, 2021 ). Since its development in 1979 ( DeFronzo et al, 1979 ), the glucose clamp technique has emerged as the most appropriate method to evaluate potential antidiabetic agents in humans ( Tam et al, 2012 ; Pelegrin et al, 2019 ).…”

The International Natural Product Sciences Taskforce (INPST) and the power of Twitter networking exemplified through #INPST hashtag analysis

“…Chemical modification of natural product molecules has also yielded multiple clinically relevant drugs such as caspofungin (Walsh et al, 2004), artemether (Hien et al, 1996), or etoposide (Cragg and Pezzuto, 2016;O'Dwyer et al, 1985). As a reflection of the high significance of natural products for the discovery and development of new pharmaceuticals, a high number of natural products or their derivatives are currently in clinical trials for a range of diverse diseases (Ahmad et al, 2021;Lima et al, 2021;Nile and Kai, 2020;Singla et al, 2022aSingla et al, , 2022b. Moreover, multi-component natural product mixtures are also studied to explore their therapeutic potential and used clinically (Wink, 2015).…”

Advancements in Drug Delivery Systems for Natural Compounds Targeting Metabolic Disorders Associated with Inflammation

“…Persistent efforts are being made to explore diabetes and uncover novel therapeutic avenues, including the identification of natural products with anti-diabetic properties. Individuals with diabetes and cancer have turned to a wide array of alternative treatments to manage their condition [40]. Both pre-clinical and clinical trials have been conducted on various natural products for diabetes and cancer treatment [41].…”