Diabetes Management by Ayurvedic Practitioners Using a Clinical Guideline Versus Usual Practice: A Feasibility Cluster Randomized Trial in Nepal.
Type 2 diabetes mellitus (T2DM) is prevalent in Nepal, with many seeking primary care through Ayurveda, a widely practiced traditional system. However, concerns exist about suboptimal care and variability in clinical practice among Ayurvedic practitioners. No evidence-based clinical practice guideline (EB-CPG) is available for managing T2DM. Therefore, an EB-CPG was developed, and a feasibility study was conducted to inform a future cluster randomized controlled trial (RCT) assessing whether EB-CPG improves T2DM management compared with usual practice.
A two-arm feasibility cluster RCT was conducted in Ayurveda centers. Centers were randomized (1:1) by an independent statistician. Adults with newly diagnosed, treatment-naïve T2DM and glycated hemoglobin (HbA1c) of 6.5%-< 9% were recruited. Data collectors and the analyst were blinded to group allocation.
Fourteen Ayurveda centers were approached, all recruited (seven/group) and completed the study. One center withdrew and did not enroll participants. Of 151 potential participants, 121 (80%) were recruited (60 in intervention and 61 in control). Of those, 84% were followed up to 6 months (51/group). The median adherence score to EB-CPG among practitioners was 1-2 (partial to adequate adherence). The median (interquartile range) number of EB-CPG-recommended medicines not consumed by participants and days without consumption was 0 (0-10) and 0 (0-2.5), respectively. No serious adverse events occurred. Preliminary estimates suggest EB-CPG's beneficial effects on HbA1c, fasting plasma glucose, and health-related quality-of-life, though not statistically significant.
This feasibility trial demonstrated successful recruitment, follow-up, and intervention adherence. A definitive trial is feasible to evaluate the intervention's effectiveness in T2DM management.
ClinicalTrials.gov Identifier: NCT05259735; first posted on March 02, 2022.
A two-arm feasibility cluster RCT was conducted in Ayurveda centers. Centers were randomized (1:1) by an independent statistician. Adults with newly diagnosed, treatment-naïve T2DM and glycated hemoglobin (HbA1c) of 6.5%-< 9% were recruited. Data collectors and the analyst were blinded to group allocation.
Fourteen Ayurveda centers were approached, all recruited (seven/group) and completed the study. One center withdrew and did not enroll participants. Of 151 potential participants, 121 (80%) were recruited (60 in intervention and 61 in control). Of those, 84% were followed up to 6 months (51/group). The median adherence score to EB-CPG among practitioners was 1-2 (partial to adequate adherence). The median (interquartile range) number of EB-CPG-recommended medicines not consumed by participants and days without consumption was 0 (0-10) and 0 (0-2.5), respectively. No serious adverse events occurred. Preliminary estimates suggest EB-CPG's beneficial effects on HbA1c, fasting plasma glucose, and health-related quality-of-life, though not statistically significant.
This feasibility trial demonstrated successful recruitment, follow-up, and intervention adherence. A definitive trial is feasible to evaluate the intervention's effectiveness in T2DM management.
ClinicalTrials.gov Identifier: NCT05259735; first posted on March 02, 2022.
Authors
Chattopadhyay Chattopadhyay, Karki Karki, Wang Wang, Regmi Regmi, Gyanwali Gyanwali, Upadhyay Upadhyay, Heinrich Heinrich, Bista Bista, Tandon Tandon, Kinra Kinra, Greenfield Greenfield, Biswas Biswas, Jeemon Jeemon, Leonardi-Bee Leonardi-Bee, Lewis Lewis, Dhimal Dhimal
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