CONTEXT: Though complementary and alternative medicine (CAM) treatments are popular, evidence to support their application to diabetes care is scarce. Previous CAM diabetes research has generally focused on single modalities, but CAM practitioners more commonly prescribe complex, multimodality interventions. OBJECTIVES: The aims of this study were to determine the feasibility and clinical impact of a whole-system, Ayurvedic intervention for newly diagnosed people with type 2 diabetes. DESIGN: Patients were randomly assigned to either an experimental or control arm. SETTING: Group model health maintenance organization. PARTICIPANTS: We recruited 60 adult patients with baseline glycosylated hemoglobin (HbA1c) values between 6.0 and 8.0. INTERVENTION: Treatment for the experimental group included exercise, an Ayurvedic diet, meditation instruction, and an Ayurvedic herb supplement (MA 471). Control patients attended standard diabetes education classes with primary care clinician follow-up. MEASUREMENTS: Clinical outcomes were assessed at 3 and 6 months and included HbA1c, fasting glucose, lipids, blood pressure, and weight. RESULTS: Ninety-two percent of randomized patients completed the study, and there were no significant adverse study-related events. Using analysis of co-variance (ANCOVA), we found no significant differences for clinical outcomes at 6 months between on-study patient groups, though trends favored the Ayurvedic group. When we included a factor measuring how much baseline HbA1c exceeded the mean (6.5%), however, we found statistically significant improvements in the Ayurvedic group for HbA1c (P = .006), fasting glucose (P = .001), total cholesterol (P = .05), low-density lipoprotein (LDL) cholesterol (P = .04), and weight (P = .035). CONCLUSIONS: These results suggest that the Ayurvedic intervention may benefit patients with higher baseline HbA1c values, warranting further research.
RCT Entities:
CONTEXT: Though complementary and alternative medicine (CAM) treatments are popular, evidence to support their application to diabetes care is scarce. Previous CAM diabetes research has generally focused on single modalities, but CAM practitioners more commonly prescribe complex, multimodality interventions. OBJECTIVES: The aims of this study were to determine the feasibility and clinical impact of a whole-system, Ayurvedic intervention for newly diagnosed people with type 2 diabetes. DESIGN:Patients were randomly assigned to either an experimental or control arm. SETTING: Group model health maintenance organization. PARTICIPANTS: We recruited 60 adult patients with baseline glycosylated hemoglobin (HbA1c) values between 6.0 and 8.0. INTERVENTION: Treatment for the experimental group included exercise, an Ayurvedic diet, meditation instruction, and an Ayurvedic herb supplement (MA 471). Control patients attended standard diabetes education classes with primary care clinician follow-up. MEASUREMENTS: Clinical outcomes were assessed at 3 and 6 months and included HbA1c, fasting glucose, lipids, blood pressure, and weight. RESULTS: Ninety-two percent of randomized patients completed the study, and there were no significant adverse study-related events. Using analysis of co-variance (ANCOVA), we found no significant differences for clinical outcomes at 6 months between on-study patient groups, though trends favored the Ayurvedic group. When we included a factor measuring how much baseline HbA1c exceeded the mean (6.5%), however, we found statistically significant improvements in the Ayurvedic group for HbA1c (P = .006), fasting glucose (P = .001), total cholesterol (P = .05), low-density lipoprotein (LDL) cholesterol (P = .04), and weight (P = .035). CONCLUSIONS: These results suggest that the Ayurvedic intervention may benefit patients with higher baseline HbA1c values, warranting further research.
Authors: Madhav Goyal; Sonal Singh; Erica M S Sibinga; Neda F Gould; Anastasia Rowland-Seymour; Ritu Sharma; Zackary Berger; Dana Sleicher; David D Maron; Hasan M Shihab; Padmini D Ranasinghe; Shauna Linn; Shonali Saha; Eric B Bass; Jennifer A Haythornthwaite Journal: JAMA Intern Med Date: 2014-03 Impact factor: 21.873
Authors: Cheryl Ritenbaugh; Mimi Nichter; Mark A Nichter; Kimberly L Kelly; Colette M Sims; Iris R Bell; Heide M Castañeda; Charles R Elder; Mary S Koithan; Elizabeth G Sutherland; Marja J Verhoef; Sarah L Warber; Stephen J Coons Journal: BMC Complement Altern Med Date: 2011-12-29 Impact factor: 3.659