Diabetes mellitus is a condition that is extremely serious from both clinical and public health standpoints. While standard allopathic modalities alone are often effective in managing diabetes, a compelling case can be made for supplementing conventional management with complementary approaches. Maharishi Vedic Medicine (MVM) represents a synthesis of Vedic sciences, including Ayur-Veda, into a single, comprehensive, natural approach to health care. The objectives of this phase II pilot trial are to determine the feasibility, acceptability, and safety of implementing a multi-modality MVM intervention for newly diagnosed type 2 diabetics, and to measure the impact of such a protocol on overall glycemic control. Newly diagnosed type 2 diabetics will be recruited through the Kaiser Permanente Diabetes Registry and those meeting eligibility criteria will be contacted and invited to participate in the study. A total of sixty patients will be recruited and randomized to either a whole practice MVM intervention or to usual care. Patients in the MVM group will receive instruction in Transcendental Meditation, an appropriate herbal supplement, and advice regarding diet, exercise, and daily routine. Patients in the usual care group will attend a series of four classes on diabetes care, along with usual primary care physician follow-up. Outcome measures will include glycosylated hemoglobin levels, assessed at baseline, 6 weeks, 3 months, and 6 months, as well as fasting glucose and serum lipids. Patients in the MVM group will additionally undergo periodic serologic assessment of hepatic, renal, and hematologic function to monitor for potential toxicities related to the herb supplement. For all patients, self-report questionnaires will be used to evaluate outcomes of compliance and quality of life. Compliance will be measured by questions asking participants to rank their adherence to individual components of the treatment protocol. Responses will be measured on a 5-point scale ranging from 'all the time' to 'none of the time'. Changes in quality of life and health status will be evaluated via the SF-12 and a current symptom checklist. This study is significant in being the first randomized controlled trial to evaluate a multi-modality MVM protocol for the management of type 2 diabetes ? ?
| Elder, Charles; Aickin, Mikel; Bauer, Vance et al. (2006) Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes. Altern Ther Health Med 12:24-30 |
