Polyherbal dietary supplementation for prediabetic adults: study protocol for a randomized controlled trial.

BACKGROUND: Prediabetes describes a state of hyperglycemia outside of normal limits that does not meet the criteria for diabetes diagnosis, is generally symptomless, and affects an estimated 38% of adults in the United States. Prediabetes typically precedes the diagnosis of type 2 diabetes, which accounts for increased morbidity and mortality. Although the use of dietary and herbal supplements is popular worldwide, and a variety of single herbal medicines have been examined for glycemic management, the potential of increasingly common polyherbal formulations to return glycemic parameters to normal ranges among adults with prediabetes remains largely unexplored. The purpose of this study is to evaluate the efficacy of a commercially available, polyherbal dietary supplement on glycemic and lipid parameters in prediabetic individuals. METHODS: In this multi-site, double-blinded, randomized controlled clinical trial, 40 participants with prediabetes will be randomized to either a daily oral polyherbal dietary supplement (GlucoSupreme™ Herbal; Designs for Health®, Suffield, CT, USA; containing cinnamon bark (Cinnamomum cassia), banaba leaf (Lagerstroemia speciosa standardized to 1% corosolic acid), kudzu root (Pueraria lobata standardized to 40% isoflavones), fenugreek seed (Trigonella foenum-graceum standardized to 60% saponins), gymnema leaf (Gymnema sylvestre standardized to 25% gymnemic acid), American ginseng root (Panax quinquefolius standardized to 5% ginsenosides), and berberine HCl derived from bark (Berberis aristata)) or placebo for 12 weeks. Short-, medium-, and comparatively long-term markers of glycemic control (blood glucose and fasting insulin, fructosamine, and glycated hemoglobin/A1c, respectively), and other glycemic parameters (GlycoMark, ß-cell function, and insulin sensitivity/resistance) will be obtained. Lipid profile (total cholesterol, LDL, HDL, and triglycerides), inflammation (hs-CRP), progression to type 2 diabetes mellitus, as well as safety indices (ALT, AST) will be obtained. An intention-to-treat analysis will be used to assess changes in study outcomes. DISCUSSION: Treatment options for adults with prediabetes are currently limited. This study aims to evaluate the safety and efficacy of a commercially available dietary supplement in the popular, but as yet insufficiently studied, category of polyherbal formulas for the management of glycemic parameters and other biomarkers associated with prediabetes. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03388762 . Retrospectively registered on 4 January 2018.

The Positive Impact of Integrative Medicine in the Treatment of Recalcitrant Chronic daily Headache: A Series of Case Reports.

People who suffer from recalcitrant chronic daily headache (CDH)-a primary, episodic headache occurring at least 15 days per month, and lasting four or more hours per day for at least three consecutive months(1)-have generally tried many pain relief medications with few positive results. These patients often continue to add more and more medications and travel from clinician to clinician seeking help, without relief. Patients with recalcitrant CDH are often caught in a vicious cycle of increasing pain which results in a substantial impact from their disease on productivity and quality of life. Studies in the United States and Europe indicate that four to five percent of the general population has recalcitrant CDH,(2) which encompasses transformed migraine and chronic tension-type headache.(3) The disability associated with recalcitrant CDH is substantial, as patients have a significantly diminished quality of life and mental health, as well as impaired physical, social, and occupational functioning.(4,5) Research shows that CDH may not be treated effectively with conventional medicine (CM). Integrative medicine (IM) offers a complex, personalized intervention necessary to treat CDH. Many integrative therapies have shown benefit, effectiveness, cost effectiveness and low side effect profile in patients with both chronic headache and chronic pain.(6-17) Yet even within the IM community, clinicians often struggle with the balance between providing evidence-based therapy and patient-centered, complex, personalized integrative approaches, which may use popular but unproven therapies. In this article, we present a series of cases comprising patients with CDH who had previously been recalcitrant to CM approaches. In each case, employing a five-pronged treatment algorithm resulted in the successful IM treatment of CDH. By using this five-pronged approach, clinicians can offer the standardized protocols and scientific rationale they are accustomed to when employing CM options while additionally offering the benefit of IM possibilities.

Patients seek integrative medicine for preventive approach to optimize health.

CONTEXT: Despite the tremendous growth of integrative medicine (IM) in clinical settings, IM has not been well characterized in the medical literature. OBJECTIVE: To describe characteristics and motivation of patients seeking care at an IM clinic. DESIGN, SETTING, AND PARTICIPANTS: Patients from a nine-site practice-based research network participated in this cross-sectional survey. Clinicians documented patients' medical conditions. MAIN OUTCOME MEASURES: Patients provided information on demographics, lifestyle factors, and reasons for seeking care at an IM center. Clinicians documented the medical condition treated and procedures performed at the visit. RESULTS: A total of 4,182 patients (84.5% white; 72.7% college-educated; and 73.4% female) reported their most important reasons for seeking IM. Top-ranked reasons were (1) "to improve health and wellness now to prevent future problems" (83.9%); (2) "to try new options for health care" (76.7%); and (3) "to maximize my health regardless of whether or not my illness is curable" (74.6%). Interestingly, the same top reasons were reported by subgroups of patients who sought IM for wellness, acute care, or chronic illness. Patient reports of lifestyle also demonstrated healthier behaviors than national samples indicate. Patients seeking clinical care at IM centers desire an expanded paradigm of health care, one that seeks to maximize health.