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.

Impact of Music Therapy on Hospitalized Patients Post-Elective Orthopaedic Surgery: A Randomized Controlled Trial.

BACKGROUND: Music therapy (MT) research has demonstrated positive effects on fatigue, depressed mood, anxiety, and pain in perioperative care areas. However, there has been limited research on the effects of MT for surgical patients on orthopaedic units. PURPOSE: The purpose of this study was to understand the impact of MT sessions on post-elective orthopaedic surgery patients' pain, mood, nausea, anxiety, use of narcotics and antiemetics, and length of stay. METHODS: This was a randomized controlled study with an experimental arm (MT sessions) and a control arm (standard medical care). Patients received MT within 24 hours of admission to the unit, as well as every day of their stay. Same-day pre- and postdata were collected 30 minutes apart for both arms, including patient self-reported mood, pain, anxiety, and nausea. Use of medications and length of stay were gleaned from the electronic medical record. RESULTS: Data were obtained for 163 patients, age 60.5 ± 11.1 years, 56% of whom were male. Joints targeted by surgeries were hips (54%), knees (42%), and shoulders (4%). There were significantly greater changes favoring the MT group on Day 1 (pain, anxiety, and mood), Day 2 (pain, anxiety, mood, and nausea), and Day 3 (pain, anxiety, and mood). Among participants with a pre-pain score of 2 or more on Day 1, a decrease of at least 2 points was noted in 36% of the MT group and 10% of the control group (P < .001). Overall, 73% of MT patients versus 41% of control patients reported improved pain (P < .001). No significant between-group differences in medications or length of stay were noted. CONCLUSIONS: We observed greater same-day improvements of pain, emotional status, and nausea with MT sessions, compared to usual care, in patients hospitalized after elective orthopaedic surgeries. Effects on narcotic and antiemetic usage, as well as length of stay, were not observed. More research needs to be conducted to better understand the benefits of MT pre- and post-elective orthopaedic surgery.

Outcomes of Music Therapy Interventions on Symptom Management in Palliative Medicine Patients.

PURPOSE: Evidence has demonstrated the positive effects of music therapy on symptom management for palliative medicine patients. Previous studies have addressed patient needs, with limited discussion involving the relationship between interventions utilized to improve symptoms. The purpose of this study was to understand the impact of music therapy sessions; identify common music therapy goals and interventions and assess their effect; and investigate the effects of gender, age, and type of cancer on symptoms in patients who experienced music therapy. METHODS: This was a retrospective study of data collected during music therapy sessions. Patients scored their symptoms (pain, anxiety, depression, shortness of breath, and mood) before and after sessions. Data collected from over 1500 patients included symptom evaluation, goals, interventions, music used, patient/family reactions, and narratives. RESULTS: Among 293 patients who met all study inclusion criteria, significant improvement in pain, anxiety, depression, shortness of breath, mood, facial expression, and vocalization scores was noted. In addition, 96% of patients had positive responses to participating in music therapy. Vocal and emotional were the 2 most effective interventions in improving symptoms. All 5 patient-reported symptoms improved when the therapist focused on these symptoms as goals. Age, gender, and diagnosis had no impact on symptom improvement. CONCLUSIONS: This study demonstrated the importance of music therapy for addressing symptoms and behaviors of palliative medicine patients. Statistically and clinically significant effects were noted. The most effective interventions were identified. More research needs to be conducted to better understand the benefits of music therapy for palliative medicine patients.

Music Therapy for Symptom Management After Autologous Stem Cell Transplantation: Results From a Randomized Study.

High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is frequently performed in patients with hematologic malignancies. ASCT can result in significant nausea, pain, and discomfort. Supportive care has improved, and pharmacologic therapies are frequently used, but with limitations. Music has been demonstrated to improve nausea and pain in patients undergoing chemotherapy, but little data are available regarding the effects of music therapy in the transplantation setting. In a prospective study, patients with lymphoma or multiple myeloma undergoing ASCT were randomized to receive either interactive music therapy with a board-certified music therapist or no music therapy. The music therapy arm received 2 music therapy sessions on days +1 and +5. Primary outcomes were perception of pain and nausea measured on a visual analog scale. Secondary outcomes were narcotic pain medication use from day -1 to day +5 and impact of ASCT on patient mood as assessed by Profile of Mood States (POMS) on day +5. Eighty-two patients were enrolled, with 37 in the music therapy arm and 45 in the no music therapy arm. Patients who received MT had slightly increased nausea by day +7 compared with the no music therapy patients. The music therapy and no music therapy patients had similar pain scores; however, the patients who received music therapy used significantly less narcotic pain medication (median, 24 mg versus 73 mg; P = .038). Music therapy may be a viable nonpharmacologic method of pain management for patients undergoing ASCT; the music therapy patients required significantly fewer morphine equivalent doses compared with the no music therapy patients. Additional research is needed to better understand the effects of music therapy on patient-perceived symptoms, such as pain and nausea.

Perceptions of family members of palliative medicine and hospice patients who experienced music therapy.

PURPOSE: Evidence shows that music therapy aids in symptom management and improves quality of life for palliative medicine and hospice patients. The majority of previous studies have addressed patient needs, while only a few addressed the needs of family members. The primary purpose of this study was to understand family members' perceptions of music therapy experienced by a relative in palliative medicine or hospice. Patient self-reported scales and music therapist assessment of change were also investigated. METHODS: Patients scored their symptoms (pain, anxiety, depression, shortness of breath, and mood) before and after music therapy sessions. One family member present during the session assessed perceived effect on the patient's pain, anxiety, depression, shortness of breath, stress level, restlessness, comfort level, mood, and quality of life. The effect on family member's stress level, quality of life, and mood and helpfulness of the music therapy session for the patient and self were studied. Recommendations about future patient participation in music therapy and qualitative comments were also solicited. RESULTS: Fifty family member/patient dyads participated in the study. Family member perceptions were positive, with 82% of responders indicating improvement for self and patient in stress, mood, and quality of life; 80% rating the session as extremely helpful; and 100% of 49 recommending further music therapy sessions for the patient. Patients reported statistically significant improvement in pain, depression, distress, and mood scores. CONCLUSIONS: Family members of patients in palliative medicine and hospice settings reported an immediate positive impact of music therapy on the patient and on themselves. More research needs to be conducted to better understand the benefits of music therapy for family members.

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.

The role of music therapy in palliative medicine and supportive care.

This paper is designed to provide an introduction to music therapy in the continuum of cancer care. The value and use of music therapy during diagnosis and treatment, palliation, hospice, actively dying, and bereavement have been well documented. The music therapy process will be identified, research will be shared, and the importance and role of music therapy in palliative medicine and supportive cancer care discussed. Music therapy is invaluable throughout the entire cancer treatment process.

The clinical effects of music therapy in palliative medicine.

GOAL: This study was to objectively assess the effect of music therapy on patients with advanced disease. PATIENTS AND METHODS: Two hundred patients with chronic and/or advanced illnesses were prospectively evaluated. The effects of music therapy on these patients are reported. Visual analog scales, the Happy/Sad Faces Assessment Tool, and a behavior scale recorded pre- and post-music therapy scores on standardized data collection forms. A computerized database was used to collect and analyze the data. RESULTS: Utilizing the Wilcoxon signed rank test and a paired t test, music therapy improved anxiety, body movement, facial expression, mood, pain, shortness of breath, and verbalizations. Sessions with family members were also evaluated, and music therapy improved families' facial expressions, mood, and verbalizations. All improvements were statistically significant (P<0.001). Most patients and families had a positive subjective and objective response to music therapy. Objective data were obtained for a large number of patients with advanced disease. CONCLUSIONS: This is a significant addition to the quantitative literature on music therapy in this unique patient population. Our results suggest that music therapy is invaluable in palliative medicine.