GWCIM is interested in collaboration to research the application and effectiveness of Complementary and Alternative Modalities in Integrative Medicine. While we welcome collaborators on several potential research studies for which we are looking to obtain funding, we are also interested in participating as a research site in multisite projects conducted by others.
Projects pending funding:
Creating Comprehensive National Intravenous Vitamin C for Cancer Data Repository
The database that we are creating would be a repository of data on intravenous high-dose Vitamin C administration as an adjunctive treatment for patients with cancer. Many practitioners in the U.S. administer this form of treatment, however, there is little data available on its effectiveness as cancer treatment, including its effectiveness for certain kinds or different stages of cancer. The database would serve as the single data bank accumulating the data from different physicians for comprehensive analysis. We hope that this future analysis would, primarily, elucidate whether this treatment has a positive effect for cancer patients and warrant a further structured study or a clinical trial. Also, the analysis of combined data would compare the effectiveness of different protocols that are being used by the practitioners to identify the best practices which maximize the benefits for the patients.
We developed a blueprint for the information to be included into the database, and we are open to suggestions. We plan to gather retrospective patient cases and then continue to collect information in a prospective manner. Since one of our primary goals is to collect statistically powerful amount of data to make a decision on feasibility of a clinical trial, we plan to continue prospective collection of information until a well informed decision can be made. We have the support of the National Cancer Institute in helping us to set up this repository.
Pilot Clinical Trial to Study Combination CAM in Cancer
The purpose of this pilot study is to test the feasibility of applying a modular approach in developing a model for CAM cancer research. The focus of CAM cancer treatment is on the patient, resulting in gradual, long-term quality of life benefits, in contrast to tumor-directed conventional treatments measured in tumor size and biomarkers. Practice of CAM includes a variety of modalities delivered in a complex and individualized manner which is practitioner and patient dependent, , unlike standardized surgical procedures and doses of chemo and radiation therapies. Without an animal model, CAM pre-clinical trial data is not available. Current CAM research is limited to the testing of phytochemicals and has not addressed the challenge of testing the holistic practice of CAM. This study is to test the application of a modular strategy by breaking down the complex whole into defined components. It will also research CAM principle that allows for individualization and integration within a framework of a standardized CAM protocol. Additionally, we will test the feasibility of conducting a complex, multi-arm clinical trial, answer recruitment and compliance concerns, and evaluate and select appropriate instruments to measure the full effect of CAM.
Forty eight volunteers with newly diagnosed stage III & IV solid tumors will be recruited from a university oncology clinic to participate in a 24-week RCT in a 2³ factorial design – 8 arms with 3 treatment modules, (Nutrition, Subtle Energy and Acupuncture), in 7 treatment combinations and 1 non-treatment control. The focus is to support the patient through aggressive treatment protocols, with primary data points measured at baseline & at eight weeks using FACT-G (32). The three selected treatment modules provide basic and independent benefit/need for every cancer patient, and each is standardized and delivered uniformly for consistent data analysis. The 8 arms will produce data to determine any incremental change in benefit between none, single and combined treatments. An operations manual will be prepared to promote and facilitate multi-center studies with multiple practitioners.
This study is designed to collect pilot data to develop methodological details and scientific rationale necessary to conduct a full scale controlled trial designed to test a new CAM cancer research model that will meet the demands of both the biomedical research standard and the holistic practice principle of CAM.
A Randomized Controlled Trial to Study the Effects of Yoga and Mind-Body Practice in the Management of Fibromyalgia and Chronic Myofascial Pain Syndrome (FMS)
FMS patients often present with poor physical function and sleep disturbances. Decreased heart rate variability (indicative of autonomic nervous system instability) and lack of sleep contribute to increased fatigue and poor quality of life. There are currently no studies comparing the effectiveness of combined Complementary and Alternative approaches on physical function, decreased sleep disturbances and sense of wellbeing compared to conventional management in patients with FMS. This study will test the effectiveness of a coordinated CAM approach to FMS patients referred to the GW Pain Center. Many of these patients have not had exposure to CAM practices thereby allowing us to study CAM modalities in patients who are naïve to CAM methods.
CAM modalities may offer novel approaches to benefit FMS patients. Using a single CAM modality in the management of FMS does not represent common usage of CAM where several modalities are often applied. Patients suffering from chronic unresolved pain may seek CAM for self-treatment, but the lack of coordination or supervision may limit the effectiveness of CAM in these patients.
We propose a combined CAM approach specifically designed to address the needs of FMS patients. Yoga will be taught to improve function using low grade exercises shown to decrease pain and promote wellbeing. Mind-Body biofeedback assisted technique has been shown to increase heart rate variability in patients with fibromyalgia. We hypothesize that combining yoga and Mind-Body biofeedback will improve physical function, promote autonomic nervous system balance and decrease sleep disturbance. The goal is to teach patients these CAM practices as lifelong skills; in other words, to equip patients with skills which they can implement to maintain a stable and balanced health at low cost to themselves and to society as a whole.
Effectiveness of Reiki on Quality of life for Elderly Residents and Staff of a Retirement Community – Phase II Trial
Elderly people living in independent or assisted-living facilities frequently suffer from multiple chronic diseases. Reiki has been reported previously to induce sense of calmness, decrease anxiety and improve wellbeing in different medical settings. However, to our knowledge, very few studies examined the effect of Reiki on elderly patients with multiple chronic conditions and their caregivers. Previously, we have completed the phase I study demonstrating the fasibility of successful implementation of Reiki Share Group within a retirement community. The majority of staff and patients reported beneficial effects of the program and high interest in continuing such a program as a self-care method. The objective of the phase II trial is to study in randomized fashion long-term effects of Reiki training and Share program and the effect of Reiki therapy on quality of life and heart rate variability of elderly residents and staff members at The Residences at Thomas Circle, a retirement community in downtown Washington, D.C. area. For information on phase I trial please visit the Overview section.
Pilot Study to Assess Effects of Acupuncture on Patients with Borderline Personality Disorder
There are multiple lines of evidence that implicate dysfunction in the endogenous opioid and neuroendorine systems in the pathogenesis and cardinal symtpomatology of Borderline Personality Disorder (BPD). Specifically, it has been argued that chronic and/or severe emotional stressors can produce long-lasting changes in neural circuits involving oxytocin and endogenous opioid receptors, contributing to perturbations in emotional regulation, allostasis, and attachment that ultimately may cause impulsivity, dissociation and self-harming behaviors. Beyond the use of opioid receptor antagonists (e.g. naltrexone), there has been little research on treatment modalities for BPD guided by this hypothesis. One potential intervention involves the use of acupuncture which has been shown to affect and modulate the endogenous opioid system. Supported by evidence that self-harmers (cutters) selectively target acupuncture points, and that acupuncture can reduce self-harming behavior, this treatment modality could create a novel approach for the treatment and/or prevention of this highly morbid and lethal illness.
Potential future projects:
We will be looking for research funding for several projects that would take advantage of the Center’s clinical resources. Below are sample topics for future studies. We are open to other ideas. Please contact us at firstname.lastname@example.org.
- Chronic gastrointestinal problems, i.e. IBS and IBD
- Chronic pain
- Rheumatologic conditions
- Neurodegenerative conditions such as dementias and Parkinson’s disease
- Ambulatory care for patients with depression and anxiety
- Efficacy of health coaching and life style consultations in overall integration of medical care.