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Clinical Studies

Reviews of Clinical Studies

Research in Progress

Research Issues

Recommendations & Guidelines

Research at the Center


Research at the Center


Recruiting for Clinical Trials at the Center
Other Clinical Trials in Progress
Recently Completed Clinical Trials
Education Research
Our Publications
Future Research Directors/Funding Needs


Recruiting for Clinical Trials at the Center


Other Clinical Trials in Progress

1. Acupuncture Therapy for Pain and Function Recovery in Spine Surgery Patients will compare the effects of acupuncture therapy on pain and recovery of function in patients undergoing low back spine surgery at Beth Israel Medical Center. The principal investigators for this study are Arya Nielsen, PhD, Andrew Casden, MD, Ben Kligler, MD, and Peter Homel, PhD.

Recruitment for the study began in September, 2010 and is still open.
People eligible to participate in the study must be patients of Dr. Neuwirth, Dr. Casden or Dr. Kuflik at the Spine Institute at Beth Israel who are having lumbar fusion surgery. To participate in the study please call 212 844-8680 or call to schedule an appointment with one of the spine surgeons below:

Dr. Casden 212 844-8674

Dr. Kuflik 212 844-8688

Dr. Neuwirth 212 844-8682

2. Practice-Based Research Network. We are one of eight leading integrative medicine clinical centers from around the country, including Maryland, San Francisco, and Harvard, recently funded by the Bravewell Collaborative to develop a Practice-Based Research Network for integrative medicine. This project—known as BraveNet—led by researchers from Duke, brings together a large network of practices to collaborate in collecting data regarding the effectiveness of a variety of CAM interventions Last year we completed a Registry study describing 500 patients seen at the CCHH in conjunction with the other PBRN sites. We are now recruiting patients for an outcome study of the integrative treatment of chronic pain in conjunction with this group. As the largest academically-affiliated clinical practice in the nation, our Center is viewed as a critical partner in this effort.

3. ADDOPT (Acupuncture to Decrease Disparities of Pain Treatment). In collaboration with the AECOM Department of Family and Social Medicine Division (DFSM) of Research we received funding from the National Center for Complementary and Alternative Medicine at NIH for an R-21 project evaluating the impact of acupuncture on chronic pain in a group of community health centers in the Bronx. This project uses the AECOM DFSM PBRN (NYC-RING) to evaluate the feasibility and the effectiveness of an acupuncture intervention in an underserved community normally without access to this type of approach. We hope this will be the first of many collaborations with NYC-RING in doing community-based research on integrative approaches.

4. Relaxation Therapies, Aromatherapy and Acupuncture for Quality of Life in Patients with Head and Neck Cancer. In cooperation with Dr. Lou Harrison, Chief of the Cancer Centers at Continuum Health Partners we have launched a clinical program of integrative medicine services in the Continuum Cancer Center. As part of this effort, we are collaborating on two studies. The first examines the impact of relaxation therapies and aromatherapy on quality of life; the second examines the impact of acupuncture on xerostomia, the dry mouth condition extremely common in patients following radiation therapy. Both of these studies are in the early stages of enrollment.

5. Web-based integrative medicine intervention for patients with diabetes. This study is a collaboration with the Division of Endocrinology at Beth Israel to examine the impact of a web-based integrative medicine program for patients on outcomes in diabetes. The Department of Informatics and Online Education is responsible for developing the content of this Web-based program. The research department will assist in evaluating the outcomes. This project is now IRB-approved and beginning patient enrollment.

6. Qualitative Research in Patient Response to Lifestyle Intervention for Asthma and Diabetes. Under an academic career development award from the NIH to Dr. Benjamin Kligler, we are now conducting qualititative research in patient response to lifestyle intervention for asthma and diabetes. In addition to the type of “quantitative” studies we have undertaken to date, there is a great need for qualitative studies as well. This type of study, which interviews patients directly regarding their experiences and then analyzes the content of those interviews, has great promise to teach us what type of patients are most likely to respond to an integrative medicine approach. We are interviewing patients completing the asthma and diabetes studies to determine if there are certain characteristics that can help integrative physicians determine who is most likely to respond to this treatment strategy.


Recently Completed Clinical Trials

1. Impact of the “Optimal Healing Environment” on Quality of Life and Cost Outcomes in Patients Admitted to Hospital for Cancer Treatment. With support from the Urban Zen Initiative, a philanthropic effort aimed at improving the care of patients with cancer, a clinical intervention with a cohort of inpatients with cancer at Beth Israel will consist of a transformation of this unit into an “optimal healing environment.” The project includes a remodeling of the physical space; training for the nursing staff in holistic nursing techniques including relaxation therapies and imagery; the presence of certified yoga therapists on the unit to work one-on-one with patients using breathing and yoga techniques; and the implementation of a “patient navigator” position to facilitate a smooth and efficient process of care. The research program evaluating this program is investigating whether this intervention improves the quality of patients’ experience when they are admitted to the hospital for cancer care as well as what impact it has on length-of-stay and medication use as markers of the cost of care.

2. Integrative Approach to Management of Asthma. This project, which was funded by a $400,000 grant from the Medical Capital Corporation, investigated the impact of an integrative medicine approach—incorporating nutritional manipulation and supplements, yoga breathing, and journaling—on the clinical and cost outcomes of a group of patients with asthma. We recruited a total of 156 subjects and demonstrated a significant improvement in disease-related quality of life in the treatment group compared to controls. The study was accepted as an oral abstract presentation at the North American Research Conference on Complementary and Integrative Medicine. The goal of the study was to demonstrate that a group-oriented, relatively low-cost integrative intervention can both improve the health status and quality of life in patients with asthma, and generate significant cost saving as well. The study was published in 2011.
Kligler B, Homel P, Blank AE, et al. Randomized trial of the effect of an integrative medicine approach to the management of asthma in adults on disease-related quality of life and pulmonary function. Alternative therapies in Health and Medicine. 17)1):10-15, 2011.

3. Doctor—Patient Communication in Integrative Medicine. In collaboration with Dr. Michael Yedidia, a sociologist from New York University and Rutgers, we have recently completed an AHRQ-funded study of how the doctor-patient interaction in integrative medicine settings differs from the conventional interaction. Dr. Yedidia completed a series of interviews with CCHH patients with Irritable Bowel Syndrome and fibromyalgia, as well as in-depth interviews with several of the Center clinicians regarding their perspective on doctor-patient communication. The results of this study are currently being analyzed and will hopefully be published in the coming year. The goal of this study is to help educate conventional physicians and medical educators on how to improve communication with their patients.

4. Yoga and Stroke. We recently completed and published a systematic review of the medical literature on yoga and stroke for a Physical Medicine and Rehabilitation journal. This article also described the results of a case series done at the Center in 2003 describing the impact of yoga training on three patients following a stroke.

5. Natural Treatment for Cold Sores Trial. In 2007-8 we participated as a study site in a large multi-center trial of an herbal product for the treatment of cold sores. Dr. David Riley from University of New Mexico was the principal investigator on this trial which was funded by the Merix Pharmaceutical Corporation. The project was extremely successful, as we recruited 42 patients and brought in a total of over $40,000 to the Center as compensation for our role as a participating site. The results of the trial are now being analyzed and prepared for publication.

6. Qualitative Study of Depression. We joined this past year with researchers from Albert Einstein College of Medicine in recruiting patients for a multi-site, NIH-funded study of patients’ experience of depression and of what type of treatment options are currently being offered to depressed patients. Here again we were very successful in recruiting as part of a multi-site trial, and the investigators from AECOM have requested our collaboration on their next NIH grant proposal.

7. Integrative Approach to Depression. This pilot study of a 12 week group oriented integrative treatment approach to depression was led by Dr. Suzanne Little, clinical psychologist at the CCHH. Subjects experienced significant improvement in depression and anxiety measures as a consequence of the treatment. This study was accepted for a poster presentation at the 2009 North American Research Conference on Complementary and Integrative Medicine and has been published in Explore: The Journal of Science and Healing.
Little SAS, Kligler B, Homel P, et al. Multimodal mind/body group therapy for chronic depression: a pilot study. Explore. 5(6):330-337, 2009.

8. Zicam for herpes labialis. This is a new multi-site evaluation of another natural medicine product for treatment of cold sores. This study was led by the same trials group we collaborated with in 2007-8 on the previous cold sore trial. Recruitment for this trial began in January 2009.

9. Mind-Body intervention for Patients Undergoing Total Knee Replacement. This is a pilot, sham-controlled study examining the impact of a mind-body intervention (the “holistic preparation for surgery program”) on pain and subjective experience of a group of 30 patients undergoing total knee replacement. Data collection has been completed on this project and analysis is in progress.


Education Research

Our Division of Education is among the leading programs in the country in medical school and post-graduate training in integrative medicine. Our most recently completed study evaluating the impact of a web-based botanical medicine education module for physicians on the knowledge of primary care residents in 12 programs around the country regarding herbal medicine. This project was run in conjunction with the University of Arizona Program in Integrative Medicine. This project has been accepted for an oral abstract presentation at the North American Research Conference on Complementary and Integrative Medicine and as a poster presentation at the 2009 National Meeting of the Society of Teachers of Family Medicine.

Our current research efforts center on the evaluation of the Integrative Medicine in Residency (IMR), a Web-based 250-hour curriculum in integrative medicine for family practice residency. We are one of eight sites around the country piloting this project in collaboration with the University of Arizona. An extensive IRB-approved evaluation protocol evaluates the impact of the educational intervention on residents’ knowledge base and practice patterns.

Our Publications

Benjamin Kligler, MD, MPH; Peter Homel, PhD; Louis B. Harrison, MD; Hanniel D. Levenson, MS; Jeanne B. Kenney, RN, BSN, HN-BC; and Woodson Merrell, MD. Cost Savings in Inpatient Oncology Through an Integrative Medicine Approach. American Journal of Managed Care. 17(12):779-784, 2011. www.ncbi.nlm.nih.gov/pubmed/22216749

Kligler B, Homel P, Harrison LB, Sackett E, Levenson H, Kenney J, Fleishman SB, Serra D, Merrell W. Impact of the Urban Zen Initiative on patients’ experience of admission to an inpatient oncology floor: a mixed-methods analysis. J Altern Complement Med. 17(8):729-34, 2011.
http://www.ncbi.nlm.nih.gov/pubmed/21745096

Nielsen A. Gua sha. In: Schleip R, Chaitow L, Huijing P, ed. Fascia in Manual Therapy. Edinburgh: Elsevier (forthcoming).

Braun M, Schwickert M, Nielsen A, et al. Effectiveness of traditional Chinese ‘gua sha’ therapy for neck pain: a randomized controlled trial. Pain Med. 12(3):362-9, 2011.

Kligler B, Homel P, Blank AE, et al. Randomized trial of the effect of an Integrative Medicine approach to the management of asthma in adults on disease-related quality of life and pulmonary function. Alternative therapies in Health and Medicine. 17(1):10-15, 2011.

Teets R, Scott E, Dahmer S. Integrative Medicine Approach to Chronic Pain. Primary Care: Clinics in Office Practice. 2010 Jun;37(2):407-21.

Dahmer S, Scott E. Health Effects of Hawthorne. Complementary/Alternative Medicine Series Template. Am Fam Physician. 2010 Feb 15;81(4):465-468.

Kielczynska B. William Segal: Attending Artist, Attending Physician? Guest Editorial. Explore 10, no.2 March/April 2010.

Kligler B, Lebensohn P, Koithan M, Schneider C, Rakel D, Cook P, Kohatsu W, and Maizes V. Measuring the “Whole System” Outcomes of an Educational Innovation: Experience From the Integrative Family Medicine Program. Family Medicine; 41(5):342-9, 2009.

Handel MJ. Integrative Primary Care and the Internet: Opportunities and Challenges. Primary Care: Clinics in Office Practice. 37(1):181-200, 2010.

Little AS, Kligler B, Homel P, Belisle S, Merrell W. Multimodal Mind/Body Group Therapy for Chronic Depression: A Pilot Study. Explore: The Journal of Science and Healing; 5(6):330-337, 2009.

Kreitzer MJ, Kligler B, Meeker W Health professions education and integrative healthcare Explore: The Journal of Science and Healing; 5(4):212-27, 2009.

Dahmer S and Scott E. Health effects of hawthorn. American Family Physician. 81(4):465-468, 2009.

Kielczynska B. Consider Alternatives. Access to Complementary and Alternative Medicine and Considerations for Boards of Trustees of Health Care Organizations. Modern Healthcare, December 4, 2009.

Guerrera M, Glick RM, Benn R, Kemper K, Kligler B, Maizes V. Integrative patient-centered care. Journal of Alternative & Complementary Medicine. 14(5):454, 2008.

Schiller R, Dahmer S. Glucosamine. Complementary/Alternative Medicine Series Template. American Family Physician. 2008 Aug 15;78(4):471-6.

Kligler B, Scott E. “Nutrition in Children” In Culbert T (ed) Integrative Pediatrics, In Press 2008.

Nielsen A, Knoblauch N, Dobos G, Michalsen A, Kaptchuk T. The effect of ‘Gua sha’ treatment on the microcirculation of surface tissue: a pilot study in healthy subjects. In: Thomas W. Findley and Robert Schleip, ed. Fascia Research: Basic Science and Implications for Conventional and Complementary Health Care. Munich, Germany: Elsevier; 249-250, 2008.

Effect of ‘Gua sha’ treatment on the microcirculation of surface tissue: a pilot study in healthy subjects. EXPLORE: J of Science and Healing, October: 3;5,456-466, 2007.

Lynton H, Kligler B, Shiflett S. Yoga in Stroke Rehabilitation: A Systematic Review and Results of a Pilot Study. Topics in Stroke Rehab. 14(4):1-8, 2007.

Kligler B, Chaudhary S. Peppermint Oil. American Family Pysician.75:1027-30, 2007.

Dahmer S. Ask the Experts: Integrative Medicine in Underserved Populations. EXPLORE: The Journal of Science and Healing. 3(5):546, 2007.

Kligler B, Koithan M, Maizes V et al. Competency-based evaluation tools for integrative medicine training in family medicine residency: a pilot study. BMC Medical Education. 7:7, 2007.

Mehl-Madrona L, Kligler B, Silverman S, et al. The Impact of Acupuncture and Craniosacral Therapy Interventions on Clinical Outcomes in Adults With Asthma. Explore: The Journal of Science and Healing. 3(1): 28-36; 2007.

Kligler B, Hanaway P, Cohrssen A. Probiotics in Children. Pediatric Clinics of North America. 54(6):949-67, 2007.

Kligler B, Dahmer S. “HIV Disease.” In: Rakel D (ed). Integrative Medicine (2nd edition) St. Louis, MO: Saunders; 2007.

Nielsen A, Knoblauch NT, Dobos GJ, Michalsen A, Kaptchuk TJ. The effect of Gua Sha treatment on the microcirculation of surface tissue: a pilot study in healthy subjects. Explore: The Journal of Science & Healing. 3(5):456-66, 2007.

Erickson K, Shalts E, Kligler B. Case study in integrative medicine: Jared C, a child with recurrent otitis media and upper respiratory illness. Explore: The Journal of Science & Healing. 2(3):235-7, 2006.

Kielczynska B. Traditional East-Asian medicine and acupuncture in the treatment of asthma and allergies in children. Explore: The Journal of Science and Healing. 1(2): 118-121, 2005.

Little S, Nielsen A, Lee R, Kligler B. Case Study In Integrative Medicine: Hannah. Explore: The Journal of Science and Healing. 1(3): 194-197, 2005.

Kligler B, Maizes V, Schachter S, Park CM, Gaudet T, Benn R, Lee R, Remen RN. Education Working Group, Consortium of Academic Health Centers for Integrative Medicine. Core competencies in integrative medicine for medical school curricula: a proposal. Academic Medicine. 79(6):521-31, 2004.

Girman A, Lee R, Kligler B. An Integrative Approach to the Treatment of Premenstrual Syndrome. American Journal of Obstetrics and Gynecology. 188 (5 Suppl):S56-65, 2003.

Kligler B, Lynch D. An integrative approach to the management of type 2 diabetes mellitus. Alternative Therapies in Health and Medicine. 9(6):24-32, 2003.

Kligler B, Dahmer S. Chapter 14 – HIV Disease. Rakel: Integrative Medicine, 2nd ed., Saunders, 2003.

Kopman AF, Ng J, Zank LM, Neuman GG, Yee PS. Residual Postoperative Paralysis. Pancuronium Versus Mivacurium, Does it Matter? Anesthesiology. 85:1253-1259, 1996.


Future Research Directions/Funding Needs

1. Mind-Body Intervention for Patients Undergoing Surgery for Colon Cancer. We recently submitted an R21 application to NCI in collaboration with the Division of Colorectal Surgery and a group of laboratory scientists at Beth Israel to evaluate the impact of our “holistic preparation for surgery” program on clinical outcomes, cost, and biological markers in patients undergoing surgery for colon cancer. The project will include sampling of melatonin and cytokine levels to look for putative biological mechanisms mediating the impact of a stress reduction intervention.

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Content last modified on Jan 11, 2012