Clinical Trial Enrollment

Effect of An Integrative Medicine Approach to the Management of Asthma in Adults on Quality of Life and Clinical Outcomes

Summary

Benjamin Kligler, MD

Asthma is a serious chronic lung disease characterized by reversible airway obstruction and airway inflammation. According to the 2002 National Health Interview Survey (National Center for Health Statistics, 2002), 30.8 million people in the U.S. have been diagnosed with asthma sometime during their lifetime. The American Lung Association reported in 2002 that asthma entails an annual economic cost to our nation of $16.1 billion, including $11.5 billion in direct healthcare costs and $4.6 billion in lost productivity.

The overall aim of this research project is to test the effectiveness of an integrative program, using journaling, yoga breathing instruction, and nutritional manipulation and supplementation, on quality of life and clinical outcomes in adults with asthma. An additional aim is to determine whether an integrative approach to asthma management leads to cost savings when compared to standard clinical care.

Previous research suggests that each of the modalities, when used separately, can assist patients with asthma. In one study, journaling about a traumatic event helped improve pulmonary function in patients with asthma. Research on vitamin C supplementation has found that it has a modest effect in protecting the airways from hyper-responsiveness to provocative stimuli and may also prevent broncho-constriction. Supplementation with omega-3 fatty acids, in the form of fish oil, when used in combination with additional dietary manipulation, led to significant improvement in asthma symptoms in a different study. While not conclusive, some research also suggests that yogic breathing can help patients with asthma.

The proposed study is designed to test the effectiveness of the integration of different modalities on asthma symptoms, as compared to standard clinical practice. The sample of 400 patients will include adults 18 years of age and older with diagnoses ranging from mild persistent to severe persistent asthma. Subjects must meet the other eligibility criteria, mostly involving the ability to participate in research activities, freedom from allergies to the proposed supplements, and freedom from other life-threatening medical conditions.

Patients will be randomly assigned to either the intervention condition or a waitlist control condition. For the intervention group, all measures will be obtained at baseline, immediately after the treatment protocol is completed, and then at three month and six month intervals after the completion of the intervention. For the control group, data will be collected at the same times as the intervention group, with one exception: data collected at the completion of the treatment protocol will be replaced with data collection at six weeks post-baseline for the control group. Data will be collected using measures of quality of life (Asthma Quality of Life Questionnaire and SF-12), pulmonary function, and healthcare utilization and expenditures.

Participants assigned to the treatment group will begin in groups of ten. The treatment protocol will consist of six (one to two hour) sessions over a six-week period as follows:

  1. Subjects will attend a two-session class on healthy eating focused on reducing nflammation-promoting foods in the diet. All subjects will also be started on fish oil and vitamin C supplements, as well as a combination of reduced iso-alpha acids (from hops extract, Humulus lupulus) and rosemary leaf extract (Rosmarinus officinalis) with anti-inflammatory action. Subjects will be provided with a take-home supply of these supplements free of charge.
  2. Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice
  3. Subjects will attend two guided journaling sessions at CCHH in which subjects will be asked to write for a 30-minute period about the most traumatic or stressful life experience to date.

Individuals assigned to the control group will receive the standard of care provided by their primary care, or other physician. At the conclusion of the six-month follow-up period, they will be offered the treatment free of charge. All participants will also receive a small stipend for completing the evaluations.

Principal Investigator, Benjamin Kligler, MD, who is Research Director at the Continuum Center for Health and Healing at Beth Israel, will lead the study. Co-investigators include Arthur Blank, PhD, Co-Director, and Division of Research of the Department of Family Medicine and Social Medicine at Albert Einstein Medical College/Montefiore Medical Center, and Roberta Lee, MD, Medical Director of the Continuum Center for Health and Healing. Study coordinators and treatment providers will soon be identified to handle daily operations.

For those who would like to participate in this study, please contact:

Hanniel D. Levenson
Research Associate
Continuum Center for Health and Healing
245 5th Avenue
NY, NY 10016
(646) 935-2243
www.healthandhealingny.org
email: hlevenso@chpnet.org