1. Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: a randomized clinical trial
- Author
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Adante Hart, Samang Ung, Callan J. Burzynski, Susan Rappaport, Bennie McWilliams, Elizabeth Lancet, Sabrena Mervin-Blake, Michael O. Daines, Tara F. Carr, Jennifer Kustwin, David M. Shade, Nicholas Eberlein, Elise Pangborn, Connie Romaine, Ellen D. Brown, Patricia D. Rebolledo, Andre Rogatko, Anna Adler, Adam Wanner, Stephanie M. Burns, Jonathan Cruse, Deanna M. Green, Janette C. Priefert, Gail Weinmann, W. Gerald Teague, John Welter, Deborah Keaney Chassaing, Leonard B. Bacharier, Tonya Greene, Nienchun Wu, Daniel A. Searing, Edward T. Naureckas, Lilian Cadet, Jason E. Lang, Laura Bertrand, Weijiang Shen, Robert A. Wise, April Thurman, Janet Hutchins, Andrea Lears, Amber Martineau, John S. Sundy, Nancy Prusakowski, Christine A. Sorkness, Kaharu Sumino, Nina Phillips, Andreas Schmid, Flavia C.L. Hoyte, Silvia Lopez, Marie C. Sandi, Cristine E. Berry, Edward B. Mougey, Gwen Leatherman, Scott H. Sicherer, Lisa Monchil, Lucius Robinson, Dima Ezmigna, Gang Zheng, Paula J. Puntenney, Joan Reibman, V. Susan Robertson, Lisa Webber, Nicholas R. Anthonisen, Blanca A. Lopez, Michael F. Land, Kristina Rivera, Jessica Ghidorzi, Denise Thompson-Batt, Christian Bime, Brian P. Vickery, Xavier Soler, Marilyn Scharbach, Agnes Banquet, Johana Arana, Richard S. Tejedor, Suzanna Roettger, Jonathan P. Parsons, Ben Xu, Ankoor S. Shah, Denise Jaggers, Thomas Lahiri, Eliana S. Mendes, Lucy Wang, Eveline Y. Wu, David Cosmar, Gary I. Salzman, Elizabeth De La Riva-Velasco, Alicia Newcomer, John G. Mastronarde, Elizabeth A. Sugar, Razan Yasin, Mary A. Nevin, Fernando D. Martinez, Anne S Casper, Melissa M. Scheuerman, William J. Calhoun, Jesus A. Wences, James N. Moy, Virginia S. Taggart, Nicola A. Hanania, Anne E. Dixon, Asem Abdeljalil, William C. Bailey, Jessica Williams, Monroe J. King, Sarah M. Croker, Kenneth S. Knox, Mary Warde, Rubin I. Cohen, Sankaran Krishnan, Mario Castro, Newel Bryce-Robinson, Karen Carapetyan, Christine Y. Wei, Roni Grad, Stephen C. Lazarus, Nancy Busk, Patti Haney, Richard F. Lockey, Lewis J. Smith, Michael Campos, Jaime Tarsi, Wayne J. Morgan, James L. Goodwin, Norman H. Edelman, Charles G. Irvin, Noopur Singh, Janet T. Holbrook, Johnson Ukken, David A. Kaminsky, Ravi Kalhan, Kyle I. Happel, Joe Ramsdell, Mustafa A. Atik, Nancy Archer, Raymond G. Slavin, Maria Teresa Santiago, Paul Ferguson, Virginia Zagaja, Rachael A. Compton, Joseph Santiago, Katherine Chee, Brenda M. Patterson, Ramona Ramdeo, Monica T. Varela, Joseph Boyer, Allen J. Dozor, Catherine M Foss, Robert Smith, Michael Busk, Maureen Dreyfus, Marie Daniel, Sobharani Rayapudi, Shirley McCullough, Jenny Hixon, Stephen Wasserman, Holly Currier, Andrea Paco, Tara M. Formisano, Nadav Traeger, Ingrid Gherson, Thomas Matthews, Subhadra Siegel, Michelle Freemer, J.N. Saams, Rosemary Weese, Alexis L Rea, Y. Cathy Kim, Michelle M. Cloutier, Deborah Nowakowski, Kristin W. Wavell, Dennis Pyszczynski, Kathryn V. Blake, Peter J. Kahrilas, Marianna Sockrider, Rohit K. Katial, Mark A. Brown, Suzette T. Gjonaj, Zenobia Gonsalves, Arleen Antoine, Lynn B. Gerald, Emily DiMango, Linda Rogers, Debra Amend-Libercci, Abbi Brees, Deanna Seymour, Abid Bhat, John J. Lima, Stephanie Allen, Diana B. Lowenthal, Katie Kinninger, Rebecca McCrery, Janice Drake, Cori L. Daines, Charlene Levine, Elizabeth K. Fiorino, Monica M. Vasquez, Terri Montgomery, Donna Wolf, and Trisha Larson
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Spirometry ,Adult ,Male ,Allergy ,medicine.medical_specialty ,Adolescent ,Placebo ,Article ,law.invention ,Young Adult ,Randomized controlled trial ,Double-Blind Method ,law ,Internal medicine ,Forced Expiratory Volume ,medicine ,Humans ,Young adult ,Child ,Lung ,Asthma ,medicine.diagnostic_test ,business.industry ,Plant Extracts ,General Medicine ,Middle Aged ,medicine.disease ,Genistein ,Isoflavones ,Clinical research ,Exhaled nitric oxide ,Dietary Supplements ,Physical therapy ,Soybean Proteins ,Female ,business ,Phytotherapy - Abstract
Importance Soy isoflavone supplements are used to treat several chronic diseases, although the data supporting their use are limited. Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control. Objective To determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease. Design, Setting, and Participants Multicenter, randomized, double-blind, placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network. Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized, and 345 (89%) completed spirometry at week 24. Interventions Participants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones (n=193) or matching placebo (n=193) in 2 divided doses administered daily for 24 weeks. Main Outcomes and Measures The primary outcome measure was change in forced expiratory volume in the first second (FEV 1 ) at 24 weeks. Secondary outcome measures were symptoms, episodes of poor asthma control, Asthma Control Test score (range, 5-25; higher scores indicate better control), and systemic and airway biomarkers of inflammation. Results Mean changes in prebronchodilator FEV 1 over 24 weeks were 0.03 L (95% CI, −0.01 to 0.08 L) in the placebo group and 0.01 L (95% CI, −0.07 to 0.07 L) in the soy isoflavone group, which were not significantly different ( P = .36). Mean changes in symptom scores on the Asthma Control Test (placebo, 1.98 [95% CI, 1.42-2.54] vs soy isoflavones, 2.20 [95% CI, 1.53-2.87]; positive values indicate a reduction in symptoms), number of episodes of poor asthma control (placebo, 3.3 [95% CI, 2.7-4.1] vs soy isoflavones, 3.0 [95% CI, 2.4-3.7]), and changes in exhaled nitric oxide (placebo, −3.48 ppb [95% CI, −5.99 to −0.97 ppb] vs soy isoflavones, 1.39 ppb [95% CI, −1.73 to 4.51 ppb]) did not significantly improve more with the soy isoflavone supplement than with placebo. Mean plasma genistein level increased from 4.87 ng/mL to 37.67 ng/mL ( P Conclusions and Relevance Among adults and children aged 12 years or older with poorly controlled asthma while taking a controller medication, use of a soy isoflavone supplement, compared with placebo, did not result in improved lung function or clinical outcomes. These findings suggest that this supplement should not be used for patients with poorly controlled asthma. Trial Registration clinicaltrials.gov Identifier:NCT01052116
- Published
- 2015