Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: A randomized clinical trial

Lewis J. Smith, Ravi Kalhan, Robert A. Wise, Elizabeth A. Sugar, John J. Lima, Charles G. Irvin, Allen J. Dozor, Janet T. Holbrook, Nicola Hanania, Marianna Sockrider, Laura Bertrand, Mustafa A. Atik, Blanca A. Lopez, Joan Reibman, Emily DiMango, Linda Rogers, Karen Carapetyan, Kristina Rivera, Newel Bryce-Robinson, Melissa ScheuermanElizabeth Fiorino, John Sundy, Deanna Green, Ankoor Shah, Catherine Foss, Jessica Ghidorzi, Stephanie Allen, Sabrena Mervin-Blake, Elise Pangborn, V. Susan Robertson, Nicholas Eberlein, Michael Land, Brian Vickery, Eveline Wu, Denise Jaggers, James Moy, Edward Naureckas, Mary Nevin, Jenny Hixon, Abbi Brees, Zenobia Gonsalves, Virginia Zagaja, Jennifer Kustwin, Ben Xu, Thomas Matthews, Lucius Robinson, Noopur Singh, Michael Busk, Paula Puntenney, Nancy Busk, Janet Hutchins, Kyle I. Happel, Richard S. Tejedor, Marie C. Sandi, Connie Romaine, Callan J. Burzynski, Arleen Antoine, Jonathan Cruse, Rohit Katial, Flavia Hoyte, Dan Searing, Trisha Larson, Nina Phillips, Holly Currier, Kathryn Blake, Jason Lang, Edward Mougey, Nancy Archer, Deanna Seymour, Mary Warde, Rubin Cohen, Maria Santiago, Ramona Ramdeo, Maureen Dreyfus, Anne E. Dixon, David A. Kaminsky, Thomas Lahiri, Stephanie M. Burns, John Mastronarde, Jonathan Parsons, Janice Drake, Joseph Santiago, David Cosmar, Rachael A. Compton, Sankaran Krishnan, Joseph Boyer, Agnes Banquet, Elizabeth De La Riva-Velasco, Diana Lowenthal, Suzette Gjonaj, Y. Cathy Kim, Nadav Traeger, John Welter, Marilyn Scharbach, Subhadra Siegel, Ingrid Gherson, Lisa Monchil, Tara M. Formisano, Jessica Williams, Mario Castro, Leonard Bacharier, Kaharu Sumino, Jaime J. Tarsi, Brenda Patterson, Terri Montgomery, Raymond G. Slavin, Deborah Keaney Chassaing, Lynn B. Gerald, James L. Goodwin, Mark A. Brown, Kenneth S. Knox, Tara F. Carr, Cristine E. Berry, Fernando D. Martinez, Wayne J. Morgan, Cori L. Daines, Michael O. Daines, Roni Grad, Dima Ezmigna, Monica M. Vasquez, Jesus A. Wences, Silvia S. Lopez, Janette C. Priefert, Monica T. Varela, Rosemary Weese, Katherine Chee, Andrea Paco, Adam Wanner, Richard Lockey, Andreas Schmid, Michael Campos, Monroe King, Eliana S. Mendes, Patricia D. Rebolledo, Johana Arana, Lilian Cadet, Rebecca McCrery, Sarah M. Croker, Shirley McCullough, Gary Salzman, Asem Abdeljalil, Dennis Pyszczynski, Abid Bhat, Patti Haney, Stephen Wasserman, Joe Ramsdell, Xavier Soler, Katie Kinninger, Paul Ferguson, Amber Martineau, Samang Ung, Tonya Greene, W. Gerald Teague, Kristin W. Wavell, Donna Wolf, Denise Thompson-Batt, William C. Bailey, Nicholas Anthonisen, Razan Yasin, Debra Amend-Libercci, Anna Adler, Anne Shanklin Casper, Marie Daniel, Adante Hart, Andrea Lears, Gwen Leatherman, Deborah Nowakowski, Nancy Prusakowski, Sobharani Rayapudi, Alexis Rea, Joy Saams, David Shade, April Thurman, Christine Wei, Alicia Newcomer, Christian Bime, Ellen Brown, Charlene Levine, Suzanna Roettger, Nienchun Wu, Weijiang Shen, Lucy Wang, Johnson Ukken, Stephen C. Lazarus, William Calhoun, Michelle Cloutier, Peter Kahrilas, Bennie McWilliams, Andre Rogatko, Christine Sorkness, Scott Sicherer, Gail Weinmann, Michelle Freemer, Robert Smith, Virginia Taggart, Lisa Webber, Gang Zheng, Elizabeth Lancet, Norman H. Edelman, Susan Rappaport

Research output: Contribution to journalArticle

12 Citations (Scopus)

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 100mg 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 measurewas change in forced expiratory volume in the first second (FEV1) 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 FEV1 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 < .001) in participants receiving the supplement. 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.

Original languageEnglish (US)
Pages (from-to)2033-2043
Number of pages11
JournalJAMA - Journal of the American Medical Association
Volume313
Issue number20
DOIs
StatePublished - May 26 2015
Externally publishedYes

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Isoflavones
Asthma
Randomized Controlled Trials
Lung
Placebos
Airway Management
Genistein
Spirometry
Forced Expiratory Volume
Hypersensitivity
Nitric Oxide
Chronic Disease
Biomarkers
Medicine
Outcome Assessment (Health Care)
Pediatrics
Inflammation

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma : A randomized clinical trial. / Smith, Lewis J.; Kalhan, Ravi; Wise, Robert A.; Sugar, Elizabeth A.; Lima, John J.; Irvin, Charles G.; Dozor, Allen J.; Holbrook, Janet T.; Hanania, Nicola; Sockrider, Marianna; Bertrand, Laura; Atik, Mustafa A.; Lopez, Blanca A.; Reibman, Joan; DiMango, Emily; Rogers, Linda; Carapetyan, Karen; Rivera, Kristina; Bryce-Robinson, Newel; Scheuerman, Melissa; Fiorino, Elizabeth; Sundy, John; Green, Deanna; Shah, Ankoor; Foss, Catherine; Ghidorzi, Jessica; Allen, Stephanie; Mervin-Blake, Sabrena; Pangborn, Elise; Robertson, V. Susan; Eberlein, Nicholas; Land, Michael; Vickery, Brian; Wu, Eveline; Jaggers, Denise; Moy, James; Naureckas, Edward; Nevin, Mary; Hixon, Jenny; Brees, Abbi; Gonsalves, Zenobia; Zagaja, Virginia; Kustwin, Jennifer; Xu, Ben; Matthews, Thomas; Robinson, Lucius; Singh, Noopur; Busk, Michael; Puntenney, Paula; Busk, Nancy; Hutchins, Janet; Happel, Kyle I.; Tejedor, Richard S.; Sandi, Marie C.; Romaine, Connie; Burzynski, Callan J.; Antoine, Arleen; Cruse, Jonathan; Katial, Rohit; Hoyte, Flavia; Searing, Dan; Larson, Trisha; Phillips, Nina; Currier, Holly; Blake, Kathryn; Lang, Jason; Mougey, Edward; Archer, Nancy; Seymour, Deanna; Warde, Mary; Cohen, Rubin; Santiago, Maria; Ramdeo, Ramona; Dreyfus, Maureen; Dixon, Anne E.; Kaminsky, David A.; Lahiri, Thomas; Burns, Stephanie M.; Mastronarde, John; Parsons, Jonathan; Drake, Janice; Santiago, Joseph; Cosmar, David; Compton, Rachael A.; Krishnan, Sankaran; Boyer, Joseph; Banquet, Agnes; De La Riva-Velasco, Elizabeth; Lowenthal, Diana; Gjonaj, Suzette; Kim, Y. Cathy; Traeger, Nadav; Welter, John; Scharbach, Marilyn; Siegel, Subhadra; Gherson, Ingrid; Monchil, Lisa; Formisano, Tara M.; Williams, Jessica; Castro, Mario; Bacharier, Leonard; Sumino, Kaharu; Tarsi, Jaime J.; Patterson, Brenda; Montgomery, Terri; Slavin, Raymond G.; Chassaing, Deborah Keaney; Gerald, Lynn B.; Goodwin, James L.; Brown, Mark A.; Knox, Kenneth S.; Carr, Tara F.; Berry, Cristine E.; Martinez, Fernando D.; Morgan, Wayne J.; Daines, Cori L.; Daines, Michael O.; Grad, Roni; Ezmigna, Dima; Vasquez, Monica M.; Wences, Jesus A.; Lopez, Silvia S.; Priefert, Janette C.; Varela, Monica T.; Weese, Rosemary; Chee, Katherine; Paco, Andrea; Wanner, Adam; Lockey, Richard; Schmid, Andreas; Campos, Michael; King, Monroe; Mendes, Eliana S.; Rebolledo, Patricia D.; Arana, Johana; Cadet, Lilian; McCrery, Rebecca; Croker, Sarah M.; McCullough, Shirley; Salzman, Gary; Abdeljalil, Asem; Pyszczynski, Dennis; Bhat, Abid; Haney, Patti; Wasserman, Stephen; Ramsdell, Joe; Soler, Xavier; Kinninger, Katie; Ferguson, Paul; Martineau, Amber; Ung, Samang; Greene, Tonya; Teague, W. Gerald; Wavell, Kristin W.; Wolf, Donna; Thompson-Batt, Denise; Bailey, William C.; Anthonisen, Nicholas; Yasin, Razan; Amend-Libercci, Debra; Adler, Anna; Casper, Anne Shanklin; Daniel, Marie; Hart, Adante; Lears, Andrea; Leatherman, Gwen; Nowakowski, Deborah; Prusakowski, Nancy; Rayapudi, Sobharani; Rea, Alexis; Saams, Joy; Shade, David; Thurman, April; Wei, Christine; Newcomer, Alicia; Bime, Christian; Brown, Ellen; Levine, Charlene; Roettger, Suzanna; Wu, Nienchun; Shen, Weijiang; Wang, Lucy; Ukken, Johnson; Lazarus, Stephen C.; Calhoun, William; Cloutier, Michelle; Kahrilas, Peter; McWilliams, Bennie; Rogatko, Andre; Sorkness, Christine; Sicherer, Scott; Weinmann, Gail; Freemer, Michelle; Smith, Robert; Taggart, Virginia; Webber, Lisa; Zheng, Gang; Lancet, Elizabeth; Edelman, Norman H.; Rappaport, Susan.

In: JAMA - Journal of the American Medical Association, Vol. 313, No. 20, 26.05.2015, p. 2033-2043.

Research output: Contribution to journalArticle

Smith, LJ, Kalhan, R, Wise, RA, Sugar, EA, Lima, JJ, Irvin, CG, Dozor, AJ, Holbrook, JT, Hanania, N, Sockrider, M, Bertrand, L, Atik, MA, Lopez, BA, Reibman, J, DiMango, E, Rogers, L, Carapetyan, K, Rivera, K, Bryce-Robinson, N, Scheuerman, M, Fiorino, E, Sundy, J, Green, D, Shah, A, Foss, C, Ghidorzi, J, Allen, S, Mervin-Blake, S, Pangborn, E, Robertson, VS, Eberlein, N, Land, M, Vickery, B, Wu, E, Jaggers, D, Moy, J, Naureckas, E, Nevin, M, Hixon, J, Brees, A, Gonsalves, Z, Zagaja, V, Kustwin, J, Xu, B, Matthews, T, Robinson, L, Singh, N, Busk, M, Puntenney, P, Busk, N, Hutchins, J, Happel, KI, Tejedor, RS, Sandi, MC, Romaine, C, Burzynski, CJ, Antoine, A, Cruse, J, Katial, R, Hoyte, F, Searing, D, Larson, T, Phillips, N, Currier, H, Blake, K, Lang, J, Mougey, E, Archer, N, Seymour, D, Warde, M, Cohen, R, Santiago, M, Ramdeo, R, Dreyfus, M, Dixon, AE, Kaminsky, DA, Lahiri, T, Burns, SM, Mastronarde, J, Parsons, J, Drake, J, Santiago, J, Cosmar, D, Compton, RA, Krishnan, S, Boyer, J, Banquet, A, De La Riva-Velasco, E, Lowenthal, D, Gjonaj, S, Kim, YC, Traeger, N, Welter, J, Scharbach, M, Siegel, S, Gherson, I, Monchil, L, Formisano, TM, Williams, J, Castro, M, Bacharier, L, Sumino, K, Tarsi, JJ, Patterson, B, Montgomery, T, Slavin, RG, Chassaing, DK, Gerald, LB, Goodwin, JL, Brown, MA, Knox, KS, Carr, TF, Berry, CE, Martinez, FD, Morgan, WJ, Daines, CL, Daines, MO, Grad, R, Ezmigna, D, Vasquez, MM, Wences, JA, Lopez, SS, Priefert, JC, Varela, MT, Weese, R, Chee, K, Paco, A, Wanner, A, Lockey, R, Schmid, A, Campos, M, King, M, Mendes, ES, Rebolledo, PD, Arana, J, Cadet, L, McCrery, R, Croker, SM, McCullough, S, Salzman, G, Abdeljalil, A, Pyszczynski, D, Bhat, A, Haney, P, Wasserman, S, Ramsdell, J, Soler, X, Kinninger, K, Ferguson, P, Martineau, A, Ung, S, Greene, T, Teague, WG, Wavell, KW, Wolf, D, Thompson-Batt, D, Bailey, WC, Anthonisen, N, Yasin, R, Amend-Libercci, D, Adler, A, Casper, AS, Daniel, M, Hart, A, Lears, A, Leatherman, G, Nowakowski, D, Prusakowski, N, Rayapudi, S, Rea, A, Saams, J, Shade, D, Thurman, A, Wei, C, Newcomer, A, Bime, C, Brown, E, Levine, C, Roettger, S, Wu, N, Shen, W, Wang, L, Ukken, J, Lazarus, SC, Calhoun, W, Cloutier, M, Kahrilas, P, McWilliams, B, Rogatko, A, Sorkness, C, Sicherer, S, Weinmann, G, Freemer, M, Smith, R, Taggart, V, Webber, L, Zheng, G, Lancet, E, Edelman, NH & Rappaport, S 2015, 'Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: A randomized clinical trial', JAMA - Journal of the American Medical Association, vol. 313, no. 20, pp. 2033-2043. https://doi.org/10.1001/jama.2015.5024
Smith, Lewis J. ; Kalhan, Ravi ; Wise, Robert A. ; Sugar, Elizabeth A. ; Lima, John J. ; Irvin, Charles G. ; Dozor, Allen J. ; Holbrook, Janet T. ; Hanania, Nicola ; Sockrider, Marianna ; Bertrand, Laura ; Atik, Mustafa A. ; Lopez, Blanca A. ; Reibman, Joan ; DiMango, Emily ; Rogers, Linda ; Carapetyan, Karen ; Rivera, Kristina ; Bryce-Robinson, Newel ; Scheuerman, Melissa ; Fiorino, Elizabeth ; Sundy, John ; Green, Deanna ; Shah, Ankoor ; Foss, Catherine ; Ghidorzi, Jessica ; Allen, Stephanie ; Mervin-Blake, Sabrena ; Pangborn, Elise ; Robertson, V. Susan ; Eberlein, Nicholas ; Land, Michael ; Vickery, Brian ; Wu, Eveline ; Jaggers, Denise ; Moy, James ; Naureckas, Edward ; Nevin, Mary ; Hixon, Jenny ; Brees, Abbi ; Gonsalves, Zenobia ; Zagaja, Virginia ; Kustwin, Jennifer ; Xu, Ben ; Matthews, Thomas ; Robinson, Lucius ; Singh, Noopur ; Busk, Michael ; Puntenney, Paula ; Busk, Nancy ; Hutchins, Janet ; Happel, Kyle I. ; Tejedor, Richard S. ; Sandi, Marie C. ; Romaine, Connie ; Burzynski, Callan J. ; Antoine, Arleen ; Cruse, Jonathan ; Katial, Rohit ; Hoyte, Flavia ; Searing, Dan ; Larson, Trisha ; Phillips, Nina ; Currier, Holly ; Blake, Kathryn ; Lang, Jason ; Mougey, Edward ; Archer, Nancy ; Seymour, Deanna ; Warde, Mary ; Cohen, Rubin ; Santiago, Maria ; Ramdeo, Ramona ; Dreyfus, Maureen ; Dixon, Anne E. ; Kaminsky, David A. ; Lahiri, Thomas ; Burns, Stephanie M. ; Mastronarde, John ; Parsons, Jonathan ; Drake, Janice ; Santiago, Joseph ; Cosmar, David ; Compton, Rachael A. ; Krishnan, Sankaran ; Boyer, Joseph ; Banquet, Agnes ; De La Riva-Velasco, Elizabeth ; Lowenthal, Diana ; Gjonaj, Suzette ; Kim, Y. Cathy ; Traeger, Nadav ; Welter, John ; Scharbach, Marilyn ; Siegel, Subhadra ; Gherson, Ingrid ; Monchil, Lisa ; Formisano, Tara M. ; Williams, Jessica ; Castro, Mario ; Bacharier, Leonard ; Sumino, Kaharu ; Tarsi, Jaime J. ; Patterson, Brenda ; Montgomery, Terri ; Slavin, Raymond G. ; Chassaing, Deborah Keaney ; Gerald, Lynn B. ; Goodwin, James L. ; Brown, Mark A. ; Knox, Kenneth S. ; Carr, Tara F. ; Berry, Cristine E. ; Martinez, Fernando D. ; Morgan, Wayne J. ; Daines, Cori L. ; Daines, Michael O. ; Grad, Roni ; Ezmigna, Dima ; Vasquez, Monica M. ; Wences, Jesus A. ; Lopez, Silvia S. ; Priefert, Janette C. ; Varela, Monica T. ; Weese, Rosemary ; Chee, Katherine ; Paco, Andrea ; Wanner, Adam ; Lockey, Richard ; Schmid, Andreas ; Campos, Michael ; King, Monroe ; Mendes, Eliana S. ; Rebolledo, Patricia D. ; Arana, Johana ; Cadet, Lilian ; McCrery, Rebecca ; Croker, Sarah M. ; McCullough, Shirley ; Salzman, Gary ; Abdeljalil, Asem ; Pyszczynski, Dennis ; Bhat, Abid ; Haney, Patti ; Wasserman, Stephen ; Ramsdell, Joe ; Soler, Xavier ; Kinninger, Katie ; Ferguson, Paul ; Martineau, Amber ; Ung, Samang ; Greene, Tonya ; Teague, W. Gerald ; Wavell, Kristin W. ; Wolf, Donna ; Thompson-Batt, Denise ; Bailey, William C. ; Anthonisen, Nicholas ; Yasin, Razan ; Amend-Libercci, Debra ; Adler, Anna ; Casper, Anne Shanklin ; Daniel, Marie ; Hart, Adante ; Lears, Andrea ; Leatherman, Gwen ; Nowakowski, Deborah ; Prusakowski, Nancy ; Rayapudi, Sobharani ; Rea, Alexis ; Saams, Joy ; Shade, David ; Thurman, April ; Wei, Christine ; Newcomer, Alicia ; Bime, Christian ; Brown, Ellen ; Levine, Charlene ; Roettger, Suzanna ; Wu, Nienchun ; Shen, Weijiang ; Wang, Lucy ; Ukken, Johnson ; Lazarus, Stephen C. ; Calhoun, William ; Cloutier, Michelle ; Kahrilas, Peter ; McWilliams, Bennie ; Rogatko, Andre ; Sorkness, Christine ; Sicherer, Scott ; Weinmann, Gail ; Freemer, Michelle ; Smith, Robert ; Taggart, Virginia ; Webber, Lisa ; Zheng, Gang ; Lancet, Elizabeth ; Edelman, Norman H. ; Rappaport, Susan. / Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma : A randomized clinical trial. In: JAMA - Journal of the American Medical Association. 2015 ; Vol. 313, No. 20. pp. 2033-2043.
@article{4824f88ef63a43d89018855840a89bae,
title = "Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: A randomized clinical trial",
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 100mg 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 measurewas change in forced expiratory volume in the first second (FEV1) 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 FEV1 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 < .001) in participants receiving the supplement. 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.",
author = "Smith, {Lewis J.} and Ravi Kalhan and Wise, {Robert A.} and Sugar, {Elizabeth A.} and Lima, {John J.} and Irvin, {Charles G.} and Dozor, {Allen J.} and Holbrook, {Janet T.} and Nicola Hanania and Marianna Sockrider and Laura Bertrand and Atik, {Mustafa A.} and Lopez, {Blanca A.} and Joan Reibman and Emily DiMango and Linda Rogers and Karen Carapetyan and Kristina Rivera and Newel Bryce-Robinson and Melissa Scheuerman and Elizabeth Fiorino and John Sundy and Deanna Green and Ankoor Shah and Catherine Foss and Jessica Ghidorzi and Stephanie Allen and Sabrena Mervin-Blake and Elise Pangborn and Robertson, {V. Susan} and Nicholas Eberlein and Michael Land and Brian Vickery and Eveline Wu and Denise Jaggers and James Moy and Edward Naureckas and Mary Nevin and Jenny Hixon and Abbi Brees and Zenobia Gonsalves and Virginia Zagaja and Jennifer Kustwin and Ben Xu and Thomas Matthews and Lucius Robinson and Noopur Singh and Michael Busk and Paula Puntenney and Nancy Busk and Janet Hutchins and Happel, {Kyle I.} and Tejedor, {Richard S.} and Sandi, {Marie C.} and Connie Romaine and Burzynski, {Callan J.} and Arleen Antoine and Jonathan Cruse and Rohit Katial and Flavia Hoyte and Dan Searing and Trisha Larson and Nina Phillips and Holly Currier and Kathryn Blake and Jason Lang and Edward Mougey and Nancy Archer and Deanna Seymour and Mary Warde and Rubin Cohen and Maria Santiago and Ramona Ramdeo and Maureen Dreyfus and Dixon, {Anne E.} and Kaminsky, {David A.} and Thomas Lahiri and Burns, {Stephanie M.} and John Mastronarde and Jonathan Parsons and Janice Drake and Joseph Santiago and David Cosmar and Compton, {Rachael A.} and Sankaran Krishnan and Joseph Boyer and Agnes Banquet and {De La Riva-Velasco}, Elizabeth and Diana Lowenthal and Suzette Gjonaj and Kim, {Y. Cathy} and Nadav Traeger and John Welter and Marilyn Scharbach and Subhadra Siegel and Ingrid Gherson and Lisa Monchil and Formisano, {Tara M.} and Jessica Williams and Mario Castro and Leonard Bacharier and Kaharu Sumino and Tarsi, {Jaime J.} and Brenda Patterson and Terri Montgomery and Slavin, {Raymond G.} and Chassaing, {Deborah Keaney} and Gerald, {Lynn B.} and Goodwin, {James L.} and Brown, {Mark A.} and Knox, {Kenneth S.} and Carr, {Tara F.} and Berry, {Cristine E.} and Martinez, {Fernando D.} and Morgan, {Wayne J.} and Daines, {Cori L.} and Daines, {Michael O.} and Roni Grad and Dima Ezmigna and Vasquez, {Monica M.} and Wences, {Jesus A.} and Lopez, {Silvia S.} and Priefert, {Janette C.} and Varela, {Monica T.} and Rosemary Weese and Katherine Chee and Andrea Paco and Adam Wanner and Richard Lockey and Andreas Schmid and Michael Campos and Monroe King and Mendes, {Eliana S.} and Rebolledo, {Patricia D.} and Johana Arana and Lilian Cadet and Rebecca McCrery and Croker, {Sarah M.} and Shirley McCullough and Gary Salzman and Asem Abdeljalil and Dennis Pyszczynski and Abid Bhat and Patti Haney and Stephen Wasserman and Joe Ramsdell and Xavier Soler and Katie Kinninger and Paul Ferguson and Amber Martineau and Samang Ung and Tonya Greene and Teague, {W. Gerald} and Wavell, {Kristin W.} and Donna Wolf and Denise Thompson-Batt and Bailey, {William C.} and Nicholas Anthonisen and Razan Yasin and Debra Amend-Libercci and Anna Adler and Casper, {Anne Shanklin} and Marie Daniel and Adante Hart and Andrea Lears and Gwen Leatherman and Deborah Nowakowski and Nancy Prusakowski and Sobharani Rayapudi and Alexis Rea and Joy Saams and David Shade and April Thurman and Christine Wei and Alicia Newcomer and Christian Bime and Ellen Brown and Charlene Levine and Suzanna Roettger and Nienchun Wu and Weijiang Shen and Lucy Wang and Johnson Ukken and Lazarus, {Stephen C.} and William Calhoun and Michelle Cloutier and Peter Kahrilas and Bennie McWilliams and Andre Rogatko and Christine Sorkness and Scott Sicherer and Gail Weinmann and Michelle Freemer and Robert Smith and Virginia Taggart and Lisa Webber and Gang Zheng and Elizabeth Lancet and Edelman, {Norman H.} and Susan Rappaport",
year = "2015",
month = "5",
day = "26",
doi = "10.1001/jama.2015.5024",
language = "English (US)",
volume = "313",
pages = "2033--2043",
journal = "JAMA - Journal of the American Medical Association",
issn = "0002-9955",
publisher = "American Medical Association",
number = "20",

}

TY - JOUR

T1 - Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma

T2 - A randomized clinical trial

AU - Smith, Lewis J.

AU - Kalhan, Ravi

AU - Wise, Robert A.

AU - Sugar, Elizabeth A.

AU - Lima, John J.

AU - Irvin, Charles G.

AU - Dozor, Allen J.

AU - Holbrook, Janet T.

AU - Hanania, Nicola

AU - Sockrider, Marianna

AU - Bertrand, Laura

AU - Atik, Mustafa A.

AU - Lopez, Blanca A.

AU - Reibman, Joan

AU - DiMango, Emily

AU - Rogers, Linda

AU - Carapetyan, Karen

AU - Rivera, Kristina

AU - Bryce-Robinson, Newel

AU - Scheuerman, Melissa

AU - Fiorino, Elizabeth

AU - Sundy, John

AU - Green, Deanna

AU - Shah, Ankoor

AU - Foss, Catherine

AU - Ghidorzi, Jessica

AU - Allen, Stephanie

AU - Mervin-Blake, Sabrena

AU - Pangborn, Elise

AU - Robertson, V. Susan

AU - Eberlein, Nicholas

AU - Land, Michael

AU - Vickery, Brian

AU - Wu, Eveline

AU - Jaggers, Denise

AU - Moy, James

AU - Naureckas, Edward

AU - Nevin, Mary

AU - Hixon, Jenny

AU - Brees, Abbi

AU - Gonsalves, Zenobia

AU - Zagaja, Virginia

AU - Kustwin, Jennifer

AU - Xu, Ben

AU - Matthews, Thomas

AU - Robinson, Lucius

AU - Singh, Noopur

AU - Busk, Michael

AU - Puntenney, Paula

AU - Busk, Nancy

AU - Hutchins, Janet

AU - Happel, Kyle I.

AU - Tejedor, Richard S.

AU - Sandi, Marie C.

AU - Romaine, Connie

AU - Burzynski, Callan J.

AU - Antoine, Arleen

AU - Cruse, Jonathan

AU - Katial, Rohit

AU - Hoyte, Flavia

AU - Searing, Dan

AU - Larson, Trisha

AU - Phillips, Nina

AU - Currier, Holly

AU - Blake, Kathryn

AU - Lang, Jason

AU - Mougey, Edward

AU - Archer, Nancy

AU - Seymour, Deanna

AU - Warde, Mary

AU - Cohen, Rubin

AU - Santiago, Maria

AU - Ramdeo, Ramona

AU - Dreyfus, Maureen

AU - Dixon, Anne E.

AU - Kaminsky, David A.

AU - Lahiri, Thomas

AU - Burns, Stephanie M.

AU - Mastronarde, John

AU - Parsons, Jonathan

AU - Drake, Janice

AU - Santiago, Joseph

AU - Cosmar, David

AU - Compton, Rachael A.

AU - Krishnan, Sankaran

AU - Boyer, Joseph

AU - Banquet, Agnes

AU - De La Riva-Velasco, Elizabeth

AU - Lowenthal, Diana

AU - Gjonaj, Suzette

AU - Kim, Y. Cathy

AU - Traeger, Nadav

AU - Welter, John

AU - Scharbach, Marilyn

AU - Siegel, Subhadra

AU - Gherson, Ingrid

AU - Monchil, Lisa

AU - Formisano, Tara M.

AU - Williams, Jessica

AU - Castro, Mario

AU - Bacharier, Leonard

AU - Sumino, Kaharu

AU - Tarsi, Jaime J.

AU - Patterson, Brenda

AU - Montgomery, Terri

AU - Slavin, Raymond G.

AU - Chassaing, Deborah Keaney

AU - Gerald, Lynn B.

AU - Goodwin, James L.

AU - Brown, Mark A.

AU - Knox, Kenneth S.

AU - Carr, Tara F.

AU - Berry, Cristine E.

AU - Martinez, Fernando D.

AU - Morgan, Wayne J.

AU - Daines, Cori L.

AU - Daines, Michael O.

AU - Grad, Roni

AU - Ezmigna, Dima

AU - Vasquez, Monica M.

AU - Wences, Jesus A.

AU - Lopez, Silvia S.

AU - Priefert, Janette C.

AU - Varela, Monica T.

AU - Weese, Rosemary

AU - Chee, Katherine

AU - Paco, Andrea

AU - Wanner, Adam

AU - Lockey, Richard

AU - Schmid, Andreas

AU - Campos, Michael

AU - King, Monroe

AU - Mendes, Eliana S.

AU - Rebolledo, Patricia D.

AU - Arana, Johana

AU - Cadet, Lilian

AU - McCrery, Rebecca

AU - Croker, Sarah M.

AU - McCullough, Shirley

AU - Salzman, Gary

AU - Abdeljalil, Asem

AU - Pyszczynski, Dennis

AU - Bhat, Abid

AU - Haney, Patti

AU - Wasserman, Stephen

AU - Ramsdell, Joe

AU - Soler, Xavier

AU - Kinninger, Katie

AU - Ferguson, Paul

AU - Martineau, Amber

AU - Ung, Samang

AU - Greene, Tonya

AU - Teague, W. Gerald

AU - Wavell, Kristin W.

AU - Wolf, Donna

AU - Thompson-Batt, Denise

AU - Bailey, William C.

AU - Anthonisen, Nicholas

AU - Yasin, Razan

AU - Amend-Libercci, Debra

AU - Adler, Anna

AU - Casper, Anne Shanklin

AU - Daniel, Marie

AU - Hart, Adante

AU - Lears, Andrea

AU - Leatherman, Gwen

AU - Nowakowski, Deborah

AU - Prusakowski, Nancy

AU - Rayapudi, Sobharani

AU - Rea, Alexis

AU - Saams, Joy

AU - Shade, David

AU - Thurman, April

AU - Wei, Christine

AU - Newcomer, Alicia

AU - Bime, Christian

AU - Brown, Ellen

AU - Levine, Charlene

AU - Roettger, Suzanna

AU - Wu, Nienchun

AU - Shen, Weijiang

AU - Wang, Lucy

AU - Ukken, Johnson

AU - Lazarus, Stephen C.

AU - Calhoun, William

AU - Cloutier, Michelle

AU - Kahrilas, Peter

AU - McWilliams, Bennie

AU - Rogatko, Andre

AU - Sorkness, Christine

AU - Sicherer, Scott

AU - Weinmann, Gail

AU - Freemer, Michelle

AU - Smith, Robert

AU - Taggart, Virginia

AU - Webber, Lisa

AU - Zheng, Gang

AU - Lancet, Elizabeth

AU - Edelman, Norman H.

AU - Rappaport, Susan

PY - 2015/5/26

Y1 - 2015/5/26

N2 - 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 100mg 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 measurewas change in forced expiratory volume in the first second (FEV1) 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 FEV1 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 < .001) in participants receiving the supplement. 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.

AB - 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 100mg 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 measurewas change in forced expiratory volume in the first second (FEV1) 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 FEV1 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 < .001) in participants receiving the supplement. 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.

UR - http://www.scopus.com/inward/record.url?scp=84929890918&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84929890918&partnerID=8YFLogxK

U2 - 10.1001/jama.2015.5024

DO - 10.1001/jama.2015.5024

M3 - Article

C2 - 26010632

AN - SCOPUS:84929890918

VL - 313

SP - 2033

EP - 2043

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

IS - 20

ER -