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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 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 (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.

Links

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  • Authors+Show Affiliations

    ,

    Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

    ,

    Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

    ,

    Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.

    ,

    Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.

    ,

    Nemours Children's Clinic, Jacksonville, Florida.

    ,

    Department of Medicine, University of Vermont, Burlington.

    ,

    Department of Pediatrics, New York Medical College, Valhalla.

    ,

    Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.

    Source

    JAMA 313:20 2015 May 26 pg 2033-43

    MeSH

    Adolescent
    Adult
    Asthma
    Child
    Dietary Supplements
    Double-Blind Method
    Female
    Forced Expiratory Volume
    Genistein
    Humans
    Isoflavones
    Lung
    Male
    Middle Aged
    Phytotherapy
    Plant Extracts
    Soybean Proteins
    Young Adult

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    26010632

    Citation

    Smith, Lewis J., et al. "Effect of a Soy Isoflavone Supplement On Lung Function and Clinical Outcomes in Patients With Poorly Controlled Asthma: a Randomized Clinical Trial." JAMA, vol. 313, no. 20, 2015, pp. 2033-43.
    Smith LJ, Kalhan R, Wise RA, et al. Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: a randomized clinical trial. JAMA. 2015;313(20):2033-43.
    Smith, L. J., Kalhan, R., Wise, R. A., Sugar, E. A., Lima, J. J., Irvin, C. G., ... Holbrook, J. T. (2015). Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: a randomized clinical trial. JAMA, 313(20), pp. 2033-43. doi:10.1001/jama.2015.5024.
    Smith LJ, et al. Effect of a Soy Isoflavone Supplement On Lung Function and Clinical Outcomes in Patients With Poorly Controlled Asthma: a Randomized Clinical Trial. JAMA. 2015 May 26;313(20):2033-43. PubMed PMID: 26010632.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: 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 - ,, PY - 2015/5/27/entrez PY - 2015/5/27/pubmed PY - 2015/5/30/medline SP - 2033 EP - 43 JF - JAMA JO - JAMA VL - 313 IS - 20 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 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 (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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/26010632/Effect_of_a_soy_isoflavone_supplement_on_lung_function_and_clinical_outcomes_in_patients_with_poorly_controlled_asthma:_a_randomized_clinical_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2015.5024 DB - PRIME DP - Unbound Medicine ER -