Effect of a proprietary Magnolia and Phellodendronextract on stress levels in healthy women: a pilot, double-blind, placebo-controlled clinical trial

Abstract Background Recent research has established correlations between stress, anxiety, insomnia and excess body weight and these correlations have significant implications for health. This study measured the effects of a proprietary blend of extracts of Magnolia officinalis and Phellodendron amur...

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Bibliographic Details
Published in:Nutrition journal 2008-04, Vol.7 (1), Article 11
Main Authors: Kalman, Douglas S, Feldman, Samantha, Feldman, Robert, Schwartz, Howard I, Krieger, Diane R, Garrison, Robert
Format: Article
Language:English
Subjects:
Anxiety
Care and treatment
Dietary supplements
Health aspects
Insomnia
Magnolia
Materia medica, Vegetable
Menopause
Plant extracts
Rutaceae
Stress (Psychology)
Testing
Women patients
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Summary:Abstract Background Recent research has established correlations between stress, anxiety, insomnia and excess body weight and these correlations have significant implications for health. This study measured the effects of a proprietary blend of extracts of Magnolia officinalis and Phellodendron amurense ( Relora ® ) on anxiety, stress and sleep in healthy premenopausal women. Methods This randomized, parallel, placebo controlled clinical stud y was conducted with healthy, overweight (BMI 25 to 34.9), premenopausal female adults, between the ages of 20 and 50 years, who typically eat more in response to stressful situations and scores above the national mean for women on self-reporting anxiety. The intervention w as Relora (250 mg capsules) or identical placebo 3 times daily for 6 weeks. Anxiety as measured by the Spielberger STATE-TRAIT questionnaires, salivary amylase and cortisol levels, Likert Scales/Visual Analog Scores for sleep quality and latency, appetite, and clinical markers of safety. The study was conducted by Miami Research Associates, a clinical research organization in Miami, FL. Results The intent-to-treat population consisted of 40 subjects with 26 participants completing the study. There were no significant adverse events. Relora was effective, in comparison to placebo, in reducing temporary, transitory anxiety as measured by the Spielberger STATE anxiety questionnaire. It was not effective in reducing long-standing feelings of anxiety or depression as measured using the Spielberger TRAIT questionnaire. Other assessments conducted in this study including salivary cortisol and amylase levels, appetite, body morphology and sleep quality/latency were not significantly changed by Relora in comparison to placebo. Conclusion This pilot study indicates that Relora may offer some relief for premenopausal women experiencing mild transitory anxiety. There were no safety concerns or significant adverse events observed in this study.
ISSN:1475-2891
1475-2891
DOI:10.1186/1475-2891-7-11