A double-blind, placebo-controlled trial of fennel (Foeniculum vulgare) on menopausal symptoms: A high placebo response

Ghazanfarpour, M. and Najafi, M. N. and Sharghi, N. B. and Mousavi, M. S. and Babakhanian, M. and Rakhshandeh, H. (2018) A double-blind, placebo-controlled trial of fennel (Foeniculum vulgare) on menopausal symptoms: A high placebo response. Journal of the Turkish German Gynecology Association, 19 (3). pp. 122-127.

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Abstract

Objective: The present study aimed to evaluate the effects of oral fennel on menopausal symptoms. Material and Methods: This double-blind, randomized, placebo-controlled trial was conducted on 50 postmenopausal women in Mashhad (Iran). Patients were randomly divided into two groups of fennel (n=25) and placebo (n=25). Measurements were performed at baseline and after three months using the Menopause-Specific Quality of Life questionnaire. Results: Both placebo and treatment groups revealed significant improvements in the hot flush score (p<0.001 for fennel and p<0.01 for placebo), night sweats (p=0.007 for fennel and p<0.01 for placebo), sweating (p=0.002 for fennel and p<0.01 for placebo), symptoms of anxiety (p=0.05 for fennel and p=0.001 for placebo), feeling depressed (p<0.01 for fennel and p=0.006 for placebo), and impatience with other people (p<0.01 for fennel and p=0.003 for placebo). There were no significant differences in any menopausal symptoms between the fennel and placebo groups, except for coughing and sneezing when urinating (p=0.03). Conclusion: The failure to indicate a significant effect may have been caused by a high placebo response. It is suggested that future trials should include a placebo run-in phase or design a sequential, parallel study with larger sample sizes to mitigate the placebo effect. © 2018 by the Turkish-German Gynecological Education and Research Foundation.

Item Type: Article
Additional Information: Export Date: 16 February 2020 Correspondence Address: Rakhshandeh, H.; Pharmacological Research Center of Medicinal Plants, Mashhad University of Medical SciencesIran; email: RakhshandehH@mums.ac.ir
Uncontrolled Keywords: Foeniculum vulgare Menopausal symptoms Menopause-specific quality of life Post menopause Quality of life agents acting on the genital system herbaceous agent placebo adult anxiety Article clinical article controlled study coughing depression double blind procedure evening dosage female fennel hot flush human Iran menopausal syndrome Menopause Specific Quality of Life questionnaire morning dosage night sweat postmenopause quality of life assessment randomized controlled trial sneezing sweating
Subjects: WP Gynecology
QV pharmacology
Divisions: Mashhad University of Medical Sciences
Depositing User: lib2 lib2 lib2
Date Deposited: 20 May 2020 04:15
Last Modified: 20 May 2020 04:15
URI: http://eprints.mums.ac.ir/id/eprint/17295

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