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Comparison between Golnar product and placebo in heavy menstrual bleeding: A double-blind randomized clinical trial

OBJECTIVE: Golnar product is a poly herbal formulation advised by Persian medicine to control heavy menstrual bleeding (HMB). This study was conducted to compare the efficacy of this product with placebo in patients with HMB. MATERIALS AND METHODS: In this double-blind randomized clinical trial, 100...

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Autores principales: Yousefi, Fatemeh, Kashanian, Maryam, Nazem, Ismail, Bioos, Soodabeh, Sadeghpour, Omid, Aliasl, Jale, Hashem-Dabaghian, Fataneh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mashhad University of Medical Sciences 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7508321/
https://www.ncbi.nlm.nih.gov/pubmed/32995330
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author Yousefi, Fatemeh
Kashanian, Maryam
Nazem, Ismail
Bioos, Soodabeh
Sadeghpour, Omid
Aliasl, Jale
Hashem-Dabaghian, Fataneh
author_facet Yousefi, Fatemeh
Kashanian, Maryam
Nazem, Ismail
Bioos, Soodabeh
Sadeghpour, Omid
Aliasl, Jale
Hashem-Dabaghian, Fataneh
author_sort Yousefi, Fatemeh
collection PubMed
description OBJECTIVE: Golnar product is a poly herbal formulation advised by Persian medicine to control heavy menstrual bleeding (HMB). This study was conducted to compare the efficacy of this product with placebo in patients with HMB. MATERIALS AND METHODS: In this double-blind randomized clinical trial, 100 women with HMB were randomly assigned into two groups. The patients in the Golnar group (n=50) took Golnar capsules 500 mg three times a day for the first 7 days of menstrual cycle for three cycles. The placebo group (n=50), took placebo capsules in the same manner. The duration and volume of bleeding (using Pictorial Blood Loss Assessment Chart: PBAC), quality of life (using Menorrhagia Questionnaire: MQ), and hemoglobin level (Hb) were measured 3 months after initiation of the intervention. RESULTS: Eighty-two patients (43 in the Golnar and 39 in the placebo groups) completed the 3-month intervention period. In the Golnar group, PBAC score decreased from 201.62 (144.11) to 109.44 (69.57) (p<0.001) and MQ score improved significantly from 0.58 (0.27) to 0.39 (0.31) (p<0.001), while changes in placebo group were not significant. Hb increased in the Golnar group from 12.78±0.98 to 12.97±0.95 mg/dl (p=0.048) and decreased in the placebo group from 12.94±1.08 to 12.44±1.01mg/dl (p<0.001). No significant adverse effects were found in the Golnar group. CONCLUSION: The Golnar product can be considered an effective intervention for patients with HMB. Assessment of side-effects is suggested to be performed in a larger sample. In addition, a comparison between the Golnar product and nonsteroidal anti-inflammatory drugs could be valuable.
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spelling pubmed-75083212020-09-28 Comparison between Golnar product and placebo in heavy menstrual bleeding: A double-blind randomized clinical trial Yousefi, Fatemeh Kashanian, Maryam Nazem, Ismail Bioos, Soodabeh Sadeghpour, Omid Aliasl, Jale Hashem-Dabaghian, Fataneh Avicenna J Phytomed Original Research Article OBJECTIVE: Golnar product is a poly herbal formulation advised by Persian medicine to control heavy menstrual bleeding (HMB). This study was conducted to compare the efficacy of this product with placebo in patients with HMB. MATERIALS AND METHODS: In this double-blind randomized clinical trial, 100 women with HMB were randomly assigned into two groups. The patients in the Golnar group (n=50) took Golnar capsules 500 mg three times a day for the first 7 days of menstrual cycle for three cycles. The placebo group (n=50), took placebo capsules in the same manner. The duration and volume of bleeding (using Pictorial Blood Loss Assessment Chart: PBAC), quality of life (using Menorrhagia Questionnaire: MQ), and hemoglobin level (Hb) were measured 3 months after initiation of the intervention. RESULTS: Eighty-two patients (43 in the Golnar and 39 in the placebo groups) completed the 3-month intervention period. In the Golnar group, PBAC score decreased from 201.62 (144.11) to 109.44 (69.57) (p<0.001) and MQ score improved significantly from 0.58 (0.27) to 0.39 (0.31) (p<0.001), while changes in placebo group were not significant. Hb increased in the Golnar group from 12.78±0.98 to 12.97±0.95 mg/dl (p=0.048) and decreased in the placebo group from 12.94±1.08 to 12.44±1.01mg/dl (p<0.001). No significant adverse effects were found in the Golnar group. CONCLUSION: The Golnar product can be considered an effective intervention for patients with HMB. Assessment of side-effects is suggested to be performed in a larger sample. In addition, a comparison between the Golnar product and nonsteroidal anti-inflammatory drugs could be valuable. Mashhad University of Medical Sciences 2020 /pmc/articles/PMC7508321/ /pubmed/32995330 Text en This is an Open Access article distributed under the terms of the Creative Commons Attribution License, (http://creativecommons.org/licenses/by/3.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Research Article
Yousefi, Fatemeh
Kashanian, Maryam
Nazem, Ismail
Bioos, Soodabeh
Sadeghpour, Omid
Aliasl, Jale
Hashem-Dabaghian, Fataneh
Comparison between Golnar product and placebo in heavy menstrual bleeding: A double-blind randomized clinical trial
title Comparison between Golnar product and placebo in heavy menstrual bleeding: A double-blind randomized clinical trial
title_full Comparison between Golnar product and placebo in heavy menstrual bleeding: A double-blind randomized clinical trial
title_fullStr Comparison between Golnar product and placebo in heavy menstrual bleeding: A double-blind randomized clinical trial
title_full_unstemmed Comparison between Golnar product and placebo in heavy menstrual bleeding: A double-blind randomized clinical trial
title_short Comparison between Golnar product and placebo in heavy menstrual bleeding: A double-blind randomized clinical trial
title_sort comparison between golnar product and placebo in heavy menstrual bleeding: a double-blind randomized clinical trial
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7508321/
https://www.ncbi.nlm.nih.gov/pubmed/32995330
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