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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Mashhad University of Medical Sciences
2020
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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. |
format | Online Article Text |
id | pubmed-7508321 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Mashhad University of Medical Sciences |
record_format | MEDLINE/PubMed |
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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