Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial
Background: Berberine is a poorly absorbed natural alkaloid widely used as nutraceutical to counteract diarrhoea and to lower cholesterol and hyperglycaemia. It has also been reported to reduce signs and symptoms of polycystic ovary syndrome (PCOS).Objective: To explore, through a multi-centric, ran...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-11-01
|
| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1269605/full |
| _version_ | 1797488516594139136 |
|---|---|
| author | Francesco Di Pierro Francesco Di Pierro Ruqqia Sultana Amna Zia Eusaph Saida Abrar Mahroo Bugti Fauzia Afridi Umer Farooq Somia Iqtadar Fareeha Ghauri Syeda Makhduma Shazia Nourin Ayesha Kanwal Aasiya Bano Ali Akbar Bugti Shah Mureed Ayesha Ghazal Romana Irshad Martino Recchia Alexander Bertuccioli Pietro Putignano Antonella Riva Luigina Guasti Nicola Zerbinati Amjad Khan Amjad Khan |
| author_facet | Francesco Di Pierro Francesco Di Pierro Ruqqia Sultana Amna Zia Eusaph Saida Abrar Mahroo Bugti Fauzia Afridi Umer Farooq Somia Iqtadar Fareeha Ghauri Syeda Makhduma Shazia Nourin Ayesha Kanwal Aasiya Bano Ali Akbar Bugti Shah Mureed Ayesha Ghazal Romana Irshad Martino Recchia Alexander Bertuccioli Pietro Putignano Antonella Riva Luigina Guasti Nicola Zerbinati Amjad Khan Amjad Khan |
| author_sort | Francesco Di Pierro |
| collection | DOAJ |
| description | Background: Berberine is a poorly absorbed natural alkaloid widely used as nutraceutical to counteract diarrhoea and to lower cholesterol and hyperglycaemia. It has also been reported to reduce signs and symptoms of polycystic ovary syndrome (PCOS).Objective: To explore, through a multi-centric, randomized, controlled and prospective study, the possible role played by a form berberine that is more easily absorbed (Berberine Phytosome®, BP) in 130 Pakistani women with a diagnosis of PCOS and fertility problems due to menstrual and ovary abnormalities.Results: Ninety days of supplementation with BP, administered at 550 mg x2/die, determined (i) resumption of regular menstruation in about 70% of women (versus 16% in the control group; p < 0.0001), (ii) normalization of the ovaries anatomy in more than 60% of women (versus 13% in the control group; p < 0.0001), (iii) acne improvement in 50% of women (versus 16% in the control group; p = 0.0409) and (iv) hirsutism reduction in 14% of women (versus 0% in the control group; p = 0.0152). The metabolic and the hormonal profiles of the women in the two groups did not significantly differentiate at the end of the study. BP was well-tolerated and no specific side-effects were registered. Respectively after one, two and 8 years of trying, three women supplemented with BP became and are currently pregnant.Conclusion: Our study showed the positive effects of BP supplementation in women with PCOS and confirmed the high safety profile of this nutraceutical.Clinical Trial Registration:https://clinicaltrials.gov/, identifier NCT05480670 |
| first_indexed | 2024-03-10T00:03:19Z |
| format | Article |
| id | doaj.art-7f24f793f66345a3a538c6f88c93310e |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-10T00:03:19Z |
| publishDate | 2023-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-7f24f793f66345a3a538c6f88c93310e2023-11-23T16:12:34ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-11-011410.3389/fphar.2023.12696051269605Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trialFrancesco Di Pierro0Francesco Di Pierro1Ruqqia Sultana2Amna Zia Eusaph3Saida Abrar4Mahroo Bugti5Fauzia Afridi6Umer Farooq7Somia Iqtadar8Fareeha Ghauri9Syeda Makhduma10Shazia Nourin11Ayesha Kanwal12Aasiya Bano13Ali Akbar Bugti14Shah Mureed15Ayesha Ghazal16Romana Irshad17Martino Recchia18Alexander Bertuccioli19Pietro Putignano20Antonella Riva21Luigina Guasti22Nicola Zerbinati23Amjad Khan24Amjad Khan25Scientific and Research Department, Velleja Research, Milan, ItalyDepartment of Medicine and Surgery, University of Insubria, Varese, ItalyDepartment of Gynaecology and Obstetrics, Ayub Teaching Hospital, Abbottabad, PakistanDepartment of Gynaecology and Obstetrics, Sir Ganga Ram Hospital, Fatima Jinnah Women University, Rawalpindi, PakistanDepartment of Gynaecology and Obstetrics, Lady Reading Hospital, Peshawar, PakistanDepartment of Gynaecology and Obstetrics, Bolan Medical Complex Hospital, Quetta, PakistanDepartment of Gynaecology and Obstetrics, Khyber Teaching Hospital, Peshawar, PakistanDepartment of Community Medicine, Ayub Teaching Hospital, Abbottabad, PakistanDepartment of Medicine, King Edward Medical University, Lahore, PakistanDepartment of Gynaecology and Obstetrics, Lady Reading Hospital, Peshawar, PakistanDepartment of Gynaecology and Obstetrics, Lady Reading Hospital, Peshawar, PakistanDepartment of Gynaecology and Obstetrics, Lady Reading Hospital, Peshawar, PakistanDepartment of Gynaecology and Obstetrics, Lady Reading Hospital, Peshawar, Pakistan0PEOC, Department of Health, Quetta, Balochistan, Pakistan1Department of General Surgery, Bolan Medical Complex Hospital, Quetta, Pakistan2Department of Paediatrics, Bolan Medical Complex Hospital, Quetta, Pakistan3Department of Microbiology, University of Health Sciences, Lahore, Pakistan4Department of Pathology, Ayub Teaching Hospital, Abbottabad, Pakistan5Unit of Clinical Epidemiology and Biostatistics, Mario Negri Institute Alumni Association (MNIAA), Milan, Italy6Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy7SP Diabetic Outpatient Clinic, Monza, Italy8Indena S.p.A, Milan, ItalyDepartment of Medicine and Surgery, University of Insubria, Varese, ItalyDepartment of Medicine and Surgery, University of Insubria, Varese, Italy9Nuffield Division of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom0Department of Biochemistry, Liaquat University of Medical and Health Sciences, Jamshoro, PakistanBackground: Berberine is a poorly absorbed natural alkaloid widely used as nutraceutical to counteract diarrhoea and to lower cholesterol and hyperglycaemia. It has also been reported to reduce signs and symptoms of polycystic ovary syndrome (PCOS).Objective: To explore, through a multi-centric, randomized, controlled and prospective study, the possible role played by a form berberine that is more easily absorbed (Berberine Phytosome®, BP) in 130 Pakistani women with a diagnosis of PCOS and fertility problems due to menstrual and ovary abnormalities.Results: Ninety days of supplementation with BP, administered at 550 mg x2/die, determined (i) resumption of regular menstruation in about 70% of women (versus 16% in the control group; p < 0.0001), (ii) normalization of the ovaries anatomy in more than 60% of women (versus 13% in the control group; p < 0.0001), (iii) acne improvement in 50% of women (versus 16% in the control group; p = 0.0409) and (iv) hirsutism reduction in 14% of women (versus 0% in the control group; p = 0.0152). The metabolic and the hormonal profiles of the women in the two groups did not significantly differentiate at the end of the study. BP was well-tolerated and no specific side-effects were registered. Respectively after one, two and 8 years of trying, three women supplemented with BP became and are currently pregnant.Conclusion: Our study showed the positive effects of BP supplementation in women with PCOS and confirmed the high safety profile of this nutraceutical.Clinical Trial Registration:https://clinicaltrials.gov/, identifier NCT05480670https://www.frontiersin.org/articles/10.3389/fphar.2023.1269605/fullberbevisphytosomeinsulinglucosecholesteroltestosterone |
| spellingShingle | Francesco Di Pierro Francesco Di Pierro Ruqqia Sultana Amna Zia Eusaph Saida Abrar Mahroo Bugti Fauzia Afridi Umer Farooq Somia Iqtadar Fareeha Ghauri Syeda Makhduma Shazia Nourin Ayesha Kanwal Aasiya Bano Ali Akbar Bugti Shah Mureed Ayesha Ghazal Romana Irshad Martino Recchia Alexander Bertuccioli Pietro Putignano Antonella Riva Luigina Guasti Nicola Zerbinati Amjad Khan Amjad Khan Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial Frontiers in Pharmacology berbevis phytosome insulin glucose cholesterol testosterone |
| title | Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial |
| title_full | Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial |
| title_fullStr | Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial |
| title_full_unstemmed | Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial |
| title_short | Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial |
| title_sort | effect of berberine phytosome on reproductive dermatologic and metabolic characteristics in women with polycystic ovary syndrome a controlled randomized multi centric open label clinical trial |
| topic | berbevis phytosome insulin glucose cholesterol testosterone |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1269605/full |
| work_keys_str_mv | AT francescodipierro effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT francescodipierro effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT ruqqiasultana effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT amnaziaeusaph effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT saidaabrar effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT mahroobugti effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT fauziaafridi effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT umerfarooq effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT somiaiqtadar effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT fareehaghauri effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT syedamakhduma effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT shazianourin effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT ayeshakanwal effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT aasiyabano effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT aliakbarbugti effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT shahmureed effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT ayeshaghazal effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT romanairshad effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT martinorecchia effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT alexanderbertuccioli effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT pietroputignano effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT antonellariva effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT luiginaguasti effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT nicolazerbinati effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT amjadkhan effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial AT amjadkhan effectofberberinephytosomeonreproductivedermatologicandmetaboliccharacteristicsinwomenwithpolycysticovarysyndromeacontrolledrandomizedmulticentricopenlabelclinicaltrial |