{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,15]],"date-time":"2026-08-15T05:21:32Z","timestamp":1786771292457,"version":"build-2736575974"},"reference-count":64,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2017,7,7]],"date-time":"2017-07-07T00:00:00Z","timestamp":1499385600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001776","name":"University of Western Sydney","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001776","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Phytotherapy Research"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:p>Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first\u2010line intervention; however, there are barriers to success for this form of self\u2010care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained <jats:italic>Cinnamomum verum<\/jats:italic>, <jats:italic>Glycyrrhiza glabra<\/jats:italic>, <jats:italic>Hypericum perforatum<\/jats:italic> and <jats:italic>Paeonia lactiflora<\/jats:italic>. Tablet 2 contained <jats:italic>Tribulus terrestris<\/jats:italic>. The primary outcome was oligomenorrhoea\/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty\u2010two women gave their consent. At 3\u00a0months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3\u201342.6, <jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.01) compared with controls, estimated as a large effect (\u03b7<jats:sub>p<\/jats:sub><jats:sup>2<\/jats:sup>\u00a0=\u00a00.11). Other significant improvements were found for body mass index (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.01); insulin (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.02) and luteinizing hormone (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.04); blood pressure (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.01); quality of life (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.01); depression, anxiety and stress (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.01); and pregnancy rates (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.01). This trial provides evidence of improved effectiveness and safety for lifestyle intervention when combined with herbal medicines in women with PCOS. \u00a9 2017 The Authors. Phytotherapy Research published by John Wiley &amp; Sons Ltd<\/jats:p>","DOI":"10.1002\/ptr.5858","type":"journal-article","created":{"date-parts":[[2017,7,7]],"date-time":"2017-07-07T12:03:21Z","timestamp":1499429001000},"page":"1330-1340","source":"Crossref","is-referenced-by-count":84,"title":["Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (<scp>PCOS<\/scp>): A Randomized Controlled Trial"],"prefix":"10.1002","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6721-472X","authenticated-orcid":false,"given":"Susan","family":"Arentz","sequence":"first","affiliation":[{"name":"National Institute of Complementary Medicine Western Sydney University  Building 5, Campbelltown Campus, Locked Bag 1797 Penrith NSW 2751 Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline A.","family":"Smith","sequence":"additional","affiliation":[{"name":"National Institute of Complementary Medicine Western Sydney University  Building 5, Campbelltown Campus, Locked Bag 1797 Penrith NSW 2751 Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Abbott","sequence":"additional","affiliation":[{"name":"School of Women's and Children's Health, Level 1, Women's Health Institute, Royal Hospital for Women University of New South Wales  Barker Street Randwick NSW 2031 Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Fahey","sequence":"additional","affiliation":[{"name":"School of Science and Health Western Sydney University  Building 24, Locked Bag 1797 Penrith NSW 2751 Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Birinder S.","family":"Cheema","sequence":"additional","affiliation":[{"name":"National Institute of Complementary Medicine Western Sydney University  Building 5, Campbelltown Campus, Locked Bag 1797 Penrith NSW 2751 Australia"},{"name":"School of Science and Health Western Sydney University  Building 24, Locked Bag 1797 Penrith NSW 2751 Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Bensoussan","sequence":"additional","affiliation":[{"name":"National Institute of Complementary Medicine Western Sydney University  Building 5, Campbelltown Campus, Locked Bag 1797 Penrith NSW 2751 Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,7,7]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"AAPCOS(2011).Evidence\u2010based guideline for the assessment and management of polycystic ovary syndrome. NHMRC. Melbourne Australia Jean Hailes Foundation for Women's Health on behalf of the PCOS Australian Alliance."},{"key":"e_1_2_9_3_1","volume-title":"Notice for Guidance on Clinical Safety Data Management: Definitions and Standards for Expidited Reporting (CPMP\/ICH\/377\/95) Department of Health and Aging","author":"Therapeutic Goods Administration","year":"2000"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6882-14-511"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6882-14-472"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.steroids.2004.09.005"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2006.10.013"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/ptr.2362"},{"key":"e_1_2_9_9_1","unstructured":"Australian government report(2005).A healthy and active Australia. Health Department. Canberra Australia. 2014: Government document."},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2005-0628"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pdi.606"},{"key":"e_1_2_9_12_1","volume-title":"Clinical Applications of Ayurvedic and Chinese Herbs: Monographs for the Western Herbal Practitioner","author":"Bone K","year":"1996"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsgi.2005.10.006"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/001316447303300111"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD005552.pub2"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.83.6.1976"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2002-021528"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2003.10.004"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/der396"},{"key":"e_1_2_9_20_1","unstructured":"FertilityFriend. (2014). \u201cFertility friend.\u201d Retrieved 8 July 2014 2014 fromhttps:\/\/www.fertilityfriend.com\/."},{"key":"e_1_2_9_21_1","first-page":"331","article-title":"Intention to treat in clinical trials","author":"Fisher L","year":"1990","journal-title":"Statistical Issues in Pharmaceutical Drug Development."},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-7-7"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.160.2.152"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/ptr.2900"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-06-0938"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1097\/HJH.0b013e328346a5af"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2004.02.104"},{"key":"e_1_2_9_28_1","unstructured":"IBM(2013).SPSS version 21:statistics software"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/ptr.5591"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2012.12.025"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1210\/jcem.85.7.6661"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2014.05.009"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-011709"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa063971"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2006.12.025"},{"key":"e_1_2_9_36_1","volume-title":"St John's Wort for Major Depression","author":"Linde K.","year":"2008"},{"key":"e_1_2_9_37_1","volume-title":"Manual for the Depressive, Anxiety, Stress Scales","author":"Lovibond S. H.","year":"1995"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/dep399"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.3945\/ajcn.2010.29261"},{"key":"e_1_2_9_40_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsams.2015.03.004"},{"key":"e_1_2_9_41_1","volume-title":"Principles and Practices of Phytotherapy Modern Herbal Medicine","author":"Mills S","year":"2000"},{"key":"e_1_2_9_42_1","first-page":"CD007506","article-title":"Lifestyle changes in women with polycystic ovary syndrome","volume":"2","author":"Moran LJ","year":"2011","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_9_43_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jand.2012.11.018"},{"key":"e_1_2_9_44_1","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/det256"},{"issue":"9","key":"e_1_2_9_45_1","first-page":"3161","article-title":"Endocrine and metabolic effects of metformin versus ethinyl estradiol\u2010cyproterone acetate in obese women with polycystic ovary syndrome: a randomized study 1","volume":"85","author":"Morin\u2010Papunen LC","year":"2000","journal-title":"The Journal of Clinical Endocrinology and Metabolism"},{"key":"e_1_2_9_46_1","unstructured":"NPAAC(2013).Guidelines for approved pathology collection centres (requirements for medical pathology specimen collection) D. o. H. National Pathology Acreditation Advisory Council Australian Federal Government."},{"key":"e_1_2_9_47_1","first-page":"1694","article-title":"Dietary intervention versus metformin to improve the reproductive outcome in women with polycystic ovary syndrome. A prospective comparative study","author":"Qublan HS","year":"2007","journal-title":"Saudi Medical Journal"},{"key":"e_1_2_9_48_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)17670-8"},{"key":"e_1_2_9_49_1","volume-title":"Clinical Naturopathy: An Evidence\u2010based Guide to Practice","author":"Sarris J","year":"2010"},{"key":"e_1_2_9_50_1","doi-asserted-by":"publisher","DOI":"10.3109\/09513590.2014.895983"},{"key":"e_1_2_9_51_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6874-1-3"},{"key":"e_1_2_9_52_1","unstructured":"Singh S. Kooy C. Der Kroy F. (2013).Chemical characterisation of a herbal formulation for the treatment of polycystic ovary syndrome. Academic thesis (Bachelor of Medical Science Honours 1A) University of Western Sydney."},{"issue":"2","key":"e_1_2_9_53_1","first-page":"69","article-title":"Effect of TJ\u201068 (shakuyaku\u2010kanzo\u2010to) on polycystic ovarian disease","volume":"39","author":"Takahashi K","year":"1994","journal-title":"International Journal of Fertility and Menopausal Studies"},{"key":"e_1_2_9_54_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD003053.pub5"},{"key":"e_1_2_9_55_1","doi-asserted-by":"publisher","DOI":"10.1186\/1741-7015-8-41"},{"key":"e_1_2_9_56_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1467-789X.2005.00166.x"},{"key":"e_1_2_9_57_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2008-0751"},{"key":"e_1_2_9_58_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.319.7216.1050"},{"key":"e_1_2_9_59_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2006.11.082"},{"key":"e_1_2_9_60_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1748-0361.2010.00348.x"},{"key":"e_1_2_9_61_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39465.451748.AD"},{"issue":"7","key":"e_1_2_9_62_1","first-page":"939","article-title":"Effect of traditional herbal medicine on serum testosterone levels and its induction of regular ovulation in hyperandrogenic and oligomenorrheic women","volume":"34","author":"Yaginuma TI","year":"1982","journal-title":"Nippon Sanka Fujinka Gakkai Zasshi"},{"key":"e_1_2_9_63_1","first-page":"CD007535","article-title":"Chinese herbal medicine for subfertile women with polycystic ovarian syndrome","volume":"9","author":"Zhang J","year":"2010","journal-title":"The Cochrane Database Of Systematic Reviews"},{"key":"e_1_2_9_64_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD007535.pub2"},{"key":"e_1_2_9_65_1","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.a2390","article-title":"Improving the reporting of pragmatic trials: an extension of the CONSORT statement","volume":"337","author":"Zwarenstein M","year":"2008","journal-title":"BMJ"}],"container-title":["Phytotherapy Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fptr.5858","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ptr.5858","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,5]],"date-time":"2023-10-05T02:50:17Z","timestamp":1696474217000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ptr.5858"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,7,7]]},"references-count":64,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2017,9]]}},"alternative-id":["10.1002\/ptr.5858"],"URL":"https:\/\/doi.org\/10.1002\/ptr.5858","archive":["Portico"],"relation":{},"ISSN":["0951-418X","1099-1573"],"issn-type":[{"value":"0951-418X","type":"print"},{"value":"1099-1573","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,7,7]]}}}