Effectiveness of ethinyl oestradiol /cyproterone acetate and ethinyl oestradiol/ desogestrel with or without low-dose metformin on perceived health-related quality of life in hirsute women with polycystic ovary disease: A randomised, double-blind, placebo-controlled study

Main Article Content

Sanjeewani Fonseka
B Subhani
V Alahakoon
CN Wijeyaratne
IB Gawarammana
NS Kalupahana
N Ratnatunga
S Rosairo
PVR Kumarasiri

Abstract

Background: Polycystic ovary disease (PCOD) is an endocrine disorder. It leads to menstrual disturbances, infertility, obesity and dermatological manifestations such as hirsutism and acne which leads to impaired health-related quality of life (QOL).


Aims: To evaluate the perceived health related QOL in patients with PCOD treated with ethinyl oestradiol (35µg)/cyproterone acetate (2 mg) (EE/CPA) and ethinyl oestradiol (20 µg)/ desogestrel (0.15mg) (EE/DES) alone and in combination with low-dose metformin.


Methods: A total of 117 patients with PCOD diagnosed according to Rotterdam Consensus Criteria 2003 with a hirsutism score of 8 or more according to modified Ferriman-Gallway Score (mFGS) were randomised to receive one of four drug combinations (arm A – EE/CPA, arm B- EE/DES, arm C- EE/CPA plus metformin, arm D- EE/DES plus metformin). The outcomes assessed were body mass index (BMI), hirsutism (using mFGS) and health-related QOL (Polycystic Ovary Syndrome Health- Related quality of life Questionnaire (PCOSQ) and a Visual Analog Scale (VAS) score) at baseline and 12 months after treatment.


Results: PCOSQ score in relation to the hirsutism, emotions, menstruation, obesity, infertility and VAS score in relation to hirsutism and obesity had improved at the end of 12 months (p< 0.001) in all treatment arms. There was no difference between treatment arms in all measured outcomes at baseline and at the end of 12 months.


Conclusion: Treatment with EE/CPA and EE/DES is associated with an improvement in perceived QOL in patients with PCOD. The addition of low-dose metformin did not have a significant benefit.

Article Details

Fonseka, S., Subhani, B., Alahakoon, V., Wijeyaratne, C., Gawarammana, I., Kalupahana, N., … Kumarasiri, P. (2019). Effectiveness of ethinyl oestradiol /cyproterone acetate and ethinyl oestradiol/ desogestrel with or without low-dose metformin on perceived health-related quality of life in hirsute women with polycystic ovary disease: A randomised, double-blind, placebo-controlled study. Archives of Psychiatry and Mental Health, 3(1), 025–031. https://doi.org/10.29328/journal.apmh.1001007
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Copyright (c) 2019 Fonseka S, et al.

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Group, REAS-Pcw. "Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS)." Hum Reprod. 2004; 19: 41-47. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/14711538

Fauser BC, Tarlatzis BC, Rebar RW, Legro RS, Balen AH, et al. "Consensus on women's health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-Sponsored 3rd PCOS Consensus Workshop Group." Fertil Steril. 2012; 97: 28-38. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/22153789

Kumarapeli V, Seneviratne Rde A, Wijeyaratne CN, Yapa RM, Dodampahala SH. "A simple screening approach for assessing community prevalence and phenotype of polycystic ovary syndrome in a semi-urban population in Sri Lanka." Am J Epidemiol. 2008; 168: 321-328. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/18550559

Misso M, Boyle J, Norman R, Teede H. "Development of evidenced-based guidelines for PCOS and implications for community health." Semin Reprod Med. 2014; 32: 230-240. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/24715518

Vrbíková J, Cibula D. "Combined oral contraceptives in the treatment of polycystic ovary syndrome." Hum Reprod Update. 2005; 11: 277-291.PubMed: https://www.ncbi.nlm.nih.gov/pubmed/15790599

Clark NM, AJ Podolski, ED Brooks, DR Chizen, RA Pierson, et al. "Prevalence of Polycystic Ovary Syndrome Phenotypes Using Updated Criteria for Polycystic Ovarian Morphology: An Assessment of Over 100 Consecutive Women Self-reporting Features of Polycystic Ovary Syndrome." Reproductive sciences (Thousand Oaks, Calif.) 2014; 21: 1034-1043.PubMed: https://www.ncbi.nlm.nih.gov/pubmed/24520081

Guidi J, Gambineri A, Zanotti L, Fanelli F, Fava GA. "Psychological aspects of hyperandrogenic states in late adolescent and young women." Clin Endocrinol (Oxf). 2015; 83: 872-878. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/25823959

McCook JG, Reame NE, Thatcher SS. "Health-related quality of life issues in women with polycystic ovary syndrome." J Obstet Gynecol Neonatal Nurs. 2005; 34: 12-20.PubMed: https://www.ncbi.nlm.nih.gov/pubmed/15673641

Himelein MJ, Thatcher SS. "Polycystic ovary syndrome and mental health: A review." Obstet Gynecol Surv. 2006; 61: 723-732. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/17044949

Bazarganipour F, Ziaei, Montazeri A, Foroozanfard F, Kazemnejad A, et al. "Psychological investigation in patients with polycystic ovary syndrome." Health Qual Life Outcomes. 2013; 11: 141.PubMed: https://www.ncbi.nlm.nih.gov/pubmed/23947827

Cronin L, Guyatt G, Griffith L, Wong E, Azziz R. "Development of a health-related quality-of-life questionnaire (PCOSQ) for women with polycystic ovary syndrome (PCOS)." J Clin Endocrinol Metab. 1998; 83: 1976-1987. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/9626128

Brady C, Mousa SS, Mousa SA. "Polycystic ovary syndrome and its impact on women's quality of life: More than just an endocrine disorder." Drug, healthcare and patient safety. 2009; 1: 9-15.PubMed: https://www.ncbi.nlm.nih.gov/pubmed/21701605

Jones GL, Benes K, Clark TL, Denham R, Holder MG, et al. "The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ): a validation." Hum Reprod. 2004; 19: 371-377. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/14747184

Malik-Aslam A, Reaney MD, Speight J. "The Suitability of Polycystic Ovary Syndrome-Specific Questionnaires for Measuring the Impact of PCOS on Quality of Life in Clinical Trials." Value in Health. 2010; 13: 440-446. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/20230548

Cronin L, Guyatt G, Griffith L, Wong E, Azziz R, et al. "Development of a Health-Related Quality-of-Life Questionnaire (PCOSQ) for Women with Polycystic Ovary Syndrome (PCOS)1." The Journal of Clinical Endocrinology & Metabolism. 1998; 83: 1976-1987.PubMed: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6053872/

Kitzinger C and J Willmott. "'The thief of womanhood': women's experience of polycystic ovarian syndrome." Soc Sci Med. 2002; 54: 349-361.

Jones GL, Palep-Singh M, Ledger WL, Balen AH, Jenkinson C. "Do South Asian women with PCOS have poorer health-related quality of life than Caucasian women with PCOS? A comparative cross-sectional study." Health and Quality of Life Outcomes. 2010; 8: 149. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/21171983

Mastorakos G, Koliopoulos C, Creatsas G. "Androgen and lipid profiles in adolescents with polycystic ovary syndrome who were treated with two forms of combined oral contraceptives." Fertil Steril. 2002; 77: 919-927. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/12009344

Van der Spuy ZM, le Roux PA. "Cyproterone acetate for hirsutism." Cochrane Database Syst Rev. 2003; 4: Cd001125.PubMed: https://www.ncbi.nlm.nih.gov/pubmed/14583927

Cosma M, BA Swiglo, DN Flynn, DM Kurtz, ML Labella, et al. "Clinical review: Insulin sensitizers for the treatment of hirsutism: a systematic review and metaanalyses of randomized controlled trials." J Clin Endocrinol Metab. 2008; 93: 1135-1142. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/18252787

Colwell HH, SD Mathias, DJ Pasta, JM Henning and JF Steege. "A health-related quality-of-life instrument for symptomatic patients with endometriosis: a validation study." Am J Obstet Gynecol. 1998; 179: 47-55.PubMed: https://www.ncbi.nlm.nih.gov/pubmed/9704764

Sriwatanakul K, Kelvie W, Lasagna L, Calimlim JF, Weis OF, et al. "Studies with different types of visual analog scales for measurement of pain." Clin Pharmacol Ther. 1983; 34: 234-239. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/6872418

Moran LJ, Hutchison SK, Norman RJ, Teede HJ. "Lifestyle changes in women with polycystic ovary syndrome." Cochrane Database of Systematic Reviews (3). 2019. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/21328294

Hahn S, Benson S, Elsenbruch S, Pleger K, Tan S, et al. "Metformin treatment of polycystic ovary syndrome improves health-related quality-of-life, emotional distress and sexuality." Human Reproduction. 2006; 21: 1925-1934. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/16549423

Ou HT, Chen PC, Wu MH, Lin CY. "Metformin improved health-related quality of life in ethnic Chinese women with polycystic ovary syndrome." Health and Quality of Life Outcomes. 2016; 14: 119. PubMed: https://www.ncbi.nlm.nih.gov/pubmed/27553217

Trent ME, Rich M, Austin SB, Gordon CM. "Quality of life in adolescent girls with polycystic ovary syndrome." Arch Pediatr Adolesc Med. 2002; 156: 556-560.PubMed: https://www.ncbi.nlm.nih.gov/pubmed/12038887