Abstract

Research Article

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

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

Published: 06 August, 2019 | Volume 3 - Issue 1 | Pages: 025-031

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.

Read Full Article HTML DOI: 10.29328/journal.apmh.1001007 Cite this Article Read Full Article PDF

Keywords:

Polycystic ovary disease; Quality of life; Hirsutism; Visual analogue scale; Clinical trial

References

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  12. 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
  13. 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
  14. 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
  15. 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/
  16. Kitzinger C and J Willmott. "'The thief of womanhood': women's experience of polycystic ovarian syndrome." Soc Sci Med. 2002; 54: 349-361.
  17. 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
  18. 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
  19. 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
  20. 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
  21. 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
  22. 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
  23. 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
  24. 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
  25. 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
  26. 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

Figures:

Figure 1

Figure 1

Similar Articles

Recently Viewed

Read More

Most Viewed

Read More

Help ?