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2 . 2024

Synbiotic as an ameliorating factor in the health-related quality of life in women with polycystic ovary syndrome: a randomized, triple-blind, placebo-controlled trial

Abstract

Background. There are complicated mechanisms that link the disruption of the gut microbiome to the symptoms and complications of polycystic ovary syndrome (PCOS). In this study, an attempt was made to assess the effects of synbiotics on the health-related quality of life (HRQoL) in women with PCOS.

Methods. Fifty-six women with PCOS were enrolled in a triple-blind controlled trial for 12 weeks. They were randomly assigned to receive a daily 2-gram synbiotic sachets (containing Bacillus coagulans (GBI-30), Lactobacillus rhamnosus, Lactobacillus helveticus, and fructooligosaccharide) (n=28) or placebo (n=28). To evaluate the impact on the HRQoL, participants were required to fill 26-Item Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ-26), 12-Item Short-Form Health Survey (SF-12) and Perceived Stress Scale (PSS-10) pre and post the intervention.

Results. Finally, statistical analyses were performed on 52 participants who finished the trial. Synbiotic supplementation improved the scores of emotional (p=0.044), body hair (p=0.016), weight (p=0.033) and infertility domains (p=0.027) of PCOSQ-26 compared to placebo group. The physical score within SF-12 also had a significant enhancement (p=0.035). No significant improvement was seen in the PSS-10 score at the end of the trial.

Conclusion. This study illustrated the advantageous effects of synbiotics on the health-related quality of life in women with PCOS. Further studies are required to confirm our findings.

Trial registration: http://www.irct.ir: IRCT20211108053007N1; date of registration: 14/02/2023.

Keywords: polycystic ovary syndrome; health-related quality of life; synbiotic; bacillus coagulans

Hariri Z., Yari Z., Hoseini S., Abhari K., Sohrab G. Synbiotic as an ameliorating factor in the health-related quality of life in women with polycystic ovary syndrome. A randomized, triple-blind, placebo-controlled trial. BMC Womens Health. 2024 Jan 3; 24 (1): 19. DOI: https://10.1186/s12905-023-02868-1 PMID: 38172876; PMCID: PMC10765720.

REFERENCES

1. Brady C., Mousa S.S., Mousa S.A. Polycystic ovary syndrome and its impact on women’s quality of life: more than just an endocrine disorder. Drug Healthc Patient Saf. 2009; 1: 9–15.

2.Broekmans F., Knauff E., Valkenburg O., Laven J., Eijkemans M., Fauser B. PCOS according to the Rotterdam consensus criteria: change in prevalence among WHO-II anovulation and association with metabolic factors. BJOG. 2006; 113 (10): 1210–7.

3.Jalilian A., Kiani F., Sayehmiri F., Sayehmiri K., Khodaee Z., Akbari M. Prevalence of polycystic ovary syndrome and its associated Complications in Iranian women: a meta-analysis. Iran J Reprod Med. 2015; 13 (10): 591–604.

4.Kitzinger C., Willmott J. «The thief of womanhood»: women’s experience of polycystic ovarian syndrome. Soc Sci Med. 2002; 54 (3): 349–61.

5.Snyder B.S. The lived experience of women diagnosed with polycystic ovary syndrome. J Obstet Gynecol Neonatal Nurs. 2006;35(3):385–92.

6.Solomon C.G. The epidemiology of polycystic ovary syndrome: prevalence and associated disease risks. Endocrinol Metab Clin North Am. 1999; 28 (2): 247–63.

7.Berni T.R., Morgan C.L., Berni E.R., Rees D.A. Polycystic ovary syndrome is associated with adverse mental health and neurodevelopmental outcomes. J Clin Endocrinol Metab. 2018; 103 (6): 2116–25.

8.Doretto L., Mari F.C., Chaves A.C. Polycystic ovary syndrome and psychotic disorder. Front Psychiatry. 2020; 11: 543.

9.Podfigurna-Stopa A., Luisi S., Regini C., Katulski K., Centini G., Meczekalski B., et al. Mood disorders and quality of life in polycystic ovary syndrome. Gynecol Endocrinol. 2015; 31 (6): 431–4.

10.Greenwood E.A., Pasch L.A., Cedars M.I., Legro R.S., Huddleston H.G.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Reproductive Medicine Network. Association among depression, symptom experience, and quality of life in polycystic ovary syndrome. Am J Obstet Gynecol. 2018; 219 (3): 279.e1–7.

11.Jones G., Hall J., Balen A., Ledger W. Health-related quality of life measurement in women with polycystic ovary syndrome: a systematic review. Hum Reprod Update. 2008; 14 (1): 15–25.

12.Cinar N., Kizilarslanoglu M.C., Harmanci A., Aksoy D.Y., Bozdag G., Demir B., et al. Depression, anxiety and cardiometabolic risk in polycystic ovary syndrome. Hum Reprod. 2011; 26 (12): 3339–45.

13.Liu R., Zhang C., Shi Y., Zhang F., Li L., Wang X., et al. Dysbiosis of gut microbiota associated with clinical parameters in polycystic ovary syndrome. Front Microbiol. 2017; 8: 324.

14.Zeng B., Lai Z., Sun L., Zhang Z., Yang J., Li Z., et al. Structural and functional profiles of the gut microbial community in polycystic ovary syndrome with insulin resistance (IR-PCOS): a pilot study. Res Microbiol. 2019; 170 (1): 43–52.

15.Insenser M., Murri M., del Campo R., Martínez-García M.Á., FernándezDurán E., Escobar-Morreale H.F. Gut microbiota and the polycystic ovary syndrome: influence of sex, sex hormones, and obesity. J Clin Endocrinol Metab. 2018; 103 (7): 2552–62.

16.Soory M. Bacterial steroidogenesis by periodontal pathogens and the effect of bacterial enzymes on steroid conversions by human gingival fibroblasts in culture. J Periodontal Res. 1995; 30 (2): 124–31.

17.Zhang F., Ma T., Cui P., Tamadon A., He S., Huo C., et al. Diversity of the gut microbiota in dihydrotestosterone-induced PCOS rats and the pharmacologic effects of diane-35, probiotics, and berberine. Front Microbiol. 2019; 10: 175.

18.Xue J., Li X., Liu P., Li K., Sha L., Yang X., et al. Inulin and metformin ameliorate polycystic ovary syndrome via anti-inflammation and modulating gut microbiota in mice. Endocr J. 2019; 66 (10): 859–70.

19.Lyte M., Vulchanova L., Brown D.R. Stress at the intestinal surface: catecholamines and mucosa-bacteria interactions. Cell Tissue Res. 2011; 343 (1): 23–32.

20.Sergeev I.N., Aljutaily T., Walton G., Huarte E. Effects of synbiotic supplement on human gut microbiota, body composition and weight loss in obesity. Nutrients. 2020;12(1):222.

21.Mendonça A.A., Pinto-Neto W.P., da Paixão G.A., Santos D.S., De Morais M.A., De Souza R.B. Journey of the probiotic bacteria: survival of the fittest. Microorganisms. 2023; 11 (1): 95.

22.Kaur I.P., Chopra K. Saini A. Probiotics: potential pharmaceutical applications. Eur J Pharm Sci. 2002; 15 (1): 1–9.

23.Li Y., Tan Y., Xia G., Shuai J. Effects of probiotics, prebiotics, and synbiotics on polycystic ovary syndrome: a systematic review and meta-analysis. Crit Rev Food Sci Nutr. 2023; 63 (4): 522–38.

24.Cronin L., Guyatt G., Griffith L., Wong E., Azziz R., Futterweit W., et al. Development of a health-related quality-of-life questionnaire (PCOSQ) for women with polycystic ovary syndrome (PCOS). J Clin Endocrinol Metab. 1998; 83 (6): 1976–87.

25.Ware J. Jr., Kosinski M., Keller S.D. A 12-Item short-form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996; 34 (3): 220–33.

26.Cohen S., Kamarck T., Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983; 24 (4): 385–96.

27.Angin P., Yoldemir T. Atasayan K. Quality of life among infertile PCOS patients. Arch Gynecol Obstet. 2019; 300: 461–7.

28.Revised. 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004; 81 (1): 19–25.

29.Leila A., Behzad G., Ali M. Iranian Version of Health-Related Quality of Life for Women with Polycystic Ovary Syndrome (PCOSQ): Translation, Reliability and Validity. 2012.

30.Montazeri A., Vahdaninia M., Mousavi S.J., Omidvari S. The Iranian version of 12-item short Form Health Survey (SF-12): factor structure, internal consistency and construct validity. BMC Public Health. 2009; 9 (1): 341.

31.Cohen S., Kamarck T., Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983; 24 (4): 385–96.

32.Lee E.-H. Review of the psychometric evidence of the perceived stress scale. Asian Nurs Res. 2012; 6 (4): 121–7.

33.Maroufizadeh S., Foroudifard F., Navid B., Ezabadi Z., Sobati B., Omani-Samani R. The perceived stress scale (PSS-10) in women experiencing infertility: a reliability and validity study. Middle East Fertil Soc J. 2018; 23 (4): 456–9.

34.Stefanaki C., Bacopoulou F., Livadas S., Kandaraki A., Karachalios A., Chrousos G.P., et al. Impact of a mindfulness stress management program on stress, anxiety, depression and quality of life in women with polycystic ovary syndrome: a randomized controlled trial. Stress. 2015; 18 (1): 57–66.

35.McCook J.G., Reame N.E., Thatcher S.S. Health-related quality of life issues in women with polycystic ovary syndrome. J Obstet Gynecol Neonatal Nurs. 2005; 34 (1): 12–20.

36.Coffey S., Bano G., Mason H.D. Health-related quality of life in women with polycystic ovary syndrome: a comparison with the general population using the polycystic ovary syndrome questionnaire (PCOSQ) and the short Form-36 (SF-36). Gynecol Endocrinol. 2006; 22 (2): 80–6.

37.Jones G.L., Palep-Singh M., Ledger W.L., Balen A.H., Jenkinson C., Campbell M.J., et al. Do South Asian women with PCOS have poorer health-related quality of life than Caucasian women with PCOS? A comparative cross-sectional study. Health Qual Life Outcomes. 2010; 8 (1): 1–8.

38.Venkataraman R., Jose P., Jose J. Impact of probiotics on health-related quality of life in type II diabetes mellitus: a randomized single-blind. placebo-controlled study. J Nat Sci Biol Med. 2019; 10 (1): 2–7.

39.Tay A., Pringle H., Penning E., Plank L.D., Murphy R. PROFAST: a randomized trial assessing the effects of intermittent fasting and Lacticaseibacillus rhamnosus probiotic among people with prediabetes. Nutrients. 2020; 12 (11): 3530.

40.Barthow C., Hood F., Crane J., Huthwaite M., Weatherall M., Parry-Strong A., et al. A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes. BMJ Open. 2022; 12 (3): e055214.

41.Diop L., Guillou S., Durand H. Probiotic food supplement reduces stress-induced gastrointestinal symptoms in volunteers: a double-blind, placebo-controlled, randomized trial. Nutr Res. 2008; 28 (1): 1–5.

42.Guyonnet D., Chassany O., Ducrotte P., Picard C., Mouret M., Mercier C.H., et al. Effect of a fermented milk containing Bifidobacterium animalis DN-173 010 on the health-related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double-blind, controlled trial. Aliment Pharmacol Ther. 2007; 26 (3): 475–86.

43.Frech T.M., Khanna D., Maranian P., Frech E.J., Sawitzke A.D., Murtaugh M.A. Probiotics for the treatment of systemic sclerosis-associated gastrointestinal bloating/distention. Clin Exp Rheumatol. 2011; 29 (2): S22–5.

44.Román E., Nieto J.C., Gely C., Vidal S., Pozuelo M., Poca M., et al. Effect of a multistrain probiotic on cognitive function and risk of falls in patients with cirrhosis: a randomized trial. Hepatol Commun. 2019; 3 (5): 632–45.

45.Guyonnet D., Schlumberger A., Mhamdi L., Jakob S., Chassany O. Fermented milk containing Bifidobacterium lactis DN-173 010 improves gastrointestinal well-being and digestive symptoms in women reporting minor digestive symptoms: a randomized, double-blind, parallel, controlled study. Br J Nutr. 2009; 102 (11): 1654–62.

46.Shoaei T., Heidari-Beni M., Tehrani H.G., Esmaillzadeh A., Askari G. Effects of probiotic supplementation on pancreatic β-cell function and c-reactive protein in women with polycystic ovary syndrome: a randomized double-blind placebo-controlled clinical trial. Int J Prev Med. 2015; 6: 27.

47.Karamali M., Eghbalpour S., Rajabi S., Jamilian M., Bahmani F., Tajabadi-Ebrahimi M., et al. Effects of probiotic supplementation on hormonal profiles, biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial. Arch Iran Med. 2018; 21 (1): 1–7.

48.Hariri Z., Yari Z., Hoseini S., Mehrnami A., Abhari K., Sohrab G. Effects of synbiotic-containing Bacillus coagulans (GBI-30) on the cardiovascular status of patients with polycystic ovary syndrome: a triple-blinded, randomized, placebo-controlled study. Clin Ther. 2023; 45 (10): e193–9.

49.Zhou L., Ni Z., Cheng W., Yu J., Sun S., Zhai D., et al. Characteristic gut microbiota and predicted metabolic functions in women with PCOS. Endocr Connect. 2020; 9 (1): 63–73.

50.Torres P.J., Siakowska M., Banaszewska B., Pawelczyk L., Duleba A.J., Kelley S.T., et al. Gut microbial diversity in women with polycystic ovary syndrome correlates with hyperandrogenism. J Clin Endocrinol Metab. 2018; 103 (4): 1502–11.

51.Tremellen K., Pearce K. Dysbiosis of gut microbiota (DOGMA) – a novel theory for the development of polycystic ovarian syndrome. Med Hypotheses. 2012; 79 (1): 104–12.

52.Zhang J., Sun Z., Jiang S., Bai X., Ma C., Peng Q., et al. Probiotic Bifidobacterium lactis V9 regulates the secretion of sex hormones in polycystic ovary syndrome patients through the gut-brain axis. mSystems. 2019; 4 (2): e00017-19.

53.Thong E.P., Codner E., Laven J.S.E., Teede H. Diabetes: a metabolic and reproductive disorder in women. Lancet Diabetes Endocrinol. 2020; 8 (2): 134–49.

54.Li A., Zhang L., Jiang J., Yang N., Liu Y., Cai L., et al. Follicular hyperandrogenism and insulin resistance in polycystic ovary syndrome patients with normal circulating testosterone levels. J Biomed Res. 2017; 32 (3): 208–14.

55.Aboeldalyl S., James C., Seyam E., Ibrahim E.M., Shawki H.E., Amer S. The role of chronic inflammation in polycystic ovarian syndrome – a systematic review and meta-analysis. Int J Mol Sci. 2021; 22 (5): 2734.

56.Shoubridge A.P., Choo J.M., Martin A.M., Keating D.J., Wong M.L., Licinio J., et al. The gut microbiome and mental health: advances in research and emerging priorities. Mol Psychiatry. 2022; 27 (4): 1908–19.

57.Zhou L., Foster J.A. Psychobiotics and the gut–brain axis: in the pursuit of happiness. Neuropsychiatr Dis Treat. 2015; 11: 715–23.

58.Sudo N., Chida Y., Aiba Y., Sonoda J., Oyama N., Yu X.N., et al. Postnatal microbial colonization programs the hypothalamic–pituitary–adrenal system for stress response in mice. J Physiol. 2004; 558 (1): 263–75.

59.Luo Y., Zeng B., Zeng L., Du X., Li B., Huo R., et al. Gut microbiota regulates mouse behaviors through glucocorticoid receptor pathway genes in the hippocampus. Transl Psychiatry. 2018; 8 (1): 187.

60.Ostadmohammadi V., Jamilian M., Bahmani F., Asemi Z. Vitamin D and probiotic co-supplementation affects mental health, hormonal, inflammatory and oxidative stress parameters in women with polycystic ovary syndrome. J Ovarian Res. 2019; 12 (1): 1–8.

61.Jamilian M., Mansury S., Bahmani F., Heidar Z., Amirani E., Asemi Z. The effects of probiotic and selenium co-supplementation on parameters of mental health, hormonal profiles, and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome. J Ovarian Res. 2018; 11 (1): 1–7.

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CHIEF EDITORS
CHIEF EDITOR
Sukhikh Gennadii Tikhonovich
Academician of the Russian Academy of Medical Sciences, V.I. Kulakov Obstetrics, Gynecology and Perinatology National Medical Research Center of Ministry of Healthсаre of the Russian Federation, Moscow
CHIEF EDITOR
Kurtser Mark Arkadievich
Academician of the Russian Academy of Sciences, MD, Professor, Head of the Obstetrics and Gynecology Subdepartment of the Pediatric Department, N.I. Pirogov Russian National Scientific Research Medical University, Ministry of Health of the Russian Federation
CHIEF EDITOR
Radzinsky Viktor Evseevich
Corresponding Member of the Russian Academy of Sciences, MD, Professor, Head of the Subdepartment of Obstetrics and Gynecology with a Course of Perinatology of the Medical Department in the Russian People?s Friendship University

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