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Published in: Systematic Reviews 1/2017

Open Access 01-12-2017 | Protocol

The effect and safety of postmenopausal hormone therapy and selective estrogen receptor modulators on kidney outcomes in women: a protocol for systematic review and meta-analysis

Authors: Sandra M. Dumanski, Sharanya Ramesh, Matthew T. James, Amy Metcalfe, Kara Nerenberg, Ellen W. Seely, Helen Lee Robertson, Sofia B. Ahmed

Published in: Systematic Reviews | Issue 1/2017

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Abstract

Background

The prevalence of menopause in women with or at risk of chronic kidney disease is increasing globally. Although international guidelines on menopause recommend the use of postmenopausal hormone therapy with or without selective estrogen receptor modulators for control of vasomotor symptoms, the effects of these treatments on kidney function and albuminuria are unclear. Furthermore, women with chronic kidney disease are at significantly increased risk of venous thromboembolism and malignancy, well-documented adverse effects of postmenopausal hormone therapy. Our study aims to establish the effect of these treatments on kidney function and albuminuria in women, as well as determine the safety of these treatments in the chronic kidney disease population.

Methods

We will conduct a systematic review and meta-analysis addressing the effect and safety of postmenopausal hormone therapy and selective estrogen receptor modulators on kidney outcomes in women. We plan to search for published (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), tables of contents of relevant journals) and unpublished (ongoing studies, conference proceedings) studies in all languages examining the effect of postmenopausal hormone therapy, including selective estrogen receptor modulators, on kidney function and albuminuria, as well as the risk of adverse outcomes of these treatments in women with chronic kidney disease. Two independent investigators will screen identified abstracts and select studies that examine the effect of postmenopausal hormone therapy and selective estrogen receptor modulators on kidney outcomes in the general population or adverse outcomes in the chronic kidney disease population. Data on study population, intervention, outcomes, as well as study quality and risk of bias will be independently extracted from each eligible study. Along with descriptive presentation of data, outcome measures will be presented as meta-analyses using a random effects model. Planned subgroup analyses will be completed, and meta-regression will be performed if significant heterogeneity is noted.

Discussion

By examining the effects of postmenopausal hormone therapy and selective estrogen receptor modulators on kidney function and albuminuria, the results of this systematic review and meta-analysis will inform management of postmenopausal women in the general population. Furthermore, it will evaluate the safety, including the risks of known adverse outcomes of postmenopausal hormone therapy and selective estrogen receptor modulators, in the already vulnerable chronic kidney disease population.

Systematic review registration

PROSPERO CRD42016050651
Appendix
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Literature
1.
go back to reference Shifren JL, Gass ML. The North American Menopause Society recommendations for clinical care of midlife women. Menopause. 2014;21:1038–62.CrossRefPubMed Shifren JL, Gass ML. The North American Menopause Society recommendations for clinical care of midlife women. Menopause. 2014;21:1038–62.CrossRefPubMed
2.
go back to reference Lutz W, Sanderson W, Scherbov S. The coming acceleration of global population ageing. Nature. 2008;451:716–9.CrossRefPubMed Lutz W, Sanderson W, Scherbov S. The coming acceleration of global population ageing. Nature. 2008;451:716–9.CrossRefPubMed
3.
go back to reference Allen C, Evans G, Sutton E. Pharmacologic therapies in women’s health: contraception and menopause treatment. Med Clin North Am. 2016;100:763–89.CrossRefPubMed Allen C, Evans G, Sutton E. Pharmacologic therapies in women’s health: contraception and menopause treatment. Med Clin North Am. 2016;100:763–89.CrossRefPubMed
4.
5.
go back to reference de Villiers TJ, Pines A, Panay N, et al. Updated 2013 International Menopause Society recommendations on menopausal hormone therapy and preventative strategies or midlife health. Climacteric. 2013;16:316–37.CrossRefPubMed de Villiers TJ, Pines A, Panay N, et al. Updated 2013 International Menopause Society recommendations on menopausal hormone therapy and preventative strategies or midlife health. Climacteric. 2013;16:316–37.CrossRefPubMed
6.
go back to reference Panay N, Hamoda H, Arya R, et al. The 2013 British Menopause Society & Women’s Health Concern recommendations on hormone replacement therapy. Menopause Int. 2013;19:59–68.PubMed Panay N, Hamoda H, Arya R, et al. The 2013 British Menopause Society & Women’s Health Concern recommendations on hormone replacement therapy. Menopause Int. 2013;19:59–68.PubMed
8.
go back to reference The global issue of kidney disease. Lancet. 2013;382(9887):101. The global issue of kidney disease. Lancet. 2013;382(9887):101.
10.
go back to reference Mills KT, Yu X, Zhang W, et al. A systematic analysis of world-wide population-based data on the global burden of chronic kidney disease in 2010. Kidney Int. 2015;88:950–7.CrossRefPubMedPubMedCentral Mills KT, Yu X, Zhang W, et al. A systematic analysis of world-wide population-based data on the global burden of chronic kidney disease in 2010. Kidney Int. 2015;88:950–7.CrossRefPubMedPubMedCentral
13.
go back to reference Xue J, Ma J, Louis T, Collins A. Forecast of the number of patients with end-stage renal disease in the United States to the year 2010. J Am Soc Nephrol. 2001;12:2753–8.PubMed Xue J, Ma J, Louis T, Collins A. Forecast of the number of patients with end-stage renal disease in the United States to the year 2010. J Am Soc Nephrol. 2001;12:2753–8.PubMed
14.
go back to reference Lim VS, Henriquez C, Sievertsen G, et al. Ovarian function in chronic renal failure: evidence suggesting hypothalamic anovulation. Ann Intern Med. 1980;93:21–7.CrossRefPubMed Lim VS, Henriquez C, Sievertsen G, et al. Ovarian function in chronic renal failure: evidence suggesting hypothalamic anovulation. Ann Intern Med. 1980;93:21–7.CrossRefPubMed
15.
go back to reference Matuszkiewica-Rowinska J, Skorzewska K, Radowicki S, et al. Endometrial morphology and pituitary-gonadal axis dysfunction in women of reproductive age undergoing chronic haemodialysis—a multicenter study. Nephrol Dial Transplant. 2004;19:2074–7.CrossRef Matuszkiewica-Rowinska J, Skorzewska K, Radowicki S, et al. Endometrial morphology and pituitary-gonadal axis dysfunction in women of reproductive age undergoing chronic haemodialysis—a multicenter study. Nephrol Dial Transplant. 2004;19:2074–7.CrossRef
16.
go back to reference Cochrane R, Regan L. Undetected gynaecological disorders in women with renal disease. Hum Reprod. 1997;12:667–70.CrossRefPubMed Cochrane R, Regan L. Undetected gynaecological disorders in women with renal disease. Hum Reprod. 1997;12:667–70.CrossRefPubMed
17.
go back to reference Holley JL, Schmidt RJ, Bender FH, et al. Gynecologic and reproductive issues in women on dialysis. Am J Kidney Dis. 1997;29:685–90.CrossRefPubMed Holley JL, Schmidt RJ, Bender FH, et al. Gynecologic and reproductive issues in women on dialysis. Am J Kidney Dis. 1997;29:685–90.CrossRefPubMed
18.
go back to reference Chakhtoura Z, Meunier M, Caby J, et al. Gynecologic followup of 129 women on dialysis and after kidney transplantation: a retrospective cohort study. Eur J Obstet, Gynecol Reprod Biol. 2015;187:1–5.CrossRef Chakhtoura Z, Meunier M, Caby J, et al. Gynecologic followup of 129 women on dialysis and after kidney transplantation: a retrospective cohort study. Eur J Obstet, Gynecol Reprod Biol. 2015;187:1–5.CrossRef
19.
go back to reference Neugarten J, Acharya A, Silbiger SR. Effect of gender on the progression of nondiabetic renal disease: a meta-analysis. J Am Soc Nephrol. 2000;11:319–29.PubMed Neugarten J, Acharya A, Silbiger SR. Effect of gender on the progression of nondiabetic renal disease: a meta-analysis. J Am Soc Nephrol. 2000;11:319–29.PubMed
20.
go back to reference Jafar TH, Schmid CH, Stark PC, et al. The rate of progression of renal disease may not be slower in women compared with men: a patient-level meta-analysis. Nephrol Dial Transplant. 2003;18:2047–53.CrossRefPubMed Jafar TH, Schmid CH, Stark PC, et al. The rate of progression of renal disease may not be slower in women compared with men: a patient-level meta-analysis. Nephrol Dial Transplant. 2003;18:2047–53.CrossRefPubMed
21.
go back to reference Nitsch D, Grams M, Sang Y, et al. Associations of estimated glomerular filtration rate and albuminuria with mortality and renal failure by sex: a meta-analysis. BMJ. 2013;346:f324.CrossRefPubMedPubMedCentral Nitsch D, Grams M, Sang Y, et al. Associations of estimated glomerular filtration rate and albuminuria with mortality and renal failure by sex: a meta-analysis. BMJ. 2013;346:f324.CrossRefPubMedPubMedCentral
22.
go back to reference Stringer KD, Komers R, Osman SA, et al. Gender hormones and the progression of experimental polycystic kidney disease. Kidney Int. 2005;68:1729–39.CrossRefPubMed Stringer KD, Komers R, Osman SA, et al. Gender hormones and the progression of experimental polycystic kidney disease. Kidney Int. 2005;68:1729–39.CrossRefPubMed
23.
go back to reference Takaoka M, Yuba M, Fujii T, et al. Oestrogen protects against ischaemic acute renal failure in rats by suppressing renal endothelin-1 overproduction. Clin Sci. 2002;103 Suppl 48:434S–7S.CrossRefPubMed Takaoka M, Yuba M, Fujii T, et al. Oestrogen protects against ischaemic acute renal failure in rats by suppressing renal endothelin-1 overproduction. Clin Sci. 2002;103 Suppl 48:434S–7S.CrossRefPubMed
24.
go back to reference Maric C, Sandberg K, Hinojosa-Laborde C. Glomerulosclerosis and tubulointerstitial fibrosis are attenuated with 17β-estradiol in the aging Dahl salt sensitive rat. J Am Soc Nephrol. 2004;15:1546–56.CrossRefPubMed Maric C, Sandberg K, Hinojosa-Laborde C. Glomerulosclerosis and tubulointerstitial fibrosis are attenuated with 17β-estradiol in the aging Dahl salt sensitive rat. J Am Soc Nephrol. 2004;15:1546–56.CrossRefPubMed
25.
go back to reference Catanuto P, Doublier S, Lupia E, et al. 17β-Estradiol and tamoxifen upregulate estrogen receptor beta expression and control podocyte signaling pathways in a model of type 2 diabetes. Kidney Int. 2009;75:1194–201.CrossRefPubMed Catanuto P, Doublier S, Lupia E, et al. 17β-Estradiol and tamoxifen upregulate estrogen receptor beta expression and control podocyte signaling pathways in a model of type 2 diabetes. Kidney Int. 2009;75:1194–201.CrossRefPubMed
26.
go back to reference Ozdemir Kumral Z, Kolgazi M, Ustunova S, et al. Estrogen receptor agonists alleviate cardiac and renal oxidative injury in rats with renovascular hypertension. Clin Exp Hypertens. 2016;38:500–9.CrossRefPubMed Ozdemir Kumral Z, Kolgazi M, Ustunova S, et al. Estrogen receptor agonists alleviate cardiac and renal oxidative injury in rats with renovascular hypertension. Clin Exp Hypertens. 2016;38:500–9.CrossRefPubMed
27.
go back to reference Mao S, Hua X, Zou L, et al. Estrogen preserves split renal function in a chronic complete unilateral ureteral obstruction animal model. Exp Ther Med. 2014;7:1555–62.PubMedPubMedCentral Mao S, Hua X, Zou L, et al. Estrogen preserves split renal function in a chronic complete unilateral ureteral obstruction animal model. Exp Ther Med. 2014;7:1555–62.PubMedPubMedCentral
28.
go back to reference Santen RJ, Allred DC, Ardoin SP, et al. Postmenopausal hormone therapy: an Endocrine Society scientific statement. J Clin Endocrinol Metab. 2010;95:s1.CrossRefPubMed Santen RJ, Allred DC, Ardoin SP, et al. Postmenopausal hormone therapy: an Endocrine Society scientific statement. J Clin Endocrinol Metab. 2010;95:s1.CrossRefPubMed
29.
go back to reference Li F, Dou J, Wei L, Li S, Liu J. The selective estrogen receptor modulators in breast cancer prevention. Cancer Chemother Pharmacol. 2016;77:895–903.CrossRefPubMed Li F, Dou J, Wei L, Li S, Liu J. The selective estrogen receptor modulators in breast cancer prevention. Cancer Chemother Pharmacol. 2016;77:895–903.CrossRefPubMed
30.
go back to reference Rizzoli R, Reginster J, Boonen S, et al. Adverse reactions and drug-drug interactions in the management of women with postmenopausal osteoporosis. Calcif Tissue Int. 2011;89:91–104.CrossRefPubMedPubMedCentral Rizzoli R, Reginster J, Boonen S, et al. Adverse reactions and drug-drug interactions in the management of women with postmenopausal osteoporosis. Calcif Tissue Int. 2011;89:91–104.CrossRefPubMedPubMedCentral
32.
33.
go back to reference Butler AM, Olshan AF, Kshirsagar AV, et al. Cancer incidence among U.S. Medicare ESRD patients receiving hemodialysis, 1996-2009. Am J Kidney Dis. 2015;65:763–72.CrossRefPubMedPubMedCentral Butler AM, Olshan AF, Kshirsagar AV, et al. Cancer incidence among U.S. Medicare ESRD patients receiving hemodialysis, 1996-2009. Am J Kidney Dis. 2015;65:763–72.CrossRefPubMedPubMedCentral
34.
go back to reference Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic reviews and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4:1–9.CrossRefPubMedPubMedCentral Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic reviews and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4:1–9.CrossRefPubMedPubMedCentral
35.
go back to reference Higgins JP, Green S. Cochrane handbook for systematic reviews of interventions. Chichester: Wiley-Blackwell; 2008. Wiley Online Library; 2008 Higgins JP, Green S. Cochrane handbook for systematic reviews of interventions. Chichester: Wiley-Blackwell; 2008. Wiley Online Library; 2008
37.
go back to reference Sampson M, McGowan J, Cogo E, et al. An evidence-based practice guideline for the peer review of electronic search strategies. J Clin Epidemiol. 2009;62:944–52.CrossRefPubMed Sampson M, McGowan J, Cogo E, et al. An evidence-based practice guideline for the peer review of electronic search strategies. J Clin Epidemiol. 2009;62:944–52.CrossRefPubMed
39.
go back to reference Likis FE, Andrews JC, Fonnesbeck CJ, et al. Cochrane risk of bias tool. 2014 Likis FE, Andrews JC, Fonnesbeck CJ, et al. Cochrane risk of bias tool. 2014
40.
go back to reference Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12.CrossRefPubMed Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12.CrossRefPubMed
41.
go back to reference Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151:264–9.CrossRefPubMed Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151:264–9.CrossRefPubMed
Metadata
Title
The effect and safety of postmenopausal hormone therapy and selective estrogen receptor modulators on kidney outcomes in women: a protocol for systematic review and meta-analysis
Authors
Sandra M. Dumanski
Sharanya Ramesh
Matthew T. James
Amy Metcalfe
Kara Nerenberg
Ellen W. Seely
Helen Lee Robertson
Sofia B. Ahmed
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Systematic Reviews / Issue 1/2017
Electronic ISSN: 2046-4053
DOI
https://doi.org/10.1186/s13643-017-0519-2

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