No increase in C-reactive protein levels during intranasal compared to oral hormone therapy in healthy post-menopausal women.
BACKGROUND
Inflammation plays an important role in the development of atherosclerotic disease. Oral post-menopausal hormone therapy increases serum C-reactive protein (CRP) levels. This study compared the effects of intranasal and oral administration of 17beta-estradiol (E2) combined with norethisterone acetate (NETA) on markers of inflammation in healthy post-menopausal women.


METHODS
Ninety healthy post-menopausal women (age 56.6 +/- 4.7 years) participated in this 1-year trial. After computerized block randomization, they daily received, in a double-blind fashion, either intranasal E2/NET [175 microg/275 microg (n = 47)] or oral E2/NETA [1 mg/0.5 mg (n = 43)]. Concentrations of high sensitivity CRP and adhesion molecules were measured at baseline and after 12, 24 and 52 weeks of treatment.


RESULTS
CRP levels were increased (P = 0.001) in the oral but not in the intranasal group. The increase in the oral group was highest at week 12 (64.9%) and was larger (P < 0.01) compared with the non-significant increase (8.6%) found in the intranasal group. Both groups showed decreases (P < 0.001) in soluble vascular cell adhesion molecule (sVCAM), soluble intracellular adhesion molecule (sICAM) and sE-selectin. The decreases were larger (P < 0.01) in the oral than in the intranasal group.


CONCLUSIONS
Intranasal E2/NET therapy did not significantly increase CRP levels, in contrast to the increase observed in the oral E2/NETA treatment group. Both intranasal and oral therapy lowered plasma concentrations of adhesion molecules, however, more so in the oral group.
Hemelaar
M
M
Project Ageing Women and Institute for Cardiovascular Research-Vrije Universiteit, Department of Obstetrics & Gynaecology, VU University Medical Center, Amsterdam, The Netherlands.
Kenemans
P
P
Schalkwijk
C G
CG
Braat
D D M
DD
van der Mooren
M J
MJ
D000281:Administration, Intranasal; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002097:C-Reactive Protein / Q000096:biosynthesis*; D004958:Estradiol / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy / Q000379:methods; D005260:Female; D005786:Gene Expression Regulation; D006801:Humans; D018799:Intercellular Adhesion Molecule-1 / Q000097:blood; D008875:Middle Aged; D017698:Postmenopause; D016032:Randomized Controlled Trials as Topic; D019010:Vascular Cell Adhesion Molecule-1 / Q000097:blood
D019010:Vascular Cell Adhesion Molecule-1; D018799:Intercellular Adhesion Molecule-1; D004958:Estradiol; D002097:C-Reactive Protein