Highlights
- •We evaluated whether MS activity was lower in continuous, vs. cyclic, oral contraceptive (OC) users.
- •Neither relapse rate or time to new relapse was different between the two groups.
- •Continuous OC users had longer time to new inflammatory brain lesion formation.
Abstract
Background
Many women with multiple sclerosis (MS) report fluctuating symptoms across their menstrual
cycle. Oral contraceptives (OCs) alter hormonal levels across the menstrual cycle.
While cyclic OCs administer hormones for 21 days, followed by a week of placebo, continuous
OCs can administer continuous doses of hormones for up to 3 months. Previous studies
have suggested that OC use is associated with lower MS-related inflammation. We hypothesized
that due to reduced hormonal fluctuations, women with MS might experience less inflammatory
activity (clinical relapses+MRI) on continuous OCs than on cyclic OCs.
Methods
We performed a retrospective analysis of prospectively collected data. For women with
MS aged 18–50 seen at the UCSF Center for MS and Neuroinflammation, we extracted data
on OC use from the Electronic Medical Records (EMR). All variables were confirmed
using manual clinical chart review. We identified 19 women with relapsing forms of
MS on continuous OCs and matched them (2:1 when possible) to women on cyclic OCs for
OC formulation, age, MS duration and DMT type. Inflammatory activity in the two groups
was then compared using log-rank tests (time to new relapse, new T2-weighted lesion
formation, and gadolinium-enhancing lesion formation) and t-tests (annualized relapse
rate). We also performed subgroup analyses in women with at least 1 year (N = 28) and 2 years (N = 21) of clinical observation. A power calculation was performed.
Results
There was no difference in time to relapse (p = 0.50) between continuous and cycling OC users. However, continuous OC users showed
a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time
to contrast-enhancing lesion formation (p = 0.05). In patients with at least 1 year of observation, there was a significant
difference in time to T2 lesion formation (p = 0.03) and time to contrast-enhancing lesion formation (p = 0.02).
Conclusion
In this exploratory study, women on continuous OCs showed a trend towards less inflammatory
activity on MRI relative to women on cyclic OCs. This difference was not reflected
in relapse rates. We estimate that 342 patients would be required for an adequately
powered cohort study to evaluate such an effect. Our findings provide reassurance
that for women using continuous OCs to alleviate menstrual fluctuations in symptoms,
there is not an increase in MS-related inflammatory activity.
Keywords
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Article info
Publication history
Published online: February 05, 2020
Accepted:
January 26,
2020
Received in revised form:
December 28,
2019
Received:
August 4,
2019
Identification
Copyright
© 2020 Elsevier B.V. All rights reserved.