Members Evidence Request - Supporting Clinical Practice

The Clinical Effectiveness Unit (CEU) provides an evidence-based enquiry service for FSRH members. The CEU will conduct a literature review and summarise the available evidence in relation to a particular medical condition and/or contraceptive method.


Recent Questions and Answers that have been submitted to the CEU can be seen below. Please note, the full answer includes references to more information and guidance.

 

To gain access to the members evidence request service, please log in to ‘My FSRH’ and click on ‘Members' evidence request’ to search for questions or submit your own question. This service is available to current FSRH members. If you are an FSRH member and have not yet created your ‘My FSRH’ account, please click the ‘Register’ button on the top right of this website and follow the steps to gain access to your account. View a video on how to register on our website here

Example Question One

Is there any evidence that an IUS can affect Meniere's disease symptoms?

Response
Meniere's disease is caused by an augmented endolymph pressure in the inner ear and is characterised by the symptoms of vertigo, fluctuating hearing loss and tinnitus. Premenstrual exacerbation of Meniere’s disease symptoms has been previously described [2,3], however, the underlying mechanism and whether/how hormonal changes may be involved remains unclear.

The CEU conducted a review of the literature and did not identify any studies which examine whether the use of levenorgestrel-releasing intrauterine system (LNG-IUS) affects the symptoms of Meniere’s diease. A recently published non-randomised controlled study  examined the effects of combined oral contraception (COC) containing drospirenone (DRSP) on the premenstrual exacerbation of Meniere’s disease. The study concluded that DRSP could be an effective treatment to manage premenstrual exacerbation of symptoms. The findings of this preliminary study are limited by its design (non-randomised, non-blinded) and it did not consider other COC formulations or other hormonal contraceptive methods. Further studies are required to strengthen the evidence to make any clear recommendation regarding the effectiveness of DRSP and/or other contraceptive hormones in managing the (premenstrual) symptoms of Meniere’s disease.

The FSRH CEU did not identify any published evidence to inform whether the LNG-IUS affects the symptoms of Meniere’s disease.

 

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Example Question Two

If a patient were to get pregnant with an implant in situ is there an increased risk of ectopic pregnancy?

Response
The 2014 FSRH guideline Progestogen-only Implants advises that, “[p]rogestogen-only implants are such effective contraceptives that the absolute risk of pregnancy (either intrauterine or ectopic) while using these methods is very low. Past ectopic pregnancy is a condition for which there is no restriction on the use of the progestogen-only implant (UKMEC 1).”

Since the publication of that guideline, a systematic review has investigated the risk of ectopic pregnancy in women using contraceptive implants. The review [2] identified only two studies of etonogestrel implants that reported any pregnancies (most studies of etonogestrel implants reported none). A cohort study reported pregnancies but none were ectopic. A case series from postmarketing data reported 218 pregnancies; only 13 were believed to be true method failures and it was not stated if the 5 ectopic pregnancies observed were part of that group. Data are too limited to allow calculation of an incidence rate for ectopic pregnancy associated with correct use of etonogestrel implants.

The FSRH CEU advises that the risk of ectopic pregnancy associated with use of the etonogestrel progestogen-only implant is extremely low. Effective contraception reduces the risk of all pregnancy, including ectopic pregnancy compared to use of no contraception.

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Example Question Three

I have a patient who has otosclerosis (as does her mother). She says she has been told in the past that she should avoid hormonal contraception due to the otosclerosis, however wishes to use a more reliable method than condoms. Otosclerosis is not mentioned in the UKMEC or any of the guidelines. Please could you advise if there is any evidence that any hormonal methods should not be used in women with otosclerosis?

 

Response

Case reports relating to otosclerosis in users of oral contraceptives (OC), together with an apparent association between parity and otosclerosis have led authors to suggest that there could be an association between OC use and development of otosclerosis.

The evidence that exists is very limited. Data from the Oxford FPA study cohort, which observed 31 cases of otosclerosis identified no association between OC use and otosclerosis; numbers of cases are, however very small which limits the conclusions that can be drawn.

Similarly, in a cohort of 600 OC users aged 16-30, Podoshin et al, reporting in 1978 identified 3 cases of otosclerosis at baseline, an incidence (0.5%) that would be expected in the general population. No new cases were observed during ongoing use. As this article was unavailable to access, it is not known if the women with otosclerosis were already OC users at baseline or how long they continued to use.

Evidence is not identified regarding the effect of contraceptive hormones on existing otosclerosis. It is recommended that you seek expert advice from the clinician managing the woman’s otosclerosis.

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Please note: The advice given by the CEU should be considered as guidance only and is meant to be used alongside clinical judgement to guide clinical practice or policy. Questions that are a matter of clinical judgment and not evidence should be directed to local sexual and reproductive health leads.