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. Watch the video below on how to access/search/submit a Members' Evidence Request.

The FSRH CEU has produced a quick guide on conducting systematic literature reviews to answer clinical questions (log in to access the guide). This brief and easy-to-use guide aims to support FSRH members to conduct a systematic literature search/review to answer clinical enquiries they may have. The process described in this guidance is adapted from the process used by the FSRH CEU when responding to enquiries made via the members evidence request service.

How to Submit a Members' Evidence Request

 

Example Question One

Behcet’s disease and contraception
A 29 year old lady known to have Behcet’s disease, she is using Microgynon last 13 years, last 6 months she has started mycophenolate mofetil and she still wants to continue the same pill. She declined any LARC even depo injection. She came to get her repeat script. Can I prescribe or reauthorise her Mycrogynon? Is there any risk?

Response:

Behcet’s disease, also known as Behcet’s syndrome, is a rare chronic autoinflammatory condition that is not well understood and the diagnosis can be difficult to establish. Blood vessels throughout the body become inflamed and typical symptoms include recurrent mouth and genital ulcers, eye inflammation, joint pain and skin lesions.[1] Vascular complications include venous thrombosis, arterial aneurysm and arterial thrombosis - estimates vary as to the (significant) percentage of individuals with Behcet’s syndrome who have major vascular complications.[2][3][4][5][6][7]

The FSRH CEU conducted a literature review on the subject of safety of use of contraception by women with Behcet’s and found no direct relevant evidence for use of any method.

You may wish to consider the following:-

  • UKMEC 2016 [8] advises that for women with multiple risk factors for cardiovascular disease, the risks associated with use of CHC and depot medroxyprogesterone acetate generally outweigh the benefits (UKMEC3). Use of the progestogen-only pill, etonogestrel implant and LNG-IUS is UKMEC2 (benefits generally outweigh risks) for women with multiple risk factors for cardiovascular disease (but evidence is limited) and use of the copper IUD is UKMEC1. ·
  • Whilst there is no interaction between hormonal contraception and mycophenolate mofetil, the patient should be advised that this drug is teratogenic, and that during and after use, a highly effective method of contraception is recommended. When making your prescribing decision, you may consider that use of combined hormonal contraception (CHC) may be best avoided, in view of the increased risk of cardiovascular complications associated with Behcet’s and given that alternative (more) effective contraceptive options are available that are not associated with the same increased risk of venous or arterial thrombotic events.

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Example Question Two

Regular bleeds during LNG-IUS use
27 year old: Mirena coil fitted 18 months ago. Return in regular menstrual cycle after 13 months amenorrhoea, no pcb or imb. Normal examination and USS confirmed that IUS is in the correct position. What percentage of women continue to have a regular cycle with Mirena or return to one after such a short period? Is there any reduction in effectiveness? She is not on any other medication.

Response

The majority of women using the 52mg LNG-IUS continue to ovulate; contraception is achieved by the effect of levonorgestrel on cervical mucus and on the endometrium. FSRH guideline ‘Intrauterine Contraception 2015’ [1] states that: “The LNG-IUS has little effect on the hypothalamic-pituitary ovarian axis, serum estradiol concentrations are not reduced, and the majority (>75%) of women continue to ovulate.” This document describes the mode of action in terms of pre- and post fertilisation effects: a progestogenic effect on cervical mucus, and a progestogenic effect on the endometrium. FSRH guideline ‘Problematic bleeding with hormonal contraception’ advises that about 24% of 52mg LMG-IUS users and about 13% of 13.5mg LNG-IUS users report amenorrhoea at 3 years. [2]

No direct study evidence is identified as to the relative contraceptive effectiveness of the 52mg LNG-IUS in women who are amenorrhoeic compared to those with cyclical bleeding. However it is noted that the 13.5mg and 19.5mg LNG-IUS, which are associated with less amenorrhoea than the 52mg LNG-IUS, are no less effective for contraception. [3]

The FSRH CEU has identified two further studies relevant to bleeding patterns during use of the 52mg LNG-IUS. In a survey of 231 52mg LNG-IUS users in Brazil, 35.5% reported amenorrhoea in the last 90 days and 7.3% reported regular monthly bleeds at the first follow up, a mean of 18 (+/-19.5) months after insertion. At the second follow up, a mean of 35.2 (+/-19.9) months after insertion, 54.9% reported amenorrhoea and 13.9% regular monthly bleeds.[4] In a cohort study (USA) of 1802 users of the 52mg LNG-IUS, at 12 months of use 15.4% of women reported no bleeding or spotting in the previous 6 months.

[5] Women with self-reported heavy bleeding at baseline were less likely to report amenorrhoea at 12 months than those with moderate bleeding atbaseline (ORadj,0.36; 95% CI, 0.16-0.69). The number of women with regular monthly bleeds was not reported.

The FSRH CEU advises that some women do continue to have monthly bleeds during use of the 52mg LNG-IUS. The contraceptive failure rate associated with use of the LNG-IUS is extremely low in typical use populations in which women have a variety of bleeding patterns.

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Example Question Three

Combined Hormonal Contraception (CHC) CPD question error?
I think the wrong answer is highlighted for question 6 in the CHC CPD answers. I think it should be answer b

Response

Question 6 is as follows:

Regarding switching to CHC, which one of the following statements is incorrect? a) 7 days of extra precautions are needed if CHC is started after taking desogestrel progestogen-only pills (POP) consistently and correctly b) No extra precautions are needed if CHC is started on same day as in-date subdermal implant is removed c) 7 days of extra precautions are needed if CHC is started on the same day that an in-date levonorgestrel-releasing intrauterine system (LNG-IUS) is removed d) Up to 9 days of extra precautions are required if an estradiol-containing COC is started and an in-date Cu-IUD is removed on day 3 of a menstrual cycle

Explanation:

As per the FSRH Starting and Switching document (Log in is required), no additional contraceptive precautions are required if CHC is started the day that an in-date implant is removed or after taking a desogestrel POP consistently and correctly. Therefore 6a is incorrect, and b is correct. 7 days of condoms are required when a LNG-IUS is removed and CHC started until anovulation is induced, thus 6c is correct. This question is also designed to test your knowledge that there are both ethinylestradiol and estradiol-containing COC with different starting recommendations. Estradiol-containing COC such as Qlaira require additional contraceptive requirements unless they are started on day 1 of menstruation - and for Qlaira specifically, additional precautions are for 9 days, rather than seven. Therefore 6d is correct.

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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.