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.

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

How do I get access to the Members' Evidence Request?

  • 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 (Diplomates, Associates, Members, Fellows). 

I haven't set up a log in yet - what should I do?

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. Please use an email address that we will have contacted you on previously.

Once you have registered you will be able to access the full service and search the database as shown in the video. 

 

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Example Question One

Would heavy use of cocaine be a contraindication to the use of the combined contraceptive pill?

Response:

The CEU did not identify any evidence relating specifically to use of contraception by recreational cocaine users. The UK Medical Eligibility for Contraceptive Use (UKMEC) [1], USMEC [2] and WHOMEC [3] do not, at present, make recommendations regarding contraception for women using recreational drugs.

Cocaine does not interact with combined hormonal contraception (CHC).[4,5] However, if a woman’s drug use impacts on her daily life such that her compliance with CHC is poor, contraceptive effectiveness may be reduced.

A review [6] of studies investigating the underlying cellular and molecular mechanisms of acute and chronic effects of cocaine on the cardiovascular system noted that the effect of cocaine on the cardiovascular system is multifactorial. The review notes that while ‘studies have consistently reported the acute effects of cocaine on the heart (e.g., electrocardiographic abnormalities, acute hypertension, arrhythmia, and acute myocardial infarction)... variable results have been reported for the chronic effects of cocaine’. Observational studies have reported an association between cocaine use and an increased risk of myocardial infarction.[6-8] and a greater risk of stroke.[8,9]. Sudden coronary events may be related to increased heart rate and blood pressure and coronary vasospasm. However, arterial thrombosis is promoted by cocaine use and some studies have demonstrated increased atherosclerosis in cocaine users.[10-13]

The review [6] also notes that the association between cocaine use and mortality is modulated by individual’s risk behaviours and cardiovascular risk. There is no evidence as to how the increased cardiovascular risk with cocaine relates to and interacts with the risk associated with CHC use.

In the absence of definitive evidence, the FSRH CEU suggests that cocaine use might best be considered an additional cardiovascular risk factor when considering prescription of CHC. UKMEC 2016 [1] advises that CHC use by women with multiple risk factors for cardiovascular disease (CVD) is UKMEC 3 (a condition where the theoretical or proven risk usually outweighs the advantages of using the method).

Importantly, cocaine use is associated with pregnancy complications, including early miscarriage, preterm labour and placental abruption[14]; it is important, therefore that women who use cocaine have effective contraception.

Clinicians should also consider whether a woman’s cocaine use increases the likelihood of sexual risk taking behaviour.

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Example Question Two

My current practice is to change Mirena every 4years if it is used for endometrial protection with oestrogen only HRT. It was mentioned to me recently that the advice on this has recently changed (by another GP, who does not fit Mirena). The online BNF still states every 4 years.

I would be grateful for advice on what is the current guideline from FSRH for how long Mirena should last for endometrial protection. Do I need to change my current practice.

Response:

It is established FSRH advice (since 2010) that Mirena® can be used for 5 years for endometrial protection. FSRH Clinical Guideline Contraception for Women Aged over 40 Years (August 2017, amended September 2019) [1] makes the following recommendation:-

“Women may use a Mirena 52 mg LNG-IUS with estrogen for up to 5 years for endometrial protection as part of an HRT regimen. Women using Mirena for this purpose must have the device changed every 5 years.”

FSRH advice that the Mirena® IUS could be used for 5 years rather than the licensed 4 years first entered guidance in FSRH Clinical Guideline Contraception for women aged over 40 years (2010- archived) which stated:

“Randomised trials have shown that the LNG-IUS is effective in providing endometrial protection from the stimulatory effects of estrogen replacement therapy. Data presented
to the regulatory authorities from these trials provided evidence of endometrial protection with a duration of just under 5 years. Therefore the LNG-IUS is only licensed for use for 4 years with HRT but may be used off licence for up to 5 years.”

Use of Mirena for 5 years for endometrial protection has since become standard practice without the appearance of reports of resulting endometrial abnormality.

FSRH CEU updated literature search this year identified a 2015 review paper [2] which summarises all the available evidence, including both the pivotal trials and subsequent key trials of use of the LNG-IUS for endometrial protection during use of estrogen replacement (at realistic standard doses - 2mg oral estradiol, 1.25mg conjugated equine estrogen, 50mcg/24 hours transdermal estradiol).

The review reports that pooled analysis of the data from the pivotal trials demonstrated no evidence of endometrial hyperplasia with use of the LNG-IUS with estrogen replacement for up to 5 years. In contrast incidence of endometrial hyperplasia in women using oral sequential HRT was 0.42 per 100 women years. All evidence indicates extremely effective endometrial protection. Of particular note are the following studies:-
• Hampton et. al. 2005 (London/Oxford) [3]: 82 perimenopausal women using Mirena with 1.25mg CEE. 80 % continued through to the end of the trial at cycle 60. 95% of women had non-proliferative endometrium at cycle 60; no endometrial hyperplasia was seen. Median endometrial thickness at study outset was 6mm (range 0-23mm); at cycle 60, mean endometrial thickness was 4mm (range 1-8).
• Varila et. al. 2001 (Finland) [4]: 29 postmenopausal women using Mirena with estrogen replacement (2mg oral estradiol or 50mcg transdermal estradiol) for 5 years. All endometrial samples showed strong suppression at 5 years, median endometrial thickness lower than at baseline; none demonstrated hyperplasia.
• Suvanto-Luukkonen et. al. 1999 (Finland) [5]: 12 postmenopausal women using Mirena with transdermal gel 1.5mg daily for 5 years. Epithelial atrophy and decidualised stroma was seen in all 12 women at 5 years, with no evidence of hyperplasia.
• The review article indicates that Bayer has further supporting data on file. The CEU has requested these data (7/10/2019).

The FSRH CEU comments that some of the evidence provided to support Mirena’s licence for endometrial protection demonstrated effectiveness up to 60 cycles, but because 60 28-day cycles is only 4 years, 7 and a bit months, the licence was granted for 4 years only. However, there is not evidence to suggest that there is a deterioration in endometrial protection between 4 years 7 months and 5 years. Therefore to avoid exposing women to the potential adverse health events that are associated with IUS insertion more frequently than necessary, current FSRH guidance is that Mirena can be used for this indication for 5 years

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Example Question Three

Does the same UKMEC apply to migraine with aura if it is catamanial? Isn't Estrogen contraindicated in stroke even if it has resulted from a cervical artery dissection? Case: 45 year old with stroke resulting from cervical artery dissection and catamanial migraine with history of aura has been advised to start COC.

Response:

Catamenial migraine is a term (not included in the International Classification of Headache Disorders [1] used to describe menstrual migraine or menstruation-associated migraine, both of which may occur with or without aura. Women who have migraine with aura and also use combined hormonal contraception (CHC) are at increased risk of thrombotic stroke. [2] The evidence is too limited to allow any differentiation to be made between types of migraine with aura. Therefore use of CHC for contraception is contraindicated if a woman has migraine with aura.

Similarly, there is inadequate evidence on which to base any specific recommendation regarding risk of adverse health events associated with use of CHC after a stroke secondary to cervical artery dissection. However, CHC is associated with increased risk of thrombotic, but not haemorrhagic stroke. [2]

If there is concern that a woman's past medical history puts her at increased risk of arterial thromboembolism, guidance suggests that an effective contraceptive method that is not associated with increased risk of thrombosis is considered in preference to CHC. Migraine associated with menstruation may be triggered by fluctuating estrogen levels (endogenous or exogenous) or by prostaglandin release associated with menstruation.[3] Hormonal contraceptives that abolish ovulation or abolish bleeding could be beneficial. If CHC was initiated by an expert in migraine management, they may consider that other management options for menstrual migraine have not been effective and that the benefits of use of CHC for management of migraine (as well as contraception) outweigh potential risks. If not you may wish to discuss effective alternative methods of contraception.

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Example Question Four

I have found conflicting information about condoms as a reliable method of contraception for IUD/IUS. Some people count it as a reliable method and some advice abstaining if only using condoms for contraception for IUD fitting.

If someone is using condoms and is reasonably sure that there was no accident, can I proceed with a coil insertion?

Response:

The FSRH Clinical Guideline Intrauterine Contraception [1] states

"For the purposes of excluding pregnancy, the CEU would advise that hormonal, intrauterine and barrier contraceptive methods can be considered reliable providing they have been used consistently and correctly on every incidence of intercourse. This should be assessed on an individual basis."
After thorough assessment of and discussion with a patient about their condom use, clinical judgement should guide your decision in individual cases.

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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.