Faculty of Sexual & Reproductive Healthcare Clinical Guidance Management of Vaginal Discharge in

Transcription

FACULTY
OF SEXUAL
& REPRODUCTIVE
HEALTHCARE
Faculty of Sexual &
Reproductive Healthcare
Clinical Guidance
Management of Vaginal Discharge in
Non-Genitourinary Medicine Settings
Clinical Effectiveness Unit
February 2012
ISSN 1755-103X
ABBREVIATIONS USED
BASHH
BNF
BV
CEU
CHC
Cu-IUD
CVR
FSRH
GUM
HIV
HVS
LNG-IUS
NAAT
OTC
RCT
SPC
STI
TV
VVC
VVS
British Association for Sexual Health and HIV
British National Formulary
bacterial vaginosis
Clinical Effectiveness Unit
combined hormonal contraception
copper-bearing intrauterine device
combined vaginal ring
Faculty of Sexual and Reproductive Healthcare
genitourinary medicine
human immunodeficiency virus
high vaginal swab
levonorgestrel-releasing intrauterine system
nucleic acid amplification test
over-the-counter
randomised controlled trial
Summary of Product Characteristics
sexually transmitted infection
Trichomonas vaginalis
vulvovaginal candidiasis
vulvovaginal swab
GRADING OF RECOMMENDATIONS
A
Evidence based on randomised controlled trials
B
Evidence based on other robust experimental or observational studies
C
Evidence is limited but the advice relies on expert opinion and has the
endorsement of respected authorities
3
Good Practice Point where no evidence exists but where best practice is based
on the clinical experience of the multidisciplinary group
Published by the Faculty of Sexual and Reproductive Healthcare
Registered in England No. 2804213 and Registered Charity No. 1019969
First published in 2012
Copyright © Faculty of Sexual and Reproductive Healthcare 2012
Permission granted to reproduce for personal and educational use only. Commercial copying, hiring and lending are prohibited.
CEU GUIDANCE
CONTENTS
Abbreviations Used
IFC
Grading of Recommendations
IFC
Summary of Key Recommendations
iii
1
Purpose and Scope
1
2
Background
1
2.1
1
3
4
5
6
7
8
Physiological discharge
What are the Commonest Causes of Altered Vaginal Discharge in
Women of Reproductive Age?
2
3.1
Non-sexually transmitted infections
2
3.2
Sexually transmitted infections (STIs)
3
3.3
Other causes of vaginal discharge
3
Management of Women Presenting with Vaginal Discharge
4
4.1
Clinical and sexual history
4
4.2
Assessment of symptoms
4
4.3
Examination, point-of-care investigations and STI testing
5
4.4
Laboratory investigations
5
Which Treatments are Appropriate for Women Complaining
of Vaginal Discharge?
8
5.1
Treatment of non-sexually transmitted infections
8
5.2
Treatment of sexually transmitted infections
9
Management of Vaginal Discharge in Special Circumstances
9
6.1
Vaginal discharge in pregnancy
9
6.2
Vaginal discharge in women with HIV
10
6.3
Recurrent vaginal discharge
10
Contraception and Vaginal Discharge
11
7.1
Is the efficacy of contraception affected by vaginal
discharge treatments?
11
7.2
Does contraception affect vaginal discharge?
11
Personal Hygiene and Vaginal Discharge
12
References
12
NHS Evidence
NHS Evidence - provided by NICE
© FSRH 2012
NHS Evidence has accredited the process used by the Faculty of Sexual and Reproductive Healthcare
of the Royal College of Obstetricians and Gynaecologists to produce guidelines. Accreditation is
valid for five years from May 2011 and is applicable to guidance produced using the processes
described in the Faculty of Sexual and Reproductive Healthcare: Clinical Effectiveness Unit
Framework for Guidance Development (May 2011). More information on accreditation can be
viewed at www.evidence.nhs.uk
i
CEU GUIDANCE
CONTENTS
Appendix 1: Development of CEU Guidance
16
Appendix 2: Summary of Laboratory Processing of Specimens from
Women with Vaginal Discharge
17
Appendix 3: Recommended Treatment Regimens for Bacterial
ii
Vaginosis, Vulvovaginal Candidiasis and Trichomonas
18
Discussion Point/Questions & Answers/Auditable Outcomes
21
Steps Involved in the Development of This Guidance Document
IBC
Comments and Feedback on Published Guidance
IBC
© FSRH 2012
CEU GUIDANCE
SUMMARY OF KEY RECOMMENDATIONS
Causes of vaginal discharge
3
Health professionals should be aware that the most common causes of altered vaginal
discharge are physiological, bacterial vaginosis (BV) and candida, but sexually
transmitted infections (STIs) and non-infective causes must be considered.
Management of vaginal discharge
3
A detailed history, including sexual history, is essential to identify the necessary
investigations and treatment options.
C
Women experiencing vaginal discharge who are at low risk of STI can be treated by
syndromic or empirical management (Figure 1).
3
All women with persistent vaginal discharge should be examined to exclude serious
pathology.
3
Women assessed as being at risk of STI, or who request testing should be offered
appropriate tests for chlamydia, gonorrhoea, syphilis and HIV.
3
A high vaginal swab (HVS) is of limited diagnostic value in the management of vaginal
discharge except in cases of inconclusive assessment, recurrent symptoms, treatment
failure, or in pregnancy, postpartum, post-abortion or post-instrumentation.
Treatment of vaginal discharge
A
Metronidazole and clindamycin administered either orally or vaginally are effective in
the treatment of BV.
C
In the management of BV, testing and treatment of male sexual partners is not
indicated but testing and treatment of female sexual partners can be considered.
A
Vaginal and oral azole antifungals are equally effective in the treatment of
vulvovaginal candidiasis (VVC).
3
Women with vulval symptoms of VVC may use topical antifungals (in addition to oral
or vaginal treatment) until symptoms resolve.
C
There is no need for routine screening or treatment of sexual partners in the
management of candidiasis.
A
Oral nitroimidazole drugs (e.g. metronidazole) are effective in treating trichomoniasis.
B
Current sexual partners of women diagnosed with Trichomonas vaginalis (TV) should
be offered a full sexual health screen and should be treated for TV irrespective of the
results of their tests.
Management of vaginal discharge in special circumstances
C
Women with BV who are pregnant or breastfeeding may use metronidazole 400 mg
twice daily for 5–7 days or intravaginal therapies. A 2 g stat dose of metronidazole is
not recommended in pregnancy or breastfeeding women.
C
Women with VVC in pregnancy should avoid oral antifungals.
A
Women with VVC in pregnancy can be treated with topical imidazoles. Single-dose
treatment is less effective than longer regimens of up to 7 days.
B
For HIV-positive women with TV, longer treatment regimens with oral metronidazole
may be more effective than a single dose.
A
For women with recurrent BV, suppressive treatment with metronidazole vaginal gel
may be considered. Evidence to support other regimens is limited.
© FSRH 2012
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CEU GUIDANCE
Management of vaginal discharge in special circumstances
3
Women using acidifying gels for recurrent BV can be advised to use them alternate
evenings for 1 month or longer if required.
B
For women with recurrent VVC, an induction and maintenance regimen may be used
for 6 months.
C
Recurrent TV is usually due to re-infection, but consideration should be given to the
possibility of drug resistance.
Contraception and vaginal discharge
C
Additional contraceptive precautions are not required when using antibiotics that do
not induce liver enzymes.
C
Women and male partners should be advised that latex contraceptives may be
damaged by some vaginal/vulval antifungal treatments.
C
Women using combined hormonal contraception who experience recurrent VVC may
wish to consider switching to an alternative method of contraception.
C
Women with a copper-bearing intrauterine device who experience recurrent BV may
wish to consider switching to an alternative method of contraception.
Personal hygiene and vaginal discharge
C
iv
Women experiencing vaginal discharge can be advised to avoid douching and local
irritants as part of general management.
© FSRH 2012
CEU GUIDANCE
FACULTY
OF SEXUAL
& REPRODUCTIVE
HEALTHCARE
Faculty of Sexual & Reproductive Healthcare
Clinical Effectiveness Unit in collaboration with
the British Association of Sexual Health and HIV
A unit funded by the FSRH and supported by NHS Greater Glasgow & Clyde
to provide guidance on evidence-based practice
FSRH and BASHH Guidance (February 2012)
Management of Vaginal Discharge in
(Update due by February 2017)
1
Purpose and Scope
This guidance provides information for health professionals working in non-genitourinary
medicine (GUM) settings on management of vaginal discharge in women of reproductive
age. Non-GUM settings include general practice, non-integrated or peripheral sexual health
clinics and gynaecology clinics. The document has been produced by the Faculty of Sexual
and Reproductive Healthcare (FSRH) in collaboration with the British Association for Sexual
Health and HIV (BASHH). It updates previous guidance published in 2006.1 Changes include:
l New tests for gonorrhoea and chlamydia
l Changes to treatments available for vulvovaginal candidiasis (VVC) and bacterial
vaginosis (BV)
l New advice on combined hormonal contraception (CHC) and antibiotics.
The guidance focuses on the most common causes of vaginal discharge in women of
reproductive age: physiological and infective. Less common causes are considered briefly
(e.g. foreign bodies, cervical ectopy and genital tract malignancy). Some recommendations
are provided on the management of VVC, BV and Trichomonas vaginalis (TV) during
pregnancy and in women with recurrent infection. This document is not intended to provide
comprehensive guidance on discharge in pregnancy or after surgical procedures where local
protocols or specific guidance may apply. The management of vaginal discharge in children
and postmenopausal women is outside the scope of this guidance.
Recommendations are based on available evidence and consensus opinion of experts. They
should be used to guide clinical practice but they are not intended to serve alone as a
standard of medical care or to replace clinical judgement in the management of individual
cases. A key to the Grading of Recommendations, based on levels of evidence, is provided
on the inside front cover of this document. Details of the methods used in developing this
guidance are outlined in Appendix 1 and in the Clinical Effectiveness Unit (CEU) section of the
FSRH website (www.fsrh.org). Information on the management of sexually transmitted
infections (STIs) can be found on the guidelines page of the BASHH website (www.bashh.org).
Information for patients is available from BASHH and from the Family Planning Association
(FPA) website (www.fpa.org.uk).
2
Background
2.1
Physiological discharge
It is normal and healthy for women of reproductive age to have some degree of vaginal
discharge. The quantity and type of cervical mucus changes during the menstrual cycle as a
result of hormonal fluctuations. Prior to ovulation, estrogen levels increase, altering cervical
mucus from non-fertile (thick and sticky) to fertile (clearer, wetter, stretchy and slippery). After
© FSRH 2012
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CEU GUIDANCE
ovulation, estrogen levels fall and progesterone levels increase; cervical mucus becomes
thick, sticky and hostile to sperm.
The vagina is colonised with commensal bacteria (normal vaginal flora). Rising estrogen levels
at puberty lead to colonisation with lactobacilli which metabolise glycogen in the vaginal
epithelium to produce lactic acid. Thus the vaginal environment is acidic and normally has a
pH≤4.5. Other commensal bacteria include anaerobes, diphtheroids, coagulase-negative
staphylococci and α-haemolytic streptococci. Some commensal organisms can cause a
change in discharge if they ‘overgrow’. These include Candida albicans, Staphylococcus
aureus and Streptococcus agalactiae (Group B streptococcus).
3
What are the Commonest Causes of Altered Vaginal Discharge in Women of
Reproductive Age?
There are three common causes of altered vaginal discharge in women of reproductive age:
3.1
l
Infective (non-sexually transmitted)
o Bacterial vaginosis
o Candida
l
Infective (sexually transmitted)
o Chlamydia trachomatis
o Neisseria gonorrhoeae
o Trichomonas vaginalis
o Herpes simplex virus
l
Non-infective
o Foreign bodies (e.g. retained tampons, condoms)
o Cervical polyps and ectopy
o Genital tract malignancy
o Fistulae
o Allergic reactions.
Non-sexually transmitted infections
3.1.1 Bacterial vaginosis
BV is the commonest cause of abnormal vaginal discharge in women of reproductive age.2
Reported prevalence varies and may be influenced by behavioural and/or
sociodemographic factors.3–5 It can occur and remit spontaneously and is characterised by
an overgrowth of mixed anaerobic organisms that replace normal lactobacilli, leading to an
increase in vaginal pH (>4.5). Typical signs and symptoms are shown in Table 1. Gardnerella
vaginalis is commonly found in women with BV but the presence of Gardnerella alone is
insufficient to constitute a diagnosis of BV because it is a commensal organism in 30–40% of
asymptomatic women. Other organisms associated with BV include Prevotella species,
Mycoplasma hominis and Mobiluncus species.
Reports of BV occurring in virgins9,10 led to the belief that BV was not an STI. However, there is
a growing body of evidence that suggests a link with sexual behaviour.7,11–13 A study that took
account of a wider range of sexual activities, including oral and digital intercourse, did not
find any cases of BV in truly sexually inexperienced women.11 Thus BV is considered to be
‘sexually associated’ rather than truly ‘sexually transmitted’. There is some evidence that
consistent condom use may help to reduce BV prevalence,7,14–16 although one study
suggested this may only be in women who were BV-negative at baseline.15
3.1.2 Vulvovaginal candidiasis
VVC is common among women of reproductive age.17 It is caused by overgrowth of yeasts;
C. albicans, in 70–90% of cases, with non-albicans species such as C. glabrata in the
remainder.17,18 The presence of candida in the vulvovaginal area does not necessarily require
treatment, unless symptomatic, as between 10% and 20% of women will have vulvovaginal
colonisation.
Candidiasis occurs most commonly when the vagina is exposed to estrogen, therefore it is
2
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CEU GUIDANCE
more common during the reproductive years and during pregnancy.17 An episode of VVC is
often precipitated by use of antibiotics.19 Immunocompromised women20,21 and women with
diabetes22,23 are predisposed to candidiasis. VVC does not appear to be associated with
tampons, sanitary towels or panty liners when they are used appropriately.24
As VVC can be found in non-sexually active individuals, it is not classed as an STI.
3.2
Sexually transmitted infections
3.2.1 Chlamydia trachomatis
Chlamydia trachomatis, the most common bacterial STI in the UK, is usually asymptomatic in
women (approximately 70%). However, women may present with vaginal discharge due to
cervicitis, abnormal bleeding (postcoital or intermenstrual) due to cervicitis or endometritis,
lower abdominal pain, dyspareunia or dysuria.
3.2.2 Neisseria gonorrhoeae
Gonorrhoea is an STI caused by Neisseria gonorrhoeae. Up to 50% of women will be
asymptomatic. Common symptoms may include increased or altered vaginal discharge and
lower abdominal pain. It can also be a rare cause of heavy menstrual, postcoital or
intermenstrual bleeding due to cervicitis or endometritis.25
3.2.3 Trichomonas vaginalis
TV is a flagellated protozoan that causes vaginitis. Women with TV commonly complain of
vaginal discharge and dysuria (due to urethral infection). Typical signs and symptoms are
shown in Table 1. TV is always sexually transmitted and is a rarer condition than BV or VVC.
3.2.4 Herpes simplex
Women with cervicitis due to herpes simplex virus infection may occasionally present with
vaginal discharge.
3.3
Other causes of vaginal discharge
Other causes of vaginal discharge include foreign bodies (e.g. retained tampons or
condoms), cervical ectopy or polyps, genital tract malignancy, fistulae and allergic reactions.
Exclusion of infective and other causes can help confirm that a vaginal discharge is
physiological.
There is some association between methods of contraception and vaginal discharge (see
Section 7 on page 11). Women complaining of vaginal discharge should be asked about
current and past contraception.
Douching is the process of intravaginal cleaning with a liquid solution. Some women use the
practice of douching as part of their general hygiene or cultural practice. Data suggest that
douching changes vaginal flora and may predispose women to BV,26–28 although not all
studies have reported this finding.29 Overall, the evidence suggests that douching should be
discouraged as there are no proven health benefits.30,31 Recommendations on personal
hygiene and vaginal discharge can be found in Section 8 on page 12.
Women with cervical ectopy may complain of increased physiological discharge. Ectopy is a
normal finding in women of reproductive age but treatments such as acidic gel, silver nitrate
cauterisation, laser or cold coagulation are occasionally used in a gynaecology setting for
symptomatic relief of vaginal discharge or postcoital bleeding. There is a lack of robust
evidence for the effectiveness of these treatments in reducing vaginal discharge. Cervical
pathology must be excluded prior to treatment, and women should be informed of potential
risks of treatment and the fact that discharge symptoms may initially worsen before there is
any improvement.
3
Health professionals should be aware that the most common causes of altered vaginal
discharge are physiological, BV and candida, but STIs and non-infective causes must be
considered.
© FSRH 2012
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CEU GUIDANCE
Table 1 Summary of signs and symptoms of infective causes of vaginal discharge
Sign/symptom
Bacterial vaginosis
Candida
Trichomoniasis
Discharge
Odour
Itch
Other possible symptoms
Thin
Offensive/fishy
None
Scanty to profuse
Offensive
Vulval itch
Dysuria
Lower abdominal pain
Visible signs
Discharge coating the
vagina and vestibule
Thick white
Non-offensive
Vulval itch
Soreness
Superficial dyspareunia
Dysuria
Normal findings
or
No vulval inflammation
Point-of-care test: vaginal pH
>4.5
Vulval erythema
Oedema
Fissuring
Satellite lesions
≤4.5
Frothy yellow discharge
Vulvitis
Vaginitis
Cervicitis
‘Strawberry cervix’ (ectocervix
sometimes resembles the surface of
a strawberry)
>4.5
4
Management of Women Presenting with Vaginal Discharge
4.1
Clinical and sexual history
When a woman presents with a vaginal discharge that she feels is different from her normal
discharge this should be assessed by first taking a clinical history. She may have underlying
concerns (e.g. STI or cancer) or specific expectations that should be explored.
The presence of vaginal discharge is, in itself, a poor predictor of an STI. Nevertheless, a sexual
history (e.g. number and gender of partners, sexual activities, use of condoms) should be
taken to assess the risk of STIs. Sexually active women are at higher risk of STI if they are aged
<25 years; or have changed their sexual partner or had more than one sexual partner in the
last 12 months. Other risk factors include a lack of consistent condom use,32 and a previous
diagnosis of chlamydia infection in the last 12 months.33
4.2
Assessment of symptoms
Symptoms associated with vaginal discharge can guide a health professional to the most
likely cause (Table 1).
The characteristics of the vaginal discharge should be determined:
l What has changed
l Onset
l Duration
l Odour
l Cyclical changes
l Colour
l Consistency
l Exacerbating factors (e.g. after intercourse).
Enquiry should also cover any associated symptoms:
l Itchinga
l Superficial dyspareuniaa
l Vulval or vaginal pain
l Dysuria
l Abnormal bleeding (heavy, intermenstrual or postcoital)b
l Deep dyspareuniab
l Pelvic or abdominal painb
l Feverb.
NB. aItching or superficial dyspareunia may indicate dermatological disease (e.g. lichen
planus), which can be associated with vaginal discharge [see Royal College of Obstetricians
and Gynaecologists (RCOG) guidance on vulval skin disease34]. bThese symptoms are
indicative of upper genital tract infection. For management see BASHH guidance on pelvic
inflammatory disease.35
4
© FSRH 2012
CEU GUIDANCE
The health professional should determine if prescribed medicines, over-the-counter (OTC)
treatments or home remedies have been tried. Guidelines are available for OTC treatment of
presumed candida in pharmacies.36,37 However, studies suggested that even women with a
previously confirmed episode of candida are not good at self-diagnosis.38 Women appear to
be very aware of VVC but less aware of BV, and therefore it may be that women who selfdiagnose themselves with VVC may actually have other conditions.
4.3
Examination, point-of-care investigations and STI testing
History-taking alone may guide health professionals towards the most likely diagnosis but
diagnostic accuracy varies. In addition to the clinical and sexual history, physical examination
and vaginal pH may be helpful.
It should be standard clinical practice to offer to examine people presenting with genital
symptoms.39 If the history indicates candidiasis or BV, the risk of STI is low, and there are no
symptoms indicative of upper genital tract infection, treatment for candidiasis or BV may be
given without examination (i.e. syndromic management).39 Women should be advised to
undergo examination if symptoms persist or reoccur (Figure 1).39
STI testing should ideally be offered to all sexually active women. For women who decline an
offer of examination, a self-taken vulvovaginal swab (VVS) may be an option for chlamydia
+/– gonorrhoea testing by nucleic acid amplification test (NAAT) (see laboratory
investigations on page 7). Urine tests are appropriate for men but in women NAAT testing of
VVS or endocervical swabs are preferable to urine.
Women who accept examination should have a vaginal pH measurement using narrowrange pH paper (pH 4–7). Secretions should be collected from the lateral sides of the vaginal
wall using a loop or swab. Vaginal pH testing can be used to assess the likelihood of candida
(pH≤4.5) or of BV or TV (pH >4.5) but it cannot distinguish between BV and TV.
If STI testing is indicated and/or requested, endocervical swabs for chlamydia and
gonorrhoea should also be taken, and a high vaginal swab (HVS) may be indicated in some
cases (see page 7).
Physical examination should include:
l Inspection of the vulva (for obvious discharge, vulvitis, ulcers, other lesions or changes)
l Speculum examination (inspection of: vaginal walls, cervix, foreign bodies; amount,
consistency and colour of discharge).
Where there is any suggestion of upper genital tract infection physical examination should
also include:
l Abdominal palpation (for tenderness/mass)
l Bimanual pelvic examination (adnexal and/or uterine tenderness/mass, cervical motion
tenderness).
3
A detailed history, including sexual history, is essential to identify the necessary investigations
and treatment options.
C
Women experiencing vaginal discharge who are at low risk of STI can be treated by
syndromic or empirical management (Figure 1).
3
All women with persistent vaginal discharge should be examined to exclude serious pathology.
4.4
Laboratory investigations
Health professionals should liaise with their local laboratory to find out how specimens are
routinely processed and what information will be provided on result forms. Relevant clinical
information should be provided to laboratory staff to help in processing of samples:
l Site sampled
l Suspicion of specific infection
l Treatment failure or recurrent symptoms
l Current/recent use of intrauterine device/system
l Current/recent pregnancy
l Recent procedure or instrumentation
l Foreign body.
© FSRH 2012
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Figure 1 Algorithm for Management of Vaginal Discharge in Non-Genitourinary Medicine Settings
Women of reproductive age complaining of vaginal discharge
Things to consider in clinical and sexual history
l
l
l
l
l
l
l
l
l
l
Reasons for presentation and concerns
Characteristics of the discharge (changes, odour, onset, duration, colour, consistency)
Any associated symptoms (itch, superficial dyspareunia, dysuria) and symptoms indicative of upper reproductive
tract infection (abdominal pain, deep dyspareunia, abnormal vaginal bleeding, dysuria, pyrexia)
Risk of STIs (aged <25 years, new sexual partner or more than one sexual partner in last year)
Contraceptive use, pregnancy, postpartum, post-abortion
Concurrent medications, previous treatments used (prescription, over-the-counter or home remedies)
Medical conditions (e.g. diabetes, immunocompromised state)
Non-infective causes of discharge (foreign body, cervical ectopy, polyps, genital tract malignancy, dermatological
disease)
Not sexually active or low risk of
STI
AND
No symptoms indicative of
upper reproductive tract
infection
Declines offer
of examination
Accepts offer
of examination
Syndromic
Treatment
Based on
clinical and
sexual history
Empirical
Treatment
Based on pH,
clinical and
sexual history.
Can be given
before results
of any
laboratory
testing
pH
≤4.5
Non-offensive
white
discharge with
itch
Candida
- treat with
antifungal
l
l
l
l
l
l
Higher risk of STI (aged <25 years, new sexual
partner or more than one sexual partner in last year)
OR Upper reproductive tract symptoms
OR Women requesting investigation/STI test
OR Pregnancy, postpartum post-abortion,
post-instrumentation
Recurrent infection
Failed treatment
Accepts
examination
Inconclusive
assessment
Awaiting
results
l
l
l
l
l
Declines
examination*
Investigate
Examination (including bimanual if
patient has symptoms of upper
reproductive tract infection)
Vaginal pH (see page 5)
Endocervical swab(s) for gonorrhoea
and chlamydia (see page 7)
Offer blood test for HIV and syphilis
Consider high vaginal swab
(see page 7)
VVS for CT +/–
NG and
syndromic
treatment
pH
>4.5
Offensive
discharge
without an itch
BV
- treat with
metronidazole
(first line)
Recurrent infection, failed treatment,
suspicion of STI (e.g. vaginitis)*
*NB. Examination should be encouraged to exclude sexually transmitted infection, malignancy or foreign body.
Abbreviations: BV, bacterial vaginosis; CT, Chlamydia trachomatis; NG, Neisseria gonorrhoeae; STI, sexually transmitted
infection; VVS, vulvovaginal swab.
6
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Investigations should be undertaken according to the latest clinical standards and/or local
protocols.39 Appendix 2 summarises the various laboratory tests and methods for investigating
vaginal discharge and testing for STIs.
There is agreement in the UK that the minimum tests that constitute an STI screen are
chlamydia, gonorrhoea, syphilis and HIV tests.39,40 Lengthy pre-test discussion is not required
unless a patient needs or requests this.41,42 HIV testing in primary care settings has been
encouraged by Chief Medical and Nursing Officers.42 Guidelines on HIV testing41,43 including
pre- and post-test discussions are available from BASHH.
4.4.1 High vaginal swabs
HVS are often used to diagnose causes of vaginal discharge but they are of limited value.44
BV may be under-diagnosed if no other diagnostic criteria are used. Reporting of commensal
bacteria can cause anxiety and lead to overtreatment.
HVS may be used to aid the diagnosis of BV, VVC, TV or other genital tract infections (e.g.
streptococcal organisms) but their use should generally be reserved for the following situations:
l When symptoms, signs and/or pH are inconsistent with a specific diagnosis
l Pregnancy, postpartum, post-abortion or post-instrumentation
l Recurrent symptoms
l Failed treatment.
If TV is suspected an HVS can be taken from the posterior fornix but sensitivity may be low
because motility reduces with transit time. Therefore, referral to GUM is recommended for
confirmation by wet microscopy +/– culture, and also for partner notification. Laboratories
may not routinely perform wet microscopy or TV culture so suspected TV should be mentioned
on the laboratory request form.
4.4.2 Nucleic acid amplification tests
NAATs should be used for the diagnosis of chlamydia and gonorrhoea (Appendix 2).
Combined chlamydia and gonorrhoea tests are now available. False-positives can occur with
NAATs. In areas of low disease prevalence the positive predictive value may be suboptimal
(<90%) and local laboratories may advise a supplementary or confirmatory test.39 This should
be agreed with your local laboratory.
4.4.3 Endocervical swabs
If a woman is being examined an endocervical swab should be used for NAAT testing for
gonorrhoea and/or chlamydia. If gonorrhoea is suspected an additional endocervical swab
should be taken for microscopy, culture and sensitivity. Facilities for direct plating of samples
for N. gonorrhoeae culture are not usually available in primary care, but transport medium
(e.g. charcoal swab) gives acceptable results if plated immediately in the laboratory. If
sending swabs to the laboratory in transport medium they should be stored at 4ºC as soon as
possible and transported to the laboratory ideally within 48 hours. Fluctuations in temperature
should be avoided during transit.
4.4.4 Microscopy
Immediate microscopy of specimens (wet mount of posterior vaginal fluid and dry Gram
stained slide of lateral vaginal wall and endocervical fluid) can potentially identify TV
(sensitivity 70%), candidiasis (sensitivity 50%) and gonorrhoea (sensitivity 30–50%).39 Dry Gram
stain is the definitive diagnostic test for BV.
When immediate microscopy is not available a dry Gram stain slide can be prepared in the
laboratory from an HVS or endocervical swab. However, this is far less sensitive for BV diagnosis
than immediate microscopy (sensitivity 37% vs >95%)39,45 (Appendix 2).
A wet mount can be prepared in the laboratory from an HVS by dipping a small amount of
discharge into saline on a microscopic slide. This is less sensitive than immediate microscopy
but can identify TV and candida.
4.4.5 Culture
Culture can be used to detect candida if microscopy is inconclusive or if the identification of
© FSRH 2012
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species type would be useful (recurrent infection). Culture media are also available for TV.
Gonococcal cultures should be performed for anyone with a positive gonorrhoea NAAT result
so that antibiotic sensitivity testing can be performed and resistant strains identified.25,39 A test
of cure is also needed and should be reported to the Health Protection Agency if positive.25
3
Women assessed as being at risk of STI, or who request testing, should be offered appropriate
tests for chlamydia, gonorrhoea, syphilis and HIV.
3
An HVS is of limited diagnostic value in the management of vaginal discharge except in cases
of inconclusive assessment, recurrent symptoms, treatment failure, or in pregnancy,
postpartum, post-abortion or post-instrumentation.
5
Which Treatments are Appropriate for Women Complaining of Vaginal
Discharge?
Appendix 3 details the treatment regimens for BV, TV and candida infection in particular
situations. Costs are available in the British National Formulary (BNF).46
5.1
Treatment of non-sexually transmitted infections
High initial cure rates (70–80%) are achieved with medical treatment. In the treatment of nonpregnant women with BV, clindamycin and metronidazole treatments show comparable
efficacy in terms of eradication of symptoms, irrespective of dosing regimen or route of
administration.2,47 Oral metronidazole is the recommended first-line treatment for BV in the UK
because it is less expensive than vaginal preparations and safer than oral clindamycin, which
has been associated with pseudomembranous colitis.2 However, alternative treatments can
be considered for women who experience side effects on oral metronidazole such as metallic
taste and gastrointestinal symptoms2,47 (Appendix 3).
There is limited evidence for the effectiveness of acidifying gels in the treatment of BV but they
may help prevent recurrence (see section on recurrent vaginal discharge on page 10).
Treatment of male partners has not been shown to be effective in preventing recurrence of
BV in women.48,49 Therefore, routine testing and treatment of male sexual partners is not
currently recommended. As studies have found high concordance rates of vaginal microflora
amongst monogamous women who have sex with women (WSW),50 consideration may be
given to testing and treating female partners of women with BV.
A
Metronidazole and clindamycin administered either orally or vaginally are effective in the
treatment of BV.
C
In the management of BV, testing and treatment of male sexual partners is not indicated but
testing and treatment of female sexual partners can be considered.
A Cochrane review51 found that for uncomplicated VVC, treatment with oral and intravaginal
imidazole and triazole antifungals has demonstrated a clinical cure of up to 80% and
mycological cure of up to 83%. No statistically significant differences have been shown
between oral and intravaginal antifungals when administered as single doses.51
Choice of treatment should take into account personal preference, cost, availability and
affordability.51
There are no data to support treatment of partners.
Topical antifungal preparations can also be offered for symptom relief but there is little
evidence of added benefit over emollients, and there is potential for local irritant reaction.
A
Vaginal and oral azole antifungals are equally effective in the treatment of VVC.
3
Women with vulval symptoms of VVC may use topical antifungals (in addition to oral or
vaginal treatment) until symptoms resolve.
C
There is no need for routine screening or treatment of sexual partners in the management of
candidiasis.
8
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5.2
Treatment of sexually transmitted infections
The management of STIs should be in line with national standards and current clinical
guidance from BASHH.25,39,52–55 Where testing for other STIs or partner notification are not
available, local integrated pathways should be in place to facilitate referral (Box 1).
Nitroimidazole drugs (e.g. metronidazole, tinidazole) are effective in achieving cure.56 While a
single oral dose can achieve cure, side effects may be more frequent when compared with
a longer course of treatment. Intravaginal treatment cure rates are low.56 In the UK, first-line
recommended treatment is oral metronidazole57 (Appendix 3).
As TV is an STI, treatment of partners is recommended.57 Test of cure is only recommended if
symptoms persist or recur.57
A
Oral nitroimidazole drugs (e.g. metronidazole) are effective in treating trichomoniasis.
B
Current sexual partners of women diagnosed with TV should be offered a full sexual health
screen and should be treated for TV irrespective of the results of their tests.
5.2.2 Chlamydia and gonorrhoea
Health professionals should refer to current national guidance for information on the
management of chlamydia and gonorrhoea.25,32,33
6
Management of Vaginal Discharge in Special Circumstances
6.1
Vaginal discharge in pregnancy
A woman’s obstetrician should be informed of vaginal discharge symptoms in pregnancy and
any tests or treatment given.
Having BV during pregnancy is associated with adverse events and in particular an increased
risk of preterm birth.4,58–60 Treatment of BV before 20 weeks’ gestation and treatment of
women with a previous preterm birth may reduce adverse pregnancy outcomes but there is
currently little evidence that screening and treating all women with asymptomatic BV will
prevent preterm birth.61 In the UK, routine screening for BV in pregnant women is not currently
recommended but if BV is identified as a cause of vaginal discharge or as an incidental
finding it should be treated.62
Although current evidence suggests that metronidazole is safe in pregnancy and is not
teratogenic, single stat doses should be avoided63,64 (Appendix 3).
C
Women with BV who are pregnant or breastfeeding may use metronidazole 400 mg twice
daily for 5–7 days or intravaginal therapies. A 2 g stat dose of metronidazole is not
recommended in pregnancy or breastfeeding women.
VVC is common during pregnancy. There is no evidence of any adverse effect on pregnancy.
Topical imidazoles (e.g. clotrimazole, econazole, miconazole, fenticonazole) have been
found to be effective in pregnant women with VVC but a longer treatment regimen may be
required65 (Appendix 3).
Oral antifungals should be avoided during pregnancy because of a lack of teratogenicity
data.46
Box 1 Indications for referral to genitourinary medicine
l
l
l
l
l
l
Partner notification not available in clinic/service
Gonorrhea culture required (gonorrhoea contact or positive nucleic acid amplification test)
Trichomonas infection suspected
Failure to respond to treatment
Diagnostic uncertainty
Pelvic inflammatory disease suspected
© FSRH 2012
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C
Women with VVC in pregnancy should avoid oral antifungals.
A
Women with VVC in pregnancy can be treated with topical imidazoles. Single-dose treatment
is less effective than longer regimens of up to 7 days.
TV may be associated with preterm delivery and low birth weight.66 A Cochrane review65
investigated the effects of different treatments for TV in pregnancy. Over 90% of women were
cleared of vaginal TV after treatment with metronidazole but it is not clear if this has any
impact on pregnancy outcomes.67 As with treatment of BV in pregnancy, single stat doses of
metronidazole should be avoided (Appendix 3).
6.2
Vaginal discharge in women with HIV
When prescribing for women with HIV using antiretroviral medication, practitioners can refer
to the Liverpool Pharmacology Group drug interactions website (www.hiv-druginteractions.
org), the BNF (www.bnf.org) or Summary of Product Characteristics (SPC) (www.medicines.
org.uk/emc/) for advice on potential interactions (Appendix 3).
A longitudinal analysis68 found that BV appears to be more prevalent and persistent among
women diagnosed with HIV, particularly women who are immunocompromised. Treatment is
as for all other women.
TV may increase the risk of HIV transmission via increased genital shedding of the virus.
Treatment of TV has been shown to reduce viral shedding.69
Treatment with metronidazole over 7 days appears to be more effective in women with HIV
than a single dose.70 A study found that although rates of treatment failure were similar
among HIV-positive and HIV-negative women, HIV-positive women were more likely to have
sexual re-exposure. Retesting 3 months after treatment completion may be warranted.71
B
For HIV-positive women with TV, longer treatment regimens with oral metronidazole may be
more effective than a single dose.
Among women diagnosed as HIV-positive, VVC has been shown to occur more commonly
and with greater persistence than amongst those who are not HIV-positive;20,21 clinical
severity of VVC is comparable.20
6.3
Recurrent vaginal discharge
If symptoms recur, the history should be revisited and other causes considered. Referral to a
specialist clinic (e.g. GUM, vulval clinic) should be considered.
6.3.1 Recurrent BV
There is no specifically agreed definition of recurrent BV. Despite high initial cure rates,
recurrence of BV is high. At 12 months a cohort study reported a median recurrence rate of
58% after treatment with metronidazole.72
Cited risk factors for recurrence include female, new or multiple sexual partners, oral sex, and
copper-bearing intrauterine device (Cu-IUD) use.12,29,72–74
Optimal treatment for recurrent BV has not been established. Evidence from an RCT75
comparing twice-weekly metronidazole vaginal gel to placebo for 16 weeks showed that
women receiving maintenance therapy were more likely to remain disease-free during
treatment, and for 12 weeks after, than those treated with placebo. However, even with
metronidazole maintenance therapy only 35% of patients remained recurrence-free 12 weeks
after stopping the treatment. Those receiving vaginal metronidazole gel had a higher rate of
symptomatic VVC than placebo users.75
A Cochrane review has suggested that there is currently insufficient evidence to recommend
the use of probiotics either before, during or after antibiotic treatment as a means of reducing
recurrence.76
10
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Evidence on the use of acidifying gels is mixed. The studies are small but there is evidence to
suggest that acidifying gels may help to reduce relapse rates77,78 and can maintain acidic
vaginal pH at 1 month follow-up.78 Compared to clindamycin vaginal cream 5 g per night for
7 nights, acidic vaginal gel used for 3 weeks following tinidazole 2 g stat dose resulted in a
higher percentage of women ‘clinically cured’ and with vaginal pH <4.5.78 However, findings
from another RCT in which individuals were randomised to either a placebo gel or 5 ml acetic
acidic gel twice daily for 7 days failed to demonstrate that this treatment was effective.79 Two
lactic acid vaginal gel products are currently available for prescription and OTC sale in the UK
(see BNF46 and Appendix 3).
A
For women with recurrent BV, suppressive treatment with metronidazole vaginal gel may be
considered. Evidence to support other regimens is limited.
3
Women using acidifying gels for recurrent BV can be advised to use them alternate evenings
for 1 month or longer if required.
6.3.2 Recurrent VVC
Recurrent VVC is usually defined as four or more episodes of symptomatic mycologically
proven VVC in 1 year. The pathogenesis is poorly understood. Recurrent VVC occurs in less
than 5% of women. Suppression and maintenance treatment is often recommended.80 An
RCT81 showed that women receiving a maintenance period of fluconazole were more likely
to remain disease-free during and for 6 months after than those treated with placebo,
although most women who received the maintenance regimen had a relapse within a year.
Non-conventional management regimens such as dietary changes, use of probiotics, tea tree
oil and not wearing tight clothing have been studied. There is currently insufficient evidence
to support their recommendation in treatment.80,82
B
For women with recurrent VVC, an induction and maintenance regimen may be used for
6 months.
6.3.3 Recurrent TV
Recurrent TV is usually due to re-infection, although resistance to treatment can also be a
cause. Treatment, advice on avoidance of sex or use of condoms and partner notification are
required. Health professionals should consider involvement of GUM services.
C
Recurrent TV is usually due to re-infection, but consideration should be given to the possibility
of drug resistance.
7
Contraception and Vaginal Discharge
7.1
Is the efficacy of contraception affected by vaginal discharge treatments?
Guidance on the concomitant use of antibiotics and hormonal contraception changed in
2010.46,83 In women using CHC additional contraceptive precautions are no longer required
when using antibiotics that do not induce liver enzymes. Enzyme-inducing antibiotics (e.g.
rifampicin) are the only antibiotics that potentially interact with hormonal contraceptives and
this type of antibiotic is not usually used in the management of vaginal discharge.
The BNF (www.bnf.org) and the SPC (www.medicines.org.uk/emc/) for vaginal and topical
preparations containing econazole, miconazole, isoconazole, fenticonazole or clotrimazole
warn that these products may damage latex contraceptives. Clindamycin cream may also
weaken condoms.84 Alternative precautions such non-latex barrier methods or avoidance of
sex should be advised during use and pragmatically for several days after stopping.
D
Additional contraceptive precautions are not required when using antibiotics that do not
induce liver enzymes.
C
Women and male partners should be advised that latex contraceptives may be damaged by
some vaginal/vulval antifungal treatments.
7.2
Does contraception affect vaginal discharge?
VVC occurs most commonly when the vagina is exposed to estrogen. However, there is no clear
© FSRH 2012
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evidence as to whether the use of hormonal contraception increases the risk of VVC.85 One
study has suggested that the progestogen-only injectable may reduce a woman’s susceptibility
to recurrent VVC,86 possibly because of its anovulatory effect and relative hypoestrogenism.
Women using CHC who have recurrent VVC may wish to consider alternative contraception but
there is a lack of evidence to show whether there is any benefit from switching to a lower dose
combined preparation or a progestogen-only method, other than the injectable.
The Cu-IUD has been identified as a possible risk factor for acute or recurrent VVC87 but there
is no consistent evidence of an association. There is some evidence to demonstrate that
yeasts adhere to IUDs88,89 and the combined vaginal ring (CVR).90 CVR users have been
reported as experiencing more vaginal irritation and discharge compared with combined pill
users.91 However, a study of the effect of CVR use on vaginal flora showed no increase in
numbers of inflammatory cells or pathogenic bacteria.92
Although cervical cytology slides from levonorgestrel-releasing intrauterine system (LNG-IUS)
users have shown increased presence of candida with time from insertion, rates of
symptomatic infection did not change significantly.93,94
Oral combined contraception and condoms have been associated with a reduced risk of
BV,14,95 whilst BV is more common in users of the Cu-IUD.74 The association between BV and
use of the LNG-IUS is unclear. The progestogen-only implant and injectable may be
associated with a decreased risk of BV.96
C
Women using CHC who experience recurrent VVC may wish to consider switching to an
alternative method of contraception.
C
Women with a Cu-IUD who experience recurrent BV may wish to consider switching to an
alternative method of contraception.
8
Personal Hygiene and Vaginal Discharge
Personal hygiene measures can be advised for women who are prone to vaginal discharge
and/or pruritis (e.g. regular changing of sanitary protection, avoidance of douching and of
potentially irritant chemicals in toiletries, antiseptics, wipes, so-called ‘feminine hygiene’
products, washing powders, fabric dyes, and so on). RCOG guidance contains patient
information on general care of the vulval skin, including use of emollients and soap substitutes
which prevent dryness and loss of the skin’s natural barrier functions.34
C
Women experiencing vaginal discharge can be advised to avoid douching and local irritants
as part of general management.
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findings from the HIV epidemiology research study. Am Coll Obstet Gynecol 2001; 984: 656–663.
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Kissinger P, Amedee A, Clark RA, Dumestre J, Theall KP, Myers L, et al. Trichomonas vaginalis treatment reduces
vaginal HIV-1 shredding. Sex Transm Dis 2009; 361: 11–16.
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Kissinger P, Mena L, Levison J, Clark RA, Gatski M, Henderson H, et al. A randomized treatment trial: single versus 7-day
dose of metronidazole for the treatment of Trichomonas vaginalis among HIV-infected women. J Acquir Immune
Defic Syndr 2010; 55: 565–571.
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Centers for Disease Control and Prevention. Diseases Characterized by Vaginal Discharge. Sexually Transmitted
Diseases Treatment Guidelines. 2010. http://www.cdc.gov/std/treatment/2010/toc.htm [Accessed 7 February 2012].
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vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence.
J Infect Dis 2006; 193: 1479–1486.
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Thulkar J, Kriplani A, Agarwal N, Vishnubhatla S. Aetiology and risk factors of recurrent vaginitis and its association with
various contraceptive methods. Ind J Med Res 2010; 131: 83–87.
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Joesoef MR, Karundeng A, Runtupalit C, Moran JS, Lewis JS, Ryan CA. High rate of bacterial vaginosis among women
with intrauterine devices in Mando, Indonesia. Contraception 2001; 64: 169–172.
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McClelland RS, Richardson BA, Hassan WM, Chohan V, Lavreys L, Mandaliya K, et al. Improvement of vaginal health
for Kenyan women at risk for acquisition of human immunodeficiency virus type 1: results of a randomized trial. J Infect
Dis 2008; 197: 1355–1357.
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Senok AC, Verstaelen H, Temmerman M, Botta GA. Probiotics for the treatment of bacterial vaginosis. Cochrane
Database Syst Rev 2009; 4: CD006289.
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Andersch B, Lindell D, Dahlen I, Brandberg A. Bacterial vaginosis and the effect of intermittent prophylactic treatment
with an acid lactate gel. Gynecol Obstet Invest 1990; 30: 114–119.
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Milani M, Barcellona E, Agnello A. Efficacy of the combination of 2 g oral tinidazole and acidic buffering vaginal gel
in comparison with vaginal clindamycin alone in bacterial vaginosis: a randomized, investigator-blinded, controlled
trial. Eur J Obstet Gynecol Reprod Biol 2003; 109: 67–71.
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Holley RL, Richter HE, Varner RE, Pair L, Schwebke JR. A randomized, double-blind clinical trial of vaginal acidification
versus placebo for the treatment of symptomatic bacterial vaginosis. Sex Transm Dis 2011; 314: 236–238.
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British Association of Sexual Health and HIV Clinical Effectiveness Group. Management of Vulvovaginal Candidiasis.
2007. http://www.bashh.org/documents/1798 [Accessed 7 February 2012].
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Sobel JD, Wiesenfeld HC, Martens M. Maintenance fluconazole therapy for recurrent vulvovaginal candidiasis. N Engl
J Med 2004; 351: 876–883.
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Watson C, Calarbretto H. Comprehensive management of conventional and non-conventional methods of
management of recurrent vulvovaginal candidiasis. Aust N Z J Obstet Gynaecol 2007; 47: 262–272.
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Contraception. 2011. http://www.fsrh.org/pdfs/CEUGuidanceDrugInteractionsHormonal.pdf [Accessed 7 February
2012].
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Limited.
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Summary
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Geiger AM, Foxman B. Risk factors for vulvovaginal candidiasis: a case-control study among university students.
Epidemiology 1996; 7: 182–187.
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Dennerstein GJ. Depo-provera in the treatment of recurrent vulvovaginal candidiasis. J Reprod Med Obstet Gynecol
1986; 31: 801–803.
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value of chromID Candida agar versus CHROMagar Candida for recovery and presumptive identification of vaginal
yeast species. Med Mycol 2011; 49: 16–25.
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Auler ME, Morreira D, Rodrigues FF, Abr AM, Margarido PF, Matsumoto FE, et al. Biofilm formation on intrauterine
devices in patients with recurrent vulvovaginal candidiasis. Med Mycol 2010; 48: 211–216.
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Chassot F, Negri MFN, Svidzinski AE, Donatti L, Peralta RM, Svidzinski TIE, et al. Can intrauterine contraceptive devices
be a Candida albicans reservoir? Contraception 2008; 77: 359.
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Camacho DP, Consolaro MEL, Putassi EV, Donatti L, Gasparetto A., Svidzinski TIE. Vaginal yeast adherence to the
combined contraceptive vaginal ring (CCVR). Contraception 2007; 76: 439–443.
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Lopez L, Grimes D, Gallo M, Schulz K. Skin patch and vaginal ring versus combined oral contraceptives for
contraception. Cochrane Database Syst Rev 2010; 3: CD003552.
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Davies G, Feng L, Newton JR, Dieben TO, Coelingh-Bennik HJ. The effects of a combined contraceptive vaginal ring
releasing ethinylestradiol and 3-ketodesogestrel on vaginal flora. Contraception 1992; 45: 511–518.
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Donders G, Berger J, Heuninckx H, Bellen G, Cornelis A. Vaginal flora changes on Pap smears after insertion of
levonorgestrel-releasing intrauterine device. Contraception 2011; 83: 352–356.
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Lessard T, Simoes J, Discacciati MG, Hidalgo M, Bahamondes L. Cytological evaluation and investigation of the
vaginal flora of long-term users of the levonorgestrel-releasing intrauterine system (LNG-IUS). Contraception 2008; 77:
30–33.
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Calzolari E, Masciangelo R, Milite V, Verteramo R. Bacterial vaginosis and contraceptive methods. Int J Gynaecol
Obstet 2000; 70: 341–346.
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Riggs M, Klebanoff M, Nansel T, Zhang J, Schwebke J, Andrews W. Longitudinal association between hormonal
contraceptives and bacterial vaginosis in women of reproductive age. Sex Transm Dis 2007; 34: 954–959.
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© FSRH 2012
2011.
15
CEU GUIDANCE
APPENDIX 1: DEVELOPMENT OF CEU GUIDANCE
GUIDELINE DEVELOPMENT GROUP
Dr Louise Melvin – Director, Clinical Effectiveness Unit
Ms Julie Craik – Researcher, Clinical Effectiveness Unit
Dr Michael Abbott – FSRH Clinical Effectiveness Committee representative; Consultant Genitourinary
Medicine Physician, Southport and Formby DGH, Southport
Professor John E Coia – Consultant Clinical Microbiologist, Department of Clinical Microbiology, Glasgow
Royal Infirmary, Glasgow
Dr Amanda Davies – Subspecialty Trainee in Sexual & Reproductive Health, Aneurin Bevan Health Board,
Wales
Dr Jane Dickson – FSRH Clinical Standards Committee representative; Community Specialist in Contraception
and Sexual Health, Woolwich, London
Dr Fiona Fargie – Sexual Health & HIV Consultant, Sandyford, Glasgow
Mrs Lorraine Forster – FSRH Meetings Committee representative; Head of Nursing, Sandyford, Glasgow
Mrs Lynn Hearton – FSRH Clinical Effectiveness Committee representative; Helpline & Information Services
Manager, Family Planning Association, London
Professor Cathy Ison – Director of the Sexually Transmitted Bacteria Reference Laboratory, Health Protection
Agency, Microbiology Services, London
Dr Carmel Kelly – Lead Nurse Sexual Health, Downe Hospital, Downpatrick
Dr Neil Lazaro – BASHH representative; Associate Specialist Genitourinary Medicine, HIV, Royal Preston
Hospital, Fulwood, Preston
Dr Rona MacDonald – Specialist Trainee in Genitourinary Medicine, Sandyford, Glasgow
Dr David J White – BASHH representative; Consultant in Sexual Health and HIV Medicine, Heartlands Hospital,
Birmingham
Dr Janet Wilson – BASHH representative; Consultant in Genitourinary Medicine, Leeds General Infirmary, Leeds
Administrative support to the CEU team was provided by Ms Janice Paterson.
INDEPENDENT PEER REVIEWERS
Dr Anna Graham – General Practitioner, Horfield Health Centre, Bristol
Dr Anne Webb – Consultant in Sexual & Reproductive Health, Central Abacus, Liverpool
Declared Interests
No significant interests were declared.
Patient Involvement
The BASHH public patient involvement (PPI) group reviewed this document.
Clinical Effectiveness Unit (CEU) guidance is developed in collaboration with the Clinical Effectiveness
Committee (CEC) of the Faculty of Sexual and Reproductive Healthcare (FSRH). This guidance document
was developed in collaboration with the British Association for Sexual Health & HIV (BASHH). The CEU
guidance development process employs standard methodology and makes use of systematic literature
review and a multidisciplinary group of professionals. The multidisciplinary group is identified by the CEU for
their expertise in the topic area and typically includes clinicians working in family planning, sexual and
reproductive health care, general practice, other allied specialties, and user representation. In addition, the
aim is to include a representative from the FSRH CEC, the FSRH Meetings Committee and FSRH Council in the
multidisciplinary group.
Evidence is identified using a systematic literature review and electronic searches are performed for:
MEDLINE (CD Ovid version) (1996–2012); EMBASE (1996–2012); PubMed (1996–2012); The Cochrane Library (to
2012) and the US National Guideline Clearing House. The searches are performed using relevant medical
subject headings (MeSH), terms and text words. The Cochrane Library is searched for relevant systematic
reviews, meta-analyses and controlled trials relevant to vaginal discharge. Previously existing guidelines from
the FSRH (formerly the Faculty of Family Planning and Reproductive Health Care), the Royal College of
Obstetricians and Gynaecologists (RCOG), the World Health Organization (WHO) and the British Association
for Sexual Health and HIV (BASHH), and reference lists of identified publications, are also searched. All papers
are graded according to the Grades of Recommendations Assessment, Development and Evaluation
(GRADE) system. Recommendations are graded as in the table included on the inside front cover of this
document using a scheme similar to that adopted by the RCOG and other guideline development
organisations. The clinical recommendations within this guidance are based on evidence whenever possible.
Summary evidence tables are available on request from the CEU. The process for the development of CEU
guidance is outlined on the inside back cover of this document and is detailed on the FSRH website
(www.fsrh.org). The methods used in the development of this guidance have been accredited by NHS
Evidence.
16
© FSRH 2012
CEU GUIDANCE
APPENDIX 2: SUMMARY OF LABORATORY PROCESSING OF
SPECIMENS FROM WOMEN WITH VAGINAL DISCHARGE
Specimen
Preparation of samples in
the laboratory
Samples prepared to
detect:
Notes
High vaginal swab
Microscopy and Gram
stain
Bacterial vaginosis (BV)
l Clue cells (epithelial
cell coated with small
bacteria)
l Gram-positive and
-negative cocci
l Reduced lactobacilli
Criteria for reporting BV
may vary. Growth of
Gardnerella vaginalis not
diagnostic of BV
Candida
(spores and
pseudohyphae)
Saline wet microscopy
(TV) (flagellate organism)
Wet microscopy not
routinely performed in all
laboratories unless TV
testing requested
Culture
Candida
Candida cultured on
Sabouraud agar. Request
candida species and
antifungal sensitivities in
cases of treatment
failure/recurrence
Culture for TV not routinely
performed in all
laboratories
Nucleic acid
amplification test (NAAT)
Chlamydia and
gonorrhoea
Culture
Gonorrhoea
If NAAT test for Neisseria
gonorrhoeae is positive,
culture should also be
performed for sensitivity
testing
Vulvovaginal swab (VVS)
NAAT
Chlamydia and
gonorrhoea
Self-taken VVS
acceptable to most
women.
More sensitive than urine
for chlamydia and
gonorrhoea testing in
women
Urine
NAAT
Chlamydia
While urine can be tested
for gonorrhoea and
chlamydia, it is less
sensitive than
endocervical or VVS for
testing in women
Blood
Fourth-generation assays HIV
(combined antibody and
antigen detection)
Endocervical swab
Treponema
pallidum enzyme
immunoassay (EIA) or
syphilis serology
Syphilis
BV, bacterial vaginosis; EIA, enzyme immunoassay; NAAT, nucleic acid amplification test: TV, Trichomonas
vaginalis; VVS, vulvovaginal swab.
© FSRH 2012
17
CEU GUIDANCE
APPENDIX 3: RECOMMENDED TREATMENT REGIMENS FOR BACTERIAL
VAGINOSIS, VULVOVAGINAL CANDIDIASIS AND TRICHOMONAS46
Treatment
regimen
BV
VVC
TV
Recommended
regimen
Oral
Metronidazole 400 mg twice
daily for 5–7 days or 2 g
single dose
Oral
Fluconazole 150 mg stat dose
Itraconozole 200 mg bd for
1 day
Vaginal
l Clotrimazole 500 mg
pessary stat
l Clotrimazole cream (10%)
5 g stat at night
l Clotrimazole pessary
100 mg x 6 nights
l Clotrimazole pessary
200 mg x 3 nights
l Miconazole nitrate 2%
78 g cream with
applicators once daily for
10–14 days or twice daily
for 7 days
l Miconazole nitrate 1.2 g
ovule stat dose at night
l Econazole nitrate 150 g
pessary x 3 nights
l Econazole nitrate 150 g
pessary stat dose
l Fenticonazole nitrate
cream 2% insert 5 g twice
daily for 3 days
200 mg capsule x 3 nights.
600 mg capsule stat dose
at night
Combined
l Clotrimazole (10%)
vaginal cream with
applicator and 2%
topical cream
l Clotrimazole 500 g
pessary and 2% topical
cream
Oral
Metronidazole: single 2 g
oral dose or 400 mg twice
daily for 5–7 days
Topical (in addition to oral or
vaginal for vulval symptoms)
20 g 2–3 times daily
20 g 2–3 times daily
l Econazole nitrate 1% 15 g
cream 14 nights
l Ketoconozole cream 2%
once or twice daily
Alternative
regimen
18
Intravaginal metronidazole
gel (0.75%) once daily for
5 days or intravaginal
clindamycin cream (2%)
once daily for 7 days or
Clindamycin* 300 mg
capsule twice daily for
7 days or Tinidazole tablet
2 g single dose
Antifungals can be applied
to the vulval area
Tinidazole 2 g orally in a
single dose
© FSRH 2012
CEU GUIDANCE
(continued)
Treatment
regimen
BV
VVC
TV
Recurrent
infection
Suppressive therapy
Induction
Fluconazole capsule
150 mg every 72 hours x
3 doses
Exclude vomiting with
metronidazole and repeat
standard regimen as above
Oral
Metronidazole 400 mg twice
daily for 3 days at the
beginning and end of
menstruation
Metronidazole 2 g stat dose
monthly
Intravaginal
Metronidazole (0.75%): 5 g
applicator twice weekly for
4–6 months after an initial
10-day course (outside
product licence)
Lactic acid gel (4.5%) 5 ml
tube at night for 2–3 nights
after menstruation
Lactic acid gel (4.9%) 5 ml
tube once or twice weekly.
Maintenance
Fluconazole capsule
150 mg once a week for
6 months
Alternative maintenance
Clotrimazole pessary 500 mg
once a week
Check risk of re-infection,
partner notification and
compliance
If drug resistance suspected
seek specialist advice
Fluconazole capsule 50 mg
daily
Itraconazole capsule
50–100 mg daily
Ketoconazole capsule
100 mg daily
[See also Good Practice
Point for recurrent BV on
page 11]
Partner
treatment
Routine screening and
treatment of sexual partners
is not recommended
Routine screening and
treatment of sexual partners
is not recommended
Partner notification and
treatment is recommended.
Test for other STIs
Treatment in
pregnancy and
breastfeeding
women
Symptomatic women should
be treated as above but
single stat doses should be
avoided
Treatment with topical azoles
as above but longer
duration of treatment
(7 days) may be required.
Avoid oral regimens due to
potential teratogenicity
No evidence of
teratogenicity of
metronidazole but single stat
doses should be avoided
Diabetes
As for non-diabetic patients
Candida albicans
Candida glabrata
Nystatin pessary 200 000 units
for 14 days (not readily
available in the UK; refer to
service with GUM)
HIV (check
for drug
interactions with
concomitant
medication)
© FSRH 2012
Women should be treated as Women should be treated as Treatment with oral
above but longer treatment above but longer treatment metronidazole but longer
treatment may be required
may be required
may be required
(7 days)
19
CEU GUIDANCE
(continued)
Treatment
regiment
BV
VVC
TV
Special notes
Alcohol should be avoided
for the duration of treatment
with nitroimidazole drugs
(e.g. metronidazole and
tinidazole) and for 48 hours
afterwards because of the
possibility of a disulfiram-like
(Antabuse® effect)
reaction46,57,97
Latex condoms and
diaphragms may be
damaged by vaginal or
topical preparations
containing econazole,
miconazole, isoconazole ,
fenticonazole clotrimazole
Alcohol should be avoided
for the duration of treatment
with nitroimidazole drugs
(e.g. metronidazole and
tinidazole) and for 48 hours
afterwards because of the
possibility of a disulfiram-like
(Antabuse® effect)
reaction46,57,97
Clindamycin intravaginal
cream can damage latex
condoms
*Associated with pseudomembranous colitis – seek local advice.
BV, bacterial vaginosis; GUM, genitourinary medicine; STI, sexually transmitted infection; TV, Trichomonas
vaginalis; VVC, vulvovaginal candidiasis.
20
© FSRH 2012
CEU GUIDANCE
Discussion Point for Management of Vaginal Discharge in
The following discussion point has been developed by the FSRH Meetings Committee.
Discussion Point
1
Consider how you would talk to a young woman presenting with a history of vaginal discharge and
odour, worse after intercourse. She finds this embarrassing.
Questions for Management of Vaginal Discharge in
The following questions and answers have been developed by the FSRH Meetings Committee.
Indicate your answer by ticking the appropriate box for each question
True
False
1 Bacterial vaginosis (BV) is the commonest cause of abnormal vaginal discharge in
women of reproductive age.
n
n
2 A high vaginal swab should be taken from all women presenting with vaginal discharge.
n
n
3 Gonococcal cultures should be taken if the patient’s nucleic acid amplification test
is positive for gonorrhoea.
n
n
4 Treatment of male sexual partners has been found to be effective in preventing
reoccurrence of BV in women.
n
n
5 Syndromic treatment is appropriate for sexually active women aged <25 years.
n
n
6 Oral antifungals are more effective than topical antifungals in the treatment of
vulvovaginal candidiasis.
n
n
7 Trichomonas vaginalis (TV) is an STI.
n
n
8 Oral metronidazole is effective in achieving parasitological cure in TV.
n
n
9 Empirical treatment based on pH, clinical and sexual history can be given before
laboratory results are available.
n
n
10 Chlamydia trachomatis, the most common bacterial STI in the UK, is usually symptomatic.
n
n
2 False
7 True
3 True
8 True
4 False
9 True
5 False
10 False
© FSRH 2012
1 True
6 False
Answers
21
CEU GUIDANCE
Auditable Outcomes from Management of Vaginal Discharge in
The following auditable outcomes have been developed by the FSRH Clinical Standards Committee.
Auditable Outcomes
1
Proportion of women with vaginal discharge who have a sexually transmitted infection (STI) risk
assessment recorded [Target 100%]
2
Proportion of women with vaginal discharge who have an enquiry of upper reproductive tract symptoms
documented [Target 100%]
3
In settings where women present with vaginal discharge there should be availability of the locally
recommended swabs to detect STIs, with onward transport to a laboratory for testing [Target 100%]
4
Where an STI is the cause of vaginal discharge, appropriate partner notification and treatment is advised
and recorded [Target 100%]
22
© FSRH 2012
NOTES
© FSRH 2012
23
NOTES
24
© FSRH 2012
NOTES
© FSRH 2012
25
NOTES
26
© FSRH 2012
NOTES
© FSRH 2012
27
NOTES
28
© FSRH 2012
STEPS INVOLVED IN THE DEVELOPMENT OF THIS
GUIDANCE DOCUMENT
l
Appointment of a multidisciplinary group by invitation to main stakeholders.
l
Revision of key questions by the Clinical Effectiveness Unit (CEU) and multidisciplinary group.
l
Systematic literature review, critical appraisal and development of evidence tables by the CEU
researcher.
l
Draft one guidance document is written by the CEU.
l
Peer review by multidisciplinary group (MDG) (written feedback and one-day meeting).
l
Preparation of draft two by the MDG, the Faculty of Sexual and Reproductive Healthcare (FSRH)
Clinical Effectiveness Committee (CEC) and two independent peer reviewers.
l
Preparation of draft three based on written feedback.
l
The MDG is asked to review the guidance and recommendations using a formal consensus process.
l
Preparation of draft four.
l
Draft four document is published on the Faculty website for 1 month for public consultation.
Stakeholders are informed of this consultation process.
l
All feedback comments are reviewed by the CEU, MDG, FSRH CEC and peer reviewers.
l
The final draft is prepared and the CEU’s response to consultation comments is posted on the FSRH
website.
l
The final document is published by the FSRH.
l
Printed copies are mailed to members and an electronic version is available on the FSRH website.
l
Post-publication feedback is reviewed by the CEC and the web version is amended as and when
necessary.
COMMENTS AND FEEDBACK ON PUBLISHED GUIDANCE
All comments on published guidance can be sent directly to the Clinical Effectiveness Unit (CEU) at
[email protected]. You will receive an automated acknowledgment on receipt of your
comments. If you do not receive this automated response please contact the CEU by telephone
[+44 (0) 141 232 8459/8460] or e-mail ([email protected]).
The CEU is unable to respond individually to all feedback. However, the CEU will review all comments
and provide an anonymised summary of comments and responses, which are reviewed by the Clinical
Effectiveness Committee and any necessary amendments made.

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