log in/ orientation introduction/ housekeeping
TRANSCRIPT
Log in/ Orientation
Introduction/ Housekeeping
Dr Meg Cairns GP Liaison Officer
Metro North Health and Brisbane North PHN
Time Task Presenter
8:00 am Log in/Orientation Dr Meg Cairns
8:15 am Housekeeping and Introductions Dr Meg Cairns
8:25 am Welcome Address Prof. Leonie Callaway
8:30 am Paediatric & Adolescent Gynaecology
Prof. Rebecca Kimble
9:00 am Cervical Screening Dr David Baartz9:30 am Termination of Pregnancy Dr Lindsay
Cochrane
Nicole Payne10:00 am Fertility Prof. Hayden
Homer10:30 am Menopause Hormone Therapy Prof. Hayden
Homer
Session 1
Time Task Presenter
11:30 am Metro North Gynaecology Services and Referral Processes
Dr Meg Cairns
Gynaecology Nurse Unit Managers/ Care Coordinators
11:45 am Case Studies (Zoom Breakout Rooms)
All
1:30 pm Summary/Evaluation/Close Dr Meg Cairns
Session 2
Acknowledgements
• Metro North Health
• Brisbane North PHN
• Caboolture Hospital, Redcliffe Hospital, Royal Brisbane & Women’s Hospital and The Prince Charles Hospital
• Metro North Health - Women’s and Children’s Stream - Metro North GP Alignment Program
• Metro North Health - Healthcare Excellence and Innovation - Outpatient and Primary Care Strategies
Useful Resources
• MN HHS Gynaecology Referral Guidelines
https://metronorth.health.qld.gov.au/specialist_service/refer-your-patient/gynaecology
• GP Smart Referrals
https://brisbanenorthphn.org.au/practice-support/digital-health
• Brisbane North PHN eReferral templates
https://www.brisbanenorthphn.org.au/practice-support/referral-and-patient-management
https://brisbanenorth.communityhealthpathways.org
HealthPathways
https://brisbanenorth.communityhealthpathways.org
HealthPathways
Brisbane North PHN – Network Link
Health Provider Portal
• Secure online access to patients’ Queensland Health records:
https://hpp.health.qld.gov.au/
• Discharge summaries, SOPD appointments, medications, adverse reactions, pathology, medical imaging, procedures
• Patients can opt out - call 13HEALTH
Useful Resources
• Australian Journal of General Practice
https://www1.racgp.org.au/ajgp/home
• RACGP gplearning and checkhttps://www.racgp.org.au/education/professional-development/online-learning
• RACGP Clinical guidelines
https://www.racgp.org.au/clinical-resources/clinical-guidelines
Useful Resources
• RANZCOG statements and guidelines
https://ranzcog.edu.au/statements-guidelines
• RCOG The Initial Management of Chronic Pelvic Pain https://www.rcog.org.uk/globalassets/documents/guidelines/gtg_41.pdf
• NICE guidelines
https://www.nice.org.uk/guidance/conditions-and-diseases/gynaecological-conditions
Useful Resources
• Gynaecological Cancer https://www.health.gov.au/initiatives-and-programs/national-cervical-screening-program
https://wiki.cancer.org.au/australia/Guidelines:Cervical_cancer/Screening
https://www.canceraustralia.gov.au/cancer-types/gynaecological-cancers/clinicians-hub
Useful Resources
• TRUE
https://www.true.org.au/course-catalogue
• Family Planning NSW
https://www.fpnsw.org.au/health-information/health-professionals
Cervical ScreeningDr David Baartz, Senior Staff Specialist Gynaecology, Clinical Lead in Gynaecology and Director of the Qld Trophoblastic Centre
Royal Brisbane and Women’s Hospital
Changes to the National Cervical Screening Program (NCSP) Guidelines for women at intermediate risk came into effect 1 February 2021
National Cervical Screening Program
https://wiki.cancer.org.au/australia/Guidelines:Cervical_cancer/Screening
HPV (not-16/18) detected LBC negative, pLSIL or LSIL
Repeat HPV test in 12 months
12 month follow up HPV (not-16/18) detected LBC negative, pLSIL or LSIL
Repeat HPV test in a further 12 months’ time
If HPV negative at second 12 month follow up
Return to 5 yearly screening
If HPV (any type) detected at second 12 month follow up, regardless of the result of reflex cytology
Refer for colposcopy
• women 2 or more years overdue for screening at the time of the initial screen
• women who identify as Aboriginal or Torres Strait Islander
• women 50–69 yo• women with self-collected samples
If HPV (any type) is detected at 12 months, regardless of the result of reflex cytology, refer for
colposcopy
Exceptions
Separate NCSP guidance for
• immune deficient women• women exposed to DES in utero• women currently undergoing Test of Cure
following treatment of histological HSIL• women aged > 70 yo attending for an exit test
Exceptions
• Symptomatico Post-coital bleeding (>1 episode)o Unexplained intermenstrual bleedingo Post menopausal bleedingo Suspicious cervixo Persistent discharge or deep pelvic pain
• Test of Cure after treatment for HSIL (CIN2/3)• Previous endocervical adenocarcinoma in situ
(AIS) – annual Co-Test• Previous DES exposure – annual Co-Test
Indicate reason for Co-Test on pathology form
Co-Test Indications
Endocervical cells are not required for specimen adequacy in a screening sample
Exception - at time of colposcopy, when the referral cytology was negative
What about endocervical cells ?
Termination of PregnancyDr Lindsay Cochrane Director Obstetrics and Gynaecology, Caboolture Hospital
Nicole Payne
MNH Termination of Pregnancy Nurse Navigator
Objectives:
•Understand key aspects of the 2018 Queensland
Termination of Pregnancy (ToP) Act
• Identify the role of a Conscientious Objector
• Identify Methods of Termination of Pregnancy
• Identify what to include in a Referral into Metro North
30
31
ToP Act 2018
On 3 December, 2018
• Termination removed from the Criminal Code Act
1899
• The Termination of Pregnancy Act 2018 (ToP Act,
2018) became law
Purpose of the ToP Act:
• Enable reasonable and safe access by women to
termination
• Regulate the conduct of registered health
practitioners in relation to termination
32
• Only a registered medical practitioner can perform a termination
• Specified registered health practitioners can assist a medical
practitioner
• It is a criminal offence if the person performing the termination is not
a registered health practitioner (as specified in the ToP Act)
• A woman does not commit an offence for termination on herself
Registered health practitioners who may assist a medical practitioner
with a termination include:
• Another medical practitioner
• Nurse, midwife, pharmacist
• Aboriginal and Torres Strait Islander health practitioner
• Others prescribed by law
Student health practitioners are not permitted under the ToP Act (2018)
to assist with a termination
ToP Act 2018
33
What involvement can student health practitioners have in ToP?
Students can assist with:
• Clinical care before the
performance of the
termination (pre-operative
preparation, referral or
non-directive counselling)
• Intrapartum or postpartum
care after feticide or
administration of a
termination drug
Students cannot assist
with:
• Dispensing, supplying
or administering the
drug(s) to terminate
pregnancy
• Direct assistance with
surgical procedure for
termination of
pregnancy or feticide
34
Less than 22 weeks gestation
At or more than 22+1 weeks gestation
A medical practitioner may perform a termination upon request
Two medical practitioners must consider all the circumstances and
both agree that a ToP should be performed
Circumstances that must be considered:
• Woman’s relevant medical, current and future physical,
psychological and social circumstances
• Professional standards and guidelines relevant to termination
35
Health care professionals may
decline to provide ToP
healthcare on the basis of
conscientious objection
Conscientious objectors are
required
under the ToP Act 2018 to:
• Disclose their conscientious
objection to the woman
and/or other practitioners
who request assistance
• Refer care to another
practitioner who is not a
conscientious objector or to
another service
Conscientious Objection
I'm a conscientious
objector…
As a GP – What do
I need to do?
36
Elly should:
• Immediately notify her line
manager of her
conscientious objection
• Discuss re allocation of
woman
• Provide support to other
staff in an emergency
situation
GPs who identify as conscientious objectors
must:
• Disclose to the patient their conscientious objection
• Refer care to another medical practitioner or service
who is not a conscientious objector
• Provide support to their patient including pregnancy
options counselling if appropriate and contraception
advice
• For women requesting M2Step – GP to GP referral is
recommended
37
MS2-Step, Medical as Inpatient or Surgical Management?
MS2-Step
• Can be taken in
patients home if
assessed as suitable
• For women ≤9 weeks
gestation (63 days
gestation)
• Mifepristone/
Misoprostol
combination
• Must be a registered
prescriber with MS
Health
• Women should have
access to 24hr
emergency care if
required
• Follow up plan in
place
Medical ToP as
Inpatient
• Mifepristone/
misoprostol
combination
• Educated around
“what to expect”
• Feticide offered
after 22+1 weeks
gestation
• Memory Creation
• Legalities of birth at
given gestations
• Disposal of remains
/cremation/funeral
• Contraception can
be provided post
ToP prior to
discharge
Surgical ToP
• Up to 16 weeks
gestation in the public
health system – as per
service capability of
facility
• Consideration of use of
mifepristone pre Surgical
ToP
• Misoprostol for cervical
priming 2-3 hours pre op
• Usually day procedure
• Under general
anaesthetic
• POC respectfully
disposed of by hospital –
Women can request
private cremation
• LARC can be inserted at
the time of procedure
(e.g. Mirena or
Implanon)
38
What to include in your referral
• Confirmed Viable Intrauterine
Pregnancy on Ultrasound – repeat
USS will be requested if viability not
confirmed
• Blood Group and Rh status, FBC,
quantitative B-HCG and current
cervical screening result
• STI screen
• BMI
• NIPT results (if attended)
• Other relevant investigations providing
evidence of fetal anomaly
40
41
42
Fertility
Professor Hayden HomerProfessor of Reproductive Medicine, University of Queensland Reproductive Endocrinology and Infertility Sub-specialist and Gynaecologist, Royal Brisbane and Women’s Hospital
Infertility
• Affects 1:6 couples in Australia
• Inability to conceive after 12 months of unprotected SI
• 50% conceive after 6 months
• 80% after 12 months
• 90% after 18 months
General considerations
• Couples should be seen together
• Welfare of the child
• Alcohol - nil
• Smoking - nil
• BMI : 19-30
• Folate : 0.5 mg per day
• Fitness for pregnancy
– Medical conditions
– Pre-conception counselling
Fertility Factors
Eggs: Ovulation + Quality (Age) + Numbers (Ovarian Reserve)
Tubes: Patent and functional
Sperm: Concentration + Motility + Morphology
What is the single most important determinant of pregnancy success?
FEMALE AGE
Cornerstone of Reproduction
The oocyte provides nearly ALL membrane and cytoplasmic determinants including organelles and macromolecules required by the embryo
Li & Albertini 2013 Nature Reviews Molecular Cell Biology
0
10
20
30
40
50
60
70
26 28 30 32 34 36 38 40 42 44 46 48
Live
bir
th r
ate
(%
)
Maternal age (years)
Own eggs
Donor eggs
Oocyte quality is rate-limiting for pregnancysuccess
0
10
20
30
40
50
60
70
26 28 30 32 34 36 38 40 42 44 46 48
Live
bir
th r
ate
(%
)
Maternal age (years)
Own eggs
Donor eggs
Oocyte quality is rate-limiting for pregnancy success
4 cycles of IVF for under 35’s
80 cycles of IVF for over 45’s
Macaldowie et al. 2015. Assisted reproductive technology in Australia
and New Zealand 2013.
National Perinatal Epidemiology and Statistics Unit, UNSW.
Real-world impact of age-induced oocyte quality decline
Ovulatory dysfunction: PCOS
• Affects 8-13% of women
• Estimated healthcare costs of up to $400M per year in Australia
• Accounts for 80% of anovulation
• Manifests three main groups of disorders:
– Hyperandrogenism (Effects of excess male hormones): hirsutism, acne and alopecia
– Infertility due to Anovulation
– Metabolic Disorders: Insulin resistance; Glucose Intolerance, Hyperlipidaemia etc.
PCOS diagnosis
Rotterdam criteria
2 out of the 3 of the following are required to make the diagnosis of PCOS:
1. Oligomenorrhoea or amenorrhoea
2. Clinical and/or biochemical evidence of hyperandrogenism
3. Polycystic ovaries - >20 follicles 2-8 mm in diameter or ovarian volume >10mls
Managing PCOS: Focus on the individual problem
• PCO ovaries do not require treatment per se
• The term PCO is a misnomer
• “Cysts” are physiological follicles
• Weight loss for overweight patients is a very important
first line treatment regarding insulin resistance and
reducing risk of diabetes etc.
• Hyperandrogenism
• Fertility: Anovulation requires OI
PCOS: Managing the endometrium
• Regular periods are not
mandatory or therapeutic
• Avoid amenorrhoea > 3
months to prevent
hyperplasia
• Progesterone to induce a
withdrawal bleed every 2-3
months e.g. Provera 10mg
daily for 7-10 days or
Prometrium 200mg daily for
12 days
Case study – Mrs HC
32 G0P0 12/12 primary infertility
• Menstrual history
– Irregular menstrual cycle (average cycle length 3 months)
– Normal menstrual flow, mild dysmenorrhoea
• Past history
– BMI = 35
– No pelvic surgery or pelvic infection
Case study: Mrs HC
• Investigation results:
– USS: PCO
– Partner’s SA - Normal
• Diagnosis:
– Anovulation secondary to
PCOS
Fertility Factors
Eggs: Ovulation + Quality (Age) + Numbers (Ovarian Reserve)
Tubes: Patent and functional
Sperm: Concentration + Motility + Morphology
Case study: Mrs HC - Treatment
• Weight loss: Diet and exercise
• Ovulation induction
– Letrozole – 2.5 mg D2-D6
– USS monitoring – 5-10% risk of multiple
pregnancy
– 3-6 ovulatory cycles
• Consider confirming tubal patency
– At the start
– If low risk, after 3 cycles if not pregnant
Letrozole: Aromatase Inhibitor
Tubal Factor
• Cause of infertility in up to 40% of women
• Main causes:
• Sexually transmitted infections (such as
chlamydia)
• Previous pelvic surgery (ruptured
appendix)
• Endometriosis
Fallopian tube occlusion: HSG
Case Study: Ms FT
28 G0P0 18/12 primary infertility
• Menstrual history
– Regular cycles /28
– Very painful
• Past history
– BMI = 23
– Previous chlamydia
Case Study: Ms FT - HSG
Normal
Ms FT:
Bilateral
hydrosalpinges
Case Study: Ms FT - Laparoscopy
Normal laparoscopy and dye Ms FT laparoscopy
Case study: Ms FT - Treatment
• In vitro fertilization (IVF)
• Salpingectomy for hydrosalpinges
IVF
In vitro fertilisation = fertilisation “in glass”
Egg fertilised by sperm outside of the body
Overview of IVF
• Superovulation
• Cycle monitoring
• USS-guided Trans-
Vaginal
Egg Pick-up
• Fertilisation
• Standard
• ICSI
• Embryo culture
• Embryo transfer
Case study: Mrs PM
• Female age = 39 years
• Narrow window of fertility left
• Do not wait for 12 months of
trying before referring
Case study: Mrs PM
39; Primary infertility; TTC for 8 months
Menstrual history◦Regular cycles
Other history:◦BMI = 28◦No pelvic infection◦No prior surgery
Partner 45 ◦Smokes 20/day◦BMI 40
Case study: Mrs PM
• Investigation results:
– Regular cycles Ovulating
– AMH = 2 pmol/L
– Partner’s SA
– Concentration = 10 M/ml
– Progressive motility = 20%
– Morphology = 1%
AMH = 2 pmol/L
Case study: Mrs PM
• Investigation results:
– Semen analysis (WHO 2010):
– Concentration > 15 M/ml
– Progressive motility 32%
– Morphology 4%
– Partner’s SA
– Concentration = 10 M/ml
– Progressive motility = 20%
– Morphology = 1%
Decline in sperm counts
Analysed samples from 42,935 men between 1973 and 2011
Overall decline in sperm counts of 50-60% in less than 40 years in North America, Europe, Australia and New Zealand
Levine et al. 2017 Human Reproduction Update
Case study: Mrs PM - Treatment
• Diagnoses:
• Significant male factor
• Advanced female age with reduced
ovarian reserve
• Treatment:
– Weight loss and stop smoking
– IVF with ICSI
Ovarian Reserve: AMH
• AMH is produced by the granulosa cells of growing preantral and small antral follicles up to 6-8 mm in diameter
• AMH levels correlate with NGF numbers assessed histologically
Hansen et al. 2011
• Do AMH levels predict natural fertility?
AMH does NOT predict natural fertility
Normal AMH Low AMH
Unlike IVF, natural fertility is dependent upon mono-ovulation
Menopause Hormone Therapy
Professor Hayden HomerProfessor of Reproductive Medicine, University of Queensland Reproductive Endocrinology and Infertility Sub-specialist and Gynaecologist, Royal Brisbane and Women’s Hospital
Overview
•Definition: Last menstrual period
•Postmenopausal: No periods for 12 months or more
•Average age of menopause: 51 years
•Early Menopause: Menopause between 40-45 years
•Premature Ovarian Insufficiency (POI): Menopause before 40 years
•Around one-third of women in Australia are above 50 years
Diagnosis
Are special tests needed to make the diagnosis of menopause?
Diagnosis
•Menopause is a normal physiological change brought about by depletion of ovarian follicles, which leads to oestrogen deficiency
•For women >45 years with menopausal symptoms, blood tests are NOT necessary or reliable
•During this time, hormone levels fluctuate widely and may include phases with normal and even high oestrogen levels
Diagnosis of POI: ESHRE Guidelines 2016
•Oligo/amenorrhea for at least 4 months, and
•Elevated FSH level >25 IU/L on two occasions >4 weeks apart
Symptoms
•Around 80% of menopausal women experience symptoms
•Symptoms typically persist for 4-8 years
•In 10-20% of women symptoms persist longer into their 60s and 70s
•Symptoms are due to lack of circulating oestrogen
Symptoms
•Vasomotor symptoms: • Hot flushes and night sweats (60-80% of women)
•Skin and hair changes• Thinning, dryness, loss of elasticity and wrinkling of the skin • Sensation of “crawling” under the skin• Wrinkling is made worse by smoking and sun exposure
•Joints and bones: ◦ Aches and pains◦ Thinning of bone: 10% of bone mass is lost in first 5 years after
menopause◦ Around one-half of women >60 will have a fracture due to
osteoporosis
Symptoms
•Weight distribution:• Altered weight distribution with fat accumulation in abdominal
region
•Disturbances in mood, memory and sleep• The occurrence of significant depressive symptoms doubles• 35-60% of women experience sleep problems
•Genitourinary syndrome of the menopause (GSM)• Vulvovaginal symptoms: Vaginal dryness • Sexual symptoms: Dyspareunia, reduced sex drive• Urinary symptoms: Dysuria, frequency, incontinence, prolapse
•Irregular bleeding
Treatment: General measures
•Lifestyle changes:•Healthier eating habits
•Regular exercise
•Maintain healthy weight
•Avoid “triggers” for hot flushes:•Alcohol
•Spicy foods
•The most effective treatment is oestrogen therapy
Menopausal Hormone Therapy (MHT)
• Formerly known as HRT
• MHT can be given as:• Oestrogen-only • Oestrogen + Progestogen (Combined MHT).
• Progestogens:• Prevent endometrial hyperplasia and are only needed in women
who have a uterus. • Women who have had a hysterectomy can use oestrogen on its
own and do NOT require progesterone.
Menopausal Hormone Therapy (MHT)
• Oestrogens can be given as tablets, skin patches, gels, vaginal creams and vaginal pessaries.
• Progestogens:• More difficult to get into the body.• For MHT, can be given as tablets, patches or vaginal pessaries.
• Hormonal preparations with the same chemical structure as hormones found in the body are known as “body-identical”.
• “Bioidentical” is another term that is used, often to refer to compounded HT.
Menopausal Hormone Therapy (MHT)
MHT is risky and should be avoided, right?
Is MHT risky?
Australian clinicians reported that a woman’s fear of breast cancer was the main barrier to prescribing MHT Yeganeh et al. 2017 Climacteric
In Australia, 4% mortality from breast cancer and 31% from cardiovascular disease
Women’s Health Initiative RCT Rossouw et al. 2002 JAMA
•Involved 27,347 women aged 50-79 years
•Mean age 63 years: much older than the peak age of 50-59 years for MHT use.
•Randomised to:•Combined MHT (CEE + MPA) or placebo (n=16,608) in women with an intact uterus
•CEE alone or placebo in hysterectomised women (n=10,739).
•Primary outcomes: Coronary heart disease and invasive breast cancer
•Combined MHT study stopped after 5.2 years due to concerns regarding breast cancer (8-9 extra cases per 10,000 per year)
•No increased breast cancer in CEE-only group
•Subsequent analyses for women 50-59 or within 10 years of menopause: No increased breast cancer risk in either group
Manson et al. 2013 JAMA
Women’s Health Initiative RCT Rossouw et al. 2002 JAMA
Women’s Health Initiative RCT
Combined MHT (CEE + MPA) in women aged 50-59 years
Manson et al. 2013 JAMA; Manson et al. 2017 JAMA
Women’s Health Initiative Study
Conjugated equine oestrogen only in women aged 50-59 years
Manson et al. 2013 JAMA; Manson et al. 2017 JAMA
MHT and breast cancer
• Oral combined MHT (CEE + MPA)• No increased risk if used for less than 5 years.
• Around 1 extra case per 1000 women if used >10 years.
• NO increased risk for oestrogen-only MHT
• Therefore, breast cancer risk linked to progesterone component
• Reduced risk with certain types of progestogens • Dydrogesterone
• Body-identical progesterone: Micronized progesterone (Prometrium)
VTE and MHT Formulation
• Oral combined MHT (Data from WHI study)• Around 1 extra VTE per 1000 women if used >5 years in women
<60 years
• Recent very large study based on the UK primary care research database• ~80,000 women aged 40-79 with a first VTE and ~400,000
without VTE between 1998-2017• Formulation of combined MHT: • Highest increased risk (2.1 times) with CEE + MPA – very similar
to risk in the WHI study• Lowest increased risk (1.18 times) with oestradiol and
dydrogesterone• NO INCREASED RISK for transdermal oestrogen regardless of dose
(0.93 times increased risk)Vinogradova et al. 2019 BMJ
Bone Health: General measures
•Calcium:• 1000-1300 mg per day is required and can be obtained from the diet. • Up to 60% of postmenopausal women do not meet dietary calcium
requirements.
•Vitamin D:• Required for calcium to be effectively used in bone formation. • Adequate levels can be derived from sufficient exposure to sunlight (5-15
minutes of exposure per day)• In Australia, 30-50% of postmenopausal women are deficient in vitamin D.
•Physical activity: • Weight-bearing exercise for 30-40 min on most days of the week such as
walking, jogging and dancing stimulate bone growth.
•Avoidance of smoking and reducing caffeine intake.
Bone health: Strengthening and preventing loss
•Combined calcium and vitamin D supplements if diet inadequate.
•MHT:
• Should be started soon after the menopause for maximal benefit
• Can increase bone density by about 5% after 2 years
• Reduces the risk of spinal and hip fractures by ~40%.
•Tibolone: increases bone density and reduces fractures
•Raloxifene (SERM)
• Acts like oestrogen on bone leading to an increase in bone mass and reduced fractures.
• Does not stimulate the endometrium.
• Slight increased risk of DVT but no increased risk of breast cancer
• May block oestrogen effects at other sites and so may cause hot flushes.
•Bisphosphonates: (e.g. Alendronate)
• Taken daily, weekly or monthly
• Reduce bone resorption
• Reduce bone loss and fractures
• Rare risk of osteonecrosis of the jaw
•Denosumab: reduces bone loss and fractures.
• 6 monthly injection
•Teriparatide:
• Bioactive fragment of parathyroid hormone.
• One 18-month course per lifetime
• Increases calcium absorption and bone formation.
• May need to be used in conjunction with calcium and vitamin D supplements.
Bone health: Strengthening and preventing loss
Vulvovaginal Atrophy (GSM)
•Unlike vasomotor symptoms, VVA symptoms are often progressive
•On-demand non-hormonal vaginal moisturisers and lubricants
•Vaginal oestrogen is the preferred form of MHT and most effective treatment
•Two recent reports from large cohorts support safety of vaginal oestrogen
• WHI – 3000 women aged 50-79, 2 years’ usage
Crandall et al. 2018 Menopause
• Nurses’ Health Study – 900 women, 3 years’ usage Bhupathiraju et al. 2018 Menopause
• No increased risk for myocardial infarction, stroke, VTE, endometrial or breast cancer after 3 years of use
Vulvovaginal Atrophy
•ACOG and North American Menopause Society recommend that low-dose vaginal oestrogen•Can be used indefinitely
•Progestogens NOT needed
American College of O&G Practice Bulletin No. 141. 2014 Obstet Gynecol
Position Statement of the North American Menopause Society. 2013 Menopause
•Treatment should be started early to prevent the development of distressing symptoms
Vulvovaginal Atrophy
•Ospemifene: 3rd generation SERM•First-in-class with nearly full oestrogen agonist effect on the vaginal epithelium
•Oestrogen-agonist on bone
•Almost neutral estrogenic effects in the endometrium
•Reduces cell proliferation of ductal carcinoma in an in situmodel
Vaginal laser use for VVA
•Lasers have not been cleared by the FDA for use specifically in VVA
•In July 2018, the FDA issued a consumer warning about CO2
laser therapy for vaginal cosmetic procedures or ‘vaginal rejuvenation’.
“These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”
Vaginal laser use for VVA
• First RCT involving vaginal laser for VVA Cruz et al. 2018 Menopause
• 45 women: • Laser + sham vaginal oestrogen • Vaginal oestrogen + sham laser • Laser + vaginal oestrogen (VE2)
• GSM scores most improved: laser+VE2 > VE2 > laser+shamVE2
• Worsened pain scores in laser only group• Very small study without a true sham-control arm
(sham laser+shamVE2) to adequately account for a placebo effect
Vaginal laser use for VVA
•Reports of post-laser complications emerging Gordon et al. 2019 Menopause
•Two class-action lawsuits in US:
• One brought by patients
• One brought by healthcare professionals regarding marketing from laser companies
•Urgent need for large sham-controlled trials with long-term follow up capable of capturing all complications like fibrosis, scarring, agglutination and penetration injury
•US trial (VeLVET): At 6 months, vaginal laser and vaginal estrogen treatment resulted in similar improvement in genitourinary syndrome of menopause symptoms as well as urinary and sexual function. Overall, 70% to 80% of participants were satisfied or very satisfied with either treatment and there were no serious adverse events. Paraiso et al. 2020 Menopause
•Australian placebo-controlled RCT ongoing involving Mona Lisa laser
Compounded “bioidentical” HT
•Use of systemic MHT has decreased by as much as 80% among U.S. women since the initial WHI publication in 2002
•Bioidentical hormones are marketed as “natural” on the basis of being derived from extracts such as yam and soybean BUT they are made from synthesized ingredients
•Unlike pharmaceutical grade MHT, compounded bioidentical hormones have not been rigorously evaluated in clinical trials
Compounded “bioidentical” HT
•Used in the form of lozenges, troches and creams
•Survey of 3725 women in the US found that 35% of HT users were taking a compounded hormone
•Not regulated by the FDA
•Concerns about dose consistency, product contamination, and unsubstantiated safety and efficacy claims
•Australasian Menopause Society does NOT recommend the use of compounded bioidentical hormone therapy in any form
Non-hormonal therapies: Vasomotor symptoms only
Nelson et al. 2006 JAMA; Position statement of the North American Menopause Society 2015 Menopause
Nelson et al. 2006 JAMA; Position statement of the North American Menopause Society 2015 Menopause
Non-hormonal therapies: Vasomotor symptoms only
Conclusions:
•Benefits outweigh risks for MHT in women 50-59 years or within the first 10 years of the menopause
•Transdermal routes are safer than oral routes and can be used in women with increased VTE risk or with BMI >30
•Vaginal oestrogen is a very safe and effective treatment for GSM
Conclusions:
•Body-identical hormones are the safest hormonal formulation
•Compounded bioidentical hormone therapy is not recommended
•MHT is not recommended for women with a history of hormone-dependent cancer
•More data are required on vaginal laser for treating GSM