1. Lecture - 4
MEDICAL MANAGEMENT OF DUB – NEW
MODALITIES
Dr. Jyoti Bhaskar
“Save
Uterus
Campaign”
Lecture Series
(1 to 4 )

2. MEDICAL MANAGEMENT
OF DUB – NEW
MODALITIES
Dr.Jyoti Bhaskar
Dr. Sharda Jain
Dr. Jyoti Agarwal

3. Definition Of HMB
“Excessive menstrual blood loss which
interferes with the woman’s physical,
emotional, social and material quality of life,
and which can occur alone or in combination
with other symptoms.”
Nice guidelines 2007

4. Treatment of DUB
Woman Centred Care

Goals
 Control
bleeding
 Correct anemia/associated conditions
 Prevent recurrence
 Improve quality of life

5. MINIMAL ACCESS
SURGERY
MEDICAL RX
HYSTERECTOMY
Any interventions should aim to improve quality of life measures. [D] -- NICE guidelines

6. Ideal Treatment Choice–Points to
Ponder





Whether cycles are
ovulatory or not
Age
Whether the patient
requires contraception
Desires Fertility
Choice of the patient

7. Pharmaceutical Treatment – Nice Guidelines
First Line
Levonorgestrel-releasing intrauterine
system (LNG-IUS)
Second Line Tranexamic acid (non-hormonal)
Can be used in parallel with
investigations. If
no improvement, stop treatment after 3
cycles
Non-steroidal anti-inflammatory drugs (NSAIDs)
If no improvement, stop treatment after 3
cycles.
Can be used in parallel with investigations
Preferred over tranexamic acid in
dysmenorrhoea

8. Third Line
Oral progestogen
Norethisterone (15 mg) daily from
days 5 to 26 of the menstrual cycle
Injected progestogen
Others
Gonadotrophin-releasing hormone
analogue (Gn-RH analogue)
If used for more than 6 months add
back
HRT therapy is recommended

9. Following Treatment Not Recommended
Oral progestogens in the luteal
phase only
 Danazol
 Ethamsylate
 Dilatation and curettage (D and C)


10. GUIDELINES FOR THE MANAGEMENT OF
ABNORMAL UTERINE BLEEDING

Age, desire to preserve fertility, coexisting medical
conditions, and patient preference are essential
considerations.

For each of the suggested methods, the patient should
be aware of the risks and contraindications to allow
informed choice.
 Progestogens given in the luteal phase of the
ovulatory menstrual cycles are not effective in
S O reducing IregularRheavy menstrual Ibleeding.
G C C L I N C A L P A C T I C E G U I D E L N E S 2001

11. DUB – Medical Management Options –
Progestational agents






Medroxyprogesterone acetate,
Norethisterone
Depo-medroxyprogesterone
Oral contraceptives
Levonorgestrel-releasing intrauterine device
Clomiphene citrate
.
Other – Antiprostaglandins, antifibrinolytics,

12. Comparative Efficacy
Percentage reduction in blood loss
Mirena
Placebo
Prostaglandins Synthetase Inhibitor
TA
COCs
0
-25
-50
-75
Decrease %
-100

13. QUEST GOES ON ………

14. Need of the Hour --- Medical Drugs
“The ideal therapy should be a
designer drug which can block
the action of estrogen on the
endometrium but not its beneficial
actions on other tissues”

15. SERM’s – The Designer Estrogens
Estrogens
SERMs
Tamoxifine
Droloxifine
Toremifine
Raloxifine
Ormeloxifine
J Clin Oncol 2000 18:3172-3186.
Antiestrogens

16. IDEAL SERM FOR DUB
“An optimally designed SERM with Varied Tissue Response”

17. Ormeloxifene – An Ideal SERM

Dysfunctional uterine bleeding at any age

Relief of PMS in perimenopausal women

For women desiring contraceptive property

Has an excellent safety profile, very well-tolerated
& practically without any undesirable side-effects

18. Ormeloxifene– Dosing Strategy


Convenient dosage – twice or once weekly
60 mg tablets twice a week ( for example, Sunday
& Wednesday) for 12 weeks followed by one tablet
of 60 mg once a week for another 12 weeks

19. Ormeloxifene




CDR Institute Lucknow 1991
Once a week Non Hormonal
Contraceptive
Marketed in India in 1992 as
Saheli and Choice-7 and
Centron
Included in the National Family
Welfare Programme in 1995

20. Efficacy in Dysfunctional Menorrhagia (AIIMS)
PILOT STUDY



Study Population: Forty-two women with menorrhagia were recruited
for the study
Dosage: Ormeloxifene was given to each patient 60 mg twice a week
for 3 months and then once a week for 1 month. Patients were
followed up at 2 and 4 months of therapy, then at 3 and 6 months after
treatment was stopped
Assessments:

Menstrual blood loss (MBL) was measured objectively by a
pictorial blood loss assessment chart (PBAC) score and
subjectively by a visual analog scale (VAS)
J. Obstet. Gynaecol. Res. vol. 35, No. 4: 746–752, August 2009

21. Efficacy in Dysfunctional Menorrhagia

The pretreatment median
PBAC score was 388
(range 169–835)

Median PBAC reduced to
80 (range 0–730) and 5
(range 0–310) at 2 and 4
months, respectively (pvalue <0.001)
J. Obstet. Gynaecol. Res. vol. 35, No. 4: 746–752, August 2009

The percentage reduction
in PBAC score - 97.7% at
Reduction in PBAC Score

22. Efficacy in Dysfunctional Menorrhagia

Amenorrhea with the
therapy – 18 patients
(42.9%)
Adverse effects
included ovarian cyst
(7.1%), cervical
erosion and discharge
(7.1%), gastric
dyspepsia (4.8%),
J. Obstet. Gynaecol. Res. Vol. 35, No. 4: 746–752, August 2009
vague abdominal pain
(4.8%) and headache
Percentage Reduction in PBAC Score
2.3%

97.7%

23. Ormeloxifene Versus MPA in the treatment of
Dysfunctional uterine Bleeding : A DoubleBlind Randomised Controlled Trial
Study Population: 84 women attending gynae OPD in Belgaum India were
.
enrolled , 42 in each arm.
Dosage: Group A – 60 mg ormeloxifene twice a week for 3 consecutive cycles
and Group B – 10 mg MPA from day 5-25 for 3 cycles. All were made to use
same type of sanitary napkins and TVS done for ET before and after treatment
Data Analysis : Mean PBAC score and endometrial thickness were compared
Result: Mean PBAC score reduction of 85.7 % and 54% in group A and B resp
ET reduction was more in Ormeloxifene group but not statistically sign.
Conclusion: oremloxifene is more effective in reducing bleeding than MPA
Journal of South Asian Federation of obstetrics and Gynaecology Jan –April 2011

24. Role of Sevista in the Management of
Dysfunctional Uterine Bleeding
Study Population: 35 cases diagnosed to have DUB after having ruled
out other causes
Dosage: Ormeloxifene was given in the dosage of a 60 mg tablet twice
a week for 3 months, followed by once a week for another 3 months.
Assesment : Hb g/dl and the endometrial thickness before and after
3 months of treatment with sevista.
Observation & results: Statistically significant increase in the Hb g/dl
(p < 0.001) and a statistically significant decrease in the endometrial
thickness (p< 0.001) after the treatment with ormeloxifene.
Conclusion: Ormeloxifene can be used as an effective drug in
the treatment of Dysfunctional uterine bleeding
Dhananjay BS, Sunil Kumar Nanda , Journal of Clinical and Diagnostic Research, 2012.

25. Our Experience ( Over 500 cases)

Indications
1.
Puberty Mennorhagia
Postnatal Bleeding
DUB- after TVS r/o Ovarian Cyst
2.
3.


Dose- 60mg twice weekly for
3months.
Effective upto 1 year after stopping it.

26. Held Back
Postmenopausal Bleeding
2. Endometrial Hyperplasia
3. Infertile patients
4. PCOS
Special mention:
1. In PMB , after balloon therapy – once a week
for 3 months
2. In hyperplasia – along with progesterone's
1.

27. Our Observations

Ovarian Cysts

28. Endometrial thickness

29. Conclusions

First Line of management of DUB should be
pharmaceutical

Available medical modalities are far from
satisfactory

Important to individualize the treatment

Mirena is the first line of treatment – Nice
Guidelines

30. Thank You
Making one person smile can change the world.
May be not the whole world but their world..
THANK YOU