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Medical management of dub – new modalities


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Medical management of dub – new modalities

  1. 1. MEDICAL MANAGEMENT OF DUB – NEW MODALITIES Dr.Jyoti Bhaskar MD MRCOG Director Lifecare IVF Consultant Lifecare Centre, Pushpanjali Crosslay Hospital Lecture 2 (2013) Save Uterus Campaign
  2. 2. 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
  3. 3. Treatment of DUB Woman Centred Care  Goals  Control bleeding  Correct anemia/associated conditions  Prevent recurrence  Improve quality of life Any interventions should aim to improve quality of life measures. [D] -- NICE guidelines
  5. 5. Ideal Treatment Choice–Points toIdeal Treatment Choice–Points to PonderPonder  Whether cycles are ovulatory or not  Age  Whether the patient requires contraception  Desires Fertility  Choice of the patient
  6. 6. 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 Combined oral contraceptives Pharmaceutical Treatment – Nice Guidelines
  7. 7. 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
  8. 8. Following Treatment Not Recommended  Oral progestogens in the luteal phase only  Danazol  Ethamsylate  Dilatation and curettage (D and C)
  9. 9. 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 reducing regular heavy menstrual bleeding. S O G C C L I N I C A L P R A C T I C E G U I D E L I N E S 2001
  10. 10. Progestational agents  Medroxyprogesterone acetate,  Norethindrone  Depo-medroxyprogesterone  Oral contraceptives  Levonorgestrel-releasing intrauterine device  Clomiphene citrate Other – Antiprostaglandins, antifibrinolytics, danazol, gonadotropin-releasing hormone analogs (GnRH) . DUB – Medical Management Options –DUB – Medical Management Options –
  11. 11. Comparative EfficacyComparative Efficacy 0 -25 -50 -75 -100 Mirena Placebo Prostaglandins Synthetase Inhibitor T A COCs Decrease % Percentage reduction in blood loss
  12. 12. QUEST GOES ON ………
  13. 13. “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” Need of the Hour --- Medical DrugsNeed of the Hour --- Medical Drugs
  14. 14. SERM’s – The Designer EstrogensSERM’s – The Designer Estrogens J Clin Oncol 2000 18:3172-3186. Estrogens Antiestrogens SERMs TamoxifineTamoxifine DroloxifineDroloxifine ToremifineToremifine RaloxifineRaloxifine OrmeloxifineOrmeloxifine
  15. 15. IDEAL SERM FOR DUBIDEAL SERM FOR DUB “An optimally designed SERM with Varied Tissue Response”
  16. 16. Ormeloxifene – An Ideal SERMOrmeloxifene – 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
  17. 17. Ormeloxifene– Dosing StrategyOrmeloxifene– 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
  18. 18. 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
  19. 19. Efficacy in Dysfunctional Menorrhagia (AIIMS)Efficacy in Dysfunctional Menorrhagia (AIIMS) PILOT STUDYPILOT 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
  20. 20. Efficacy in Dysfunctional MenorrhagiaEfficacy 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 (p-value <0.001)  The percentage reduction in PBAC score - 97.7% at 4 months J. Obstet. Gynaecol. Res. vol. 35, No. 4: 746–752, August 2009 Reduction in PBAC Score
  21. 21. Efficacy in Dysfunctional MenorrhagiaEfficacy 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%), vague abdominal pain (4.8%) and headache (4.8%) J. Obstet. Gynaecol. Res. Vol. 35, No. 4: 746–752, August 2009 Percentage Reduction in PBAC ScorePercentage Reduction in PBAC Score 97.7%97.7% 2.3%2.3%
  22. 22. Ormeloxifene Versus MPA in the treatment of Dysfunctional uterine Bleeding : A Double- Blind Randomised Controlled Trial Journal of South Asian Federation of obstetrics and Gynaecology Jan –April 2011 .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
  23. 23. 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. Dhananjay BS, Sunil Kumar Nanda , Journal of Clinical and Diagnostic Research, 2012. Conclusion: Ormeloxifene can be used as an effective drug in the treatment of Dysfunctional uterine bleeding
  24. 24. Our Experience ( Over 500 cases)  Indications 1. Puberty Mennorhagia 2. Postnatal Bleeding 3. DUB- after TVS r/o Ovarian Cyst  Dose- 60mg twice weekly for 3months.  Effective upto 1 year after stopping it.
  25. 25. Held Back 1. 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
  26. 26. Our Observations  Ovarian Cysts
  27. 27. Endometrial thickness
  28. 28. Breaking Myths with Scientific EvidenceBreaking Myths with Scientific Evidence  No effect on hypothalmo-pituitary-ovarian axis  Its effect as a contraceptive is local with no effect on hypothalmo- pituitary-ovarian axis  No effect on ovulation  It does not affect ovulation as evidenced by good luteal activity, but causes an increase in cycle length by lengthening the follicular phase. Its contraceptive action is primarily due to the prevention of endometrial decidualization and failure of implantation J. Obstet Gynaecol Res. Vol. 35, No. 4: 746–752, August 2009.
  29. 29. Breaking Myths with Scientific EvidenceBreaking Myths with Scientific Evidence  It does not cause cystic enlargement of ovaries  It is reported that only 15% patients may develop these, which disappear in subsequent cycles. In the study by Kriplani et al, ovarian enlargement was found only in three patients (7.1%)  It does not cause endometrial thickness  In the study by Kriplani et al, increased endometrial thickness was found in 9.5% of patients, but there was no atypia on histology. J. Obstet Gynaecol Res. vol. 35, No. 4: 746–752, August 2009.
  30. 30. 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  Ormeloxifene is safe, efficacious, cheap and easy to administer.
  31. 31. Thank YouThank You THANK YOU Making one person smile can change the world. May be not the whole world but their world..
  32. 32. PALM - COEIN
  33. 33. Ideal SERM for DUBIdeal SERM for DUB  Ideal SERM for DUB is one that has No uterine stimulation Prevents bone loss Has no risk for breast cancer Has a positive effect on lipids & cardiovascular system Maintains cognitive function of the brain Estrogen in CNS Antiestrogen in the breast No DNA adducts Lowers cholesterol No uterine stimulation Maintains bone density
  34. 34. SERM’s – The Designer EstrogensSERM’s – The Designer Estrogens Depending on their functional activities, SERMs could then be developed for a variety of clinical uses, including  Prevention and treatment of osteoporosis  Treatment and prevention of estrogen-regulated malignancies  Fibrofatty disease of breast and mastalgia J Clin Oncol 2000 18:3172-3186.
  35. 35. Levonorgestrel Intrauterine System  Cost limits its widespread use  Irregular bleeding in the first 3 months and leads to amenorrhea 15-20% of patients by 1 year  Needs to be changed every 5 years  It acts as a contraception and cannot be used in women desiring pregnancy. First line of treatment in DUB – Nice guidelines
  36. 36. Ormeloxifene  Central Drug Research Institute, Lucknow, is a nonsteroidal once-a- week oral contraceptive.  It was introduced in Delhi in July, 1991, marketed in India in 1992 as Saheli and Choice-7 and Centron  Included in the National Family Welfare Programme in 1995.  100,000 women were using this pill and apprx 1100,000 menstrual cycles were covered until 1996  Long terminal serum half life of 168 hr in women and exhibits duration of anti-implantation/estrogen antagonistic action of 120 hr.  In lactating women, it is excreted in milk in quantities considered unlikely to cause any deleterious effect on suckling babies Med Res Rev. 2001 Jul;21(4):302-47.
  37. 37. Hysterectomy Minimal access surgery Medical Rx
  38. 38. ADDRESS 35 , Defence Enclave, Opp. Preet Vihar Petrol Pump, Metro pillar no. 88, Vikas Marg , Delhi – 110092 CONTACT US 011-22414049, 42401339 WEBSITE : E-MAIL ID &