Mohammed Khairy Ali; MD Levonorgestrel-releasing intrauterine system compared to low dose combined oral contraceptive pills for treatment of adenomyosis: a randomized controlled trial Mohammed Khairy Ali; MD Lecturer of obstetrics and Gynecology Women Health Hospital-Assiut university-Egypt m_khairy2001@yahoo.com

INTRODUCTION INTRODUCTION

The prevalence of adenomyosis in literature varies from 5% to 70%. INTRODUCTION Adenomyosis defines as benign invasion of endometrium into the myometrium, producing a diffusely enlarged uterus which microscopically displays ectopic, non-neoplastic endometrial glands and stroma surrounded by hypertrophic and hyperplastic myometrium. The frequent cited profile of adenomyosis symptomatology includes the triad of abnormal uterine bleeding, secondary dysmenorrhea and an enlarged tender uterus. The prevalence of adenomyosis in literature varies from 5% to 70%. The rate of preoperative diagnosis of adenomyosis is poor, ranging from 2.6% to 26% .

INTRODUCTION Until few years ago, hysterectomy was considered the main procedure that can treat the adenomyosis. Other medical and surgical treatment options are of limited value for long term treatment because of its associated side effects.

Its effect on down-regulation of estrogen receptors. INTRODUCTION The LNG-IUS has been suggested as a treatment option for adenomyosis because of: Its effect on down-regulation of estrogen receptors. Decidualization and subsequent atrophy of the adenomyotic foci. Reduction of prostaglandin production within the endometrium which leads to pain relief. The COCs can also induce endometrial atrophy and decrease endometrial prostaglandin production thus improve dysmenorrhea and menorrhagia associated with adenomyosis.

The increased blood flow to the uterus may associate with adenomyosis. INTRODUCTION The increased blood flow to the uterus may associate with adenomyosis. So studying the effect of various treatment modalities on blood flow of adenomyotic uterus is important. This may pave the way to understand the direct effect of these treatment modalities on adenomyotic uterus. Up to our knowledge, this was the first randomized study to compare the effect LNG-IUS with COCs on treatment of adenomyosis.

AIM OF THE WORK

AIM OF THE WORK Compare the efficacy of LNG-IUS with that of low-dose COCs in the treatment adenomyosis associated pain and bleeding after 6 months of use. In addition, in this study, we were also testing the effect of mentioned treatment modalities on uterine volume and uterine blood flow from before to 6 months after treatment.

PATIENTS AND METHODS

Type of study: It was registered open, parallel, RCT (NCT01601366) PATIENTS AND METHODS Type of study: It was registered open, parallel, RCT (NCT01601366) Study Setting : WHH, Assiut University, Egypt Study period : From August 2012 to Jun 2014. Ethical aspect : Our study was approved by The Ethical Review Board of Faculty of Medicine, Assiut University

PATIENTS AND METHODS Inclusion criteria Women who were complaining of dysmenorrhoea and/or CPP with or without IUB. Women in which 2D-TV/US and color Doppler US suggested adenomyosis. 2D-TV/US suggested adenomyosis when one of the following appeared: Myometrial linear striation Myometrial cysts Heterogenous myometrial echotexture Uterine wall asymmetry Color Doppler suggested adenomyosis when there was punctate vascular pattern within the myometrium. 3. Women aged between 20–45 years old.

PATIENTS AND METHODS 4. Women requested contraception for at least 6 months. 5. Women who were living in the nearby area to make the follow-up easy and feasible. Exclusion criteria Contraindications for LNG-IUS or COCs Any adnexal abnormality on ultrasound.

Sequence of evaluation PATIENTS AND METHODS Sequence of evaluation 1- Full history: including basal evaluation of the degree of pain (VAS) and uterine bleeding(menstrual diary). 2- Ultrasound evaluation (2D-TV/US and Color Doppler) Baseline information about Uterine volume. The uterine arteries and intramyometrial blood vessels Doppler indices (S/D, RI and PI). Randomization: using a computer generated random table.

PATIENTS AND METHODS Study Intervention The LNG-IUS (Mirena) was inserted and COCs (Gynera tablets) were used cyclic for 6 months.

PATIENTS AND METHODS Study outcomes: The improvement of pelvic pain. Secondary outcomes included menstrual blood loss, uterine volume and Doppler blood flow indices changes in uterine arteries and intramyometrial blood vessels from before to 6 months after treatment. Follow-up schedule: after 1, 3 and 6 months . Clinical follow up Evaluation of dysmenorrhae/CPP: by VAS. Evaluation of bleeding pattern: by menstrual diary. 2. Ultrasonographic follow up Evaluation of uterine volume and Doppler blood flow indices.

RESULTS

The study flow chart Assessed for eligibility (n=142) Excluded (n=80) RESULTS Assessed for eligibility (n=142) Excluded (n=80) 22 choose hysterectomy 18 not requested contraception 40 refused without clear reasons Randomization(n=62) Allocation Mirena group (n=31) Gynera group (n=31) Follow up for 6 months VAS Menstrual diary Uterine volume Doppler indices Stop intervention(n=1) Lost follow up (n=2) Stop intervention(n=2) Analysis Analyzed(n=29) The study flow chart Analyzed (n=28)

Table1: Personal characteristics of the studied women RESULTS Table1: Personal characteristics of the studied women

Effect of treatment on pain before and 6 months after treatment RESULTS Effect of treatment on pain before and 6 months after treatment

Table 3: Effect of treatment on uterine bleeding pattern before and 6 months after treatment

Table 3: Uterine volume by 2D-TV/US before and 6 months after treatment with LNG-IUS and COCs Group I LNG-IUS Group II COCs p-Value Mean ± SD Uterine volume At baseline 245.42 ± 25.33 250.06 ± 23.82 0.511 After 6 months 183.20 ± 11.76 199.74 ± 21.81 <0.001

Table 4: Uterine arteries and intramyometrial blood vessel Doppler indices before and 6 months after treatment with LNG-IUS and COCs

CONCLUSION

CONCLUSION Both LNG-IUS and COCs are effective in reducing pain and bleeding associated with adenomyosis after 6 months of use. However, LNG-IUS is more effective than COCs for reducing both symptoms. Reduction of the uterine volume and increased the resistance of blood flow in both uterine arteries and intramyometrial blood vessels may be behind the treatment effect which was more pronounced with the LNG-IUS use.

Thanks for your attention by MOHAMMED KHAIRY