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Research Article | DOI: https://doi.org/10.31579/2642-9756/122
1 Assistant Specialist in Department of Obstetrics and Gynecology – Elgalaa Teaching Hospital -Cairo - Egypt
2 Department of Obstetrics and Gynecology – Ain Shams university Maternity Hospital - Cairo - Egypt
*Corresponding Author: Sultan Yasmin, Assistant Specialist in Department of Obstetrics and Gynecology – Elgalaa Teaching Hospital - Cairo - Egypt
Citation: Sultan Y, Sherif Daoud. the Reproducibility of Treatment of Perimenopausal Abnormal Uterine Bleeding Due to Ovulatory Dysfunction with Hysteroscopic Endometrial Resection Versus Mirena, J. Women Health Care and Issues,5(3): DOI: 10.31579/2642-9756/122
Copyright: © 2022 Sultan Y, this is an open-access article distributed under the terms of The Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Received: 10 January 2022 | Accepted: 24 February 2022 | Published: 20 May 2022
Keywords: levonorgestrel; menorrhagia; endometrium
Objective: To compare the efficacy of local levonorgestrel intrauterine releasing system and transcervical resection of the endometrium (TCER) in the management of perimenopausal dysfunctional uterine bleeding.
Patients and Methods: This study was done at Ain Shams and Al-Azhar University Maternity Hospitals during a period started from January 2019 to January 2021. Patients were followed up at the outpatient gynaecology clinics at regular schedules (3, 6 and 12 months) for one year duration. Perimenopausal patients with DUB were assigned randomly to either the levonorgestrel intrauterine system (n = 35) or endometrial resection (n = 45). Blood loss assessment charts were used to measure menstrual blood loss.
Results: Total bleeding score/month decreased from a baseline median of 47.26 to 33.5 (P<0.01) for the levonorgestrel intrauterine system and from 47.13 to 33.9 (P<0.01) for transcervical resection of the endometrium. There was no statically difference in bleeding score before and during treatment between the two groups of women.
Conclusion: Both treatments levonorgestrel intrauterine system and transcervical resection of the endometrium efficiently reduced menstrual bleeding. levonorgestrel intrauterine system should be considered the first-line treatment for idiopathic menorrhagia because it is easy to insert, has a sustained effect, provides contraception, may reduce the need for surgery, and is cost-effective and well tolerated.
Menorrhagia is the commonest cause of iron deficiency anemia in premenopausal women.[1] Anemia is one of the most widespread and neglected nutritional deficiencies in the world today, predisposing women to ill health and disease.[2] Menorrhagia is estimated to occur in 30% of women in their childbearing years. By definition, diagnosis of menorrhagia is made when the duration of bleeding is equal to or greater than six days or blood loss is at least 80 ml and other pathological conditions have been excluded. However, many women seek consultation for even milder bleeding episodes, due to the associated stress, discomfort, and quality of life impairment, thus making menorrhagia one of the most frequent reasons for gynecological consultation [3-5].
Traditional medical treatment for menorrhagia has been only temporarily effective, if at all, and most patients refuse to be subjected to prolonged administration of medications. Surgical treatment, including hysterectomy and endometrial ablation, is not suitable for women wishing to preserve fertility. Though successful pregnancies have been reported after endometrial ablation, this procedure is generally not recommended for women wishing to retain the option of future pregnancy [3-5].
The levonorgestrel-releasing intrauterine system (LNG-IUS) has emerged in recent years as a valuable alternative to classical medical and surgical methods of menorrhagia treatment. The system consists of a 32-mm T- shaped polyethylene frame with a reservoir containing 52 mg of Levonorgestrel (LNG), covered by a silicone membrane.6 After insertion, the initial release of LNG into the uterine cavity is 20μg/d and a stable plasma concentration of 150-200 pg./ml is achieved after the first few weeks.6 The plasma concentration of LNG in patients using the LNG- IUS is less than 25% of that seen with 150 μg of oral LNG.6 By slowly releasing the progestin LNG into the uterine cavity, the LNG-IUS suppresses endometrial growth, causing atrophy of the endometrial glands, decidualization of the stroma, thickening of the cervical mucous, and desensitization of the endometrium to estrogen, which all lead to excellent control of menorrhagia, providing in parallel a highly satisfactory contraceptive action.7 In the present study, the efficacy of the LNG-IUS LNG-IUS for menorrhagia control is compared to thermal endometrial ablation.
This study was carried out at Ain Shams and Al-Azhar University Maternity Hospitals during a period started from January 2019 to January 2021. It included 60 patients all had failed medical treatment (in the form of antiprostaglandins, hemostatics and progestins) for DUB for at least 6 months. All patients had at least one D&C which revealed no malignant changes but failed to improve the condition. So, the patients were good candidates for hysterectomy.
Inclusion criteria:
* Perimenopausal patients at the age of 40 -50 years
* The main complaints dysfunctional uterine bleeding with no bleeding tendency
* The patients completed their families & refusing hysterectomy
* Uterine enlargement ≤ 12 weeks size and the uterine cavity ≤ 12 cm, no uterine malformations
* No endometrial malignancy
* Normal adnexa
Exclusion Criteria:
* Patients not fulfilling the inclusion criteria
* Patients who were breast feeding or uncertain about a future wish for children.
All patients were submitted to:
* Careful history taking,general, abdominal and pelvic examination
* Assessment of menstrual blood
* Routine laboratory studies as hemoglobin, hematocrit values, serum iron level, fasting blood level, liver and renal
function tests and coagulation profile
* Chest X ray and ECG
* Premenstrual pelvic sonographic assessment for:
- terine size and dimensions
- Endometrial thickness
- Presence of foci of adenomyosis or fibroids
- Ovarian size, texture and the presence of follicles
* Assessment of menstrual blood loss
For proper evaluation of the patient complain and results of the treatment a numerical expression of subjective estimate of the menstrual blood loss was needed [7]
* Score 0: no bleeding
* Score 1: spotting-1 pad/day
* Score 2: mild bleeding- 2 pads/day
* Score 3: moderate bleeding- 3-4 pads/day
* Score 4: severe bleeding- 5-6 pads/day
The total bleeding score per month was calculated for each patient before and after 3-, 6-and 12-months use of Mirena or endometrial resection.
There was no statistically significant difference between the two groups as regards the demographic characteristics of the patients under the study as shown in table 1.
Tables of the study:
Variable | Mirena group (n = 35) | TCER group (n = 45) | t- value | P- value | |
Age (years) | 42.1 ± 2.1 | 41.8 ± 1.2 | 0.8 | 0.43 | |
Body mass index | 28.3 ± 1.4 | 28.1 ± 1.23 | 0.68 | 0.5 | |
Parity | 4.8 ± 1.1 | 3.9 ± 4.2 | 1.23 | 0.22 | |
| Values are expressed as means ± standard deviation or number and percentage. No significant difference between the two groups in all variables (P value >0.05) | |||||
Table(1): show the demographic characteristics of the patient sunder the study
The clinical characteristics of the two groups were compared with no significant difference as regard duration of menses and symptoms, endometrial thickness by transvaginal ultrasound, bleeding score/month, hemoglobin and hematocrit value as shown in table 2.
| Variable | Mirena group (n = 35) | TCER group (n = 45) | t- value | P- value | ||||
| Menses (days) | 8.1 ± 1.43 | 8.4 ± 1.12 | 1.05 | 0.3 | ||||
| Duration of symptoms (months) | 10.1 ± 1.4 | 9.81 ± 1.23 | 0.98 | 0.33 | ||||
| Endometrial thickness (mm) | 9.8 ± 3.1 | 10.1 ± 1.2 | 0.595 | 0.55 | ||||
| Bleeding score/month | 47.26 ± 0.48 | 47.13 ± 0.21 | 1.6 | 0.11 | ||||
| Hemoglobin (g/dl) | 8.13 ± 0.19 | 8.1 ± 0.14 | 0.8 | 0.42 |
| Hematocrit (%) | 32.66 ± 0.18 | 32.64 ± 0.13 | 0.58 | 0.56 | ||||
| Values are expressed as means ± standard deviation or number and percentage.No significant difference between the two groups in all variables (P value >0.05) | ||||||||
Table 3 & 4 compare the posttreatment data of the two groups. Both treatment modalities have a highly significant positive impact on patient's hematological profile (Hb, serum iron levels and HCT value) where hemoglobin level increased in LNG-IUS from mean baseline value of 8.13 gm/dl to 11.1 gm/dl at the end of the study (p<.05) while in the resection group increased from baseline of 8.1 gm/dl to 11.3 gm/dl (p<0>
| variable | Bleeding score | Hemoglobin (g/dl) | Hematocrit value(%) | Endometrial thickness |
| Before treatment in LNG group | 47.26 ± 0.48 | 8.13 ± 0.19 | 32.66 ± 0.18 | 9.8 ± 3.1 |
| After 12 month in LNG group | 33.5 ± 6.2 | 11.1 ± 1.5 | 35.9 ± 1.2 | 5.3 ± 1.4 |
| t- value | 13.1 | 11.6 | 15.8 | 5.8 |
| p- value | There are highly significant differences between the two groups (P <0> | |||
before treatment in TCER group | 47.13 ± 0.21 | 8.1 ± 0.14 | 32.64 ± 0.13 | 10.1 ± 1.2 |
| After 12 months in TCER group | 33.9 ± 4.5 | 11.3 ± 1.2 | 36.6 ± 3.1 | 4.94 ± 1.5 |
| t- value | 19.7 | 17.8 | 8.6 | 18.01 |
| p- value | There are highly significant differences between the twogroups (P < 0.01) | |||
Table (3) : shows the effect of treatment on bleeding score & hematological profile
| variable | Mirena group (n = 35) | TCER group (n = 45) | t- value | P- value | ||
| Bleeding score/month | ||||||
| After 3 months | 24.8 ± 3.1 | 23.9 ± 4.2 | 1.062 | 0.29 | ||
| After 6 month | 26.8 ± 4.5 | 27.2 ± 3.2 | 0.46 | 0.64 | ||
| After 12 months | 33.5 ± 6.2 | 33.9 ± 4.5 | 0.33 | 0.74 | ||
| Hemoglobin (g/dl) | ||||||
| After 3 months | 9.9 ± 1.2 | 9.4 ± 1.3 | 1.76 | 0.08 | ||
| After 6 months | 10.9 ± 1.02 | 10.6 ± 2.2 | 0.75 | 0.455 | ||
| After 12 months | 11.1 ± 1.5 | 11.3 ± 1.2 | 0.66 | 0.511 | ||
| Hematocrit (%) | ||||||
| After 3 months | 34.1 ± 2.2 | 33.9 ± 3.2 | 0.316 | 0.75 | ||
| After 6 months | 35.2 ± 3.1 | 36.1 ± 1.5 | 1.7 | 0.09 | ||
| After 12 months | 35.9 ± 1.2 | 36.6 ± 3.1 | 1.26 | 0.211 | ||
| Endometrial thickness | 5.3 ± 1.4 | 4.94 ± 1.5 | 1.1 | 0.27 | ||
| Values are expressed as means ± standard deviation or number and percentage. No significant difference between thetwo groups in all variables (P value > 0.05) | ||||||
Table (4) : shows the comparison between both lines of treatment on bleeding score & hematological profile
Oral medical treatments have been shown to provide partial relief of menorrhagia. Despite an average decrease in menstrual blood loss of up to 50%, many women remain menorrhagic when treated with tranexamic acid, mefenamic acid, flurbiprofen, norethisterone acetate, and ethamsy late [8]. The effectiveness of the levonorgestrel intrauterine system up to 1 year has been shown previously and, in a noncomparative study, up to 3 years9. Menstrual blood losses of less than 80 mL per cycle at one year were consistently achieved by 91.5% of women in these studies [9].
Further, Rauramo et al., Clegg et al. and Gupta et al. [10,11,12] demonstrated that the levonorgestrel intrauterine system and transcervical resection of endometrium were comparable regard to efficacy, amenorrhea rate, and satisfaction in a 12-month comparative study. We showed that both the levonorgestrel intrauterine system and transcervical resection of endometrium substantially reduced menstrual blood loss during the first year of use where the total bleeding score dropped from mean baseline value of 47.26 to 33.5 and from 47.13 to 33.9 in the LNG- IUS and in the resection group respectively. highly significant (P less then 0.01).
There was no statically difference in bleeding score before and during treatment between the two groups of women. The effect of the levonorgestrel intrauterine system on menstrual bleeding is produced predominantly by local suppression of the endometrial epithelium. This endometrial effect has been shown to persist over the course of 5 years in women who were in their fertile years.8 Therefore; along therapeutic effect of the levonorgestrel intrauterine system was expected.
In contrast, other investigators reported that endometrial resection is superior to LNG-IUS in reduction the amount of menstrual blood loss, Irvine et al. [13] reported that the mean reduction in MBL was not significantly different from that achieved with high dose norethisterone at 3 months (P 0.56). While Crosignani et al. [14] reported that the mean MBL of 79% with LNG IUS at 6 months was less than that achieved with endometrial resection 89% (P=0.015). Furtherly, Kittelsen and Istre15 reported a mean MBL reduction of 90% with LNG TUS at one year, compared with 98% MBL reduction for endometrial resection.
As regard to suppression of endometrial growth, it was found that the endometrial thickness measured by transvaginal ultrasonic examination decreased significantly 12 months after insertion of the device (P less than 0.01). This is in accordance with several studies which found that LNG IUS can cause endometrial atrophy by suppressing endometrial growth and this takes about three cycles after insertion of the system [16,17]. Sturdee [18] reported a possible application for the LNG IUS in cases of endometrial hyperplasia, hormonal replacement therapy to protect the endometrium and in combination with tamoxifen for treatment of breast cancer.
Also, in this study found that both treatment modalities have a highly significant positive impact on patient's hematological profile (Hb, serum iron levels and HCT value) where hemoglobin level increased in LNG- IUS from mean baseline value of 8. 13 gm/dl to 11.1 gm/dl at the end of the study (p less than 0.05) while in the resection group increased from baseline of 8.1gm/dl to 11.3 gm/dl (p less then 0.05) at the end of the study, the same positive effects was observed in other hematological parameters. The increase in hematological profile corresponds to the decrease in the bleeding patterns (TBS/M). The increase in hemoglobin concentration and other hematological profile was reported by many authors [12,19,20].
The need for further surgical treatment was higher in the TCER group than LGN-IUS group; however, it was of non-significant importance as five of the LNG-IUS users (14.2%) subsequently underwent surgery following 12 months of their treatment, three of these patients (8.6%) underwent hysterectomy and two patients (5.7%) had endometrial resection. Three patients (8.6%) refused further treatment. In TCER group ten patients (22.2%) required further treatment, four patients (8.9%) underwent hysterectomy within the study-reporting period and other six patients (13.3%) underwent surgery following 12 months of their treatment, two of these patients (4.4%) underwent hysterectomy and four patients (8.9%) had endometrial resection, while five patients (1.1%) refused further treatment. Our results are in accordance with that observed by Fedele et al. [21] who reported that three of the LNG-IUS users (2%) subsequently underwent surgery within the study-reporting period, following discontinuation of their treatment. Two of these patients underwent hysterectomy and it is not clear whether the third patient had hysterectomy or endometrial resection. Molnár [22] reported that in TCER group 35.7% of women had repeated surgery for failed endometrial resection, 20.4% of women required dilatation and curettage, while 15.3% underwent hysterectomy, he reported that the chance of avoiding hysterectomy reached plateau after 72 months. Litta [23] reported failure of TCER in 24.6% of women, half of this group underwent hysterectomy.
On the basis of our data and the literature, strong evidence exists to suggest that the levonorgestrel intrauterine system should be considered the first-line treatment for idiopathic menorrhagia because it is easy to insert, has a sustained effect, provides contraception, may reduce the need for surgery, and is cost-effective and well tolerated
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