|Year : 2022 | Volume
| Issue : 1 | Page : 42-47
Evaluation of the efficacy of levonorgestrel intrauterine system in the management of heavy menstrual bleeding: An analytical observational study
Koyel Halder, Rathindra Nath Ray, Priyam Biswas, Pritha Kolay, Shefali Kumari, Dibyojyoti Das
Department of Obstetrics and Gynecology, Institute of Post-Graduate Medical Education and Research, Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India
|Date of Submission||08-Feb-2022|
|Date of Acceptance||07-Mar-2022|
|Date of Web Publication||23-Mar-2022|
Dr. Rathindra Nath Ray
Department of Obstetrics and Gynecology, Institute of Post-Graduate Medical Education and Research, Seth Sukhlal Karnani Memorial Hospital, Kolkata 700020, West Bengal.
Source of Support: None, Conflict of Interest: None
Background: Heavy menstrual bleeding (HMB) poses threat to the quality of life among women. To prevent HMB, the levonorgestrel-releasing intrauterine system (LNG-IUS) is a well-known nonsurgical, long-performing, and alternative method. Objectives: The objective of this study was to determine the efficacy of LNG-IUS in women with HMB through an analytical observational study. Materials and Methods: This study was performed among 60 patients who visited the gynecology and obstetrics outpatient department (OPD) at the Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital (IPGMER and SSKMH), Kolkata, West Bengal, India from May 2019 to April 2020 due to HMB. The mean demographic and clinical profiles were evaluated, and comparative analysis was performed for hemoglobin (Hb), spotting, pain, and endometrial thickness on day 0 and follow-up 3 months, 6 months, and 12 months. Results: The mean age of patients was 37.77 ± 4.58 years was obtained. The Hb level was significantly (P < .001) increased, whereas pictorial blood loss assessment chart (PBAC) score, endometrial thickness, spotting, and pain were significantly (P < .01 and P < .001) reduced. The majority of patients had pallor, but the rates of spontaneous expulsion and hysterectomy were observed lower after using LNG-IUS among studied patients. Conclusion: the usage of LNG-IUS is potential in the treatment of HMB in women, which may lead to a better quality of life. This can be the alternative to hysterectomy and oral pills for long-term use. It is suggested in a future study with larger sample size and multicentric approach to minimize hospital biasness.
Keywords: Heavy menstrual bleeding, levonorgestrel-releasing intrauterine system, PBAC score, quality of life
|How to cite this article:|
Halder K, Ray RN, Biswas P, Kolay P, Kumari S, Das D. Evaluation of the efficacy of levonorgestrel intrauterine system in the management of heavy menstrual bleeding: An analytical observational study. MGM J Med Sci 2022;9:42-7
|How to cite this URL:|
Halder K, Ray RN, Biswas P, Kolay P, Kumari S, Das D. Evaluation of the efficacy of levonorgestrel intrauterine system in the management of heavy menstrual bleeding: An analytical observational study. MGM J Med Sci [serial online] 2022 [cited 2022 May 17];9:42-7. Available from: http://www.mgmjms.com/text.asp?2022/9/1/42/340581
| Introduction|| |
Heavy menstrual bleeding (HMB) is defined as prolonged (>7 days) or excessive blood loss during the menstrual period, which is estimated greater than or equal to 80 mL per menstrual cycle. Moreover, HMB, which is also commonly known as menorrhagia, constitutes a considerable problem for many women, resulting in much discomfort, anxiety, and disruption in their regular lives. It interferes with a woman’s physical, social, emotional, and/or material quality of life (QOL). Abnormal uterine bleeding (AUB) is a common reason for consulting a gynecologist and hysterectomy is often used to treat women with menorrhagia, but medical therapy may be a successful alternative.,,,
HMB is an important cause of ill health in women worldwide. Approximately one-third of women report HMB at some time in their lives. HMB is the presenting symptom in most of the women who undergo hysterectomy, and recent data suggest that HMB is an increasingly common health problem.
In past, the levonorgestrel-releasing intrauterine system (LNG-IUS) is a well-known nonsurgical, long-performing, and alternative to the traditional medical and surgical treatments for HMB. On the contrary, LNG-IUS has become one of the most acceptable medical treatments for menorrhagia, reducing referrals to specialists and decreasing the need for operative gynecological surgery.,,, Levonorgestrel is released from this system at a rate of 20 mcg/24 h. It suppresses endometrial growth, the glands of the endometrium become atrophic, and the epithelium becomes inactive. Along with the high contraceptive efficacy, LNG-IUS has shown benefits and improvement of symptoms in menorrhagia, adenomyosis, and endometriosis. LNG-IUS device has also been found to be cost-effective with fewer side effects and to increase the QOL. The QOL of women treated with the LNG-IUS is markedly improved, causing high levels of patient satisfaction. The LNG-IUS (Mirena) has been extensively studied in the treatment of dysfunctional HMB., It has been advocated for the treatment of HMB as an alternative to surgery. The LNG-IUS is an intrauterine system that releases 20 μg of levonorgestrel every 24 h over 5 years. The LNG-IUS was developed during the 1980s. The estimated number of current LNG-IUS users worldwide is more than 4 million in approximately 120 countries.
The LNG-IUS reduces menstrual blood loss (MBL) more than tranexamic acid, nonsteroidal anti-inflammatory drugs, danazol, oral progestogens, combined oral contraceptives, or long-term norethisterone. No difference in patient satisfaction or health-related quality of life (HRQOL) has been found between the LNG-IUS and endometrial destruction, and both are effective in reducing MBL. However, data regarding the impact of LNG-IUS on myoma-related HMB are very scarce.
The study related to the efficacy of LNG-IUS on HMB has been found in many parts of the globe viz. USA,, Africa, Australia, Turkey, and the Netherlands as well as in India,,,, but the study is lacking related to therapeutic efficacy among women with HMB in the eastern part of India, especially in West Bengal.
In this study, it was evaluated to determine the efficacy of LNG-IUS in women with HMB through an analytical observational study.
| Materials and methods|| |
It was an analytical observational study carried out over 1 year (May 2019–April 2020) in the Department of Obstetrics and Gynaecology, Institute of Post-Graduate Medical Education and Research, and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India with longitudinal follow-up.
The study consisted of 60 patients with HMB who attended the Gynae OPD in SSKM Hospital and IPGMER, Kolkata, India.
The sample was designed according to the inclusion and exclusion criteria mentioned below. All women with a complaint of HMB (30–50 years) have at least one living child.
- Patients who had AUB.
- Multiparous women.
- Those patients who had a history of different complications related to pregnancy.
- Those patients who had anomalous fetuses during the gestational period.
- Those patients who had a history of pregnancy with oligohydramnios/polyhydramnios.
- Those patients who had a bulky uterus.
All women had a transvaginal scan (TVS), Pap smear, thyroid profile, and complete blood picture as a preliminary workup for AUB. Women with no cervical, vaginal pathology, less than 12 weeks’ uterine size, and a negative pap smear only were included in our series.
- Women with congenital or acquired uterine anomaly.
- Intramural and subserous fibroids more than 3 cm.
- Submucous fibroids distorting the uterine cavity.
- Acute pelvic inflammatory disease.
- Genital bleeding of unknown etiology.
- Liver disease and renal diseases.
- Known or suspected carcinoma of the breast was excluded.
Laboratory investigations such as complete blood count (CBC), liver function test (LFT), fasting blood sugar (FBS), post-prandial blood sugar (PPBS), thyroid function test (TFT), renal function tests (RFT), free thyroxine (FT4), thyroid-stimulating hormone (TSH), prolactin, coagulation profile, ultrasound pelvis, TVS, Pap smear, and endometrial biopsy were performed.
- Clinical profiles: Height, weight, BMI, BP, pallor, and HR.
- Blood test: Complete blood count, Liver function test, FBS, PPBS, FT4, TSH, and coagulation profile.
Scheme of case taking
A detailed history and examination (general, systemic, pelvic, and breasts) were done. TVS ultrasound was done using a 7.5-MHz transducer probe. Any obvious pathologies like fibroids, adenomyosis, endometriosis, endometrial polyps, ovarian cysts, or any other adnexal pathology were diagnosed.
Sixty women aged between 30 and 50 years with at least one issue with abnormal HMB with or without associate dysmenorrhea or, chronic pelvic pain, adenomyosis, endometriosis, having young age and who require contraception and wishes to preserve fertility or medical and surgical high-risk factors making unsuitable for surgery and had no contraindication for IUS insertion were included in the study after taking written and informed consent. HMB was determined by the history of HMB more than 7 days and pictorial blood loss assessment chart (PBAC) scoring more than 100 per menstrual cycle correlated with >80 mL objective blood loss (William’s gynecology 3rd edition page 180), and also the patients’ subjective complaints of discomfort, anxiety, and disruption of their regular daily activities. The patients who fulfilled the inclusion criteria were selected for the study. The women were called for follow-up after 1 month, then 3 months, and then 6 months, and then after 12 months and asked regarding the relief they have obtained from the antecedent menstrual complaints checked information booklet for the pattern of bleeding and spotting. A detailed general, systemic, pelvic (seen the threads), and breasts examination was done at every visit. A follow-up ultrasound was done at every visit to see for LNG IUS location and if there are any changes in the original pelvic pathology or development of a new pathology like ovarian cysts and to measure the endometrial thickness (ET). Hemoglobin (Hb) estimation was done at each visit. The efficacy of LNG IUS was measured in the form of subjective symptomatic improvement along with improvement in QOL.
Pictorial blood loss assessment chart scoring system
During the menstrual period, the patient recorded her usage of tampons and sanitary towels by placing a tally mark under the day next to the box that represents how stained her sanitary materials were in each time she changed them. Patients recorded clots by indicating whether they used the size of large clots or small clots/flooding row under the relevant day. On day 1 she said about large clot × 1 and small clots × 3. She recorded any incidences of flooding by placing a tally mark in the clots/flooding row under the relevant day. A lightly stained towel was scored 1 point, a moderately stained towel 5 points, a towel that was saturated with blood was scored 20 points. A lightly stained tampon was scored 1 point, a moderately stained tampon 5 points and a tampon that is fully saturated was scored 10 points.
For statistical analysis, data were entered into a Microsoft Excel spreadsheet and then analyzed by SPSS (version 27.0; SPSS, Chicago, Illinois). Data had been summarized as mean and standard deviation for numerical variables and count and percentages for categorical variables. Two-sample t tests for a difference in mean involved independent samples or unpaired samples. The “chi-square test” was used as short for Pearson’s chi-squared test. A value of P ≤ 0.05 was considered statistically significant.
| Results|| |
This study was evaluated the efficacy of LNG-IUS in women with HMB. The data relating to clinical profiles (mean ± SD) viz. body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), total bilirubin (TB), serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), total protein (TP), total alkaline phosphatase (ALP), total cholesterol (TC), Triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), Hb for day 0, 1 month, 3 months, 6 months, and 12 months, PBAC score day 0, 1 month, 3 months, 6 months, and 12 months, ET (mm) day 0, 1 month, 3 months, 6 months, and 12 months were recorded. Moreover, frequency (%) distribution of spots, pain for 1 month, 3 months, 6 months, and 12 months, as well as frequency (%) distribution of perforation, spontaneous expulsion, and hysterectomy were also noted. A total of 60 patients were enrolled in this study after strictly following inclusion and exclusion criteria.
In [Table 1], a maximum frequency of approximately 68.3% of age groups 31–40 years, whereas minimum of approximately 31.7% of 41–50 years were obtained and the mean age of patients was 37.77 ± 4.58 years was obtained. The mean BMI (22.69 ± 3.04 kg), SBP (122.13 ± 11.60 mm Hg), DBP (82.20 ± 6.09 mm Hg), HR (87.87 ± 8.84 bpm), TB (0.98 ± 0.14 mg/dL), SGOT (37.72 ± 2.73 IU), SGPT (37.66 ± 2.48 IU), TP (7.06 ± 0.77 mg/dL), ALP (202.98 ± 19.89 IU), TC (182.17 ± 14.46 mg/dL), TG (193.33 ± 13.73 mg/dL), HDL (48.10 ± 4.98 mg/dL), and LDL (100.78 ± 7.57 mg/dL) were observed in the studied patients.
The mean ± standard deviation (SD) values of Hb level [Figure 1] were significantly (P < .001) increased in 3 months (9.18 ± 0.88), 6 months (9.84 ± 0.94), and 12 months (10.42 ± 0.92) but in 1 month (7.85 ± 0.78) data was comparable when compared to day 0 (7.76 ± 0.78) among patients.
|Figure 1: Comparative analysis of Hb level (gm%) in different follow-up (*P < .001)|
Click here to view
The mean ± SD values of the PBAC score [Figure 2] were significantly (P < .001) decreased in 1 month (265.30 ± 23.58), 3 months (113.74 ± 20.76), 6 months (95.27 ± 32.63), and 12 months (90.12 ± 26.6) when compared to day 0 (369.33 ± 15.05) among patients.
|Figure 2: Comparative analysis of PBAC score in different follow-up (*P < .001)|
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The mean ± SD values of the ET [Figure 3] were significantly (P < .01 and P < .001) decreased in 1 month (10.85 ± 0.79), 3 months (9.46 ± 0.73), 6 months (7.74 ± 1.64), and 12 months (7.20 ± 1.51) when compared to day 0 (11.31 ± 0.85) among patients. [Table 2] evaluates the frequency (%) distribution of spotting among patients in which 1st month all the patients had spotting (100%), whereas approximately 85% patients had spotted in 3rd month followed by 13% had spotted in 6th month and only 5% had spotted in 12th month. The improvement of spotting during follow-up was statistically significant (P < .001).
|Figure 3: Comparative analysis of endometrium thickness in different follow-up (**P < .01; *P < .001)|
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[Table 3] evaluates the frequency (%) distribution of pain among patients in which day 0 approximately 58.3% patients had pain, whereas in 1st month approximately 48.3% patients had pain, 30% patients had pain in 3rd month, 20% had spotted in 6th month and only 15% had pain in 12th month follow-up. The relief of pain during follow-up was statistically significant (P < .001).
[Table 4] evaluates the frequency (%) distribution of clinical parameters among patients in which patients had pallor, spontaneous expulsion, and hysterectomy of approximately 68.3%, 5.0%, and 6.7%, respectively, whereas no perforation was observed among patients.
|Table 4: Frequency distribution of clinical parameters in studied subjects|
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| Discussion|| |
LNG-IUS is a better alternative to other treatments such as oral pills, hysterectomy, etc. in HMB related to the low-cost procedure and improving the QOL of the patients.,,,,,,, The blood loss in HMB poses lowering of Hb level, whereas LNG-IUS therapy observed efficacious and elevation of Hb, which is supported by earlier studies from India and abroad.,,,, Kriplani et al. and Dahiya et al. found significantly increasing (P = .000) Hb at 12 months follow-up, which showed a similar result in this study.
Regarding PBAC score Kriplani et al. observed significant (P = 0.00) at 1 month, and the decrease continued with treatment duration, which is similar in this study and also supported by Dahiya et al.
The ET was significantly (P = .0001) decreased at 12 months observed by Kriplani et al. but this study revealed the decreasing trend from 1st month. Tariq et al. found that at the end of 3 months 42% complained of vaginal spotting reduced to 10% at the end of 1 year but Dash et al. reported no spot at the end of 12 months. It was seen in our study that spotting reduced to 5% at the end of 12 months follow-up. In the case of pain relief, earlier studies by Dash et al. and Bayer and Hillard confirmed that long-term follow-up reduced pain due to the long-lasting contraception effect.
In this study, major patients had pallor but the lower value of spontaneous expulsion, and a hysterectomy but an earlier study reported a higher rate of expulsion.
| Conclusion|| |
In conclusion, the usage of LNG-IUS is potential in the treatment of HMB in women, which may lead to a better QOL. This can be the alternative to hysterectomy and oral pills for long-term use. As per this study, it was noticed that this device increased the HB level and reduced the PBAC score, ET, and relief from menstrual pain. It is suggested in a future study with larger sample size and multicentric approach to minimize hospital biasness.
Ethical policy and institutional review board statement
The ethical approval to undertake the proposed study has been obtained from Institutional Ethics Committee, Department of Obstetrics and Gynecology,, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India vide letter no. IPGME and R/IEC/2019/563 dated November 30, 2019.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]