Abnormal uterine bleeding (AUB) is a common gynecological disorder in women of reproductive age, It encompasses any deviation from the normal menstrual cycle concerning frequency, duration, or blood loss.(1) AUB accounts for a substantial proportion of gynecological outpatient visits and impacts women's living quality, sexuality, social engagement and participation, mental well-being (including anxiety, stress, and depression), access to education and employment prospects, experiences of stigma and shame, as well as economic challenges.(2) To standardize the terminology and facilitate accurate diagnosis and management, the International Federation of Gynecology and Obstetrics (FIGO) proposed the PALM–COEIN classification system, an etiopathogenesis-based nomenclature for AUB. The PALM group includes structural causes—Polyp, Adenomyosis, Leiomyoma, and Malignancy and Hyperplasia—whereas the COEIN group comprises non-structural causes—Coagulopathy, Ovulatory disorders, Endometrial factors, Iatrogenic causes, and Not yet classified entities.(3) Medical management forms the cornerstone of treatment for both acute and chronic AUB and includes combined oral contraceptives, the levonorgestrel-releasing intrauterine system (LNG-IUS), progestogens, tranexamic acid, mefenamcid, ormeloxifene, danazol, and gonadotropin-releasing hormone analogues such as leuprolide, depending on the underlying etiology and patient characteristics.(4) Quality of life (QOL) has emerged as an important outcome measure in modern health care. Hence effectiveness of medical management should be assessed by considering both clinical improvement and also its influence on the patient’s daily functioning, emotional health, social relationships, and overall well-being.(5) Understanding the impact of medical management on quality of life can help clinicians identify unmet patient needs, optimize therapeutic strategies, improve adherence, and provide holistic care. This study is aimed to investigate the patient characteristics, prescription patterns, and health-related quality of life (HRQoL) in patients receiving medical management for AUB.

The study was conducted among women with a history of abnormal uterine bleeding (AUB) who had been receiving the same medical treatment for at least three months attending the outpatient Department of Obstetrics and Gynaecology at Vanivilas Hospital, Bangalore Medical College and Research Institute (BMCRI), Bengaluru. A cross-sectional design was adopted and the study was carried out over a period of two years, Participants were selected using convenient sampling method. Based on previously reported prevalence rates of AUB patients receiving medical therapy, the calculated sample size was 200 at a 95% confidence level with 5% precision/n. Inclusion criteria Women aged 18–55 years who were on same medical treatment for AUB for at least three months and who provided written informed consent were included in the study. Exclusion criteria Patients who were non-adherent to therapy or unable to understand the questionnaire were excluded. After approval from the Institutional Ethics Committee, eligible participants were enrolled and informed consent was obtained. Information regarding demographic characteristics, clinical history, examination findings, and prescribed medications was documented using a structured case record form. The primary outcome measure of the study was quality of life assessed through the EQ-5D-3L instrument.(6) Statistical Analysis: The sample size was calculated using the prevalence of abnormal uterine bleeding (AUB) among women receiving medical treatment reported in previous literature (17.9%)(7), with a 95% confidence interval and 5% absolute precision. Using the standard formula N = Z²pq/d², 200 participants were ultimately enrolled in the study. Data were analysed using IBM SPSS Statistics version 30.0. Descriptive statistics were presented as mean ± standard deviation with 95% confidence intervals where appropriate. Categorical variables were compared using the Chi-square test or Fisher’s exact test. Variables showing significance in univariate analysis were included in a multiple logistic regression model to determine independent predictors of poor quality of life. A p value < 0.05 was considered statistically significant.

Out of 200 patients, mean age was 35 years and majority (35%) of them belonged to 21 to 30 years age group. Among these 200 patients who were on medical treatment, 98% of the patients had regular menstrual cycle and only 2% patients had irregular cycles. Flow of menstrual bleeding became normal in 90% , 4% patients had Amenorrhea, 4% patients had Hypomenorrhoea and only 2% patients had Menorrhagia. According to FIGO etiological classification of AUB, among the 200 patients AUB-O (Ovulatory dysfunction) was 89(44.5%), AUB-E (Endometrial) was 36 (18%), AUB-L (Leiomyoma) was 30 (15%), AUB-A (Adenomyosis) was 18 (9%), AUB –P ( Polyp) was 8 (4%), AUB-I ( Iatrogenic) was 8 (4%), AUB-N (Not otherwise classified) was 7 (3.5%), AUB-M ( malignancy and Hyperplasia) was 2 (1%) followed by AUB-C (Coagulopathy) 2 (1%).(3) Depicted in Figure 1. Figure1. : Aetiology of AUB Among 200 AUB patients 106 patients had comorbidities. Of which 40% patients had anaemia, 20% patients had hypothyroidism, 23% patients had sexually transmitted infections, 7% had infertility, 6% had type 2 diabetes mellitus, 2 % had hypertension. Among the participants receiving hormonal therapy, the most commonly prescribed regimen was levonorgestrel with ethinylestradiol in 70 women (59.8%). This was followed by oral progestins (medroxyprogesterone acetate or norethisterone) in 24 women (20.5%), levonorgestrel intrauterine system (LNG-IUS, Mirena) in 10 women (8.5%), cyproterone acetate with ethinylestradiol in 6 women (5.1%), ormeloxifene in 3 women (2.5%), and leuprolide (GnRH analogue) in 2 women (1.7%). Among those receiving non-hormonal therapy, tranexamic acid combined with mefenamic acid was prescribed to 33 women (48.5%), while tranexamic acid alone was used in 32 women (47.0%). A smaller proportion received mefenamic acid with dicyclomine (3 women, 4.4%). Some received combination of hormonal and non-hormonal treatment also. Regarding concomitant medications, iron and folic acid supplementation was the most common, received by 38 women (40%). Other concomitant treatments included thyroxine in 25 women (20%), antibiotics in 24 women (23%), infertility treatment in 8 women (7%), antidiabetic drugs in 6 women (6%), antihypertensive drugs in 4 women (2%), and blood transfusion in 4 women (2%). The EQ-5D-3L index score among the 200 women with abnormal uterine bleeding (AUB) who had been receiving medical treatment for at least three months showed a median value of 0.768. Depicted in Figure 2.The EQ-5D Visual Analogue Scale (EQ-VAS) scores ranged from 20 to 90, with a median score of 70, indicating the overall self-perceived health status of the study participants. Figure 2: QOL of AUB patients as per EQ-5D- 3L Scale The median EQ-5D-3L index score of the study population was 0.768. Participants with scores below the median value were classified as having poor quality of life (QOL), whereas those with scores equal to or above the median were considered to have good QOL. Various factors were compared between the two groups. Parity and type of treatment (hormonal or non-hormonal) showed a significant association with quality of life. Variable Good QOL n=125 Poor QOL n=75 P value Age <45 years >45 years 109(65.3%) 16(48.5%) 58(34.7%) 17(51.5%) 0.069 Marital status 104 65 0.5 Parity 85 62 0.02 Co-morbidity 61 45 0.12 Adverse drug reaction 07 11 0.93 Treatment Only Hormonal Only Non-hormonal 79 31 35 38 0.02 <0.001 Table 1. Showing predictors of poor QOL, a univariate regression analysis was performed using variables having a P value < 0.2. Higher parity was associated with approximately 2.2 times greater odds of poor quality of life, indicating a significant positive association. Women receiving only hormonal therapy had about 50% lower odds of poor quality of life, suggesting a protective effect. Women receiving only non-hormonal therapy had about three times higher odds of poor quality of life, and this association was statistically significant. A multiple logistic regression model was generated using the variables of significance value of <0.2 from univariate regression analysis. Multiparous women, women and women on non-hormonal treatment were the predictors of poor QOL.

In the present study majority of AUB patients (35%) belonged to the age group of 21 to 30 years, similar to the studies by Wagh et.al. showed majority patients belonged to same age group as present study. (8) It may be because in the reproductive age women are more concerned with completing family and any variation in menstrual cycle will make her to seek medical help and lesser number of patients was seen in the perimenopausal ages may be due to earlier evaluation, detection as well as management of the disease. In present study high percentage of patients had regular menstrual cycle as the study included women with AUB who were already on treatment for 3 months. This shows that the women were responding to the medical management. In studies conducted by Radha Nair et al and Susheela et al patients with regular menstrual cycle were 76% and 54% respectively. (9,10) The pattern of menstrual bleeding showed that majority presented with menorrhagia followed by oligomenorrhea, polymenorrhea and menometrorrhagia and least being intermenstrual bleeding. This is similar to the studies by Avantika Gupta et al, LithingoLotha et al. This is because the main presenting symptom of PALM COEIN is menorrhagia. (11,12) In the present study cause of AUB was mainly ovulatory dysfunction (AUB-O)(44.5%) in reproductive age group and Endometrial disorders (AUB-E)(18%) in perimenopausal age group. Leiomyoma (AUB-L) 15%, Adenomyosis (AUB –A) 9 %, Polyp (AUB-P) 4%, Iatrogenic (AUB-I) 4%, Not otherwise specified (AUB-N) 3.5%, least being Malignancy and hyperplasia (AUB-M) and Coagulopathy (AUB-C) (1% respectively). Majority of patients of AUB –O presented with PCOS. In the reproductive age group, PCOS is the commonest cause of ovulatory dysfunction that disrupts the Follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels and prevent ovulation resulting in AUB. In hormonal treatment majority of the prescriptions contained COC 22% and most common was Ethinylestradiol and Levonorgestrel combination followed by cyproterone acetate and ethinylestrdiol. These produce effects similar to endogenous female sex hormones and help in reducing menstrual flow volume, especially when used uninterruptedly. (13) Oral progestin alone was prescribed for 7.5% patients and levonorgestrel-intrauterine system (LNG-IUS) for 3.1% patients Women desiring continued fertility were given progestins alone. Progestins effectively decrease excessive menstrual bleeding. The continuous progesterone release provided by the levonorgestrel-releasing intrauterine system reduces menorrhagia more effectively than oral progestins. It is better tolerated than the 21-day oral regimen and has patient satisfaction scores similar to endometrial ablation and hysterectomy at a significantly lower cost. (14) Non hormonal treatment consisted of combination of tranexamic acid and mefenamic acid in 10.2%. Tranexamic acid alone was prescribed for 10% patients. Combination of mefenamic acid and dicyclomine was prescribed for 1% patients. At scheduled pharmacologic doses, nonsteroidal anti-inflammatory drugs (NSAIDs) decrease prostaglandin levels, reducing menstrual bleeding. (15)Tranexamic acid two 650-mg tablets taken three times per day in the initial five days of the cycle decreased bleeding significantly more than NSAIDs alone. Cost remains a limiting factor for the use of tranexamic acid. It is most appropriate in women with bleeding disorders who desire fertility or have contraindications to oral contraceptives.(16) The EQ-5D-3L index score is a questionnaire based score that describes the heath profile of women during menstruation. In the present study, the median value was 0.768 and women with values above median value were considered to have better QOL. Fifty seven percent (113/200) of women in our study had better QOL indicating that the medical management was facilitating them to have a better QOL. In study done by Cozza et.al. EQ-5D-3L score was 0.861 for hysterectomy group and 0.891for LNG-IUS treatment and for 6 months.(17).

Patients with abnormal uterine bleeding should be educated with relevant lifestyle changes (physical exercise, meditation, healthy diet, avoid unnecessary medications, self-care, personal hygiene), options for treatment (medical and surgical) their prognosis and when to seek emergency care. Medical treatment should be the first line of treatment, unless contraindicated. Which include Tranexamic acid, NSAIDs, COCs, GnRH analogue, Ormeloxifene. In conclusion, the present study highlighted that medical management of AUB consisted of mainly hormonal treatment. The patients who were medically managed reported to have good quality of life.

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