Comparative Effectiveness of Tranexamic Acid Vs NSAIDS in Management of Heavy Menstrual Bleeding in Reproductive-Age Women.

Heavy menstrual bleeding (HMB) is a common gynecological disorder in women of childbearing age and is characterized by excessive loss of menstrual bleeding that disrupts the physical, emotional, social, and material quality of life of a woman. It represents a large percentage of outpatient gynecology visits in the world. The condition is often associated with iron deficiency anemia, fatigue, and decreased productivity, especially in low-resource settings where delayed presentation is common [1,2]. HMB is multifactorial in etiology, both in structural (fibroids and polyps) and non-structural (coagulopathies, ovulatory dysfunction, and endometrial disorders) causes. A standard method of identifying underlying causes is offered by the International Federation of Gynecology and Obstetrics (FIGO) classification system (PALM-COEIN). Nevertheless, empirical management of medical care is commonly started in most clinical situations, particularly in resource-constrained and limited settings, even before much investigation is conducted [3,4]. Treatment of HMB is based on the symptom severity, etiology, patient preferences, and fertility. Non-hormonal medical interventions are usually employed as a first-line treatment in women who are interested in fertility or do not want to experience hormonal side effects. Two of these, tranexamic acid (TXA) and nonsteroidal anti-inflammatory drugs (NSAIDs), are highly recommended because of their effectiveness, availability, and cost-efficiency [5,6]. Tranexamic acid is an antifibrinolytic agent that acts by blocking plasminogen activation, thus stabilizing fibrin clots and lowering menstrual blood loss. In different clinical trials, it has been found to minimize menstrual bleeding by up to 50%. NSAIDs, on the other hand, like mefenamic acid, decrease the production of prostaglandins and hence cause a decrease in uterine contractions and vasodilation. They are especially useful in women who have dysmenorrhea that is related, but their impact on lessening blood loss is relatively limited [7,8]. Although both treatment methods are available, direct comparative studies are still required to establish the relative effectiveness of both in real-life clinical practices. Although past  study implies that TXA is better at decreasing menstrual blood loss, NSAIDs can be used to provide extra advantages in pain management. Nonetheless, the differences in outcome measures, study populations, and methodologies have resulted in different conclusions [9].In the developing world, such as in Pakistan, where access to advanced therapies may be scarce, it is important to maximize the use of more affordable and more easily accessible medications. Awareness of the comparative effectiveness of TXA and NSAIDs would enable clinicians to make evidence-based decisions to suit patient needs. Thus, the present study will assess and compare the effectiveness of tranexamic acid and NSAIDs in the treatment of heavy menstrual bleeding in reproductive-age women [10].

Study Design & Setting

The study was a retrospective study carried out in the Department of Obstetrics and Gynecology Gomal Medical College,Dera Ismail Khan from 05 January  2024 05  june 2024 during a period of six months, which offered standardized assessment and treatment of patients with heavy menstrual bleeding.

Participants

One hundred reproductive-age women (18 to 45 years) who were referred with heavy menstrual bleeding were recruited. Outpatient clinics were used to recruit patients. Individuals who met the eligibility criterion were selected in two groups randomly, with an equal number in each. All participants were informed and provided informed consent before inclusion to guarantee that there was voluntary participation and confidentiality of clinical information.

Sample Size Calculation

The sample size of 100 patients (50 in each group) was based on a confidence level of 95, a power of 80, and the anticipated difference in reduction of menstrual blood loss among groups using past study. The margin of error was taken to be 5%, which included the possibility of dropouts.

Inclusion Criteria

•         Women aged 18–45 years

•         Diagnosed with heavy menstrual bleeding (PBAC score >100)

•         Regular menstrual cycles

•         Ready to play and consent.

Exclusion Criteria

•         Pregnancy or lactation

•         Known bleeding disorders

•         Uterine malignancy

•         Use of hormonal therapy in the last 3 months

•         Severe systemic illness

Diagnostic and Management Strategy

Clinical history, examination, and PBAC scoring were used to make the diagnosis. Baseline hemoglobin was taken. Patients were given tranexamic or NSAIDs in the three menstrual cycles, and then PBAC scores and hemoglobin were reassessed.

Statistical Analysis

The data was analyzed by SPSS 25. The quantitative variables were given in the form of mean, standard deviation, and the qualitative variables in the form of frequencies and percentages. Comparison was done using an independent t-test and a chi-square test. A p-value <0.05 was considered statistically significant.

Ethical Approval Statement

Ethical approval for this study was obtained from the Institutional Review Board/Ethics Committee of the participating tertiary care hospital prior to commencement of the study. All procedures were conducted in accordance with institutional ethical standards and the principles of the Declaration of Helsinki.

The current paper was a comparison between the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDS) and tranexamic acid (TXA) in the management of heavy menstrual bleeding (HMB) in women of reproductive age.The study showed that TXA was much more effective in decreasing menstrual blood loss and in ameliorating hemoglobin level, but NSAIDs were superior in ameliorating dysmenorrhea. These findings are in line with existing literature and support the use of TXA as the non-hormonal treatment mode of HMB [11]. The decrease in PBAC scores in this study was also much higher in the TXA group than in the NSAID group (p < 0.001). Recent systematic reviews and meta-analyses have found similar study to conclude that antifibrinolytic therapy like TXA is better than NSAIDs and other non-hormonal interventions in reducing menstrual blood loss [12]. One of the network meta-analyses performed in the recent past also included TXA in the list of the most effective first-line medical interventions in managing HMB, with NSAIDs demonstrating relatively small blood loss reductions [13]. These studies lend great credence to the high efficacy of TXA that was seen in our study.The fact that the hemoglobin levels improved in the TXA group also indicates the clinical advantage of the substance in the prevention of anemia related to chronic HMB. Recent literature has highlighted the positive effects of quality of life and hematological parameters resulting in effective reduction of menstrual blood loss with TXA [14]. Conversely, though NSAIDs showed some improvement in hemoglobin levels in our study, the effect was not as significant, which is in line with other study who found that NSAIDs mainly act on the prostaglandin-mediated pathways, but not the underlying fibrinolytic activity [15]. In terms of alleviating symptoms, we found that NSAIDs were significantly better at alleviating dysmenorrhea (p = 0.01). This observation is in line with the known action of NSAIDs, which lower the production of the prostaglandins, thus decreasing uterine contractions and pain. Other past study has also indicated the same findings that NSAIDs can be especially useful in patients with HMB and are associated with considerable menstrual pain, and so are a useful adjunct or alternative treatment in certain situations [16].Randomized trials comparing evidence indicate that in the range of 80-87 per cent of patients respond to TXA therapy as opposed to about 60 per cent to NSAID therapy, which further reinforces the use of TXA as a better agent over NSAIDs in the management of bleeding [17]. Moreover, recent reviews and clinical recommendations have always indicated that TXA has the potential to decrease menstrual blood loss by as much as 50-60% compared to the 20-40% reduction of NSAIDs [18]. These quantitative differences are evident in the extent of the PBAC score reduction in our study. In our study, safety profiles were similar in both groups, where NSAIDs were linked to a greater incidence of gastrointestinal side effects. This is in line with the past findings, which show that NSAIDs can lead to gastric irritation and other gastrointestinal complications, which restrict their use in the long term [19]. On the contrary, TXA was widely tolerated, and adverse effects were few, which underscores its safety in normal clinical practice. The study of this study can be specifically important in the conditions of low resources, where treatment solutions are needed that are cost-effective and available. TXA and NSAIDs are both readily accessible and cheap; however, due to its greater effectiveness in reducing menstrual blood loss, TXA must be the first-line non-hormonal treatment of HMB. Instead, NSAIDs can be better used in patients with dysmenorrhea as the leading cause, or when TXA is contraindicated [20]. On the whole, this study contributes to the existing evidence on the effectiveness of TXA as a treatment for HMB compared to NSAIDs. It is suggested that future large-scale and multicentric studies should help to confirm this study and discuss the long-term outcomes and patient satisfaction.

LIMITATIONS

The limitations of this study are that it is a single-center study, and the sample size is relatively small, which could restrict generalization. Limited long-term outcome evaluation was due to short follow-up. Blinding has not been done, and this could have led to bias. Also, there was no stratification of the underlying causes of heavy menstrual bleeding, which could affect the variability in treatment response.

Compared to NSAIDs, tranexamic acid is more effective in reducing menstrual blood loss and enhancing hemoglobin levels in women with heavy menstrual bleeding. But NSAIDs are more effective at relieving pain. Both are safe and effective, and treatment should be tailored according to patient symptoms, preferences, and clinical presentation.

ACKNOWLEDGEMENT

The authors acknowledge the support of the Gomal Medical College,Dera Ismail Khan for facilitating data collection and diagnostic procedures.

CONFLICT OF INTEREST

The authors declare no conflict of interest.

FUNDING

No external funding was received for this study.

INFORMED CONSENT

Written informed consent was obtained from all participants prior to enrollment in the study.

DATA AVAILABILITY STATEMENT

The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.

DISCLAIMER

The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the affiliated institution.

Author Contributions

Nayyer Latif contributed to the conception and design of the study, data interpretation, and critical revision of the manuscript. Rubina Baber contributed to data collection, statistical analysis, and drafting of the manuscript. Uzma Zaman contributed to study supervision, manuscript review, and final approval of the version to be published. All authors meet the ICMJE authorship criteria and approved the final manuscript.

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