Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Bhanu K Bhakhri

"The Journal of Clinical and Diagnostic Research (JCDR) has been in operation since almost a decade. It has contributed a huge number of peer reviewed articles, across a spectrum of medical disciplines, to the medical literature.
Its wide based indexing and open access publications attracts many authors as well as readers
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Dr Bhanu K Bhakhri
Faculty, Pediatric Medicine
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018




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Professor & Head,
Department of Dematolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



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Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
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I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




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"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
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Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011

Important Notice

Original article / research
Year : 2010 | Month : October | Volume : 4 | Issue : 5 | Page : 3020 - 3025

Comparison of Traneximic Acid with a Combination of Traneximic Acid and Mefenamic Acid in Reducing Menstrual Blood Loss in Ovulatory Dysfunctional Uterine Bleeding (DUB)

Najam R *, Agarwal D **, Tyagi R ***, Singh S ****

1. Assistant professor, Department of Obstetrics and Gynecology, 2. Associate professor, Department of Pathology, 3. Resident, Department of Obstetrics and Gynecology, 4. Resident, Department of Obstetrics and Gynecology, Teerthanker Mahaveer Medical College, Moradabad,U.P. (India)

Correspondence Address :
Dr. Rehana Najam
Assistant Prpfessor
Department of Obstetrics and Gynecology
Teerthanker Mahaveer Medical College, Bagarpur, Delhi Road,
Moradabad, U.P. (India)
E mail: najamnajam@rediffmail.com

Abstract

Objective: To compare the efficacy of traneximic acid (Txa), with a combination of traneximic acid (Txa) and mefenamic acid (Mfa) in reducing menstrual blood loss in patients of ovulatory DUB.
Design: Prospective, randomised trial performed in 110 patients of ovulatory dysfunctional uterine bleeding.
Intervention: Patients diagnosed with ovuatory DUB based on the history of regular heavy cyclical bleeding, with normal transvaginal sonography (n= 110 patients), were included in the study. The patients were grouped into two, group T receiving tablets of 500mg Txa, three times a day from day 1 to 5 of the menstrual cycle, and group TM receiving tablets of 500mg Txa +250mg Mfa, three times a day from day 1 to 5 of the menstrual cycle, for 3 cycles i.e. 3 months. The efficacy of the treatment in both the groups was evaluated by recording the reduction in menstrual blood loss (measured by calculating pictorial blood assessment chart scores) and the improvement in post-treatment haemoglobin concentrations at 3 and 6 months follow up.
Results: Of the 110 patients who were followed up for a period of 6 months, 38.1% (n=42) were in the age group of 30-39 years. 54.5% of the patients (n=60) presented with moderate anaemia at the first outpatient visit. In the T group, the mean pre-treatment haemoglobin concentration was 9.5 g/dl and the mean PBAC score was 250. At 6 months of follow up, the mean haemoglobin concentration was 12.0 g/dl, which showed an improvement by 26.3% and the mean PBAC score was 125, which showed an improvement by 50%. In group TM, the mean pre-treatment haemoglobin concentration and the PBAC score were 8.6 g/dl and 246, respectively, while at 6 months of follow up, the mean haemoglobin concentration was 12.3g/dl, which showed an improvement of 38.9% and the PBAC score was 100, with a decline of 59.3%.
Conclusion: Both traneximic acid and a combination of traneximic acid and mefenamic acid are effective in decreasing PBAC scores and reducing menstrual blood loss in DUB, though a combination of traneximic acid and mefenamic acid showed better long term results.

Keywords

: Dysfunctional uterine bleeding (DUB), traneximic acid (Txa), mefenamic acid (Mfa), haemoglobin concentration, pictorial blood assessment chart (PBAC), menstrual blood loss (MBL).

Introduction
DUB is defined as excessive, heavy, prolonged or frequent bleeding of uterine origin that is not due to pregnancy, or any recognisable pelvic or systemic disease. The diagnosis of DUB is that of exclusion, where all pelvic and systemic causes of excessive menstruation have been ruled out. DUB is of two types, ovulatory and anovulatory. Ovulatory DUB accounts for 80% of the cases and is seen in women of the reproductive age group, while anovulatory DUB is seen at menarchae and during perimenopause. Nearly 28% of the female population consider their menstruation as excessive and plan their social activities according to their menstrual cycles, while nearly 10% of the employed women take time off work because of excessive menstrual loss. (1). About 35-40% of the females with excessive uterine bleeding are referred to hospitals and 60% will have a hysterectomy done in the next five years (2). DUB is diagnosed in 40-60% of the women with excessive menstrual bleeding, which is defined as blood loss greater than 80ml. The management of DUB includes general measures, including maintaining a menstrual calendar, correction of anaemia, medical treatment and finally, surgical treatment. The medical management of DUB includes NSAIDs, traneximic acid, progestogens, combined OCPs, danazol and levonorgestrel releasing intra uterine device. Morana B et al reported that the medical treatment of DUB results in patient satisfaction and a fall in the number of hysterectomies (3). It has been proved that fibrinolytic activity is increased in the menstrual fluid in menorrhagia and synthetic antifibrinolytics reduce menstrual bood loss (4). Traneximic acid, a synthetic derivative of the amino acid lysine, exerts its antifibrinolytic activity through the reversible blockade of lysine binding sites on plasminogen molecules. It is 6-10 times more potent than other synthetic antifibrinolytic agents and reduces menstrual blood loss by 45-60%. The side effects of tranaxemic acid therapy include nausea and leg cramps and rarely, deep vein thrombosis. NSAIDs or anti-prostaglandins act by reducing the elevated levels of prostaglandins which are seen in patients of excessive menstrual bleeding. Mefenamic acid, an NSAID and an anthranilic acid derivative, is also known to reduce menstrual blood loss by 20% (3),(4),(5).

Previous studies have evaluated the efficacy of various medical modalities (NSAIDS, hormones, antifibrinolytics, etc) and have established their role, but none has compared an anti-fibrinolytic with a combination of anti-fibrinolytics and NSAIDs in reducing menstrual blood loss in patients of DUB. This study was designed to compare the clinical efficacy of traneximic acid alone and in combination with mefenamic acid in reducing blood loss in patients with ovulatory DUB.

The improvement in the clinical parameters which are associated with dysfunctional uterine bleeding, such as degree of anaemia and reduction in menstrual blood loss, were also evaluated as appropriate responses to therapy.

Material and Methods

This prospective trial was conducted in the Department of Obstetrics and Gynecology of our institute from October 2008 to September 2009 (12 months), after approval from the institutional ethical committee. Out of the 670 patients of abnormal uterine bleeding, 110 cases having heavy regular cycles (ovulatory DUB) were included in the study after taking written/ informed consent. The inclusion criteria were:
• Patients between 12-45 years.
• In married females, transvaginal sonography (TVS) evaluation on either the 4th, 5th or 6th day of their menstrual cycle, revealing an endometrial thickness of less than 5mm.
• Normal Pap test, thyroid function test, renal function tests, liver function tests, coagulation profile.
• Endometrium sampling for the secretory phase, only in cases of the perimenopausal age group.
• The exclusion criteria included patients with a history of recent IUCD or hormonal therapy, anovulatory or irregular cycles, absence of pregnancy or any pelvic pathology, coagulation disturbances, polycystic ovarian disease and thyroid, liver or renal dysfunction.
Abdominal ultrasound was performed in unmarried females to evaluate any pelvic pathology. All these cases were assessed with detailed history and meticulous physical examination, including per vaginal and per abdominal assessment. The pre-treatment haemoglobin concentration was measured and recorded in each patient.

The menstrual blood loss was assessed by the pictorial blood assessment chart (PBAC) scores. This was a subjective method of assessing menstrual blood loss (MBL), whereby the patient was asked to examine her pad/tampon/towel for the amount of staining on it and a score was given. In our study, all patients were advised to use sanitary pads of a particular brand (Johnson and Johnson, India Ltd.) to standardize the assessment of blood loss. We decided to use the PBAC because it was simpler, less time consuming and cost effective and did not require a collection of sanitary products. A PBAC score of ≥ 100 shows a diagnosis of menorrhagia and signifies that the MBL is more than 80ml. PBAC had showed a sensitivity of 86% and a specificity of 89% in previous studies (6). The patients who were enrolled in the study were randomly distributed to the T or the TM group by using computer generated numbers. In the T group, patients received tablets of 500 mg traneximic acid, thrice daily, from day 1 to 5 of the menstrual cycle. In the TM group, patients were given tablets of 500mg traneximic acid and 250mg mefenamic acid, thrice daily, from day 1-5 of the cycle, till 3 cycles. The medication was supplied in an individual pack for each subject.

The patients were followed up at 1, 3 and 6 months intervals after their first prescription and were asked to report earlier in case of any problem. Haemoglobin levels and PBAC scores were used to assess the response to treatment at 3 and 6 months. The occurrence of any side effects was recorded in both the groups during the study period.

Statistical Analysis
The power study was calculated by taking an alpha error of 0.05 and a beta error of 0.8% to evaluate a 30% improvement in the haemoglobin concentration post treatment, as mentioned in previous studies. A sample size of 110 patients was required. Therefore, we enrolled this number of patients in our study.

The data were analyzed by using the statistical software, SPSS, version 16.0 (SPSS ltd, Chicago, IL). The categorical data was analyzed by using the x2 test, while the continuous variables were analyzed by using the Student’s t-test. The results are presented as median (range) and number (percentage) for continuous variables. A P-value <0.05 was considered as statistically significant and a P value <0.001 was considered as highly significant.

Results

The patient characteristics were comparable in both the groups (P>0.05) prior to intervention (Table/Fig 1).Of the 110 cases, 40.9% (n=45) were in the age group of 30-39 years, followed by 26.3% (n=29) cases in the perimenopausal age group (40-45 years). In our study, the maximum number of patients were para 3 (n=25). The common bleeding patterns observed were; menorrhagia (n=75; 68%), polymenorrhagia (n=28; 25.4%) and metrorrhagia (n=7; 6.3%). The leuteal phase progesterone study revealed normal results (>5pg/ml) in 15 cases of adolescent females with either nulliparity or unmarried status and having a clinical suspicion of anovulatory DUB. Endometrial sampling was performed only in 29 cases of the perimenopausal age group and it revealed no hyperpastic or neoplastic changes.

In the TM group, the average pre-intervention PBAC score was 246, at 1 month follow up it was 155 and at the end of 6 months of follow up, it was 100, which was a significant improvement (P < 0.01) (Table/Fig 2). In the T group, the average pre injection PBAC score at the 6th month was 250. At 1 month follow-up, it was 185 and at 6 months of follow up, it was 125, , which depicted an insignificant improvement (P > 0.05).
The haemoglobin levels recorded at the first outpatient visit revealed that moderate anaemia was the commonest presentation (n=60), while 30 cases had mild anaemia and 14 patients had severe anaemia (Table/Fig 3). We followed the ICMR classification of anaemia in our study. The incidence of anaemia in both the groups was non-significant (P > 0.05). In the TM group, the mean haemoglobin concentration was 10.6g/dl at 1 month, 11.8g/dl at 3 months and 12.3g/dl at 6 months of follow up, which was significantly high (P=0.04; 0.02 and 0.016 respectively) (Table 3). In the T group, it was 10.2g/dl at 1 month (P > 0.05), 11.4g/dl at 3 months and 12.0g/dl at 6 months of follow up (P= 0.04) (Table/Fig 4). In the T group, the mean haemoglobin concentration registered an improvement of 26.3% at 6 months of follow up, with a PBAC score of 50% improvement. In the TM group, the mean haemoglobin concentration improved by 43% and the PBAC score improved by 59.3% at the end of 6 months.

The side effects of the drugs included minor complaints of nausea and GI disturbances in 9 cases and leg cramps in 7 cases in group T, while in the TM group, 8 and 12 cases presented with the above complaints respectively. No major side effects were encountered in any patient of either group.

Discussion

DUB is defined as excessive or prolonged and regular or irregular menstrual bleeding, in the absence of any organic uterine pathology, endocrine or haematological disorder. The diagnostic aids laid down by the RCOG (7) and the ACOG (8) guidelines include meticulous and detailed history, examination and normal TVS findings, with the exclusion of any organic disorder, in patients of the pre-menopausal age. Considering the burden of unnecessary investigations and financial implications, especially in developing countries, the leuteal phase progesterone study is indicated in nulliparous or unmarried females with clinical suspicion of anovulatory DUB (8),(9). Moreover, endometrial sampling is indicated in patients of the perimenopausal age group, with suspected hyperplastic/ neoplastic changes; bleeding not responding to medical therapy; history of prolonged unopposed oestrogen stimulation secondary to chronic anovulation (8).

In our study, 67% of the cases (n=74) were in the age group of 30-49 yrs, which was similar to the findings observed by Gleeson NC et al (12), where the median age of the cases was 38.3 years, with a range between 28-49 years.

Gultekin M et al (13), in their study, reported the role of traneximic acid in the management of DUB and observed that it reduces the menstrual bleeding by 66%. The baseline haemoglobin concentration in their study was 10.6 g/dl, which increased to 12.1 g/dl after three cycles of treatment with traneximic acid. In our study, the mean haemogobin concentration increased in both the groups, but the percentage increase was more in the TM group (43% vs. 26.3%) at 6 months of follow up. Similar improvements in mean haemoglobin levels after treatment with tranaxemic acid, have been reported by other researchers in their studies (14),(15),(16).

Bonnar J et al (14) conducted a randomised controlled trial on 76 women to compare the efficacy of traneximic acid, ethamsylate and mefenamic acid in DUB. The results showed that ethamsylate was ineffective in reducing MBL, whereas mefenamic acid effectively reduced blood loss by 20% and traneximic acid by 54%. Kriplani A et al (15) found that patients who were treated by traneximic acid for three cycles showed a significant decrease in the PBAC score from 356.9 to 141.6, i.e. a decline of 60.3%. Sukanya S et al (16) conducted a study on the role of traneximic acid in idiopathic menorrhagia and found that the PBAC score improved by 46.1% at the end of 3 cycles of treatment. This was comparable to the results of our study, where traneximic acid improved the PBAC score by 50%, while the combination of traneximic acid and mefenamic acid improved the PBAC score by 59.3%. Ylikorkala et al (17) compared traneximic acid with NSAIDs in females with IUD induced menorrhagia and reported a 56% reduction in menstrual bleeding with traneximic acid, as compared to 21% with NSAIDs. In a study conducted by Ulrich HW (18) on the effect of traneximic acid in improving the quality of life in women with heavy menstrual bleeding, the mean haemoglobin concentration showed improvement by 10.5% after three cycles of treatment.
The occurrence of side effects such as leg cramps and nausea was transient in 20-25 % of our cases and was comparable with other studies (13),(15),(16).

There is no doubt that traneximic acid is a highly effective haemostatic agent and that it has shown encouraging results in reducing menstrual bleeding in many previous researches (12),(13),(15),(16),(19). The combination of tranaxemic acid with mefanamic acid showed good evidence in reducing DUB in the Royal College of Obstetrics and Gynecology (RCOG) guidelines (7). Our study confirms the efficacy of traneximic acid in the treatment of menorrhagia due to DUB (ovulatory) and a more promising response in combination with mefenamic acid.

A few limitations in the present study were, that it was single blinded, which could have added to a bias in the results. Taking a control group and increasing the sample size could have added to more precision in our results.

In future trials, a larger sample size may be undertaken to compare anti-fibrinolytics with other medical modes of treatment. Further studies can also investigate the role of polytherapy including OCPs, GnRH analogues and antifibrinolytics, with newly introduced agents in the management of DUB.

Conclusion

We conclude that traneximic acid alone or in combination with mefenamic acid, is effective in reducing menstrual blood loss, though the efficacy of combination therapy is more superior. We recommend its use for reducing the severity of blood loss which is associated with ovulatory DUB and for providing symptomatic improvement for the general health of the patients.

References

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