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A RANDOMIZED CONTROLLED TRIAL USING VITAMIN K AS ADJUVANT TREATMENT FOR BENIGN CAUSES OF MENORRHAGIA. Loo CV 1 , Noor Azmi MA 1 , Marzuki Isahak 2 1 Dept of O&G, University of Malaya, Kuala Lumpur 50603, Malaysia.
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A RANDOMIZED CONTROLLED TRIAL USING VITAMIN K AS ADJUVANT TREATMENT FOR BENIGN CAUSES OF MENORRHAGIA. Loo CV1, Noor Azmi MA1, Marzuki Isahak2 1Dept of O&G, University of Malaya, Kuala Lumpur 50603, Malaysia. 2Dept of Social & Preventive Medicine, University of Malaya, Kuala Lumpur 50603, Malaysia. OPTIONALLOGO HERE Objectives Methods Results Conclusions ► Patient presented with heavy menstrual bleeding were then randomly allocated into two groups. ► Patient in Group I, will be given the standard treatment and oral Vitamin K 10mg. ► Patient in Group II, will only be given the standard treatment. (Standard treatment can be either mefenemic acid and tranexamic acid, COCP or oral progestogen pill) ► Baseline blood investigation included full blood count and coagulation profile to rule out pre-existing coagulation defect. ► Primary outcomes were changes in menstrual blood loss by full blood count and pictorial blood assessment chart (PBAC) during the two menstrual cycles study period. ► The result was calculated as the percentage of Hb or haematocrit changes (Post Hb–pre Hb) x 100% / pre Hb. ► Secondary outcomes include side effects, quality of life, participant's perceived satisfaction in quality of life, compliancy with the treatment and acceptability of the adjuvant therapy. ► Data was collected and analysed with SPSS. ► Table shows the correlation between the blood loss measurements presented by the two groups of patients. Primary Outcomes ► Addition of Vitamin K to the standard oral therapy helps to reduce total blood loss without significant changes in the quality of life or any major side effect. ► This was reflected in the improvement in hemoglobin, but not significant in the increased of haematocrit and pictorial chart. ► There was also some evidence of potential bigger benefits if use together with COCP / Progestogen agents. ►The study aims to show the advantages and disadvantages of adding Vitamin K to different standard oral treatment in the management of menorrhagia. ► We also wanted to know its potential side effect and whether it is acceptable to the participants. ► About 80% per cent of women treated for menorrhagia have no anatomical pathology and over a third of all hysterectomies for heavy menstrual bleeding showed normal uterus5,6. Hence an effective medical therapy, with the possible avoidance of surgery, is an attractive alternative, thus this study is conducted. ► The “K” in Vitamin K, meant ‘Koagulation’ (coagulation), due to its ability to induce the blood to clot, is a fat-soluble vitamin. ► It involves in the formation of five important clotting factors: prothrombin, Factor VII, Factor IX, Factor X, and protein C in the liver. ► Although bleeding time and prothrombin levels in most women with menorrhagia are typically normal, there may be some degree of Vitamin K deficiency that may contributed towards their symptoms. ► Vitamin K has been proposed as a treatment for excessive menstrual bleeding due to its ability to help blood clot even without much clinical evidence.9, 10 Furthermore, according to Total Diet Study based on Nationwide Food Consumption Survey versus US RDA, young adults in 25 to 30 years old are likely to be vitamin K deficient without realizing it.11 ► This might contribute to the reasons of repeat gynaecological clinic follow up for heavy menstrual bleeding despite taking standard treatment. ► Therefore, based on the assumption that inadequate intake of natural Vitamin K may contribute towards heavy bleeding and failed medical therapy, we embark to do this study to ascertain if addition of Vitamin K will help to improve the efficacy of the standard treatment. ► Hematocrit changes and PBAC showed some improvement but not statistically significant. ► Significant improvement of mean percentage haemoglobin changes of 3.22 (CI 0.16 - 10.26) vs -1.99 (P<0.043), was noted in favour of Vitamin K supplementary group. ► The haematocrit and pictorial pad chart were also improved but not statistically significant. ► There were no different in patients acceptance, compliance and perceive quality of life. 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