Komaram Ravibabu1, Jayasree Palla2, Ganapathi Swamy Chintada2. 1. Associate Professor, Department of Pharmacology, GSL Medical College, Rajahmundry, EGDT, Andhra Pradesh, India. 2. Senior Resident, Department of Obstetrics & Gynaecology, GSL Medical College, Rajahmundry, EGDT, Andhra Pradesh, India.
Abstract
OBJECTIVE: This study was carried out to evaluate the efficacy of Ormeloxifene in the pharmacological management of dysfunctional uterine bleeding. DESIGN AND SETTING: A prospective study was conducted on women with dysfunctional uterine bleeding, who attended to out - patient department of Obstetrics & Gynaecology in a tertiary care general hospital. MATERIAL AND METHODS: Women with DUB were diagnosed by presence of excessive, prolonged, or frequent intervals of bleeding for eight or more days, unrelated to anatomical lesions or systemic diseases. They were enrolled randomly and after baseline assessment each patient was treated with Ormeloxifene 60 mg orally twice a week for first 12 weeks, followed by once a week for another 12 weeks. The efficacy of the study drug was analyzed by comparing the baseline and post treatment PABC score, haemoglobin level, endometrial thickness, presence of clots in menstrual blood and dysmenorrhoea. The data obtained was analyzed using the paired t-test and Z-test. RESULTS: There was significant decrease in median PABC score from baseline to 25th week of treatment follow-up and the reduction was found to be statistically significant (p<0.001). There was also significant decrease in the mean endometrial thickness (p<0.001) after treatment with Ormeloxifene when compared to mean baseline value. The difference in mean haemoglobin level is 1.3 gm/dl between baseline and post treatment levels and was found to be statistically significant (p<0.001). There was significant improvement, 84% of patients had relief from dysmenorrhoea (p<0.001). No major adverse events were experienced by patients in this study. CONCLUSION: The results in this study indicate that Ormeloxifene, a non-steroidal, non-hormonal agent, provides effective and favourable pharmacological management option with least side effects, suitable for the treatment of dysfunctional uterine bleeding.
RCT Entities:
OBJECTIVE: This study was carried out to evaluate the efficacy of Ormeloxifene in the pharmacological management of dysfunctional uterine bleeding. DESIGN AND SETTING: A prospective study was conducted on women with dysfunctional uterine bleeding, who attended to out - patient department of Obstetrics & Gynaecology in a tertiary care general hospital. MATERIAL AND METHODS:Women with DUB were diagnosed by presence of excessive, prolonged, or frequent intervals of bleeding for eight or more days, unrelated to anatomical lesions or systemic diseases. They were enrolled randomly and after baseline assessment each patient was treated with Ormeloxifene 60 mg orally twice a week for first 12 weeks, followed by once a week for another 12 weeks. The efficacy of the study drug was analyzed by comparing the baseline and post treatment PABC score, haemoglobin level, endometrial thickness, presence of clots in menstrual blood and dysmenorrhoea. The data obtained was analyzed using the paired t-test and Z-test. RESULTS: There was significant decrease in median PABC score from baseline to 25th week of treatment follow-up and the reduction was found to be statistically significant (p<0.001). There was also significant decrease in the mean endometrial thickness (p<0.001) after treatment with Ormeloxifene when compared to mean baseline value. The difference in mean haemoglobin level is 1.3 gm/dl between baseline and post treatment levels and was found to be statistically significant (p<0.001). There was significant improvement, 84% of patients had relief from dysmenorrhoea (p<0.001). No major adverse events were experienced by patients in this study. CONCLUSION: The results in this study indicate that Ormeloxifene, a non-steroidal, non-hormonal agent, provides effective and favourable pharmacological management option with least side effects, suitable for the treatment of dysfunctional uterine bleeding.