ABSTRACT
Background: Benign breast diseases are common pathological entities with which women in her early reproductive age present to OPD with fear of malignancy and significant morbidity. Except for surgery and use of non-selective estrogen receptor blockers, there are no other treatment options, and these have lot side effects. Ormeloxifene a newer drug has shown promising results with minimal side effects and used as the first line of treatment reducing the morbidity of surgery and subjecting the patient to less hormonal side effects.Methods: Diagnosis of benign breast diseases was made by baseline investigation which included measurement of size of fibroadenoma using Vernier caliper and USG, fibroadenosis,ie nodularity measured using Lucknow-Cardiff scale and VAS score was used for pain assessment of mastalgia after which patients will be given the drug and placebo and the response for the drug and its side effects are noted.Results: 61.9% (44) were diagnosed with fibroadenoma, 16.9% (12) with fibroadenosis and 21.1% (15) with mastalgia. Lucknow Cardiff score for fibroadenosis exhibited 50% had smooth breasts with no nodularity at the end of six months, in fibroadenoma group 52% showed decrease in size and 31% showed complete disappearance of the lump and in the mastalgia group 40% had no pain (VAS score of 0). 16(22.5%) of had menstrual abnormality as the major side effect.Conclusions: Ormeloxifene can be used as the first line of treatment in patients with fibroadenosis and mastalgia and used as an alternative to surgery for fibroadenoma.
ABSTRACT
Background: Menorrhagia (menstrual blood loss more than 80% per cycle) affects 10-33% of women at some stage of their lives. Medical management is the first line of therapy for menorrhagia (heavy menstrual bleeding: HMB). Progestins have been found to be very effective in the management of heavy menstrual bleeding especially during acute episodes, norethisterone acetate being widely used for the same. Ormeloxifene is a new drug with promising results in managing HMB. The study was undertaken to compare the efficacy, safety and acceptability of Ormeloxifene /Norethisterone acetate in the medical management of heavy menstrual bleeding.Methods: This was a retrospective study conducted from January 2016 till December 2018 in which 98 women of reproductive age group presented with abnormal uterine bleeding without any organic, systematic and iatrogenic causes. The patients were divided into 2 groups. Those wanting contraception along with control of HMB were assigned to Group O and given Ormeloxifene and others were given norethisterone (Group N). The primary outcomes measured were menstrual blood loss assessed subjectively by patients and ultrasonography for endometrial thickness. The secondary outcomes measured were acceptability and side effects of Ormeloxifene and norethisterone.Results: There is a significant reduction in menstrual blood loss as evidenced by the history of patients recorded on follow up and there was a significant reduction in the endometrial thickness as evidenced on follow up scan at the end of 3-4 months. no major side effects were observed with both the drugs.Conclusions: Ormeloxifene in comparison to norethisterone acetate with its effectiveness, significant results, convenient dosages schedule and no major side effects is an effective and safe alternative medical management of HMB.
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Background: Dysfunctional uterine bleeding is one of the most often encountered gynecologic problems causing anemia, reduced quality of life and unnecessary hysterectomies. A prospective study was conducted on women with DUB to study the effect of ormeloxifene versus combined oral contraceptive pills in controlling blood loss in them.Methods: 100 Women with DUB were enrolled randomly in three groups. After baseline assessment each patient in group A was treated with iron tablets, containing 100 mg elemental iron and folic acid 1.5 mg, for three months and were termed as control group. Group B patients were treated with ormeloxifene in dose of 60 mg twice a week for twelve weeks. Group C patients were treated with combined oral contraceptive pills for twenty- one days starting from third day of their LMP. The treatment was continued for three consecutive cycles. The efficacy of the studied drugs was analyzed by comparing the baseline and post treatment PBAC score, haemoglobin level and endometrial thickness, using appropriate statistical tests.Results: Ormeloxifene was more effective than only iron or combined oral contraceptive therapy in controlling menstrual blood loss (79.11% versus 58.57%). There was a reduction in endometrial thickness in group receiving ormeloxifene as well as in the group receiving combined oral contraceptive pills (p=0.486), however this was statistically not significant.Conclusions: Ormeloxifene was significantly better than combined OCP in reduction of menstrual blood flow in cases of DUB. It has better compliance and marked improvement in subjective symptoms as compared to OCP.
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Background: Centchroman (INN: Ormeloxifene), was developed at CDRI, Lucknow in 1967. This drug was finally approved and licensed in 1991 and launched as Saheli and Choice-7 for marketing in 1992. The Ministry of Health and Family Welfare, India has now introduced centchroman in national family planning programme under the trade name “Chhaya” from April 2016. Centchroman is a novel nonsteroidal contraceptive that inhibits the fertilised ovum from implantation and thus prevents pregnancy. The aim of this study was to assess the effectiveness, side effects, discontinuation rates and failure rate among the users of Centchroman (Chhaya).Methods: The retrospective study was conducted by reviewing the records of Centchroman (Chhaya) contraceptives acceptor over the period of one year from September 2017 to August 2018 in family welfare clinic of Department of Obstetrics and Gynecology at Tomo Riba Institute of Health and Medical Science, a tertiary level center in Naharlagun, Arunachal Pradesh, India.Results: A total of 146 women were evaluated for the study. Majority of the women were in the age group of 20-30 years (76.02%) with mean age of 26 years. Most of the centchroman acceptors were multipara (74.65%) and women in post-abortion (38.35%) and postpartum group (36.3%). Duration of use ranged from 3 months in 146 women to 12 months in 98 women. The discontinuation rate was 31.5%. The major menstrual complaint was delayed menstrual cycle in 15.06% women and irregular cycle in 10.95%. Of the 146 women in the study group, pregnancy occurred in 3 women. Pearl index calculated for centchroman was 2.05/HWY.Conclusions: Centchroman is a non-steroidal, non-hormonal oral contraceptive drug with good therapeutic efficacy and a favourable side effect profile. Centchroman has an important place in postpartum contraception due to its safety profile in breastfeeding women.
ABSTRACT
Background: The term dysfunctional uterine bleeding (DUB) is used for abnormal uterine bleeding occurring in the absence of identifiable pathology. A number of drugs are available for management of DUB- nonsteroidal anti-inflammatory drugs, tranexamic acid, ethamsylate, hormones like Oral contraceptives progestins etc. The present study was done to determine the efficacy and safety of ormeloxifene in the management of DUB.Methods: This prospective clinical study involved 50 cases with DUB who were treated with ormeloxifene 60 mg tablet twice a week for first 12 weeks and the once a week for next 12 weeks. They were followed after 6 months of therapy. The outcome was studied by assessment of menstrual blood loss by PBAC score, Hb level in g/dl, endometrial thickness in mm, relief of dysmenorrheal and any side effects of drugs.Results: The median PBAC score was significantly reduced from 316 to 52 after 6 months of therapy. The mean Hb concentration was significantly increased from 7.8 g/dl to 9.1 g/dl at 6 months of therapy. The mean endometrial thickness was reduced from 10 mm to 7.9 mm after 6 months of therapy. 66% of women showed marked subjective improvement in symptoms. Amenorrhea was the main side effect (12%).Conclusions: Ormeloxifene has significant effect in reducing endometrial thickness, decreasing the amount of menstrual blood loss, reducing dysmenorrhea and thereby improving the general condition of the patient. It is definitely a better alternative to hysterectomy in women who wish to avoid surgeries and maintain their reproductive functions.
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Background: Abnormal uterine bleeding affects 50% women of perimenopausal age group. The use of ormeloxifene (SERMS) in management of AUB is well known. The objective of the present study was aimed to see the effects of ormeloxifene on different types of endometrium.in the medical management of Abnormal Uterine Bleeding (AUB).Methods: It was Prospective, interventional study. A total of 90 women who attended Outpatient Gynaecology Department, Guwahati with complain of AUB in perimenopausal age group (37-48) were prescribed 60mg ormeloxifene twice weekly for 3 months followed by once weekly for next 3 months after preliminary D and C.Results: Ormeloxifene was found to be more effective in reducing PBAC score and ET in patients with proliferative and secretory endometrium The reduction in mean PBAC score with ormeloxifene (175.3 to 20.93)(p value 0.0001) and ET (9.6 to 2.9 mm) (p value 0.0001) in proliferative endometrium, (179.2 to 14.8 (p value 0.0001) ) and ET 11.1 to 1.9 mm (p value 0.0003)in secretory endometrium was observed after 6 months. However, it was found not to be effective in reducing PBAC score and ET in patients with atrophic endometrium. Change in PBAC SCORE from 176.4 to 150.8 (p value 0.08) and in ET from 2.8 to 2.1mm( p value 0.3) was observed. No major side effects were reported.Conclusions: Ormeloxifene is effective in AUB with proliferative and secretory endometrium.
ABSTRACT
Background: Menstrual disorders are the second most common gynecological condition resulting in hospital referrals. Dysfunctional Uterine Bleeding is defined as abnormal uterine bleeding in the absence of organic disease. Menorrhagia (menstrual blood loss >80 ml per cycle) affects 10-33% of women at some stage in their lives. Approximately 90% of dysfunctional uterine bleeding result from anovulation and 10% occur with ovulatory cycles. Only half of women complaining of heavy menstrual bleeding fit the clinical criteria of more than 80 ml blood loss per cycle. Among women aged 30-49, one in 20 consults her general practitioner each year with menorrhagia . it can be managed both medically and surgically. Material and methods: Thirty women presenting with DUB were randomly allocated to 2 equal groups, Group-A, which received 60 mg ormeloxifene twice a week for 12 weeks and Group-B, which received 5 mg norethisteron twice daily for 21 days for 3 months. The primary outcome measures were reduction in menstrual blood loss which was measured by fall in PBAC (Pictorial Blood loss Assessment Chart) score, rise in hemoglobin level and reduction in endometrial thickness Results: The reduction in mean PBAC score with ormeloxifene (277.33 to 70.11) was significantly more than that seen with norethisterone (246 to 108.5) after 3 months of therapy (p<0.05). The increase in hemoglobin level and reduction in endometrial thickness were also found to be significantly more with ormeloxifene than norethisterone (9.68 g %to 11.07 g% vs. 10.17 g% to 10.58 g%, p<0.05, and 7.8 mm vs. 6.7 mm to 5.9 mm, p<0.05, respectively). No major side effects were reported in any group. Conclusion: Ormeloxifene was found to be more effective than norethisterone in reducing blood loss and reducing endometrial thickness
ABSTRACT
Background: Menorrhagia accounts for 12% of all gynaecology consultations and is one of the most common causes of iron deficiency anaemia in females after nutritional anaemia. Objectives: To evaluate the efficacy and side effects of ormeloxifene in cases of dysfunctional uterine bleeding. Material and Methods: 30 women aged 28-46 years who attended the outpatient gynaecology department in a tertiary care hospital with complaint of heavy menstrual flow were recruited for the study. Two pretreatment baseline cycles were compared to the treatment cycles of ormeloxifene. The main outcomes measured were menstrual blood, blood haemoglobin levels and endometrial thickness in proliferative phase as studied by TVS. Data thus collected was compared and analysed statistically. Results: Total number of bleeding days per year decreased by 76%. Total no. of pads soiled per cycle decreased by 76.3%. All the patients reported disappearance of clots, 66.66% within 1 month of the treatment only. Dysmenorrhoea was relieved in 62.5% patients. Mean increase in Hb was 0.42g%. Conclusion: Ormeloxifene is very effective in improving all the parameters of blood loss in DUB including the no. of days of bleeding, no. of pads soiled and the passage of clots. Ormeloxifene has a good patient acceptability and compliance due to its minimal side effects, low cost and simple dosage schedule. In the peri-menopausal age group, drug is protective against breast malignancy and osteoporosis. Ormeloxifene has the potential to be an effective treatment for DUB and should always be considered amongst the treatment options.