{"paper_id":"3e7c7512-1228-4522-abd5-65ef0e137f6d","body_text":"~ 290 ~ \nInternational Journal of Clinical Obstetrics and Gynaecology 2019; 3(5): 290-292 \n \nISSN (P): 2522-6614 \nISSN (E): 2522-6622 \n© Gynaecology Journal \nwww.gynaecologyjournal.com \n2019; 3(5): 290-292 \nReceived: 09-07-2019 \nAccepted: 13-08-2019 \n \nDr. Shobha A Toshniwal \nMD OBGY (Private Practitioner), \nToshniwal Chest Hospital & \nMaternity Home, Ghamodia \nFactory area, Doctors Lane, \nNanded, Maharashtra, India \n \nDr. Pooja Chandak \nResident Doctor, Dr. SCGMC \nMedical College Nanded, \nMaharashtra, India \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \nCorresponding Author: \nDr. Shobha A Toshniwal \nMD OBGY (Private Practitioner), \nToshniwal Chest Hospital & \nMaternity Home, Ghamodia \nFactory area, Doctors Lane, \nNanded, Maharashtra, India \n \nA study of efficacy of ormeloxifene in treatment of \nadenomyosis \n \nDr. Shobha A Toshniwal and Dr. Pooja Chandak \n \nDOI: https://Doi.org/10.33545/gynae.2019.v3.i5e.365  \n \nAbstract \nObjective: This study is carried out to find out efficacy of ormeloxifene in the treatment of Adenomyosis. \nStudy design: Prospective study conducted on the patients attending outpatient department of a tertiary \nhealth care institute in Maharashtra. \nStudy duration: 4 Months. \nMaterials and Methods: Patients in reproductive age group with symptoms suggestive of and are \nultrasonographically confirmed with adenomyosis were given Tab ormeloxifene according to standard dose \nafter initial assessment. These patients were followed after 3 months of treatment and earlier if required and \nassessment of success of treatment done on the basis of relief of symptoms. If the patients still complains of \nthe symptoms Laparoscopic hysterectomy done as the ultimate line of management. The data was analyzed \nusing simple charts and tables. \nResults: The average age of occurrence of adenomyosis in our institute is 38.5 years. Most commonly they \npresented with the symptoms of dysmenorrhea (62.50%) others were menorrhagia and polymenorrhea. \nThere is significant reduction in the symptoms of adenomyosis with ormeloxifene. With minor side effects \nlike nausea, headache and oligomenorrhoea which is ultimately beneficial to the patients. \nAlmost 83.33% patients improved symptomatically with its use. Only 16.67% patients w ere not relieved of \nsymptoms and required hysterectomy as the ultimate line of management.  \nConclusion: The results of our study suggest that ormeloxifene is a promising conservative treatment for \nadenomyosis with minimal side effects provided the patients chosen wisely. However long term effects and \nside effects needs to be evaluated. \n \nKeywords: Adenomyosis, ormeloxifene, SERM \n \nIntroduction  \nAdenomyosis though common is an under -diagnosed disease of the uterus . The incidence of \nadenomyosis in hysterectomy specimens of women is reported to range between 15 and 57 % [1, \n2, 3]. The first description of this condition was provided in 1860 by the German pathologist Carl \nvon Rokitansky, who found endometrial glands in the myometrium and subsequently referred to \nthis finding as “cystosarcoma adenoids uterinum” [4]. The modern definition of adenomyosis was \nprovided in 1972 by Bird who stated: “Adenomyosis may be defined as the benign invasion of \nendometrium into the myometrium, producing a diffusely enlarged uterus which microscopically \nexhibits ectopic non -neoplastic, endometrial glands and stroma surrounded by the hypertrophic \nand hyperplastic myometrium” [5, 6]. \nAdenomyosis may present as heavy menstrual bleeding, dysmenorrhea, abnormal uterine \nbleeding, bloating, dyspareunia, pelvic pain, infertility, and miscarriage [7, 8]. \nAdenomyosis can be diagnosed both by transvaginal ultrasound and MRI.  With the addition of \n3D ultrasound and a closer evaluation of the transition zone from the endometrium to the \nmyometrium (The JZ), ultrasound evaluation is reproducible and may show improved diagnostic \naccuracy [9, 10, 11]. \nMedications such as NSAIDs, oral contraceptive pills, high -dose progestins, a LNG IUS, \ndanazol, gonadotropin-releasing hormone agonists are often used to manage the symptoms of \nadenomyosis and to temporarily induce relief [12, 13, 14, 15] . However, many women require more \naggressive forms of treatment. Historically, the most common treatment for symptomatic \nadenomyosis has been hysterectomy which increases operation related morbidity and mortality \n[16]. Moreover, hysterectomy is also not appropriate in women who has not completed their \nfamily.\n\n\nInternational Journal of Clinical Obstetrics and Gynaecology http://www.gynaecologyjournal.com \n~ 291 ~ \nThis study is conducted to evaluate efficacy of ormeloxifene in \ntreatment of adenomyosis. \nOrmeloxifene ( Also known as centchroman) is one of the \nselective estrogen receptor modulators, or SERMs, a class of \nmedications which acts on the estrogen receptor. In India, \nOrmeloxifene has been available as a birth control product since \nthe early 1990s. It mediates its effects  by high affinity \ninteraction with ER, antagonizing the effect of estrogen on \nuterine and breast tissue and stimulating effect on vagina, bone, \ncardiovascular system and central nervous system [17, 18]. \n \nMaterials and Methods \nThis is prospective study carried out in Dr. Shankarrao Chavhan \ngovernment medical college and hospital a tertiary health care \ncenter in Maharashtra over the period of 4 months after \nobtaining permission from institutional ethical committee. Total \n28 patients in reproductive age group with symptoms suggestive \nof and sonographically diagnosed with adenomyosis were \nincluded in the study after taking consent. Out of these 4 patients \nlost the follow up so the ultimate study included on 24 patients. \nOn initial visit the patients were asked detailed history regarding \nthe symptoms and a thorough clinical examination was done. \nPAP smear was taken of every patient as an opportunistic \nscreening and ultimately the patients were subjected to \nultrasonography. The patients with adenomyosis were given \ntablet Ormeloxifene 60 mg twice weekly for the period of 3 \nmonths and were asked to follow up after 3 months or earlier \nwhenever necessary. \nThe success of treatment was assed based on the symptomatic \nrelief of the patients without subjecting the patients t o follow up \nUSG. We also asked for any side effects with drug and recorded \nthem separately. The collected data was analyzed afterword. \nThose who were relived of symptoms advised to continue the \ntablet once weekly for another 3 months and those who were \nstill having the complaints underwent laparoscopic \nhysterectomy. \nResults \nOut of 28 patients of reproductive age group enrolled 4 patients \nlost the follow up. Minimum age of the patient with \nadenomyosis was 30 yrs and maximum was 47 yrs, so the \naverage age of  occurrence of adenomyosis in the study group \nwas 38.5 yrs. \n \nTable 1: Age wise incidence of adenomyosis in study population \n \nAge group No. of patients with adenomyosis Percentage \n25 - 30 yrs 4 16.70% \n31 - 35 yrs 2 8.31% \n36 - 40 yrs 8 33.34% \n41 - 45 yrs 8 33.34% \n46 - 50 yrs 2 8.31% \n \n \n \nFig 1: Age wise distribution of patients with adenomyosis \n \nThe study showed that maximum patients i.e. 66.8% with \nadenomyosis occurred in the age group of 36 to 45 years \nnumbering 16 patients among 24 patients in this a ge group. The \npercentage and number of patients in other age groups are \nshown the chart. \n \nTable 2: common symptoms of adenomyosis and their prevalence in study population \n \nSymptoms with which patients present No. of patients Percentage \nDysmenorrhoea 15 62.50% \nMenorrhagia 6 25.00% \nPolymenorrhoea 3 12.50% \n \nCommonly patients present with the symptoms of \ndysmenorrhea, menorrhagia and polymenorrhoea with \ndysmenorrhea being the most common with 62.50% of patients \npresenting with this symptom 15 among 24 pat ients presented \nwith this symptom. \n \nTable 3: Success of ormaloxifene in treatment of adenomyosis \n \nRelief from symptoms No. of Patients Percentage \nYes 20 83.33% \nNo 4 16.67% \n \nAt the end of 3 months the patients were categorized as those \nwho were relieved of their symptoms and those who were not \nand accordingly the success of treatment was calculated. The \nstudy showed that among 24 patients who were given \normeloxifene 20 were relieved of symptom which corresponds \nwith 83.33% of study population while 4 rema ined symptomatic \nat the end of the treatment in whome laparoscopic hysterectomy \nwas done as the ultimate treatment measure. \nThus ormeloxifene was successful in treating approximately \n83.33% of patients with adenomyosis. \n \nTable 4: Side effects of ormaloxifene in study population \n \nSide effects No. of patients Percentage \nHeadache 1 4.17% \nHeadache & Nausea 1 4.17% \nNausea 3 12.50% \nOligomenorrhoea 5 20.83% \nNone 14 58.33% \n \nSpeaking of the side effects most of the patients didn’t get any \nadverse effects with others having only minor side effects like \nheadache, nausea and oligomenorrhoea which in a way was \nuseful for patients with menorrhagia. \n \nDiscussion \nAdenomyosis is an important clinical challenge in gynecology \nand healthcare economics; in its fully develop ed form, \nhysterectomy is often used to treat it in premenopausal and \nperimenopausal women. Symptoms of adenomyosis typically \n\nInternational Journal of Clinical Obstetrics and Gynaecology http://www.gynaecologyjournal.com \n~ 292 ~ \ninclude menorrhagia, pelvic pain and dysmenorrhea. The other \nconservative options being use of medications like oral \ncontraceptive pills, progestogens, danazol, LNG IUS etc. \nIn our study we studied the efficacy of ormeloxifene a SERM \nfor treatment of adenomyosis. Symptomatic relief was used as \nthe parameter of comparison and ultrasonography was used as \nthe measure of diagnosis. \nIn our  study we found out that most of the patients with \nsymptomatic adenomyosis belong to 36 to 45 years of age \ngroup. The most common symptom with which they present was \ndysmenorrhoae and others being menorrhagia and \npolymenorrhoea and finally the ormeloxifene is effective for \nconservative management of adenomyosis. 20 patients among \n24 patients were symptomatically got better with ormeloxifene. \nAlthough our sample size was small, we got significant success \nrate with ormeloxifene for adenomyosis (83.33%) with m inor \nside effects like headache, nausea and oligomenorrhoea which in \na way is a boon for patients. However long term effects and side \neffects needs to be evaluated. \n \nConclusion \nOur study concludes that Ormeloxifene a SERM commonly \nknown as centchroman used  as contraceptive pill is a potential \npharmacological treatment for adenomyosis. However further \nlong term studies to be carried out to find out long term \ntreatment success and long term side effects ormeloxifene. \n \nConflicts of interest: None \n \nReferences \n1. Garcia L, Isaacson K. 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