Volume : 6, Issue : 4, April - 2017

REGRESSION OF FIBROADENOMA IN RESPONSE TO CENTCHROMAN THERAPY - A RANDOMIZED CONTROL TRIAL

Dr Lakshminarasimhan Nallagounder, Dr Varungandhi Rajendran, Dr Sadasivam Samikannu

Abstract :

Background:       Fioadenoma is a common cause of east lump in young girls. Nearly 10–15 % of lesions regress spontaneously over the period of 6 to 60 months<o:p></o:p> Aims:  <o:p></o:p>      The aim of study was to investigate the role of Centchroman in regression of  fioadenoma in comparison to natural observation in persons who is willing for observation instead of excisional biopsy (enucleation) between 18 -30 yrs old.<o:p></o:p> Settings and Design:  <o:p></o:p>      The study was  carried out at the outpatient clinic of  Department of General Surgery, Govt. Dharmapuri  medical College from November 2015  to October 2016 <o:p></o:p> Study design: Randomized control trial<o:p></o:p> Material: 80 Patients<o:p></o:p> Methods and Material:<o:p></o:p>       Patients aged ≤30 years with fioadenoma were included. Patients with fioadenoma equal to or larger than 3 cm and with polycystic ovarian disease were excluded. Patients were randomized in two groups. Patients in active therapy arm were prescribed Centchroman 30 mg on alternative days for 12 weeks, and another group was observed without any intervention (control group). Patients were followed at weeks 4, 8, 12, and 24 . USG Breast done at 0 days, 12 and 24 weeks for both groups to  assess volume  regression <o:p></o:p> Statistical analysis used:<o:p></o:p>       The collected data was analysed with SPSS 16.0 version.To describe about the data descriptive statistics frequency analysis, percentage analysis were used for categorical variables and the mean & S.D were used for continuous variables. To find the significant difference between the bivariate samples in Independent groups (Study group & Control group) Unpaired sample t-test was used. For the repeated measures (Volume zero day ,12th week & 24th week ) the Repeated measures of ANOVA with adjustment for multiple comparisons to control the type I error, the Bonferroni test was used.To find the significance in categorical data Chi-Square test was used.<o:p></o:p> Results:<o:p></o:p>      At the end of 12 weeks follow- up, 38 (95%) patients showed decrease in size in study as compared to 11( 27%) in control group. At the end of 24 weeks follow-up,  15 (37.5%) patients showed  complete disappearance compared to 5 (12.5%) patients in control group. 22 (55%) patients showed decrease in size as compared to 6 (15%) patients in control group. <o:p></o:p> Conclusions:<o:p></o:p> Centchroman therapy  in Fioadenoma treatment showed satistifically significant regression of volume in Patients more than 30 yrs old and  young patients  (<30 yrs)  with  suspicious histology, recurrence, family h/o carcinoma east, anxiousness and no response to conservative management.<o:p></o:p>

Keywords :

Fibroadenoma (FA) Centchroman Polycystic ovarian disease

Article:

Download PDF Journal DOI : 10.15373/2249555X

Cite This Article:

DR LAKSHMINARASIMHAN NALLAGOUNDER, DR VARUNGANDHI RAJENDRAN, DR SADASIVAM SAMIKANNU, REGRESSION OF FIBROADENOMA IN RESPONSE TO CENTCHROMAN THERAPY‾A RANDOMIZED CONTROL TRIAL, GLOBAL JOURNAL FOR RESEARCH ANALYSIS : Volume-6, Issue-4, April‾2017