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

DR LAKSHMINARASIMHAN NALLAGOUNDER; DR VARUNGANDHI RAJENDRAN; DR SADASIVAM SAMIKANNU

Volume : VI, Issue : IV, 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

Aims:

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.

Settings and Design:

The study was carried out at the outpatient clinic of Department of General Surgery, Govt. Dharmapuri medical College from November 2015 to October 2016

Study design: Randomized control trial

Material: 80 Patients

Methods and Material:

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

Statistical analysis used:

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.

Results:

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.

Conclusions:

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.