Finasteride and Tamsulosin Combination in Benign Prostatic Enlargement in a Tertiary Hospital

Introduction: Due to aging of the general population, prevalence of Benign Prostatic Enlargement is increasing. Symptoms of BPE may vary between the patients. Aim of the study was to analyze and compare the usefulness of combination drugs therapy and monotherapy after a trial period of six months. Methods: Out of 100 male patients aged 45 years and above diagnosed with BPE, 92 were included in the study. Patients were randomized using computer generated random number table. Of which, 47 patients received combination therapy with Tamsulosin plus Finasteride and 45 patients received monotherapy with Tamsulosin once daily at bed time. Results: The baseline demographic variables were comparable in both groups. The decrease in the total American Urological Association symptom score was statistically significant in the combination group (p<0.0001) as compared to monotherapy (p=0.0715) respectively. There was a statistically significant reduction in the residual urine volume with combination therapy (p<0.0001) than in patients with monotherapy (p= 0.1271). Conclusions: The combination therapy is effective in decreasing the irritative and obstructive symptoms in patients with BPE than monotherapy. _______________________________________________________________________________________


INTRODUCTION
Benign enlargement of prostate (BPE) is a common problem in aging males.At the age of 40, 5 to 10% of men have prostate enlargement whereas at 80 years, prevalence is as high as 80%. 1 However the size of prostate correlates poorly with severity of symptoms such that patients with huge palpable prostate may be asymptomatic whereas those with small prostate may have severe symptoms. 2,3he impact of Lower Urinary Tract Symptoms (LUTS) on patient's quality of life is variable.It is not directly related to any measurable physiological factors.The patient's perception of severity of condition and the degree to which it interferes with his lifestyle should be the primary consideration in choosing therapy.
We conducted a study to evaluate the efficacy of Tamsulosin plus Finasteride and Tamsulosin alone in the management of patients with BPE.

METHODS
After getting approval from Institute's Ethics Committee and obtaining written informed consent from patients, randomized trial was conducted in 100 patients from September 2013 to August 2014.Patients were randomized into two groups using computer generated random number tables such that 50 patients received combination drug therapy of Tamsulosin 0.4 mg plus Finasteride 5mg and remaining 50 patients received monotherapy with Tamsulosin 0.4 mg every day at bed time for a duration of six months.
Patients aged 45 years and above with symptomatic BPE as categorized by American Urological Association (AUA) symptom scoring system were included in the study. 4tients with diabetes mellitus, prostate and bladder carcinoma, prostatitis, neurogenic bladder, stricture urethra, vesical calculus, and those on drugs likely to affect bladder function, were excluded from the study.
Study procedures: All patients presenting to the surgical outpatient department (OPD) of Manipal Teaching Hospital with symptoms of BPE were initially examined by the surgical resident in training under the supervision of consultant of General Surgery.All patients underwent an ultrasonography (USG) of abdomen and pelvis to assess the post voidal residual volume (PVRV) in milliliter (ml).Patients were interviewed with questionnaire as per AUA scoring and results recorded.
Follow-up and assessment: The patients were followed up for six months and AUA symptom score evaluation was recorded.A complete clinical and ultrasonography examination was carried out.
Statistical analysis was done using SPSS 17. Changes in various parameters from baseline values to values after six month were evaluated by using student t test.
The minimum level of significance was fixed at 95% confidence limit and a p value of <0.05 was considered significant.

RESULTS
Out of 100 patients, eight underwent surgery, three from combination therapy and five from monotherapy for recurrent retention of urine and were excluded from study.The baseline demographic age details showed no significant difference between the two groups.Mean age was 57.27 years in monotherapy group and 60.49 years in combination group (Table 1).2, Figure 1).3).

DISCUSSION
BPE is one of the most common conditions affecting elderly males with a resultant impact on the surgical practice as elderly constitute an increasing population throughout the world.A decade back, surgery and watchful waiting were the only treatment options available for BPE.However, at present era medical management is widely accepted modality of treatment and 80% of the population can be treated with medication. 5,6pha blockers are the mainstay of treatment.Alfuzosin-uroselective alpha-1 blocker, Tamsulosinprostate specific alpha-1a blocker and Finasteride-5 alpha reductase inhibitor are mostly used for the management of BPE.
Results from the Medical Therapy of Prostatic Symptoms (MTOPS) trial, emphasize the superiority of combination therapy (alpha blocker plus 5 alpha reductase inhibitor) over individual drug treatment which is in accordance to the finding of our study. 7In the current study, the significant reduction in the AUA symptom score at the end of six month in combination group indicate that Finasteride plus Tamsulosin provide significant symptomatic relief in BPE, which may be due to a significant reduction in the prostate size as well as increased contractility of urinary bladder.The beneficial effect of combination therapy is due to the synergistic action of its ingredients which also helped to decrease PVRV significantly.However in contrast to study by Hasan M et al, there is no clinically significant improvement in symptoms in patients treated with Tamsulosin alone. 8At present only combination therapy with 5alpha-reductase inhibitors with alpha-adrenergic antagonists is recommended in clinical practice guidelines. 9 In this study we have not evaluated the incidence of side effects, urinary flow rate and change in the quality of life.

CONCLUSIONS
Our study has also shown a promising result in decreasing the irritative and obstructive symptoms both subjectively and objectively in patients treated with combination drug therapy.Thus the combination therapy might be recommended for treating patients with symptomatic BPE.