Introduction and Objectives
The Comb TAMSR trial compared one of the possible drugs combination [tamsulosin (TAM) and Serenoa repens (SR)] with TAM alone, to see if there was any difference in effectiveness and to evaluate the clinical tolerance of each in patients (pts) with benign prostatic hyperplasia (BPH).
Material and Methods
In this retrospective non-randomized study pts had to have PV < 40 ml, PSA < 4 ng/ml, IPSS score from 7 to 19, QOL > 3, Qmax from 7 to 15 ml/s and PVR < 150 ml. TAM (0.4 mg) was administered once a day for median period of 6 months or SR (320 mg per day)+TAM. PV and PSA were measured at selection and at end-point, whereas IPSS, QOL, Qmax and PVR were evaluated at baseline and later every 3 months.
77 pts were recruited, 70 were fully available: 38 into the TAM group and 32 into the TAM+SR group. No statistically significant difference was found between 2 groups, neither for the major end-point (change in total IPSS score between the baseline value and the final evaluation (TAM −4.6±3.3 vs TAM+SR −4.9 ±2.3;p = 0.16) nor for the second-end point [changes in the voiding scores −1.5±2.4 vs −1.7±2.8 (p = 0.95) and filing scores−1.7±2.8 vs −1.5±2.4(p = 0.92) of the IPSS, improvement of QOL − 2.1±0.8 vs 2.2±1.0 (p = 0.14), Qmax 3.7±2.6 vs 4.2±2.5 (p = 0.38), PV −0.2±12.8 vs −0.99±20.9 (P = 0.27), PVR −23.6 ±20.2 vs −25.4±14.8]. Both treatment groups showed similar but no significant changes in total PSA (−0.1±3.5 vs −2.5±0.2) and changes in sexual function score (0.4±3.5 vs 0.5±2.5). During the treatment period, 10 pts (26%) managed with TAM and 5 (13%) with TAM+SR had drug related adverse reactions wich included postural hypotension, dizziness, libido decrease, dry mouth, rhinitis, fatigue and asthenia. Mean improvement in IPSS was greater in men experiencing retrograde ejaculation (13%) than men who did not (−7.3±3.3 vs −6.1±2.3)(p = 0.03865) but not regarding Qmax (4.0±2.3 vs 3.4±2.5)(p = 0.0699).
The addition of SR to TAM did not provide any significant benefit to pts. TAM can be considered as 1st line medical treatment of LUTS due to BPH.
© 2009 European Association of Urology. Published by Elsevier Inc. All rights reserved.