Double-blind randomized placebo-controlled study of Bixa orellana in patients with lower urinary tract symptoms associated to benign prostatic hyperplasia.
OBJECTIVE
To determine the efficacy of Bixa Orellana (BO) in patients with benign prostatic hyperplasia (BPH) presenting moderate lower urinary tract symptoms (LUTS).


METHODS
It is a prospective double-blind randomized placebo-controlled study. One thousand four hundred and seventy eight patients presenting moderate LUTS associated to BPH were interviewed, from whom we selected 136 to fulfill the criteria of inclusion and exclusion. Assignation was performed at random in blocks of four to receive B0 at a dose of 250 mg 3 times a day or placebo (Pbo) for 12 months, 68 patients were assigned to each group. From the patients in the study we obtained data of demographic, epidemiologic, symptom score, uroflowmetry and post void residual urine variables.


RESULTS
Basically both groups were compared clinically, demographically and biochemically. Throughout the study variations of symptom score, mean delta symptom score during each visit and the final average delta were similar for both groups (BO - 0.79 +/- 1.87 and Pbo - 1.07 +/- 1.49) (p = 0.33). Similarly variations of Qmax mean, Qmax average delta and final average delta were similar (BO 0.44 +/- 1.07 and Pbo 0.47 +/- 1.32) (p = 0.88). Variations of post void residual urine mean, post void residual urine average delta in each visit and the final average delta were similar for both groups (BO 4.24 +/- 11.69 and Pbo 9.01 +/- 18.66) (p = 0.07). No differences were found in the answers of clinically significant improvement assessed with relative risk and risk differences, even though the proportion of adverse effects was similar for both groups.


CONCLUSIONS
Patients with BPH that present moderate LUTS did not show any benefit receiving BO when compared to placebo.
Zegarra
Luis
L
Department of Surgery, Faculty of Medicine Alberto Hurtado, Peruvian University Cayetano Heredia, Lima, Peru. lzegarram@upch.edu.pe
Vaisberg
Abraham
A
Loza
Cesar
C
Aguirre
Roxana L
RL
Campos
Miguel
M
Fernandez
Irma
I
Talla
Oscar
O
Villegas
Leon
L
D000368:Aged; D031212:Bixaceae / Q000737:chemistry*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D010568:Peru; D008517:Phytotherapy; D010919:Placebos; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D018515:Plant Leaves / Q000737:chemistry; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications*; D053448:Prostatism / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D001748:Urinary Bladder Neck Obstruction / Q000188:drug therapy* / Q000209:etiology
D010919:Placebos; D010936:Plant Extracts