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NIS - libdoc.who.int - World Health Organization

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Radix Urticae<br />

tion of a hydroalcoholic extract of the root to dogs with BPH (30 mg/kg<br />

body weight) decreased prostate volume by 30% after 100 days of treatment<br />

(49).<br />

The effect of various root extracts was assessed after implantation of<br />

the fetal urogenital sinus <strong>int</strong>o the prostate gland of adult mice. Intragastric<br />

administration of a butanol, cyclohexane or ethyl acetate extract of the<br />

root (0.25 ml/daily for 3 weeks) had no effect on the development of BPH<br />

in mice. However, <strong>int</strong>ragastric administration of the same dose of a 20%<br />

methanol extract of the root reduced the development of BPH by 51.4%<br />

(50).<br />

Toxicology<br />

The LD 50<br />

of an aqueous extract or infusion of the roots after <strong>int</strong>ravenous<br />

administration to rats was 1721 mg/kg body weight and 1929 mg/kg body<br />

weight, respectively. Oral administration of an infusion of the roots to<br />

rats was well tolerated at doses up to 1310 mg/kg body weight (3).<br />

Clinical pharmacology<br />

Benign prostatic hyperplasia<br />

Placebo-controlled clinical trials<br />

Three double-blind, placebo-controlled clinical trials have assessed the<br />

efficacy of oral administration of Radix Urticae for the symptomatic<br />

treatment of lower urinary tract disorders resulting from BPH (24, 27,<br />

35). One study assessed the efficacy of a 20% methanol extract of the<br />

roots in 50 men with BPH stages I and II (35). A significant increase in<br />

urine volume (by 43.7%; P = 0.027) and a significant decrease in serum<br />

levels of SHBG (P = 0.0005) was observed in patients treated with 600 mg<br />

extract daily for 9 weeks. A modest increase in maximum urinary flow of<br />

8% was also observed in the treated group; however, it was not significant<br />

(35). Another study assessed the efficacy of a 20% methanol extract in<br />

40 men with BPH. Treatment with 1200 mg extract daily for 6 weeks decreased<br />

the frequency of micturition and serum levels of SHBG (27). The<br />

third study assessed the efficacy of a methanol extract in the treatment of<br />

32 men with BPH stage I (24). A 4–14% increase in average urinary flow<br />

and a 40–53% decrease in postvoid residual volume were observed in patients<br />

treated with 600 mg extract daily for 4–6 weeks (24).<br />

Clinical trials without controls<br />

Numerous clinical trials without controls have assessed the efficacy of<br />

oral administration of various Radix Urticae extracts (20% methanol or<br />

415

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