Clinical efficacy and tolerability of Gosha-jinki-gan, a Japanese traditional herbal medicine, for nocturia.

We evaluated the efficacy and tolerability of Gosha-jinki-gan (GJG; jì shēng shèn qì wán) in 30 cases of nocturia ( yè niào) unresponsive to α1-blockers or antimuscarinic drugs. All patients received GJG extract powder (2.5 g) three times a day for 12 weeks as an add-on therapy to α1-blockers or antimuscarinic drugs. Subjective outcomes assessed by the International Prostate Symptom Score-quality of life, and the benign prostatic hyperplasia impact index and objective outcomes assessed by urinary frequency and the urine production rate at night showed significant improvement after treatment. Moreover, other objective outcomes assessed by maximum flow rates, postvoid residual, serum human atrial natriuretic peptide levels, and urinary 8-hydroxy-2'-deoxyguanosine levels did not change. Adverse events were observed in 10% of cases; however, these events were mild. GJG appears to be a safe and effective potential therapeutic alternative for patients with nocturia unresponsive to α1-blockers or antimuscarinic drugs. Further clinical investigations are required to elucidate the precise pathophysiologic mechanisms of GJG in nocturia.