A preliminary study of the efficacy of the polyherbal preparation Sao Thong Tai for erectile dysfunction among elderly men: a double-blind, randomized controlled trial

Abstract

BackgroundThe traditional Thai polyherbal formulation “Sao Thong Tai” (STT) contains four medicinal plants, namely Boesenbergia rotunda (L.) Mansf., Sida acuta Burm.f., Dactyloctenium aegyptium (L.) Willd., and Oryza sativa L. and it is considered an aphrodisiac and remedy for the effective treatment of decreased male libido in Thai traditional medicine and it may ameliorate erectile function. This pilot study was carried out to investigate the efficacy and safety of the polyherbal STT for mild to moderate erectile dysfunction in a small group of elderly men in Thailand in a double-blind, randomized controlled trial.MethodsThis research is a preliminary study. Fifty-four elderly males aged 50-69 years who had been diagnosed with mild to moderate ED were randomized into two groups of equal size: an STT group (n=27) and a placebo control group (n=27). The patients received either an 800 mg dose of STT extract or a lactose placebo twice a day for the eight-week treatment period, after which they were followed up for four weeks. Erectile function, sexual activity, self-reported attitudes toward sexual dysfunction, and partner-reported sexual dysfunction were investigated to confirm the efficacy of the polyherbal preparation. The International Index of Erectile Function (IIEF-5) and the Scale for Quality of Sexual Function (QSF) were used for primary outcome assessment.ResultsThe IIEF-5 scores of the STT group were significantly increased compared with those of the placebo group (p<0.001). The severity of ED decreased from "mild" or "mild to moderate" to normal in 88.9% of the STT group vs. 0% of the placebo group, and the QSF score increased in the STT group (p<0.001). Sexual activity, self-reported views of sexual dysfunction, and partners’ views of sexual dysfunction showed significant improvement in the STT group, and there was no significant difference in psychosomatic quality of life. No adverse events were observed in either group.ConclusionCompared with a placebo, an oral aqueous extract of STT taken daily at a dose of 1,600 mg for eight weeks can effectively treat mild to moderate ED in elderly men. The preparation was also shown to be safe with respect to all parameters assessed. This finding demonstrates that STT can be used for the effective treatment of decreased male libido in Thai traditional medicine and may ameliorate ED.Trial registrationTCTR/20180126001 033/2560. Registered 16 January 2018, Thai Clinical Trials Registry http://www.thaiclinicaltrials.org/