Penile vibratory threshold changes with various doses of SS-cream in patients with primary premature ejaculation

SS-cream made with extracts from natural products is a topical agent for treating premature ejaculation (PE). In order to elucidate the penile vibratory threshold changes and clinical effects of various doses of SS-cream, 53 patients with primary PE were investigated in a double-blind randomized placebo-controlled study. The mean age was 37.3 +/- 6.4 years and mean ejaculatory latency was 1.37 +/- 0.52 minutes. Neither the patients nor their sexual partners were satisfied with their sexual lives. Vibratory threshold at the glans penis, penile shaft, scrotum and index finger were measured using a biothesiometer twice during the screening period and three times one hour after the application of respective creams (SS-cream 0.05, 0.10. 0.15, 0.20 gm and placebo 0.10 gm) on the glans penis according to the order of the allocation table in a randomized fashion. The efficacy of SS-cream was defined as when the vibration threshold increased by more than 4 microns compared to the value tested during the screening period. The vibratory thresholds at the glans penis increased significantly in a dose-dependent manner after the application of various doses (0.05, 0.10, 0.15, 0.20 gm) of SS-cream (p < 0.001), and the efficacy of SS-cream on the penile vibration threshold increased according to the increased dosage (penile shaft: 48.4, 51.6, 54.8, 64.5%, glans penis: 58.1, 67.7, 77.4, 83.9%, respectively). With these results, we concluded that SS-cream increased the penile sensory threshold dose dependently, and therefore it is clinically effective for treating the heightened penile sensory response in patients with PE.

Clinical Study of SS-cream in Patients with Primary Premature Ejaculation / 대한비뇨기과학회지

PURPOSE: To determine the clinical efficacy of SS-cream, the topical agent made from the extracts of natural products for treating premature ejaculation(PE), a double blind, randomized placebo controlled phase III study on the patients with primary PE was performed in three medical centers. MATERIALS AND METHODS: Mean age of patient with primary PE was 38.7+/-0.6 years and duration of suffer from PE was 15.8+/-0.4 years. We investigated the ejaculatory latency calculated by stop watch and sexual satisfaction rate after the treatment(1 placebo and 5 SS-cream 0.2gm). Patients were instructed to apply the cream on the glans penis 1 hour before sexual intercourse in double blind randomized fashion. Clinical efficacy was compared with the prolongation of ejaculatory latency and improvement of sexual satisfaction rate. RESULTS: 106 patients with primary premature ejaculation completed this study. Mean ejaculatory latency tested at screening period was 1.37+/-0.1 min and both of patient and partner were not satisfied with their sexual lives. The mean ejaculatory latency was significantly prolonged as 10.92+/-1.0 min with SS-cream, while 2.45+/-0.3 min with placebo. In 79.8%, there was prolongation of ejaculatory latency longer than 2 minutes with SS-cream, while in 15.1% with placebo. The sexual satisfaction rate was also significantly improved as 82.2% with SS-cream, while 12.6% with placebo. 103 (16.2%) out of 636 trials of SS-cream showed mild local irritation including 82 mild burning senses and 21 mild pain, which disappeared in less than 1 hour. No adverse effect on sexual function and partner and no systemic side effects were observed. CONCLUSIONS: With these results, SS-cream is effective and safe in the treatment PE with mild local side effect.

Somatosensory Evoked Potential (SEP) and Effect of SS-cream on rabbit / 대한비뇨기과학회지

The cause of premature ejaculation (PE) has been thought to be psychological in the majority of patients but we have suggested hyperexcitability of the ejaculatory center for an organic basis of premature ejaculation, SS-cream is a topical agent containing 9 oriental herbs for treating PE. Therefore, in order to determine the effects of SS-cream on the excitability of the ejaculation center, we investigated somatosensory evoked potential (SEP) stimulated at glans penis and its effect of SS-cream on rabbits. 30 rabbits were randomly divided into two groups. Group A (n=15) was used as control, and Group B (n=15) was used with the application of SS-cream (0.1gm) on the glans penis. SEP were monitored every 30 minutes in all rabbits. Electrical stimulation was done on the glans penis with surface electrode. The latencies and amplitudes were recorded at Cz and Fz. EEG system. Throughout the studies SEP was reproducible in all rabbit, which were not significantly changed throughout the procedures. The mean latency and amplitude of SEP in control was 20.83+/-0.79msec and 2.13+/-0.10uV. After the topical application of SS-cream on the glans penis, the mean latency was prolonged and the mean amplitude was reduced significantly (p<0.001). With these results, we suggest that SS-cream with the application on the glans penis prolongs the latency and reduces the amplitude from the glans penis in the rabbit, that is, the effect of SS-cream in the treatment of premature ejaculation is testing the ejaculatory reflex from the glans penis.

Studies for the Surface Desensitizing Activity of SS-cream on the Rabbit Cornea / 대한비뇨기과학회지

SS-cream is a topical agent for treating the premature ejaculation (PE) which was made up with extracts of 9 oriental herbs (Ginseng Radix alba, Angelicae gigantic Radix, Cistanchis Herba, Zanthoxylli Fructus, Torilidis Semen, Asiasari Radix, Caryophylli Flos, Cinnamoni Cortex and Bufonis Veneum). According to the active compositions, the main mechanism of SS- cream on PE was thought to be the local desensitizing effect. In order to realize the pharmacological action of SS-cream on PE, we performed the corneal sensitivity test with SS- cream and lidocaine in the rabbit (n=80). Both SS-cream and lidocaine inhibited the pin-prick induced corneal reflex dose-dependently (p<0.001). The anesthetic effect of lidocaine was appeared 5 minutes after the application and the duration of action persisted for 10 minutes. The intensities of desensitizing effect of SS- cream were almost same with those of 2% lidocaine, but the time of onset and duration of action was longer than 2% lidocaine. The time of onset was 10 minutes and the duration of action was persisted for more than 30 minutes. There were no local histopathologic changes after the application of SS-cream and lidocaine. With these result, we can conclude that SS-cream has a desensitizing effect on the cornea of rabbit. The believed main pharmacologic mechanism of SS-cream on PE is the desensitization of the Local Surface sensitivity.

The Histopathologic Effects of SS-cream in Local and Systemic Organs after Applying the SS-cream on Glans Penis of Rabbit and Rat / 대한비뇨기과학회지

SS-cream is a topical agent containing 9 oriental herbs for treating the premature ejaculation. In preclinical tria1, SS-cream has been effective in the treatment of premature ejaculation with only mild side effect of local penile burning sense, and other serious complications were not noted, but there were no exact histopathologic effects as for topical applying. Therefore. we investigated the local and systemic histopathologic effects of SS-cream after applying the SS-cream on glans penis with the rabbits(n=38) and white rats(n=10). SS-cream exhibited no histopathologic changes in the glans penis with temporary application. In long-term application(3-5 months) of the SS-cream on glans penis, there was a transient lymphocytes infiltration and mild congestion at submucous layer of the glans penis, which was subsided spontaneously in a 7 days later after the end of study. But these phenomena were not seen in group which the SS-cream was washed away 30 minutes later with applying on the glans penis. The other systemic histopathologic changes(testes, kidney, liver and spleen) were not seen in any experiments. With these results, we can conclude that there were no significant local and systemic histopathological changes in the temporary and long-term application of SS-cream on glans penis, and the SS-cream is proven safe for treating the premature ejaculation without untoward local and systemic histopathologic changes if it is respectively washed away 30 minutes later after the application on the glans penis.

The Effect of SS-cream on the Isolated Rabbit Corpus Cavernosum / 대한비뇨기과학회지

SS-cream is a complex mixture containing 9 oriental herbs for treating the premature ejaculation, which is based on the traditional chinese royal herb remedy. Clinically SS-cream has been effective in the treatment of premature ejaculation and in some patients, potentiating effect of their erectile capacity was noted probably due to its combined activity of several vasoactive principles. Therefore, we investigated the pharmacological action of SS-cream in the isolated rabbit corporal smooth muscle. Strips of rabbit corpus cavernosum were isolated and mounted in 10ml organ chambers to measure isometric tension. Muscle strips treated with increasing concentrations of SS-cream(0.05mg/ml to 0.3mg/ml) showed initial rapid contraction followed by slow gradual relaxation. Muscle strips submaximally precontracted with phenylephrine(PHE:5x0.000001M) and treated with increasing concentrations of SS-cream(from 0.05mg/ml to 0.2mg/mI) showed also initial rapid contraction above the precontracted level and thereafter, relaxed to the basal level at the dose larger than 2mg/ml of SS-cream. Relaxations of muscle strips to SS-cream were not inhibited even partially by endothelial disruption or by pretreatment with pyrogallol or methylene blue. Pretreatment of muscle strips with SS-cream caused concentration dependent inhibition of PHE(5x0.000001M) induced contraction With these results we can conclude that SS-cream has dual action, initial rapid contractile effect which is mediated by adrenergic alpha receptor stimulation, and delayed nonspecific relaxing effect which is not mediated by EDRF or nitric oxide.

A Double Blind Clinical Trial of SS-cream on Premature Ejaculation / 대한비뇨기과학회지

To confirm the effect of SS-cream, which was based on the traditional Chinese Royal herb remedy including 8 oriental herb combinations, 43 out of 150 patients with premature ejaculation (PE) were selected and investigated for a double-blind clinical trial between Nov. 1993 and Feb. l994. There mean age was 41.4 years. The 28 patients complained of PE only but 15 had concurrent mild psychogenic impotence. Only 20% of their spouse was satisfied for sexual lives. The packages of SS-cream and controls such as 1.25% (LL), 5%(ML) and 10%(HL) lidocaine cream were made similarly as much as 0.2g. They were randomly divided into the 5 groups. Each patient was assigned to apply LL, ML or SS cream once a weak for 4 consecutive weeks as scheduled. A within subjects comparison of pre and post application for ejaculation time and spouse's satisfaction was investigated. The applied groups such as LL, ML and HL cream were not effective. After SS-cream application, ejaculation time was delayed upto mean 11.3min. in 40(93%) and most of them with PE only as well as PE associated with impotence were satisfied. These data suggest that SS-cream is effective in treating PE as well as PE with mild impotence.