Multicenter clinical trials on a novel polyherbal formulation in allergic rhinitis.

Allergic rhinitis is the most frequently occurring immunological disorder. It affects men, women and children and represents significant cost in terms of suffering and loss of productivity. Allergy is termed as an excessive reaction to an environmental allergen. Pollen, mold, dust, mite and animal allergens that contact the nasal or eye lining cause sneezing, nasal congestion and itchy, watery, swollen, red eyes. Although a broad spectrum of therapeutic options is available, the treatment of allergic rhinitis appears to be far from satisfactory. A novel polyherbal formulation (PF; Aller-7/NR-A2) comprising seven medicinal herbal extracts was assessed in a multicenter clinical trial involving 545 patients (321 males and 224 females) aged 18-59 years for 12 weeks to evaluate its clinical efficacy in patients suffering from allergic rhinitis. A total of 171 patients participated in double-blind, randomized, placebo-controlled studies in three centers, while 374 patients were included in the open-label studies in 11 centers. The three major symptoms (sneezing, rhinorrhea and nasal congestion) of allergic rhinitis were significantly reduced. Significant improvement was also observed in absolute eosinophil count, mucociliary clearance time, peak expiratory flow rate and peak nasal flow rate. No serious adverse events that warranted cessation of treatment were observed. Minor adverse effects were noted in both the treatment and placebo groups. Thus, this study demonstrates that Aller-7/NR-A2 is well tolerated and efficacious in patients with allergic rhinitis.

Clinical guidelines panel on erectile dysfunction: summary report on the treatment of organic erectile dysfunction. The American Urological Association.

PURPOSE: The American Urological Association convened the Clinical Guidelines Panel on Erectile Dysfunction to analyze the literature regarding available methods for treating organic erectile dysfunction and to make practice recommendations based on the treatment outcomes data. MATERIALS AND METHODS: The panel searched the MEDLINE data base for all articles from 1979 through 1994 on treatment of organic erectile dysfunction and meta-analyzed outcomes data for oral drug therapy (yohimbine), vacuum constriction devices, vasoactive drug injection therapy, penile prosthesis implantation and venous and arterial surgery. RESULTS: Estimated probabilities of desirable outcomes are relatively high for vacuum constriction devices, vasoactive drug injection therapy and penile prosthesis therapy. However, patients must be aware of potential complications. The outcomes data for yohimbine clearly indicate a therapy with marginal efficacy. For venous and arterial surgery, based on reported outcomes, chances of success do not appear high enough to justify routine use of such surgery. CONCLUSIONS: For the standard patient, defined as a man with acquired organic erectile dysfunction and no evidence of hypogonadism or hyperprolactinemia, the panel recommends 3 treatment alternatives: vacuum constriction devices, vasoactive drug injection therapy and penile prosthesis implantation. Based on the data to date, yohimbine does not appear to be effective for organic erectile dysfunction and, thus, it should not be recommended as treatment for the standard patient. Venous surgery and arterial surgery in men with arteriolosclerotic disease are considered investigational and should be performed only in a research setting with long-term followup available.

Long-term results with vacuum constriction device.

From November 1985 to April 1990, 216 consecutive patients were treated with the vacuum constriction device. Patients were mailed an initial questionnaire (group 1) and a long-term questionnaire (group 2) at a median followup of 3 and 29 months, respectively. Of 202 available patients 161 in group 1 (75%) and 115 in group 2 (57%) responded. Regular use of the vacuum constriction device was reported by 69% group 1 and 70% group 2 patients. patient and partner satisfaction was 82% and 87% in group 1, and 84% and 89% in group 2, respectively. There were no significant differences between the groups with respect to regular use and patient or partner satisfaction (p < 0.05). Quality of erection was evaluated for hardness, length and circumference, and with satisfaction greater than 90% in both groups. Median times per month of successful intercourse were 1, 4 and 4 for the year before, during and after obtaining the vacuum constriction device in group 2. Also, 79% of the patients in group 2 reported a statistically significant increase in the frequency of intercourse per month in the first year, which was sustained beyond the first year in 77% (p < 0.01). Our results support the efficacy of the vacuum constriction device for the treatment of impotence. Overall regular use rates as well as patient and partner satisfaction appear to be high. Furthermore, excellent initial results appear durable in most patients.

Pathophysiology of prolonged penile erection associated with trazodone use.

Treatment with the antidepressant trazodone has been associated with the occurrence of prolonged penile erection and priapism. To evaluate the effect of trazodone on erection we monitored the periodic physiological sleep-related erections in 6 healthy volunteers in a double-blind crossover study comparing the effect of trazodone, trimipramine (a tricyclic antidepressant) and placebo. In addition, to determine the effects of trazodone on the neurovascular control of penile smooth muscle we performed in vitro studies on corpus cavernosum tissue obtained from patients undergoing penile prosthesis implantation. Trazodone significantly increased the total interval of nocturnal erectile activity, while trimipramine had no effect. During the high dose treatment (nights 4 and 5) the average duration of erectile activity per night with placebo was 158 +/- 41 minutes (mean +/- standard deviation) for night 4 and 177 +/- 21 minutes for night 5. During trazodone treatment the erectile activity per night was significantly prolonged to 285 +/- 115 minutes during night 4 and 232 +/- 86 during night 5 (p less than 0.01). Analysis of the erectile activity in relation to the rapid eye movement sleep period during which erectile activity usually occurs revealed that the detumescence phase of erection, under sympathetic control, was significantly prolonged an average of 2.4 times by trazodone compared to placebo (p less than 0.05). In vitro, trazodone at concentrations comparable to those reached in plasma significantly impaired corporeal smooth muscle contractions elicited by electrical stimulation of adrenergic nerves and antagonized contractions induced by exogenous norepinephrine. We conclude that trazodone can enhance penile erection in man and propose a mechanism related to the alpha-adrenoceptor blocking properties of trazodone by interference with the sympathetic control of penile detumescence.

Noninvasive device to produce and maintain an erection-like state.

In 35 men with organic impotence we have tested a noninvasive device which uses a vacuum to produce an erection-like state and rubber bands to maintain this state. The subjects were first evaluated to determine the cause of their impotence and to establish that it had an organic basis. Using this device 32 of the 35 subjects achieved penile rigidity sufficient for vaginal penetration. Subjects were studied with the rubber bands constricting the base of the penis for thirty minutes. During that period, blood flow continued, but at a less than normal rate. Of 30 men followed up from eight to twenty-two months, 24 use the device regularly and report that they are satisfied. Four subjects have not yet tried to use it, and 1 no longer needs it. One man was dissatisfied because the rigidity begins to decrease after five to ten minutes of sexual activity, even though it did not change over a thirty-minute period when originally tested in the laboratory. Ecchymoses of the penis, probably due to excess vacuum, developed in 3 subjects. In 8 other men petechiae of the skin of the penis developed on one or more occasions. These ecchymoses and petechiae were painless and disappeared without treatment. No other complications occurred. The vacuum device appears to be a safe and inexpensive way for an impotent man to make the penis rigid enough to engage in sexual intercourse.