A total of 36 patients completed the first month of therapy with either the PROS-TECT nutriceutical bar (Food-Nutrition Inc, Canada) or the placebo bar. Each patient was directed to ingest one bar per day for the first month, followed by two months of alternate day therapy. A complete response was allotted to those patients who achieved at least a four-point reduction in their IPSS. A partial response was defined by at least a two-point improvement in the symptom score. Patients were re-evaluated after the third month to assess further improvement and/or maintenance or deterioration of their 30-day symptom response.
In all of the parameters compared, including uroflow rates, post-void residual studies and IPSS scores, the nutriceutical bar was significantly more effective than the placebo (Table 2). In the active compared with placebo arm there was a significantly increased response, both absolute and percentage, in IPSS scores and uroflow rates. In the BPH patients, the bar to placebo overall improvement rate was 75% compared with 37%, respectively. buy flovent inhaler
Side effects were minimal, but if present, were related to gastrointestinal distress, flatulence and diarrhea, or unacceptable taste. Three patients withdrew due to side effects from the bar after the first month of therapy. No patient complained of dizziness, postural hypotension, asthenia, nasal stuffiness, headaches, erectile dysfunction (ED) or altered ejaculation.
Only 20% of patients who initially reported either a complete or partial response reported a deterioration of symptom response after the change to alternate day therapy (Table 3).
No patient in the active arm responded in a negative manner to the question, “Has there been a change in your erectile function or ability to ejaculate in the preceding treatment period?”.
TABLE 2 Pre- and post-treatment results in benign prostatic hyperplasia patients after 30 days of treatment
|Parameter||Nutraceutical bar||Placebo bar|
|Number of patients||20||16|
|Age range (years)||45 to 79||45 to 80|
|(mean = 67)||(mean = 66)|
|Average IPSS – Before treatment||17||17|
|Average IPSS – After treatment||13||16|
|Average UF – Before treatment||7||7|
|Average UF – After treatment||9.5||7.5|
|Total responses||15 (75%)||6 (37.5%)|
TABLE 3 Sixty-day follow-up results of patients who achieved a complete or partial response after 30 days. The patients ate the bars on alternate days during the second 60-day trial
|Benign prostatic hyperplasia|
|No Change and Improved||8 (80%)||4 (80%)|
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