Prostate Restored
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Results. Subjects treated with β-sitosterol enriched saw palmetto oil showed significant decrease in IPSS, AMS and ADAM scores along with reduced postvoiding residual volume (p < 0.001), PSA (p < 0.01) and 5α-reductase from baseline to end of 12-week treatment as compared to placebo.
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Read More »A total of 118 human volunteers were screened of which 99 subjects meeting the inclusion criteria were enrolled in the study. Of the 99 subjects randomized to three treatment groups (n = 33 in each group), 91 subjects completed the study. There were 8 dropouts in the study (reason: lost to follow up). The intention-to-treat (ITT) analysis was used to assess the outcome of the study. The participant flow through the study is presented in Fig. 2. The demographic characteristics of subjects between the groups were not significantly different (Table 2). The efficacy and safety analysis were performed using ITT population.
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Read More »Table 5 Summary of total Aging male symptoms (AMS) score by visit and treatment Full size table Table 6 Summary of Aging male symptoms (AMS) subscale analysis Full size table Table 7 shows the urodynamic measurements obtained before and after the intervention period. The residual urine volume decreased significantly (p < 0.001) in VISPO group (from 112.55 ± 36.19 mL to 99.79 ± 29.27 mL) after the 12-week treatment. SPO group showed a slight improvement in residual urine volume, though not to a significant extent (110.12 ± 34.71 mL to 108.24 ± 33.22 mL). A significant improvement (p < 0.001) of Qmax was observed in the VISPO group (from 11.85 ± 2.06 mL/s to 14.27 ± 2.54 mL/s). In the SPO group a non-significant increase in the Qmax was recorded from 12.33 ± 1.61 mL/s to 12.82 ± 1.72 mL/s. Table 7 Summary of urodynamic measurements by visit and treatment Full size table Assessment of serum BPH markers are presented in Table 8. Serum levels of PSA was decreased in the VISPO group from 2.77 ± 0.56 ng/mL to 2.70 ± 0.59 ng/mL while it was increased in SPO and placebo groups after the treatment. The subjects in VISPO group showed an increase in free testosterone levels (6.23 ± 1.16 to 6.46 ± 1.43) after treatment (p < 0.05). On the contrary there was a reduction of serum levels of free testosterone in SPO and placebo groups. The change in free testosterone from baseline to end of treatment was significant in VISPO group as compared to placebo (p < 0.05). There was a reduction in total testosterone noted in all the treatment groups. However, the data were not significant. 5α-reductase activity was non-significantly reduced in VISPO group from baseline to the end of 12-week treatment (445.90 ± 105.40 ng/L to 438.24 ± 98.56). However, it was noticed that unexpectedly, the enzyme activity was increased in SPO group towards the end of study.
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Read More »The Short-Form Health Survey (SF-12) is one of the most widely used questionnaire for assessing self-reported health-related quality of life. VISPO group subjects demonstrated a significant improvement (p < 0.001) in the quality of life as evident from the increase in the mean total score. Comparatively, SPO group showed moderate increase in the SF-12 total score. Both VISPO and SPO groups showed significant change in mean score from visit 1 to visit 3 as compared to placebo. The subset analysis revealed that VISPO group also showed significant improvement in PCS-12 and MCS-12 scores after 12-week treatment (p < 0.001), Fig. 3 shows the change in SF-12 scores from baseline to the end of treatment. Fig. 3 Mean change in SF-12 score of the study participants. The changes from baseline (visit 1) to the end of treatment (visit 3) in SF-12 total score (a), physical health composite (PCS-12) score and mental health composite (MCS-12) score (b) . The values are represented as mean ± SD (n = 33 in each group). The data were analysed by one way ANOVA followed by Scheffe test. ***p < 0.001 vs. placebo Full size image No serious adverse events (SAEs) were recorded during the study. The investigational products were well tolerated among the subjects. There were no significant alterations in the biochemical and haematological parameters among the subjects during the intervention period. The results of safety assessment are provided in supplementary file 4.
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