Table 2.
Results after 6 months of treatment
| Outcomes | Treatment group A (112 cases) | Treatment group B (94 cases) | Control group C (101 cases) | Statistical analysis (P-value)
|
||
|---|---|---|---|---|---|---|
| A vs B | A vs C | B vs C | ||||
| Mean pain resolution (% [n/N]) | 67.69 (44/65) | 67.27 (37/55) | 6.89 (4/58) | 0.961 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean changes in PI-NRS score in patients with penile pain ± SD | −4.12±2.01 | −3.40±2.03 | −1.15±2.88 | 0.054 (t-test) | <0.0001 (t-test) | <0.0001 (t-test) |
| Mean onset of penile pain (% [n/N]) | 0 (0/47) | 0 (0/39) | 48.83 (21/43) | 1.000 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean plaque volume reduction (% [n/N]) | 100.0 (112/112) | 79.78 (75/94) | 0 (0/101) | <0.0001 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean actual changes in plaque volume ± SD (%) | −46.99±21.23 | −24.84±27.76 | +123.38±238.49 | <0.0001 (t-test) | <0.0001 (t-test) | <0.0001 (t-test) |
| Mean increase in plaque volume (% [n/N]) | 0 (0/112) | 5.31 (5/94) | 98.01 (99/101) | 0.0186 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean plaque resolution (% [n/N]) | 0.89 (1/112) | 1.06 (1/94) | 0 (0/101) | 0.900 (χ2 test) | 0.341 (χ2 test) | 0.971 (χ2 test) |
| Mean calcification volume reduction (% [n/N]) | 96.77 (30/31) | 70.83 (17/24) | 0 (0/26) | 0.0159 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean actual changes in calcification volume ± SD (%) | −54.02±30.43 | −40.27±36.11 | +109.29±206.16 | 0.131 (t-test) | <0.0001 (t-test) | 0.001 (t-test) |
| Mean calcification resolved (% [n/N]) | 9.67 (3/31) | 8.33 (2/24) | 0 (0/26) | 0.863 (χ2 test) | 0.301 (χ2 test) | 0.435 (χ2 test) |
| Mean increase in volume of calcification (% [n/N]) | 3.2 (1/31) | 0 (0/24) | 80.7 (21/26) | 0.374 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean appearance of new calcification (% [n/N]) | 0 (0/81) | 0 (0/70) | 33.3 (25/75) | 1.000 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean improvement in penile curvature (% [n/N]) | 96.8 (91/94) | 56.41 (44/78) | 3.61 (3/83) | <0.0001 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean variations in angle of penile curvature ± SD (°) | −10.1±6.5 | −4.8±5.7 | +15.7±16.1 | <0.0001 (t-test) | <0.0001 (t-test) | <0.0001 (t-test) |
| Mean variation in percentage of penile curve angle + SD (%) | −40.7±22.1 | −21.7±23.5 | +68.2±66.8 | <0.0001 (t-test) | <0.0001 (t-test) | <0.0001 (t-test) |
| Mean no variation in penile curvature (% [n/N]) | 3.19 (3/94) | 41.02 (32/78) | 15.66 (13/83) | <0.0001 (χ2 test) | 0.0069 (χ2 test) | 0.0004 (χ2 test) |
| Mean resolution of penile curvature (% [n/N]) | 6.38 (6/94) | 1.28 (1/78) | 0 (0/83) | 0.128 (χ2 test) | 0.0304 (χ2 test) | 0.484 (χ2 test) |
| Mean worsening in penile curvature (% [n/N]) | 0 (0/94) | 0 (0/78) | 80.72 (67/83) | 1.000 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean onset of penile curvature in patients with no curvature (% [n/N]) | 0 (0/18) | 0 (0/16) | 94.4 (17/18) | 1.000 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean improvement in penile rigidity in patients with ED (% [n/N]) | 92.6 (38/41) | 61.7 (21/34) | 0 (0/36) | 0.0016 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
| Mean recovery of penile rigidity in patients with ED (% [n/N]) | 56.09 (23/41) | 23.5 (8/34) | 0 (0/36) | 0.0052 (χ2 test) | <0.0001 (χ2 test) | 0.0019 (χ2 test) |
| Mean variations in IIEF-EF score in patients with ED ± SD | +3.6±3.1 | +1.1±2.6 | −1.4±2.1 | 0.0004 (t-test) | <0.0001 (t-test) | <0.0001 (t-test) |
| Mean variation percentage of IIEF-EF score in patients with ED ± SD (%) | +23.99±31.46 | +6.94±15.33 | −7.44±11.36 | 0.0051 (t-test) | <0.0001 (t-test) | <0.0001 (t-test) |
| Onset of ED in patients with previously normal penile rigidity (% [n/N]) | 0 (0/71) | 0 (0/60) | 48.0 (36/65) | 1.000 (χ2 test) | <0.0001 (χ2 test) | <0.0001 (χ2 test) |
Notes: Group A: PTX 400 mg twice a day + propolis 600 mg/d + blueberry 160 mg/d + vitamin E 600 mg/d + diclofenac 4% gel twice/day + PTX 100 mg via perilesional penile injection/every other week (12 injections in all); Group B: the same treatment as Group A except for the penile PTX injections; Group C: control group with no treatment. Continuous variables were compared using the two-tailed Student’s t-test whereas categorical variables were statistically compared by use of the χ2 test.
Abbreviations: n, patients; N, total patients; PI-NRS, pain intensity numeric rating scale; SD, standard deviation; ED, erectile dysfunction; IIEF-EF, index of erectile function.