Table 1.
Baseline characteristics of included studies.
| Authors | Country/publication year | Design | Follow-up | Total cases | Sample size | Treatment | Age (years) | Blood pressure (mmHg) | BMI (kg/m2) | ED severity | Adverse reaction | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Experimental | Control | Experimental | Control | Experimental | Control | Experimental | Control | ||||||||
| Andrea Ledda et al. (20) | Italy/2009 | RCT, double-blindstudy | 6 months | 124 | 54 | 57 | ① | 44.5 ± 4 (30–50) | 44 ± 4 (30–50) | 138.9 ± 8.0/none | 137.0 ± 6.8/None | 24.6 ± 2.6 | 22.3 (2.6) | Mild to moderate | None |
| Hiromitsu Aoki et al. (21) | Japan/2011 | RCT, double-blind study | 2 months |
24 | 12 | 12 | ② | 51.4 ± 9.0 | 50.6 ± 7.5 | 128.4 ± 12.9/80.8 ± 10.0 | 125.7 ± 13.9/76.6 ± 10.2 | 24.4 ± 2.0 | 23.4 ± 2.9 | Mild to moderate |
None |
| R Stanislavov et al. (22) | Bulgari/2008 | RCT, double-blind crossover study | 1 month | 50 | 25 | 25 | ③ | 36.8 (30–50) | 37.2 (30–50) | 134.6 ± 7.1/85.8 ± 4.5 | 132.4 ± 7.7/86.0 ± 5.0 | 26.2 | 25.9 | Mild to moderate |
None |
① Each PAL tablet contained 20 mg of Pycnogenol® plus 700 mg of L–arginine aspartate. In the placebo tablets, dicalcium phosphate replaced the active components. The standard is two tablets in the morning and two in the evening.
② Subjects were instructed to take a supplement (Pycnogenol® at 60 mg/day, L‐arginine at 690 mg/day, and aspartic acid at 552 mg/day) or an identical placebo for 8 weeks.
③ The daily dose of PAL corresponds to an intake of 80 mg of Pycnogenol® and 3 g of L-arginine aspartate. The standard is two tablets in the morning and two in the evening.