Table 1.
Main clinical studies regarding Aminaphtone (LASCA = Laser Speckle Contrast Analysis; RCS = Raynaud’s condition score; RP = Raynaud’s phenomenon; SD = standard deviation; SSc = Systemic sclerosis; VAS = visual analogue scale).
| Consoli (30) | De Anna (2) | De Godoy (4) | Scorza (12) | De Godoy (28) | Belczak (13) | De Godoy (32) | Parisi (47) | Ruaro (7) | |
|---|---|---|---|---|---|---|---|---|---|
| Country | Italy | Italy | Brazil | Italy | Brazil | Brazil | Brazil | Italy | Italy |
| Year | 1985 | 1989 | 2008 | 2008 | 2011 | 2013 | 2014 | 2015 | 2019 |
| Enrolled patients, n | 42 | 66 | 15 | 24 | 82 | 136 | 30 | 108 | 92 |
| Age range or mean age (years ± SD) | 20–70 | 53 ± 11 | 22–49 | 53 ± 14 | 18–58 | 51 | 13 | 52 | 59 |
| Disease investigated | Traumatic injuries | Chronic venous insufficiency | Idiopathic cyclic edema syndrome | SSc-related RP | Cellulite and idiopathic edema syndrome | Chronic venous insufficiency | Gingival bleeding | SSc-related RP | Primary and SSc-related RP |
| Aminaphtone patients, n | 42 | 66 | 15 | 12 | 82 | 36 | 15 | 57 | 46 |
| Control patients, n | No | 48 | No | 12 | No | 57 | No | 51 | 46 |
| Placebo patients, n | No | No | No | No | No | 43 | 15 | No | No |
| Methods of evaluation | Semiquantitative | Semiquantitative and quantitative | Quantitative | Quantitative | Quantitative | Semi-quantitative and quantitative | Qualitative (yes/no) | Semi-quantitative and quantitative | Semi-quantitative and quantitative |
| Subjective measures | Tumefaction, range of movements, spontaneous and or provoked pain | Itching, venous pain, night cramps, paresthesia | / | / | / | Quality of life | / | Pain VAS, RCS, tingling, numbness | RCS, Raynaud frequency and duration |
| Objective measures | / | Circumference of ankle, district venous pressure | Lower limb volumetry (mL) | Serum concentration of ECAM-1, VCAM-1, and ICAM-1 | Weight | Mean limb volumetry, tibio-tarsal joint range of movements | Intraoral clinical examination | Average attacks RP (n°/day) | Skin blood perfusion (LASCA) |
| Posology (mg per day) | 150–225 | 300–450 | 225 | 225 | 225 | 150 | 150 | 150 | 150 |
| Duration of treatment | 6–30 days | 90 days | 5 days | 12 weeks | 3 days | 30 days | 5 days | 12 months | 24 weeks |
| Concomitant therapy | Yes | Yes | Yes | Yes | Not specified | No | No | Yes | Yes |
| Efficacy | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Side effects | Heartburn (6 pts), skin rash (1 pt) | Heartburn (2 pts) | Not reported | Not reported | Not reported | Headache (1 pt) | Not reported | None | Headache (2 pts) |