Baseline | 2 months | Change (2 months–baseline) | p Value* | 6 months | Change (6 months–baseline) | p Value† | |
---|---|---|---|---|---|---|---|
RCS/10 | |||||||
Mean±SD | 7.2±0.9 | 4.5±1.9 | −2.7±2.2 | <0.001 | 2.9±1.4 | −4.3±2.1 | <0.001 |
Median (range) | 7.5 (6.5–8.0) | 5.0 (4.0–5.5) | −2.0 (−6.5–−1.0) | 3.0 (2.5–3.0) | −4.5 (−7.0–−1.5) | ||
Hand visual analogue scale/100 | |||||||
Mean±SD | 59.4±17.2 | 21.6±17.5 | −37.8±28.6 | 0.001 | 17.8±15.3 | −41.7±22.7 | <0.001 |
Median (range) | 58.5 (50.0–72.5) | 19.0 (7.0–40.0) | −39.0 (−80.0–21.0) | 13.6 (9.0–26.0) | −44.0 (−80.0–10.0) | ||
Capillaroscopy data | |||||||
Number of capillary loops | |||||||
Dominant hand | |||||||
Mean±SD | 136.3±78.9 | 124.1±60.1 | −12.2±40.9 | 0.325 | 138.5±60.8 | 2.3±47.9 | 0.874 |
Median (range) | 124.0 (42–298) | 118.0 (30–226) | −12.5 (−98–61) | 132.5 (48–232) | 8.0 (−97–92) | ||
Non-dominant hand | |||||||
Mean±SD | 159.5±96.9 | 142.1±71.0 | −23.5±54.1 | 0.181 | 152.3±75.2 | −11.7±42.0 | 0.377 |
Median (range) | 122.0 (45–298) | 139.0 (42–277) | −13.0 (−137–33) | 131.5 (70–308) | −10.0 (−103–34) | ||
Number of giant capillaries | |||||||
Dominant hand | |||||||
Mean±SD | 20.3±20.3 | 17.8±18.0 | −2.4±8.4 | 0.341 | 15.3±17.9 | −4.9±7.8 | 0.035 |
Median (range) | 12.0 (0–64) | 13.0 (1–67) | 1.0 (−22–7) | 9.0 (0–63) | −1.0 (−17–6) | ||
Non-dominant hand | |||||||
Mean±SD | 18.3±11.7 | 18.2±20.5 | −5.5±7.9 | 18.1±18.6 | −5.1±8.9 | 0.074 | |
Median (range) | 13.0 (0–39) | 12.5 (0–77) | −3.0 (−20–3) | 0.046 | 13.0 (0–72) | −3.0 (−23–4) | |
Number of dystrophic capillaries | |||||||
Dominant hand | |||||||
Mean±SD | 23.3±26.8 | 13.0±11.6 | −10.3±17.9 | 0.115 | 11.0±10.3 | −12.3±20.2 | 0.047 |
Median (range) | 14.0 (0–79) | 14.0 (0–30) | −2.0 (−53–6) | 8.5 (0–29) | −1.0 (−57–5) | ||
Non-dominant hand | |||||||
Mean±SD | 23.2±22.8 | 11.2±9.5 | −11.4±14.9 | 9.7±6.7 | −13.5±19.8 | 0.047 | |
Median (range) | 17.0 (0–58) | 8.0 (0–29) | −4.0 (−37–6) | 0.030 | 10.5 (0–22) | −6.0 (−45–15) | |
Vascular suppression score | |||||||
Dominant hand | |||||||
Mean±SD | 1.7±0.8 | 1.6±0.6 | −0.1±0.4 | 0.656 | 1.5±0.7 | −0.2±0.3 | 0.010 |
Median (range) | 1.9 (1.0–2.3) | 1.5 (1.1–2.1) | 0.0 (−1.0–0.4) | 1.4 (0.9–2.0) | −0.2 (−0.4–0.0) | ||
Non-dominant hand | |||||||
Mean±SD | 1.6±0.7 | 1.5±0.7 | −0.2±0.2 | 1.3±0.7 | −0.3±0.3 | 0.003 | |
Median (range) | 1.8 (0.9–2.2) | 1.6 (0.8–2.0) | −0.1 (−0.6–0.0) | 0.031 | 1.1 (0.8–2.0) | −0.4 (−0.8–0.2) |
Bold values correspond to the p value columns. p≤0.05 (2-sided) was considered significant.
Data are mean±SD, median (minimum–maximum).
*p Value from baseline to M2.
†p Value from baseline to M6.
Dystrophic capillaries are enlarged loops over four times the normal afferent, transition and efferent limbs width. Giant capillary loops are 10 or more times the normal width of capillary limbs. The avascular score was assessed according to Lee's method18, in which each finger was rated from 0 to 3: grade 0=no avascular area; 1=one or two discrete avascular areas; 2=more than two discrete avascular areas; 3=extensive and confluent avascular areas. Vascular suppression score are the mean of fingers. RCS, Raynaud's Condition Score.