Article Figures & Data
Figures
- Figure 1
Flowchart of patients in the trial.
- Figure 2
Patient-reported scores for complaints (VOC) and disability VOD (not corrected for temperature) for each arm and study phase.
VAS = visual analogue scale; VOC = visual analogue scale on complaints; VOD = visual analogue scale on disability.
Notes: Scores measured on 100-mm scales where higher values indicate more complaints (symptoms) or greater disability. Phase 0: no-treatment baseline; phase 1: first assigned treatment; phase 2: second assigned treatment.
Tables
Characteristic Placebo-First Arm (n = 17) Nifedipine-First Arm (n = 15) Age, mean, y 50 59 Sex Women, No. 8 10 Men, No. 9 5 Chilblain symptoms Mean duration at intake, wk 7 6 Experiencing first episode, No. 2 2 Experienced >1 episode, No. 4 4 Experiences episode every year, No. 12 10 Mean VOC score, mma,b 25 24 Mean VOD score, mmb 17 15 Smoking, No. 3 3 Comorbidity Diabetes, No. 0 1 Peripheral arterial disease, No. 1 0 Raynaud phenomenon, No. 6 3 Relevant medication use β-blocker, No. 0 0 Nicotine replacement drug, No. 0 0 Acetylsalicylic acid, No. 0 1 ACE or angiotensin II receptor blocker, No. 3 2 ACE = angiotensin-converting enzyme; VOC = visual analogue scale on complaints; VOD = visual analogue scale on disability.
↵a The higher of either the visual analogue scale itch score or the visual analogue scale pain score.
↵b Scores measured on 100-mm scales where higher values indicate more complaints (symptoms) or greater disability.
Outcome Score, mma Test of Fixed Effects Mean (95% CI) Difference (95% CI) F Value P Value (r>F) Primary: VOC score Treatment Nifedipine 11.44 (6.12 to 16.75) – – – Placebo 13.28 (7.96 to 18.59) −1.84 (−6.67 to 2.99) 0.61 .44 Arm Placebo first 14.07 (7.16 to 20.98) – – – Nifedipine first 10.65 (4.16 to 17.14) 3.43 (−6.08 to 12.93) 0.54 .47 Temperature – – 3.62 .07 Secondary: VOD score Treatment Nifedipine 4.65 (1.65 to 7.65) – – – Placebo 4.09 (1.09 to 7.09) 0.56 (−2.97 to 4.09) 0.10 .75 Arm Placebo first 4.95 (1.40 to 8.50) – – – Nifedipine first 3.79 (0.46 to 7.12) 1.17 (−3.72 to 6.05) 0.24 .63 Temperature – – 1.63 .21 VAS = visual analog scale; VOC = visual analogue scale on complaints; VOD = visual analogue scale on disability.
↵a On a visual analogue scale in week 6 of treatment. Scores measured on 100-mm scales where higher values indicate more complaints (symptoms) or greater disability.
Outcomea Placebo Nifedipine Mean Difference (95%CI) P Value Redness score, mean, mm 17.0 18.3 1.9 (−3.8 to 7.6) .50 Purpleness score, mean, mm 6.6 4.9 −1.5 (−5.6 to 2.6) .47 Edema score, mean, mm 4.9 7.8 3.2 (−0.5 to 6.9) .09 Ulceration score, mean, mm 0.0 0.2 0.2 (−0.2 to 0.6) .33 ↵a Assessed using 100-mm visual analogue scales where higher values indicate greater severity.
Outcomea Placebo Nifedipine Mean Difference (95% CI) P Value Systolic blood pressure, mean, mm Hg 147.1 134.5 −13.1 (−24.1 to −2.01) .02 Headache score, mean, mma 2.2 6.9 4.7 (−0.8 to 10.3) .09 Dizziness score, mean, mma 1.6 4.7 3.1 (−1.0 to 7.2) .13 Peripheral edema score, mean, mma 2.5 12.1 9.6 (1.1 to 18.1) .03 ↵a Assessed using 100-mm visual analogue scales where higher values indicate greater severity.
The Article in Brief
Nifedipine vs Placebo for Treatment of Chronic Chilblains: A Randomized Controlled Trial
Ibo H. Souwer , and colleagues
Background The drug nifedipine is commonly prescribed for the treatment of chilblains, a condition with painful or itching lesions on the fingers, feet, ears or thighs due to exposure to cold. This study compared nifedipine to placebo for the treatment of patients with chronic chilblains in a primary care setting.
What This Study Found In this study, the drug nifedipine was no more effective than placebo for treating chronic chilblains and may even cause harm. Researchers randomized 32 patients with chronic chilblains to receive either nifedipine or placebo and found after 6 weeks of treatment, the nonsignificant difference in patient-reported symptoms tended to favor nifedipine, while the nonsignificant difference in patient-reported disability tended to favor placebo. Nifedipine was associated with a lower systolic blood pressure and a higher incidence of edema.
Implications
- The authors conclude that these findings underscore the importance of rigorous evaluation of treatments with adequate numbers of patients and control for potential cofounders before widespread adoption of nifedipine.
