Vitamin D3 is not effective in the treatment of chronic chilblains

Souwer, I.H.; Lagro-Janssen, Antoine L. M.

doi:10.1111/j.1742-1241.2008.01912.x

Cited by 14 publications

(12 citation statements)

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“…In an earlier study on the effectiveness of vitamin D3 with 33 participants recruited in a similar way, two of the current authors observed a baseline VOC of 27.97 mm (standard deviation [SD] 18.82). 5 An estimate was used of the correlation between two VAS scores from the same individual on two occasions of 0.5. Treatment effect was considered to be clinically relevant in the case of a 10 mm decrease in the VOC.…”

Section: Sample Sizementioning

confidence: 99%

“…1,7 The validity of the confirmation of the diagnosis had previously been demonstrated. 5 The authors excluded people with a known rheumatic disorder (for example, rheumatoid arthritis or systemic lupus erythematosus), those who were using nifedipine or other calcium antagonist, those who had been using a corticosteroidcontaining cream in the previous 4 weeks, and females who were pregnant or lactating.…”

Section: Introductionmentioning

confidence: 99%

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Assessing the effectiveness of topical betamethasone to treat chronic chilblains: a randomised clinical trial in primary care

Souwer

Bor²,

Smits³

et al. 2017

Br J Gen Pract

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BackgroundGPs prescribe topical corticosteroids to patients with chronic chilblains despite poor evidence for their effectiveness. The authors of the current study therefore decided to assess the effectiveness of topical steroids in a primary care setting.AimTo assess the effectiveness of topical application of betamethasone valerate 0.1% cream in patients with chronic chilblains.Design and settingA placebo-controlled, double-blind, crossover, randomised clinical trial in a Dutch primary care setting.MethodThe study population consisted of 34 participants suffering from chronic chilblains. Intervention was topical application of betamethasone valerate 0.1% cream twice a day for 6 weeks compared with placebo. Primary outcome was the visual analogue scale on complaints (VOC). Secondary outcome was the visual analogue scale on disability (VOD). Both were assessed with a diary of daily scores on a 100 mm visual analogue scale. The authors took ambient temperatures into account, checked for a carry-over effect, performed additional analysis, and monitored adverse effects.ResultsOn the primary outcome mean VOC, there was a difference of 0.56 mm (95% confidence interval [CI] = −2.88 to 3.99 mm) in favour of placebo (P = 0.744). On the secondary outcome mean VOD, there was a difference of 0.88 mm (95% CI = −2.22 to 3.98 mm) in favour of placebo (P = 0.567). This study found no carry-over effect and no adverse effects.ConclusionIn this study, topical betamethasone was not superior to placebo in the treatment of chronic chilblains. Topical betamethasone should not be used for chronic chilblains without new evidence.

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Section: Sample Sizementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Assessing the effectiveness of topical betamethasone to treat chronic chilblains: a randomised clinical trial in primary care

Souwer

Bor²,

Smits³

et al. 2017

Br J Gen Pract

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“…3,4 In an earlier study, we found that vitamin D 3 was not superior to placebo, however. 5 Five studies evaluating the effectiveness of nifedipine in patients with chilblains have been published and have concluded that the drug is an effective treatment. These studies included only 1 randomized controlled trial, having 10 patients and conducted in 1989, compared nifedipine with placebo.…”

Section: Introductionmentioning

confidence: 99%

“…We used an estimate of 0.5 for the correlation between 2 scores from the same patient on 2 occasions. 5 We considered the treatment effect to be clinically relevant if patients experienced a decrease in the VOC score of at least 10 mm.On the basis of use of a t test for the difference between 2 dependent means, 1-tail testing, an α of 0.05, and a β of 0.10 (power of 90%), we calculated that we would need a minimum of 32 participants for the trial. …”

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confidence: 99%

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Nifedipine vs Placebo for Treatment of Chronic Chilblains: A Randomized Controlled Trial

Souwer

Bor

Smits

et al. 2016

The Annals of Family Medicine

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PURPOSE Nifedipine is commonly prescribed for the treatment of chilblains (pernio, perniosis) on the basis of observational studies and a single small, older clinical trial. We aimed to confirm the proposed superiority of oral nifedipine 60 mg per day over placebo for treatment of chronic chilblains in primary care. METHODSWe performed a randomized, placebo-controlled, double-blind, crossover trial, closely following the design of the older trial. A total of 32 patients with chronic chilblains were randomly assigned to nifedipine (30 mg controlled release twice a day) or placebo. The primary outcome was patient-reported complaints; the secondary outcome was patient-reported disability. Both were assessed from daily ratings on 100-mm visual analogue scales recorded in a diary. We took ambient temperatures into account and checked for a carry-over effect, and monitored for adverse effects.RESULTS After 6 weeks of treatment, mean scores on the visual analogue scale on complaints showed a nonsignificant difference of 1.84 mm (95% CI, -6.67 to 2.99 mm) in favor of nifedipine (P = .44). Mean scores on the visual analogue scale on disability showed a nonsignificant difference of 0.56 mm (95% CI, -2.97 to 4.09 mm) in favor of placebo (P = .75). There was no carry-over effect of prior study treatment. Nifedipine was associated with significantly lower systolic blood pressure and a significantly higher incidence of edema.CONCLUSIONS In our study, nifedipine was not superior to placebo for treating chronic chilblains. These findings contrast with those of the older study and do not support routine use of nifedipine for this condition. 2016;14:453-459. doi: 10.1370/afm.1966. Ann Fam Med INTRODUCTIONC hilblains (pernio, perniosis) are cold-induced, painful or itching lesions on the fingers, feet, ears, or thighs. The condition occurs throughout the world during the winter months when daily mean temperatures drop below the range of 12 o C to 15 o C. 1 The prevalence in the Netherlands as reported by the Netherlands Institute for Health Services Research (NIVEL) varies between 0.9 per 1,000 and 1.7 per 1,000 depending on year-to-year variation and coding issues. The condition is more common among women than men, with respective prevalences of 0.9 to 2.1 per 1,000 vs 0.6 to 1.2 per 1,000 (written information provided by NIVEL).Patients with chilblains report serious restrictions in daily life and feel an urgent need for effective treatment.2 A review of the literature through March 15, 2016 revealed evidence that vitamin D 3 , corticosteroidcontaining cream, nifedipine, and pentoxyfylline, among a wide range of other therapies, are used to treat symptoms of chronic chilblains. 3,4 In an earlier study, we found that vitamin D 3 was not superior to placebo, however.5 Five studies evaluating the effectiveness of nifedipine in patients with chilblains have been published and have concluded that the drug is an effective treatment. These studies included only 1 randomized controlled trial, having 10 patients and conducted in ...

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209 Wintertenen/perniones

Souwer¹,

Lagro-Janssen²

2016

Kleine Kwalen in De Huisartsenpraktijk

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Vitamin D3 is not effective in the treatment of chronic chilblains

Abstract: Oral administration of 2000 IU vitamin D3 per day is not better than placebo in the treatment of patients with chronic chilblains.

Cited by 14 publications

References 13 publications

Assessing the effectiveness of topical betamethasone to treat chronic chilblains: a randomised clinical trial in primary care

Assessing the effectiveness of topical betamethasone to treat chronic chilblains: a randomised clinical trial in primary care

Nifedipine vs Placebo for Treatment of Chronic Chilblains: A Randomized Controlled Trial

209 Wintertenen/perniones

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