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

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. METHODS: We 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.

Phenotypic familial aggregation in chronic chilblains.

BACKGROUND: Our clinical observations and two earlier studies indicate familial clustering to be involved in chronic chilblains. Demonstrating phenotypic familial aggregation is a next step to investigate the origin of familial clustering. OBJECTIVE: This study was initiated to assess evidence for phenotypic familial aggregation in chronic chilblains. METHODS: Using a case-control family design in a primary care setting, we computed the familial relative risk of at least one episode of chronic chilblains during life with 95% confidence intervals (CIs). The study population consisted of 192 relatives of 31 case probands (at least one confirmed episode of chronic chilblains). The control population consisted of 178 relatives of 31 sex- and age-matched index controls (no history of chronic chilblains). RESULTS: The familial relative risk of chronic chilblains was 3.6 (95% CI 1.9-7.3). Additional sensitivity analysis shows similar figures. CONCLUSION: We demonstrate robust phenotypic familial aggregation in chronic chilblains.

Exploring the impact of chronic obstructive pulmonary disease (COPD) on diabetes control in diabetes patients: a prospective observational study in general practice.

BACKGROUND: Little is known about the association between COPD and diabetes control parameters. AIMS: To explore the association between comorbid COPD and longitudinal glycaemic control (HbA1C) and systolic blood pressure (SBP) in a primary care cohort of diabetes patients. METHODS: This is a prospective cohort study of type 2 diabetes patients in the Netherlands. In a mixed model analysis, we tested differences in the 5-year longitudinal development of HbA1C and SBP according to COPD comorbidity (present/absent). We corrected for relevant covariates. In subgroup effect analyses, we tested whether potential differences between diabetes patients with/without COPD were modified by age, sex, socio-economic status (SES) and body mass index (BMI). RESULTS: We analysed 610 diabetes patients. A total of 63 patients (10.3%) had comorbid COPD. The presence of COPD was not significantly associated with the longitudinal development of HbA1C (P=0.54) or SBP (P=0.33), but subgroup effect analyses showed significant effect modification by SES (P<0.01) and BMI (P=0.03) on SBP. Diabetes patients without COPD had a flat SBP trend over time, with higher values in patients with a high BMI. For diabetes patients with COPD, SBP gradually increased over time in the middle- and high-SES groups, and it decreased over time in those in the low-SES group. CONCLUSIONS: The longitudinal development of HbA1C was not significantly associated with comorbid COPD in diabetes patients. The course of SBP in diabetes patients with COPD is significantly associated with SES (not BMI) in contrast to those without COPD. Comorbid COPD was associated with longitudinal diabetes control parameters, but it has complex interactions with other patient characteristics. Further research is needed.

Encounters for common illnesses in general practice increased in obese patients.

BACKGROUND: Obese patients are known to have more chronic medical conditions. OBJECTIVE: To compare the frequency of encounter for episodes of the 10 most common illnesses in general practice between obese and non-overweight patients. METHODS: Data were derived from the Continuous Morbidity Registration, containing data from four general practices in and around Nijmegen (The Netherlands). In this research and registration network, a matched cohort study was performed. Each obese patient (body mass index > or = 30 kg/m(2)), aged 20-75 years, was matched for age, gender, socio-economic status and general practice, to approximately two patients without the diagnosis 'overweight' or 'obesity'. Over a period of 5 years (January 1, 2000 to December 31, 2004), the frequency of encounter for episodes of the 10 most common illnesses was compared, taking chronic medical conditions into account. RESULTS: At the start, 550 patients with obesity could be identified and were matched to 954 controls. Obese patients presented more common illnesses than non-overweight patients (incidence rate ratio 1.28, 95% confidence interval 1.12-1.47), in particular common cold (without fever), myalgia of the upper girdle, dermatophytosis and bruise (contusion, haematoma). CONCLUSION: Obese patients present more common illnesses to their GP, such as common cold (without fever), myalgia of the upper girdle, dermatophytosis and bruise (contusion, haematoma). This is in addition to their higher co-morbidity of chronic medical conditions.

Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940).

BACKGROUND: Paratonia, a form of hypertonia, is associated with loss of mobility and with the development of contractures especially in the late stages of the dementia. Passive movement therapy (PMT) currently is the main physiotherapeutic intervention. General doubt about the beneficial effects of this widely used therapy necessitates a randomised clinical trial (RCT) to study the efficacy of PMT on the severity of paratonia and on the improvement of daily care. METHODS/DESIGN: A RCT with a 4-week follow-up period. Patients with dementia (according to the DSM-IV-TR Criteria) and moderate to severe paratonia are included in the study after proxy consent. By means of computerised and concealed block randomisation (block-size of 4) patients are included in one of two groups. The first group receives PMT, the second group receives usual care without PMT. PMT is given according to a protocol by physical therapist three times a week for four weeks in a row. The severity of paratonia (Modified Ashworth scale), the severity of the dementia (Global Deterioration Scale), the clinical improvement (Clinical Global Impressions), the difficulty in daily care (Patient Specific Complaints) and the experienced pain in daily care of the participant (PACSLAC-D) is assessed by assessors blind to treatment allocation at baseline, after 6 and 12 treatments. Success of the intervention is defined as a significant increase of decline on the modified Ashworth scale. The 'proportion of change' in two and four weeks time on this scale will be analysed. Also a multiple logistic regression analysis using declined/not declined criteria as dependent variable with correction for relevant confounders (e.g. stage of dementia, medication, co-morbidity) will be used. DISCUSSION: This study is the first RCT of this size to gain further insight on the effect of passive movement therapy on the severity of paratonia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN43069940.