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Randomized controlled trial of adjuvant oral dexamethasone pulse therapy in pemphigus vulgaris: PEMPULS trial.
MedLine Citation:
PMID:  16702494     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To determine the therapeutic effect of adjuvant dexamethasone pulse therapy when given in addition to conventional treatment of pemphigus vulgaris. DESIGN: A randomized, placebo-controlled trial. SETTING: International European, multicenter outpatient and inpatient study. PATIENTS: Of the 20 enrolled patients, 11 were randomized to the dexamethasone pulse (DP) group and 9 to the placebo pulse (PP) group. INTERVENTIONS: Oral dexamethasone in 300-mg pulses or PPs 3 days per month. During the intervention, the DP and PP groups received conventional treatment with prednisolone, 80 mg/d, which was tapered across 19 weeks, and azathioprine sodium, 3 mg/kg per day, until the end of the study. Monthly pulses were continued until prednisolone treatment was tapered to 0 mg. MAIN OUTCOME MEASURES: Number of patients in remission, time to and duration of remission, cumulative prednisolone dose, and occurrence of adverse events during 1 year of follow-up. RESULTS: Eight of the 11 DP-treated patients and all 9 PP-treated patients achieved remission. Mean time to remission was 173 days with DP and 176 days with PP. The mean duration of remission within the first year was 151 days for DP and 141 days for PP. Mean cumulative prednisolone dose was 5300 mg for DP and 4882 mg for PP. Weight gain (>5% of baseline) occurred in 8 DP-treated patients compared with 1 PP-treated patient (P<.01). We found no statistically significant difference (P>.05) of an adjuvant effect of DP on remission of pemphigus vulgaris. CONCLUSION: In patients with new pemphigus vulgaris disease activity, there was no benefit of oral DP therapy given in addition to conventional treatment. TRIAL REGISTRATION: Identifier: NCT00127764.
Leon F Mentink; Maria W Mackenzie; Gábor G Tóth; Marianne Laseur; Frank P G Lambert; Nic J G M Veeger; Giuseppe Cianchini; Milos D Pavlovic; Marcel F Jonkman
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Archives of dermatology     Volume:  142     ISSN:  0003-987X     ISO Abbreviation:  Arch Dermatol     Publication Date:  2006 May 
Date Detail:
Created Date:  2006-05-16     Completed Date:  2006-05-26     Revised Date:  2009-07-01    
Medline Journal Info:
Nlm Unique ID:  0372433     Medline TA:  Arch Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  570-6     Citation Subset:  AIM; IM    
Center for Blistering Diseases, Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
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MeSH Terms
Administration, Oral
Anti-Inflammatory Agents / administration & dosage*
Azathioprine / administration & dosage
Chemotherapy, Adjuvant
Dexamethasone / administration & dosage*
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Middle Aged
Pemphigus / drug therapy*,  pathology
Prednisolone / administration & dosage
Pulse Therapy, Drug
Severity of Illness Index
Treatment Outcome
Reg. No./Substance:
0/Anti-Inflammatory Agents; 446-86-6/Azathioprine; 50-02-2/Dexamethasone; 50-24-8/Prednisolone
Erratum In:
Arch Dermatol. 2006 Aug;142(8):1014
Note: Dosage error in article text

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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