Article type
Year
Abstract
Background: Bullous pemphigoid (BP) is the commonest autoimmune blistering disease of the skin. It is a self limiting but debilitating disease and is often treated with highly toxic medication. We conducted a systematic review to identify and critically evaluate all existing evidence from randomized controlled trials for the effectiveness of therapeutic interventions for the treatment of bullous pemphigoid (BP).
Review methods: Search strategy: Randomized controlled trials were identified from MEDLINE and EMBASE, from their inception to September 1999 and from the Cochrane controlled trial register (CCTR). Bibliographies from identified studies were searched. We also wrote to authors who have conducted clinical trials in the field to identify unpublished trials. Inclusion criteria: All randomized controlled trials (RCT) of therapeutic interventions that include patients with BP confirmed by immunoflourescence studies. All age groups were included. Each study was individually critically appraised using a checklist to assess methodological quality (such as concealment allocation, blinded outcome assessment and inclusion of all randomized patients in the analysis). Data extraction: data was extracted from all included studies using a pre-defined protocol to include the following information: age of patients, types of intervention, disease regression and relapse on stopping treatment, disease complications, drug dosages and adverse effects.
Results: Six small RCT's fulfilled the inclusion criteria with a total of only 293 patients. Two trials one comparing prednisolone 0.75 with 1.25 mg/kg and another of methyl prednisolone versus prednisolone did not find any statistical difference in the groups compared for effectiveness. Two trials, one of prednisolone versus prednisolone and azathioprine and another of prednisolone versus prednisolone and plasma exchange suggested that the combination maybe better that prednisolone alone. Yet another with three treatment groups, prednisolone alone, prednisolone and azathioprine, prednisolone and plasma exchange found no difference between combination treatment and prednisolone alone. The sixth trial compared prednisolone with tetracycline and nicotinamide suggested that there was no statistically significant difference in response parameters in the two groups but the prednisolone group had more serious adverse effects.
Conclusions: The studies in this review are all very small; and highlight the need for bigger RCT's. In view of the seriousness of adverse effects of systemic treatments used in BP, a comparison of topical treatment for localized disease and in combination with antibiotics or lower doses of prednisolone (or other immunosuppressive drugs) for extensive disease might prove useful. From these RCT's there in no evidence that higher starting doses of prednisolone are more effective than 0,75 mg/kg/day.
Review methods: Search strategy: Randomized controlled trials were identified from MEDLINE and EMBASE, from their inception to September 1999 and from the Cochrane controlled trial register (CCTR). Bibliographies from identified studies were searched. We also wrote to authors who have conducted clinical trials in the field to identify unpublished trials. Inclusion criteria: All randomized controlled trials (RCT) of therapeutic interventions that include patients with BP confirmed by immunoflourescence studies. All age groups were included. Each study was individually critically appraised using a checklist to assess methodological quality (such as concealment allocation, blinded outcome assessment and inclusion of all randomized patients in the analysis). Data extraction: data was extracted from all included studies using a pre-defined protocol to include the following information: age of patients, types of intervention, disease regression and relapse on stopping treatment, disease complications, drug dosages and adverse effects.
Results: Six small RCT's fulfilled the inclusion criteria with a total of only 293 patients. Two trials one comparing prednisolone 0.75 with 1.25 mg/kg and another of methyl prednisolone versus prednisolone did not find any statistical difference in the groups compared for effectiveness. Two trials, one of prednisolone versus prednisolone and azathioprine and another of prednisolone versus prednisolone and plasma exchange suggested that the combination maybe better that prednisolone alone. Yet another with three treatment groups, prednisolone alone, prednisolone and azathioprine, prednisolone and plasma exchange found no difference between combination treatment and prednisolone alone. The sixth trial compared prednisolone with tetracycline and nicotinamide suggested that there was no statistically significant difference in response parameters in the two groups but the prednisolone group had more serious adverse effects.
Conclusions: The studies in this review are all very small; and highlight the need for bigger RCT's. In view of the seriousness of adverse effects of systemic treatments used in BP, a comparison of topical treatment for localized disease and in combination with antibiotics or lower doses of prednisolone (or other immunosuppressive drugs) for extensive disease might prove useful. From these RCT's there in no evidence that higher starting doses of prednisolone are more effective than 0,75 mg/kg/day.