Interventions for bullous pemphigoid: An updated systematic review of randomized clinical trials

Abstract

Background: Bullous pemphigoid (BP) is a widely recognized autoimmune blistering disease (AIBD) linked with a high incidence of morbidity and mortality. The aim of this study was to evaluate the available findings of randomized clinical trial studies to update interventions for Bullous pemphigoid. Methods: This article provides an updated overview of interventions for BP. A literature search was performed using Cochrane Central Register of Clinical Trials, MEDLINE, Scopus, and Web of Science from August 2010 to December 2020. All randomized clinical trials (RCTs) were done on adults and investigated the effectiveness of administered topical or systemic medications versus placebos or controls included in the current systematic review. Three RCTs comprising 363 patients were included in the systematic review. One of the eligible studies was placebo-controlled. All of the included studies used various interventions including, methylprednisolone plus azathioprine versus methylprednisolone plus dapsone, doxycycline versus prednisolone, and intravenous immunoglobulin (IVIG). Results: Following their potentials in disease control, no difference was observed between dapsone and azathioprine; although, dapsone had a higher corticosteroid-sparing potential. The evaluation of the effect of doxycycline in short-term blister control in comparison to corticosteroids showed that the medication was not inferior to prednisolone, although it had a higher long-term safety. Conclusion: Therapeutic outcome of IVIG for steroid-resistant patients was satisfactory. Moreover, the effectiveness and reliability of various immunosuppressive drugs and tetracyclines are investigated by blinded RCTs for the treatment of BP.

Quality of systematic reviews on the treatment of vesiculobullous skin diseases. A meta-epidemiological study

“…Systematic reviews classified as critically low quality 22 , 23 , 26 , 29 , 30 presented a negative response in almost the same items. None of them reported a review protocol registration (item 2), an explanation of the primary study design selection (item 3), a list of excluded studies with reasons (item 7), and funding sources of each included RCT (item 10).…”

“…Thus, 15 studies were analyzed in full text, and six were excluded: one was the earliest version of an included systematic review 16 and five because they had not only RCTs. 17 , 18 , 19 , 20 , 21 Therefore, nine systematic reviews 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 were included ( Fig. 1 ).…”

“…Of the nine systematic reviews analyzed, 55.6% (5/7) 23 , 24 , 28 , 29 , 30 studied patients with bullous pemphigus (pemphigus foliaceus and/or vulgaris), 22.2% (2/9) 22 , 25 with bullous pemphigoid; 11.1% (1/9) 26 with epidermolysis bullosa and 11.1% (1/9) 27 with toxic epidermal necrolysis.…”

“…The methodological quality of the reviews was analyzed using the AMSTAR-2 tool. In the assessment, 55.6% (5/9) 22 , 23 , 26 , 29 , 30 of reviews were classified as critically low quality, 22.2% (2/9) 25 , 27 as moderate quality, 11.1% (1/9) 24 as low quality and 11.1% (1/9) 28 as high quality. Fig.…”

“…None of them reported a review protocol registration (item 2), an explanation of the primary study design selection (item 3), a list of excluded studies with reasons (item 7), and funding sources of each included RCT (item 10). Of these reviews, 40% (2/5) 22 , 23 did not present a comprehensive search strategy (item 4); 60% (3/5) 26 , 29 , 30 did not perform study selection and data extraction by two independent authors (items 5 and 6); and 40% (2/5) 22 , 30 did not use a satisfactory technique for assessing the Risk of Bias (RoB) in individual RCTs (item 9). The only study in this classification that performed meta-analysis 23 did not evaluate the impact of risk of bias of individual studies in the meta-analysis (item 12) and did not perform publication bias investigation (item 15).…”