Abstract
Background Type 1 diabetes mellitus (T1DM) causes the irreversible destruction of pancreatic beta cells. The Bacillus Calmette–Guerin (BCG) vaccine can modulate the immune response and decelerate disease progression. The aim of this study is to investigate the efficacy of the BCG vaccine for the treatment of T1DM. Objective Six databases were systematically searched from inception to the end of August 2019. The randomized controlled trials (RCTs) that evaluated glycemic control in response to the BCG vaccine for T1DM were enrolled. The primary outcome was glycated hemoglobin (HbA1c) level, and secondary outcomes included fasting and stimulated C-peptide level, daily insulin dosage, and clinical remission. The revised Cochrane risk of bias tool was used for quality assessment, and meta-analyses were conducted to evaluate the efficacy of the BCG vaccine. Results Four studies with a total of 198 subjects were included. The results of HbA1c and fasting C-peptide levels were extracted for further quantitative assessment. The pooled meta-analysis demonstrated no significant difference in HbA1c levels (mean difference [MD], −0.12; 95% confidence interval [CI], −0.53 to 0.30; I2 = 56%) or fasting C-peptide levels (MD, −0.15; 95% CI, −0.35 to 0.06; I2 = 0%) in the BCG intervention group as compared with that in the placebo group. Conclusions There is no robust evidence to support the use of the BCG vaccine for the treatment of T1DM although the HbA1c levels tended to improve. Additional RCTs to assess the long-term effects of the BCG vaccine on glycemic control are warranted.
Highlights
Type 1 diabetes mellitus (T1DM) involves the autoimmune destruction of pancreatic beta cells, which eventually leads to absolute insulin deficiency
The Embase, PubMed, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, Cumulative Index to Nursing and Allied Health, and PerioPath: Index to Taiwan Periodical Literature databases were systematically searched from the earliest date available to the end of August 2019 without any language or time restriction with the following medical subject headings combined by applying Boolean operators: “Bacillus Calmette– Guerin (BCG) vaccine,” “Bacillus Calmette Guerin,” “type 1 diabetes mellitus,” “insulin-dependent diabetes mellitus,” “glycated hemoglobin,” and “blood sugar.”
The results showed that participant age (p = 0:49), disease duration (p = 0:43), and BCG dosage (p = 0:38) had no effect on the efficacy of the BCG vaccine on T1DM
Summary
Type 1 diabetes mellitus (T1DM) involves the autoimmune destruction of pancreatic beta cells, which eventually leads to absolute insulin deficiency. Cardiovascular disease results in 8–13-year shorter life expectancy for T1DM patients than for healthy subjects [1]. Type 1 diabetes mellitus (T1DM) causes the irreversible destruction of pancreatic beta cells. The aim of this study is to investigate the efficacy of the BCG vaccine for the treatment of T1DM. The randomized controlled trials (RCTs) that evaluated glycemic control in response to the BCG vaccine for T1DM were enrolled. The revised Cochrane risk of bias tool was used for quality assessment, and meta-analyses were conducted to evaluate the efficacy of the BCG vaccine. The results of HbA1c and fasting C-peptide levels were extracted for further quantitative assessment. There is no robust evidence to support the use of the BCG vaccine for the treatment of T1DM the HbA1c levels tended to improve. Additional RCTs to assess the long-term effects of the BCG vaccine on glycemic control are warranted
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