OBJECTIVE: A variety of immune therapies have been used in an attempt to reduce the immune destruction of the insulin secreting beta cells which results in insulin dependent diabetes mellitus (IDDM). This study investigated the use of intravenous gammaglobulin therapy (IVIG) in children and adults with IDDM who participated in a two-year randomised controlled trial which also examined the effect of transfer factor in altering the natural course of IDDM. METHODS: Treatment was administered every two months for the duration of the study. IVIG was given in a dose of 2 g/ kg body weight in divided doses over two days. The other two groups received an intramuscular injection-the control group received normal saline and the transfer factor group received 1 i.u. of transfer factor. Remission rates, beta cell function and treatment side effects were assessed. RESULTS: Compared with the control group, IVIG therapy given every 2 months for 2 years, did not result in an increased number of complete remissions or differences in insulin dose, diabetes control or endogenous insulin secretion assessed as fasting and stimulated C-peptide responses to glucagon and a meal. IVIG therapy was associated with significant side effects. CONCLUSION: It is unlikely that IVIG therapy will be a viable option for immunotherapy in IDDM.
RCT Entities:
OBJECTIVE: A variety of immune therapies have been used in an attempt to reduce the immune destruction of the insulin secreting beta cells which results in insulin dependent diabetes mellitus (IDDM). This study investigated the use of intravenous gammaglobulin therapy (IVIG) in children and adults with IDDM who participated in a two-year randomised controlled trial which also examined the effect of transfer factor in altering the natural course of IDDM. METHODS: Treatment was administered every two months for the duration of the study. IVIG was given in a dose of 2 g/ kg body weight in divided doses over two days. The other two groups received an intramuscular injection-the control group received normal saline and the transfer factor group received 1 i.u. of transfer factor. Remission rates, beta cell function and treatment side effects were assessed. RESULTS: Compared with the control group, IVIG therapy given every 2 months for 2 years, did not result in an increased number of complete remissions or differences in insulin dose, diabetes control or endogenous insulin secretion assessed as fasting and stimulated C-peptide responses to glucagon and a meal. IVIG therapy was associated with significant side effects. CONCLUSION: It is unlikely that IVIG therapy will be a viable option for immunotherapy in IDDM.
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