Photopheresis at onset of type 1 diabetes: a randomised, double blind, placebo controlled trial. Issue 2 (1st August 2001)

• Record Type: Journal Article
• Authors: Ludvigsson, J; Samuelsson, U; Ernerudh, J; Johansson, C; Stenhammar, L; Berlin, G
• Is Part Of: Archives of disease in childhood. Volume 85:Issue 2(2001)
• Page Start: 149
• Page End: 154
• Publication Date: 2001-08-01
• Subjects: photopheresis -- diabetes -- photochemotherapy -- placebo; Children -- Diseases -- Periodicals; Infants -- Diseases -- Periodicals; 618.920005
• DOI: 10.1136/adc.85.2.149
• Languages: English
• ISSNs: 0003-9888

Abstract

Abstract : BACKGROUND: In recent years photopheresis, an extracorporeal form of photochemotherapy using psoralen and ultraviolet A irradiation of leucocytes, has been claimed to be an effective form of immunomodulation. AIM: To evaluate its effect in type 1 diabetes we performed a double blind, controlled study using placebo tablets and sham pheresis in the control group. METHODS: A total of 49 children, aged 10–18 years of age at diagnosis of type 1 diabetes were included; 40 fulfilled the study and were followed for three years (19 received active treatment with photopheresis and 21 placebo treatment). RESULTS: The actively treated children secreted significantly more C peptide in urine during follow up than control children. C peptide values in serum showed corresponding differences between the two groups. The insulin dose/kg body weight needed to achieve satisfactory HbA1c values was always lower in the photopheresis group; there was no difference between the groups regarding HbA1c values during follow up. The treatment was well accepted except for nausea (n = 3) and urticaria (n = 1) in the actively treated group. There were no differences regarding weight or height, or episodes of infection between the two groups during follow up. CONCLUSION: Photopheresis does have an effect in addition to its possible placebo effect, shown as a weak but significant effect on the disease process at the onset of type 1 diabetes, an effect still noted after three years of follow up.