Photopheresis at onset of type 1 diabetes: a randomised, double blind, placebo controlled trial.
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.


OBJECTIVE
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.


CONCLUSIONS
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.
Ludvigsson
J
J
Division of Pediatrics, Department of Health and Environment, Linköping University, S-581 85 Linköping, Sweden. Johnny.Ludvigsson@lio.se
Samuelsson
U
U
Ernerudh
J
J
Johansson
C
C
Stenhammar
L
L
Berlin
G
G
D000293:Adolescent; D019540:Area Under Curve; D002096:C-Peptide / Q000652:urine; D002648:Child; D003131:Combined Modality Therapy; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy / Q000378:metabolism / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007328:Insulin / Q000008:administration & dosage; D007515:Islets of Langerhans / Q000528:radiation effects; D008297:Male; D017893:Photopheresis / Q000379:methods*; D018709:Statistics, Nonparametric
D002096:C-Peptide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin