Nicotinamide

StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Pozzilli et al, 199653211 children, young people and adults with newly diagnosed type 1 diabetes
Studies had mean ages ranging from 10.0 to 23 years
Nicotinamide
versus
control
  1. Adverse effects in the 291 patients treated with nicotinamide (additional patients from non-RCTs)
  1. Standardised difference at 6 months 0.08% approximate 95% CI –0.67 to 0.83
  2. n = 2 skin rashes, n = 2 recurrent hypoglycaemia, n = 2 liver serum aspartate aminotransferase and alanine aminotransferase levels slightly elevated
Unknown which trials used in the HbA1c calculation or the number of people
Unknown exclusion criteria or inclusion criteria
Meta-analysis of 10 RCTs
7 trials used in HbA1c calculation (systematic review does not specify which of the 10 RCTs were included in the meta-analysis)
Ia
Taboga et al, 19946021 recently diagnosed patients with type 1 diabetes
Ages: nicotinamide group 23.0 ± 5.9 years, control group 26.7 ± 5.5 years
Italy
Insulin and nicotinamide, 3 g/day for 1 year (n = 11)
versus
control – insulin alone (n = 10)
Trial length: 1 year, with follow-up: 1 year after end of trial
  1. Remission phase
  1. At 6 months: 4/11 vs. 4/10 in partial remission phase, 2/11 and 3/9 in total remission
    At 12 months: 3/11 vs. 3/9 in partial remission
    At 2 years: 1/11 and 1/9 in partial remission
  2. At 6 months: 5.7 ± 0.5% vs. 5.4 ± 0.9%
    At 12 months: 6.0 ± 0.6% vs. 5.8 ± 0.9%
    At 2 years: 6.6 ± 0.9% vs. 6.0 ± 0.4% No description of randomisation
1 drop-out due to pregnancy in control groupRCT
Included in meta-analysis
Ib
Vague, 19876116 patients with newly diagnosed type 1 diabetes
Aged 10–35 years
France
Nicotinamide 3 g/day and intensive insulin therapy (n=7)
versus
placebo and intensive insulin therapy (n = 9)
Trial length: if insulin was still required after 6 months nicotinamide was discontinued, follow-up at 1 year
  1. Remission phase (not requiring any insulin)
  1. At 6 months: 5/7 vs. 2/9
    At 1 year: 3/7 vs. 0/9
  2. At 6 months: 7.0 ± 0.5% SE vs. 7.7 ± 0.7% SE
    At 1 year: 6.4 ± 0.6 SE vs. 8.6 ± 0.5 % SE
Short letter onlyControlled study, unknown if randomisedIIa

From: Evidence tables

Cover of Type 1 Diabetes
Type 1 Diabetes: Diagnosis and Management of Type 1 Diabetes in Children and Young People.
NICE Clinical Guidelines, No. 15.2.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2004 Sep.
Copyright © 2004, National Collaborating Centre for Women’s and Children’s Health.

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