Table 4 Adverse events by treatment group

From: The effect of the dietary supplement, Chitosan, on body weight: a randomised controlled trial in 250 overweight and obese adults

Adverse event Chitosan N a Placebo N a Relative rate 95% Confidence interval P-value
Serious events 4 6 0.67 0.19, 2.36 0.53
Nonserious eventsb 109 108 1.01 0.77, 1.32 0.95
Gastrointestinal events—noninfectious      
Abdominal pain 6 4 1.50 0.42, 5.32 0.53
Bloating 10 3 3.33 0.92, 12.11 0.07
Constipation 17 8 2.13 0.92, 4.92 0.08
Indigestion 3 2 1.50 0.25, 8.98 0.66
Diarrhoea (presumed noninfectious) 3 3 1.00 0.20, 4.95 1.00
Other digestive disorder 7 2 3.50 0.73, 16.85 0.12
Total 36 19 1.89 1.09, 3.30 0.02
Gastrointestinal—infectious      
Diarrhoea (presumed infectious) 9 9 1.00 0.40, 2.52 1.00
Nausea/vomiting 12 10 1.2 0.52, 2.78 0.67
Total 17 18 0.94 0.49, 1.83 0.87
Other nonserious events 105 100 1.05 0.80, 1.38 0.73
  1. aDenotes number of people who experienced one or more adverse events.
  2. bAnalyses compared the number of people who experienced one or more adverse events. Participants may have reported more than one event and a total of 420 nonserious adverse events were reported in the chitosan group and 309 in the placebo group (P<0.01).