Table 3.
Cox proportional hazards and negative binomial regression analyses of cancer incidencea.
| Hazard ratiob (95% CI) | P value | Incidence rate ratioc (95% CI) | P value | |
|---|---|---|---|---|
| Colorectal Cancer | ||||
| Intention-to-treat analysis (N = 918, 105 events) | ||||
| Resistant Starch (RS) versus placebo | 0.92 (0.62–1.34) | 0.63 | 0.85 (0.58–1.25) | 0.41 |
| Per-Protocol Analysisd (N = 521, 71 events) | ||||
| ≥2 years' placebo | 1.0 | — | 1.0 | — |
| ≥2 years' Resistant Starch | 1.10 (0.69–1.76) | 0.69 | 0.96 (0.60–1.53) | 0.86 |
| Cumulative RS dosee (N = 918, 105 events) | ||||
| Units of 100 Resistant Starch | 1.00 (0.98–1.02) | 0.73 | 1.00 (0.98–1.02) | 0.91 |
| Non-colorectal LS cancers | ||||
| Intention-to-treat analysis (N = 918, 75 events) | ||||
| Resistant Starch versus placebo | 0.54 (0.33–0.86) | 0.010 | 0.52 (0.32–0.84) | 0.0075 |
| Per-Protocol Analysisd (N = 521, 44 events) | ||||
| ≥2 years' placebo | 1.0 | — | 1.0 | — |
| ≥2 years' Resistant Starch | 0.42 (0.22–0.81) | 0.0090 | 0.37 (0.19–0.73) | 0.0040 |
| Cumulative RS dosee (N = 918, 75 events) | ||||
| Units of 100 Resistant Starch | 0.96 (0.93–0.98) | 0.0025 | 0.95 (0.92–0.98) | 0.0018 |
| All LS cancers | ||||
| Intention-to-treat analysis (N = 918, 174 events) | ||||
| Resistant Starch versus placebo | 0.76 (0.56–1.02) | 0.066 | 0.69 (0.52–0.93) | 0.014 |
| Per-Protocol Analysisd (N = 521, 110 events) | ||||
| ≥2 years' placebo | 1.0 | — | 1.0 | — |
| ≥2 years' Resistant Starch | 0.80 (0.55–1.16) | 0.24 | 0.68 (0.47–0.99) | 0.044 |
| Cumulative RS dosee (N = 918, 174 events) | ||||
| Units of 100 Resistant Starch | 0.99 (0.97–1.00) | 0.082 | 0.98 (0.97–1.00) | 0.031 |
| All non-LS cancers f | ||||
| Intention-to-treat analysis (N = 918, 89 events) | ||||
| Resistant Starch versus placebo | 0.97 (0.64–1.47) | 0.88 | 0.88 (0.56–1.40) | 0.60 |
| Per-Protocol Analysisd (N = 521, 54 events) | ||||
| ≥2 years' placebo | 1.0 | — | 1.0 | — |
| ≥2 years' Resistant Starch | 0.96 (0.56–1.64) | 0.89 | 0.97 (0.54–1.73) | 0.92 |
| Cumulative RS dosee (N = 918, 89 events) | ||||
| Units of 100 Resistant Starch | 1.00 (0.97–1.02) | 0.69 | 1.00 (0.97–1.02) | 0.72 |
aAdjusted for age and gender in all participants up to 10 years and up to 20 years in England, Finland, and Wales, randomly assigned to Resistant Starch (RS) or placebo.
badjusted for age at consent and gender.
cIncidence rate ratio from negative binomial regression adjusted for age at consent and gender.
dThe threshold for 2 years’ intervention was consumption of more than 1,400 starch sachets; rounded from a 2-year total of 1,461 to allow for early scheduling of the exit colonoscopy or occasional missed dosage.
eUnits of 100 starch = total number of starch sachets taken divided by 100.
fFor details of non-LS cancers, see Supplementary Table S9.