Zie ook literatuurlijst specifiek bij darmkanker , waaronder preventiestudies van arts-bioloog drs. Engelbert Valstar
9 mei 2019: Medscape schreef ook een artikel over onderstaande publicatie. Zij schrijven dat aspirine gebruiken als preventie zijn tijd heeft gehad en niet is aan te raden.
Klik op de titel voor het artikel en lees ook ons artikel daaronder:
7 januari 2019: Bron: The Lancet
Aspirine heeft in enkele kleinere postpectieve studies wel bewezen darmkanker te kunnen voorkomen, al hoewel daar ook studies tegenover staan die dit niet aantonen. Ook Omega-3 vetzuren - EPA = eicosapentaenoic acid blijkt uit studies kanker te kunnen voorkomen. Beide producten met weinig bijwerkingen en risico al zijn de risico's bij aspirine wel groter dan bij EPA. (zie in gerelateerde artikelen).
Nu blijkt uit een grote gerandomiseerde placebo gecontroleerde studie bij 709 patienten totaal dat er geen enkele verschil zit in het ontwikkelen van darmpoliepen (adenomen), die vaak voorlopers zijn van adenocarcinomen / darmkanker tussen zowel aspirine en EPA alleen gegeven of ook samen in vergelijking met een placebo.
Uit vier groepen kwamen deze resultaten na vijf jaar bij totaal 709 deelnemers in de periode vanaf 11 November, 2011, en 10 juni 2016:
Adenomen (ADR) traden op bij:
- 61% (100 uit 163) in de placebo groep,
- 63% (97 uit 153) in de EPA groep,
- 61% (100 uit 163) in de aspirine groep,
- 61% (98 of 161) in de EPA plus aspirine groep,
met dus geen bewijs van enig effect voor EPA (risk ratio 0·98, 95% CI 0·87 to 1·12; risk difference -0·9%, -8·8 to 6·9; p=0·81) of aspirine (RR 0·99 (0·87 to 1·12; risk difference -0·6%, -8·5 to 7·2; p=0·88).
Zie onderstaande grafiek voor alle karakteristieken
Table 1Baseline characteristics
| Placebo (n=176) | EPA (n=178) | Aspirin (n=176) | EPA plus aspirin (n=177) | Total (n=707) | |||
|---|---|---|---|---|---|---|---|
| Age (years) | 65 (62–69) | 65 (62–69) | 65 (62–69) | 66 (62–69) | 65 (62–69) | ||
| Sex | |||||||
| Male | 139 (79%) | 138 (78%) | 140 (80%) | 146 (82%) | 563 (80%) | ||
| Female | 37 (21%) | 40 (22%) | 36 (20%) | 31 (18%) | 144 (20%) | ||
| Excess bodyweight | |||||||
| Overweight (BMI 25–29·9) | 76 (43%) | 77 (43%) | 81 (46%) | 77 (44%) | 311 (44%) | ||
| Obese (BMI ≥30) | 68 (39%) | 70 (39%) | 71 (40%) | 61 (34%) | 270 (38%) | ||
| History of diabetes | 24 (14%) | 24 (13%) | 18 (10%) | 15 (8%) | 81 (11%) | ||
| Cigarette smoking | |||||||
| Current smoker | 34 (19%) | 13 (7%) | 27 (15%) | 32 (18%) | 106 (15%) | ||
| Previous smoker | 82 (47%) | 96 (54%) | 89 (51%) | 80 (45%) | 347 (49%) | ||
| Never smoked | 60 (34%) | 69 (39%) | 60 (34%) | 65 (37%) | 254 (36%) | ||
| Regular medication | 81 (46%) | 93 (52%) | 88 (50%) | 92 (52%) | 354 (50%) | ||
| Medication before trial entry | |||||||
| Statin | 50 (28%) | 54 (30%) | 51 (29%) | 55 (31%) | 210 (30%) | ||
| Calcium | 1 (1%) | 3 (2%) | 3 (2%) | 0 | 7 (1%) | ||
| Calcium plus vitamin D | 2 (1%) | 1 (<1%) | 4 (2%) | 4 (2%) | 11 (2%) | ||
| Metformin | 14 (8%) | 12 (7%) | 11 (6%) | 9 (5%) | 46 (7%) | ||
| Glitazone | 1 (<1%) | 1 (<1%) | 1 (<1%) | 0 | 3 (<1%) | ||
| Proton-pump inhibitor | 19 (11%) | 27 (15%) | 24 (14%) | 20 (11%) | 90 (13%) | ||
| Aspirin | 0 | 0 | 0 | 1 (<1%) | 1 (<1%) | ||
| Fish oil | 1 (1%) | 4 (2%) | 2 (1%) | 2 (1%) | 9 (1%) | ||
| Non-aspirin NSAID | 1 (1%) | 4 (2%) | 1 (<1%) | 5 (3%) | 11 (2%) | ||
| Other | 34 (19%) | 34 (19%) | 37 (21%) | 48 (27%) | 153 (22%) | ||
| Colorectal adenoma characteristics | |||||||
| Total number of adenomas | 856 | 892 | 927 | 856 | 3531 | ||
| Number of adenomas per participant | 4·9 (2·6) | 5·0 (2·2) | 5·3 (2·7) | 4·8 (2·3) | 5·0 (2·5) | ||
| Number of advanced adenomas per participant | 1·2 (0·9) | 1·3 (1·0) | 1·2 (0·9) | 1·1 (0·9) | 1·2 (0·9) | ||
| ≥1 adenoma proximal to splenic flexure | 141 (80%) | 146 (82%) | 153 (87%) | 144 (81%) | 584 (83%) | ||
| Histological type | |||||||
| Conventional | 812/856 (95%) | 844/892 (95%) | 895/927 (97%) | 809/856 (95%) | 3360 (95%) | ||
| Tubular or tubulovillous | 807/856 (94%) | 834/892 (93%) | 885/927 (95%) | 803/856 (94%) | 3329 (94%) | ||
| Villous | 5/856 (1%) | 10/892 (1%) | 10/927 (1%) | 6/856 (<1%) | 31 (1%) | ||
| Serrated | 22/856 (3%) | 30/892 (3%) | 18/927 (2%) | 21/856 (2%) | 91 (3%) | ||
| Not sent to pathology | 18/856 (2%) | 16/892 (2%) | 13/927 (2%) | 21/856 (2%) | 68 (2%) | ||
| Missing data | 4/856 (<1%) | 2/892 (<1%) | 1/927 (<1%) | 5/856 (1%) | 12 (<1%) | ||
| Repeat screening endoscopy | |||||||
| No | 136 (77%) | 128 (72%) | 133 (76%) | 133 (75%) | 530 (75%) | ||
| Yes | 25 (14%) | 33 (19%) | 24 (14%) | 34 (19%) | 116 (16%) | ||
| Missing | 15 (9%) | 17 (10%) | 19 (11%) | 10 (6%) | 61 (9%) | ||
One participant in the EPA group and one in the aspirin group withdrew from the study immediately after providing consent and so their data are not reported here. Data are median (IQR), n (%), or mean (SD). BMI=body-mass index. EPA=eicosapentaenoic acid. NSAID=non-steroidal anti-inflammatory drug.
* As per WHO guidelines, BMI is measured as kg/m2.
† Not mutually exclusive, some participants reported more than one category.
‡ Diameter of at least 10 mm, high-grade dysplasia, or tubulovillous or villous histology.
§ Colorectal adenoma-level data.
Het volledige studierapport:
Hier het abstract van de studie plus referentielijst:
Neither EPA nor aspirin treatment were associated with a reduction in the proportion of patients with at least one colorectal adenoma. Further research is needed regarding the effect on colorectal adenoma number according to adenoma type and location. Optimal use of EPA and aspirin might need a precision medicine approach to adenoma recurrence.
Eicosapentaenoic acid and aspirin, alone and in combination, for the prevention of colorectal adenomas (seAFOod Polyp Prevention trial): a multicentre, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial
- et al.
Summary
Background
The omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) and aspirin both have proof of concept for colorectal cancer chemoprevention, aligned with an excellent safety profile. Therefore, we aimed to test the efficacy of EPA and aspirin, alone and in combination and compared with a placebo, in individuals with sporadic colorectal neoplasia detected at colonoscopy.
Methods
In a multicentre, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial, patients aged 55–73 years who were identified during colonoscopy as being at high risk in the English Bowel Cancer Screening Programme (BCSP; ≥3 adenomas if at least one was ≥10 mm in diameter or ≥5 adenomas if these were <10 mm in diameter) were recruited from 53 BCSP endoscopy units in England, UK. Patients were randomly allocated (1:1:1:1) using a secure web-based server to receive 2 g EPA-free fatty acid (FFA) per day (either as the FFA or triglyceride), 300 mg aspirin per day, both treatments in combination, or placebo for 12 months using random permuted blocks of randomly varying size, and stratified by BCSP site. Research staff and participants were masked to group assignment. The primary endpoint was the adenoma detection rate (ADR; the proportion of participants with any adenoma) at 1 year surveillance colonoscopy analysed in all participants with observable follow-up data using a so-called at-the-margins approach, adjusted for BCSP site and repeat endoscopy at baseline. The safety population included all participants who received at least one dose of study drug. The trial is registered with the International Standard Randomised Controlled Trials Number registry, number ISRCTN05926847.
Findings
Between Nov 11, 2011, and June 10, 2016, 709 participants were randomly assigned to four treatment groups (176 to placebo, 179 to EPA, 177 to aspirin, and 177 to EPA plus aspirin). Adenoma outcome data were available for 163 (93%) patients in the placebo group, 153 (85%) in the EPA group, 163 (92%) in the aspirin group, and 161 (91%) in the EPA plus aspirin group. The ADR was 61% (100 of 163) in the placebo group, 63% (97 of 153) in the EPA group, 61% (100 of 163) in the aspirin group, and 61% (98 of 161) in the EPA plus aspirin group, with no evidence of any effect for EPA (risk ratio 0·98, 95% CI 0·87 to 1·12; risk difference −0·9%, −8·8 to 6·9; p=0·81) or aspirin (RR 0·99 (0·87 to 1·12; risk difference −0·6%, −8·5 to 7·2; p=0·88). EPA and aspirin were well tolerated (78 [44%] of 176 had ≥1 adverse event in the placebo group compared with 82 [46%] in the EPA group, 68 [39%] in the aspirin group, and 76 [45%] in the EPA plus aspirin group), although the number of gastrointestinal adverse events was increased in the EPA alone group at 146 events (compared with 85 in the placebo group, 86 in the aspirin group, and 68 in the aspirin plus placebo group). Six upper-gastrointestinal bleeding events were reported across the treatment groups (two in the EPA group, three in the aspirin group, and one in the placebo group).
Interpretation
Neither EPA nor aspirin treatment were associated with a reduction in the proportion of patients with at least one colorectal adenoma. Further research is needed regarding the effect on colorectal adenoma number according to adenoma type and location. Optimal use of EPA and aspirin might need a precision medicine approach to adenoma recurrence.
Funding
Efficacy and Mechanism Evaluation Programme, a UK Medical Research Council and National Institute for Health Research partnership.
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Article Info
Publication History
Published: November 19, 2018
IDENTIFICATION
Copyright
© 2018 The Author(s). Published by Elsevier Ltd.
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