Registration Dossier

Administrative data

Endpoint:
epidemiological data
Type of information:
experimental study
Adequacy of study:
supporting study

Data source

Reference
Reference Type:
publication
Title:
Statistical analyses on the pattern of food consumption and digestive-tract cancers in Japan
Author:
Hara N, Sakata K, Nagai M, Fujita Y, Hashimoto T and Yanagawa H
Year:
1985
Bibliographic source:
Nutrition and Cancer, Vol 6, pp 220-228

Materials and methods

Study type:
cross sectional study
Endpoint addressed:
carcinogenicity
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Cancer mortality data for 6 digestive-tract cancers were acquired for males from different Japanese regions for a 10 year period starting in 1969. Data on food consumption were obtained from the Fourth National Survey of Family Income and Expenditures (1974) and 26 food items, including vinegar (acetic acid) were chosen to include those commonly eaten and those suspected to have an association with cancer. Various statistical analyses were conducted to correlate the standardised mortality ratio with different sites of cancer and food variables in the different regions.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Vinegar
IUPAC Name:
Vinegar
Details on test material:
- Name of test material (as cited in study report): Vinegar
- Other: no other details reported

Method

Type of population:
general
Ethical approval:
not applicable
Details on study design:

METHOD OF DATA COLLECTION
- Type: Record review
- Details: Cancer mortality data for 6 digestive-tract cancers were aquired from standardised cancer mortality ratios on a prefectural basis.

STUDY PERIOD: 10 year period starting in 1969.

SETTING: Japan

STUDY POPULATION
- Males in general population in 46 Japaense prefectures.

HEALTH EFFECTS STUDIED
- Disease(s): Six digestive-tract cancers - oesophagus, stomach, colon, rectum, biliary passages and pancreas.

Exposure assessment:
estimated
Statistical methods:
Correlations between the SMR for the 6 different cancer sites and 26 food variables were calculated and also correlations were calculated between the cancer SMR in different prefectures for the six cancer sites. Factor analysis of the 26 food variables was performed to reduce the number of variables and correlations were calculated between the factors derived from the factor analysis and the cancer SMR.

Results and discussion

Results:
Vinegar showed a negative correlation with the SMR for all digestive-tract cancers examined (oesophageal, stomach, colon, rectal, biliary passsages and pancreatic cancers).
Confounding factors:
No adjustment was made for confounding factors
Strengths and weaknesses:
Strengths: Hypothesis generation
Weaknesses: The study only correlated SMR and food consumption values for prefectures. No adjustments were made for potential confounding factors or other food items consumed. No information was supplied about the number of people surveyed in each prefecture to obtain information about the consumption of the 26 food items, and levels of consumption during the middle of the study period (1974) may not have reflected more relevant exposures several years previously. Vinegar consumption only accounts for about a tenth of acetic acid intake and hence results cannot be extrapolated to acetic acid consumption.

Applicant's summary and conclusion

Conclusions:
Consumption of vinegar in Japan was negatively associated with standardised mortality ratios for all cancers of the gastro-intestinal tract, including bile ducts and pancreas.
Executive summary:

In an epidemiological study comparing of local food consumption patterns in Japan with geographical distributions of gastro-intestinal cancers, vinegar consumption was shown to be negatively associated with standardised mortality ratios for all cancers of the gastro-intestinal tract, including bile ducts and pancreas.