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It is accepted that a washout period would be ideal but this would have extended the study inordinately. Also, it was considered that by omitting the last three days of each week of consumption of a food, the carry-over effect was minimized. This meant that during the assessment period no new food had been consumed within 96 hr. During a food challenge week the patient was asked to eat the particular food freely throughout the week.
Throughout this period diary cards were kept and completed on a daily basis and if problems arose or inane food challenge caused a reaction the patients contacted the research nurse who instructed them to stop and return the elimination diet until the next challenge was due.
After the full 14 weeks of dietary manipulation, the patients were assessed by a clinician and a research nurse, the diary cards were examined and compliance discussed. The end of this period represented the end of the study and a global assessment was made as to whether these were associated with non-compliance.
ANALYSIS
The global scores for all symptoms were analyzed using an analysis of variance with assessment of residuals in order to determine the validity of assumptions. To analyze the effect of individual food challenges, the symptom scores of the last three days of the initial two-week elimination period were summed to provide to provide a baseline for the subsequent challenges. A similar total was taken for each of the food challenge weeks (three positive, three negatives foods).
The scores for the last three days of each week were summed separately for each symptom and compared with the same three days in each elimination week. The individual symptom scores were analyzed using the Student t test.
Results -Clinical Results-
The clinical scores were analyzed for the initial two week period, the six individual food challenges and the final six week exclusion period.
The clinical symptoms following food challenge were analyzed by dividing the data into two classes: ‘negative’ foods where the F.I.Test score was 1%-9% and ‘positive’ foods where the change was greater than 13%. As a result of analyzing symptom scores of 120 separate double-blind food challenges using an analysis of variance, 43 out of 60 positive foods on the Food Intolerance Test produced symptoms whereas 11 out of 60 negative foods produced symptoms, which is statistically significant (p<=0.5).
The symptom scores were significantly higher in the positive food group (p=0.02) and this group also needed more drugs than those weeks where they were eating foods which were negative on the F.I.T (p=0.01).
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A wide range of drugs were used for these patients but it was not considered necessary to make a long list of the different of treatment that they received, but included were fibre products, - anticholinergic, anti-inflammatory and anti-spasmodic agents plus, in many instances, nystatin. It is also interesting to note that most patients were able to continue their challenge for a full week. In those patients (n=5) who stopped their challenges before the end of the full week (nine food challenges), the majority (eight out of nine) were positive on the Food Intolerance Test. Thus F.I.Test classed as positive or negative and, omitting borderline values (9%-13%), was associated with an appropriate symptom score during blind challenge in 72% of positive foods and 81% of negative foods. The 9%-13% has been considered borderline based empirical on results from Food Intolerance Test accumulated so far.
This again was a comparison between the healthy volunteers from the Miami football club and those attending Dr. Sandberg’s clinic. Considering individual symptoms as shown in Table 2, there is a significant increase in symptom score following relevant challenges for all symptoms (p<0.05). There was one exception Backache, which was not improved but also confined to three patients so it was considered insufficient to record. All these sums were aggregated from the last three days of challenge versus the last three days of elimination. Means are not recorded because like most diary card keeping, the results skewed. At the end of the further six week elimination period, ten out of the 20 (50%) patients had maintained improvement and were still symptom free. Though we have no statistical evidence of this we consider the most likely cause of failure in 50% of the patients was due to lack of compliance. The diary cards in several indicated this.
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