1965 · BMJ
Corn Oil in Treatment of Ischaemic Heart Disease
Verdict
UNSCIENTIFIC
The study only partly follows the scientific method inside its paradigm, and the paradigm itself does not pass. The worse layer decides. The verdict is unscientific.
1·Study methodology · inside the paradigm
MIXED
Partly follows the scientific method within Diet-Heart Hypothesis / Allopathic Medicine.
2·Paradigm · Diet-Heart Hypothesis / Allopathic Medicine
UNSCIENTIFIC
Fails the tests. The worse layer decides.
How the verdict is decided
The verdict grades both layers: the paradigm this study assumes, and how the study was carried out inside it. Both must be scientific for the whole thing to be scientific. A clean method inside an unscientific paradigm is unscientific. An unscientific method inside a better paradigm is unscientific. A split on either layer is mixed. The worse layer decides.
1·Study methodology
Did this study test its claim with methods that are independent, falsifiable, and non-circular?
MIXED
This study claims that feeding heart patients 80 grams of corn oil a day lowered their blood cholesterol but left them with more cardiac events than untreated controls after two years. The tests split.
Independently Verifiable
Fail
Most events counted were chest-pain episodes the model converted into 'infarction' by reading tracings against code criteria and a 40-unit enzyme cutoff; only the sudden deaths were watchable on their own.
Falsifiable
Pass
A corn-oil group with fewer events would have appeared in the six-month tables and been reported as benefit, and nothing in this design could reclassify or filter it away.
Non-Circular
Pass
The oils were assigned by sealed random envelopes, the tracings were read without knowing the group, and no instrument in the trial was built from the conclusion about corn oil.
Why
Eighty heart patients were split by sealed envelope into corn oil, olive oil, or no oil, with the physicians told only a code number. Each oil patient was prescribed 80 grams a day. At monthly clinics blood was drawn and a chemical reaction produced a number the model calls serum cholesterol. Wires on the chest produced tracings, read blind against code criteria. An episode of central chest pain plus a tracing change or an enzyme level above 40 units was counted as an infarction, and that patient was withdrawn. After two years, 75 percent of controls were event-free against 52 percent on corn oil. Nobody saw cholesterol or an infarction. They saw a number fall and the patients fare worse anyway.
2·Paradigm · Diet-Heart Hypothesis / Allopathic Medicine
Does the framework this study assumes pass the three tests?
UNSCIENTIFIC
Independently Verifiable
Fail
Diet-heart's cause exists only as a number a chemical reaction produces, which the model names cholesterol and reads as artery-blocking fat; the visible part, people dying suddenly, was never in dispute.
Falsifiable
Fail
This trial delivered the killing result, cholesterol down about 30 points while the corn-oil patients fared worst, and the field kept the framework by calling the trial small, short, and started too late.
Non-Circular
Fail
The assay names the number cholesterol, the model calls that number the cause of heart disease, and treatment success is confirmed by the same number falling.
Why
The framework says fat in food raises a substance in the blood and that substance narrows the arteries behind heart disease. Every link is a readout. The substance is a number from a color reaction; the narrowed arteries are tracings and autopsy findings read through the model. This paper ran the framework's own test cleanly: swap the fat for corn oil and watch the number. It fell about 30 points, and the corn-oil patients still did worst of the three groups. That was the result that could have killed the framework, and the field declined it, calling the trial too small and too late in the disease. The framework keeps its blood number as both the disease's cause and the cure's measure, instead of asking what damaged these patients in the first place.
From the study
Thus the physicians in charge knew which patients were receiving oil, but they did not know until the end of the trial the kind of oil that they were receiving.
Non-fatal infarction, diagnosed on the basis of a suggestive history, together with either S.G.O.T. level exceeding 40 units/ml. or electrocardiographic (E.C.G.) evidence of new Q wave or typical ST elevation.
The depressions seen in the corn-oil group are highly significant, except in the final period.
At two years the proportion of patients remaining free of major cardiac events is greater for the control group (75%) than for the two oil groups (olive oil 57%, corn oil 52%).