2022 · Biomedicine & Pharmacotherapy
Randomized trial of topical ascorbic acid in DMSO versus imiquimod for the treatment of basal cell carcinoma
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 Allopathic Medicine.
2·Paradigm · 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 a skin solution of vitamin C in a solvent cleared basal cell skin cancer in about 87% of lesions, beating the standard cream imiquimod, with fewer side effects. The tests split.
Independently Verifiable
Fail
The headline result is a pathologist's call on stained skin slivers, where the cancer model decides which stained cells count as carcinoma and which count as gone.
Falsifiable
Pass
Had fewer vitamin C lesions cleared than cream lesions in this randomized head-to-head, superiority would have died, and nothing in the design explains that away.
Non-Circular
Pass
The yardstick for entering the trial and for clearing it came from pathology practice, not from the vitamin C claim, so the treatment did not build its own proof.
Why
Twenty-five patients with 29 skin lesions were randomly given either a vitamin C and solvent solution or imiquimod cream. Before treatment, a lab examined stained slivers of each lesion, and the cancer model told the pathologist those cells were carcinoma. After 8 weeks they sliced out more tissue and the pathologist judged whether any of those cells remained. Counts were compared: 13 of 15 versus 8 of 14. The random split and the head-to-head count could have gone against vitamin C, and that part is honest. But the outcome that matters is the pathologist's reading of stained tissue, not a lesion anyone could see gone. Lighter skin and side effects are visible, but they are secondary.
2·Paradigm · Allopathic Medicine
Does the framework this study assumes pass the three tests?
UNSCIENTIFIC
Independently Verifiable
Fail
Cancer here means stained cells that a pathologist reads as malignant, so the thing being cured exists only as the field's reading of a slide.
Falsifiable
Fail
When a treatment fails to clear a lesion, the field calls it resistance, a poor responder, or a different tumor type, and the cancer model itself is never put at risk.
Non-Circular
Fail
Pathologists defined what counts as carcinoma, and the same pathologists' reading of the next slice decides whether the drug worked, so the field's own category grades its treatments.
Why
The framework behind this trial is that disease is a local defect, here a clump of cells under a microscope, and treatment means making that reading go away. The only thing anyone can see without the pathologist is a skin lesion, and the trial's headline endpoint is not that. Failed treatments are explained as resistance or patient variation, so the framework never has to be wrong. It also never asks what in the patient's body let the growth appear. A tumor that disappears from the slide is counted as healing, whether or not the patient's condition changed. A trial can be run cleanly inside that framework without testing the framework.
From the study
Twenty-five patients with 29 biopsy confirmed basal cell carcinomas were randomly assigned to receive either the topically applied ascorbic acid treatment twice daily for 8 weeks or topical imiquimod, a standard and well characterized topical treatment.
After 8 weeks, post-treatment biopsy of lesions showed complete resolution of 13/15 (86.7%) in the ascorbic acid group, while 8/14 (57.1%) lesions in the IMQ group were resolved (p < 0.05 Chi Square).
70% of patients in the imiquinod group showed residual hypopigmentation at 30mo follow up versus 0% in the ascorbate group.