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DocPhilMD
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Are there FDA approved scales to assess hemorrhoid bleeding

Customer Question

Are there FDA approved scales to assess hemorrhoid bleeding severity?
Submitted: 9 months ago.
Category: FDA
Expert:  DocPhilMD replied 9 months ago.

The FDA doesn't really have jurisdiction over this

however, there are scales that are accepted by the medical community

why do you want to know?

Customer: replied 9 months ago.

Dr. Phil,

I would like to explore the possibility of using hemorrhoidal bleeding as an endpoint in a clinical study. Although, the FDA may not have jurisdiction over a scale to use, if they are not in agreement, I will be wasting my time and effort.

I do like your response by asking a question; "why do you want to know?" That, however, is not helpful, because there must be a scale which may be acceptable to the FDA, unless hemorrhoidal bleeding may not be acceptable as a clinical end-point to measure the severity of the disease. Is this the case?

Kindest regards,

avi

Expert:  DocPhilMD replied 9 months ago.

Are you familiar with the grading scale of hemorrhoids?

That is the only accepted scale as of right now.

Grade 1 (hemorrhoids with bleeding) can be sub categorized into mild, moderate, severe bleeding

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