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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: 1 year ago.
Category: Legal
Expert:  DocPhilMD replied 12 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 12 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 12 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