Ethics

[jmdme]

Hello Everyone.

Just to be sure.

Is it unethical to offer placebo, or any deviation in protocol during a clinical trial? Specifically phase I.

Thanks

-John

[RandyW]

St. George's Hospital Medical School On Placebo use

If we wish to conduct a double blind trial to compare a new treatment with no treatment we need to give the control group a dummy pill or placebo. This makes the two treatments indistinguishable and prevents psychological effects whereby a patient's condition may improve simply due to the knowledge that he is receiving a particular treatment. This psychological response to treatment is known as the placebo effect. Placebo tablets should be identical in appearance and taste to the active treatment, but be pharmacologically inactive. The use of placebos enables us to assess any benefit or side effects of the new treatment. The placebo effect can be very strong. For example in a trial of analgesics three active drugs were compared with a placebo, but in addition each drug was manufactured in four colours. It turned out that overall, the active treatments did better than the placebos but strangely, red placebos were as effective as the active drugs (Huskisson 1974).

Placebos can be used in non-drug trials but their use may not be ethical. For example in a vaccination trial a saline injection could be used but may not be ethically acceptable. Sometimes we may wish to compare two drugs which cannot be made to look alike. In this case to maintain blindness we can use a double dummy - i.e. we give each patient two drugs, the allocated active one and a placebo resembling the alternative one. An example would be if we were to compare a tablet with a cream. Then each patient would get either an active tablet plus a placebo cream or a placebo tablet plus active cream.

I believe personally you should be informed if either doubl blind or placebi is administered to you.Hope this helps some.