Results so far:
| Yes | 42% | 20 votes | Total: 48 votes | |
| No | 58% | 28 votes |
Botox injections have been approved by the Food and Drug Administration (FDA) for the treatment of back pain. In order to be approved by the FDA there must have been a study conducted on 1,000 to 3000 people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely. To date, it is only know to be effective for 3-6 months.
FDA approval of a drug requires three phases of clinical trials:
Phase I - the drugs is tested on a small group of people to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II - the drug is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III is discussed above.
After a drug is approved, a fourth phase of studies may be conducted to provide additional information on the drug's benefits, and optimal use.
Phase IV studies are still recruiting subjects.
http://clin icaltrials.gov
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