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[Placebo use in clinical studies]
Udi Nussinovitch1, Leonid Eidelman, Yehuda Shoenfeld
1Department of Medicine B, Chaim Sheba Medical Center, Tel-Hashomer, Israel.
Placebo use in clinical trials is debated due to ethical concerns and potential side effects. This review examines the evidence for placebo benefits and current guidelines for their use in research.
Area of Science:
- Clinical Research Ethics
- Evidence-Based Medicine
- Pharmacology
Context:
- Placebo use in clinical settings dates back to the 1930s.
- Placebo-controlled trials are crucial for evaluating new treatment efficacy.
- Ethical considerations surrounding placebo administration remain a significant debate.
Purpose:
- To explore the ethical dilemmas associated with placebo use in clinical research.
- To review the evidence supporting or refuting placebo efficacy and side effects.
- To discuss current guidelines for conducting placebo-controlled trials.
Summary:
- Placebo use is ethically complex, particularly regarding 'significant discomfort'.
- Evidence suggests placebos can be effective in some contexts but may also cause side effects.
- The discussion encompasses ethical challenges, empirical evidence, and regulatory guidelines for placebo-controlled trials.
Impact:
- Informs ethical decision-making in clinical trial design.
- Contributes to a nuanced understanding of placebo effects in medical research.
- Provides a basis for updating guidelines on responsible placebo use.
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