title: Risk-benefit analyses of drugs: fundamental considerations and requirements from the point of view of the biometrician. Problems in the assessment of the combination of trimethoprim with sulfamethoxazole.
abstract: Risk-benefit analyses are a prerequisite for a rational decision about therapies, e.g. drugs. Ingredients of a risk-benefit analysis are: 1. quality and quantity of the benefit; 2. quality and quantity of the harm; 3. benefit and harm of the natural history of the disease; 4. benefit and harm of therapeutic alternatives; 5. commensurability of harm and benefit; 6. consideration of all types of adverse drug reactions together. The available evidence was not suitable for a sound risk-benefit analysis of the use of trimethoprim-sulfamethoxazole. However, there seems to be enough evidence to restrict the use of trimethoprim-sulfamethoxazole in diseases with a benign prognosis and/or when there are therapeutic alternatives with a smaller risk/benefit ratio. Reliable rules for risk-benefit analyses have to be developed and the necessary information has to be gained also in methodologically sound phase IV research.
mesh_terms: D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects*; D001699:Biometry; D004338:Drug Combinations / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D012307:Risk Factors; D013420:Sulfamethoxazole / Q000009:adverse effects* / Q000627:therapeutic use; D014295:Trimethoprim / Q000009:adverse effects* / Q000627:therapeutic use; D015662:Trimethoprim, Sulfamethoxazole Drug Combination
chemical_list: D000890:Anti-Infective Agents; D004338:Drug Combinations; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; D014295:Trimethoprim; D013420:Sulfamethoxazole