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Table 5 Adverse drug reaction supervision center of the Ministry of Health. Evaluation criteria for the relationship between AE and research drug use

From: Efficacy and safety of the Chinese herbal formula Hewei Jiangni recipe for NERD with cold-heat complex syndrome: study protocol for a double-blinded randomized controlled trial

Judgment index Judgment result
Definitely Probably Probably Suspiciously Impossible
1. Whether there is a reasonable relationship between the time of starting medication and the time of suspicious occurrence. + + + + +
2. Whether the suspected ADR (ADR) conforms to the known ADR type of the drug + + +
3. Whether the suspected ADR can be explained by the patient's pathological condition, combined medication, therapy or previous therapy. ± ± +
4. It is doubtful whether the withdrawal or reduced dose of ADR alleviates or disappears + + ± ±
5. Does the same reaction occur again after re-exposure to suspicious drugs + ? ? ? -
  1. Description: + for positive, − for negative, ± for positive or negative, ? indicates that the situation is unknown