Table 2.
Adherence Criteria of Adverse Events Case Reports Based on the International Society of Epidemiology's “Guidelines for Submitting Adverse Event Reports for Publication”4
| Item | Description | Point Value | Case With Item Present(%) |
|---|---|---|---|
| Demographics | Age | 1 | 127 (99) |
| Sex | 1 | 110 (86) | |
| Current health status | Disease or symptoms being treated with suspect herb | 1 | 115 (90) |
| Medical history | Medical history relevant to adverse event | 1 | 101 (79) |
| Physical examination | Abnormal physical or laboratory findings | 1 | 121 (95) |
| Patient disposition | Presence or absence of death, life-threatening circumstances, hospitalization or prolonged hospitalization, or significant disability | 1 | 127 (99) |
| Herb information | Latin binomial name of herb ingredients | 1 | 66 (52) |
| Generic name vs proprietary name of herb | 1 | 113 (88) | |
| Plant part(s) | 1 | 52 (41) | |
| Type of preparation: crude herb or extract | 1 | 120 (94) | |
| Manufacturer: producer of herb | 1 | 26 (20) | |
| Dosage | Dosage: approximate amount of herb | 1 | 76 (59) |
| Duration of therapy: how long herb has been taken | 1 | 118 (92) | |
| Duration of herb use before adverse event | Therapy duration before adverse event and its interface with the adverse event | 1 | 52 (44) |
| Concomitant therapies | Assessment of potential contribution of concomitant therapies | 1 | 28 (22) |
| Description of adverse event | Description of adverse event and its severity compared with established definitions and outcome of adverse event | 1 | 127 (99) |
| Discussion | Presence or absence of evidence supporting causal link including timing, dechallenge, and rechallenge (or state why these were not possible) | 1 | 119 (93) |
| Discussion of previous reports of adverse event in biomedical | |||
| Total points achievable | 17 |