A Short-term Safety Assessment of Herbal Medicine Combination Intended for External Application: A Randomized Cross-over Controlled Trial in Healthy Volunteer

บทคัดย่อ

We investigated short-term adverse drug events(ADEs) of 2% Asiaticoside and 1% Acemannan and added 2% acetyl-salicylic-acid external administration in 20 healthy volunteers. Data collection conducted in hospital setting looking at(i)a spontaneous safety report (ii) a weekly-diary summary of participants' self-reporting (iii) a Naranjo's algorithm assessment and physical examinations and alanine aminotransferase blood level test. A descriptive statistic with likelihood ratio Chi-square test for ADEs comparing active with placebo was analyzed. We founded (1) Outstanding ADEs were 50(40.3%) pruritus/itching sensation (ICD-10 L29), 45(36.2%) rash/other nonspecific skin eruption (ICD-10 R21), 15(12.1%)non-specified contact dermatitis/uncomfortable skin sensations (ICD-10 L25). No significant changes for physical examination. During the first two weeks, (2) The adjusted standardized likelihood ratio Chi-square test for active as compared with placebo confirmed a significant different risk proportion of 1.113, 95% CI, 0.955 to 1.296, p-value <0.001, attributable risk of 0.057, 95% CI, -0.025 to 0.136. Later during the second to the third week, no significant different 1.164, 95% CI, 0.924 to 1.467, p-value of 0.28 for placebo vs active, attributable risk of 0.080, 95% CI, -0.042 to 1.999. In conclusion: The ADE found were (1) localized skin reactions at application site and was similar between drug and placebo (2) No different changes on physical function and liver enzymes. (3) Other formulation adjuvant should be further established.