Abstract
OBJECTIVE: This study aims to evaluate the efficacy of premedication protocols in preventing immediate hypersensitivity reactions (HSRs) to taxane chemotherapy by comparing protocols that omit H2 antagonists with those that include famotidine. METHODS: This was an open-label, single-center, randomized clinical trial. Randomization was 1:1 to two groups. The experimental arm omitted H2 antagonists from the premedication protocol, while the control arm included famotidine. The efficacy of the premedication protocol for preventing HSRs in the experimental group was compared with that of the control group using a multilevel regression analysis with a random intercept and random effect model. RESULTS: Between September 2022 and December 2023, 150 patients enrolled. The group without H2 antagonists had 331 cycles, averaging 3.15 per patient. The famotidine group had 327 cycles, averaging 3.39 per patient. The total number of cycles was not significantly different (p = 0.951). There were six HSRs (1.81%) in the group without H2 antagonists and five (1.53%) in the famotidine group. The HSRs risk difference between groups was 0.28% (95% CI -0.02 to 0.02, p = 1.000). A multilevel regression analysis with a random intercept and effect model compared the efficacy of premedication protocols for preventing HSRs between the experimental and control groups. The risk ratio for HSRs in the group without H2 antagonists was 1.00, which was not statistically significant compared to the famotidine group (95% CI 0.98 to 1.04, p = 0.528). CONCLUSION: The clinical trial demonstrated that omitting the H2 antagonists premedication protocol for taxane chemotherapy is as effective in preventing HSRs as using famotidine. These findings suggest that this protocol can be implemented in clinical practice.