Effectiveness of Bazhengsan formula as an adjunctive therapy to ceftriaxone for female patients with uncomplicated gonorrhea: A pilot study

BACKGROUND: This pilot study aimed to investigate the feasible effectiveness and safety of Bazhengsan formula (BZSF) as an adjunctive therapy to ceftriaxone for female patients with uncomplicated gonorrhea. METHODS: This pilot randomized controlled trial compared BZSF as an adjunctive therapy to ceftriaxone with ceftriaxone alone for Chinese female patients with uncomplicated gonorrhea. A total of 40 eligible patients were randomly allocated to a treatment group (received BZSF and ceftriaxone) or a control group (received ceftriaxone alone). All patients in both groups were treated for a total of 10 days. The primary outcome included bacteriological cure. It was assessed by the eradication of urogenital gonorrhea at any site cultured after taken the study medications. The secondary outcome was clinical response. For the safety assessment, adverse events were recorded during the study period. RESULTS: After treatment, patients in both groups achieved promising effectiveness. However, no significant differences in bacteriological cure (P = .34), clinical response (P = .11), and safety were found between 2 groups. CONCLUSION: The findings of this study showed that BZSF as an adjunctive therapy to ceftriaxone may be not superior to the ceftriaxone alone for Chinese female patients with uncomplicated gonorrhea after 10 days treatment.