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

2019-03
Medicine 98(9)
- Ning Li
- Li Li

PubMed: 30817597
DOI: 10.1097/md.0000000000014679

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 40
Population: 40 Chinese female patients with uncomplicated gonorrhea
Methods: Pilot randomized controlled trial comparing BZSF as an adjunctive therapy to ceftriaxone with ceftriaxone alone for 10 days
Duration: 10 days
Funding: Unclear

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.