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Background <p>Praziquantel is the only drug recommended against <i>Clonorchis sinensis</i>, while adverse events are usually high. Albendazole is documented in treatment of clonorchiasis, but the evidence is low due to lack of high-quality randomized controlled trials.</p> Methods <p>We did an exploratory randomized controlled trial in Binyang county, Guangxi, China. Eligible participants were adults aged 18–70 years with <i>C. sinensis</i> infection. Patients with light intensity (eggs per gram of feces (EPG): 1-999) and moderate plus heavy intensity (EPG: ≥ 1000) were randomly assigned to treatment groups respectively, with block sizes of two, four, and six, to receive praziquantel (25&#xa0;mg/kg three times a day for 1&#xa0;day) or albendazole (400&#xa0;mg twice a day for 4 days) in a 1:1 ratio. Laboratory diagnosis technicians were blinded to group assignment. We assessed efficacy as cure rate and egg reduction rate in available-case analysis, while adverse events were also analyzed.</p> Results <p>Fifty-two patients with light intensity and 50 with moderate plus heavy intensity were assigned, when three were lost to follow-up. The cure rate was 84.0% (21/25, 95% confidential intervals: 63.9%-95.5%) using praziquantel and 30.8% (8/26, 14.3%-51.8%) using albendazole in light intensity stratum (χ²=14.7, <i>p</i> &lt; 0.001). It was 60.9% (14/23, 38.5%-80.3%) using praziquantel and 8.0% (2/25, 1.0%-26.0%) using albendazole in moderate plus heavy intensity stratum (χ²=15.1, <i>p</i> &lt; 0.001). The corresponding egg reduction rate using geometric mean of EPG was 99.9% (99.7%-100.0%), 97.1% (94.1%-98.8%), 100.0% (99.9%-100.0%), and 98.9% (97.8%-99.5%), respectively. The overall cure rate was 72.9% (35/48, 58.2%-84.7%) in praziquantel groups and 19.6% (10/51, 9.8%-33.1%) in albendazole groups (χ²=28.3, <i>p</i> &lt; 0.001), while the corresponding egg reduction rate was 99.9% (99.8%-100.0%) and 98.3% (97.1%-99.1%). The proportion of adverse events was higher in praziquantel than albendazole in light intensity stratum (46.2% vs. 15.4%), while there was no difference in moderate plus heavy intensity stratum (20% vs. 20%). The overall proportion was 33.3% in praziquantel groups and 17.6% in albendazole groups.</p> Conclusions <p>Albendazole (400&#xa0;mg twice a day for 4 days) demonstrates high egg reduction rate and low adverse events, but low cure rate in <i>C. sinensis</i> infection. Its application in preventive chemotherapy for morbidity control deserves further exploration.</p> Trial registration <p>Controlled-Trials.com, ISRCTN46268871.</p>

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Efficacy and safety of albendazole versus praziquantel in the treatment of Clonorchis sinensis infection: an infection intensity-stratified, open-label, phase 2, randomized controlled trial

  • 期刊论文

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  • 发表日期：

    2026年7月20日

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  • Men-Bao Qian,
  • Jia-Guang Zhao,
  • Xiao-Ping Han,
  • Liu Liu,
  • Chang-Hai Zhou,
  • Ji-Lei Huang,
  • Yu-Ying Zhu,
  • Xiao-Qin Gan,
  • Jun Meng,
  • Shi-Zhu Li

摘要

Background

Praziquantel is the only drug recommended against Clonorchis sinensis, while adverse events are usually high. Albendazole is documented in treatment of clonorchiasis, but the evidence is low due to lack of high-quality randomized controlled trials.

Methods

We did an exploratory randomized controlled trial in Binyang county, Guangxi, China. Eligible participants were adults aged 18–70 years with C. sinensis infection. Patients with light intensity (eggs per gram of feces (EPG): 1-999) and moderate plus heavy intensity (EPG: ≥ 1000) were randomly assigned to treatment groups respectively, with block sizes of two, four, and six, to receive praziquantel (25 mg/kg three times a day for 1 day) or albendazole (400 mg twice a day for 4 days) in a 1:1 ratio. Laboratory diagnosis technicians were blinded to group assignment. We assessed efficacy as cure rate and egg reduction rate in available-case analysis, while adverse events were also analyzed.

Results

Fifty-two patients with light intensity and 50 with moderate plus heavy intensity were assigned, when three were lost to follow-up. The cure rate was 84.0% (21/25, 95% confidential intervals: 63.9%-95.5%) using praziquantel and 30.8% (8/26, 14.3%-51.8%) using albendazole in light intensity stratum (χ²=14.7, p < 0.001). It was 60.9% (14/23, 38.5%-80.3%) using praziquantel and 8.0% (2/25, 1.0%-26.0%) using albendazole in moderate plus heavy intensity stratum (χ²=15.1, p < 0.001). The corresponding egg reduction rate using geometric mean of EPG was 99.9% (99.7%-100.0%), 97.1% (94.1%-98.8%), 100.0% (99.9%-100.0%), and 98.9% (97.8%-99.5%), respectively. The overall cure rate was 72.9% (35/48, 58.2%-84.7%) in praziquantel groups and 19.6% (10/51, 9.8%-33.1%) in albendazole groups (χ²=28.3, p < 0.001), while the corresponding egg reduction rate was 99.9% (99.8%-100.0%) and 98.3% (97.1%-99.1%). The proportion of adverse events was higher in praziquantel than albendazole in light intensity stratum (46.2% vs. 15.4%), while there was no difference in moderate plus heavy intensity stratum (20% vs. 20%). The overall proportion was 33.3% in praziquantel groups and 17.6% in albendazole groups.

Conclusions

Albendazole (400 mg twice a day for 4 days) demonstrates high egg reduction rate and low adverse events, but low cure rate in C. sinensis infection. Its application in preventive chemotherapy for morbidity control deserves further exploration.

Trial registration

Controlled-Trials.com, ISRCTN46268871.