OBJECTIVE To compare active acupuncture with sham acupuncture for the treatment of persistent allergic rhinitis among children. METHODS Subjects with persistent allergic rhinitis were recruited from the pediatric outpatient clinic. They were randomized to receive either active acupuncture or sham acupuncture. Main outcome measures included daily rhinitis scores, symptom-free days, visual analog scale scores for immediate effects of acupuncture, daily relief medication scores, blood eosinophil counts, serum IgE levels, nasal eosinophil counts, patients' and parents' preferences for treatment modalities, and adverse effects. RESULTS Eighty-five patients were recruited from the pediatric outpatient clinic at Kwong Wah Hospital, in Hong Kong. Thirteen patients withdrew before randomization; 35 patients (mean age: 11.7 +/- 3.2 years) were randomized to receive active acupuncture for 8 weeks, and 37 patients (mean age: 11 +/- 3.8 years) were randomized to receive sham acupuncture for 8 weeks. Acupuncture was performed twice per week for both groups. Both the assessing pediatricians and the patients were blinded. There were significantly lower daily rhinitis scores and more symptom-free days for the group receiving active acupuncture, during both the treatment and follow-up periods. The visual analog scale scores for immediate improvement after acupuncture were also significantly better for the active acupuncture group. There was no significant difference in the following outcome measures between the active and sham acupuncture groups: daily relief medication scores, blood eosinophil counts, serum IgE levels, and nasal eosinophil counts, except for the IgE levels before and 2 months after acupuncture in the sham acupuncture group. No severe adverse effects were encountered. Numbness, headache, and dizziness were found in both the active and sham acupuncture groups, with no difference in incidence, and the effects were self-limiting. CONCLUSIONS This study showed that active acupuncture was more effective than sham acupuncture in decreasing the symptom scores for persistent allergic rhinitis and increasing the symptom-free days. No serious adverse effect was identified. A large-scale study is required to confirm the safety of acupuncture for children.