BACKGROUND: Seasonal allergic rhinitis (SAR) is a common condition with relatively high prevalence in Australia. It causes a significant impact on sufferers' quality of life (QoL). Meta-analysis has shown that the efficacy of acupuncture for SAR is uncertain. OBJECTIVE: To evaluate the efficacy and safety of 12 sessions of acupuncture treatment during 4 weeks for SAR in a randomized, subject- and assessor-blinded, sham-controlled trial conducted during the pollen seasons in 2009 through 2011 in Melbourne. METHODS: Patients diagnosed with SAR and confirmed allergic to rye grass pollen were randomly allocated to receive real acupuncture (RA) or sham acupuncture (SA) treatment. RA was delivered manually, whereas SA involved superficial needling at non-acupoints without additional stimulation. Severity of SAR symptoms was the primary outcome measurement. Secondary outcomes were QoL, global change, SAR-related medication usage, and adverse events. Analysis of covariance using pollen count as a covariate was used to analyze outcome data. RESULTS: A total of 175 participants were included in this trial. RA was significantly better than SA for decreasing SAR symptom severity (sneezing mean difference -0.28, 95% confidence interval -0.51 to -0.05; itchiness of ears and palate mean difference -0.40, 95% confidence interval -0.69 to -0.11) at the end of treatment and improving participants' QoL at the end of the treatment and follow-up phases. Furthermore, the acupuncture treatment was safe and well tolerated. CONCLUSION: Four weeks of acupuncture treatment is a safe and effective option for clinical management of SAR in the Melbourne area for patients' symptom relief and QoL improvement.

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