ABSTRACT
<b>Background:</b> Gingyo-gedoku-san (GGGS) is an herbal medicine approved for upper respiratory infections in Japan. We conducted an open-label, multi-center, prospective trial, comparing GGGS with oseltamivir in patients with influenza and influenza-like illness (ILI) as a pilot study.<br><b>Methods:</b> Subjects were healthy persons aged between 16 and 40, and were enrolled from January 12, 2010 to March 24, 2011. Fifteen patients were enrolled in this trial (8 and 7 for GGGS and oseltamivir, respectively). RT-PCR was positive for pandemic influenza A (H1N1) in 10 patients. The patients were provided with either GGGS or oseltamivir for 5 days. The primary outcome was mortality and/or hospitalization 7 days after the initial diagnosis. Body temperature and other clinical characteristics were also evaluated.<br><b>Results:</b> All patients recovered from illness without complication or hospitalization. The mean time to resolve symptoms for the GGGS and oseltamivir groups was 3.9 days and 3.3 days, respectively (p=0.43). The GGGS group appeared to have a smaller symptom score AUC than the oseltamivir group, (p=0.26). Time to recover activity level appeared to be shorter in the GGGS group (p=0.10), with shorter time to recover health status (p=0.02). Sub-group analysis on patients with positive PCR showed similar results between the two groups.<br><b>Conclusion:</b> GGGS was associated with symptom improvements resembling oseltamivir for both influenza and ILI. Randomized controlled trials involving larger sample sizes are needed to confirm these results.