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Effect of Seihai-to, a Kampo medicine, in relapsing aspiration pneumonia--an open-label pilot study.

Two published case reports described palliation of disease after Seihai-to therapy for refractory aspiration pneumonia caused by recurrent laryngeal nerve paralysis and cerebrovascular disease. We undertook an open-label trial in patients with relapsing aspiration pneumonia. Fifteen patients with relapsing aspiration pneumonia were randomly divided into conventional therapy group (n = 8) or Seihai-to group (n = 7). In Seihai-to group, patients were treated with Seihai-to in addition to conventional therapy (Western medicines). Frequency of feverish days and antibiotics-use, CRP value and chest CT or X-ray findings were compared between the two groups during the study period of 16 weeks. In the Seihai-to group, the latency of swallowing reflex was measured in 6 patients before and after administration of Seihai-to. The mean values of fever index, CRP value and antibiotics-use in the Seihai-to group were decreased significantly, compared with those of the conventional therapy group. However, the latency of the swallowing reflex after 4 weeks of treatment was not significantly changed (p = 0.249), compared with the latency before administration of Seihai-to. No adverse reaction was observed in either group. Seihai-to was effective in reducing relapse of aspiration pneumonia in this small group. Seihai-to might not improve the swallowing reflex, but might instead improve a defense mechanism or excessive inflammation caused by pneumonia in the lower airway. Further evaluation of Seihai-to therapy for patients with aspiration pneumonia in a larger population is warranted.