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To determine the efficacy of smoking cessation combined with of seihaito for chronic obstructive pulmonary disease (COPD).

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Evidence Reports of Kampo Treatment

Task Force for Evidence Reports / Clinical Practice Guideline Committee for EBM, the Japan Society for Oriental Medicine

050006e

10. Respiratory Diseases (including Influenza and Rhinitis) Reference

Kato S, Matsuda T, Nakajima T, et al. Clinical significance of the combination therapy of smoking cessation and seihaito for chronic obstructive pulmonary disease. Kampo to Saishin-chiryo (Kampo &

the Newest Therapy) 2005; 14: 260-5 (in Japanese). Ichushi Web ID: 2005292823

Kato S, Oda K, Hasumi H, et al. The combined effect of smoking cessation and Seihai-to on airway clearance on COPD patients. Kampo to Meneki-Arerugi (Kampo and Immuno-Allergy) 2006; 19: 26-35 (in Japanese with English abstract).

1. Objectives

To assess the efficacy of smoking cessation combined with administration of seihaito (清肺湯) for chronic obstructive pulmonary disease (COPD).

2. Design

Randomized controlled trial using sealed envelopes for allocation (RCT- envelope)

3. Setting

Two university hospitals, Japan.

4. Participants

Patients with GOLD stage 0, 1, or 2 COPD who had stopped smoking, but whose respiratory symptoms (cough, sputum, and dyspnea) were still present one month after smoking cessation, n=31.

5. Intervention

Arm 1: smoking cessation and administration of TSUMURA Seihaito (清肺湯) Extract Granules 9.0 g/day, for 24 months, n=16.

Arm 2: smoking cessation only, for 24 months, n=15.

6. Main outcome measures Respiratory symptoms.

Chest radiography and chest CT findings (emphysema, organizing pneumonia, bronchial obstruction by sputum).

7. Main results

Respiratory symptoms were significantly improved in arm 1 compared with arm 2 for 1 to 6 months; however, no significant difference was found after 12 months. The imaging findings were significantly improved in arm 1 at 24 months. Diagnostic imaging showed significant improvement in organizing pneumonia and bronchial obstruction in arm 2 after 24 months and no improvement in emphysema in both arms.

8. Conclusions

Administration of seihaito for 6 months improves clinical symptoms, and administration for 24 months is necessary for improvement in imaging findings.

9. From Kampo medicine perspective None.

10. Safety assessment in the article Not documented.

11. Abstractor’s comments

The information from this RCT included guidance on how to stop smoking using Kampo medicine as an add-on treatment. Dyspnea is a respiratory symptom that can be evaluated objectively by respiratory function testing and measurement of blood oxygen saturation. Future use of these tests in the follow-up period is desired. Future developments in this area of research hold promise.

12. Abstractor and date

参照

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