RESUMEN
ObjectiveTo explore the effectiveness and safety of vibration-kneading abdominal tuina as an adjunct treatment for insomnia of phlegm-heat harassing the interior syndrome with "stomach disharmony" symptom. MethodsSeventy-six insomnia patients of phlegm-heat harassing the interior syndrome with "stomach disharmony" symptom were recruited， and randomly divided into the treatment group and the control group with 38 cases in each group. The control group received eszopiclone 2mg once a night and sleep hygiene guidance， while the treatment group received vibration-kneading abdominal tuina additionally， 5 times a week， 30 min each time. Both groups were treated for 4 weeks. The Pittsburgh Sleep Quality Index （PSQI） （including sleep quality， time to fall asleep， sleep duration， sleep efficiency， sleep disorders， daytime functioning scores， and total scores） and traditional Chinese medicine （TCM） symptom scores of "stomach disharmony" was assessed before and after 4-week treatment and at follow-up （12 weeks after treatment）. Adverse events were also observed and recorded during the study. Pearson correlation analysis was used to assess the correlation between the pre-treatment PQSI total score and TCM symptom score of "stomach disharmony". ResultsThe PSQI scores of sleep quality， time to fall asleep， sleep duration， sleep efficiency， sleep disorders， daytime dysfunction scores， and total scores reduced in both groups decreased after treatment and at follow-up （P＜0.05 or P＜0.01）， as well as the TCM symptom score of "stomach disharmony" （P＜0.01）. After treatment， the PSQI scores of sleep quality， sleep duration， and TCM symptom score of "stomach disharmony" of the treatment group were lower than those of the control group （P＜0.05 or P＜0.01）. At follow-up， the PSQI scores of sleep quality， sleep duration， sleep efficiency， daytime dysfunction score， total score， and TCM symptom score of "stomach disharmony" of the treatment group were lower than those of the control group （P＜0.05 or P＜0.01）. No adverse reactions occurred in any participants during the study. There was a positive correlation between the patients' pre-treatment PQSI total scores and TCM symptom score of "stomach disharmony" （r=0.88， P＜0.01）. ConclusionVibration-kneading abdominal tuina as an adjunct treatment could significantly improve the symptoms of stomach and epigastric symptoms in insomnia patients of phlegm-heat harassing the interior syndrome with "stomach disharmony" symptom， and improve the quality of sleep， with good immediate and long-term therapeutic effects， and sound safety.