Traditional Chinese medicine diagnosis and response to acupuncture for insomnia: An analysis of two randomized placebo-controlled trials

Abstract Introduction Acupuncture is commonly used as a complementary and alternative medicine therapy for insomnia. Traditional Chinese medicine (TCM) diagnosis is sometimes used to guide treatment decisions. This study aimed to examine whether TCM diagnosis and symptom clusters were related to acupuncture response in subjects with insomnia. Methods Two-hundred and seven participants diagnosed with dual deficiency of the heart-spleen, non-interaction between the heart and kidney, depressed liver qi transforming into fire, or yin deficiency with effulgent fire who were randomly allocated to receive real acupuncture, completed treatment and had available follow-up data were analyzed. Standardized electroacupuncture was administered 3 times per week for 3 weeks. Primary outcome measure was Insomnia Severity Index (ISI). A 92-item symptom checklist was used to assist TCM diagnosis. A final agreed TCM diagnosis was made based on 2 Chinese medicine practitioners. Results Participants with depressed liver qi transforming into fire had the highest response rate of 36.6% from baseline to 1-week posttreatment, while the lowest response rate occurred in yin deficiency with effulgent fire at 13.0%; however, the difference was not statistically significant. There was a significant negative correlation between ISI change score and ratings on weary limbs, sore knees, or backache (ρ = –0.17, P  Conclusion The response to acupuncture was unrelated to TCM diagnosis, possibly because the zang fu system was not sensitive to detect individual difference in acupuncture or the acupuncture points chosen were non-specific.