Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia: A Randomized Placebo Controlled Triple-Blinded Trial.

OBJECTIVE: To assess efficacy of Chinese medicine (CM) on insomnia considering characteristics of treatment based on syndrome differentiation. METHODS: A total of 116 participants aged 18 to 65 years with moderate and severe primary insomnia were randomized to the placebo (n=20) or the CM group (n=96) for a 4-week treatment and a 4-week follow-up. Three CM clinicians independently prescribed treatments for each patient based on syndromes differentiation. The primary outcome was change in total sleep time (TST) from baseline. Secondary endpoints included sleep onset latency (SOL), wake time after sleep onset (WASO), sleep efficiency, Pittsburgh Sleep Quality Index (PSQI) and CM symptoms. RESULTS: The CM group had an average 0.6 h more (95% confidence interval (CI): 0.3-0.9, P<0.001) TST and 34.1% (10.3%-58.0%, P=0.005) more patients beyond 0.5 h TST increment than that of the placebo group. PSQI was changed -3.3 (-3.8 to -2.7) in the CM group, a -2.0 (-3.2 to -0.8, P<0.001) difference from the placebo group. The CM symptom score in the CM group decreased -2.0 (-3.3 to -0.7, P=0.003) more than the placebo group. SOL and WASO changes were not significantly different between groups. The analysis of prescriptions by these clinicians revealed blood deficiency and Liver stagnation as the most common syndromes. Prescriptions for these clinicians displayed relative stability, while the herbs varied. All adverse events were mild and were not related to study treatment. CONCLUSION: CM treatment based on syndrome differentiation can increase TST and improve sleep quality of primary insomnia. It is effective and safe for primary insomnia. In future studies, the long-term efficacy validation and the exploratory of eutherapeutic clinicians' fixed herb formulas should be addressed (Registration No. NCT01613183).

Patterns of herbal combination for the treatment of insomnia commonly employed by highly experienced Chinese medicine physicians.

OBJECTIVE: To explore the most effective herbal combinations commonly used by highly experienced Chinese medicine (CM) physicians for the treatment of insomnia. METHODS: We collected and analyzed data related to insomnia treatment from the clinics of 7 highly experienced CM physicians in Beijing. The sample included 162 patients and 460 consultations in total. Patient outcomes, such as sleep quality and sleep time per day, were manually collected from the medical records by trained CM clinicians. Three data mining methods, support vector machine (SVM), logistic regression and decision tree, and multifactor dimensionality reduction (MDR), were used to determine and confirm the herbal combinations that resulted in positive outcomes in patients suffering from insomnia. RESULTS: Results show that MDR is the most efficient method to predict the effective herbal combinations. Using the MDR model, we identified several combinations of herbs with 100% positive outcomes, such as stir-fried spine date seed, Szechwan lovage rhizome, and prepared thinleaf milkwort root; white peony root, golden thread, and stir-fried spine date seed; and Asiatic cornelian cherry fruit with fresh rehmannia. CONCLUSIONS: Results indicate that herbal combinations are effective treatments for patients with insomnia compared with individual herbs. It is also shown that MDR is a potent data mining method to identify the herbal combination with high rates of positive outcome.