[Clinical effect of acupuncture based on the specific response of -well point for intractable insomnia: a randomized controlled trial].

Objective: To evaluate clinical effect and safety on the basis of detecting the specific response of -well point in treatment of intractable insomnia with acupuncture by meridian differentiation.

Methods: Sixty-four patients with intractable insomnia were randomized into an observation group (32 cases, 1 case dropped out and 1 case was eliminated) and a control group (32 cases, 1 case was eliminated). In the observation group, the meridian imbalance value detected at the -well point was taken as the evidence so that the corresponding -source and back- points were stimulated with acupuncture. In the control group, the routine acupuncture was operated at Baihui (GV 20), Sishencong (EX-HN 1), and bilateral Shenmen (HT 7), Sanyinjiao (SP 6), Shenmai (BL 62) and Zhaohai (KI 6). Besides, the detection at -well point was performed for blindness in the control group. In the two groups, the interventions were delivered once daily, 5 times a weeks and for consecutive 4 weeks. In the two groups, the scores of Pittsburgh sleep quality index (PSQI), insomnia severity index (ISI) and the TCM symptom scale were observed before treatment and after 2 and 4 weeks of treatment; the clinical effect and safety were evaluated after treatment; the changes of meridian imbalance value were observed before and after treatment and the correlation analysis with the total score of PSQI was conducted.

Results: After 2 and 4 weeks of treatment, except the scores for hypnotic drug in the two groups and sleep disorder after 2 weeks of treatment in the control group, the scores of the other factors and the total scores of PSQI were all reduced when compared with those before treatment in the two groups (<0.05). After 4 weeks of treatment, except the scores for hypnotic drug in the two groups and sleep disorder in the control group, the scores of the other factors and the total scores of PSQI were lower than those after 2 weeks of treatment in the two groups (<0.05). After 2 weeks of treatment, the scores for time to fall asleep, sleep efficiency and daytime dysfunction in the observation group were lower than those of the control group (<0.05); and after 4 weeks of treatment, except the scores for sleep disorder and hypnotic drug, the scores of the other factors and the total score of PSQI in the observation group were all lower than those of the control group (<0.05). After 2 and 4 weeks of treatment, ISI scores and the scores of TCM symptom scale decreased when compared with those before treatment (<0.05), and the scores of these two scales after 4 weeks of treatment were lower than those after 2 weeks of treatment (<0.05) in the two groups; and the scores in the observation group were lower than thoese in the control group (<0.05). The total effective rate was 93.3% (28/30) in the observation group, higher than that (90.3% [28/31]) in the control group (<0.05). Of 64 cases, there was only 1 case of mild hematoma in the control group; and no any other adverse events occurred. Among 64 cases, the meridians, with the imbalance frequency ≥30 times, included the pericardium meridian of hand- and the heart meridian of hand-; those with the imbalance frequency ≥20 times, were the kidney meridian of foot-, the triple energizers meridian of hand-, the gallbladder meridian of foot-, the spleen meridian of foot- and the stomach meridian of foot-. Except the lung meridian of hand- in the control group, the imbalance value of each meridian was reduced after treatment (<0.05, <0.001, <0.01), and the meridian imbalance value presented a linear positive correlation with the total score of PSQI in the two groups .

Conclusion: Meridian differentiation acupuncture based on detecting the specific response of -well point can significantly improve the sleep quality and reduce the related symptoms in the patients with intractable insomnia. This therapy promotes the conversion of the meridians from the imbalance to the balance and is satisfactory in its safe operation.