J. Acupunct. Tuina. Sci. 2010, 8 (1): 35-37 DOI: 10.

1007/s11726-010-0035-6

Special Topic Study

Clinical Observation on Application of Jiao Tai Pill on Shenque (CV 8) in Treating Insomnia
LI Yong () Jianan Hospital of Xuchang City, Henan 461000, P. R. China

152 2 76 76 4 l24 l 24 4 AbstractObjective: To observe the clinical efficacy of application of Jiao Tai Pill on acupoint Shenque (CV 8) in the treatment of insomnia. Methods: A total of 152 subjects were randomized in visit sequence into two groups: a treatment group in which 76 cases were treated by application of Jiao Tai Pill on point Shenque (CV 8) and a control group in which 76 cases were treated by oral administration of Jiao Tai Pill, both with a course of four weeks. Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the clinical efficacy respectively before treatment, at one-week, two-week and four-week treatment, and one week, two weeks and four weeks after treatment. Results: After four-week treatment, the sleep quality had improved in both groups, with no statistical difference between the two groups; there was no side-effect and the sleep quality kept improving thereafter. Conclusion: Application of Jiao Tai Pill on point Shenque (CV 8) and oral administration of Jiao Tai Pill both have positive effects on insomnia and no apparent withdrawal reaction after treatment. Key WordsInsomnia; Acupoint Sticking Therapy; Syndrome Differentiation Treatment; Disharmony between the Heart and Kidney CLC NumberR246.6 Document CodeA Insomnia is a common complaint in the clinic. About one-third of adults in the world suffered from or are suffering from insomnia. There have been many reports on sleep disorders treated by Chinese medicine. Jiao Tai Pill is generally acknowledged to be an effective formula against insomnia due to disharmony between the heart and kidney. We observed and compared the clinical efficacy of different administration of Jiao Tai Pill in the treatment of insomnia. It is reported as follows. Criteria of Mental Disorders, Version 3 (CCDM3)[1]; sedatives and soporifics were discontinued one week before this observation, electrocardiogram, blood routine and laboratory examinations showed no abnormality; exclusion of sleep disorders from mental diseases, postoperative pain and addiction to some substances. 1.2 Standard for syndrome differentiation Heart-kidney disharmony syndrome was established in accordance with the Criteria of Diagnosis and Therapeutic Effects for TCM Diseases and Syndromes[2]. Restlessness and sleeplessness, inability to maintain asleep, feverish palms and soles, dizziness and tinnitus, palpitations, forgetfulness, soreness and weakness of low back

1 Clinical Data
1.1 Inclusion criteria Conformity to the diagnostic standard for insomnia in Chinese Classification and Diagnostic
Author: LI Yong (1957- ), male, associate chief physician

Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010 35

J. Acupunct. Tuina. Sci. 2010, 8 (1): 35-37

and knee, flushed cheeks and tidal fever, dry mouth with little fluids, red tongue with little coating, and a small rapid pulse. 1.3 General data The 152 out-patients from our department of insomnia were randomized into 2 groups according to the visit sequence. Among 76 cases in the treatment group, 32 cases were male and 44 cases were female; the average age was (3011) years; the average duration of disease was (5.122.2) years. Among 76 cases in control group, 36 cases were male and 40 cases were female; the average age was (3211) years; the average duration of disease was (5.101.4) years. All these patients were treated with unknown Western medicines or Chinese herbs. The general data were of no statistical differences between the two groups, showing comparability between the two groups.

2 Treatment Methods
2.1 Treatment group Acupoint: Shenque (CV 8). Methods: Herbal powder was applied on acupoint Shenque (CV 8). Huang Lian (Rhizoma Coptidis) powder and Rou Gui (Cortex Cinnamoni) powder were mixed in proportion as 10:1. Azone and honey in proportion as 0.4:10 were adopted as supplementary materials to make herbal ointment with the powders above, and then sealed in the bottle for use. Before sleep, the patients navel was cleaned and then filled with 4 g herbal ointment, which was fixed with adhesive plaster. In the morning of the third day, the herbal ointment was removed and the navel was cleaned; and in the evening of that day, another treatment was started. 2.2 Control group The herbs were the same as those in the treatment group were ground into powder and then filled into capsules, which were taken three times a day and four capsules each time. The two groups were treated for 4 weeks.

3 Observation of Clinical Effects

3.1 Observational item Sleep efficiency is calculated by the internationally used formula. Sleep efficiency = sleep duration / the time between going to bed and getting up 100%. According to the updated sleep observation methods issued by WHO, sleep

condition is classified into five grades. Grade: Sleep efficiency between 70% and 80%, fair sleep; Grade : Sleep efficiency between 60% and 70%, difficulty in sleep; Grade : Sleep efficiency between 50% and 60%, sleep disturbance; Grade : Sleep efficiency between 40% and 50%, moderate sleep disturbance; Grade : Sleep efficiency between 30% and 40%, severe sleep disturbance. Pittsburgh Sleep Quality Index (PSQI)[3] was adopted to assess the clinical efficacy before treatment, after a one-week, two-week and four-week treatment, and one week, two weeks and four weeks after treatment. 3.2 Therapeutic effects criteria Cure: Clinical symptoms disappeared, sleep efficiency over 70%. Marked effectiveness: Clinical symptoms were relieved, sleep efficiency over 60%. Effectiveness: Clinical symptoms improved, sleep efficiency over 50%. Ineffectiveness: Clinical symptoms remained unchanged, sleep efficiency below 50. 3.3 Statistical analysis REMS 3.1 was employed to make statistical analysis in accordance with the equivalent test. Rank data were analyzed with rank sum test, enumeration data with 2 test and measurement data with t test. 3.4 Results 3.4.1 Comparison of PSQI outcomes After the one-week, two-week and four-week treatments, the PSQI scores got a marked decrease in comparison with pre-treatment (P<0.05 or P<0.01); the PSQI scores were of statistical differences between the two groups respectively one week and two weeks after treatment (P<0.01), and of no difference four weeks after treatment. 3.4.2 Effective rates At the end of the four-week treatment, the total effective rate was 78.9% in the treatment group and 81.6% in the control group, with no statistical difference between them. One week, two weeks and four weeks after treatment, the marked effective rate was of insignificant difference between the two groups.

36

Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010

J. Acupunct. Tuina. Sci. 2010, 8 (1): 35-37 Table 1. Comparison of PSQI outcomes between the two groups ( x s) Groups Treatment Control n 76 76 Pre-treatment 14.21.2 14.41.1 During Treatment One week 11.61.7 12.11.5 Two weeks 7.72.2 7.92.0 Four weeks 6.21.9 7.12.1 One week 6.42.11) 10.32.2 Post-reatment Two weeks 8.22.0 1) 9.82.3 Four weeks 9.51.6 9.61.9

Note: Compared with the control group, 1) P<0.01

3.5 Side effects No side effects were found in the treatment group; while 3 cases suffered from slight nausea in the control group.

4 Discussion
Insomnia includes difficulty falling asleep, shallow sleep, easy and early morning wakening, dreaminess, inability to fall asleep after wakening, discomforts and tiredness after awakening, and daytime fatigue. When the sleep abnormality lasts over four weeks, it can be diagnosed as insomnia. Sleep interruption is major caused by emotional, psychic, physical and environmental factors. For example, changes in living habits or dwellings, and noise can all lead to insomnia. Insomnia is complicated in pathogenesis; emotional irregularity, heart-kidney disharmony, improper diet, heartspleen insufficiency, and heart deficiency can bring about insomnia. Insomnia due to heart-kidney disharmony is commonly seen in clinical practice. Heart belongs to fire and yang, housing spirit; kidney belongs to water and yin, storing essence. According to yin-yang and fire-water theories, heart and kidney should be harmonious to keep physiological functions dynamically balanced. Nevertheless, some people cannot adapt themselves to the rapid pace and competitive stress of modern life; or they have irregular life, excessive sexual intercourse, or excessive worry, or emotional depression which results in excess fire. All these factors may cause kidney water insufficiency, failing to control heart fire. Also, deficient kidney yang is not able to activate kidney water to suppress heart fire, leaving heart fire hyperactive; or hyperactive heart fire consumes kidney yin, causing kidney water insufficiency. In a word, if the physiological balance of heart-kidney harmony is impaired, the heart is not harmonious with the kidney, and insomnia develops. Jiao Tai Pill, originated from Han Shi Yi Tong

(HANs Medicine) by HAN Mao in the Ming dynasty, is a famous prescription for heart-kidney disharmony. In this prescription, Huang Lian (Rhizoma Coptidis) and Rou Gui (Cortex Cinnamoni) act on complex heat-cold syndrome. Huang Lian (Rhizoma Coptidis), cold and bitter in nature, serves to clear heart fire and prevents Rou Gui (Cortex Cinnamoni) from consuming yin. Rou Gui (Cortex Cinnamoni), acrid and hot in nature, has the function to warm kidney yang and conduct heart fire down to supplement kidney yang, to prevent Huang Lian (Rhizoma Coptidis) from retaining cold, and to warm and unblock meridians and collaterals[4]. Combined use of these two herbs can coordinate fire and water; harmonize heart and kidney to achieve the purpose of yin-yang balance. We applied the herbal ointment on point Shenque (CV 8) in an attempt to compare the clinical efficacy of different herbal administrations. This observation showed that herbal ointment on point Shenque (CV 8) has a positive effect on insomnia, similar to that by oral administration; but the application of herbal ointment on Shenque (CV 8) is easily conducted by doctors and better accepted by patients.

References
[1] Psychological Association of All-China Medical Society. China Classification of Mental Diseases. Third Edition. Jinan: Shandong Scientific and Technical Press, 2001: 118-119. [2] The State Administration of Traditional Chinese Medicine. Criteria of Diagnosis and Therapeutic Effects for TCM Diseases and Syndromes. Nanjing: Nanjing University Press, 1994: 19-20. [3] Kryger M.H, Roth T, Dement W.C. Principles and Practice of Sleep Medicine. 3rd Edition. Philadelphia, PA: Saunders, 2000: 108-275. [4] ZHANG Yun-jian, YANG Guang-sheng. Treatment of 32 Patients with insomnia by Ningxin Jiaotai Pill Combined with Acupoint Sticking. China's Naturopathy, 2004, 12(8): 28. Translator: XIAO Yuan-chun () Received Date: December 10, 2009

Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010 37