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z$z����Multiple central clinical studies on the needling method for regulating wei and strengthening brain for treatment of insomnia
GAO Xiyan1�XU Cuixiang1,  GAO Ling1,  WANG Peiyu1,  REN Shan1,  YANG Xuguang1,  ZHOU Yanli1,  MA Qiaolin1,  ZHANG Haijie2�WANG Jun3 , WANG Xuemei4
(1�The Third Affiliated Hospital of Henan College of TCM�Zhengzhou 450008�China�2�Henan Provincial Hospital of TCM �3�The First Affiliated Hospital of Henan College of TCM �4�Henan Provincial People s Hospital)
ABSTRACT
Objective To observe the clinical therapeuric effect of the needling method for regulating wei and strengthening brain on insomnia�Methods Two hundred cases of insomnia were randomly divided into a test group and a control group�100 cases in each group�The test group were treated with the needling method for regulating wei and strengthening brain with Baihui(GV 20)�Dazhui(GV 14)�Shenmai(BL 62)�Zhaohai(KI 6)and ear points Yuanzhong�Shenmen selected�and in the control group�Sisheneong(EX-HN 1)�Shenmen(HT 7)  and Sanyinjiao(SP 6) were selected�Acupuncture was given once daily for 15 days�Pittsburgh sleep quality index(PSQI) was used for scoring before and after treatment�Results The total effective rate was 89.0 in the test group and 65.0 in the control group with a very significant difference between the two groups(P< 0.01)�the difference of PSQl scores before and after was 9.15�X5.68 in the test group and 5.64�X5.73 in the control group, with a very significant difference before and after treatment in the two groups(P< 0.01)�Conclusion The therapeutic effect of the needling method for regulating and strengthening brain on insomnia is better than that of normal needling method�
KEY WORDS Insomnia�Acupuncture Therapy�Multicenter Studies
Insomnia, as a clinical common and frequently occurring disease, affects people�s normal work, study and life, also may induce or aggravate heart palpitations, chest pain, dizziness, headache, stroke and other diseases. The morbidity of insomnia is high and increasingly year by year.  From Jan. 2003 to Dec. 2006, the author in the Third Affiliated Hospital of Henan College of  Traditional Chinese Medicine (center 1), Henan  Provincial Hospital of TCM (center 2), the First Affiliated Hospital of Henan University of TCM(center3), conducted a study by a multicentre, randomised controlled trial to 200 cases of patients with insomnia, the report is as follows.
1 Clinical Data
1.1 General Data
200 subjects were enrolled in this study, 100 cases in each group, 8 cases in the test group and 8 cases in the control group were dropped out, the pass rate were 92% and 89%. Finished cases were up to the set standards.
Cases distribution: of center 1, 40 cases in each group, 3 cases in the test group and 6 cases in the control group were dropped out, respectively 37, 34 cases of qualified, the pass rate respectively 92.5% and 85%; and of center 2, 28 cases in each group, 4 cases in both groups were dropped out, 24 cases of qualified and with a pass rate of 85.7%; of center 3, 32 cases in each group, 1 cases in both groups were dropped out, 31 cases of qualified and with a pass rate of 96.9%; the number of cases met the statistical requirements.
1.2 Comparability Analysis
In the test group, 53 male cases, 47 female cases; the control group, 52 male cases, 48 female cases, after test, P>0.05, gender of two groups was comparable. The average age of test group 39.46 � 12.69 years old, the control group 39.90 � 13.40 years old, by t test, P>0.05, age of the two groups was comparable.
Patient's Condition: in the test group, 49 cases were mild, 23 were moderate and 28 cases of severe; in the control group, 48 cases were mild, 23 were moderate and 29 cases of severe; after chi-square test, P>0.05, disease condition of two groups was comparable.
Syndrome Types: in the test group, 22 cases were liver yang hyperactivity type, 38 cases were deficiency of both heart and spleen type, 24 cases were type of imbalance between heart-yang and kidney-yin, 16 cases were type of disharmony between spleen and stomach; in the control group, 17, 43, 24, 16 respectively; after chi-square test, P>0.05, syndrome types of two groups were comparable.
Pittsburgh Sleep Quality Index (PSQI) total integral: with minimum 6 and maximum 24 scores in the test group, average scores were 18.25�3.81; minimum 6 and maximum 24 scores in the control group, average scores were 17.42 � 4.11; by t test, P>0.05, PSQI total interal of the two groups were comparable.
1.3 Diagnostic Standards
(1)Diagnostic criteria of western medicine: according to "Classification of China Mental illness and Diagnostic criteria) (CCMD-3 R): `$ Sleep disorder is almost the only symptom, other symptoms are secondary to insomnia, such as difficulty in falling asleep, sleep but not deep, easy to wake up and difficult to fall sleep again, dreamness, early wake up and feel unwell, dizziness, fatigue, sleepiness and so on;  = 2 \* GB3 a$The above  disorders took place at least 3 times each week, and continued for more than 1 month; b$Accompanied by mental activity efficiency depression, affect normal work, or hinder social activities;  = 4 \* GB3 c$Not the complications of any physical or mental diseases.
(2)TCM diagnostic criteria: according to the �Guiding principle of clinical research on new drugs in the treatment of insomnia" decreed by National Ministry of Health in 1993. Deficiency of both heart and spleen type: palpitation and forgetful, dizziness and vertigo, anorexia and fatigue, lusterless complexion, sweating, a pale tongue with thin fur, thready pulse; type of imbalance between heart-yang and kidney-yin: dizziness and tinnitus, soreness and weakness of waist and knees, dysphoria  in chest, palms-soles, spermatorrhea and night sweats, red tongue, rapid pulse; liver yang hyperactivity type: irritability, dizziness and headache, chest and hypochondrium distension, red tongue, string pulse; type of disharmony between spleen and stomach: epigastric distension and belch, putrid belching and acid regurgitation, bitter taste in the mouth, thick and greasy fur, slippery rapid pulse.
(3)Grade criteria of patient's condition: according to the �Guiding principle of clinical research on new drugs in the treatment of insomnia" decreed by National Ministry of Health in 1993. Mild: sleep often awakening or unstable, waking early but not interfere normal work; moderate: sleep less than 4 hours but can hold on work; severe: stay up all night and difficult to adhere to the normal work.
1.4 Statistical Analysis Method
Firstly, review the cases accomplish and drop out circumstances, determine the datasets, then analysis demographic and baseline data between the two groups, investigate their comparability; if premise, evaluate the curative effect of each group and compare it between the two; lastly, do the safety evaluation.
Chi-square test, t test and rank sum test were used to test equilibrium; clinical curative effect analysis: measurement of self-control before and after treatment use the  matched t test; compared the efficacy of two groups use rank sum test, t test, CMH test; SAS software package was used for statistical analysis. The test statistics and its corresponding P value were given, and take P<0.05 for granted that there was significant difference.
2 Treatment Method
2.1 Acupuncture Needles
Use 0.35�13mm, 0.35�25mm, 0.35�40mm, 0.35�50mm needles produced by Shanxi Sanyuan modern acupuncture equipment Co.
 2.2 Acupoints
(1) Two groups� points selection were according to the ordinary higher education textbook. Test group: Baihui(GV 20)�Dazhui(GV 14)�Shenmai(BL 62)�Zhaohai(KI 6), and ear points Yuanzhong, Shenmen. For deficiency of both heart and spleen type, combine Xinshu(BL15), Pishu(BL20); for type of imbalance between heart-yang and kidney-yin, combine Xinshu(BL15), Shenshu(BL23); for liver yang hyperactivity type, combine Taichong(LR3), Ganshu(BL18); for type of disharmony between spleen and stomach, combine Weishu(BL21), Zusanli(ST36).
(2)Control group: Sisheneong(EX-HN 1)�Shenmen(HT 7), Sanyinjiao(SP 6). Combined acupoints were same as the test group.
2.3 Operation
(1) The test group: `$According to the selected acupoints, the patient prone or lying, after normal disinfection, puncture the points, when Qi arriving, performing lifting, twirling and rotating technique, reinforcing the deficiency and reducing the excess. Retaining needles for 30 minutes and manipulating every 10 minutes. Every afternoon, acupuncture 1 times, 15 days as a course.  = 2 \* GB3 a$Then, use vaccaria seed plaster ear points every 3 days, then the patient does self pressing 2 times per day, each time 10 ~ 15 minutes. Press to the ear feels fever, redness, swell, next time, plaster the other ear.
(2) The control group: According to the selected acupoints, the patient prone or lying, after normal disinfection, puncture the points, when Qi arriving, performing  lifting, twirling and rotating technique, reinforcing the deficiency and reducing the excess. Retaining needles for 30 minutes and manipulating every 10 minutes. Every afternoon, acupuncture 1 times, 15 days as a course.
2.4 Observation Method
 = 1 \* GB2 t$Sleep time, sleep and awake degree, mental state after wake were scored by PSQI, a person specially appointed there for asking and recording, according to the symptoms by mild, moderate and severe, respectively 0, 1, 2, 3.
(2) Recording time: Before and after treatment 1 and 2 weeks, respectively record 1 time, when clinical cure, stop treatment for 7 days and then take a record, each group were treated for 15 days.
3 Curative Effect Observation
3.1 Efficacy Criteria
According to the �Guiding principle of clinical research on new drugs" decreed by National Ministry of Health in 1993 to judge the curative effect. Clinical cure: sleep time return to normal or sleep more than 6 hours:xz�����					(	*	@	B	\	^	t	v	�	�	�	�	�	�	�	�	�	�	�	�	�	�������洩����q�q�q�q�q�q�gZq�Z���h&IhTy_CJKHaJhTy_CJKHaJh�%h�%CJH*KHaJo(hTy_CJKHaJo(h�%hTy_CJH*KHaJo(h&Ih&ICJKHaJh&ICJKHaJo(h&ICJKHaJh&Ih&I5�CJKHaJo(h&I5�CJKHaJo(h&I5�CJKHaJh&Ih&I5�CJKHaJh�	�5�CJKHaJ#�"
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=======-=.=B=a=b=m=n=o=�=�=�=�=�=�=�=�=�=�=�=�=�=�=|||+|,|>|_|c|n|x|�������������������������������������{����h�	jh�	jCJKHaJUh�h�h�&^h�CJKHaJo(h�CJKHaJh�&^h�CJKHaJh�CJKHaJo(h�h�CJKHaJh�$CJKHaJo(h�*ECJKHaJo(h�$h�$CJKHaJh�$h�$CJKHaJo(0, deep sleep, wake up with full of spirit; Obviously effective: sleep improved markedly, sleep time increased more than 3 Hours, sleep deeper; Effective: symptoms alleviated, compared with before treatment sleep time increased less than 3 hours; Ineffective: no significant improvement, or got worse, also include the droped out cases.
3.2 Treatment Results
Total efficiency: of test group 89%, clinical cure 0 cases, obviously effective 29 cases, effective 60 cases, ineffective 11 cases; The control group 65%, cured 0 cases, obviously effective 12 cases, effective 53 cases, ineffective 35 cases. Considering the center factor, test group�s total efficiency is obviously higher than that of the control group (see Table 1).
Table 1  Comparison of curative effect between two groups     cases
groupcasescureobviously effectiveeffectiveineffectivetotal efficiencyCMHPtest group
control group100
1000
029
1260
5311
3589.0
65.020.010.000
Table 1 shows, by CMH chi square test and ITT analysis, total effectiveness comparison between the two groups, P<0.01, there was significant difference, the test group was better than control group.
Two groups of PSO1 total integral comparison (see Table 2).
Table 2  PSQI total integral comparison between two groups     (x�s)
groupcasesbefor treatmenafter treatmentd-valuetptest group
control group100
10018.25�3.81
17.42�4.119.10�4.44
11.78�5.40-9.15�5.68
-5.64�5.73-16.12
-9.850.000
0.000
Table 2 shows, by t test and ITT analysis, PSQI totle integral comparison between befor and after treatment in each group, all P<0.01, there were significant differences.
3.3 Condition of Follow-up
Comparison of follow-up after 30 days in the two groups, sleep time, cough and snore (time per week), drowsiness (time per week), morning physical recovery, TCM syndrome type all had improvement, P<0.05, there were significant differences, the test group was better than control group. Comparison of easy to wake up and wake up early (time per week), night urination(time per week), P>0.05, there were no significant difference. ITT analysis was the same with PP analysis.
3.4 Safety Analysis
There was no adverse events in this clinical trial.
4 Discussion
Regulating wei and strengthening brain acupuncture manipulation is under the guidance of the eight extra meridians theory, selecte Baihui(GV 20)�Dazhui(GV 14)�Shenmai(BL 62)�Zhaohai(KI 6) and ear-point Yuanzhong, Shenmen, use acupuncture and auricular point therapy, adjust the circulation of Wei Qi, strengthen the brain and calm the nerves, to improving the imbalance condition of brain, achieve the purpose of tonify the brain and sleep well. The most commonly used method is tonify the heart and calm the nerves in textbooks, it�s emphasis is the heart; This method�s emphasis is regulating Wei Qi and strengthen brain.
Acupuncture treatment of insomnia is still in the stage of clinical observation, clinical reports are growing day by day. Treatment always according to personal experience and syndrome differentiation, combined with auricular point, massage and other methods. Insomnia closely associated with deficiency of both heart and spleen, liver-qi stagnation, treatment should based on holistic concept. From the domestic literature statistics, evaluation standard is not uniform, so that the curative effect has a huge difference, can not fully reflect the efficacy level of acupuncture. So, to improve level of diagnosis and treatment of traditional Chinese medicine is a major issue at present.
Treatment of insomnia by acupuncture can regulating yin and Yang, coordinate Wei Qi and strengthen brain, x|y|z|�|�|�|�|�|�|�|�|�|�|�|�|�|�|�|�|�|�|}}}!},}-}2}9}=}>}O}P}T}U}^}_}e}f}g}v}w}������������������ӭ���ӕ�t�譊����j��h�bCJKHaJ*h�*E0JB*CJOJQJ^JaJo(ph333hXO�CJKHaJo(hXO�h�*ECJKHaJh�bCJKHaJo(h�bh�bCJKHaJ1h�bh�b0JB*OJQJ^JaJmH	ph333sH	h�*ECJKHaJo(h�CJKHaJh�CJKHaJo(h�h�CJKHaJ)w}|}}�}�}�}�}�}�}�}�}�}�}�}�}�}�}�}~~~~B~M~P~R~]~p~q~s~u~w~{~�~�~�~�~�~�~�~�~�~�~�~�~��������޹����Ӯ��������󤮚����������ӹӹӹ�h�
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