| ObjectiveTo study the influences of routine acupuncture and sham acupuncture on migraine through the observation to migraine patients. The "acupuncture with minimal stimulation on skin superficial layer of meridian point or non-meridian points", the so called control method of sham acupuncture (placebo acupuncture), used commonly in foreign studies will also be studied.MethodsSource of casesAll the cases were outpatients in the Acupuncture and Moxibustion Hospital of CACMS and First Hospital of Tsinghua University from January of2010to May of2012.Method of study designIn this randomized block trial, all the seventy two cases were divided into3groups in the ratio of1:1:1(24cases in every group) randomly. Cases were brought into the study according to the visiting sequence (No.1to No.72) first, and then were divided into different groups randomly. The block size is9. and the block number is10. Clinical doctor asked the randomized number and the group number from randomized scheme depositary according to the patient’s inclusive number, and then started clinical study according to identified therapeutic protocol in different groups. The center randomized method was used in this study, but detailed randomized scheme shouldn’t be mentioned here because of allocation concealment.Method of treatmentRoutine acupuncture in meridian points group: Main points:Sizhukong (SJ23) penetrating to Shuaigu (GB8) in affected side, Taiyang (EX-HN5), Fengchi (GB20), Hegu (L14), Taichong (LR3) and Zulinqi (GB41). Selective points according to syndrome differentiation:Taixi (KI3) and Yanglingquan (GB34) can be added in liver yang hyperactivity type. Fenglong (ST40), Zhongwan (CV12) and Neiguan (PC6) can be added in phlegm type. Geshu (BL17), Xuehai (SP10) and Sanyinjiao (SP6) can be added in blood stasis type. Taixi (KI3) and Shenshu (BL23) can be added in kidney deficiency type. Zusanli (ST36), Qihai (CV6), Xuehai (SP10), Sanyinjiao (SP6) and Baihui (GV20) can be added in insufficiency of qi and blood type.Operation:In Sizhukong (SJ23), horizontal needling aiming at Shuaigu (GB8) was used after inserting the needle, twirling was also used without lifting and inserting. Routine needling method was used in other points, and needle sensation should appear in every point. The time of need retaining was30min, and2times of needle manipulation were given during this30min. Shallow acupuncture in meridian points group:Points:the same to the routine acupuncture in meridian points group. Operation:Shallow needling was used in all the points. The depth of perpendicular insertion was less than4mm. and no manipulation was used to get qi. The time of needle retaining was30min without needle manipulation.Shallow acupuncture in non-meridian points group:Points:More than5non-meridian points (two sides) should be selected avoiding meridian points in upper arm. thigh and the area lower than scapulars. Upper arm:in the area between lung meridian and large intestine meridian, one point is lcun above the level of Shouwuli (L113), and the other point is lcun lower than the level of Shouwuli (LI13). Thigh:in the front middle line of thigh between stomach meridian and spleen meridian, one point was2cun above the level of midpoint of superior border of patella and inguinal, and the other point was2cun lower than the same level. The area lower than scapulars:1cun lower than the inferior angle of scapula. Operation:Shallow needling was used in all the points. The depth of perpendicular insertion was less than4mm, and no manipulation was used to get qi. The time of needle retaining was30min without needle manipulation.Needles:disposable acupuncture needles in diameter from0.25to0.30mm and length from25to40mm.Course of treatment:The courses of all the groups were8weeks. The frequency was2times a week in first4weeks, and1time a week in later4weeks.Diagnostic and effect evaluation criteria Diagnostic criteria①The migraine diagnostic criteria established by International Headache Society (IHS) in2004.②The TCM diagnostic and syndrome differentiated criteria of migraine was determined according to the diagnostic criteria of head wind in Diagnostic and Effective Standards of TCM Syndromes established by State Administration of TCM of PRC.③The migraine criteria in Guideline of New Traditional Chinese Medicine in Clinical Research established by Ministry of Health of PRC in1995.The content and time of effect evaluationInvestigate the attacking condition of migraine in4weeks before treatment. This condition was the baseline value. Give directions to patients on recording headache diary, and make patients record the strength, days, frequency and lasting time of attack. Recover and analyze these data every4weeks, and compare these data with baseline value. Recovering time includes the ends of the8th week, the12th week, the16th week and the28th week. Analysis contents include value of migraine, lasting time of attack, VAS and safety indexes. Time of effect evaluation includes the first4weeks (baseline stage)(WO), the second4weeks(treatment stage)(W1), the third4weeks (treatment stage)(W2), the forth4weeks (follow up stage)(W3) and the seventh4weeks (follow up stage)(W4).Effect evaluation criteria①Calculate the score of severity of headache referring to the comprehensive scoring method in Guideline of New Traditional Chinese Medicine in Clinical Research.②The severity of headache in attack stage was evaluated by Visual Analogue Scale (VAS).③Calculate the effective rate referring to the calculating method in foreign studies. Effective rate=the number of patients whose reduction of times or days of attack after treatment is no less than40%(or50%)/the total number of patients in the group×100%.Data management and analysisData management:establish database using EpiData3.1, then input data from CRF into the database twice by different researchers. Check the data input by different researchers, and correct the wrong data according to original data in CRF if there is difference between the data. Establish the terminal database for statistics. Statistical method:Analyze the basal levels and therapeutic effects of three groups according to the characters of clinical datum and related statistics principle using CHISS. During the statistics, ranked data is analyzed by rank sum test. Test of normality is given first to enumeration data, variance analysis is used if it is normal. T test is used if variance analysis is homogeneous, and t’test is used if variance analysis is non-homogeneous. Normal transformation is given first if the data is non normal. Parametric test is used for data in accordance with normal distribution after transformation, while rank num test is used for that in non normal distribution after transformation.ResultsW1At the time of W1, the comprehensive score of migraine, the lasting time of attack and the VAS were all reduced than those before treatment, but the differences of them before and after treatment were all insignificant (P>0.05). At this time point, the differences of all these indexes between groups were all insignificant (P>0.05).W2At the time of W2, the comprehensive score of migraine, the lasting time of attack and the VAS were all reduced than those before treatment, but only the differences of them before and after treatment in shallow acupuncture in meridian points group were significant (P<0.05), them in other two groups were both insignificant (P>0.05). At this time point, the differences of all these indexes between groups were all insignificant (P>0.05).W3At the time of W3, the comprehensive score of migraine, the lasting time of attack and the VAS were all reduced than those before treatment. The differences of them before and after treatment in shallow acupuncture in meridian points group were significant (P<0.05), while them in shallow acupuncture in non-meridian points group were insignificant (P>0.05). In routine acupuncture in meridian points group, the difference of comprehensive score of migraine and the lasting time of attack before and after treatment was significant obviously (P<0.01), while the differences of VAS was insignificant (P>0.05). At this time point, the differences of all these indexes between groups were all insignificant (P>0.05).W4At the time of W4, the comprehensive score of migraine, the lasting time of attack and the VAS were all reduced than those before treatment. In shallow acupuncture in meridian points group, the difference of comprehensive score of migraine before and after treatment was significant (P<0.05), while the differences of other2indexes were insignificant (P>0.05). In routine acupuncture in meridian points group, the difference of comprehensive score of migraine before and after treatment was obviously significant (P<0.01), and the differences of other2indexes were also significant (P<0.05). In shallow acupuncture in non-meridian points group, the differences of these3indexes before and after treatment were all insignificant (P>0.05). At this time point, the differences of all these indexes between groups were all insignificant (P>0.05).Effective rateW1:Shallow acupuncture in meridian points group (80.00%)> Routine acupuncture in meridian points group (55.56%)=Shallow acupuncture in non-meridian points group (55.56%)W2:Shallow acupuncture in meridian points group (80.00%)> Routine acupuncture in meridian points group (55.56%)> Shallow acupuncture in non-meridian points group (44.44%)W3:Routine acupuncture in meridian points group (100.00%)> Shallow acupuncture in meridian points group (80.00%)> Shallow acupuncture in non-meridian points group (44.44%)W4:Routine acupuncture in meridian points group (77.78%)> Shallow acupuncture in non-meridian points group (55.56%)> Shallow acupuncture in meridian points group (50.00%)At the time point of W3, differences of effective rate between the three groups were significant (P<0.05). At other time points, there was no statistical significance between effective rates in3groups.Conclusion1During the treatment period, the effect in shallow acupuncture in meridian points group is more significant than routine acupuncture in meridian points group and shallow acupuncture in non-meridian points group on comprehensive score of migraine, lasting time of attack and VAS.2During follow up period, the shallow acupuncture and routine acupuncture in meridian points methods can all effect at different time points on these three indexes, but the effect in shallow acupuncture in meridian points group is the most stable.3The differences of all indexes between groups are all insignificant at any time point. At the time points of W3and W4, the differences of all indexes before and after treatment are all significant. The effective rates in routine acupuncture in meridian points group (W3=100.00%, W4=77.78%) are higher than those in shallow acupuncture in meridian points group (W3=80.00%, W4=50.00%) and in shallow acupuncture in non-meridian points group (W3=44.44%, W4=55.56%). It shows that the long term effect of routine acupuncture in meridian points group is the best.4In the shallow acupuncture in non-meridian points group, the comprehensive score of migraine, the lasting time of attack and the VAS are all reduced than those before treatment at any time point, but the differences are all insignificant. The possibility of placebo effect is high in this group.This research has studied the comprehensive score of migraine, lasting time of attack, VAS, effective rate and safety indexes of routine acupuncture in meridian points, shallow acupuncture in meridian points and shallow acupuncture in non-meridian points in treating migraine. The results show that the long-term effect of routine acupuncture in the preventive treatment of migraine at remission stage is better, while the effect at treatment stage of shallow acupuncture is more obvious. These two methods can both be used in the treatment, and can provide some guidance to clinical practice. |
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