Clinical Research On ADHD Treatment With Jin's Three-needle Therapy

Aim:This clinical comparison research intends to discuss the clinical efficacy of attention deficit hyperacticivity disorder(ADHD) with acupuncture;the relationship between curative efficacy and syndromes,and between the curative efficacy and age,etc.With randomized clinical trial,this paper objectively evaluates the efficacy and safety of Jin' s Three-needle Therapy in ADHD treatment.Methods:Research objects are patients who were diagnosed as ADHD from June 2007 to December 2008 in Zhengde Chinese Medicine Clinic in Taipei city,Taiwan Province and who met the inclusion criteria.Western Medicine:diagnosis is enacted according to ADHD diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders(DSM-â…£) by American Psychiatry Society with reference to the 3^rd Version of the Classification and Diagnostic Criteria of Chinese Psychiatric Disorders.Chinese Medicine diagnoses it as liver and kidney-yin deficiency.The trial adopts randomized comparison method.Cases' grouping is undertaken in the simple randomized way.The detailed randomization way is that the research panel members get the randomized figure by clicking the INV or RAN key on calculators of Casio(fx-3600p),make the randomization cards and put them in envelopes.The serial number on the envelopes and cards are the same.In the trial,the 108 qualified patients open the envelopes with same number in order and go to the corresponding group to receive treatment,including Acupuncture Group and Western Medicine Group. 63 patients are in the Acupuncture Group and receive acupuncture treatment in accordance with Jin' s Three-needle Therapy.45 patients are in the Western Medicine Group and take Ritalin orally.The acupoint-selection principles are:(1) the major acupoints are Sishenzhen(1.5 cun lateral and circa to the Baihui point) which is punctured externally and horizontally and Dingshenzhen (5 fen above ophryon,5 fen above Yangbai on both sides) which is punctured downward and horizontally.Treatment method and curative course:insert the needle horizontally on the acupoints on the head for 8-9 fen with stainless steel fine needles of 1 cun of No.30.Remain the needles for 30 minutes after the acupoints obtain qi and move the needles every 15 minutes.Take the mild reinforcing-reducing method and treat twice each week.Take 3 months as a curative course.(2) In ear acupoint paste and pressing,select the corresponding acupoints on the subcortex brain stem:liver,kidney and sympathesis point are selected for liver and kidney-yin deficiency;heart, liver and spleen points are selected for stagnation of liver-qi;heart,spleen and excitement point are selected for liver and spleen qi and blood deficiency. Treatment methods and curative course:Sterilize the auricles with 75%alcohol and paste the cowherb seeds on the strapping of 0.5*0.5cm and paste them on the ear acupoints.Left and right ears are treated alternatively.Ask the parents to press for 5-10 minutes each time and no less than 3 times each day until the auricles engorge and generate heat.Treat twice each week and 3 months as a curative course.Treatment methods and curative course of Ritalin:take 5-10 mg each time and twice a day before breakfast and lunch and generally the daily dosage is less than 30 mg.Take it 5 days a week and stop twice on weekends.3 months form a curative course.The observation items:collect the comprehensive clinical information of ADHD patients,including general information,safety observation,curative efficacy observation,clinical symptoms observation;Chinese Medicine differentiation,symptoms,body signs and other various examination items. Observation methods:observe every week and record Chinese Medicine syndromes, Chinese Medicine differentiation,symptoms,scoring index and tongue and pulse parameters.Examination may be undertaken anytime when necessary.The curative efficacy evaluation criteria refer to the criteria made by the ADHDPanel of National Chinese Medicine Theory Committee.The ADHD curative efficacy are made as follows:clinical cure:18 items of symptoms basically disappear of ADHD of DSM-â…£:excellence:5 or more than 5 symptoms of the 18 items of ADHD disappear compared with that before treatment;utility:2 or more than 2 symptoms disappear compared with that before treatment;invalidity: no symptom improvement.Material collection and data processing:check and accept the case reports according to the clinical trial plan strictly.The case reports shou]d be complete and don' t omit any items.Collect all the observation forms for material analysis and summary.Input the information into computer,set up database with the software of EPIDATA 3.0,process and analyze statistically, summarize the clinical trials and give objective evaluation of the curative effect and safety of Jin' s Three-needle Therapy on ADHD.Statistical and analysis methods:examine the classified material withχ²;the ranked data is obtained by comparing the two samples with Wilcoxon rank sum test;the measurement data is obtained by comparing the mean of the two samples with t analysis;self circa comparison takes the t analysis or Wilcoxon rank sum test:the statistical analysis is completed with SPSS 11.5 software.Result:This trial takes 108 qualified examinees with 45 patients in the Controlled Group.The Western Medicine diagnosis is ADHD and the Chinese Medicine diagnosis is liver and kidney-yin deficiency.Take the comparability analysis of the baseline features of patients in two groups and find there' s no statistical significance in gender,age,average age,disease course,Chinese Medicine total score,hyperactivity index total score,Chinese Medicine major syndromes like restlessness,distraction of attention,low learning efficiency,Chinese Medicine minor syndromes like burning sensation of 5 centers,frigidity,loss of nourishment in hair,vermilion and dryness of lips, fond of cold drinks,night sweat,tongue texture,coated tongue,pulse tracing, 18 ADHD symptoms of DSM-â…£and hyperactivity level,etc.The above comparability examination before treatment shows that there' s no significant difference in Chinese Medicine major and minor syndromes and 18 ADHD symptoms of DSM-â…£.It indicates that there' s equilibrium in the major prognostic factors of the two groups.There' s statistical significance of the total curative efficacy 3 months after treatment in the 2 groups(P=0.012).There' s no statistical significance in the improvement level of indexes like Chinese Medicine syndrome total score(P=0.00 ),Chinese Medicine major symptoms like restlessness(P=0.026),distraction of attention(P=0.001),low learning efficiency(P=0.035),Chinese Medicine minor syndromes like burning sensation of 5 centers(P=0.014),frigidity(P=0.042),loss of nourishment in hair (P=0.011),vermilion and dryness of lips(P=0.007),fond of cold drinks (P=0.017) and night sweat(P=0.036),etc.It indicates that the curative efficacy of Acupuncture Group is better than that of the Western Medicine Group.Compare the 18 items of ADHD symptoms' improvement 3 months after treatment of two groups and find there' s statistical difference in hyperactivity indexes(P=0.00),the disappearance rate of distraction of attention(P=0.0496) like not being able to finish homework,housework or work according to other' s instructions not because of defiance or inability to understand,etc.There' s statistical significance between curative efficacy and age in the Acupuncture Group(P=0.03).The younger the age,the better the effect.Compare the total periodic efficacy of two groups and find the Acupuncture Group has better curativeefficacy than the Western Medicine group.Compare the side effects and find that the Acupuncture Group has fewer side effects than the Western Medicine group.In summary,ADHD treatment with Jin' s Three-needle Therapy achieves good curative effect and the total efficacy is better than taking Western Medicine orally.Conclusion:Jin' s Three-needle Therapy on ADHD treatment takes Chinese Medicine basic theories as guidance and selects different acupoints and corresponding needling methods according to Chinese Medicine differentiation.The clinical observation shows that it has confirmed good efficacy and little pain.It' s easy to be accepted by children patients and suitable for clinical promotion. As ADHD has long disease course and may accompany patients life long and has high recurrence rate,therefore it needs long-term follow up and interviews, so as to clarify Jin' s Three-needle Therapy' s efficacy more definitely and help children patients improve their social functions and improve their survival quality.This also indicates us the next research direction.No obvious impairment to heart,liver,kidney and blood system is found in clinic and it' s safe in clinical application.