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ORIGINAL ARTICLE
Multicenter Clinical Study on the Treatment of Children's Tic Disorder with Qufeng Zhidong Recipe ()
WU Min ( )1, XIAO Guang-hua ()2, YAO Min ( )3 , ZHANG Jian-ming ()1, ZHANG Xin ( )1, ZHOU Ya-bing ()1, ZHANG Jing-yan ()4, WANG Shu-xia ()2, MA Bo ( )2, and CHEN Yan-ping ()3
ABSTRACT Objective: To assess the effect and adverse reaction of Qufeng Zhidong Recipe (,

QZR) in treating children's tic disorder (TD). Methods: With multicenter randomized parallel open-controlled method adopted, the patients enrolled were assigned to two groups, 41 cases in the Chinese medicine (CM) group and 40 in the Western medicine (WM) group. They were treated by QZR and haloperidol plus trihexyphenidyl respectively for 12 weeks as one course. In total, two courses of treatment were given. The curative effect and adverse reactions were evaluated by scoring with Yale Global Tic Severity Scale (YGTSS), Traditional Chinese Medicine Syndrome Scale (TCMSS), and Treatment Emergent Symptom Scale (TESS), as well as results of laboratory examinations. Results: After one course of treatment, the markedly effective rate in the CM and the WM group was 14.6% and 17.5%, respectively, and the total effective rate 43.9% and 47.5%, respectively, which showed insignificant difference between groups (P >0.05). However, after two courses of treatment, markedly effective rate in them was 73.2% and 7.5%, and the total effective rate was 100.0% and 57.5%, both showing significant differences between groups (P <0.05). Besides, the adverse reactions occurred in the CM group was less than that in the WM group obviously. Conclusion: QZR has definite curative effect with no apparent adverse reaction in treating TD, and it can obviously improve the symptoms and signs and upgrade the quality of life and learning capacities in such patients. KEY WORDS tic disorder, Chinese medicine, Qufeng Zhidong Recipe, haloperidol, multicenter study

Tic disorder (TD) is a kind of complex chronic neuropsychopathic disturbance characterized by a certain form of involuntary quick and repeated arrhythmic motions and/or purposeless burst of tics(1), which is mostly seen in children and the youth. A report published in 2007 show that 5%-20% of school aged children have suffered from transient tic, 1%-2% children suffered from chronic TD, and about 0.1%-0.5% children have Gilles de la Tourette's syndrome(2). In addition, an increasing tendency of incidence of the disease was shown in recent years. Besides, the frequently accompanied behaviors like attention-deficit hyperkinetic, obsessive, social disorder, learning difficulty, and self-inflicted actions could severely affect learning, quality of life, and social activities of the ill children, bringing heavy mental pressure to their parents. No special treatment for TD has been found so far, but Chinese medicine (CM) is of importance in this field. According to the academic thesis of "Treatment from the View of Fei ()" established by well-known pediatrician Prof. LIU Bichen, the authors created the Qufeng Zhidong Recipe

(, QZR) based on the principle of regulating both Gan ( )-Fei ( ) and applied it in clinical practice to treat TD. It has been proven by prophase toxicological experimental study that the recipe and its single components have no toxicity and basically have no side effects on mice(3). For the sake of evaluating its clinical effectiveness for treatment of children TC, a prospective multi-center randomized parallel opencontrolled trial was conducted.
Supported by Funds from Shanghai Bureau of Health (No. 2006L014); Developing Center of Shanghai Shenkang Hospital (No. SHDC12007409); and Second Group of Construction Projects of Traditional Chinese Medicine Clinical Predominant Item (No. 2008YSZK003) 1. Xinhua Hospital Affiliated to Medical School of Shanghai Jiaotong University, Shanghai (200092), China; 2. Medical School of Shanghai Jiaotong University, Shanghai (200025), China; 3. Yueyang Hospital of Integrative Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai (200437), China; 4. Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai (200032), China Correspondence to: Dr. WU Min, Tel: 86-13916191254, E-mail: xinhuayiyuan123@126.com DOI: 10.1007/s11655-009-0254-1

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METHODS
Standard for Western Medical Diagnosis
According to the "ICD-10, Classification, Clinical Description, and Diagnostic notes of Mental and Behavior Disorder(4)", the criteria for diagnosis of TD was defined as (1) with one or several motive and/ or vocal tic, manifested as sudden quick repeated arrhythmic and rigid motion or phonation; (2) illness could induce apparent restlessness and has an impact and influence on social activities and the occupation of the patients; (3) initiated before 18 years old; and (4) the symptoms induced by certain drugs, like analeptic or some internal diseases, such as Huntington's chorea or postviral infectious encephalitis, could be excluded. According to the "Diagnostic and Statistical Manual for Mental Disorders (DSM- )" (5), patients with TD may be classified into three types depending on their course of illness and symptoms presented. (1) The transient tic disorder (TTD) type: patients with motive and/or vocal tic, with several attacks every day for at least four weeks but not over one year. (2) Chronic tic disorder (CTD) type: patients with motive or vocal tic, with several attacks every day for over one year continuously or remittent interval shorter than three months. (3) Tourette syndrome (TS) type: patients with multiple motive tics and one or several vocal tic attacks every day, which might not present at various times, and the disease had progressed continuously for over one year or had intermittent attacks for over one year with remittent intervals not longer than three months.

is accompanied with symptoms of wind cold or wind heat. The secondary symptoms were restlessness, bad temper, dizziness, headache, yellow complexion, thinness, spiritlessness, darkish red cheek, vexed hot sensation in palms, soles, chest, etc. All patients enrolled matched the above mentioned standards for TD diagnosis and CM syndrome differentiation. Those with habitual tic, muscular spasmatic epilepsy, rheumatic chorea, Wilson's disease, brain trauma, postencephalitis, and extrapyramidal diseases were excluded.

Case Selection
Trials were conducted in the TD children who visited the TD special clinic of the Xinhua Hospital affiliated to Shanghai Jiaotong University and the pediatric clinic of the Yueyang Integrative Hospital of Shanghai Traditional Chinese Medicine University from October 2007 to September 2008. Patients were assigned by randomized digital method made in Excel, with the predisposed drop-out rate less than 10%. Totally, 88 cases were enrolled and were assigned to the CM group and the Western medicine (WM) group equally. Comparisons among groups showed that the sex, age of initiation, age visiting, duration, clinical type, and syndrome type of illness were not significantly different (P >0.05), neither were they significantly different in baseline scores by Yale Global Tic Severity Scale (YGTSS)(8) and Traditional Chinese Medicine Syndrome Scale (TCMSS), see Table 1.

Standard for Chinese Medicine Syndrome Differentiation

In reference to the related national standard and the criteria for CM syndrome typing of children TD in the teaching materials for higher TCM schools(6,7) and the clinical characteristics of TD, the CM syndromes presented in patients were differentiated to four types: Type , the external wind invasion to Fei with internal upset Gan wind (W-FG); Type : W-FG combined with Gan stagnancy induced fire; Type : W-FG combined with Pi ()-deficiency induced phlegm accumulation; and Type : W-FG combined with yin-deficient induced Wind stirring. The dominant symptoms were tics of head, face, and limbs, wrinkling at the brow with blinks, mouth corner spasm, phlegmy song in throat, or strange voice and bawdry speech. In addition, it

Treatment
In the CM group, the decoction of QZR was administered twice a day, 100 mL each time. One dose of QZR consisted of magnolia immature flower 10 g, gastrodia rhizome 10 g, scorpion 5 g, uncaria stem with hooks 10 g, isatis root 10 g, pawpaw 10 g, and buck grass 10 g. It was prepared with autodecocting and packing machine (type DJQ252, Korea) by boiling down two times to 200 mL of decoction. Patients in the WM group were treated by haloperidol tablet (product of Shanghai Xinyi Jiufu pharmaceutical Co. Ltd., Batch number 080302) at the dose of 25 g/kg twice a day, and the dosage might be reduced gradually after the condition of disease was controlled. Meanwhile, equal dosage of trihexyphenidyl was given for alleviating adverse

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Chin J Integr Med 2009 Aug;15(4):254-260 Table 1. Baseline Data of Patients in the Two Groups
CM Male Female TTD CTD TS 35 (85.4) 6 (14.6) 18 (43.9) 16 (39.0) 7 (17.1) 26 (63.4) 8 (19.5) 3 (7.3) 4 (9.8) 7.101.67 9.702.01 17.906.15 56.003.33 8.602.95 WM 31 (77.5) 9 (22.5) 17 (42.5) 15 (37.5) 8 (20.0) 21 (52.5) 10 (25.5) 3 (7.5) 6 (15.0) 6.431.02 9.101.13 18.537.02 58.104.67 9.602.95 2=0.97 0.81 2=0.10 0.95 Test value =0.74
2

Item Sex [Case (%)] Clinical type [Case (%)]

P value
0.57

Syndrome type [Case (%)]

Initiation age (Yr, s ) Visiting age (Yr, s ) Illness course (Month, s ) YGTSS score ( s ) TCMSS score ( s )

t =0.93 t =-0.22 t =-2.89 t =-2.23 t =-1.06

0.31 0.32 0.10 0.63 0.09

reactions. The therapeutic course for both groups was 12 weeks (3 months), and the trial involved two courses.

months. YGTSS scoring was performed at the end of 4th, 8th, 12th, 16th, 20th, and 24th week of treatment. Then, the SSR and the total effective rate (the sum of markedly effective rate and effective rate) were calculated. TCMSS was made in reference to the format of questionnaire worked out by the Integrative Medical Institute of Xiangya Hospital affiliated to Zhongnan University. The severity of syndromes, including 27 symptoms and figures of tongue and pulse, was divided into four grades and was scored, respectively, with no symptom scored as 0, mild grade as 1, moderate grade as 2, and severe grade as 3.

Standard for Efficacy Evaluation

Scores estimated by YGTSS and TCMSS [formulated in the National key scientific and technological projects of tenth five-year (No.2001BA701A22)] were used for efficacy evaluation. YGTSS was established by the Children Researching Center of Yale University, USA, which consisted of three portions. The first portion was the questionnaire for motive or vocal tic, including the main position and the form of the tics. The second portion was the criteria for scoring the severity of tic, which was scored to 05, from grade 0 to grade 5 in five dimensions, i.e., quantity, frequency, intensity, complexity, and interference on normal behavior, to make the total scores as 25. The third portion was the criterion for global injury estimation by scoring in 05, with a total score of 50. The score subtraction rate (SSR), calculated by formula: (pre-treatment scores post-treatment scores)/pre-treatment scores 100%, was taken as the index for efficacy evaluation. The efficacy was evaluated as markedly effective if SSR 67%, as effective if SSR >33% but <67%, as ineffective if SSR 33%, and as cured if symptoms completely disappeared with no relapse in the six follow-up

Items and Methods of Laboratory Indexes

Scoring by Treatment Emergent Symptom Scale (TESS)(9) was estimated for adverse reaction assessment. Electroencephalogram (EEG), antistreptolysin O test, and erythrocyte sedimentation rate (ESR) were detected before treatment; routine tests on blood and urine, as well as kidney and liver function, were tested before and after treatment.

Statistical Analysis
Software SPSS 13.0 was used to perform the statistical analysis. The t -test or variance analysis was

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applied for measurement data in different groups and 2 analysis was applied for enumeration data.
YGTSS

100 80 60 40 20 0 0 4 8 12 16 Time (Week) 20 24

CM WM

RESULTS
Cases Dropped Out
In the 66 cases observed in Xinhua Hospital, five cases dropped out (2/33 in CM group and 3/33 in WM group); and in the 22 cases observed in Yueyang Hospital, two cases dropped out (1/11 in each group). Thus, the trial was completed ultimately in 81 cases in which the dropping rate is 8.0% wherein seven cases dropped out.

Figure 1. YGTSS Scores at Different Time Points

Comparison of YGTSS Scores

Comparison showed that the YGTSS scores in the CM group were higher than that in the WM group after a four-week treatment, showing a significant difference between groups (P <0.05). It decreased gradually in the CM group with a significant difference to that before treatment (P <0.05) after the 12th week. While in the WM group, after a toboggan took place at the 4th week, it elevated gradually after then and basically maintained at an even level. Thus, the YGTSS score in the CM group became lower than that in the WM group at the 20th and 24th week (P <0.05), see Table 2 and Figure 1.

it changed in the waveform. Thus, a higher total effective rate was presented in the WM group before the 12th week, but after then, the higher level changed to the CM group, especially at the 24th week, and the difference between the two groups became significant statistically (P <0.05, See Figure 2).

Comparison of Improvement in CM Syndromes

After a 24-week treatment, the TCMSS scores in patients of the CM group of various syndromes, especially that in the patients of syndrome type and , were all decreased to a certain extent, showing statistical significances as compared with those before treatment (P <0.05). In patients treated with WM, it also showed some decrease, but no significant
100 80 60 40 20 0 4 8 12 16 20 Time (week) 24
CM WM

At the 12th week, the markedly effective rate was 14.6% and 17.5% and the total effective rate 43.9% and 47.5%, respectively, in the CM group and the WM group; while after the two courses of treatment (24 months), the markedly effective rate was 73.2% and 7.5%, and the total effective rate 100% and 57.5%, respectively. It could be seen in Figure 2 that the total effective rate in the CM group at the sequent time points raised continuously, while in the WM group,
Table 2.
Group Case CM WM 41 40

Total Effective Rate (%)

Comparison of Clinical Efficacy

Figure 2.Comparison of Total Effective Rate between Groups

Comparison of YGTSS Score between Groups at Different Time Points (Score, s )

YGTSS score 0 4 week 54.203.43 30.303.36 8 week 46.003.13 37.303.66 12 week 38.803.55 38.422.85 16 week 30.903.78 35.804.38 20 week 26.102.56

24 week 14.832.11 35.562.74

57.803.20 58.103.67

36.603.29

Notes: P <0.05, compared with before treatment; P <0.05, compared with the WM group at the same time point

Table 3.
Group CM WM Case 41 40

Comparison of SSR in Patients of Different Syndrome Types between Groups (Score, s )

SSR 0.930.30 0.590.24 0.900.25 0.590.27 0.750.24 0.640.21 0.600.15 0.570.19

F value
3.24 4.40

P value
<0.05 >0.05

Note: P <0.05, compared with the corresponding syndrome type in the WM group

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difference was found in patients of different syndrome types. Comparison between groups showed that significant difference of SSR was shown in patients of syndrome type and (P <0.05, Table 3).

Except for the data that the platelet count in the WM group at the 12th week was significantly lower than that in the CM group (227.7109/L vs 246.5109/L, P <0.05), all the laboratory indexes tested before and after treatment were in the normal range.

Comparison of Score on Single Item of YGTSS

As shown in Tables 4 and 5, after 24 weeks of treatment, significant improvement was shown in all the items of motive tic in the CM group (P <0.05), but significant improvement in the WM group was only shown in items of intensity, complexity, and interference on normal behavior (P <0.05). As for the vocal tic, significant improvement was shown in both groups in terms of frequency, intensity, and interference (P <0.05). Comparison between groups after treatment showed that all scores of motive tic, except that on intensity, and the scores of vocal tic on frequency, intensity, and interference were lower in the CM group than those in the WM group (P <0.05).

DISCUSSION
TD is a group of neuropsychopathis disturbance manifested as paroxysmal involuntary tic and/or accompanied with bursts of gutturophony and behavior disorder(10), which mostly occurred in children and the youth and its incidence tends to increase in recent years. The pathogenesis and mechanism of TD are still unclear, and someone conferred that it might be related with some dopamine associated genes(11). The name of TD could not be found in CM historical medical literature. Scholars assort the disease according to its clinical manifestations to the categories of clonic convulsion, chronic spasm, Ganwind syndrome, etc (12). Moreover, it holds that its location is mainly at Gan, with close relation to Xin (), Fei, Pi, and Shen (), and its basic pathogenesis is generally internal Gan-wind upsetting. Following the academic thesis of "Treatment from View of Lung"established by the well-known pediatrician Dr. LIU Bi-chen's work and in combination with modern medical theories, the authors proposed that the chief principle for treatment of TD is to adjust both Gan and Fei, wherein the aim of which is for ventilating Fei to dispel external Wind, for

Adverse Reaction
TESS scores in the CM group at the 12th and 24th week were all significantly lower than those in the WM group (P <0.05). Moreover, the score in the latter increased as treatment progressing, showing a significant difference between the scores estimated at the time points of 24th and 12th week (P <0.05). Symptoms of adverse reactions in the CM group were mainly slight poor appetite, while in the WM group (P<0.05), learning achievement, body weight gaining, hypopraxia, drowsiness, etc. appeared.
Table 4.
Group CM WM Case 41 40 Time BT AT BT AT

Comparison on YGTSS Motive Tic Scores between Groups ( s )

Scores on different items of motive Tic Quantity 3.260.36 1.200.89 3.210.49 2.820.67

Frequency 3.520.69 1.210.79 3.660.38 2.880.91

Intensity 3.170.60 1.880.67* 3.320.46 0.930.38

Complexity 2.680.71 0.450.39 2.500.43 0.750.58

Interference 2.440.62 0.260.43 2.100.66 0.730.37

Notes: P <0.05, compared with BT in the same group; P <0.05, compared with the WM group at the same time; BT: before treatment; AT: after treatment. The same in the table below.

Table 5.
Group CM WM Case 41 40 Time BT AT BT AT

Comparison on YGTSS Vocal Tic Scores between Groups ( s )

Scores on different items of vocal tic Quantity 2.380.61 2.110.29 2.610.70 2.290.44 Frequency 2.410.71 0.140.24 2.480.15 0.400.33

Intensity 2.250.53 0.270.09 2.390.26 0.940.39

Complexity 0.990.59 0.780.20 1.080.62 0.880.29

Interference 1.540.71 0.110.18 1.310.54 0.180.31

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smoothening Gan, and dredging collaterals to stamp out internal Wind. On the basis of this principle, QZR was formulated by modifying the classic recipe for dispelling external Wind, the Cangerzi Powder ( ), and that for smoothening Gan-wind, the Tianma Gouteng Decoction ( ). In QZR, magnolia flower effects to disperse evil pathogen for clearing the nasal passage; gastrodia tuber to smoothen Gan, stamp out wind, stop spasm, and dredge collaterals; scorpion to dispel Wind, stop spasm, dredge collaterals, and alleviate pain, the three are set as monarch drugs, which work together to achieve the function of dispersing wind, clearing passage, removing evil pathogen, smoothening Gan, dispelling wind, and stopping spasm. Besides, uncaria could clear heat, smoothen Gan, dispel Wind, and dredge Collateral; istis root could clear heat, remove toxic substances, and refresh throat. These are set as adjuvant drugs for assisting monarch to lustrate evil pathogen, protect Fei, smoothen Gan, and relieve tic. Pawpaw and buck grass could clear heat to dissolve phlegm dampness, dispel wind, and unblock meridian collateral, which are used for guidance. The whole recipe can dispel either external or internal wind, treat both the essence and the superficiality, and regulate Gan and Fei(13). Modern medicine suggested that TD might be a streptococcal infection associated pediatric autoimmune neuropsychiatric disorders (14), which proves the rationality of authors' viewpoint on the pathogenesis of TD, i.e., TD is caused by external Wind invasion to Fei, and it induces Gan-wind upsetting. The current Western medical treatment on TD is mostly the use of dopamine receptor blocking agents such as haloperidol for relieving symptoms. However, the restriction of its dose in use due to adverse reactions such as lethargy, dizziness, and extrapyramidal system symptoms that would have a direct influence on the usage of the treatment and serve as a foil to the advantages of CM in its persistent action, definite efficacy, and less adverse reactions. The cases enrolled in this study were basically consistent with those reported abroad but with a slightly shorter course of illness(15). Results of the study showed that the YGTSS score in the CM group

decreased along with the progress of the treatment, while in the WM group, it decreased after an abrupt decrease at the 4th week. This fact displayed evidently the persistent, stable, and reliable effect of QZR in treating TD, while haloperidol, although with obvious immediate effects, had its therapeutic effects lowering gradually in the maintenance period. In spite of the fact that the total effective rates in the WM group at various time points before the 12th week were higher than those in the CM group, significant difference between groups was only shown at the 4th week after the treatment started (P <0.05). On one hand, the total effective rate after then in the CM group kept increasing, which reached 100% finally, and on the other hand, the WM group showed a decreasing tendency, with the effective rate fluctuating a little but kept on 50% after the 24th week. Thus, we can say that the total effective rate in the former was significantly higher than that in the latter ultimately (P <0.05). YGTSS is the authoritative scale for clinical estimation of the severity of TD. It was found in this study that after treatment, the vocal tic was evidently improved in both groups in terms of frequency, intensity, and interference (P <0.05). However, the showed that improvements in all scores were better in the CM group than those in the WM group (P <0.05); as for the various dimensions of motive tic, ultimate YGTSS scores on the tic volume, frequency, complexity, and interference were lower in the CM group than in the WM group (P <0.05). However, a lower score on intensity was shown in the WM group, which might be due to the strong antagonizing effect of haloperidol on dopamine receptor and also could result from adverse reactions of haloperidol on central nervous system like drowsiness and lassitude. The adverse reactions of haloperidol, such as drowsiness, lassitude, dizziness, constipation, dysuria, and extrapyramidal system reaction, are severe. Although trihexyphenidyl, an antiextrapyramidal reaction drug, had been medicated coordinately, the adverse reactions such as underachievement in studies, body weight gaining, hypopraxia, drowsiness, etc., still revealed in a part of the patients in the WM group. However, in the CM group, adverse reactions that occurred were merely slight poor appetite, etc. In summary CM has a definite clinical efficacy

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China; 1997:7-84. 7. Wang SC. Traditional Chinese pediatrics. Beijing: China Press of Traditional Chinese Medicine;2002:137-140. 8. Leckman JF, Eiddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, et al. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry 1989;28:566-573. 9. Zhang MY. Manual for rating scale of psychopathy. 2nd ed. Changsha: Hunan Science Press; 1998:150-153. 10. Li DN. Modern neurologic medicine. Jinan: Shandong Science and Technology Publishing House; 2004:542. 11. X i a o G H , W u M . S t u d y o n T o u r e t t e ' s s y n d r o m e and dopamine relative genes. Shanxi Med J (Chin) 2008;37:716-717. 12. Liu BC, Wang JH, Chen D, Wang HL. Review of clinical researches on TCM treatment of Gilles de la Tourette's syndrome. J Beijing Univ Tradit Chin Med (Chin) 1996;19:2-6. 13. Wu M, Ni HB, Ge AK, Zhou YB, Lu WW. Clinical study on liver-lung harmonization therapy for children's Tourette's syndrome. Shanghai J Tradit Chin Med (Chin) 2005;39:35-36. 14. WU M, Lu WW, Zhang JM. Clinical effect of traditional Chinese medicine on childhood Gilles de la Tourette's syndrome. Chin J Inf Tradit Chin Med (Chin) 2006;13:68-69. 15. Spencer T, Biederman J, Coffey B, Geller D, Crawford M, Bearman SK, et al. A double-blind comparison of desipramine and placebo in children and adolescents with chronic tic disorder and comorbid attentiondeficit/hyperactivity disorder. Arch Gen Psychiatry 2002;59:649-656. (Received November 7, 2008) Edited by GUO Yan

in treating children's TD. QZR shows evident effects after a 12-week medication, which is obviously superior to that of haloperidol. Its advantage is also shown by less adverse reactions. Accordingly, the authors proposed that TD should be diagnosed and treated early, and patients should take CM therapy as the first choice, which should be implemented normally for at least one course (three months), with two courses recommended, and a half-year treatment for consolidation preferred. If there are severe unendurable tic attacks, short-term full dose haloperidol may be administered for assistance. The dosage of haloperidol should be gradually reduced after symptoms are relieved. Meanwhile, continuous CM therapy should be given to consolidate the effect.

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