| 1. Background, purpose and significant of the researchGeneralized tonic-clonic seizure (GTCS) is a common type of seizure in epilepsy.Among the different types of seizures, GTCS affect most of one's intellectual function. Theadministration of the Anti-epileptic drug had been proven to be an effective treatment forepilepsy. Despite of its clinical effectiveness, the side effects of the anti-epileptic drugmaking doctors and patients facing another problem. Recent clinical studies hadconcentrated in the investigation for controlling the attack of GTCS, decreasing the sideeffect of anti-epileptic drug, and improving patient's quality of life. The target of thepresent study was patient suffers from GTCS. The objective was to compare the treatmenteffectiveness of using combine "Acupoint catgut embedding therapy" and "sodiumvalproate (VPA)" verse using VPA alone as control. The clinical significance of the presentstudy was to provide theoretical and clinical support for using the Acupoint catgutembedding therapy in the treatment of epilepsy.2. MethodsAncient and contemporary medical expert had described in literatures for the etiology,pathogenesis, treatment, and development of clinical use of acupuncture and Acupointcatgut embedding therapy for epilepsy. Modern medicine also described and gave commentand outlook for the pathogenesis, diagnosis, medication and medication side effect forepilepsy.Patients suffered from GTCS were screened according to the inclusion and exclusioncriteria and were recruited as the subjects for the present randomized control clinical trailstudy. The subjects were randomized into 2 groups naming 'treatment group' and 'controlgroup'. Subject in the 'control group' require to take VPA 0.2g tid daily whereas subject in the 'treatment group' require to receive Acupoint catgut embedding therapy in addition totake the same dosage of VPA as in the control group. Three group of main acupuncturepoint naming group A (Dazhui (Du 14), jinsuo (Du 8), bilateral Fenglong (S 40)), groupB (left Xinshu (B 15), left Ganshu (B 18), bilateral Yanglingquan (G 34)), and groupC(right Xinshu (B 15), left Ganshu (B 18), bilateral Binao (LI 14)) were chosen alternatelyand according to the syndrome differentiation principle for catgut embedment at 15 daysinterval. The duration of treatment lasts for three months. The treatment effectiveness wereexpressed in terms of the difference between the pre and post treatment scoring of theepileptic signs and symptom, quality of life in epilepsy, improvement inelectroencephalography (EEG), and clinical global impression scale. The combine effect ofthe "Acupoint catgut embedding therapy" and western medication of "sodium valproate(VPA)" and the relationship among the different syndrome differentiation group, course ofdisease and treatment effectiveness were also analyzed.3. ResultsThe overall effective rate in treatment group was 88.33% which was significantlygreater than the control group of 65%. The difference between two group was statisticallysignificant (p＜0.01). For the treatment effectiveness to decrease the frequency of seizuresattack, the overall effective rates in the treatment group was 91.67% which wassignificantly better than the control group of 71.67% (p＜0.01).For the quality of life in epilepsy, the treatment group showed a mark significantimprovement in the subscale of satisfaction of daily living, emotion, energy/fatigue,medication effect and social function (p＜0.01). The control group also showed significantimprovement in the same subscale as the treatment group (p＜0.05). To compare thetreatment group and the control group, the overall score and subscale of emotion,energy/fatigue and medication in the treatment group showed significant betterimprovement than that of the control group (p＜0.01).For the results of EEG improvement, both treatment group and control group were nosignificant improvement between the pre and post treatment evaluation (p＜0.01); however,there was also no significant difference between the treatment group and control group.For the clinical global impression scale (CGI), there was no significant differencebetween the treatment group and control group under the measure of 'severity of illness(SI)' and global improvement (GI). It might imply that there was similar clinical globalimpression for the overall effectiveness between the two group. There was a significantdifference between the treatment group and control group under the measure of 'efficacy index (EI)'. It might imply that the treatment group had significantly less sideeffect than the control group.In comparing the side effect occurred during the treatment process, the neurologicalside effect for patient taking the sodium valproate (VPA) include dizziness, fatigue, nausea,anorexia and loss of concentration. The treatment group showed a significant bettercontrol of the side effect than that of the control group (p＜0.01).In the study of the relationship between the treatment effectiveness and courses ofdisease, it was found that those patients with course of disease less than 5 years had thehighest overall effective rates of 100%. For those with course of disease range between 5 to10 years, the overall effective rate was 83.33%. Lowest overall effective rate of 40% wasfound in those with course of disease more than 10 year. There was statistically significantdifference among the different stratification of course of disease (p＜0.01). It was also foundthat the courses of disease was inversely proportional to the treatment effectiveness, theshorter the course of disease the better the treatment effectiveness.In studying the treatment effectiveness among the different types of syndromedifferentiation, the overall effective rate was syndrome of stirring wind with phlegmobstruction and Syndrome of wind fire flaming upward had the greatest treatmenteffectiveness whereas the treatment effectiveness for the group belongs to syndrome ofdeficiency of kidney essence was the least.4. ConclusionIn treating patient suffered from GTCS, the combined treatment using 'Acupointcatgut embedding therapy' and 'medication of VPA' showed definite clinical improvementand was significantly better and had less side effect than that of using 'medication of VPA'alone. It was also found that the effectiveness of using combined Acupoint catgutembedding therapy and medication of VPA correlate with the course of disease as theshorter the course of disease, the better the outcome. Lastly, the treatment effectiveness wasfound to be correlated to the syndrome differentiation according to the traditional Chinesemedicine theory. The groups belong to syndrome of stirring wind with phlegm obstructionand syndrome of wind fire flaming upward had the greatest treatment effectiveness whereasthe treatment effectiveness for the group belongs to syndrome of deficiency of kidneyessence was the least. |
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