| ObjectiveThe present study is to explore the profile of generalized anxiety disorder patients with painful physical symptoms in a TCM hospital, and to investigate the efficacy and safety of Chaihu Guizhi Decoction on the syndrome of Stagnation of liver Qi in GAD with PPS.MethodsFirst, we investigated215GAD patients with PPS and153without PPS from September2010to February2012in Guangzhou Hospital of Traditional Chinese Medicine. A self-designed questionnaire was used which covers the information of age, gender, blood type, marital status, occupation, educational background, economic conditions and duration of GAD. GAD was assessed by Hamilton Anxiety Scale (HAMA), PPS was assessed by Short-form of McGill Pain Questionnaire (SF-MPQ) Social Disability was assessed by Social Disability Screening Schedule (SDSS).Next,80cases with the syndrome of stagnation of liver qi in GAD Patients with PPS were randomly assigned into study group (n=40), treated by Chaihu Guizhi Decoction and control group (n=40), treated by Flupentixol and Melitracen Tablets for6weeks. HAMA, SF-MPQ, SDSS and self-designed TCM Syndromes Scale were used to evaluate the efficacy of Chaihu Guizhi Decoction. Treatment Emergent Symptom Scale (TESS) was used to assess side effects. Assessments began at baseline, and the2nd,4th and6th weekend as well as2week later after a withdrawal.All statistical analyses were performed by SPSS13.0software, including t-tests, Wilcoxon singed-rank tests, Wilcoxon rank sum tests, x2tests and tests of Fisher's exact probability.Results1. There are no difference on Age, gender, blood type, marital status between GAD patients with PPS and the group without PPS (P>0.05), but occupation, educational background, economic conditions, course of the disease, TCM syndromes, HAMA scores, SDSS scores were found some difference (P<0.05).2. In the Full Analysis Set (FAS), we found that HAMA score of both2groups decreased significantly after treatment (P<0.01).In the4th weekend after treatment, the effect of study group was better than in the2nd weekend (P<0.01). The effect in study group had no significant difference in the4th and6th weekend after treatment (P>0.05), as well as in the6th weekend after treatment and2nd weekend after withdrawal (P>0.05).The effect of control group had no significant difference in the2nd,4thweekend after treatment (P>0.05), as well as in the4th,6thweekend after treatment (P>0.05), and had no significant difference between the6th weekend after treatment and2nd weekend after withdrawal (P>0.05).In the2nd,4thweekend after treatment, the effect between2groups had no significant difference (P>0.05). At the6th weekend after treatment and2nd weekend after withdrawal, the effect of study group was better than that in control group (P<0.05).But Per-Protocol Population Set (PPS), revealed a different result. In the2nd,4th,6th weekend after treatment, the effect between2groups had no significant difference (P>0.05). In the2nd weekend after withdrawal, the effect of study group was better than control group (P<0.05).3. Full Analysis Set (FAS) showed that SF-MPQ score of both groups decreased significantly after treatments (P<0.01).The effect of study group in the4th weekend was better than that in the2nd weekend after treatment (P<0.01), and that in the6th weekend was better than that in the4th weekend (P<0.01), and there was no significant difference between the6th weekend and2nd weekend after withdrawal (P>0.05).In the4th weekend after treatment, the effect of control group was better than that in the2nd weekend (P<0.05), but has no significant difference compared with that in6thweekend (P>0.05), and no difference between that in the6th weekend and that in2nd weekend after withdrawal (P>0.05). In the2nd,4thweekend, the effect between2groups had no significant difference (P>0.05). In the6th weekend after treatment and2nd weekend after withdrawal, the effect of study group was better than control group (P<0.01).This study gained the same results from the Per-Protocol Population Set (PPS).4. In the Full Analysis Set (FAS), we found that SDSS score of both2groups after therapy decreased significantly (P<0.01).In the4th weekend after treatment, the effect of study group was better than in the2nd weekend after treatment (P<0.01). In the6th weekend after treatment, the effect of study group was same as in the4th weekend after treatment (P>0.05). The effect of study group had no significant difference in the6th weekend after treatment and2nd weekend after withdrawal (P>0.05). The effect of control group had no significant difference in the2nd,4thweekend after treatment (P>0.05).The effect of control group had no significant difference in the4th6thweekend after treatment (P>0.05). The effect of control group had no significant difference in the6th weekend after treatment and2nd weekend after withdrawal (P>0.05).In the2nd,4thweekend after treatment, the effect between2groups had no significant difference (P>0.05). In the6th weekend after treatment and2nd weekend after withdrawal, the effect of study group was better than comparative group (P<0.05).There were same results in the Per-Protocol PoPulation Set (PPS).5. In the Full Analysis Set (FAS), we found that TCM syndromes score of both2groups decreased significantly after treatment (P<0.01).In the4th weekend, the effect of study group was better than that in the2nd weekend (P<0.01), and that in the6th weekend was better than that in the4th weekend (P<0.05). Study group had no different results in the6th weekend and in the2nd weekend after withdrawal (P>0.05).The effect of control group had no significant difference in the2nd and the4thweekend after treatment (P>0.05), and no significant difference in the4th and the6thweekend (P>0.05), and no significant difference in the6th weekend and in the2nd weekend after withdrawal (P>0.05).In the2nd weekend, the effect between2groups had no significant difference (P>0.05). But in the4th,6th weekend after treatment and2nd weekend after withdrawal, study group was better than control group (P<0.01).Otherwise, Per-Protocol Population Set (PPS), revealed some difference. In the2nd and the4th weekend after treatment, the effect between2groups had no significant difference (P>0.05), but study group was better than control group in the6th weekend and the2nd weekend after withdrawal (P<0.05, P<0.01, P<0.01).6. There were no serious side effects in both groups. The side effects found in study group were dry mouth, anorexia, and found in control group were insomnia, dry mouth, tremor, anxiety, dizzy, anorexia, fatigue. TESS evaluation revealed that the side effect between two groups had no significant difference(P>0.05).Conclusion1. The poorly educated, low income level, jobless, retiree, farmer, self-employed, Stagnation of liver Qi are risk factors for PPS. The patients of GAD with PPS are more anxious and have a longer history and worse social disability than ones without PPS. The main TCM pathogenesis for PPS is stagnation of qi activity.2. Chaihu Guizhi Decoction has certain effect in the treatment of Liver Qi Stagnation GAD with PPS. This therapy is more effective in releasing symptoms such as anxiety and pain, and has less side-effect compared with Deaxit after6weeks of treatment.3. Chaihuguizhitang Recipe is an effective therapy in improving anxiety, pain, social disability and chinese symptoms.4. Chaihuguizhitang Recipe and Deaxit has the same short-time efficacy, but Chaihuguizhitang Recipe are better in long-time.5. There is minor side-effect in treatment with Chaihuguizhitang Recipe. |
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