| BackgroundGeneralized anxiety disorder (GAD) is a kind of anxiety disorder, with extensive and persistent anxiety mood as the main performance, often accompanied by symptoms of insomnia, nervous, dry mouth, and other autonomic nerve function symptoms, affected the quality of the patients’ life.Repetitive transcranial magnetic stimulation (repetitive transcranial magnetic stimulation, rTMS) is a new type of physical therapy, there were a lot of studies have confirmed the significant effects on the treatment of many mental disorders, but studies about the effect of rTMS in the treatment of generalized anxiety disorder is still less, and fewer reports about the effect and safety of different frequency rTMS combined with paroxetine in the treatment of generalized anxiety disorder. It is worthy evaluating so as to better guiding clinical application.Objective1.Through the HAMA and SAS score before and after the high and low frequency rTMS treatment combined with paroxetine ,to explore the anti-anxiety effect of high and low frequency rTMS combined with paroxetine on generalized anxiety disorder.2.By P300 and determination of eye movement, to explore the influence on cognitive function of high and low frequency rTMS combined with paroxetine in the treatment of generalized anxiety disorder.3.Based on the score changes of TESS scale before and after the treatment,evaluating the safety of high and low frequency rTMS combined with paroxetine in the treatment of generalized anxiety disorder.Methods1.According to the "American diagnostic and Statistical Manual of mental disorders Fourth Edition (DSM-IV)" diagnostic criteria for generalized anxiety disorder, with Hamilton Anxiety Scale (Hamilton-14,HAMA) score more than 14 points into the group, were randomly divided into study group and control group,the study group was divided into high frequency rTMS+ drug group (HF group), low frequency rTMS+ the medicine group (LF group).The control group is drug and sham stimulation (Control group), 20 cases in each group.It’s a basis maintenance treatment by given proxetine with a fixed dose of 20mg/d.2.Assess the treatment efficacy by Hamilton Anxiety Scale (HAMA), Self Rating Anxiety Scale (SAS); Event related potential P300, and determination of Eye Movement.3.Safty evaluation:At the end of every rTMS treatment,assess patients with general life signs and syncope, seizures, discomfort and pain, hearing loss, the lack of memory and other symptoms carefully, and evaluate Side Effects Scale (TESS),ECG,blood routine,liver function,renal function,myocardial enzyme and EEG before treatment,and the end of the 2st,4st week.Results1. HAMA and SAS score and reducing rate of change(1) HAMA and SAS score:Three groups of generalized anxiety patients before treatment and after 1 weeks of treatment, the SAS and HAMA scores had no statistical difference(P>0.05). The difference was statistically significant compared at the second weekend in HAMA score of high frequency group and the control group (P=0.005), no significant difference between low frequency group and the control group (P=0.147). There’s no significant difference between high frequency group and the low frequency group (P=0.147). SAS score high frequency group and low frequency group compared with the control group, the difference was statistically significant (P=0.006,P=0.002). There’s no significant difference between high frequency group and the low frequency group (P=0.720). After fourth weeks, the high frequency group and low frequency group compared the control group, the difference was statistically significant (P=0.000). No significant difference between high frequency group and the low frequency group (P=0.808, P=0.464).(2) The reduction rate of scores of HAMA and SAS:After the first week treatment, compared with control group, high frequency group and the low frequency group had no statistical difference (P=0.081, P=0.471).At 2st,4st weekend, high frequency group and the low frequency group HAMA score reduction rate is higher than the control group, the difference has statistical significance (P<0.05). And for second week the difference of high frequency group and the low frequency group was statistically significant (P=0.000). At 2st, 4st weekend, high frequency group and the low frequency group SAS score reduction rate is higher than the control group, the difference was statistically significant (P<0.05). No significant difference between high frequency group and the low frequency group (P=0.738,P=0.733).2. The latency and amplitude of each event related potential P300(1) The latency of P300:before treatment, high frequency group, low frequency group and control group latency difference have no statistical significance (P=0.971). After 4 weeks the latency of the three group shortened than before treatment, and there was statistical significance differences before and after treatment in high frequency group and the low frequency group (P=0.000, P=0.001). Before and after treatment, the control group had no statistical difference (P=0.206), after 4 weeks’ treatment, compared with control group, high frequency group and the low frequency group had significant difference (P=0.019), and there was significant differences compared high frequency group and the low frequency group (P=0.027).(2) The amplitude of P300:Three groups have no significant difference before treatment (P=0.816). After treatment, there was statistical significant differences in high frequency group and the low frequency group (P=0.003, P=0.002), the control group had no statistical difference (P=0.658). After the 4 weeks’ treatment, high frequency group and low frequency group compared with the control group had significant difference (P=0.013, P=0.023). There’s no significant difference between high frequency group and the low frequency group (P=0.814).3. Change of NEF and RSS on EEM in each group(1) Change of NEF in each group:The changes of NEF were compared before treatment in three groups:NEF no significant difference (P=0.651). After 4 weeks of treatment, three groups of NEF were increased than before treatment, but there is statistical significant differences before and after treatment between high frequency group and the low frequency group (P=0.000,P=0.011), while the control group, although the NEF treatment has increased than before, but no significant difference before and after treatment (P=0.319). After 4 weeks of treatment, compared with control group, high frequency group had significant difference (P=0.006), while the low frequency group had no significant difference (P=0.330). No significant difference between high frequency group and the low frequency group (P=0.063).(2) The change of RSS before and after treatment in three groups:The changes of RSS has no significant difference before treatment in the three groups (P=0.965). After 4 weeks of treatment, three groups of RSS were increased than before. There is statistical significant differences before and after high frequency group and the low frequency group (P=0.000,P=0.023), and in control group the difference between before and after treatment were no statistics difference significance (P=0.082). After 4 weeks of treatment, compared with control group, high frequency group had significant difference (P=0.007), while the low frequency group had no significant difference (P=0.424), and there was significant differences compared the high frequency group and low frequency group (P=0.049).4. Change of Tess scale score in each groupBefore the treatment, the second weekend,4th weekend, there have no significant difference in each groups’TESS rating scale scores.Conclusions1. On the basis of low dose of paroxetine, low and high frequency rTMS in the treatment of generalized anxiety disorder can obviously improve the symptoms of anxiety patients.The high frequency of rTMS combined with drug therapy can work faster and better relieve anxiety symptoms in the early time;2. On the basis of low dose of paroxetine, rTMS can improve the cognitive function significantly in the treatment of generalized anxiety disorder. Compared to low frequency rTMS, high frequency rTMS is better on cognitive function improvement effection;3. There were not obvious side reaction in the treatment of low frequency and high frequency rTMS Combined with Paroxetine for generalized anxiety disorder, they both have high security in the treatment. |
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