| BackgroundStroke is a one of the most common cause of disability and can have a profound impact on a person’s physical, emotional, and social functioning and wellbeing. Following a stroke, individuals can experience a loss in functional ability, barriers to community integration, increases in idle time, social isolation, depression, anxiety, financial and vocational changes, and lower feelings of personal autonomy. Because of that, emotional disorders after stroke become very important. It is a common long-term complication of cerebral vascular disease. Foreign and domestic epidemiological study show that incidences of anxiety disorder in post-stroke patients is from20%to40%. Studies indicated that post-stroke anxiety is the most common psychiatric disorder in stroke complication which will seriously influence the physical rehabilitation. Now the conventional treatment includes medication and psychological treatment. Treatment with benzodiazepines and newer antidepressants is often inadequate because of their limited clinical efficacy and side effects. Psychological treatment is limited due to slow working, uncertain efficacy and time consuming etc. In recent years, more and more researchers start to look for new treatments which have better clinical effect, safe and well-tolerated. Acupuncture treatment may be one of the hot spot for its rapid onset of action, equivalent efficacy and safety. To further investigate the effect of acupuncture treatment which include short and medium term effects on post-stroke anxiety, this study aims to demonstrate through a RCT whether acupuncture produces equivalent result to the result of first-lined antidepressant.Research objectivesThe primary research objective was to observe the clinical effect of electro-acupuncture (EA) treatment on post-stroke anxiety disorder when compared to control group using Paroxetine. The clinical observation included onset time, short-term effect and follow-up. The other objectives were to identify the specific advantage of electro-acupuncture (EA) treatment and to evaluate the safety of both therapies. To evaluate theMethods140PSAD patients were randomized into two groups (treatment group and control group). Patients in treatment group were treated with electro-acupuncture, while patients in control group were treated with paroxetine hydrochloride. Both of the two groups consisted of four-week sessions. Outcome measures which include the scores of HAMA, SDS CGI-EI of all participants were collected at similar time points (baseline,1week,2weeks and4weeks post intervention) to evaluate the onset and short-term effects. The score of spiritual anxiety factor, somatic anxiety factor and sleep factor of the Hamilton anxiety scale (HAMA) were also measured. Self-care ability assessment Barthel index (BI) is used to evaluate the improvement of physical rehabilitation. At the same time, the safety of two treatments was also evaluated with Treatment emergent symptom scale (TESS). Follow-up was carried out at3months and6months after the last treatment.ResultsBetween May2010and February2012,672cases were checked while140patients met the entry criteria for the study and were invited to participate. They were randomized into treatment group (n=70) or control group (n=70). There was no significant difference between the two groups on demographic and clinical characteristics which mean baselines were equal.Clinical effective rate was evaluated according to the decreasing score rate of HAMA. It was84.7%in Treatment group while was82.9%in medicine group. There was no significant difference between the two groups after the rates being statistic analyzed.Both HAMA and SAS scores showed significant difference before and after treatment in both groups (P<0.05). However there was no statistical difference between the two groups which mean they have equal effect (P>0.05). The scale scores of three factors in HAMA (spiritual anxiety factor, somatic anxiety factor, sleep factor) decreased obviously after treatment and showed significant statistical difference in both groups. Furthermore the final result showed significant difference between the two groups in somatic factors’ score (P<0.05) while show no difference in other two factors’(P>0.05). The score of CGI showed significant difference between both groups (P<0.05).Both HAMA and SAS scores showed significant difference between before and after2-weeks’treatment in both groups (P<0.05). And there was significant statistical difference between the two groups which mean treatment group took effect earlier than the other. The somatic anxiety factors’ score in treatment group showed significant difference after1-week’s treatment while it didn’t in control group. It indicated that Treatment group took effect much earlier than the other on somatic anxiety factor. The scale scores of two factors in HAMA (spiritual anxiety factor, sleep factor) also decreased obviously after2weeks treatment and showed significant statistical difference in both groups. Furthermore the final result showed significant difference between the two groups in spiritual anxiety factor while show no difference in the other.The score of BI showed significant difference before and after treatment in both groups (P<0.05). However there was no statistical difference between the two groups which mean they have equal effect (P>0.05).3months and6months later, compared to the last treatment the score of HAMA showed no significant statistical difference(P>0.05). It indicated that the effect remained.Safety evaluation showed that two cases had slight dizziness in Treatment group during treatment period. But in medicine group,16cases suffered from medical side effect.ConclusionBoth electro-acupuncture and western medicine could provide satisfactory outcome of post-stroke anxiety disorders, and there were no significant difference in both short-term and middle-term effects between them. Acupuncture treatment took effect earlier than west medicine. Furthermore, acupuncture treatment showed superiority in somatic anxiety relief over Paroxetine. And acupuncture was well-tolerated. |
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