| BackgroundDepression is a common emotional disorder syndrome, characterized by significant and lasting low mood, accompanied by corresponding cognitive and behavioral changes. Its clinical performance is for a wide range of mental, emotional, physical obstacles and pain, such as depression, depressed, blaming themselves from sin, retardation, memory loss, dizziness, headache, insomnia, dreaminess, anepithymia, coldness of limbs, tiredness, weight loss, menstrual disorders, decreased libido, etc.Depression has become a serious worldwide public health and social problem. According to a report of the world health organization in2001, the prevalence of depression is the fourth in the world, and to2020it may rank only second to the heart disease’s. It bothers psychosomatic health of mankind. It not only affects the patient’s spirit and behavior, reduce the quality of life, and it can even lead to aggressive behavior which is harmful to oneselves and others.At present,the main mean for treating depression is antidepressant drugs, which are curative, but the side effects are big. Meanwhile the disease is easy to relapse after the drug withdrawal. Non-drug treatment is an effective complement to the drug therapy. Because of its certain curative effect and less side effects, it gradually become the hot topics in the study of antidepressant treatment. Now the non-drug therapy mainly include the transcranial magnetic stimulation, Magnetic spasm stimulus, electroshock therapy, vagus nerve stimulation, transcranial direct current stimulation and so on.TCM holds that depression belongs to the category of emotional disease, mainly referring to melancholia and depressive psychosis. The depression syndrome is often related to the name of melancholia, hysteria, baihe disease, pavor, madness, headache, insomnia, up-rushing gas syndrome in the documents of ancient TCM books. As a kind of TCM therapy, acupuncture has little side effect and its disease spectrum is wide. According to the ancient documents, we can find the evidence that acupuncture is effective for the depression syndrome. In addition, some existing clinical trials can also confirm that acupuncture has definite curative effect to the depression. It is mainly reflected in improving depression symptom scores. And acupuncture is safe with little side effects, suitable for long-term treatment. But at present, those clinical studies on acupuncture treatment for depression were almost for body point therapy. The treatment of electric stimulation on auricular concha alone for treating depression were rare, needless to say related rigorous randomized controlled trial about it.Research objectiveEvaluate the efficacy and safety of the treatment of electric stimulation on auricular concha for mild-to-moderate depression.MethodsWe recruited the mild-to-moderate depression patients in the Guang’an men Hospital, China academy of Chinese Medical Science in March2012to September2013. The total number of screening volunteers is358. And finally64patients were included. According to the scheme of random software (SAS), these volunteers were randomly assigned to the test group and the control group.The patients in test group were treated by electric stimulation on both ears’ auricular concha for the12weeks all through while the patients in the control group were treated by electric stimulation on both ears rims’for the first4weeks and then changed into the electric stimulation on both ears’auricular concha also as the same with the test group for the rest of the8weeks. Our study period is12weeks totally. It meant that the patients started the treatment after the baseline assessment immediately. The patients in both of the group took the vagus nerve stimulator (TENS-200) for their treatment, using dilatational wave,20Hz frequency, less or equal than1ms wave wide,1mA current strength. The ear lip ends which contact with the patients were with moderate electric stimulation (no pain or pain tolerance). The curative effect evaluations were separately after4weeks,8weeks,12weeks. The evaluation indexes included 24Hamilton Depression Rating Scale (24HAMD), Self Rating of Depression Scale (SDS) and14Hamilton Anxiety Scale (14HAMA), Self Rating of Anxiety Scale (SAS) and TCM symptoms classification of quantitative assessment.ResultsThere were64cases of patients participated in our research,32in test group and32in control group respectively. There were2cases off until4weeks later in control group,1case in test group and6cases off in control group until8weeks end, and1case off in test group until12weeks end. Rest of them completed the treatment according to the test plan. According to the principle of ITT analysis, all the patients were included in the statistical analysis.1main outcome indicators evaluation1.1Effect Comparison (electric stimulation on auricular concha for4weeks VS electric stimulation on ear rims for4weeks)After4weeks of treatment, the reductive rate of the24HAMD for the auricular concha’s group was43.0%±3.5%>25%,(compared with25%, P<0.01); while the reductive rate of the24HAMD for the ear rims’group was12.6%±3.6%<25%(compared with25%, P<0.01);the difference between them was highly statistically significant (P<0.01). The qualitative analysis showed that the effectiveness for the auricular concha’s group and ear rims’group were84.4%and25.5%respectively, the difference between them was also highly statistically significant (P<0.01). The results show that the treatment of electric stimulation on auricular concha for4weeks for mild-to-moderate depression is effective(the reduction rate>25%); the treatment of electric stimulation on ear rims for4weeks for mild-to-moderate depression is invalid (the reduction rate<25%); the treatment of electric stimulation on auricular concha for4weeks for mild-to-moderate depression is more effective to the treatment of electric stimulation on ear rims for4weeks, and the cases of patients which have gain clinical effects are more. 1.2Effect Comparison (electric stimulation on auricular concha for12weeks VS electric stimulation on ear rims for4weeks±electric stimulation on auricular concha for8weeks)After12weeks of treatment, the reductive rate of the24HAMD for the former was69.4%±3.9%>50%,(compared with50%, P<0.01), while the reductive rate of the24HAMD for the latter was53.2%±4.6%>25%(compared with25%, P<0.01;compared with50%, P>0.05), the difference between them was highly statistically significant (P<0.01). The qualitative analysis showed that the effectiveness for the former group and latter group were93.8%and65.6%respectively, the difference between them was also highly statistically significant (P<0.01). The results show that the treatment of electric stimulation on auricular concha for12weeks for mild-to-moderate depression is remarkably effective(the reduction rate>50%); the treatment of electric stimulation on ear rims for4weeks±electric stimulation on auricular concha for8weeks for mild-to-moderate depression is effective(the reduction rate>25%);the treatment of electric stimulation on auricular concha for12weeks for mild-to-moderate depression is more effective to the treatment of electric stimulation on ear rims for4weeks±electric stimulation on auricular concha for8weeks, and the cases of patients which have gain clinical effects are more.2Secondary outcome indicators evaluation2.124HAMD Ratings comparison in different evaluation time-point (electric stimulation on auricular concha for12weeks VS electric stimulation on ear rims for4weeks+electric stimulation on auricular concha for8weeks)The former’s baseline rating,4weeks’evaluation rating,8weeks’ evaluation rating and12weeks’evaluation rating, in turn, were26.93±6.22,26.93±4.85,10.64±5.88,8.11±5.57;the latter’s baseline rating,4weeks’ evaluation rating,8weeks’evaluation rating and12weeks’evaluation rating, in turn, were27.17±3.94,27.17±4.39,15.96±5.19,12.48±5.68. The ratings of both groups decreased persistently with the extension of the treatment, the difference was highly significant among the ratings in different evaluation time point (P<0.01); difference between the two groups was significant (P<0.05), the rating for the former group was lower than that for the latter group at the same time. The results show that the two groups of treatment mode for patients with depressive syndrome were improved sustainably with longer time of treatment, but we consider the improvement of the electric stimulation on the auricular concha alone for12weeks are better from the data.2.2Rating comparison for the factors of24HAMD(electric stimulation on auricular concha for4weeks VS electric stimulation on ear rims for4weeks)(1)The anxiety and somatization factor:the rating of the auricular concha’ s group for this factor had highly improved after4weeks’electric stimulation on auricular concha(P<0.01);while the rating of the ear rims’group for this factor had no improvement after4weeks’electric stimulation on ear rims(P>0.05); the improvement of the auricular concha’s group for this factor was better than the ear rims’group (P<0.01).(2)The weight factor:the rating of both groups for this factor had improved after4weeks’electric stimulation on auricular concha or on ear rims (P<0.01,P <0.05), and the improvement of the both group was equal (P>0.05).(3)The cognitive impairment factor:the rating of both groups for this factor had highly improved after4weeks’electric stimulation on auricular concha or on ear rims(P<0.01,P<0.01), while the improvement of the auricular concha’ s group for this factor was better than the ear rims’group(P<0.01).(4)The day and night change factor:the rating of the auricular concha’ s group for this factor had highly improved after4weeks’electric stimulation on auricular concha(P<0.01);while the rating of the ear rims’group for this factor had no improvement after4weeks’electric stimulation on ear rims(P>0.05); but failed to reflect the difference between them(P>0.05).(5)The retardation factor:the ratings of both groups for this factor had improved after4weeks’electric stimulation on auricular concha or on ear rims(P <0.01,P<0.01); while the improvement of the auricular concha’s group for this factor was better than the ear rims’group(P<0.01).(6)the sleep disturbance factor:the ratings of both groups for this factor had highly improved after4weeks’electric stimulation on auricular concha or on ear rims(P<0.01,P<0.01); while the improvement of the auricular concha’ s group for this factor was better than the ear rims’group(P<0.01). (7)The desperation factor:the rating of the auricular concha’s group for this factor had highly improved after4weeks’electric stimulation on auricular concha(P<0.01);while the rating of the ear rims’group for this factor had no improvement after4weeks’electric stimulation on ear rims(P>0.05); the improvement of the auricular concha’s group for this factor was better than the ear rims’group(P<0.01).In conclusion of the results showed above:the ratings of the auricular concha’s group for all the factor of the24HAMD were significantly improved. It suggested that this therapy can effectively relieve the patients with mild-to-moderate depressive syndrome, getting improvement for the condition. While only the ratings of the slow weight factor, the cognitive impairment factor, the slow factor and the sleep disturbance factor had improved. The improvement of the cognitive impairment factor and the sleep disturbance factor were worse than the auricular concha’s group. And there was no significant improvement for the ear rims’group to the desperation factor that are closely associated with suicide.2.3Comparison of the rating for all the auxiliary scales(electric stimulation on auricular concha for4weeks VS electric stimulation on ear rims for4weeks)After4weeks of treatment, the reductive rate of the auricular concha’ s group for the SDS was19.4%±3.0%,the reductive rate of the ear rims’group for the SDS was10.2%±3.7%, the difference between them was highly statistically significant (P<0.01); the reductive rate of the auricular concha’s group for the14HAMA was43.2%±4.5%>25%(compared with25%, P<0.01), the reductive rate of the ear rims’group for the14HAMA was18.4%±5.1%<25%(compared with25%, P>0.05), the difference between them was highly statistically significant (P <0.01); the reductive rate of the auricular concha’s group for the SAS was14.0%±3.2%, the reductive rate of the ear rims’group for the SAS was8.3%±4.4%,but fail to reflect the difference between them(P<0.01); the reductive rate of the auricular concha’s group for the TCM symptom classification of quantitative assessment was25.7%±3.8%,the reductive rate of the ear rims’group for the TCM symptom classification of quantitative assessment was10.2%±6.2%, the difference between them was statistically significant(P<0.01). Those results declared that both the electric stimulation on auricular concha for4weeks and the electric stimulation on ear rims can reduce the rating of the SDS, the14HAMA, the SAS, and the TCM symptom classification of quantitative assessment to some extent, and the treatment of electric stimulation on auricular concha is better than the treatment of electric stimulation on the ear rims in improving these auxiliary scale rating(P<0.01for all),except the SAS (P>0.05).In conclusion of the results showed above:both the treatment can improve the symptoms of depression and anxiety of mild-to-moderate depression patients to a certain extent, and accepted by those patients. And through the comparison of these scales’reduction rate(except the SAS),we can know the improvement of the treatment of the electric stimulation on auricular concha is better than that on the ear rims. Among these datum, the reduction rate of14HAMA for the auricular concha’s group is greater than25%,the difference is highly significant comparing with25%(P<0.01),so we know that the treatment of the electric stimulation on auricular concha is effective to the anxiety symptoms; While the reduction rate of14HAMA for the ear rims’group is less than25%,but the difference is not significant comparing with25%(P>0.05), we can’t consider it is invalid to anxiety symptoms, but to compare with the auricular concha’ s group, the latter one is better(P<0.01).2.4Ratings comparison for all the auxiliary scales on different time-point evaluation (electric stimulation on auricular concha for12weeks VS electric stimulation on ear rims for4weeks+electric stimulation on auricular concha for8weeks)The former group’s SDS baseline rating,4weeks’evaluation rating,8weeks’ evaluation rating and12weeks’evaluation rating, in turn, were65.11+8.23,52.72±10.32,47.40±10.29,42.45±10.56; the latter group’s SDS baseline rating,4weeks’evaluation rating,8weeks’evaluation rating and12weeks’evaluation rating, in turn, were65.41±9.44,59.37±9.92,54.50±11.60,49.54±10.10. The former group’s SAS baseline rating,4weeks’evaluation rating,8weeks’ evaluation rating and12weeks’evaluation rating, in turn, were54.14±8.66,45.50±9.25,41.69±8.97,39.84±7.93; the latter group’s SAS baseline rating,4weeks’evaluation rating,8weeks’evaluation rating and12weeks’evaluation rating, in turn, were57.29±11.09,59.37±9.92,48.29±9.67,46.17±9.33. The former group’s classification of quantitative assessment of TCM baseline rating,4weeks’evaluation rating,8weeks’evaluation rating and12weeks’evaluation rating, in turn, were35.85±9.59,25.75±8.92,21.07±10.60,16.29±8.72; the latter group’s classification of quantitative assessment of TCM baseline rating,4weeks’evaluation rating,8weeks’evaluation rating and12weeks’evaluation rating, in turn, were39.17±8.69,35.46±11.33,25.67±11.81,23.83±11.85. The ratings of these auxiliary scales of both groups decreased persistently with the extension of treatment, the difference was highly significant among the ratings in different evaluation time-point (P<0.01for all); difference between the two groups was statistically significant (P<0.01for SDS and SAS;P<0.05for TCM), the ratings of all these auxiliary scales for the former group were lower than the rating for the latter group at the same time.The results show that the two groups of treatment mode for patients with depressive and anxious symptoms were improved sustainably with longer time of treatment, but we can consider the improvement of the electric stimulation on the auricular concha alone for12weeks are better from the data of all these auxiliary scales.ConclusionThe treatment of the electric stimulation on auricular concha is effective for curing mild-to-moderate depression, and the effect is stable;it is more significant effective, comparing with the treatment of the electric stimulation on ear rims. And this therapy is easy to operate, safe and noninvasive. So it can be used as an effective therapy to promote in clinic for the cure of mild-to-moderate depression. |
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