| 1. Background informationBipolar Depression prefers to the depressive episode of Bipolar affective disorder. It is the important parts of Mood Disorder Pedigree. It is a long-term chronic disease with high comorbidity rate. Compared with unipolar depression, It has a higher recurrence rate, suicide risk and morbidity rate and shorter average life expectancy. According to the survey, In the general population, The lifetime prevalence rate of bipolar depression is 1.5%～1.8%, the recurrence rate is about 90%, mortality is higher, about 25% to 50% of suicide attempts,10% to 15% of suicide death, the highest in the mental disorders. Global burden of disease survey in 2002 showed that bipolar depression came in non-fatal burden of disease list of the top ten. In recent years, Research on bipolar depression is more and more concerned and attended by academia of spirit diseases. to find a effective, less side effects, patients with high treatment compliance therapy become the focus of research.The causes of bipolar disorder are complex. Considerable amount of research data suggests that genetic factors, biological factors and psychosocial factors have significant effect on its occurrence. but the exact cause remains unclear. Pathogenes research current focuses on biochemical studies, neuroendocrine studies and genetic research. Neural and biochemical research of affective disorders is one of the deepest areas studied most for recent 30 years. Biogenic amines in patients with affective disorder theory that the level of biogenic amines or biogenic amines neural pathways as well as the structure of the abnormal function. In the classic neurotransmitter 5-hydroxytryptamine and its receptor in the abnormal gene regulation, norepinephrine and dopamine and its receptors are also some changes. In recent years special attention to glutamate andγ-aminobutyric acid and a variety of neuropeptides and depression relationship. Neuroendocrine study suggests that endocrine abnormalities may be the cause of affective disorders. Study found that mood disorders are cortisol hyperthyroidism, hypothyroidism and other endocrine disorders. Genetics study suggests that bipolar disorder is a multi-gene genetic diseases. The mechanism involved in the mutual interaction of multiple genes and environmental factors. It shows that the stress of life events and genetic susceptibility interact to participate in the pathogenesis of BP.The treatment of bipolar depression is very difficult.Its complexity and difficulty has been more and more attention. High risk manic switch rate of single antidepressant-induced is the world-wide difficult problem. The treatment of bipolar depression many norms and guidelines have pointed out that Mood stabilizers are the basis for treatment of bipolar depression. In the acute and maintenance phase, all the guidelines particular emphasis on the application of mood stabilizers. In fact, Stress on combination of mood stabilizers has been the main spirit of the world's biological Psychiatric Association Foundation (WFSBP) and the American Psychiatric Association (APA) treatment guidelines for bipolar depression.Anti-epilepsy drugs is currently the most widely used mood stabilizers. Sodium valproate in North America has become the first line drug in the treatment of bipolar depression. As a mood stabilizer, its pharmacological action is related with the regulation of brain amino acid neurotransmitters. Sodium valproate can increase 5-HT and increase NE has the effect to beγ-aminobutyric acid. Sodium valproate has increased by 5-HT can inhibit NE could, to beγ-aminobutyric acid effect. Chronic depletion of glutamic acid sodium valproate may also, in theory, can prevent long-term glutamatergic nerve damage caused by hyperthyroidism.The clinical and experimental studies on Acupuncture treatment of epilepsy have shown that:Acupuncture can regulate the cortical excitatory amino acids and inhibitory amino acid balance, regulating cortical GABA/Glu ratio, which play a role in epilepsy. The basis of these studies show that: Antiepileptic mechanism of acupuncture is similar to the pharmacological of antiepileptic drugs as mood stabilizers. The Positive effect of acupuncture in treating unique depression has been affirmed in clinical and experimental research. The Mood-destabilizing Effect of Acupuncture on bipolar depression is worth exploring. In the method we have chosen Combination Therapy with Electro-Acupuncture and Ear Points Imbedding Needle. As the bipolar depression is the result of various factors, hard to be cured, need long-term medication. Single acupuncturetherapy has each limitations. The combination therapy as a multiple target therapy is undoubtedly a better choice. Many previous studies have shown Electro-Acupuncture has Positive effect on depression. It can improve the neural, endocrine, immune function of depressive patients, and thus play a role in depression.Although previous studies on Electro-acupuncture are mostly just include cases of unipolar depression or involve cases of bipolar depression. There is no special study on Electro-acupuncture in treating bipolar depression without special study. but the previous studies still provides a good reference. Auricular therapy, one of holographic therapy, in the treatment of many diseases, such as ear weight, ear beauty, its role in endocrine regulation is obvious. clinical reports auricular acupuncture can improve hypofunction of Thyroid function of mentally handicapped children. Patients with bipolar depression have hyperfunction of COR and hypothyroidism Thyroid function and other endocrine endocrine function of the change. for above reasons, select the combination of auricular acupuncture needle buried in an alternative mood stabilizer treatment of bipolar depression.2. Clinical Research2.1 ObjectiveTreatment of bipolar depression needs not only anti-"depression" but also against turning mania. Acupoints has the function of biphasic regulation. Because of Great side effects of Western medicine, It is difficult for patiebts to persist in long-term Western medicine therapy. This study will explore Mood-destabilizing Effect of Combination Therapy with Electro-Acupuncture and Ear Points Imbedding Needle in the Treatment of Bipolar Depression on three aspects, improving the symptoms of depression, manic switch rate and adverse drug reactions. 2.2 Method60 bipolar depression patients in accordance with diagnostic standard of CCMD-3 were randomly divided into 2 groups:treatment group (treated with Combination Therapy with Electro-Acupuncture and Ear Points Imbedding Needle) and control group(treated with sodium valproate),30 cases each. Groups were based on the treatment of antidepressant treatment, using one of fluoxetine, paroxetine or other SSRIs antidepressants, the conventional dose. Treatment group used Combination Therapy with Electro-Acupuncture and Ear Points Imbedding Needle as mood stabilizer. Electro-Acupuncture main point:GV20, EX-HN3, TE23, GB8, PC7, SP6. GV20 and EX-HN3, TE23 and GB8 connectied with G6805 Shanghai electric acupuncture-type instrument, using a continuous wave frequency of 80 times/MIN, stimulus degree which patients can tolerate. Needle retention for 30 minutes every other day,3 times per week for 8 weeks. Ear Points Imbedding Needle:TF4, AT4, C018, temporal, C012, AT12. keep intradermal needles that has been sterilized into the ear point, fasten with a small sticking paster for3 days. Turn another ear next time. The treatment lasted for 8 weeks.The control group was treated with mood stabilizers sodium valproate, the dose from 0.4g/d at the beginning, increased to dose (0.8g/d-1.2g/d) in a week.8 weeks. The treatment lasted for 8 weeks.Hamilton-17(HAMD-17), Bech-Rafaelsen Mania Scale (BRMS), Clinical Global Impression Scale (CGI) and adverse drug reaction scale (TESS) were used to measure the efficacy. Two groups would be evaluate before treatment and after treatment 1,2,4,6,8 weeks respectively.2.3 ResultThe results showed that total score of 17-item Hamilton Rating Scale between two groups was no significant difference after treatment 1,2,4,6,8 weeks (P>0.05). Compared the clinical efficacy by calculating HAMD reduction rate, clinical cure rates were 10.00% and 16.67%, markedly effective rates were 33.33% and 36.67%, efficiency 26.67 and 30.00% respectively in the treatment group and control group. There were no significant differences by Ridit analysis (P> 0.05). The rates of switching to minia calculated by Bech-Rafaelsen mania scale were 20.00% and 10.00% respectively. Two groups have no significant difference by chi-square test (P> 0.05). On somatic symptoms Combination therapy with Electro-Acupuncture and Ear Points lmbedding Needle faster onset of improvement was better than western medicine group (P<0.01), and factor in improving the role of cognitive dysfunction better than the Western medicine group. On the improvement of somatic symptoms the treatment group improved more quickly and has a better effect than the control group (P<0.01). In improving cognitive dysfunction, the treatment group was also better than the western group (P<0.05). On the mental anxiety symptoms Sodium valproate improved more quickly and has a better effect than the treatment group (P<0.01). On the improvement of sleep disorders two groups has no significant difference.Comparison of TESS total score, Ttwo groups have significant difference after treatment 1,2,4,6,8 weeks (P<0.01). The assessment of CGI-EI between the two groups was significant difference (P<0.05). On the occurring rate of dry mouth, nausea, vomiting Treatment group was lower than the control group at the end of the treatment. Chi-square test showed significant difference (P<0.05).3 ConclusionCombination therapy with Electro-Acupuncture and Ear Points Imbedding Needle in the treatment of Bipolar Depression has a certain mood stabilizer. The overall therapeutic effects of it is equal with western medicine. but its side effects are less than western medicine.And particularly It can reduced gastrointestinal side effects caused by the SSRIs antidepressant.
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