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穴位音乐电刺激治疗焦虑症的临床多中心随机对照研究

更新时间:2016-07-05

The rise in incidence of anxiety disorder has occurred along with the rapid pace of life[1]. It affects up to 20%of the adult population[2]. Although anxiety disorder is commonly seen in outpatient department of internal medicine, its diagnosis is mainly based on a patient’s medical history and symptoms. This often results in missed diagnosis or misdiagnosis[3-4]. Long-lasting anxiety may disturb the normal functioning of the brain and adversely affect both the body and mind[5-6].Anxiety disorder is characterized by significant feelings of anxiety, fear or panic attack. It is more commonly seen in women around the age of 40 years old. Its onset can be sudden or insidious. Clinical manifestations include uneasiness, fear, worries or restlessness for no apparent reason, and frequent worrying about future events or imminent threats. Individuals may also experience palpitations, tremor of the hands/feet,somatic discomfort and sleep disturbance. These symptoms may greatly affect the patients’ study and work efficiency. Music electric stimulation involves a systematic professional process to intervene with music or musical elements to improve the patients’ quality of life, mood, emotion, and happiness index[7]. This study applied music electric stimulation therapy to a total of 125 anxiety cases and compared with the efficacy in 117 cases treated with oral doxepin. The results are now summarized as follows

1 Clinical Materials

1.1 Diagnostic criteria

It’s based on the diagnostic criteria for anxiety disorders in the Chinese Classification and Diagnostic Criteria of Mental Disorders[8]. In accordance with the diagnostic criteria for neurosis; with persistent anxiety symptoms as predominant complaint, and conforming to the 2 items below: frequent or lasting fear or uneasiness without a particular object or content;accompanied by autonomic nervous symptoms or psychomotor agitation.

1.2 Inclusion criteria

Conforming to the above diagnostic criteria;Hamilton anxiety rating scale (HAMA) >14 points[9], and Chinese revised edition of self-rating anxiety scale(SAS-CR) >50 points[10]; aged 19-70 years old; not on any anti-anxiety drugs in the recent 1 month; having signed informed consent form.

1.3 Exclusion criteria

Pregnant or breast-feeding women; subsequent anxiety following physical illness or mental disorders;Alzheimer’s or Parkinson’s disease; anxiety due to alcohol abuse or drugs; taking anti-anxiety drugs during the recent 1 month.

1.4 Dropout criteria

Unable to tolerate music electric stimulation because of adverse reactions; poor compliance, failed to stick to the treatment protocol or take the prescribed medications on time; symptoms aggravated during the intervention or coupled with other illnesses, unwilling or unable to complete the intervention; against the design of the trial and switched to other treatments during the intervention; quitted the trial voluntarily.

1.5 Statistical method

The SPSS 11.0 version software was used for data analyses. The comparisons of HAMA and SAS-CR scores before the treatment, and respectively after 1-week,2-week and 4-week treatment were processed by two-factor repeated measures ANOVA; the data of clinical efficacy, belonging to ranked data, were analyzed by Ridit analysis. Fisher’s exact test was used to compare the data of gender. The data of age and disease duration were in normal distribution and analyzed by independent samples t-test. P<0.05 indicated a statistical significance.

如此,她对秦川的爱,或者秦川对她的爱,就像她的旧时记忆,不过是一种幻像或者假象——假如购买她的不是秦川而是别的男人,她会同样如此。假如购买她的不是男人而是一条公狗,她亦会同样如此。充气娃娃没有选择。充气娃娃的爱与情感没有选择。那个下午她一直劝说自己讨厌秦川憎恨秦川,可是她做不到。她仍然爱他,疯狂地、奋不顾身地爱他。她不知道这是她作为充气娃娃的本能,还是她作为妻子的本能。

1.6 General data

A total of 270 patients with anxiety disorders were recruited from the inpatients of the Third Hospital of Mianyang, Sichuan Mianyang 404 Hospital and Mianyang Hospital of Traditional Chinese Medicine between January 2012 and January 2015. By using the Proc plan in SAS software to determine the seed, with block-9 and center-rand-10, the 270 subjects were divided into a treatment group and a medication group,135 each. Three groups of 90 successive numbers were distributed respectively to the three study centers, i.e.001-090, 091-180, and 181-270. The randomized allocation design was concealed by complete allocation concealment, sealed in kraft paper envelopes following its sequence. The envelopes were attached to the case report forms (CRF). When there was a to-be-enrolled subject, the clinician would take the coded CRF according to the order, open the attached envelope and allocate the subject into the corresponding group according to the contained randomized allocation.

Of the 270 subjects, 242 cases completed the whole study and 15 dropped out; five patients quitted in the treatment group because of failure to continue the treatment, while 10 quitted in the control group due to dizziness and dry mouth; 13 cases were screened out: 5 in the treatment group due to change of the intervention method and 8 in the medication group because of poor compliance in taking medications on time. The whole study process is shown in Figure 1.

关羽平生以义气著称,《三国演义》中记载着很多关于他的故事和传说,比如“温酒斩华雄”“千里走单骑”“华容捉放曹”“水淹七军”“单刀赴会”等。

Figure 1. Flow chart

3.3.1 Clinical efficacy

Table 1. Comparison of the general data

Group n Gender (case) Average age(x±s, year)Male Female Disease duration(x±s, month)Treatment 125 64 61 46.0±9.0 65.7±6.8 Medication 117 55 62 50.0±8.0 67.5±7.6

2 Treatment Methods

2.1 Treatment group

Markedly effective: The reduction rate of HAMA score ≥60%, but <80%.

Adjunct acupoints: The five-mind acupoints [Pohu(BL 42) for lung, Shentang (BL 44) for heart, Hunmen(BL 47) for liver, Yishe (BL 49) for spleen, and Zhishi(BL 52) for kidney] were properly selected based on the symptoms prescribed by patients, e.g. Shentang (BL 44)added for palpitations, insomnia and restlessness; Yishe(BL 49) for stomachache, reduced intake of food and abdominal bloating.

Operation: Music electric stimulation appliance(model 8808) was adopted for treatment. The appliance has 5 electrodes. Five acupoints, including Baihui(GV 20), Yintang (GV 29), bilateral Fengchi (GB 20) and the selected five-mind acupoint on the left side were treated on single days; bilateral Taiyang (EX-HN 5),bilateral Fengchi (GB 20) and the selected five-mind acupoint on the left side were treated on even days.After sterilization by alcohol swab, the five electrodes were attached to the five acupoints respectively. The electrode at scalp acupoint was fixed by a specific bandage, and the one at the emotion point was fixed by paper tape. The instrument was then turned on to play the patient’s favorite music. The output intensity was slowly increased till the patient felt tolerable and comfortable tingling. The stimulation was given once a day, 30 min each session, at an interval on Sunday, 30 d as a course of treatment.

2.2 Medication group

Patients in the medication group were intervened by oral administration of doxepin (lot number: J14901207,produced by Hubei Wuhan Pharmaceutical Co., Ltd.,China, 25 mg/tablet). Generally, the medication was taken at a dose of 25 mg and 3 times a day during the first week, then either reduced or increased according the efficacy and adverse reactions, averaged at 150 mg per day. Treatment of 30 d was taken as a treatment course.

3 Therapeutic Efficacy

3.1 Observation items

HAMA and SAS-CR were evaluated before the intervention, and respectively after 1-week, 2-week and 4-week treatment.

Adverse reactions occurred in the medication group mainly were dizziness (10 cases), dry mouth (9 cases),headache (3 cases), nausea (2 cases), constipation (5 cases), insomnia (3 cases), and urination difficulty (4 cases), forming up an occurrence rate of 30.8%; in the treatment group, adverse reactions mainly were dizziness (3 cases), and the occurrence rate was 2.4%.There was a significant difference in the occurrence rate of adverse reactions between the two groups (P<0.01).

本次交通要素的更新方式采用直接提取2017版1∶50 000 DLG数据的交通要素进行综合处理。道路的选取应按道路等级从高到低进行选取,高速、国道、省道、县道均应选取。并参照国家下发1∶250 000 DLG数据的路网密度对乡道以下道路进行适当选取,优先选取通往行政村的,保持道路构网密度与更新前一致,注意道路与河流等其他要素的相互关系,并且注意道路属性的连通性。对于新增的道路(国家下发1∶250 000 DLG数据中没有的),其选取也是根据道路的等级、道路的连通性来选取。已选取的道路有道路附属设施的且道路附属设施达到上图指标的均应选取,并注意协调道路与其附属设施之间的相互关系。

3.1.1 HAMA

HAMA consists of 14 items, scored 0-4: 0 point, no symptoms; 1 point, mild; 2 points, moderate; 3 points,severe; 4 points, extremely severe. The aggregate HAMA score can well reflect the severity of anxiety symptoms. By referring to the data provided by the Chinese Scale Collaboration Group: aggregate score ≥29 points, possibly significant anxiety; ≥21 points, definitely significant anxiety; ≥14 points, determined anxiety; >7 points, anxiety possible; <7 points, no anxiety symptoms.

3.1.2 SAS-CR

SAS-CR consists of 20 components, scored 0-4 points.After test, the sum of the 20 component scores is taken as the aggregate. The higher the aggregate score of SAS-CR, the severer the anxiety symptoms.

3.1.3 Safety evaluation

The general tests included body temperature, blood pressure, pulse and respiration; routine blood test;electrocardiogram; liver and renal function tests.

The therapeutic efficacy was evaluated based on the reduction rate of HAMA score.

基于对医院药品费用的定义及以往的评价,参考“医院合理用药指标评价体系”中的部分指标,请无锡市某三甲综合医院专家(省级重点临床科室科主任7名,药学部主任1名,医保办主任1名,医务科科长1名,副院长1名)进行论证,遵循完整性、科学性、可测性、灵活性和简捷性的筛选原则,将影响医院药品费用的因素按照不同方面自上而下分解成若干层次,建立条理化、层次递进的指标评级体系。

3.2 Criteria of therapeutic efficacy[5]

通常情况下,试卷得分达标良好等级的比重不允许小于74.49%。针对这一结果,专家展开反复性评定,最终保证意见的一致性。若良好等级的标准得分率被确定成75%,而测试的满分是100分,那么良好等级标准则要设定成75分。

Reduction rate of HAMA score = (Pre-treatment aggregate HAMA score - Post-treatment aggregate HAMA score) ÷ Pre-treatment aggregate HAMA score ×100%.

1.如图1,下列正方形网格中,小正方形的边长均相等,三角形的顶点都在格点上,则与△ABC相似的三角形所在的网格图形是( )

Recovered: The reduction rate of HAMA score ≥80%.

Major acupoints: Baihui (GV 20), Yintang (GV 29),bilateral Taiyang (EX-HN 5) and Fengchi (GB 20).

Improved: The reduction rate of HAMA score ≥30%,but <60%.

Invalid: The reduction rate of HAMA score <30%.

3.3 Treatment results

Finally, there were 125 cases in the treatment group,with age ranged between 19 and 65 years old, and disease duration ranged between 1 month and 10 years.Of the 117 cases in the medication group, the age ranged between 20 and 70 years old, and disease duration ranged between 20 d and 12 years. There were no significant differences in gender, age and disease duration between the two groups (all P>0.05),indicating the comparability (Table 1).

The total effective rate was 85.6% in the treatment group versus 92.3% in the medication group, and the between-group difference was statistically insignificant(P>0.05), indicating that the clinical efficacies of the two groups were equivalent (Table 2).

3.3.2 HAMA and SAS-CR scores

The two groups of patients underwent these tests once 1 week before the intervention and 1 week after.

After 1-week treatment, the HAMA and SAS-CR scores dropped in both groups. The intra-group differences compared with the scores before the intervention were insignificant in the treatment group(P>0.05), while the intra-group differences were statistically significant in the medication group (P<0.01).The between-group differences in the scores after 1-week treatment were statistically significant (P<0.01),indicating that the medication group took a faster action.

各小微企业规模较小,市场竞争力相对较弱,难以承接大量订单及其他业务。技术落后,产品更新换代较慢,与外界信息沟通不畅,对外依赖严重,缺乏关键技术,大部分商家业务、设备仍旧停留在本世纪初水平,缺乏创新能力、创新意识能耗与产出脱节,对市场把握力度不够,难以符合市场需求。 家族式管理模式为主,内部管理封闭且混乱,个人利益与企业利益易产生冲突,忽视制度建设,限制了企业潜力,不利于企业长期发展

Respectively after 2-week and 4-week treatment, the HAMA and SAS-CR scores showed significant changes compared to those before the intervention in both groups (P<0.01), but the between-group differences were insignificant (P>0.05), indicating that the two interventions produced similar effects in improving the anxiety symptoms (Table 3 and Table 4).

Table 2. Comparison of the clinical efficacy (case)

Group n Recovered Markedly effective Improved Invalid Total effective rate (%)Treatment 125 37 50 30 8 93.6 Medication 117 32 52 24 9 92.3

Table 3. Comparison of HAMA score (x±s, point)

Note: Compared with the medication group at the same time point, 1) P<0.01; compared with pre-treatment score in the same group, 2) P<0.01

Group n Pre-treatment After 1-week treatment After 2-week treatment After 4-week treatment Treatment 125 31.26±7.23 28.58±5.371) 19.98±5.862) 15.87±6.812)Medication 117 30.85±7.45 25.28±4.302) 19.21±6.862) 16.21±3.182)

Table 4. Comparison of SAS-CR score (x±s, point)

Note: Compared with the medication group at the same time point, 1) P<0.01; compared with pre-treatment score in the same group, 2) P<0.01

Group n Pre-treatment After 1-week treatment After 2-week treatment After 4-week treatment Treatment 125 65.22±10.23 61.56±5.371) 39.81±6.212) 34.53±7.692)Medication 117 64.37±11.21 50.64±7.602) 40.21±5.862) 32.68±6.482)

3.3.3 Adverse reactions

(2)学生可以在Bb平台上进行自主学习。不同于传统灌输式教学,学生可以按照自己的学习思路制定学习计划,能对新知识及延伸知识进行拓展学习,个性化的学习方式可以激发学生的学习热情,同时让课堂教学更加高效,提高学生课堂参与度。

The general tests, including body temperature, blood pressure, pulse, respiration, routine blood test, liver and renal function tests, and electrocardiogram didn’t present abnormal changes after the intervention in the two groups.

4 Discussion

Music electric stimulation is a treatment method by stimulating acupoints on human body with low-mid frequency currents synchronously transformed from music signals by a therapeutic appliance. Modern scientific research has proven that music can work on the limbic system and reticular formation of brain stem to regulate cerebral cortex[11-14]. Music electric stimulation to Yintang (GV 29) (the frontal lobe), Baihui(GV 20) (the parietal lobe), Fengchi (GB 20) (the occipital lobe) and Taiyang (EX-HN 5) (the temporal lobe)can boost blood circulation and benefit the secretion of neurotransmitters, regulating organ function and emotion, and finally relieve anxiety[15]. It has been testified in animals that music electroacupuncture (EA)can inhibit the cell apoptosis in rat’s neurons after acute cerebral hemorrhage[16-17].

Anxiety, belonging to the scope of depression syndrome in traditional Chinese medicine, is usually caused by fire transformed by depression, phlegm heat disturbing the spirit, or deficiency of heart, liver and kidney. Emotions and moods are all psychological activities. Although the minds are respectively governed by the five Zang organs, their relationship with the heart is especially close[18]. Anxiety patients often present restless, anxious, frightened, sad, and angry, etc.Based on the patient’s symptoms, corresponding five-mind acupoints can be selected to regulate the emotion and mind. Governor Vessel connects with the brain, which is the house of original spirit. Also, from the angle of modern medicine, brain is where thoughts originate. Governor Vessel is the sea of yang meridians.The manifestations of anxiety disorders such as sleep disturbance, fright and uneasiness are often associated with the blocked meridian qi of Governor Vessel.Therefore, Baihui (GV 20) and Yintang (GV 29) can be used to regulate the meridian qi. To treat a disease, its root must be sought. Zang-fu organs are the origin of meridians and the meridian qi of five Zang organs transports into the back. Treatment based on syndrome differentiation by taking the five-mind acupoints as the center can dredge the meridians, regulate qi and blood,and eliminate the discomforts related to the internal organs. When the five Zang organs are in harmony, the patient can get cured.

在小学数学教学中培养学生的自主学习能力,需要加强对数学课程的策略改革,创新教学方式,激发学生的学习兴趣,促使学生积极进行学习活动,鼓励学生进行自主学习,提高学生的自主学习能力,促进学生素质能力的培养。

Music electric stimulation is a novel therapy combining modern electric technique and traditional acupuncture-moxibustion method[19]. Ordinary EA uses electric pulse to replace manual needling skills by connecting the needles and electrodes after needle insertion to treat disease or kill pain. With a built-in stereo CD player to provide music waves, ML8808 music electric stimulation instrument first processes the music wave into medical music wave, which consists of a couple of unit pulse waves and still maintains the melody and rhythm of the music waves. Stimulating acupoints with medical waves can adjust information of human body and achieve the purpose of treatment.With its own headphones and monitor, the instrument makes patients able to receive music electric stimulation in nice light music. With medical music waves input directly into acupoints via electrodes, this therapy truly realizes acupuncture without needles, not only eradicating the fear of patients towards the needling pain, but also preventing from possible cross infection.

In this study, with relaxing, delightful and harmonious music, patients were able and willing to receive treatment in a pleasant environment. Listening to dulcet music can regulate the excitability and inhibition of cerebral cortex, so as to help patients release the unhappiness. Fengchi (GB 20), Baihui (GV 20), Yintang(GV 29) and Taiyang (EX-HN 5) are major points in the treatment of anxiety disorders. Stimulation to these points with tranquilizing and soft medical music waves can modulate the Governor Vessel, dredge meridians,and harmonize qi and blood, and finally release anxiety and tension. The results of the current study suggested that music electric stimulation can produce equivalent effects in treating anxiety disorders compared to doxepin. But, oral administration of doxepin may cause kinds of adverse reactions, including dizziness, dry mouth, constipation, urinary difficulty, and drowsiness.On the contrary, music electric stimulation rarely causes any adverse reactions, thus it is applicable for those who can’t take drugs.

Conflict of Interest

那一年我刚大学毕业,又很幸运地考取了省委组织部的选拔生,终于长吁了一口气,人生的大门又将是一个新的开启。看到同学们一个个满脸焦急地穿梭于人才市场的人群中,我的心底有了稍许欣喜,但脸上却静如止水。我不想让同学疾妒我的幸运。

The authors declared that there was no potential conflict of interest in this article.

3、贴近农机教学现场、农业生产现场和机具维修现场,课件制作素材来源广泛。课件的制作需要素材,对于农机培训来说,素材的来源应当是相当广泛的。农机驾驶培训中,教练的正确操作方法,可以拍成完整连贯的演示视频,也可以抓重点动作拍摄细节。对于错误的操作动作,也可以在视频中将其反映出来,避免教练纯粹口头讲解、学员难以理解的情况出现。机具技术培训中,可以将机具的各个细节组件和机构动作知识点的讲解制作成视频或PPT,在教学中播放。农田中农民作业和农机维修点的维修现场,经过长期跟踪,也可以积累获取大量生动素材。

This work was supported by Scientific Project of the Third Hospital of Mianyang, Sichuan Province [四川省绵阳市第三人民医院科研科题, No.(12) 2013].

Statement of Informed Consent

基于大数据技术的中药饮片外观性状与内在成分数据的研究与应用 ……………………………………… 谭超群等(16):2287

Informed consent was obtained from all individual participants in this study.

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张洪,邓鸿,贾联斌,艾双春
《Journal of Acupuncture and Tuina Science》2018年第1期文献

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