比较针灸与药物治疗减少中国患者焦虑和抑郁的效果
2026年7月28日 更新者：Claudia Nisa、Duke Kunshan University
Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China: A Preference-based Trial Comparing Clinical Efficacy, Cost-effectiveness and Environmental Footprint
本研究的主要目的是比较药物治疗（常规护理）与针灸（作为独立对照），以确定最能有效（且具有成本效益）、环境可持续的干预措施，以减少中国成年人焦虑和轻中度抑郁。
研究概览
详细说明
本研究的主要目的是比較藥物（常規護理）與針灸（作為獨立對照）之間的療效，以確定最具（成本）效益和環境可持續性的干預措施，從而減輕中國成人輕度至中度抑鬱症。
近年來，如何緩解情緒困擾、促進心理健康越來越受到關注，促使研究者從臨床角度尋找最有效的治療方法。
同時，醫療體系也面臨財務壓力和環境可持續性的挑戰，這要求在選擇患者護理方案時考慮多種因素。
因此，本計畫擬比較針灸與藥物在緩解中國成人（18歲及以上）焦慮和抑鬱症狀方面的臨床療效、成本效益和環境足跡。
這些分析為制定嚴謹的循證政策建議提供了必要的基礎。
世界衛生組織（WHO）和《「健康中國2030」規劃綱要》都高度重視將中醫藥體系納入整體醫療體系。
作為中醫藥的重要組成部分，針灸被納入WHO傳統醫學戰略，並鼓勵其在醫療保健治療中發揮更主流的作用。
然而，WHO和健康中國2030都尚未明確針灸在心理健康這一特定領域的作用。
這種與心理健康相關的嚴謹科學證據的缺乏——尤其是針灸方面的證據——伴隨著更廣泛的對「補充和替代醫學」（CAM）日益增長的關注，其中包含針灸、其他形式的中醫藥以及全球範圍內的其他傳統醫學體系。
CAM與西方醫學在概念、方法和資源利用方面存在顯著差異。
由於使用天然成分和強調預防，CAM通常被假設對環境的直接影响較小，但其實際環境足跡仍需嚴謹評估。
如果療效不足（通常也被假設為如此），可能會延長疾病病程，增加患者痛苦、經濟負擔和環境足跡。
目前，CAM主要在身體健康方面顯示出驗證過的療效。
例如，一些研究表明針灸在緩解慢性下背痛和關節炎疼痛方面有一定效果。
冥想、瑜珈等身心療法也對心血管健康有正面影響，例如降低血壓、提高呼吸效率。
然而，在心理健康領域，相關研究不足。
現有證據通常方法學有限，並受到基於西方樣本的研究偏見的限制，難以全面評估CAM的全球適用性。
儘管有初步證據表明針灸可能對心理健康有積極作用，但仍缺乏系統性的比較研究，特別是與主流西方療法的直接比較以及它們在環境效應方面的差異。
研究类型
介入性
注册 (估计的)
180
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Claudia F. Nisa
- 电话号码：008618151144079
- 邮箱：claudia.nisa@duke.edu
学习地点
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Jiangsu
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Kunshan、Jiangsu、中国
- 招聘中
- Kunshan Mental Health Center and Kunshan Hospital of Traditional Chinese Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
入选标准：
- 中国国籍，年满18周岁及以上
- 近6个月内未接受过精神卫生治疗
患者诊断需符合以下ICD-10诊断代码之一（或诊断为抑郁状态/焦虑状态/焦虑性抑郁状态）：
- 抑郁障碍（F30-F39）
- 恐惧性焦虑障碍（F40）
- 其他焦虑障碍（F41）
- 适应障碍（F43.2）
- 器质性/继发性相关障碍（F06）
- F1x.4 精神活性物质所致抑郁障碍（x为物质类别，如F10.4酒精，F11.4阿片类等）
- F1x.0 精神活性物质所致焦虑障碍
- F42.- 强迫障碍（常伴有明显焦虑）
- F48.8 神经衰弱（可能伴有焦虑和抑郁症状）
使用量表结果时（可采用以下任一量表，或其他可测量分数/结果提示抑郁/焦虑倾向）：
抑郁状态
- 抑郁自评量表（SDS）标准分≥53分，或提示抑郁倾向
- 汉密尔顿抑郁量表（HAMD-17）≥7分，提示存在抑郁症状
- 患者健康问卷-9（PHQ-9）≥5分，提示存在抑郁症状
焦虑状态
- 焦虑自评量表（SAS）标准分≥50分，或提示焦虑倾向
- 汉密尔顿焦虑量表（HAMA）≥7分，提示存在焦虑症状
- 广泛性焦虑障碍量表（GAD-7）≥5分，提示存在焦虑症状
排除标准：
- 严重的心血管、脑血管、肝脏、肾脏等严重危及生命的原发性疾病
- 控制不佳的糖尿病
- 存在自杀风险
- 头部外伤、意识丧失或严重精神障碍者
- 药物、毒品或酒精滥用者
- 半年内接受过改良电抽搐（MECT/ECT）、重复经颅磁刺激（r-TMS）、迷走神经电刺激（VNS）
- 半年内接受过抗抑郁或精神科药物者
- 严重皮肤损伤及皮肤病者
- 研究过程中出现自伤甚至自杀行为
- 研究期间突然出现其他不适宜继续参加研究的疾病
- 主管医师认为不适合继续参加研究的其他情况
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Psychotropic Drugs
Patients may also be prescribed 3. Escitalopram oxalate tablets (10-20 mg; once daily, 30 minutes after breakfast) in cases where Insomnia is Caused by Depressive and Anxious Symptoms |
Patients may also be prescribed 3. Escitalopram oxalate tablets (10-20 mg; once daily, 30 minutes after breakfast) in cases where Insomnia is Caused by Depressive and Anxious Symptoms The treatment is planned for 4 weeks. After 2 weeks, patients are invited for a check-in visit but there will be no change in the treatment prescribed for 4 weeks |
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实验性的：Acupuncture
Acupuncture Points Selected: Bilateral Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), Zhaohai (KI6), Shenmai (BL62), and Taichong (LR3)
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Manual acupuncture (no sham) will be compared to medication. Acupuncture Points Selected: Bilateral Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), Zhaohai (KI6), Shenmai (BL62), and Taichong (LR3) (29, 30) Operational Procedure:
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Between-groups and within-subjects mean change in depression
大体时间：Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Changes in depression will be measured with Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 is a versatile tool for screening, diagnosing, monitoring, and assessing depression severity.
The prompt instruction is: Over the last 2 weeks, how often have you been bothered by any of the following problems?
Example of items: "Little interest or pleasure in doing things"; "Feeling down, depressed, or hopeless".
Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day.
Lower mean values suggest aggregate reductions in depression.
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Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Between-groups and within-subjects mean change in anxiety
大体时间：Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Change in anxiety will be measured with the Generalised Anxiety Disorder Assessment (GAD-7).
GAD-7 is a brief measure for symptoms of anxiety, based on the generalised anxiety disorder (GAD) diagnostic criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM).
The prompt instruction is: Over the last 2 weeks, how often have you been bothered by any of the following problems?
Example of items: "Feeling nervous, anxious, or on edge"; "Not being able to stop or control worrying".
Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day.
Lower mean values suggest aggregate reductions in anxiety.
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Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Between-groups and within-subjects mean change in sleep condition
大体时间：Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Changes in sleep will be measured with Sleep Condition Indicator (SCI).
The Sleep Condition Indicator (SCI) is an eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria.
It has been shown previously to have good psychometric properties among several language translations.
The prompt instruction is: Thinking about a typical night in the last month... Example of items: "How long does it take you to fall asleep?";
"How would you rate your sleep quality?".
Scoring options from 0 to 4, SCI total from minimum 0 to maximum 32; a higher score means better sleep.
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Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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组间比较环境足迹
大体时间：治疗结束后（时间点1）和3个月随访时（时间点2）
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为了计算针灸与抗抑郁药在减少产后抑郁症方面的环境影响比较，我们将考虑一系列因素，包括资源清单、使用量（如电力、水）、排放因子和间接排放（如供应链）。
我们将遵循经过验证的医疗计算方法，这使我们能够识别、测量和评估不同健康治疗的总排放影响。
此计算将记录试验两组中使用的所有资源，包括药物、针灸材料、交通、基础设施使用（如诊室空间）以及试验期间使用的任何其他资源。
两种治疗都会产生需要管理的废弃物。
我们将按每位患者或每单位临床改善来标准化足迹数据，以促进两种治疗之间的直接比较。
最终的单一综合值将以吨二氧化碳排放量的形式报告。
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治疗结束后（时间点1）和3个月随访时（时间点2）
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Between-groups and within-subjects mean change in Side Effects
大体时间：Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Participants will be asked to rate the frequency of possible side effects.
The prompt instruction is: How often have you been bothered by these problems in the last 2 weeks?
Nausea; Headache; Tremor/ shaking hands; Heart palpitations; Constipation; Dizziness; Indigestion; Pain; Insomnia; Fatigue.
Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day.
Lower values suggest lower rates of side effects.
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Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Between-groups Comparative Cost-Effectiveness (Exploratory)
大体时间：After treatment is concluded (Time 1) and at 3-months follow-up (Time 2)
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To conduct a cost-effectiveness analysis, we will delineate all direct and indirect costs associated with interventions, including treatment session fees, medication costs, healthcare professional time, and travel expenses for patients.
Incremental cost-effectiveness ratios (ICERs) will be calculated by comparing the difference in mean costs to the difference in mean effectiveness between the two treatments, with effectiveness measured in quality-adjusted life years (QALYs) gained, derived from validated, condition-specific health-related quality of life measures.
A decision-analytic model will be employed to extrapolate trial results to a longer time horizon, and sensitivity analyses involving varying key parameters will be used to assess the robustness of the results and account for uncertainty in the trial data and model projections.
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After treatment is concluded (Time 1) and at 3-months follow-up (Time 2)
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Alcohol Use Rate (Exploratory)
大体时间：Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Alcohol use rate will be evaluated with the Alcohol Use Disorders Identification Test (AUDIT-C).
One question: How often do you have a drink containing alcohol?
From Never (0), Monthly or less (1), 2-4 month (2), 2-3 times per week (3) to 4+ times per week (4).
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Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Smoking Rate (Exploratory)
大体时间：Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Smoking rate will be measured with the Cigarette Dependence Scale short version (CDS).
The CDS scale will ask e.g., On average, how many cigarettes do you smoke per day?
From zero (0) I don't smoke to 30+ (5).
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Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Between-groups and within-subjects mean change in Social Media Addiction (Exploratory)
大体时间：Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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The Smartphone Application-Based Addiction Scale (SABAS) (21) will be used to evaluate mean changes in phone use behavior.
This scale comprises six items (e.g., "My smartphone is the most important thing in my life").
The six items are responded to using a five-point Likert type scale ranging between 1 (very rarely) and 5 (very often).
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Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Between-groups and within-subjects mean change in physical exercise (Exploratory)
大体时间：Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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International Physical Activity Questionnaire (IPAQ) (22): In the past 7 days, how many days have you engaged in the following physical activities, each lasting at least 20-30 minutes?
Light activity: the heart rate is only slightly faster than usual, such as walking to the supermarket or doing housework; Moderate-intensity activity: heart rate noticeably faster than usual, such as brisk walking, jogging, or light cycling.
High-intensity activities: The heart rate noticeably speeds up significantly, such as playing badminton, aerobic exercise, or heavy weight training.
(0 days - 5 days or more)
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Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Between-groups and within-subjects mean change in positive emotional states (Exploratory)
大体时间：Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Adapted PANAS scale and single-item happiness/ life satisfaction question will be asked (23).
Participants are asked how often you feel these emotions: Happiness, Calm, Joy, Love, Contentment, Enthusiasm, and Hope (1=never to 5=always).
Overall, how happy are you with your life?
1=very unhappy to 7=very happy.
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Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Between-groups and within-subjects mean change in emotional regulation (Exploratory)
大体时间：Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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Emotional Regulation Inventory (24): To what extent do you agree with these statements: e.g., "When I experience negative emotions, I feel I have little control over my behavior" (from 1=not at all to 5=All the time)
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Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Claudia Nisa、Duke Kunshan University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月1日
初级完成 (估计的)
2027年6月30日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年3月30日
首先提交符合 QC 标准的
2026年4月20日
首次发布 (实际的)
2026年4月27日
研究记录更新
最后更新发布 (实际的)
2026年7月29日
上次提交的符合 QC 标准的更新
2026年7月28日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.