Comparing Acupuncture With Medication to Reduce Anxiety and Depression in China

Comparing Acupuncture With Medication to Reduce Anxiety and Depression in China: A Preference-based Trial Comparing Clinical Efficacy, Cost-effectiveness and Environmental Footprint

The main objective of this study is to compare medication (usual care) with acupuncture (as a standalone comparator) to identify the most (cost)effective and environmentally sustainable intervention to reduce anxiety and mild to moderate depression in adults in China.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Depression
• Intervention / Treatment: Drug: Selective serotonin reuptake inhibitor (SSRI); Other: Acupuncture

Detailed Description

The main objective of this study is to compare medication (usual care) with acupuncture (as a standalone comparator) to identify the most (cost)effective and environmentally sustainable intervention to reduce mild to moderate depression in adults in China. In recent years, there has been a growing focus on how to alleviate emotional distress and promote psychological well-being, prompting researchers to find the most effective treatment from a clinical perspective. At the same time, the healthcare system is also facing financial pressures and environmental sustainability challenges, which requires multiple factors to be considered when choosing patient care options. Therefore, this project intends to compare the clinical efficacy, cost-effectiveness, and environmental footprint of acupuncture versus medication in alleviating anxiety and depressive symptoms in Chinese adults (aged 18 years and above). These analyses provide the necessary basis for the development of rigorous evidence-based policy recommendations.

The World Health Organization (WHO) and the "Healthy China 2030" Plan Outline both attach great importance to integrating the traditional Chinese medicine (TCM) system into the overall medical system. As an important part of TCM, acupuncture is included in the WHO Traditional Medicine Strategy and is encouraged to play a more mainstream role in healthcare treatments. However, neither WHO nor Healthy China 2030 have yet to clarify the role of acupuncture in the specific field of mental health.

This lack of rigorous scientific evidence related to mental health, and acupuncture in particularly, co-exists with the broader growing focus on "complementary and alternative medicine" (CAM), which includes acupuncture, other forms of traditional Chinese medicine and other traditional medicine systems worldwide. CAM and Western medicine differ significantly in terms of concepts, methods, and resource use. CAM is often hypothesized to have a low direct environmental impact due to the use of natural ingredients and the emphasis on prevention, but its actual environmental footprint still needs to be rigorously evaluated. If the efficacy is insufficient (which is often also hypothesized to be the case), it may prolong the course of the disease, increase patient suffering, financial burden and environmental footprint. At present, CAM mainly shows validated efficacy in physical health. For example, some studies have shown that acupuncture has certain effects in relieving chronic lower back pain and arthritis pain. Mind-body practices such as meditation and yoga also have a positive impact on cardiovascular health, such as lowering blood pressure and improving respiratory efficiency.

However, in the field of mental health, relevant research is insufficient. The available evidence is often methodologically limited and limited by research bias based on Western samples, making it difficult to fully assess the global applicability of CAM. Although there is preliminary evidence that acupuncture may have positive effects on mental health, there is still a lack of systematic comparative studies, especially direct comparisons with mainstream Western therapies and differences in their environmental effects.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Claudia F. Nisa; Phone Number: 008618151144079; Email: claudia.nisa@duke.edu

Study Locations

• China
  • Jiangsu
    • Kunshan, Jiangsu, China
      • Kunshan Mental Health Center and Kunshan Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Chinese nationals 18 years old and above
2. No mental health treatment in the past 6 months

3. The patient diagnosis should meet one of the following ICD-10 diagnostic codes (or diagnosed as depressive state/anxiety state/anxious depression state):

   1. Depressive disorder (F30-F39)
   2. Fear anxiety disorder (F40)
   3. Other anxiety disorders (F41)
   4. Adjustment disorder (F43.2)
   5. Organic/secondary related disorders (F06)
   6. F1x.4 Depressive disorder caused by psychoactive substances (x is a substance category, e.g., F10.4 alcohol, F11.4 opioids, etc.)
   7. F1x.0 Anxiety disorder caused by psychoactive substances
   8. F42.- Obsessive-compulsive disorder (often accompanied by significant anxiety)
   9. F48.8 Neurasthenia (may be accompanied by symptoms of anxiety and depression)

4. When using scale results (any of the following scales can be used, or other measurable scores/results suggestive of depression/anxiety tendencies):

   1. Depressive state

      • Depression Self-Rating Scale (SDS) standard score ≥ 53 points, or suggesting depressive tendencies
      • Hamilton Depression Rating Scale (HAMD-17) ≥7 points, suggesting the presence of depressive symptoms
      • Patient Health Questionnaire-9 (PHQ-9) ≥ 5 points, suggesting the presence of depressive symptoms.

   2. Anxiety state

      • Anxiety Self-Rating Scale (SAS) standard score ≥ 50 points, or suggesting anxiety tendencies
      • Hamilton Anxiety Scale (HAMA) ≥ 7 points, suggesting the presence of anxiety symptoms
      • Generalized Anxiety Disorder Scale (GAD-7) ≥ 5 points, suggesting the presence of anxiety symptoms.

Exclusion criteria:

1. Serious cardiovascular, cerebrovascular, liver, kidney and other serious life-threatening primary diseases
2. Poorly controlled diabetes
3. There is a risk of suicide
4. Those with head trauma, loss of consciousness or severe mental disorders
5. Drug, drug or alcohol abusers
6. Received modified electrical convulsions (MECT/ECT), repetitive transcranial magnetic stimulation (r-TMS), vagus electrical stimulation (VNS), within half a year.
7. Those who have received antidepressant or psychotic drugs within half a year;
8. Those with severe skin injuries and skin diseases.
9. Self-injury or even suicidal behavior occurs during the research process;
10. Other diseases that suddenly become unsuitable for continued participation in the study during the study;
11. Other conditions that the supervising physician deems unsuitable for continued participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selective serotonin reuptake inhibitor (SSRI); Toludesvenlafaxine (40-80 mg daily) or imported Sertraline (50-200 mg daily), supplemented with Lorazepam (0.4-0.8 mg) or Alprazolam (0.4-0.8 mg) as needed for sleep support.	Drug: Selective serotonin reuptake inhibitor (SSRI); This pharmacological intervention (selective serotonin reuptake inhibitor (SSRI)) will be compared to acupuncture (for which no drugs will be involved). Treatment options for medication will be determined by the medical team, the usual care recommended for patients diagnosed with anxiety and depression. Treatment is expected to last 1 month per patient. Expected treatment plan: Administer Toludesvenlafaxine (40-80 mg daily) or imported Sertraline (50-200 mg daily), supplemented with Lorazepam (0.4-0.8 mg) or Alprazolam (0.4-0.8 mg) as needed for sleep support.
Active Comparator: Acupuncture; Manual acupuncture (not sham)	Other: Acupuncture; Manual acupuncture (no sham) will be compared to medication. Bilateral Baihui (GV20), Yintang (GV29), Shenmen (HT7), Taichong (LR3), Neiguan (PC6), Sanyinjiao (SP6), and Zusanli (ST36). Procedure: Positioning: The patient lies in a supine position.; Needles: Disposable sterile acupuncture needles (specification: 0.25 mm × 40 mm, brand: Wuxi Jiajian) are used.; Sterilization: Strict disinfection is performed before needle insertion.; Needling Technique: After insertion, lifting-thrusting and twisting techniques are applied to achieve deqi* (needling sensation).; Retention Time: Needles are retained for 20 minutes.; Treatment Schedule:Sessions per week: 3 times.Course duration: 9-10 sessions per treatment course. Detailed Needling Methods for Each Acupoint Acupoint Location Needling Insertion Technique and Depth Baihui (GV20) On the head, 5 cun* directly above the midpoint of the anterior hairline. Horizontal insertion to a depth of 0.5-0.8 c

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-groups and within-subjects mean change in depression	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.	Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.
Between-groups and within-subjects mean change in anxiety	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.	Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-groups Comparative Environmental Footprint	To calculate the comparative environmental impacts of acupuncture versus antidepressants to reduce postpartum depression, we will consider a range of factors including list of resources, quantities used (e.g., electricity, water), emissions factors and indirect emissions e.g., supply chain. We will follow validated calculation methods for healthcare, which will allow to identify, measure and evaluate the total emission impacts of different health treatments. This calculation will document all resources used in both arms of the trial, including medications, acupuncture materials, travel, infrastructure use (e.g., clinic space), and any other resources engaged during the trial. Both treatments have waste that must be managed. We will normalize the footprint data per patient or per unit of clinical improvement to facilitate a direct comparison between the two treatments. The final single, combined value will be reported as CO2 emissions in tonnes.	After treatment is concluded (Time 1) and 3-months follow-up (Time 2)
Between-groups Comparative Cost-Effectiveness	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.	After treatment is concluded (Time 1) and at 3-months follow-up (Time 2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-groups and within-subjects mean change in Side Effects	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.	Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.
Alcohol Use Rate	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).	Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.
Smoking Rate	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).	Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.
Between-groups and within-subjects mean change in Social Media Addiction	The Bergen Social Media Addiction Scale (BSMAS) will be used to evaluate mean changes in online use behavior. This scale comprises six items based on the six core components (salience, mood, modification, tolerance, withdrawal conflict and relapse) e.g., "Use a lot of time thinking about or planning using social media"), and smartphone apps addiction (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). A higher score in the BSMAS indicates a greater likelihood of being at risk of developing a social media addiction.	Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.

Collaborators and Investigators

• Sponsor: Duke Kunshan University
• Collaborators: National Natural Science Foundation of China; Kunshan Hospital of Traditional Chinese Medicine; Kunshan Mental Health Center
• Investigators: Principal Investigator: Claudia Nisa, Duke Kunshan University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Acupuncture; anxiety; Antidepressants
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Neurotransmitter Uptake Inhibitors; Serotonin Agents; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Complementary Therapies; Selective Serotonin Reuptake Inhibitors; Acupuncture Therapy
• Other Study ID Numbers: 2025CN019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Guidelines from the Chinese Government prevent sharing Chinese nationals individual participant data (IPD) with foreigners

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No