Comparing Acupuncture With Medication to Reduce Anxiety and Depression in China

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.

Inclusion criteria

• Chinese nationals 18 years old and above
• No mental health treatment in the past 6 months
• The patient diagnosis should meet one of the following ICD-10 diagnostic codes (or diagnosed as depressive state/anxiety state/anxious depression state):

• Depressive disorder (F30-F39)
• Fear anxiety disorder (F40)
• Other anxiety disorders (F41)
• Adjustment disorder (F43.2)
• Organic/secondary related disorders (F06)
• F1x.4 Depressive disorder caused by psychoactive substances (x is a substance category, e.g., F10.4 alcohol, F11.4 opioids, etc.)
• F1x.0 Anxiety disorder caused by psychoactive substances
• F42.- Obsessive-compulsive disorder (often accompanied by significant anxiety)
• F48.8 Neurasthenia (may be accompanied by symptoms of anxiety and depression)
• When using scale results (any of the following scales can be used, or other measurable scores/results suggestive of depression/anxiety tendencies):

• 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.
• 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

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