Clinical effect of abdominal Tuina on patients with generalized anxiety disorder: A randomized controlled study and evaluation of event-related potentials

doi:10.21203/rs.3.rs-4700877/v1

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Study protocol

Clinical effect of abdominal Tuina on patients with generalized anxiety disorder: A randomized controlled study and evaluation of event-related potentials

https://doi.org/10.21203/rs.3.rs-4700877/v1

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Background

Generalized anxiety disorder (GAD) is a highly prevalent disorder that affects patients’ physical and mental health and overall quality of life. GAD is often accompanied by palpitations, chest tightness, muscle tension, restlessness, and other autonomic nervous disorders and symptoms, but its underlying mechanism is incompletely understood. Abdominal Tuina is effective in relieving the clinical symptoms of patients with GAD; therefore, to objectively evaluate the efficacy of abdominal Tuina, which is essential to make appropriate treatment decisions, we will use event-related potentials to assess cognitive function in patients with GAD.

Methods

We will enroll 114 patients diagnosed with GAD who will be randomly assigned to either the abdominal Tuina or drug group at a 1:1 ratio. The main outcome indicator will be the Hamilton Anxiety Scale (HAMA), while secondary outcome indicators will include the Self-rating Anxiety Scale (SAS), the Traditional Chinese Medicine (TCM) syndrome scale, the Chinese Attention to Positive and Negative Information Scale (APNI), attention to deviation index changes, negative potential (N1), vertex positive potential (VPP) amplitude, and latency. We will use the German Brain Products electroencephalogram (EEG) collection device to perform one EEG session before and after treatment for both the treatment and control groups. Through the changes in N1, VPP amplitude, and the latency of event-related potentials, we will analyze the specific neural mechanism by which abdominal Tuina affects the attention bias of negative stimuli in patients with GAD.

Discussion

The results of this randomized controlled clinical trial will help to demonstrate the efficacy of abdominal Tuina.

Trial registration:

ClinicalTrials.gov ChiCTR2300068257. Registered on February 13, 2023.

Abdominal Tuina

generalized anxiety

randomized controlled study

event-related brain potentials

Generalized anxiety disorder (GAD) is a common chronic anxiety disorder, which makes it difficult for individuals to control their feelings of nervousness, anxiety, and fear, and is often accompanied by sleep disorders, muscle tension, and general discomfort.^1,2 In recent years, with the increase in complex social factors such as work pressure, life pressure, and marital status, the prevalence rate of GAD has shown a gradually increasing trend.³ According to epidemiological statistics, anxiety is the most common disorder among many mental diseases, with a lifetime prevalence of up to 5.7% and an annual prevalence of up to 3.1%.^4,5 The prevalence rate in developed countries is higher than that in developing countries, and the prevalence rate in women is approximately twice as high as that in men.⁶ In China, the lifetime prevalence rate of GAD is 1.2%.⁷ With the progression of the disease, the risk of major depression, drug abuse, and other abnormal risks increases significantly, and patients may even develop serious physical illnesses that severely impair their living ability to lead a normal life and fulfill social functions.⁸ The goal of treatment is to relieve the symptoms of GAD and improve quality of life.⁹ Currently, drug therapy is often used in the clinical treatment of GAD, but long-term excessive use may cause discomfort, poor compliance, many adverse reactions,¹⁰ drug resistance or dependence, and other phenomena, as well as cognitive impairment and a high recurrence rate after drug withdrawal.¹¹ Non-drug therapies are also used, mainly psychotherapy, which is effective in reducing anxiety symptoms in the short-term treatment of GAD. However, the long-term effect of psychological intervention is unknown, and the cost is significantly higher than that of drug therapy. Moreover, the effects of psychotherapy may be exaggerated due to the existence of bias. Although the above therapies are effective in reducing clinical symptoms in patients with GAD, it is unclear how best to treat patients who do not respond or are only partially responsive to these therapies.¹²

Abdominal Tuina, as an external traditional Chinese medicine treatment, has the advantages of simple operation, excellent comfort, no drug toxicity, and side effects, and is more easily accepted by patients compared with drug therapies. Therefore, abdominal Tuina is considered an effective, safe, and green therapeutic method and clinical treatment for GAD, with fewer adverse reactions and high patient compliance.¹³

Among the research techniques for GAD-induced cognitive dysfunction, including the attention network test (ANT),¹⁴ functional magnetic resonance imaging (fMRI), and event-related potentials (ERPs), ERPs stand out for their ability to record the brain potential generated during the processing of specific stimuli (e.g., threats, emotions, hearing, vision), with excellent temporal resolution and spatial resolution,¹⁵ and are widely used in clinical neurology and psychiatry.¹⁶ In addition, compared with ANT, fMRI, and other detection methods, ERP has various social and ethical advantages, including non-injury and easy implementation. ERPs are an important means to understand the cognitive process of patients with GAD and have been widely used in the research of cognitive processes. Therefore, this method can be effectively used to evaluate the cognitive function of patients with GAD.

This high-quality RCT was designed using practical trial methods to objectively evaluate the efficacy of abdominal Tuina for treating GAD.

2.1. Objectives

Our research objectives are as follows: (1) To explore the safety and clinical efficacy of abdominal Tuina in the treatment of patients with GAD; and (2) To provide an exploratory study that can serve as a reference for investigating the brain-gut mechanism of abdominal Tuina.

2.2. Study setting

One hundred and fourteen patients meeting the RCT standard for GAD will be divided into either the abdominal Tuina or western medicine groups, with 57 cases in each group, to observe the clinical efficacy of both groups before and after treatment. The HAMA, SAS, and TCM syndrome scales will be used to evaluate the safety and effectiveness of abdominal Tuina for patients with GAD, with the aim to provide a plan for clinical treatment. The participant timeline is shown in Fig. 1.

2.3. Recruitment

A total of 114 patients aged 20–50 years with GAD will be enrolled in the study. The participants with GAD will be recruited from the outpatient and inpatient rehabilitation departments of three clinical sub-centers (the Third Affiliated Hospital of Henan University of Chinese Medicine, the First Affiliated Hospital of Henan University of Chinese Medicine, and Zhengzhou People’s Hospital). Research leaflets, hospital bulletin boards, and online advertisements will also be used to recruit patients. The treatments and measurements will be performed at the Third Affiliated Hospital of Henan University of Chinese Medicine. The participants will be able to contact the recruitment staff by telephone or WeChat, and the recruitment staff will be responsible for enrolling participants.

If they meet the research criteria, they will be invited to the Rehabilitation Department of the Third Affiliated Hospital of Henan University of Chinese Medicine for research. Qualified candidates will be required to sign an informed consent form before the intervention.

2.3.1. Inclusion criteria

Referring to the Chinese classification and diagnostic criteria for mental disorders (CCMD-3), the Western diagnostic criteria are as follows: (1) meeting the diagnostic criteria of neurosis; (2) persistent primary anxiety symptoms and meeting the following two conditions of ① frequent or persistent fear or anxiety without a clear object and fixed content that is ② accompanied by autonomic nervous symptoms or motor discomfort; and (3) meeting the symptom criteria for ≥6 months.

Referring to the "Traditional Chinese Medicine industry standard disease diagnosis and efficacy criteria ZY/T001.1-94" in the diagnostic criteria for "depression," the traditional Chinese medicine diagnostic criteria include the presence of depression and worry, emotional restlessness, or irritability and crying as the main symptoms, and are as follows: (1) depression is not smooth, lack of spirit, chest swelling, and good breath, or alternatively, a lack of appetite, insomnia and dreaminess, irritability, and crying; (2) a history of emotional injury, such as experiences of depression, anger, excessive worry, sadness, or sorrow; (3) exclusion of organic diseases through systematic examination and laboratory tests; and (4) identification with epilepsy and madness.

The recruitment conditions are as follows: (1) meeting the diagnostic criteria of GAD in both Chinese and Western medicine; (2) no intake of anti-anxiety or anti-psychotic drugs 1 month before enrollment; (3) Hamilton Anxiety Scale HAMA score > 14 points, < 27 points; (4) 20–50 years old, primary school or above, mother tongue Chinese, right-handed; and (5) voluntary consent of the patient and their family and signing of the informed consent form.

2.3.2. Exclusion criteria

Potential participants will be excluded for the following reasons: (1) women who are nursing or pregnant; (2) patients with obsessive compulsive disorder, neurasthenia, depression, phobia, schizophrenia, or other complicated anxiety disorder; (3) secondary anxiety due to coronary heart disease, hypertension, thyroid gland, and other diseases; (4) patients with severe primary diseases of the heart, brain, liver, kidney, or hematopoietic system; and (5) unable to take care of themselves or with severe cognitive impairment.

2.4. Withdrawal standards

Patients who voluntarily withdraw from the trial for their own reasons.
Patients with incomplete treatment or who have lost contact for various reasons.

2.5. Dropout criteria

The treatment causes a serious adverse reaction, or the investigator believes that the test is no longer suitable for continued research.
The patient requests to stop the trial.
The subject no longer cooperates with the investigator for personal reasons, and the investigator believes that the patient’s compliance is too poor to continue with the study.

2.6. Randomization

The enrolled patients will be randomly assigned to the two experimental groups at a 1:1 ratio using the random number table generated by the statistical software SPSS21.0. The random coding table will be arranged in order according to the number of selected cases. The random allocation scheme used the complete allocation scheme hiding method, involving a sequentially coded, sealed, and opaque envelope.

2.7. Blinding

The blinding will strictly follow the single blind principle (blind patients), in that the patients will not know the situation of grouping in advance and will use a single treatment room. The clinical evaluator will not know the groupings. The researcher will be responsible for the randomization design and writing of the paper, but will not participate in the subsequent specific grouping, treatment, and data analysis process.

2.8. Intervention

All practitioners involved in the trial are traditional Chinese medicine rehabilitation therapists with Tuina experience, and they will be trained to master the research protocol.

2.8.1. Abdominal Tuina group

The following acupoint locations will be used: Location according to “Name and Position of Acupoints” (GB/Tl 2346-2006); Qihai (CV6), lower abdomen, umbilical 1.5 inches, anterior median line; Shenque (CV8), in the umbilical region, the center of the umbilical; Zhongwan (CV12), in the upper abdomen, 4 inches above the umbilical cord, on the anterior median line; Juque (CV14), in the upper abdomen, umbilical 6 inches, anterior median line; Zhangmen (LR13), on the lateral abdomen, inferior to the free end of the 11th rib; and Qimen (LR14), in the chest, 6th intercostal space, 4 inches lateral to the anterior median line.

Operation: The experimental group will receive abdominal Tuina, during which the patients will be asked to lay supine on the treatment bed, with their knees relaxed and lower limbs slightly flexed. The patients will be asked to breathe normally and relax the abdomen as much as possible. The acupoints will be selected (e.g., Qihai, Zhongwan, Shenque, Juque, Qimen, and Zhangmen) and the following basic operations will be performed: (1) the abdomen will be pressed, in which the Qihai will be pressed for approximately 5 min; (2) the abdomen will be kneaded, in which the Zhongwan will be kneaded for approximately 5 min; (3) for abdominal transportation, the Yun Shen Que on both sides will be subjected to Tuina with the "Yun Fa" technique for approximately 2 min; (4) for abdominal pushing, pushing will be performed from the Juque to Shenque acupoints, with a treatment time of approximately 5 min; and (5) cross-wiping of the chest and flank will be conducted, in which both palms will be used to wipe both sides of the patient’s Qimen and Zhangmen acupoints, with a treatment time of approximately 3 min. The entire operation will take approximately 20 min.

2.8.2. Western medicine group

Paroxetine (Beijing Fuyuan Pharmaceutical Co., Ltd., batch number: H20133084), 20 mg, 1 tablet, once a day will be used as the western medicine in this study.

Drug combination regulation: During the clinical trial, the subjects will be advised not to use other targeted drugs, acupuncture, traditional Chinese medicine, or other methods. In case of other symptoms, clinicians should make corresponding treatment plans and record the time, dose, frequency, and reaction after the medication.

3.1. Primary outcomes

The main outcome indicator was the HAMA scale, which is mainly used to evaluate the severity of anxiety symptoms, the criteria for the classification of anxiety, and the clinical efficacy. The HAMA scale comprises 14 items, each of which is divided into five levels. A score ≥ 14 indicates definite anxiety. For the efficacy evaluation criteria, ≤ 7 is classified as basic recovery; a score reduction rate ([baseline HAMA score – HAMA score after 4 weeks]/ baseline HAMA score) ≥ 50% is classified as effective; a reduction rate of 25%–49% is classified as effective; and a score reduction rate ≤ 25% or a score increase is considered invalid. Total effective rate = number of effective cases/total number of cases ×100%; Total apparent efficiency = number of cases with an obvious effect and number of cases × 100%.

3.2. Secondary outcomes

The self-evaluation of secondary outcome indicators will be conducted using the anxiety scale (SAS), TCM syndrome scale, APNI, attention deviation index change, N1, VPP amplitude and latency, and other indicators (e.g., treatment expectation index, treatment satisfaction evaluation, and blind evaluation).

3.3. Self-rating anxiety scale (SAS)

The SAS is mainly used to assess changes in the anxiety symptoms of patients. The SAS is divided into 20 items, each of which is divided into four levels, where the higher the score, the more serious the anxiety symptoms.

3.4. TCM syndrome scale

The TCM syndrome scale is mainly used to assess the severity of patients’ anxiety symptoms and to classify the type of anxiety. The TCM syndrome scale comprises 11 items, including three main symptoms (positive thinking and worrying, insomnia or dreaminess, and palpitations), six secondary symptoms (loss of appetite, fatigue, dizziness, excessive sweating, frequent sighing, and facial paleness), and two tongue pulse items (pale tongue, thin white moss, and fine or heavy pulse string). The main symptoms of positive thinking, excessive worry, and incomprehension were graded from 0 to 6, and the other items, except tongue and pulse, were graded 0–3 or 0–2, where a higher score indicates more severe anxiety symptoms.

3.5. Chinese version of the APNI

The APNI has 40 items, which are used to measure individuals’ attention bias toward positive or negative information, including the two dimensions, positive attention bias (22 items) and negative attention bias (18 items). Using a 5-point Likert scale, a score of 1 represents “very inconsistent,” while a score of 5 represents “very consistent.” The exponential change in deviation will also be noted; the higher the attention deviation index, the more anxious the individual.

3.6. N1, VPP amplitude and latency

The indicators for the N1 and VPP include (1) latency (ms), measured as the linear distance from the beginning of stimulation to the point of maximum amplitude of each component, with N1 and VPP representing target indicators; and (2) wave amplitude (μV), measured as the vertical distance from the baseline to crest, with N1 and VPP representing target indicators.

Other indicators include the treatment expectation index, treatment satisfaction evaluation, and blind evaluation.

3.7. Adverse events

Common treatment-related adverse events include abdominal pain and cyanotic ecchymosis of the abdominal skin after treatment with or without Tuina. The adverse event data will record the occurrence, duration, and severity (signs and symptoms) of the adverse event, as well as how the event was resolved (or not) during treatment. Adverse events will be classified as treatment-related or unrelated by the physician and relevant specialist within 24 h of their occurrence. If a subject reports serious adverse events, they should be reported to the principal investigator and the Ethics Committee of the Third Affiliated Hospital of Henan University of Chinese Medicine, who will decide whether to unblind and withdraw the subject from the study. Depending on the situation, the patient will be referred to the emergency department or receive appropriate treatment. Adverse events that are spontaneously described by subjects will be collected, assessed, and reported.

3.8. Follow-up

Follow-up will occur 4 and 24 weeks after completion of the treatment program. This time point was selected to assess the sustained long-term effectiveness of the intervention.

The trial work plan is summarized in Fig. 2.

3.9. Sample size

Previous studies have reported mean HAMA scores in the abdominal Tuina and drug groups of 9.04, with standard deviations of 1.85 and 2.25, respectively. The sample size estimation method selected the test level α = 0.05 (bilateral) and efficiency 1−β = 0.90, using the two-sided test. PASS15.0 software was used to estimate the total sample size of 95, considering a 20% shedding rate, resulting in a total sample size of 114 cases.

3.10. Data management and monitoring

The case report form (CRF) will include observation time points, outcome indicators, adverse events, and safety evaluation. For the results, the assessor shall fill in the relevant information timely and accurately according to the requirements of the CRF. Data collection and entry will be performed independently by two staff members and by a third staff member. Lead investigators, rehabilitation doctors, and laboratory staff will not be involved in data collection. Data will be obtained from the CRF, and only members of the trial team will have access to the CRF and perform double data entry. The paper information will be kept sealed with the identification number. Electronic data will be stored in the ResMan Research Manager.

The anonymized trial data will be shared with other researchers for at least 3 years after publication. If any referees or readers of the published data have any questions, they will be able to contact the corresponding author to obtain the original data or access ResMan (http://www.medresman.org/uc/project/projectadd.aspx). The study will be supervised by the IEC of the Third Affiliated Hospital of Henan University of Chinese Medicine, independent of the researchers and sponsor, who will audit the trial every 12 months. Any changes and corrections to the operating procedures will be fully documented using the Violation Reporting Form, before being monitored and submitted to the Director of the Ethics Committee and the Director of the China Clinical Trials Registration Board.

3.11. Data analysis

One-way analysis of variance (ANOVA) (a variance test) will be used for intra-group comparison. The pound-for-pair comparison LSD test (or nonparametric test) will be used for intergroup comparison, and a paired t-test (or Wilcoxon paired sign rank sum test) will be employed for intra-group comparison before and after treatment. The total response rate was compared between groups using the chi-square test (or Fisher’s exact probability method). Bilateral t-test was used for all statistics. The test level is set as 0.05, and P-values < 0.05 were considered statistically significant. To better quantify the actual change, missing values were excluded, and all significance tests were performed using missing values, with an alpha value of 0.05.

3.12. Ethics and dissemination

The research subjects must pass a review undertaken by the ethics committee of the research unit before the initiation of clinical research. Informed consent shall be obtained in accordance with the Declaration of Helsinki and with reference to the Regulations for the Management of Clinical Studies of Pharmaceutical Products. All subjects will be required to sign informed consent forms before starting the trial.

All original informed consent forms signed and dated by the subject or his/her legal representative and the person presiding over the informed consent process shall be retained by the investigator.

This study has been designed to investigate the effect of abdominal Tuina on GAD, in which event-related potentials will be used to assess cognitive function in patients with GAD. As it is critical to design suitable control groups for clinical trials, we used the western drug group as a control. Although measures were taken to ensure a good controlled trial, this study still has some methodological limitations. For instance, a treatment intervention time of 4 weeks may be too short to ensure patient compliance.

Other studies, such as trials designed to describe the treatment of a typical patient, do not predict all possibilities; in such cases, the clinician must conduct a careful clinical assessment based on sound clinical judgment of each patient’s situation and consideration of the patient’s preferences. Despite its limitations, we hope that this trial will provide new insights into the value of abdominal Tuina and the treatment of GAD.

Trial status

This trial is currently recruiting participants and has been since February 2023, with the recruitment process expected to finish in May 2024. The protocol version number is 1, and the date is September 10, 2022.

GAD: Generalized anxiety disorder, HAMA: Hamilton Anxiety Scale, SAS: Self-rating anxiety scale, TCM: Traditional Chinese medicine, ANPI: Attention to Positive and Negative Information Scale, EEG: Electroencephalogram, ANT: Attention network test, fMRI: Function magnetic resonance imaging, ERPs: Event-related potentials, RCT: Randomized controlled trial.

Funding

This experiment was funded by the Special Research Project of Traditional Chinese Medicine of Henan Province (No. 2022ZYZD12) (Tel.: 0371-56283180) and the Joint Fund for the Provincial Science and Technology Research and Development Plan in 2022 (222301420083), and the "Double First-Class" initiative in Henan Province aims to establish a research project focused on Chinese medical science disciplines by 2023(HSRP-DFCTCM-T-10). The sponsor and funder were not involved in the study design, data collection and management, data analysis and interpretation, writing reports, and the decision to publish or the preparation of the manuscript. In addition, the funders have no final authority over these activities.

Competing interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest or conflict with the subject matter or materials discussed in the manuscript; this includes employment, consultancies, compensation, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Acknowledgements

We thank LetPub (www.letpub.com) for its linguistic assistance during the preparation of this manuscript.

Author contributions

Yiming Wu: Conceptualization. Yayong He: Data curation; Formal analysis; Funding acquisition; Investigation; Methodology; Project administration; Resources; Software; Supervision; Validation; Visualization; Writing - original draft; and Writing - review & editing.

Availability of data and materials

Not applicable.

Ethics approval and consent to participate

This study was approved by the Institution Ethics Committee of the Third Affiliated Hospital of Henan University of TCM (No. 2022HL-028). Written informed consent is required for participation. Protocol amendments, adverse event reporting, and annual review will be overseen by the Institution Ethics Committee of the Third Affiliated Hospital of Henan University of TCM Medicine.

Consent for publication

A copy of the written consent is available for review by the editor of this journal.

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You are reading this latest preprint version

Clinical effect of abdominal Tuina on patients with generalized anxiety disorder: A randomized controlled study and evaluation of event-related potentials

Status:

Version 1

Abstract

Background

Methods

Discussion

Trial registration:

Figures

1. Background

2. Methods and design

3. Outcomes

4. Discussion

Abbreviations

Declarations

References

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Status:

Version 1