Introduction

Many reports, including experimental, clinical and epidemiological studies, have demonstrated that stress is associated with the onset and progression of diseases. Stress can be caused by many factors, including changes in living environment, social pressure and relationship problems. It increases the risk for chronic diseases, such as anxiety, depression, hypertension, heart disease, diabetes and obesity, leading to a decline in quality of life [1-3]. Therefore, in modern society, various methods have been used to alleviate or prevent stress. Qigong is a traditional health practice that originated in China and is reported to effectively relieve stress. The basic elements of qigong are breathing techniques, body movements, visual and sensory images, etc. Combining these elements achieves a mind– body balance [4-6]. In recent years, qigong has been attracting attention in the medical field, and it is used as a complementary therapy for cancer treatment, stress relief and type 2 diabetes, etc., as “medical qigong” [7-10]. However, there are various medical qigong methods, depending on the practitioner and culture; no consensus has been reached. Awareness of medical qigong is low, especially in Japan; there are no reports of randomized controlled trials evaluating stress relief associated with medical qigong using blood tests. This study’s purpose was to examine our medical qigong method’s effects on stress in healthy subjects by evaluating plasma cortisol in a pilot randomized controlled trial.

Materials and Methods

This study was a prospective, randomized, single blind (subjects were blinded), blinded-endpoint, parallel-group, controlled clinical trial conducted at a single center from December 2021 to May 2023 (University Hospital Medical Information Network identifier: UMIN000046305). The protocol was based on the Declaration of Helsinki and approved by the Haneginomori Eye Clinic Ethics Committee (IRB number: 21001). We invited 40 subjects and enrolled 28 (aged 36-59 years) with no underlying disease. These subjects did not include individuals who had previously received medical qigong treatment. All subjects were adults who could stand for 20 min or more and provided consent after receiving our sufficient explanation about participating in this study. Table 1 shows acupuncture points used in our medical qigong method, which included the following five steps:

1. Medical interview (Figure 1a).
2. Relieve mental and physical tension in the supine position. The practitioner gently touches four acupuncture points (Hyakue, Indo, Mizoochi and Tanden), which requires approximately 10 to 15 min (Figure 1b).
3. Maintain a distance of approximately 100 cm from the standing subject, and transmit the qigong energy emitted from the practitioner’s hands to the subject’s brainstem and frontal lobe, which requires approximately 10 min (Figure 1c).
4. The practitioner transmits qigong energy around the Ninmyaku acupuncture point for approximately 5 min while the subject is seated (Figure 1d).
5. Transmit energy into the governor vessel meridian (Tokumyaku) for approximately 5–10 min while the subject is standing (Figure 1e).
6. Each subject’s treatment was approximately 40 min duration. Subjects in both groups were blindfolded and under the same conditions. This study’s procedures were performed by only one specialist with more than 20 years of experience.

Table 1: Definitions of acupuncture points and meridians.

Figure 1: Our medical qigong protocols: (a) medical interview; (b) gently touching four acupuncture points (Hyakue, Indo, Mizoochi and Tanden); (c) transmitting qigong energy emitted from the practitioner’s hands to the subject’s brainstem and frontal lobe; (d) transmitting qigong energy to the seated subject around the Ninmyaku; and (e) transmitting qigong energy into the subject’s governor vessel meridian (Tokumyaku).

In this study, we defined “medical qigong” as qigong that involves medical interviews and tests to determine its effectiveness under a doctor’s supervision at a medical facility. One of oriental medicine’s important concepts is “Qiketsu”, commonly known as qi and blood flow in the body. The path through which Qiketsu flows is called the meridian, and this is where acupuncture and moxibustion are performed. There are approximately 360 acupuncture points over the human body on meridians that open to the body surface [11]. Our medical qigong transmits qi to acupuncture points on these meridians without using invasive stimulation, such as acupuncture needles. Applying this energy to each organ through the body’s meridians brings about changes in the mind and body. The primary outcome was the change in plasma cortisol in blood tests before and after treatment. The secondary outcome was the change in adrenocorticotropic hormone (ACTH) before and after treatment. In addition, white blood cell (WBC), red blood cell (RBC), hemoglobin (Hb), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets and C-reactive protein (CRP) were also examined to evaluate each subject’s condition and confirm reproducibility. Considering the circadian rhythm of plasma cortisol, pre-treatment blood tests were performed from 10:00 to 10:15 am, and posttreatment blood tests were performed from 11:30 to 11:45 am. No data were excluded from any analyses except for an apparent outliner, which could affect the unbiased comparison. Categorical data were summarized as the frequency (%), and continuous data were expressed as the mean and standard deviation (SD). Group comparisons between medical qigong and control groups were performed using Fisher’s exact test for categorical variables and the Mann–Whitney U test for continuous variables. All statistical analyses were performed using Mathematica software version 13.0 (Wolfram Research, Champaign, IL, USA). A value of p < 0.05 was considered significant.

Results

Of 40 invited subjects, 28 were enrolled, and 14 were randomly assigned to each of the medical qigong group and the control group. All enrolled subjects completed the protocol; there were no dropouts (Figure 2).

Figure 2: CONSORT flow chart showing the subjects’ flow through this trial.

There were no significant differences in sex, age, WBC, RBC, Hb, HCT, MCV, MCH, MCHC, platelets, CRP, ACTH or cortisol between groups, as illustrated in Table 2.

Table 2: Characteristics and comparison between the study groups.

The medical qigong group’s plasma cortisol was 11.8 ± 4.3 μg /dL before treatment and 8.8 ± 2.5 μg/dL after treatment, showing a significant difference (p = 0.039). In contrast, the control group’s plasma cortisol was 12.3 ± 7.1 μg/dL before treatment and 10.8 ± 6.6 μg/dL after treatment, with no significant difference (p = 0.1). There was no significant difference in the amount of change in ACTH between the medical qigong group and the control group (Figure 3).

Figure 3: Changes in plasma cortisol and ACTH in qigong and control groups. * p < 0.05.

There were no significant differences in the amount of change in WBC, RBC, Hb, HCT, MCV, MCH, MCHC, platelets or CRP between groups (Table 3). No adverse events occurred during the study.

Table 3: Comparison of changes before and after treatment.