Observation of the Clinical Effect of Auricular Acupressure in the Treatment of Insomnia

Abstract

Insomnia leading to an inadequate fulfillment of the body’s physiological sleep requirements in terms of both quality and duration. A single-arm clinical trial was employed. N = 84 and were given auricular acupressure treatment, 10 times as a course of treatment. The Pittsburgh Sleep Quality Index (PSQI), TCM Syndrome Score Scale, Insomnia Severity Index Scale, Flinders Fatigue Scale, Health Status Questionnaire, Patient Satisfaction Score and Auricular Temperature Change were filled in at the time of enrollment and after treatment, and the adverse reactions were recorded to evaluate the safety of treatment. According to the rate of reduction in the total score of the PSQI as the evaluation standard, 12 patients were cured, 46 significantly improved, 22 improved, and 4 showed no improvement, resulting in a total effective rate of 95.29% and a patient satisfaction rate of 90.58%, both showing statistically significant differences (P < .05). So ear acupressure can effectively treat insomnia.

1. BACKGROUND

Quality sleep is paramount for maintaining normal physiological functions in the human body, as it can alleviate fatigue, sustain the normal functioning of the nervous system, regulate emotions, and alleviate stress.¹ With the continuous development of society, an increasing number of people are experiencing sleep disorders due to increased life pressures and changes in lifestyle, impacting the health and quality of life of affected individuals significantly. Among these disorders, insomnia is the most common, with statistics showing that over one-third of adults have experienced insomnia at some point.² The global prevalence of insomnia in the general population is approximately 10%, while it is around 50% among primary care patients.³ Currently, over 300 million individuals in China are troubled by sleep disorders, with insomnia affecting 10% to 15% of adults.⁴

According to traditional Chinese medicine (TCM) theory, stimulating ear acupoints can regulate the balance of yin and yang in the body, improve the functions of internal organs, and thereby achieve the therapeutic effect of treating insomnia. Multiple clinical studies have demonstrated that ear acupressure can increase parasympathetic activity of the heart, reduce sympathetic activity, improve sleep quality, and shorten the time to fall asleep.^5,6 In 2019, a new clinical practice guideline jointly approved by the U.S. Department of Veterans Affairs and the U.S. Department of Defense recommended ear acupuncture as a treatment for chronic insomnia.⁷ Ear acupuncture therapy regulates the functions of internal organs through the skin-meridian channels-acupuncture channels-viscera, aiming to regulate the flow of qi, open up the meridians, harmonize qi and blood, strengthen the body, dispel pathogenic factors, promote blood circulation, balance yin and yang, and treat diseases.⁸ Multiple studies have proven the definite efficacy of ear acupressure in treating insomnia.⁹ However, there is currently no longitudinal tracking study on the specific treatment process of ear acupuncture therapy. Therefore, this study aims to conduct a longitudinal investigation of the clinical efficacy and safety of TCM-pattern-based ear acupressure therapy for insomnia. By conducting a single-arm clinical trial, we aim to evaluate the clinical efficacy and safety of this therapy for treating insomnia.

2. METHODS

2.1 Study design

In the period from January 2023 to August 2023, a single-center, single-arm, prospective clinical trial was conducted at the TCM Characteristic Nursing Clinic of Yunnan Provincial Hospital of Traditional Chinese Medicine (Figure 1).

FIGURE 1.

Consort flow chart of the study.

2.2 Sample size

All study subjects were insomnia patients diagnosed insomnia, who sought treatment at the Traditional Chinese Medicine Hospital in Yunnan Province from January 2023 to August 2023. Participants who met the inclusion and exclusion criteria were selected in order of admission, resulting in a total of 90 patients initially enrolled. 2 patients were subsequently excluded, 1 patient was lost to follow-up, and 3 patients were removed, leaving 84 participants.

2.3 Inclusion and exclusion criteria

Inclusion criteria:

1. Meet the diagnostic criteria for insomnia in the “Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.”

2. Duration of illness exceeding 1 month.

3. Voluntarily participate in the study and sign an informed consent form.

4. Have not received insomnia-related medication or non-pharmacological treatment in the past month.

5. Experience difficulty falling asleep or staying asleep, including waking up frequently during the night, or even experiencing complete sleeplessness.

6. Frequently experience symptoms such as headaches, dizziness, palpitations, forgetfulness, and excessive dreaming.

7. No abnormalities found in the overall physical examination.

8. Age >18 years old.

Note: All criteria must be met.

Exclusion criteria:

1. Failure to meet the inclusion criteria.

2. Presence of severe organic diseases, liver or kidney dysfunction, severe cardiovascular diseases, mental disorders, or coagulation disorders.

3. Inability or unwillingness to comply with the study requirements.

4. Patients with bleeding disorders, coagulation mechanism abnormalities, or malignant tumors, which contraindicate gua sha therapy.

5. Known allergy to ear acupressure stickers or alcohol.

6. Patients with ear skin damage, eczema, infections, or other conditions.

Note: Any one of these criteria not being met will result in exclusion.

2.4 Intervention

This study is based on the principles of TCM syndrome differentiation treatment for the selection of acupoints. The chosen acupoints include those related to the liver, kidneys, “Shenmen” (HT7), subcortical regions of the nervous system, sympathetic nervous system, and endocrine system, as well as the occiput. The location of these acupoints follows the “Standard Nomenclature and Location of Auricular Points of the People’s Republic of China” issued by the National Bureau of Technical Supervision in 1992. During the treatment process, every 10 sessions constitute 1 course of treatment, and each patient undergoes 1 complete course of treatment. The therapeutic medium employed is Vaccaria Seeds (Wang Bu Liu Xing), a traditional Chinese medicinal seed belonging to the Caryophyllaceae family. Anti-allergic tape is utilized to affix the Wang Buliuxing seeds onto specific auricular acupoints. Participants in the study underwent a comprehensive treatment program spanning 10 weeks, with weekly visits to the TCM characteristic nursing clinic for auricular acupressure therapy. Upon application, the Vaccaria Seeds adhere to the auricular acupoints and remain in place until the subsequent treatment session, ensuring continuous stimulation of the auricular points. The ear seeds are replaced weekly, with both ears undergoing Wang Buliuxing seed acupressure. Patients are advised to stimulate these points at least 5 times daily, using the pads of their thumb and index finger to apply pressure both anteriorly and posteriorly to the ear, until a gentle warmth sensation is perceived.

2.5 Data collection and outcome measurements

Assessment indices included the TCM Syndrome Score Scale, Pittsburgh Sleep Quality Index (PSQI), Flinders Fatigue Scale (FFS), Insomnia Severity Index (ISI), Health Status Questionnaire (SF-36), and Patient Satisfaction Score, with the infrared non-contact thermometer employed to measure changes in auricular temperature before and after the initial auricular acupressure treatment.

2.6 Study ethics

All study participants were provided with a comprehensive explanation of the protocol and were required to sign a written informed consent form before study entry.

2.7 Statistical analysis

We used SPSS26.0 software for statistical analysis, and the collected metrical data were statistically expressed as mean ± standard deviation (±s) and the calculating data were calculated using the chi-square test. We compared measures before and after the intervention using a paired samples t-test with 95% confidence intervals (CIs) to estimate the size of the difference. A P value of ≤.05 was considered statistically significant.

3. RESULTS

3.1 Outcomes

Table 1 illustrates the final results of this study involved a total of 84 patients (72 women and 12 men), with a mean age of 46.21 ± 12.77 years, and shows the demographic characteristics of the patients enrolled in the study. Seventy-two percent of the participants were women, similar to the¹⁰ study, which showed women were at a higher risk of insomnia due to hormonal changes in the reproductive system compared to men. The highest proportion of primary patients at 37 percent were health care workers, consistent with other studies showing that health care workers are at high risk of insomnia, which is related to the predisposition of sleep disturbances due to the hospital’s circadian shift system.¹¹ The age of 30 to 50 is the group with the highest proportion of insomnia, which may be related to the fact that this group has a more stressful life.

TABLE 1.

Demographic Characteristics of the Study Participants

Variable	Frequency (%)
Sex
Women	72 (85.71)
Man	12 (14.29)
Ethnic group
Han Chinese	74 (88.09)
Yi	6 (7.14)
Bai	4 (4.77)
Occupational status
White collar workers	35 (41.67)
Medical personnel	37 (44.05)
Governmental employee	6 (7.14)
Freelancer	6 (7.14)
Age,
27-30 years old	6 (7.14)
30-40 years old	25 (29.76)
40-50 years old	22 (26.19)
50-60 years old	19 (22.62)
Over 60 years old	12 (14.29)
Time of illness
Within 1 month	6 (7.14)
January-March	7 (8.33)
March-June	32 (38.10)
6 months-1 year	21 (25.00)
1 year-2 years	12 (14.29)
>2 years	6 (7.14)
Satisfaction
Satisfied	76 (90.48)
Not very satisfied	4 (4.76)
Dissatisfied	4 (4.76)

There was no statistically significant difference in the scores of various questionnaires before treatment (P > .05). However, there were statistically significant differences in the scores after treatment (P < .05). Table 2 and Figure 2 outcome measures before and after 10 weeks of using auricular acupressure treatment illustrates the remarkable effects of TCM syndrome differentiation auricular acupressure treatment on the patient’s condition. Following the treatment, there was a significant improvement in the patient’s TCM symptoms (score decreased from 9.762 ± 0.3420 to 3.298 ± 0.2459, P < .001), indicating substantial progress. Additionally, the patient experienced enhanced sleep quality (PSQI score decreased from 9.131 ± 0.2441 to 3.917 ± 0.2055, P < .001) and reduced daytime fatigue (FFS score decreased from 8.262 ± 0.4892 to 3.595 ± 0.3054, P < .001), both of which were statistically significant. Notably, the severity of insomnia was reduced (ISI score decreased from 10.74 ± 0.2630 to 3.774 ± 0.2125, P < .001), resulting in a notable improvement. The patient’s overall quality of life showed significant enhancement (SF-36 score increased from 69.27 ± 0.2587 to 80.43 ± 0.3320, P < .001), reflecting an auspicious outcome. Moreover, the auricular temperature noticeably increased before and after the initial auricular compression (from 36.10 ± 0.01909°C to 37.16 ± 0.03826 °C, P < .001), indicating positive physiological changes. Assessing the improvement based on the reduction rate of the total score on the PSQI scale, 12 cases achieved clinical cure, 46 cases yielded effective results, 22 cases showed improvement, and 4 cases exhibited ineffectiveness, resulting in an overall effective rate of 95.29% and a high patient satisfaction rate of 90.58%, which was statistically significant (P < .05). Notably, the TCM syndrome cure rate was 14.11%, with an apparent effective rate of 30.59%, an effective rate of 47.56%, and a total clinical effective rate of 94.26%, with statistical significance (P < .05).According to the PSQI scale total score reduction rate as the evaluation criteria, 12 cases were clinically cured, 46 cases were effective, 22 cases were effective, and 4 cases were ineffective, with a total effective rate of 95.29% and a patient satisfaction rate of 90.58%, with a statistically significant difference (P < .05). The cure rate of TCM syndrome was 14.11%, the apparent effective rate was 30.59%, the effective rate was 47.56%, and the total clinical effective rate was 94.26%, and the difference was statistically significant (P < .05).

TABLE 2.

Outcome Measures Before and After 10 Weeks of Using Auriculo-Acupressure Therapy

Outcome	Measured Value		Mean Difference (95% CI)	P Value
	Before	After
The scoring scale for traditional Chinese medicine (TCM) syndromes	9.762 ± 0.3420	3.298 ± 0.2459	−7.296 to −5.633	<.001
Pittsburgh Sleep Quality Index (PSQI)	9.131 ± 0.2441	3.917 ± 0.2055	−5.844 to −4.584	<.001
Flinders Fatigue Scale (FFS)	8.262 ± 0.4892	3.595 ± 0.3054	−5.805 to −3.528	<.001
Insomnia Severity Index (ISI)	10.74 ± 0.2630	3.774 ± 0.2125	−7.632 to −6.297	<.001
36-Item Short-Form (SF-36)	69.27 ± 0.2587	80.43 ± 0.3320	10.32 to 11.99	<.001
Auricular temperature (°C)	36.10 ± 0.01909	37.16 ± 0.03826	0.9692 to 1.138	<.001

FIGURE 2.

Observe the outcomes of the metrics.

As shown in Table 3, the majority of patients experienced improvements in insomnia after the first or second ear acupressure treatment, reporting a significant amelioration of insomnia symptoms. Following the completion of treatment, patients reported improvements not only in insomnia-related symptoms, but also in other areas such as mental state, tinnitus, lower back pain, and symptoms of menopausal syndrome in women. This indirectly validates the holistic concept of TCM and suggests that the auricle. The research results also indicate that in clinical practice, for patients with reasonably good bodily functions experiencing short-term insomnia, the desired therapeutic effect can be achieved with 1-2 treatments of this therapy. Sixty-nine percent of patients reported improvements in insomnia after 4 treatments, and for patients with a longer course of illness or prone to recurrence, satisfactory results can be achieved with 10 treatments of this therapy.

TABLE 3.

Time to Symptom Improvement

Outcome	Time	Frequency (%)
Insomnia improves the duration of the effect	1st time	23(27.38)
	2nd	25(29.76)
	3rd	5(5.95)
	4th	16(19.05)
	5th	2(2.4)
	6th	2(2.4)
	7th	1(1.18)
	8th	4(4.75)
	10th	6(7.13)
Improvement of other symptoms	Poor mental state	10
	Tinnitus	5
	Lumbago	5
	Some symptoms of perimenopausal syndrome (hyperhidrosis, hot flashes, etc)	8

Figure 3 illustrates that before treatment, there was a crack on the tongue surface, the tongue surface was dry, and the insomnia cracks became shallow and moist and shiny after a ear acupoint compression.

FIGURE 3.

Tongue image before and after a session of auricular acupressure.

3.2 Adverse event

The patients reported no adverse events during this study.

4. CONCLUSIONS AND DISCUSSION

The results indicated that Ear acupressure has been shown to increase the temperature of the auricle, improve sleep quality, reduce the severity of insomnia, alleviate fatigue, and enhance the overall quality of life for patients. The results indicated minimal adverse reactions or significant safety concerns associated with auricular acupoints and TCM acupoints. The improvement of symptoms varies depending on individual differences and the course of the disease, as well as the prognosis and treatment time. This aligns with previous research and further reinforces the safety of this treatment approach.

It is worth noting that the overall fatigue scores after insomnia were not exceptionally high, indicating that tiredness may not solely stem from insomnia itself. Interestingly, the amelioration of symptoms other than those directly evaluated, such as poor mental state, tinnitus, low back pain, and perimenopausal syndrome, can be attributed to the syndrome differentiation and treatment approach in TCM. This approach aims to restore the balance of yin and yang within the internal organs to treat diseases.

Auricular acupressure is a green, safe, and effective treatment option that demonstrates positive therapeutic effects on insomnia caused by various factors. It has also been found to be effective in managing insomnia associated with chronic diseases.¹² For instance, researchers investigated the use of auricular acupressure therapy on seafarers with sleep disorders. The study involved the use of wrist sleep monitors to evaluate indicators such as sleep efficiency and sleep onset time. The results revealed that auricular acupressure therapy yielded comparable efficacy to drug therapy, with the added advantage of avoiding the potential risks of drug dependence.¹³ Other studies have explored the combination of auricular acupressure with other treatment modalities. For example, Zhou et al¹⁴ utilized the acupoint embedding method in conjunction with auricular acupressure to address spleen and stomach disharmony-related insomnia. Tang et al¹⁵ incorporated auricular acupressure into specialized nursing intervention and estazolam tablets for acute exacerbations of chronic obstructive pulmonary disease with insomnia, resulting in improved sleep duration, shortened sleep onset, and a significant reduction in PSQI scores post-treatment. Fu Li et al¹⁶ applied Wang Buliuxing seeds to acupuncture points related to depression and insomnia, resulting in significantly reduced HAMD and PSQI scores.This study provides a non-pharmacological treatment option based on TCM theory and merits further clinical promotion and application. However, the study has limitations, such as a relatively small sample size, and future multicenter studies with larger sample sizes could be conducted to address these limitations. In the future, future researches should involve randomized controlled trials to assess the scientific validity of auricular acupressure therapy. Additionally, multi-center RCTs with large sample sizes should be conducted to further substantiate its efficacy and safety.