Effects of traditional Chinese medicine on symptoms of patients with spleen and stomach deficiency-related tinnitus

Abstract

BACKGROUND

Tinnitus affects 10%-30% of the population. Recent evidence suggests that tinnitus is associated with spleen deficiency. However, compared with kidney deficiency-related tinnitus, less research has been conducted on the impact of spleen deficiency-related tinnitus.

AIM

To investigate the clinical efficacy of using Guipi Wan and dietary and lifestyle modification based on traditional Chinese medicine for treatment of patients with spleen and stomach deficiency-related tinnitus.

METHODS

We enrolled 110 patients with spleen and stomach deficiency-related tinnitus who were distributed into treatment (58 cases) and control (52 cases) groups. Tinnitus severity, sleep quality and emotional state were assessed by questionnaires [Tinnitus Evaluation Questionnaire (TEQ); Pittsburgh Sleep Quality Index (PSQI); Depression-Anxiety-Stress Scale-21 (DASS-21)] that were used for analysis in the two groups during the initial and intervention and after. In the treatment group, patients were treated with oral administration of Guipi Wan and consulted for healthy dietary and lifestyle modification. In the control group, patients were only assessed and not treated.

RESULTS

At the end of the 6-months, TEQ scores decreased significantly in the treatment group (P = 0.021) but not in the Control group. Significant effects in the treatment group were noted for PSQI total score (P = 0.043) and several PSQI component scores in the treatment group (P < 0.05). After treatment, the DASS-21 scores were significantly reduced in the treatment group (P < 0.05).

CONCLUSION

Guipi Wan combined with dietary and lifestyle modification based on regulating the spleen and stomach can be considered core to the treatment of tinnitus related to spleen and stomach deficiency.

Key Words: Spleen and stomach deficiency-related tinnitus, Traditional Chinese medicine, Guipi Wan, Dietary modification, Lifestyle modification

Core Tip: To investigate the clinical efficacy of Guipi Wan and dietary and lifestyle modification based on traditional Chinese medicine for the treatment of patients with spleen and stomach deficiency-related tinnitus. The study found that Guipi Wan combined with dietary and lifestyle modification therapy based on regulating the spleen and stomach can be considered as core treatment of tinnitus related to spleen and stomach deficiency.

INTRODUCTION

Tinnitus is an auditory perception in the absence of an external sound source. Population surveys estimate a prevalence of tinnitus of 10%-30%[1]. The prevalence of persistent tinnitus increases with age, reaching a peak for persons in the seventh decade of life[2]. Many patients with tinnitus report that the auditory perception impairs sleep, concentration, and cognitive function that are required for day-to-day functioning[3]. In traditional Chinese medicine (TCM), tinnitus is classified[4] into five categories based on the cause: (1) Wind evil invasion; (2) Liver fire disturbance; (3) Phlegm-fire stagnation; (4) Spleen and stomach weakness; and (5) Kidney essence loss. Kidney deficiency type tinnitus has been reported and well-studied in East Asia for a long time. Recent evidence has found correlations between bothersome tinnitus and deficiency of spleen and stomach[5]. Spleen and stomach deficiency-related tinnitus affects mental health and contributes to anxiety, stress and depression[6]. However, studies regarding the impact of spleen deficiency-related tinnitus are scarce compared with studies of kidney deficiency type tinnitus.

TCM has been used for treatment for > 2500 years. TCM includes herbal medicine, acupuncture, massage, dietary therapy, exercise and other lifestyle changes. From the perspective of TCM, all diseases originate from the imbalance of Yin and Yang. Starting from the theory of "kidney opening in ear", most researchers have correlated the main pathogenesis of tinnitus with kidney deficiency, but the clinical effect of treating tinnitus from the angle of tonifying kidney is not satisfactory in most cases. Huang Di Nei Jing clearly recorded the pathogenesis of tinnitus and emphasized the relationship between tinnitus and spleen and stomach disorders. More seriously, increasing numbers of young people are now suffering from tinnitus, and unhealthy lifestyle factors have been associated with the risk and severity of tinnitus. Spleen-stomach weakness type tinnitus refers to tinnitus caused by fatigue, less talk, excessive thinking, or aggravation when squatting and standing up. It is characterized by poor appetite, complexion pallor, sluggish expression, abdominal distension and sloppy stools. The tongue is light red, the tongue coating is thin and white, and the pulse is weak. All diagnostics were administered by a TCM practitioner who had ≥ 5 years of clinical experience. We used the method regulating the spleen and stomach as the core to treat tinnitus. Combining with healthy lifestyle modification, patients with spleen and stomach deficiency-related tinnitus were treated with oral Guipi Wan synchronously to help regulate sleep, diet and emotions. The aim was to investigate the effects of the therapy based on TCM, which includes Guipi Wan and healthy lifestyle consultation, on symptoms of patients with spleen and stomach deficiency-related tinnitus, and to provide a scientific basis for clinical strategy.

MATERIALS AND METHODS

Study population and design

This was a retrospective observational study conducted at the Department of Otolaryngology in the China-Japan Union Hospital of Jilin University from January 2021 to December 2021. The study was designed for 120 patients, who were divided into treatment and control groups. Patients who met the inclusion criteria and gave written informed consent were enrolled in the study that lasted for 6 months. Data collection included demographic data, history of spleen-stomach diseases, dietary and sleeping habits, and binaural hearing tests (PTA and SRT). After completion of baseline measurements, patients in the same stratification were randomly assigned to two groups (1: 1 ratio) using SPSS 22.0 (IBM, Chicago, IL, United States). Finally, 58 patients in the treatment group (2 with incomplete records excluded) and 52 patients in the control group (8 with incomplete records excluded) completed the trial. Tinnitus severity, sleep quality and emotional state were assessed by questionnaires [Tinnitus Evaluation Questionnaire (TEQ); Pittsburgh Sleep Quality Index (PSQI); Depression-Anxiety-Stress Scale-21 (DASS-21)] which were used for the analysis in the two groups during the initial intervention and after. All procedures of this study were reviewed and approved by the Ethics Committee of the China-Japan Union Hospital of Jilin University (No. 20211130003). Figure 1 shows the trial procedure flowchart.

Figure 1 Trial flowchart. TEQ: Tinnitus Evaluation Questionnaire; PSQI: Pittsburgh Sleep Quality Index; DASS-21: Depression-Anxiety-Stress Scale-21.

Inclusion criteria

The definition of tinnitus was in the textbook Otolaryngology Head and Neck Surgery (9^th edition)[7]: In the absence of an external sound source or external stimulation, the subject feels a sound inside the ear or inside the skull. Spleen-stomach weakness type tinnitus is caused by fatigue, less talk, excessive thinking, or aggravation when squatting and standing up[8]. It is characterized by poor appetite, complexion pallor, sluggish expression, abdominal distension and sloppy stools. The tongue is light red, the tongue coating is thin and white, and the pulse is weak. All diagnostics were administered by a TCM practitioner who had ≥ 5 years of clinical experience. The duration of tinnitus was > 3 months. Adult patients who presented with spleen and stomach deficiency-related tinnitus were included. All patients were > 18 years old but < 70 years.

Exclusion criteria

The exclusion criteria were: (1) Patients with previous ear disease or surgery; (2) Patients with cognitive impairment and inability to complete the relevant questionnaire; and (3) Patients who refused to participate for any reason.

Treatment

The patients were categorized into the treatment and control groups. The first step was to complete the questionnaire survey for each participant, to assess their sleep and eating habits and the severity of tinnitus. The patients were guided one-on-one into a healthy lifestyle and sleep and dietary habits according to the survey results. Each patient in the treatment group received oral Guipi Wan (3 g three times/d, after each meal). Based on the theory of TCM diet and sleep therapy guidance, patients with spleen deficiency-related tinnitus were counseled for healthy lifestyle to help regulate emotions, diet and sleep. The control group did not receive any treatment.

Lifestyle counseling

Emotion: A physician helps patients find their own bad emotions and pressure, inform them about the importance of good adjustment, and establish confidence in overcoming tinnitus. Behavioral intervention: Inform patients about the ways to regulate their bad emotions, such as relaxation, shifting excessive attention, taking proper rest and exercise, finding appropriate ways to release stress, and paying attention to reduce stress in life, work and family.

Diet: TCM theory used to inform patients about the importance of staple food to the function of spleen and stomach, and to correct bad eating habits. For patients who eat excessive fatty, sweet, heavy and greasy food, they should change to a light diet. For patients who do not control their diet, they should eat regularly and quantitatively. Do not eat raw cold food, such as cold drink. Patients told to eat a diet based on staple food, supplemented by appropriate amounts of meat, fruits and vegetables, and eat until 80% full.

Sleep: Patients sleep at night, avoid staying up late and wake at dawn. The recommended time to fall asleep is before 22: 00, and waking around 07: 00, thereby ensuring a sleeping window between 23: 00 and 05: 00. Patients can have a short sleep for 30-60 minutes between 11: 00 and 13: 00, stay relaxed, and sleep as naturally as possible. Suggest patients to do appropriate physical exercise and enhance physical fitness.

TEQ

TEQ is used to assess the severity of tinnitus. It consists of six questions. For the first five questions, there are four possible answers, corresponding to a score of 0-3. The sixth question was the tinnitus severity score, which was rated by the evaluator on a scale of 0-6. The total score ranges from 0 to 21. According to the grading of TEQ, patients were classified as Grade I [score 0-6, II (7-10), III (11-14), IV (15-18) and V (19-21)]. The first five questions were used for follow-up evaluation and contrasted with the previous face-to-face assessments. Evaluation of therapeutic effect: When tinnitus disappeared, it was considered as healing; when tinnitus decreased by two grades, it was considered as a significant curative effect; when tinnitus decreased by one grade, it was considered as effective; when tinnitus did not change, it was considered as ineffective.

PSQI

PSQI is used to assess sleep quality[9]. The survey includes seven items to assess sleep quality over the past month; namely, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, daytime dysfunction and sleep medication use. The score range of each item is 0-3, and the total score is 0-21. A score of 0-5 indicates that there is no clinically significant sleep difficulty, while a score of 6-21 indicates poor sleep quality.

DASS-21

DASS-21 is a self-reported 21-item scale used to assess depression, anxiety and stress symptoms, with 7-item subscale dimensions for each symptom[10,11]. Participants responded to each question based on the actual situation over the past week, using a 4-point scale (0-3). Higher scores indicate more severe symptoms of depression, anxiety and stress.

Statistical analysis

Statistical analysis was performed with SPSS 22.0 (SPSS, Chicago, IL, United States) and Graph Pad Prism 8.0 (La Jolla, CA, United States). P < 0.05 was considered statistically significant. Descriptive data are presented as mean ± SD, median ± interquartile range, or percentage. Fisher’s exact test (two-tailed) was used to compare patient characteristics. The Kruskal-Wallis test was used for comparisons between groups. The Mann-Whitney U test was used for within-group comparisons. Correlations were assessed using Pearson's rank correlation.

RESULTS

Baseline clinical characteristics and demographics before treatment

Tinnitus severity, sleep quality and emotional state were assessed by TEQ, PSQI and DASS-21 during the initial intervention and after (Figure 1). Data collection included demographic data, history of spleen-stomach diseases, dietary and sleeping habits, and binaural hearing tests (PTA and SRT). The baseline levels of the two groups’ data were almost homogeneous (P > 0.05), as shown in Table 1. There was no evidence of adverse effects in patients.

Table 1 Characteristics of patients.

	Treatment group (n = 58)	Control group (n = 52)	P value1
Gender (M/F)	34/24	32/20	0.5412
Age (year)	63.3 ± 10.22	65.4 ± 8.15	0.532
Duration of tinnitus (month)	8.0 ± 5.4	8.2 ± 4.6	0.556
Hearing loss (yes/no)	29/21	30/20	0.1722
Sleep disturbance (yes/no)	46/12	43/10	0.0912
Poor dietary habits (yes/no)	38/20	34/18	0.3852
Spleen-stomach diseases (yes/no)	48/10	43/9	0.8912
TEQ	13.56 ± 2.88	12.78 ± 2.98	0.423
PSQI	10.5 ± 5.20	10.7 ± 4.82	0.361
DASS-21
Depression	10.17 ± 4.10	11.22 ± 5.53	0.475
Anxiety	9.05 ± 3.66	9.78 ± 4.32	0.197
Stress	12.51 ± 6.32	13.09 ± 5.76	0.061

¹Mann-Whitney U test.

²Fisher’s exact test.

M: Male; F:Female; TEQ: Tinnitus Evaluation Questionnaire; PSQI: Pittsburgh Sleep Quality Index; DASS-21: Depression-Anxiety-Stress Scale-21.

Assessment of tinnitus severity using TEQ before and after treatment

After 6 months of Guipi Wan combined with dietary modification, symptoms of spleen and stomach deficiency-related tinnitus were significantly improved, and the TEQ score was significantly decreased (P = 0.020; Table 2 and Figure 2A). Treatment was effective in more than half of the patients (58.6%, 34/58). After intervention, the number of patients with Grade II tinnitus decreased from 28 to 17, and the number with Grade III decreased from 19 to 13. Tinnitus symptoms no longer affected daily life in 18 patients; tinnitus no longer disturbed concentration in 13 patients; and tinnitus symptoms disappeared in three patients. For those with worse tinnitus symptoms at baseline, TEQ also showed a trend of improvement.

Figure 2 Assessment of tinnitus severity, sleep quality, and emotional state before and after treatment. A, B and D: Significant differences for Tinnitus Evaluation Questionnaire (TEQ; A), Pittsburgh Sleep Quality Index (PSQI; B) and Depression-Anxiety-Stress Scale-21 (DASS-21) scores (D) in patients with spleen and stomach deficiency-related tinnitus before and after treatment; C: PSQI total score was positively correlated with TEQ score of tinnitus severity. TEQ scores in patients with spleen and stomach deficiency-related tinnitus before treatment were positively correlated with PSQI scores. ^aP < 0.05. TEQ: Tinnitus Evaluation Questionnaire; PSQI: Pittsburgh Sleep Quality Index; DASS-21: Depression-Anxiety-Stress Scale-21.

Table 2 Changes in major variables of the measurements before and after 6 months of treatment.

	Treatment group (n = 58)		P value1	Control group (n = 52)		P value1	P value1
	Pre-test	Post-test		Pre-test	Post-test
TEQ score	13.56 ± 2.88	8.21 ± 2.54	0.021	12.78 ± 2.98	11.59 ± 3.77	0.046	0.020
I	6/58	23/58	0.008	5/52	10/52	0.012	0.042
II	28/58	17/58	0.027	25/52	23/52	0.57	0.003
III	19/58	13/58	0.042	16/52	14/52	0.095	0.021
IV	6/58	4/58	0.046	5/52	4/52	0.328	0.073
V	2/58	1/58	0.061	2/52	1/52	0.055	0.65
PSQI total score	10.95 ± 5.20	6.85 ± 4.56	0.043	10.07 ± 4.82	11.21 ± 6.34	0.945	0.038
DASS-21	31.12 ± 7.23	24.87 ± 6.35	0.003	32.21 ± 6.59	28.32 ± 6.66	0.043	0.032
Depression	10.17 ± 4.10	8.32 ± 3.98	0.027	11.22 ± 5.53	10.56 ± 4.23	0.543	0.045
Anxiety	9.05 ± 3.66	7.21 ± 2.54	0.011	9.78 ± 4.32	10.11 ± 5.54	0.842	0.019
Stress	12.51 ± 6.32	10.38 ± 4.78	0.045	13.09 ± 5.76	11.87 ± 4.65	0.065	0.076

¹Mann-Whitney U test.

TEQ: Tinnitus Evaluation Questionnaire; PSQI: Pittsburgh Sleep Quality Index; DASS-21: Depression-Anxiety-Stress Scale-21.

Assessment of sleep quality using PSQI score before and after treatment

After 6 months, significant effects in the treatment group were noted for PSQI total score (P = 0.043). Before treatment, 46 patients had sleep disorder in the treatment group and after 3 months of treatment, 24 patients had significantly improved sleep quality. In addition, 13 patients reported that tinnitus no longer affected their falling asleep. Similarly, patients in the treatment group had improved symptoms compared to those in the control group, as assessed by PSQI total score and several component scores (all P < 0.05; Table 2 and Figure 2B). Severity of tinnitus in patients with sleep disorder was significantly higher than that in patients with normal sleep (P = 0.032). According to Pearson correlation analysis, PSQI total score was positively correlated with TEQ score of tinnitus severity, with a correlation coefficient of 0.7695 (r = 0.7695, P < 0.05; Figure 2C).

Assessment of emotional state using DASS-21 before and after treatment

After 6 months of intervention, the DASS-21 scores of patients in both groups decreased significantly (treatment group, P = 0.003; control group, P = 0.043; Table 2 and Figure 2D). DASS-21 score in the treatment group decreased more than in the control group (P = 0.032). Compared with the control group, the scores for depression (P = 0.045) and anxiety (P = 0.019) in the treatment group decreased significantly. Changes in the stress score were not significantly different between the two groups (P = 0.076). There was no significant difference in the scores of the binaural hearing tests (PTA and SRT) between the two groups (P > 0.05).

DISCUSSION

Tinnitus is a common disorder that can have a serious impact on sleeping quality, mental health and quality of life. In the tinnitus population, the prevalence of comorbid insomnia or sleep disorder ranged from 10.1% to 79.5%, and the prevalence of comorbid anxiety and depression ranged from 15.2% to 28.7%[12,13]. There is substantial heterogeneity in the etiology of tinnitus. No effective drug treatments are available, although much research is underway on mechanisms and possible treatments[14].

TCM has been used for > 2500 years, and has been demonstrated to have therapeutic potential for tinnitus[15]. Huang Di Nei Jing clearly recorded the pathogenesis of tinnitus and emphasized the relationship between tinnitus and spleen and stomach disorders. Huang Di Nei Jing proposed that stomach disharmony leads to restless sleep, which then leads to stomach disharmony, which both contribute to tinnitus. From the perspective of TCM, poor diet, lack of sleep and emotional dysfunction lead to tinnitus. More seriously, increasing numbers of young people are now suffering from tinnitus associated with unhealthy lifestyle and diet, and spleen and stomach deficiency-related tinnitus has become common. Sleep disorders cause negative emotions and further damage the function of spleen and stomach, thus aggravating tinnitus. Sleep deprivation is a risk factor for mental health problems such as anxiety and depression[16]. The impact of sleep deprivation on the severity of tinnitus may be mediated by sleep itself and its negative emotions[17,18].

We used the TCM method to regulate the spleen and stomach as the core treatment of tinnitus. We recommend that patients with spleen and stomach deficiency-related tinnitus are treated with oral Guipi Wan combined with dietary and healthy lifestyle modification to helping them regulate sleep, diet and emotions. Based on this theory, the treatment strategy should take into account the causal relationship between tinnitus and spleen and stomach deficiency, reduce the psychological burden of patients through communication, and then supplement drug therapy to improve the sleep quality and regulate the spleen and stomach function. Our results indicate that sleep quality is positively correlated with the severity of tinnitus, suggesting that worse sleep quality is associated with more severe tinnitus, and the severity of tinnitus gradually decreases with improvement of sleep[19]. In the treatment group, more than half (58.6%, 34/58) the patients were considered to have effective treatment. Tinnitus symptoms no longer affected daily life in 18 patients; tinnitus no longer disturbed concentration in 13 patients, and tinnitus symptoms disappeared in three patients. For patients with tinnitus accompanied by anxiety disorder, the DASS-21 scores were also significantly improved after the treatment of regulating the spleen and stomach. The mechanism may be related to invigoration of the spleen and stomach, which improves sleep quality and emotional state of patients with tinnitus, and improves their tinnitus symptoms.

Our results show that there is no correlation between severity of hearing loss and tinnitus and hearing loss does not increase the severity of tinnitus.

The recovery of spleen and stomach function and the adjustment of visceral balance is a long-term process, and self-regulation of patients' diet, sleep and emotion is a core part of the treatment. When patients have a regular diet, regular daily life and smooth mood adjustment, the function of the spleen and stomach gradually recovers and tinnitus disappears. Dietary and lifestyle modification can be considered as a key in the treatment of tinnitus. Even when medication is stopped, self-regulation continues, and the longer it lasts, the better is the outcome.

There were some limitations to our study. The recovery of spleen and stomach function and the adjustment of visceral balance is a long-term process, and short-term drug treatment is only part of the treatment. This study was only for 6 months, which was too short.

CONCLUSION

The study found that Guipi Wan combined with dietary and lifestyle modification therapy based on TCM theory for spleen and stomach deficiency-related tinnitus may exert additional efficacy on improving psychological sensation of spleen and stomach deficiency-related tinnitus and sleep quality. Much attention must be paid to clinic about tinnitus with spleen and stomach deficiency syndrome.