Acupuncture Treatment Improves the Swallowing Function and Nutritional Status of the Elderly with Dysphagia : A Randomized Controlled Trial

Dysphagia is a prevalent and increasingly common problem in the elderly population [1]. Dysphagia affects an individual's ability to safely and effectively eat and drink [2]. Over 13% of the total population 65 years of age and 51% of institutionalized elderly individuals are affected by dysphagia. Additionally, dysphagia affects 16% of independently living individuals aged 70–79 and 33% of the older-than-80 age group with an even higher prevalence among older hospitalized patients [3]. Dysphagia caused by functional impairment of structures such as the mandible, lips, soft palate, pharynx, and esophagus, or due to psychological reasons, which prevents individuals from safely transporting food from the mouth to the stomach. Its clinical features mainly include difficulties in eating and drinking, coughing while drinking water, and speech disorders [4]. Consequences of dysphagia include malnutrition, dehydration, an increased risk of aspiration pneumonia and death from choking [5]. As elderly individuals age, the muscles in their oral and pharyngeal areas gradually degenerate. Moreover, esophageal - related diseases like esophageal cancer and gastroesophageal reflux disease, as well as neurodegenerative diseases or injuries, can lead to the onset of dysphagia [6]. Dysphagia has become one of the common diseases in the elderly. However, due to the non-specific symptoms and communication difficulties of elderly patients, dysphagia is often overlooked, leading to insufficient diagnosis and intervention. Therefore, early diagnosis and treatment of dysphagia are of paramount importance. 

Acupuncture is a traditional Chinese medicine therapy that treats swallowing disorders by modulating the nervous system. When specific points such as Hegu and Jiaji are stimulated, neural input to swallowing - related muscles can be adjusted. The technique also promotes local blood circulation, enhancing muscle nutrition and function. Moreover, acupuncture is guided by the meridian theory of traditional Chinese medicine. By stimulating specific acupoints, it aims to regulate the flow of Qi and blood in the meridians connected to the throat and zang - fu organs. This helps to restore the normal function of these areas and improve swallowing ability. Studies have shown that acupuncture can enhance the contraction and relaxation of swallowing - related muscles. It also promotes the release of neurochemical substances in the brain, regulates neural reflexes, and enhances the body's self - repair and regulatory capabilities. This makes acupuncture a safe and effective treatment option for patients with swallowing disorders [7-9]. 

In elderly individuals, disuse atrophy of swallowing - related muscles is common. Swallowing rehabilitation training is one of the most commonly used methods for treating dysphagia [10]. It can strengthen the movement of the lips, tongue, and chewing muscles, enhance the flexibility of the swallowing reflex, and improve eating and swallowing ability, reducing complications like aspiration pneumonia [11]. 

Therefore, the purpose of this study is to observe whether acupuncture treatment can improve swallowing function in elderly patients with dysphagia who have been swallowing rehabilitation training, and to observe whether it can improve the nutritional status, occurrence and mortality of aspiration pneumonia in elderly patients.

• Clinical Data 

A total of 112 elderly patients who have dysphagia and were admitted to Shanghai Sixth People’s Hospital Affiliated with Shanghai Jiaotong University School of Medicine between January 2021 and January 2024 were enrolled in this randomized controlled trial. The screening, diagnosis and treatment of dysphagia were accomplished through multidisciplinary collaboration. Each patient was assigned a number based on the order of their arrival. They were then provided information about the study and asked to sign an informed consent form. Non-participants generated random numbers using SPSS 23.0 software. These random numbers and the grouping information were placed in sealed, opaque envelopes. The envelopes were extracted in sequence according to the treatment order. The patients were then divided into an experimental group and a control group at a 1:1 ratio, with 56 patients in each group. To reduce potential bias, the assessors were blinded to the treatment allocation of the participants. There was no difference in age and gender data between the two groups. Each participant was adequately informed of the whole study and gave writing informed consent. Participants will be blinded to their group allocation. To test the patient-blinding effects, all patients will be asked to guess whether they received acupuncture or sham acupuncture. This study was approved by the Medical Ethics Committee of the Shanghai Sixth People's Hospital (No. 2022-KY-157(K)). 

The formula for sample size calculation is: N = Z²*σ²/d², where Z represents the confidence interval, n is the sample size, d is the margin of error, and σ represents the standard deviation. 

All patients were collected demographic information such as gender, age, and the prevalence of hypertension, diabetes, coronary heart disease, stroke, chronic obstructive pulmonary disease, and neoplasm, etc. Before enrollment, the patients were given venous blood collection, and were evaluated by Complete Blood Count (CBC), biochemistry, chest CT, and cranial nuclear magnetic examination. The patients were evaluated for their swallowing disorders and nutritional status within 48 hours of stabilization. 

After 3 months of acupuncture treatment combined with swallowing rehabilitation training, the patients' swallowing disorders and nutritional status were evaluated again, and the occurrence of pneumonia, indwelling gastric tube, and death of the patients during the treatment period were recorded. The flowchart of the trial design is shown in figure 1. 

 Figure 1: Trial flowchart.

• Inclusion and Exclusion Criteria 

Inclusion Criteria: (1) Elderly patients aged 80 years or older. (2) Have difficulty drinking water or eating and are screened as grade III or above using the Pudding Drinking Test. (3) Have normal cognitive function and be able to understand and cooperate with medical staff instructions for completing the assessment and treatment. (4) Voluntarily sign an informed consent form. 

Exclusion criteria: (1) Those with serious cognitive impairment or communication disorders. (2) Those with serious, unstable diseases. (3) Patients with swallowing disorders caused by stroke. (4) Those with serious oral, pharyngeal, or cervical spine disorders, or skin breaks or infections at the treatment site. 

Dropout criteria: (1) Subjects who have poor compliance during the clinical trial, or are unwilling to continue participating in the study and withdraw voluntarily. (2) Those who experience serious adverse reactions, serious complications, or deterioration during the study are unfit to continue. (3) Subjects who did not follow the treatment protocol or had incomplete observation data that affected the assessment.

• Treatment methods 

Swallowing Training: Patients in both groups were treated with standard swallowing training according to the results of the VFSS tests. Functional training was applied to the feeding and swallowing organs (lip, cheek, tongue, soft palate, pharynx, throat, and esophageal sphincter). Standard swallowing training was performed by qualified and experienced nurses. 

This oral rehabilitation method focuses on functional recovery of sensory and muscle strength in patients with swallowing dysfunction. Sensory function uses the modified oral care method. First, room temperature saline cotton balls clean the oral cavity. Then, ice saline, warm saline, and acetic acid cotton balls scrub the tongue surface, upper jaw, lower jaw, palatine arches, soft palate, and posterior wall of the pharynx in that order. Each site receives 10 seconds of dwell time, and each site is repeated five times. This process is performed twice daily, in the morning and evening. (b) Recovery of muscle strength refers to performing the following exercises:

Tongue exercises: Tongue extension, tongue topping, and tongue rolling. The purpose of these exercises is to strengthen the tongue muscles. 

Oral cavity exercises: The purpose of these exercises is to improve muscle coordination in the various parts of the oral cavity. This includes cheek, open mouth, teeth, knocking, and swallowing movements. Each action is repeated 20 times, and two groups are performed every morning and evening, 60 minutes after meals.

• Acupuncture Treatment 

Patients in the experiment group were treated with additional acupuncture after standard swallowing training. The acupuncture needles used in the above procedures were all 0.25 × 40 mm disposable sterile stainless steels needles (Suzhou Medical Appliance Factory Co., Ltd.). The acupuncture operation was performed in accordance with the Reporting Practice for Interventions in Acupuncture Clinical Trial (Standards for Reporting Interventions in Clinical Trials of Acupuncture, STRICTA). Acupoints include bilateral GV26 (Shuigou), and bilateral GB20 (Fengchi), GB12 (Wangu), TE17 (Yifeng), ST9 (Renying), and CV23 (Lianquan) (Table 1). Each acupuncture treatment lasted 20 min, twice a week, and the course of treatment lasted 3 months.

• Sham Acupuncture Treatment

Acupuncture will be performed at 6 non-acupoints. The selection of non-acupoints in control group are the points locating on non-meridians, but near the acupoints we select in experiment group, which is a common method in the design of sham acupuncture [12]. Shallow needling method will be used on these nonacupoints, without making sensation of Deqi. The protocol for choosing the non-acupoints are listed and shown in table 1. The requirements for acupuncturists are the same as for experiment group.

Primary outcomes: swallowing function 

Swallowing function was assessed before and after treatment in both groups. All post-treatment examinations were completed on the same day after treatment. 

• The Standardized Swallowing Assessment (SSA) score was divided into 3 parts, the first part was clinical examination, including pharyngeal reflex, voluntary cough, soft palate movement, laryngeal function, lip closure, consciousness, head and trunk control and respiration, with a value of 8~23 points; the second part was to instruct the patients to swallow 5 mL of water three times, and then to observe the laryngeal function, wheezing, laryngeal movement and repetitive swallowing, with a value of 5~11 points; if there was no abnormality in the above two parts, the patients were instructed to continue to swallow 60 mL of warm water, and then to observe whether there was choking during swallowing and record the time of swallowing, with a value of 5~12 points. If there is no abnormality in the above two parts, instruct the patient to continue to swallow 60 mL of warm water, observe whether there is any choking during swallowing, and record the swallowing time, with a score of 5 to 12. The total score of the scale was 18-46 points, and the stronger the swallowing function, the lower the score [13]. The scale was evaluated by a physician before and after treatment.
• The Kubota drinking test was used to assess swallowing function. Specific method: the patient is asked to take a sitting position or semi-recumbent position, drink 30 mL of warm water, according to the drinking water choking situation and the time used from low to high scoring for 1-5 grades. 1 grade is excellent, can be smooth one time to drink the water down; 2 grades is good, more than two times, cannot choke swallow; 3 grades medium, can be swallowed once, but there are symptoms of choking; 4 grades can be divided into two times more than swallowing, but there are symptoms of choking; 5 grades is poor, frequent choking, and can not be swallowed in full. and unable to swallow all the way down. The rating is normal for grade 1, can be grade 1 within five seconds, grade 2 for more than five seconds, and abnormal for grades 3-5 [14].
• Videofluoroscopic Swallowing Study (VFSS) is the most commonly used method for examining swallowing function and is considered the “gold standard” for detecting and diagnosing swallowing dysfunction. Liquid (30 mL) containing 60% barium sulfate was prepared. The patient was asked to sit down and swallow the liquid, during which the swallowing process was observed using an ICONOS R200 X-ray machine (SIEMENS AG, Germany). The severity of symptoms in the oral phase (0–3 points), throat phase (0–3 points), and aspiration (0–4 points) were evaluated, respectively. VFSS scores ranged from 0 to 10, with a higher score indicating a better swallowing ability. The score of 10 indicated normal swallowing, a score of 7 to 9 indicated a mild abnormality, 4 to 6 points indicated a moderate abnormality, and a score of 0 to 3 points indicated a severe abnormality [15]. Methods of evaluating effectiveness [16]: after treatment, a VFSS score of 10 points indicated a cured condition, an increase in the VFSS score ≥ 2 points and not reaching the normal level was considered to have been excellently effective, and an increase ≥ 1 point and not reaching the normal level was considered effective; no increase or a decrease was considered an effective outcome. 

Secondary outcomes 

Nutritional status assessment: Venous blood was drawn from both groups before treatment and after 3 months of treatment, and serum albumin (ALB), serum prealbumin (PA), and hemoglobin (Hb) levels were measured using an automatic biochemical analyzer. 

Incidence of pneumonia, indwelling gastric tube, and death. Diagnostic criteria for aspiration pneumonia include clinical signs/symptoms of pneumonia in patients with a history or risk factors for aspiration. a complete blood count (CBC) often shows Total number of leukocyte greater than 10,000 or more, with or without leftward shifting of the nucleus of the cells. A chest X-ray typically shows new infiltrates, often in gravity-dependent lung areas. Other indicators are risk factors like impaired consciousness or swallowing dysfunction, and possible foul-smelling breath or frothy sputum. A definitive diagnosis may require tests like videofluoroscopy to confirm aspiration.

SPSS 23.0 software was used for statistical analysis. P value less than 0.05 was considered statistically significant. The Chi-square tests were used to analyze categorical data. Count data were expressed as a percentage (%) and compared among groups using the chi-square (Χ²) test. Normally distributed data were expressed as mean ± standard deviation (x? ± SD). An intergroup comparison was conducted using an independent sample t-test, and an intra-group comparison was conducted among different time points using a paired t-test. Ridit analysis was used to compare the grade information of the two groups.

A comparison of the basic data between the 2 groups 

A total of 112 elderly patients with swallowing dysphagia were included in the study. The control group comprised 56 cases, including 45 males and 11 females, aged 80 to 95 years, with an average age of (87.32±4.78) years. The experimental group included 56 cases, 42 males and 14 females, aged 81 to 95 years, with an average age of (88.46±3.72) years. There were no significant differences between the 2 groups in the basic data, such as age, gender, tumor, Coronary Heart Disease (CHD), hypertension, stroke (cerebral apoplexy), Diabetes Mellitus (DM), chronic obstructive pulmonary disease (COPD) (all P > 0.05; Table 2).

Table 2: Comparison of basic data between the 2 groups.

Compared with the same group before treatment, *P < .05, **P < .01.

A comparison of the therapeutic effects between the 2 groups

Comparison of Kubota Swallowing Test Grades between 2 groups: After three months of acupuncture treatment combined with swallowing rehabilitation training, the Kubota Swallowing Test grades of patients in the experimental group demonstrated significant improvement compared to those in the control group (P < 0.05; Table 3).

Table 3: Comparison of Kubota Swallowing Test Grades between 2 groups.

Compared with the same group before treatment, *P < .05, **P

A comparison of the SSA scores between the 2 groups before and after treatment 

Before treatment, no significant difference was observed in Swallowing Screening Assessment (SSA) scores between the 2 groups (P > 0.05). Conversely, following treatment, the scores of SSA decreased in both groups, but the scores in the experimental group were lower than those in the control group, and the differences were statistically significant (P < 0.05; Table 4).

Table 4: Comparison of SSA scores between the 2 groups before and after treatment.

SSA = Standardized Swallowing Assessment.

Compared with the same group before treatment, *P < .05, **P < .01.

• Comparison of the therapeutic effects between the 2 groups 

After treatment, the total effective rate of the experimental group was higher than that of the control group; the effective rates of the 2 groups were 71.4% and 19.6%, respectively (P = 0.006). (P < 0.05; Table 5).

Table 5: Comparison of the therapeutic effects between the 2 groups before and after treatment.

Compared with the same group before treatment, *P < .05, **P <.01.

Comparison of nutritional status indicators between 2 groups 

Before treatment, there were no statistically significant differences in serum albumin, serum pre-albumin, and hemoglobin levels between the two groups (P > 0.05). After 3 months of combined diagnosis/treatment and swallowing rehabilitation training, the experimental group had significantly higher levels of serum albumin, serum pre-albumin, and hemoglobin than the control group (P < 0.05; Table 6).

Table 6: Comparison of t nutritional status Indicators between the 2 groups.

Compared with the same group before treatment, *P < .05, **P < .01.

Comparison of pneumonia, indwelling gastric tube, and mortality rates between 2 groups

The experimental group had significantly lower incidence rates of pulmonary infection and indwelling gastric tube placement than the control group (P < 0.05). Although the mortality rate in the experimental group was lower than that in the control group, this difference was not statistically significant. (P > 0.05; Table 7). 

Table 7: Comparison of Pneumonia, Indwelling Gastric Tube, and Mortality Rates between the 2 groups.

Compared with the same group before treatment, *P < .05, **P < .01.

Older adults often experience swallowing difficulties, or dysphagia, a condition that can significantly impact their quality of life. Dysphagia can occur in any of the swallowing phases, including oral, pharyngeal, and esophageal phases. It is estimated that around 20% to 25% of people aged 50 and above experience dysphagia [17]. This condition is more common in older adults and can be caused by various factors such as neurological disorders, muscle weakness, dry mouth, esophageal cancer, etc [18]. Symptoms of dysphagia may include coughing while eating or drinking, difficulty chewing, feeling like food is stuck in the throat, a wet or gurgly-sounding voice during meals, and unexplained weight loss [19]. It can lead to malnutrition in patients, and may also cause dehydration, electrolyte disturbances, and oral inflammation due to food residue [5]. Additionally, food entering the trachea can result in severe complications such as aspiration pneumonia, which can even be life-threatening [20]. The management of dysphagia varies depending on the individual and the underlying cause. Treatments may include behavioral changes, dietary modifications, oral care, swallowing therapy with a speech-language pathologist, medications to manage underlying conditions, and in severe cases, feeding tube placement [21]. 

Acupuncture is gaining prominence as a therapeutic modality for elderly dysphagia. At present, it has been used both independently and in conjunction with conventional therapies to address swallowing disorders in the elderly [22]. By inserting fine needles into specific acupuncture points that are intricately linked to swallowing function, acupuncture is believed to stimulate the nervous system, enhancing neural reflexes and promoting the release of neurochemical mediators. This can lead to improved muscle tone and coordination in the oral and pharyngeal regions, which are crucial for the swallowing process [23]. Studies have indicated that acupuncture can significantly reduce the severity of dysphagia symptoms, such as coughing and choking during eating, and can improve the efficiency of swallowing [24]. It offers a non-invasive and generally low-risk treatment option, making it particularly suitable for elderly patients who may have multiple comorbidities and be at higher risk for complications from more invasive procedures. Furthermore, acupuncture can be tailored to the individual patient's needs and symptoms, allowing for a more personalized treatment approach [25]. However, it's worth noting that while research into the use of acupuncture for dysphagia is growing, large-scale, randomized controlled trials are still somewhat limited. More rigorous studies are needed to fully elucidate the mechanisms of action and to establish standardized treatment protocols. 

Additionally, the integration of acupuncture with other rehabilitation techniques, such as swallowing exercises and dietary modifications, is increasingly being explored to provide a more comprehensive and effective management strategy for elderly patients with dysphagia [26]. The significance of acupuncture in treating elderly dysphagia lies not only in its potential to alleviate symptoms and improve quality of life but also in its contribution to a more holistic and individualized approach to managing this complex condition [27]. Acupuncture stimulates specific points linked to swallowing, enhancing neural reflexes and muscle coordination. Functional training strengthens the oral and pharyngeal muscles through targeted exercises. Together, they improve swallowing function, reduce complications like aspiration pneumonia, and enhance quality of life [28]. This integrated method leverages the benefits of both therapies, offering a more comprehensive and effective solution for elderly patients with swallowing difficulties. 

In this study, we treated patients with swallowing disorders in advanced age using acupuncture specific points combined with swallowing rehabilitation training and obtained good results. We used the Kubota drinking test, the SSA score and VFSS to evaluate patients' swallowing function. The Kubota drinking test is a commonly used method for clinically assessing patients with swallowing disorders. It is simple to operate, has clear and distinct grading, and higher grades indicate more severe disorders [29]. The results of this study showed no statistically significant difference in Kubota drinking test ratings between the experiment and control groups before treatment. After treatment, the grade 3 and grade 5 rates were lower in the experiment group than in the control group (28.6% and 17.8%, respectively, versus 37.5% and 33.9%, respectively). There was also an increase in the grade 2 rate in the experiment group after treatment (25%, P < 0.05). 

The SSA score, first reported by Ellul et al. in 1996, provides a comprehensive assessment of swallowing function. It ranges from 18 to 46 points, with lower scores indicating better function [30]. Before treatment, the SSA scores of patients in the two groups were compared, and the difference was not statistically significant (P > 0.05). After treatment, however, the SSA scores of patients in the experiment group were lower than those in the control group, and the difference was statistically significant (29.34±5.71 versus 34.72 ±5. 28, P < 0.05). 

The VFSS is a dynamic imaging method to evaluate swallowing function. VFSS offers a real-time, dynamic visualization of the entire swallowing process, enabling clinicians to identify abnormalities that might be missed with static imaging. It is relatively safe and non-invasive, requiring minimal patient preparation. The results are highly accurate and reliable, making it the gold standard for swallowing function evaluation. Overall, VFSS is an invaluable tool for healthcare professionals in managing patients with swallowing difficulties [31]. Comparison of efficacy before and after treatment was evaluated using the VFSS: after treatment, the total effective rate of the experiment group was higher than that of the control group (71.4% vs. 19.6%), with P=0.006 (P<0.05) by the nonparametric rank sum test. 

The Kubota test, SSA scores and VFSS revealed that acupuncture treatment on the basis of standardized swallowing rehabilitation significantly reduced dysphagia in elderly patients. This is because the Lianquan and Yifeng acupoints selected in our study are specialized in treating dysphagia symptoms [32]. Together with the Fengchi acupoints, they improve cerebral blood flow and promote nerve repair [33]. Local blood circulation, alleviating edema and inflammation is improved in the pharyngeal area, stimulating local nerves (e.g., the hypoglossal nerves) to enhance nerve function, improving muscle flexibility and coordination, and promoting patient rehabilitation. This promotes the patient's recovery. Combined with rehabilitation therapy, acupuncture further promotes the regeneration and repair of damaged nerves and enhances muscle strength and coordination, thus improving swallowing function [34]. 

Dysphagia often leads to inadequate nutrient intake due to the difficulties in swallowing and eating. This stimulation can enhance the reflex function of nerves and improve the flexibility and coordination of the muscles involved in swallowing [35]. As a result, patients may experience a reduction in symptoms such as coughing and choking during meals, making eating a more comfortable and efficient process. Together, acupuncture and rehabilitation training can lead to a notable improvement in swallowing ability, enabling patients to consume a wider variety of foods and increase their overall food intake [36]. 

With enhanced swallowing function, patients are better able to meet their nutritional needs, which can help prevent malnutrition, dehydration, and other complications associated with dysphagia. This integrated approach not only alleviates the symptoms of dysphagia but also has a positive impact on the overall nutritional status of elderly patients, thereby improving their quality of life and general well – being [37].This study showed that the nutritional status of patients in the experiment group improved further after treatment. Levels of serum albumin (ALB), serum prealbumin (PA), and hemoglobin (Hb) were higher than in the control group. The incidence of pneumonia and indwelling gastric tubes was lower in the experiment group than in the control group, and the difference was statistically significant (P < 0.05). Although not statistically significant, the incidence of death was lower in the experiment group (19.6%) than in the control group (25.0%). These results suggest that the treatment method combining acupuncture and swallowing rehabilitation training reduces the occurrence of complications, improves prognosis, increases self-care ability, minimizes dependence on others, and reduces mortality. 

This study has some limitations. First, the patients were not studied over the medium or long term to determine the effects of this treatment method over time. Second, the sample size needs to be expanded to obtain more reliable results.

In conclusion, the acupuncture can effectively improve swallowing function in elderly patients with dysphagia, alleviate symptoms such as choking while eating or drinking, and reduce the risk of malnutrition, aspiration pneumonia, and other adverse events. This method can also improve quality of life, reduce the burden on families and society, and help maintain the dignity of elderly patients. This method compensates for the limitations of single swallowing function training and is worthy of reference, promotion, and learning.v

All authors of this article declare that they have no conflicts of interest.

Zhe Zhao & Yingying Ke: Conceptualization, Methodology, Software. Zhe Zhao & Yingying Ke: Data curation, Writing- Original draft preparation. Ping Yuan & Wei Chen: Visualization, Investigation. Ping Yuan & Wei Chen: Supervision. Zhe Zhao, Junfeng Zhang & Yingying Ke: Writing- Reviewing and Editing.

Ethics approval for this study was obtained from the Medical Ethics Committee of the Shanghai Sixth People's Hospital at Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiaotong University School of Medicine (approval number: 2022-KY-157 (K) ). All participants were provided with information regarding the study and gave their written informed consent prior to participation. This study was conducted in compliance with the Declaration of Helsinki and all applicable ethical guidelines.

The authors have not declared a specific grant for this research from any funding agency.

We sincerely thank all the collaborating investigators, subjects and their families for their support of the project.

All co-investigators (CIs) will have equal access to the completed dataset, and will collectively decide upon who shall have access to the data and how the data shall be used.

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