Clinical study on tube moxibustion plus point-toward-point needling method in treating refractory facial paralysis

XIONG Zhonghao (熊中豪), ZHOU Xi (周熙), SONG Na (宋娜), TIAN Fengwei (田丰玮)

Chongqing Traditional Chinese Medicine Hospital, Chongqing 400021, China

Abstract

Keywords: Acupuncture Therapy; Point-toward-point Needling Method; Moxibustion Therapy; Thermal Box Moxibustion;Tube Moxibustion; Electromyography; Facial Paralysis

Facial paralysis, or facial nerve palsy, is a common clinical disease that can occur at any age. Research has shown that facial paralysis has a certain self-healing property. Most patients with facial paralysis recover well after timely, systematic, and standardized treatment, and a few patients recover without treatment. However, clinical statistics have shown that there are still about 30% of facial paralysis patients are lingering unhealed due to severe facial nerve injury or improper treatment[1], or at the same time, presenting with sequelae such as ptosis, orofacial perversion, facial spasm, crocodile tears, and mimetic muscle synkinesis on the affected side[2]. This condition is called refractory facial paralysis or intractable facial paralysis, which needs a long treatment time, but the prognosis is usually poor, seriously affecting the work and life of patients.

Modern medical treatments of refractory facial paralysis are mainly neurotrophic drugs and surgery, but the curative effect is not ideal. For acupuncture, the treatment of refractory facial paralysis is also very difficult. Tube moxibustion therapy originates from the ancient reed tube moxibustion, which directly acts on the ear canal with the warming effect of moxibustion through a special reed tube. On the basis of classical reed tube moxibustion, the acupuncture department of our hospital has independently developed and continuously improved tube moxibustion instruments.The composite electric heating tube moxibustion device made by 3D-printing technology has high combustion efficiency and constant temperature and can maximize the warming effect of moxibustion on the ear canal. It has been widely used in the treatment of facial paralysis[3-4]. In this study, we observed the clinical efficacy of tube moxibustion plus point-toward-point needling method for refractory facial paralysis.

1 Clinical Materials

1.1 Diagnostic criteria

This study referred to the diagnostic criteria for facial nerve palsy (facial neuritis) in theNeurology[5]. Clinical manifestations included unilateral facial nerveinnervated expression muscle paralysis, absence or reduction of forehead wrinkles, enlarged palpebral fissure, incomplete eye closure, flattened nasolabial folds, drooping mouth corner; patients could not frown,eyes of the affected side tore with wind, salivated when drinking water, had incomplete cheek blowing and food retention in the mouth, and might be accompanied by taste loss of the anterior 2/3 of the tongue on the affected side.

1.2 Inclusion criteria

Those who met the above diagnostic criteria, with the duration of the disease over 2 months and within one year; House-Brackmann (H-B) facial nerve function grading Ⅲ-Ⅵ; aged over 18 years old; agreed to participate in this trial and signed informed consent;those who had other diseases at the same time but did not affect the treatment of this disease during the treatment period.

1.3 Exclusion criteria

Those who had peripheral facial palsy secondary to other diseases, such as acute infectious polyradiculoneuritis, parotitis or parotid tumor,posterior cranial fossa disease, and cerebrovascular accident; patients with severe underlying diseases, such as heart disease, liver failure, kidney failure, tumors, or hematopoietic system disease; psychotic; women during pregnancy; unable to accept acupuncture treatment.

1.4 Elimination and dropout criteria

Those who failed to complete the treatment protocol that affected efficacy evaluation; those who presented with severe adverse events or other severe complications; those who dropped out during the trial.

1.5 Statistical methods

All data were statistically analyzed by the SPSS version 21.0 statistical software. Counting data were processed by Chi-square test. Measurement data were all in normal distribution and were expressed as mean ± standard deviation (±s). Independent samplet-test was applied to the comparisons between the two groups. Rank-sum test was used for the comparisons of ranked data.P＜0.05 was considered to indicate a statistically significant difference.

1.6 General data

This study was reviewed and approved by the Ethics Committee of Chongqing Traditional Chinese Medicine Hospital (Approval No. ZY201802029).

A total of 100 patients were enrolled from outpatient and inpatient cases of the Acupuncture Department in our hospital, between May 2019 and January 2020. All patients were randomly divided into an observation group and a control group by the random number table method, with 50 cases in each group. During the trial,3 patients in the observation group dropped out(2 cases discontinued because of the epidemic, and 1 case dropped out due to severe herpes recurrence and drug combination), and 2 patients in the control group dropped out (both cases discontinued because of the epidemic). Among the patients, the shortest disease duration was 2 months and 2 d, and the longest duration was 11 months and 27 d. The patients were 23-82 years old. There were no significant differences in the data of gender, age, or disease duration between the two groups (P＞0.05), indicating that they were comparable (Table 1).

2 Treatment Methods

2.1 Control group

The control group was treated only with acupuncture by point-toward-point needling method, mainly in the affected eye, cheek and mouth areas.

Method: Points selected for the eye region were Yangbai (GB14) toward Touwei (ST8) and Cuanzhu (BL2)toward Jingming (BL1); points selected for the cheek region were Quanliao (SI18) toward Sibai (ST2) and Sibai(ST2) toward Yingxiang (LI20); points selected for mouth region were Dicang (ST4) toward Jiache (ST6) and Jiachengjiang (EX-HN17) toward the angle of the mandible. After routine disinfection, the Hwato brand disposable sterile acupuncture needles of 0.30 mm in diameter and 50 mm in length (Suzhou Medical Appliance Factory, China) were used. The needles were obliquely punctured at an angle of 15° between the needle and the skin. Cuanzhu (BL2) was punctured by 15 mm in depth (0.5 Cun), Yangbai (GB14) was punctured by 25 mm in depth (1 Cun), and Quanliao(SI18), Sibai (ST2), Dicang (ST4), and Jiachengjiang(EX-HN17) were punctured by 40 mm in depth (1.5 Cun).Even reinforcing-reducing manipulation was performed for all points, and the needles were retained for 30 min after Qi arrival (Deqi).

2.2 Observation group

The observation group was treated with tube moxibustion plus point-toward-point needling method.The acupuncture treatment was the same as that of the control group.

Tube moxibustion: After acupuncture, a 3D-printed electric heating tube moxibustion device (Patent No. ZL 2011 2 0010303.3) was used for the treatment. It was made of a new type of resin composite material,which was divided into two parts: a tube body that could place moxa and a base with an electric fan. Before being used, a piece of moxa stick 2 cm in diameter and 3 cm in length (3-4 g) was placed in the tube body and then ignited. The power supply of the tube moxibustion device was turned on, and the air was circulated through the rotation of the small fan on the base to help the moxa cone burn fully. The two parts of the tube moxibustion device were connected, and the long end of the tube body was inserted into the external acoustic meatus on the affected side about 1 cm. The tube moxibustion device was held by the patient(Figure 1). The moxibustion was performed for about 20 min each time.

Patients in both groups were treated once a day,6 consecutive times a week, with a one-day interval for 4 consecutive weeks (24 times in total). During the treatment period, those who were evaluated as cured according to the efficacy criteria could stop the treatment.

Table 1. Comparison of clinical data between the two groups

Figure 1. Tube moxibustion therapy

3 Efficacy Observation

3.1 Observation items

3.1.1 H-B facial nerve function grading system[6]

The H-B facial nerve function grading system is divided into grades Ⅰ-Ⅵ. Among them, grade Ⅰ is normal, and grade Ⅵ is complete paralysis.

3.1.2 Facial paralysis complications

At present, the common complications of facial paralysis include facial synkinesis, facial spasm, facial paralysis perversion, and crocodile tears. The incidence of new-onset facial paralysis complications after treatment was counted.

Invalid: Symptoms and signs did not improve significantly. The improvement of H-B grading was less than 1 level.

3.3 Results

3.3.1 Comparison of clinical efficacy

After treatment, the total effective rate was 93.6% in the observation group and 64.6% in the control group.The difference between the two groups was statistically significant (P＜0.05), indicating that the efficacy of the observation group is superior to that of the control group (Table 2).

3.3.2 Comparison of H-B grading

Before treatment, there were no patients with H-B grades Ⅰ-Ⅱ in either group. The rank-sum test showed no statistical difference in the H-B grading between the two groups, indicating that they were comparable (P＞0.05). Compared with the same group before treatment, the H-B grading after treatment in both groups was improved, and the observation group was superior to the control group (P＜0.05). See Table 3.

3.3.3 Relationship between different degrees of H-B grading and curative effect

The two groups of patients with the same H-B grade were compared, among which, there was no statistical difference in the curative effect in patients with gradesⅢ and Ⅳ between the two groups (P＞0.05). And there was a statistical difference in the curative effect in patients graded Ⅴ and Ⅵ between the two groups,indicating that the observation group was superior to the control group (P＜0.05). See Table 4.

The changes in H-B grading after treatment in the two groups were analyzed. The changes in H-B grading after treatment in the observation group were better than those in the control group. The difference between the two groups was statistically significant (P＜0.05),indicating that the improvement of symptoms in the observation group was more significant than that in the control group (Table 5).

Table 2. Comparison of clinical efficacy between the two groups (case)

3.1.3 Electromyogram (EMG)

Electromyography was performed using the KEYPOINT.NET V2.33 EMG detector (Dantec,Netherlands). The electrodes were connected to the ipsilateral arm, and the recording electrodes were surface skin electrodes, which were placed at the orbicularis oculi and the midpoint of the forehead,respectively. The stimulating electrode was placed at the corresponding position of the facial nerve out of the stylomastoid foramen. The stimulation frequency was 1 time/s. The pulse current was a square wave with a wave width of 0.2 ms. The stimulation intensity started from 0 mA and gradually increased until the motorevoked myoelectric action potential presented the highest amplitude. The latency and M-wave amplitude at the onset of the motor-evoked action potential were measured. First measured the healthy side, then the affected side. EMG indicators referred to the evaluation criteria in theClinical Electromyography[7]. The action potential amplitude ratio of the affected side to the healthy side ＜10% indicated severe injury; the amplitude ratio ≥10% but ≤30% indicated moderate injury; the amplitude ratio ＞30% indicated mild injury.

3.2 Criteria of clinical efficacy

According to the criteria of curative efficacy for facial neuritis in theClinical Diagnostic Basis and Criteria for Cure and Improvement of Disease[8]combined with the H-B grading system, curative efficacy was assessed.

Cured: Facial nerve function graded Ⅰ, the symmetry and tension were normal in a static state;bilateral eyes closed normally during exercise, bilateral forehead wrinkles and nasolabial folds were symmetrical, no leaking when blowing cheek, pouted symmetrically, and teeth fully showed.

Markedly effective: Symptoms and signs improved significantly. The H-B grading increased by 2 levels or more.

Effective: Symptoms and signs were improved. The H-B grading increased by 1 level.

Table 3. Comparison of House-Brackmann facial nerve function grading between the two groups before and after treatment (case)

Table 4. Comparison of efficacy between the two groups with the same House-Brackmann facial nerve function grading (case)

Table 5. Comparison of House-Brackmann facial nerve function grading changes between the two groups after treatment

3.3.4 Comparison of EMG data

Before treatment, the distribution of facial nerve EMG in the two groups was processed by the rank-sum test, and there was no statistical difference (P＞0.05),indicating that they were comparable. After treatment,there was no statistical difference in the distribution of facial nerve EMG between the two groups (P＞0.05).Compared with the same group before treatment, the ratio of the action potential amplitudes between the affected side and the healthy side of the facial nerve EMG after treatment changed significantly in both groups. The intra-group differences were statistically significant (P＜0.05). See Table 6.

The increase in the action potential amplitude ratio of the affected side to the healthy side after treatment in the two groups was analyzed (the ratio of the amplitude of the affected side to the healthy side after the treatment minus the ratio of the amplitude of the affected side to the healthy side before the treatment).Compared with the control group, the observation group had more cases in the increased range of 10%-30% and over 30% in the amplitude ratio of the affected side to the healthy side. The difference between the two groups was statistically significant(P＜0.05). See Table 7.

3.3.5 Comparison of the new-onset facial paralysis complications between the two groups

After 4 weeks of treatment, the incidence of the newonset facial paralysis complications (referring to the number of new-onset facial paralysis complications after treatment) in the observation group was lower than that in the control group, and the difference between the two groups was statistically significant(P＜0.05). See Table 8.

Table 6. Comparison of action potential amplitude ratio of the affected side to the healthy side between the two groups

Table 7. Comparison of the improvement of action potential amplitude ratio of the affected side to the healthy side between the two groups after treatment (case)

Table 8. Comparison of new-onset facial paralysis complications between the two groups after treatment (case)

4 Discussion

At present, it is generally believed that a facial paralysis that has not recovered significantly for more than 2 months from the date of onset is called refractory facial paralysis[9-11]. Refractory facial paralysis is a stubborn disease. Modern medicine believes that it is caused by neuroaxonal injury, fracture, or extensive demyelination and is closely related to herpes virus invasion[12-14]. Chinese medicine believes that refractory facial paralysis is mostly caused by lingering unhealed diseases, insufficiency of healthy Qi, and blood stasis due to Qi deficiency. It is a syndrome of intermingled deficiency and excess, and its main cause is Qi deficiency and blood stasis[15-16].

Clinically, the point-toward-point needling method and bloodletting therapy are commonly used in the treatment of refractory facial paralysis. The point-toward-point needling method is a commonly used acupuncture manipulation[17]. Although this method alone can unblock collaterals and dispel blood stasis, it cannot solve the cause of Qi deficiency in refractory facial paralysis. The tube moxibustion therapy can warmly unblock the meridians and collaterals and benefit Qi for activating blood circulation. It is a unique moxibustion method developed on the basis of ancient reed tube moxibustion[18]. Clinical studies have confirmed that tube moxibustion can increase the facial and periotic temperature of the affected side,significantly improve local blood circulation, and promote the repair of facial nerve injury. Compared with the commonly used methods such as facial ginger-partitioned moxibustion or thermal box moxibustion on the face, tube moxibustion has a stronger effect of warmly unblocking the meridians and collaterals and better curative effects[18-23].

In this study, tube moxibustion plus point-towardpoint method was used for refractory facial paralysis.The results showed that the curative effect of the observation group was significantly better than that of the control group. The facial nerve function gradings in both groups after treatment were better than those before treatment. And the improvement of H-B facial nerve function grading in the observation group after treatment was better than that in the control group. In patients with refractory facial paralysis of H-B grades Ⅴ(severe) and Ⅵ (complete paralysis), the improvement of facial nerve function in the observation group was more significant than that in the control group,indicating that tube moxibustion plus point-towardpoint method has a better curative effect in treating refractory facial paralysis of severer H-B grading than point-toward-point needling method alone. In addition,the H-B grading in both groups improved after treatment, and the improvement of the observation group was more notable than that of the control group,indicating that although both methods can improve the facial nerve function of the patients, the effect of tube moxibustion plus point-toward-point needling method is better than that of point-toward-point needling method alone. Moreover, the number of cases of new-onset facial paralysis complications in the observation group was smaller than that in the control group.

There were significant changes in facial nerve EMG in both groups after treatment, but there was no statistical difference between the two groups. The increase in the action potential amplitude ratio of the affected side to the healthy side after treatment in the two groups was analyzed. It was found that the observation group was superior to the control group in the increased range of 10%-30% and over 30%, which indicates that tube moxibustion plus point-toward-point needling method has a better effect on promoting the repair of facial nerve injury. It is worth noting that in this study, there was no hysteresis in the results of facial nerve electrophysiological examination reported in other individual literature[24]. By analyzing the reasons,we believe that the studies reporting this phenomenon mainly aim at patients with acute facial paralysis. In the acute stage, there is a severe inflammatory reaction in the facial nerve, with obvious nerve edema, and once the nerve is damaged, the recovery will be slow,possibly causing the electrophysiological results to lag behind the clinical efficacy. However, this trial was based on refractory facial paralysis with a long duration as the study object. Before enrollment, cases with the ratio of the action potential amplitude of the affected side to the healthy side in the range of 10%-30% and over 30% accounted for 84.2%. The regeneration and repair of facial neurons in most patients had improved compared with the acute stage. But the specific reasons need to be confirmed by further clinical trials.

In summary, the results of this study suggest that tube moxibustion plus point-toward-point needling method can better improve the symptoms of refractory facial paralysis than the point-toward-point needling method alone, decreasing complications and increasing clinical efficacy, and is worth clinical promotion.

Conflict of Interest

The authors declare that there is no potential conflict of interest in this article.

Acknowledgments

This work was supported by Chongqing Science and Health Joint-project of Chinese Medicine Science and Technology (重庆市科卫联合中医药科技项目, No.ZY201802029); Chongqing Science and Health Jointproject of Chinese Medicine Technology Innovation and Development (重庆市科卫联合中医药技术创新与技术发展项目, No. 2021ZY3571).

Statement of Informed Consent

Informed consent was obtained from all individual participants.

Received: 9 May 2021/Accepted: 27 September 2021