Clinical observation of heat-sensitive moxibustion for acute ischemic stroke

Yang Chao (楊超), Wang Hong-ye (王宏業(yè))

Hengshui People’s Hospital, Hebei Province, Hengshui 053000, China

Abstract Objective: To observe the clinical efficacy of heat-sensitive moxibustion in intervening acute ischemic stroke.

Keywords: Moxibustion Therapy; Moxa Stick Moxibustion; Heat-sensitive Moxibustion; Ischemic Stroke; Randomized Controlled Trial

Acute ischemic stroke (AIS) is an acute cerebrovascular disease in which the blood supply in the brain is impaired due to various reasons, causing irreversible damage to relevant brain tissues, leading to ischemic hypoxic necrosis of brain tissues[1]. Its onset is sudden, with high morbidity, fatality and disability rates. It seriously threatens the health of the patients, affects their ability to live and work, and causes great economic burden and psychological pressure on the family and society[2]. Early thrombolysis can restore blood supply, save ischemic penumbra, and restore peripheral nerve function.However, the short time window of thrombolytic therapy,complex procedure, lack of first aid awareness among residents, and high risk of thrombolytic bleeding limit the wide application of thrombolysis[3]. Study showed that the thrombolysis rate in patients with ischemic stroke was only 2.40%-5.39%[4]. At present, most patients are treated with conservative pharmacotherapy. On the basis of general treatment, mediations mainly include those for antiplatelet, improving brain circulation and protecting nerves[5]. How to further improve the efficacy and improve the prognosis of AIS patients has always been the focus and difficult task in neuromedical research. Moxibustion is mostly used for the sequelae of stroke, as it can promote the recovery and has the advantages of safety, effectiveness and simplicity[6].Therefore, in this study, we applied heat-sensitive moxibustion to the intervention of AIS, and observed the clinical efficacy and its effects on serum superoxide dismutase (SOD) and homocysteine (HCY) levels of the patients.

1 Clinical Materials

1.1 Diagnostic criteria

1.1.1 Diagnostic criteria in Western medicine

This study referred the diagnostic criteria in Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2014[7]: acute onset, focal neurological deficits, and a few with comprehensive neurological deficits; symptoms and signs lasting for several hours;diagnosis confirmed by CT or MRI examination, with exclusion of cerebral hemorrhage and other diseases.

1.1.2 Criteria for syndrome differentiation of traditional Chinese medicine (TCM)

According to theGuiding Principles for Clinical Study of New Chinese Medicines[8], criteria for syndrome of blood stasis due to qi deficiency in this study was established.Primary manifestations: sudden hemiplegia, weak limbs,hemi-numbness, and crooked mouth and tongue.Secondary manifestations: pale complexion, panting and weakness, palpitations and spontaneous sweating, a dark tongue with thin and white coating, thready and unsmooth pulse.

1.2 Inclusion criteria

Those who met the diagnostic criteria in Western medicine and syndrome differentiation of TCM; first onset, and the time of onset was within 24 h; aged 20-70 years; patients and their families agreed to participate in this trial and signed informed consents.

1.3 Exclusion criteria

Those who intended to receive thrombolytic therapy;those with cerebral hemorrhage or other brain diseases;those who had severe diseases of heart, lung, liver or kidney; those who were allergic to the medications in this trial; those who were unconscious and unable to cooperate to complete this trial.

1.4 Elimination and dropout criteria

Those had severe adverse reactions; those got worse during the trial; those who dropped out; those took other medications or therapies during the trial.

1.5 Statistical methods

All data were statistically analyzed by the SPSS version 20.0 statistical software. Counting data were processed by Chi-square test. Measurement data were in accordance with the normal distribution after test, and thus expressed as mean ± standard deviation (±s). The intra-group comparison was analyzed by pairedt-test,and the comparison between the groups was analyzed by groupt-test.P＜0.05 was considered to indicate a statistically significant difference.

1.6 General data

A total of 112 patients with AIS were enrolled from Hengshui People’s Hospital, Hebei Province, between January 2017 and December 2018. All patients were randomly divided into a control group and an observation group by the random number table method,with 56 cases in each group. During the trial, there were 2 dropout cases from the control group due to deterioration of the disease, and 54 cases were counted in the final data. In the observation group, 3 cases dropped out because of deterioration of the disease, and 53 cases were counted in the final data. There were no significant differences in gender, age and duration of the disease between the two groups (allP＞0.05), indicating that the two groups were comparable (Table 1).

Table 1. Comparison of general data between the two groups

2 Treatment Methods

2.1 Control group

The control group was treated with conventional treatment. On the basis of controlling body temperature,blood pressure and blood glucose, and nutritional support, medications for anti-platelet, improving cerebral circulation, neuroprotection and lipid-lowering were given. The course of treatment was 1 month.

2.2 Observation group

The observation group was treated with heat-sensitive moxibustion on the basis of the conventional treatment in the control group.

Acupoints: Bilateral Xuehai (SP 10), Zusanli (ST 36) and Xuanzhong (GB 39).

Methods:Pure moxa sticks of 1.8 cm in diameter and 20 cm in length were used (Nanyang Wolong Chinese Medicine Moxa Factory, China). The heat-sensitive moxibustion operation referred theAcupoint Heatsensitization Moxibustion: A New Moxibustion Therapy[9].The patient took a supine position, exposing the acupoints. The physician sought heat-sensitized points first, which was to apply mild moxibustion to the above acupoints with an ignited moxa stick 3-5 cm away from skin. When the patient felt heat penetration, expansion,and transmission, heat in distant area but not in local area or non-heat sensation at certain spots, which would be the heat-sensitized points. After that, the physician continued to perform mild moxibustion at this heatsensitized point till disappearance of the heat sensitization, generally 5-10 min for each point. The physician repeated the above steps until the selected acupoints were completed for moxibustion in turn. The treatment was performed once other day, continuous for 1 month.

3 Observation of Curative Efficacy

3.1 Observation items

3.1.1 National Institute of Health stroke scale (NIHSS)

NIHSS was scored before and after treatment. NIHSS scores reflect the severity of neurological deficits in AIS patients. The highest score is 42 points. The higher the score, the more severe the neurological deficit[10].

3.1.2 Modified Barthel index (MBI)

MBI was scored before and after treatment for the two groups. MBI is often used to evaluate the daily activity ability of AIS patients[11]. The higher the score,the stronger the ability of daily activities.

3.1.3 Intracranial hemodynamic indicators

Before and after treatment, transcranial Doppler ultrasound was used to detect the hemodynamic indicators of middle cerebral artery of the affected side.The mean velocity (Vm), pulsatility index (PI) and resistance index (RI) were recorded.

3.1.4 Serological indicators

The morning fasting venous blood of the patient was collected before and after treatment. The levels of serum SOD and HCY were measured by chemical colorimetry.

3.2 Criteria of curative efficacy

The reduction rate of NIHSS score was used as the criteria of efficacy evaluation[12].

NIHSS reduction rate = (NIHSS score before treatment - NIHSS score after treatment) ÷ NIHSS score before treatment × 100%.

Basically cured: NIHSS reduction rate was 90%-100%.

Markedly improved: NIHSS reduction rate ≥45%, but＜90%.Improved: NIHSS reduction rate ≥18%, but ＜45%.Invalid: NIHSS reduction rate ＜18%.

3.3 Results

3.3.1 Comparison of clinical efficacy

The total effective rate in the observation group was 96.2%, which was significantly higher than 77.8% in the control group. The difference between the groups was statistically significant (P＜0.05), (Table 2).

3.3.2 Comparison of NIHSS and MBI scores

Before treatment, there were no significant differences in the NIHSS and MBI scores between the two groups (bothP＞0.05). After treatment, the NIHSS scores in both groups decreased, and the MBI scores increased. And the scores were statistically different from those before treatment in the same group (allP＜0.05). The NIHSS and MBI scores in the observation group were all statistically different from those in the control group (bothP＜0.05), (Table 3).

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

Table 3. Comparison of NIHSS and MBI scores between the two groups (±s, point)

Table 3. Comparison of NIHSS and MBI scores between the two groups (±s, point)

Note: Compared with the same group before treatment, 1) P＜0.05; compared with the control group after treatment, 2) P＜0.05

Group n NIHSS MBI Before treatment After treatment Before treatment After treatment Observation 53 14.75±3.39 6.47±2.141)2) 45.53±6.23 80.49±8.941)2)Control 54 15.15±2.95 11.89±2.191) 45.83±5.33 67.00±6.671)

3.3.3 Comparison of intracranial hemodynamic indicators

Before treatment, there were no statistically significant differences in Vm, PI and RI of the middle cerebral artery in the affected side between the two groups (allP＞0.05). After treatment, Vm in both groups increased significantly (bothP＜0.05), and PI and RI decreased (allP＜0.05). Vm, PI and RI in the observation group were all statistically different from those in the control group (allP＜0.05), (Table 4).

3.3.4 Comparison of serum SOD and HCY levels

Before treatment, there were no significant differences in the serum levels of SOD and HCY between the two groups (bothP＞0.05). After treatment, the serum SOD levels in both groups significantly increased,and HCY levels significantly decreased, and the levels were all statistically different from those before treatment in the same group (allP＜0.05). The serum SOD and HCY levels in the observation group were both statistically different from those in the control group(bothP＜0.05), (Table 5).

3.3.5 Adverse reactions

During treatment, there were no cases of obvious adverse reactions in the patients. After treatment,routine examinations of blood, urine, fecal, and liver and kidney functions showed no obvious abnormalities.

Table 4. Comparison of intracranial hemodynamic indicators between the two groups (±s)

Table 4. Comparison of intracranial hemodynamic indicators between the two groups (±s)

Note: Compared with the same group before treatment, 1) P＜0.05; compared with the control group after treatment, 2) P＜0.05

Group n Time Vm (cm/s) PI RI Observation 53 Before treatment 37.32±4.19 0.98±0.17 0.74±0.15 After treatment 49.34±5.491)2) 0.77±0.131)2) 0.56±0.131)2)Control 54 Before treatment 37.66±4.14 1.01±0.16 0.75±0.16 After treatment 43.96±6.001) 0.86±0.151) 0.64±0.131)

Table 5. Comparison of serum SOD and HCY levels between the two groups (±s)

Table 5. Comparison of serum SOD and HCY levels between the two groups (±s)

Note: Compared with the same group before treatment, 1) P＜0.05; compared with the control group after treatment, 2) P＜0.05

Group n SOD (U/mL) HCY (μmol/L)Before treatment After treatment Before treatment After treatment Observation 53 116.13±7.66 138.18±7.041)2) 21.25±1.89 14.79±1.301)2)Control 54 115.24±8.93 128.50±10.901) 21.22±1.79 19.56±2.181)

4 Discussion

The occurrence and development of AIS are closely related to many factors. Hypertension, diabetes, heart disease, hyperlipidemia, increased blood viscosity,hypotension, smoking, alcoholism and obesity are the main risk factors for AIS[13]. The pathogenesis of AIS is complicated. It is generally believed that the interaction of pathogenic factors such as energy depletion, the toxic effects of excitatory amino acids, depolarization of the penumbra around the infarct, inflammatory response,apoptosis and free radical damage leads to the onset of AIS, resulting in brain cell damages and neurological dysfunction[14].

In recent years, with the continuous deepening of molecular biology studies, the role of SOD and HCY in the pathogenesis of AIS has received extensive attention.SOD is an important antioxidant enzyme that can maintain cell redox homeostasis and is the primary substance for scavenging free radicals. SOD can clear the free radicals of peroxides that are accompanied by the process of inflammation, and has a powerful antiinflammatory effect. SOD can also regulate blood lipid,prevent cardiovascular and cerebrovascular diseases caused by atherosclerosis and hyperlipidemia, and reduce the content of lipid peroxides[15]. Huang YH[16]detected the serum SOD level of patients with AIS, and the result suggested that the decreased serum SOD level was significantly increased after treatment, and indicators such as NIHSS score also improved significantly.HCY is an important intermediate product in the metabolic process of methionine and cysteine. High HCY is an independent risk factor for stroke and atherosclerosis. It is related to the degree of neurological defect, and also of great significance in the occurrence,aggravation and treatment of stroke. High HCY level is positively correlated with the occurrence of cerebral infarction, and it has an impact on the effect of thrombolytic therapy. The effect of short-term treatment is poor in patients with high HCY, and the prognosis is disappointing[17]. High HCY damages vascular endothelial cells through cytotoxicity, and promotes the generation of oxygen free radicals, increases platelet adhesion and aggregation, accelerates the process of atherosclerosis,induces AIS, reduces the possibility of vascular recanalization, and affects the recovery of brain cells and treatment effect[18].

AIS falls under the category of apoplexy in TCM. The causes of AIS are nothing more than six pathogens of wind, phlegm, fire, qi, blood stasis and deficiency. The pathogenesis is always qi and blood disorder, and blood stasis in the brain vessels. AIS patients are mostly middleaged and elderly people with physical weakness inside,and insufficient qi and blood. Deficiency of qi causes disability to promote blood circulation, resulting in blood stasis. Therefore, syndrome of blood stasis due to qi deficiency is one of the main syndromes in AIS. Therefore,patients with AIS due to blood stasis resulting from qi deficiency were selected to observe in this study. And we observed the clinical efficacy of heat-sensitive moxibustion in assisting the intervention for AIS, and explored its possible mechanism.

Heat-sensitive moxibustion is characterized by sensitized acupoints with suspended moxibustion. It is a new therapy that enhances the therapeutic effect of moxibustion by provoking heat-sensitized moxibustion sensation and transmission of meridian-qi[19]. It focuses on the heat-sensitization and propagated sensation along meridian, so that qi can reach the disease location,thus producing a more significant therapeutic effect compared with the traditional moxibustion. It is suitable for deficiency syndrome, syndrome of blood stasis and cold syndrome[20]. Xuehai (SP 10) can replenish and nourish blood, invigorate spleen and benefit qi, combine unblocking with tonifying. It is a crucial acupoint for all kinds of blood syndromes. Zusanli (ST 36) is the He-Sea point of the Stomach Meridian and the Lower He-Sea point of stomach, with the effect of benefiting qi and blood, invigorating spleen and stomach. And, according to ‘treating Wei-flaccidity syndrome by Yangming Meridian alone’, it is a key point for AIS caused by blood stasis due to qi deficiency. Xuanzhong (GB 39) is marrow convergence of the Eight Influential Points, with the effect of soothing liver and dredging gallbladder,unblocking and activating meridians and collaterals, and nourishing marrow and strengthening bones. It is an important acupoint for treating and preventing apoplexy diseases[21-22]. The combination of the above three acupoints can produce the effect of benefiting qi and activating blood circulation, dispelling pathogenic wind and unblocking collaterals.

The results of this study suggested that the total effective rate of the observation group was significantly higher than that of the control group (P＜0.05). After treatment, NIHSS and MBI scores in both groups were significantly improved (allP＜0.05), and the observation group was superior to the control group (bothP＜0.05).Vm in both groups increased significantly (bothP＜0.05),while PI and RI decreased (allP＜0.05), and Vm, PI and RI in the observation group were all superior to those in the control group (allP＜0.05). The serum SOD and HCY levels in both groups were significantly improved (allP＜0.05),and there were statistical differences between the two groups (bothP＜0.05). These results indicated that heatsensitive moxibustion is effective in intervening acute ischemic stroke. It can promote the recovery of neurological function, improve the ability of daily activities and intracranial blood flow, which may be related to the regulation of serum SOD and HCY levels.However, there were some limitations in this study such as small sample size and lack of follow-up, which need to be improved in further studies.

Conflict of Interest

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

Acknowledgments

There was no project-fund supporting for this study.

Statement of Informed Consent

Informed consent was obtained from all individual participants.

Received: 2 March 2020/Accepted: 10 July 2020