Acupuncture combined with Buyang Huanwu decoction in treatment of patients with ischemic stroke.

OBJECTIVE: This study was performed to investigate the effect of acupuncture combined with Buyang Huanwu decoction in patients with ischemic stroke.
METHODS: In total, 115 patients with ischemic stroke were recruited and divided into 3 groups. The control group received normal treatment, the acupuncture group received additional acupuncture treatment, and the combined group received additional acupuncture combined with Buyang Huanwu decoction treatment. The National Institutes of Health Stroke Scale (NIHSS) and Chinese Stroke Scale (CSS) were used to evaluate the stroke condition, and the Barthel index (BI) was used to measure life quality. Blood lipids and recurrence were also analyzed.
RESULTS: The CSS and NIHSS scores were significantly lower in the acupuncture group and combined group than in the control group; however, the BI score was significantly higher in the acupuncture group and combined group. Similarly, the levels of cholesterol, triglycerides, and low-density lipoprotein were all significantly increased, while the level of high-density lipoprotein showed no significant difference in all groups. The recurrence rate was significantly lower in the combined group than in the other two groups.
CONCLUSION: Acupuncture combined with Buyang Huanwu decoction could improve the clinical outcomes and reduce the recurrence rates in patients with ischemic stroke.

RCT Entities:   Population Interventions Outcomes

Introduction

Stroke is a substantial health threat and one of the leading causes of disability worldwide, representing a huge burden to the patient’s family and to society.[1-4] The incidence of stroke in China is high (1.5–2.0 million new cases every year); it is the second most common cause of death in cities, the third most common cause of death in rural areas, and the leading cause of adult disability throughout the whole country.[5,6] The treatment strategy for stroke mainly involves administration of antihypertensive drugs, hypoglycemic and antiplatelet aggregation drugs, and constraint-induced movement therapy.[7,8] However, the treatment efficacy requires improvement.

Acupuncture is an important part of traditional Chinese medicine and has attracted more attention in recent decades.[9] The treatment efficacy of acupuncture has been proven for many diseases, including neck disorders,[10] postoperative nausea and vomiting,[11] and atrial fibrillation.[12] Additionally, acupuncture can reportedly be used in the treatment of ischemic stroke and may enhance the clinical outcomes of patients with stroke.[13] Buyang Huanwu decoction is a compound Chinese medicine containing raw Astragalus, angelica, longan meat, antler gum, Salvia miltiorrhiza, frankincense, myrrh, and dried pine.[14] Several studies have shown that Buyang Huanwu decoction can be used in the treatment of neuronal injury.[15,16] Others have demonstrated that it is also effective in the treatment of ischemic stroke.[17] However, no study to date has focused on the efficacy of acupuncture combined with Buyang Huanwu decoction in the treatment of patients with ischemic stroke.

In the present prospective study, we investigated the treatment effect of acupuncture combined with Buyang Huanwu decoction in patients with ischemic stroke. Our goal was to provide more clinical evidence for the application of acupuncture and Buyang Huanwu decoction in the treatment of ischemic stroke.

Materials and methods

Patients

This prospective study included patients with ischemic stroke who presented to our hospital from April 2015 to December 2016. All patients were hospitalized within 72 h and were first diagnosed with ischemic stroke by imaging techniques such as magnetic resonance imaging or computed tomography. The following patients were excluded from the study: patients with a history of stroke; patients with severe infection; patients with other severe organ dysfunction such as severe liver, renal, or heart disease; patients with hemorrhagic cerebrovascular disease or epilepsy; and patients with severe cognitive dysfunction that prevented them from cooperating during the examination.

The patients were divided into three groups: the control group, acupuncture group, and combined group. All patients were treated by normal methods including antihypertensive drugs, hypoglycemic and antiplatelet aggregation drugs, and constraint-induced movement therapy according to the Chinese guideline for the prevention and treatment of cerebrovascular disease.[18] Patients in the acupuncture group received acupuncture treatment as described elsewhere.[19] Briefly, the main acupoints were Shuigou (DU 26), Baihui (DU20), and Fengfu (DU16), and the auxiliary acupoints were Neiguan (PC6), Shenmen (HT7), Jiquan (HT1), Chize (LU5), Weizhong (BL40), and Sanyinjiao (SP6). Patients with dysphagia were also treated at the acupoints Fengchi (GB20), Yifeng (SJ17), and Wangu (GB12); those with limb disorders were treated at Hegu (LI4), Houxi (SI3), Qiuxu (GB40), Yanglingquan (GB34), and Zulinqi (B41); and those with a language disadvantage were treated at Lianquan (RN23) and Yuye (HN12). The acupuncture treatment was conducted every day during the treatment period, and each session lasted for 30 minutes. Patients in the combined group were treated with Buyang Huanwu decoction every day during the treatment period. The composition of the decoction was raw Astragalus 30 g, angelica 15 g, longan meat 15 g, antler gum 10 g, Salvia miltiorrhiza 10 g, frankincense 10 g, myrrh 10 g, and dried pine 5 g. All treatments continued for 4 weeks. Written informed consent was obtained from all patients for publication of their individual details and accompanying images in this manuscript. The consent form is held by the authors and is available for review by the Editor-in-Chief. The present study was approved by the First People’s Hospital of Xuzhou.

Data collection and follow-up

Demographic data such as age and sex and clinical information including complications and medication conditions were recorded. The National Institutes of Health Stroke Scale (NIHSS) score, Chinese Stroke Scale (CSS) score, and Barthel index (BI) score were measured within 24 h after admission as well as after treatment. The levels of cholesterol (CHO), triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) were also evaluated before and after treatment. All patients were followed up for recurrence by direct visits or phone calls, and the follow-up duration was 1 year.

Statistical analysis

Continuous data are expressed as mean ± standard deviation. The chi square test was used to compare count data and rates. Comparisons between two groups of continuous data were performed using Student’s t-test, and comparisons among three groups were conducted by one-way analysis of variance. A Kaplan–Meier curve was used analyze recurrence at 1 year. A P value of <0.05 was considered statistically significant. All calculations were performed using SPSS 22.0 (IBM Corp., Armonk, NY, USA).

Results

Basic clinical information for all patients

In total, 115 patients with ischemic stroke were included in the present study (control group, n = 38; acupuncture group, n = 39; and combined group, n = 38). The characteristics of all patients are listed in Table 1. The patients’ mean age was 61.6 ± 13.8 years, and the male:female ratio was 63:53. Complications; medication conditions; pretreatment CSS, BI, and NIHSS scores; and pretreatment levels of CHO, TG, HDL, and LDL were not significantly different among the three groups.

Table 1.

Basic clinical information for all patients.

Variables	Controln = 38	Acupuncturen = 39	Combinedn = 38
Age, years	61.2 ± 14.5	62.8 ± 13.7	60.9 ± 12.1
Male:female	20:18	21:18	22:17
Diabetes	15 (39.5)	12 (30.8)	14 (36.8)
Hypertension	13 (34.2)	16 (41.0)	15 (39.5)
Hyperlipidemia	19 (50.0)	21 (55.3)	18 (47.4)
Medication use
Antiplatelet agents	6 (15.8)	7 (17.9)	9 (23.6)
Anticoagulants	5 (13.2)	7 (17.9)	7 (18.4)
Lipid-lowering agents	15 (39.5)	12 (30.8)	13 (34.2)
NIHSS score	10.8 ± 2.1	11.2 ± 2.3	10.9 ± 1.9
CSS score	20.3 ± 4.1	19.7 ± 5.8	19.8 ± 3.4
BI score	43.7 ± 14.5	45.6 ± 13.7	44.9 ± 12.9
CHO, mmol/L	6.8 ± 2.3	6.6 ± 2.0	6.7 ± 2.4
TG, mmol/L	1.8 ± 0.4	1.8 ± 0.5	1.8 ± 0.5
HDL, mmol/L	0.8 ± 0.2	0.9 ± 0.1	0.8 ± 0.1
LDL, mmol/L	5.8 ± 1.1	5.6 ± 0.9	5.7 ± 1.0

Data are presented as mean ± standard deviation or n (%).

NIHSS, National Institutes of Health Stroke Scale; CSS, Chinese Stroke Scale; BI, Barthel index; CHO, cholesterol; TG, triglycerides; HDL, high-density lipoprotein; LDL, low-density lipoprotein.

Acupuncture combined with Buyang Huanwu decoction improved the clinical outcomes of patients with ischemic stroke

We compared the clinical outcomes among the three groups to investigate the treatment effects of acupuncture combined with Buyang Huanwu decoction in patients with ischemic stroke. The CSS and NIHSS scores were significantly lower in the acupuncture group and combined group than in the control group; however, the BI score was significantly higher in the acupuncture group and combined group than in the control group (P < 0.05) (Table 2). Among all three groups, the CSS and NIHSS scores were lowest and the BI score was highest in the combined group (P < 0.05). Similarly, the levels of CHO, TG, and LDL were all significantly increased (P < 0.05) while the level of HDL showed no significant difference among all groups; these changes were the most significant in the combined group than in the other two groups (P < 0.05). These results indicate that acupuncture combined with Buyang Huanwu decoction can improve the clinical outcomes of patients with ischemic stroke.

Table 2.

Clinical outcomes for all patients after treatment.

Variables	Controln = 38	Acupuncturen = 39	Combinedn = 38
NIHSS score	6.2 ± 2.1	4.9 ± 1.8	3.6 ± 1.3
CSS score	15.7 ± 4.5	12.2 ± 3.9	9.6 ± 3.0
BI score	69.3 ± 12.7	75.6 ± 14.5	81.7 ± 16.8
CHO, mmol/L	5.1 ± 1.1	4.4 ± 0.9	3.2 ± 1.1
TG, mmol/L	1.4 ± 0.7	1.2 ± 0.5	1.0 ± 0.6
HDL, mmol/L	0.9 ± 0.4	0.8 ± 0.4	0.8 ± 0.3
LDL, mmol/L	3.8 ± 1.0	3.3 ± 1.2	3.0 ± 1.1

Data are presented as mean ± standard deviation.

NIHSS, National Institutes of Health Stroke Scale; CSS, Chinese Stroke Scale; BI, Barthel index; CHO, cholesterol; TG, triglycerides; HDL, high-density lipoprotein; LDL, low-density lipoprotein.

Acupuncture combined with Buyang Huanwu decoction reduced the recurrence rate of ischemic stroke

We also analyzed the influence of acupuncture combined with Buyang Huanwu decoction on the recurrence rate of ischemic stroke. As shown in Figure 1, the recurrence rate was significantly lower in the combined group than in the other two groups (P < 0.05). However, the recurrence rate in the acupuncture group was not significantly different from that in the control group, suggesting that acupuncture combined with Buyang Huanwu decoction can reduce the recurrence rate of ischemic stroke.

Figure 1.

Kaplan–Meier analysis of recurrence among different groups of patients.

Discussion

Despite the development of therapeutic techniques and medications for stroke, the treatment efficacy still requires improvement. The benefits of acupuncture and Buyang Huanwu decoction have been proven for many diseases, including stroke. However, no study to date has focused on the efficacy of acupuncture combined with Buyang Huanwu decoction in the treatment of patients with ischemic stroke. In the present study, we demonstrated for the first time that acupuncture combined with Buyang Huanwu decoction can improve the clinical outcomes and reduce the recurrence rate of ischemic stroke.

The application of acupuncture in the treatment of ischemic stroke has been reported in several studies. Wei et al.[20] found that acupuncture pretreatment can improve ischemic stroke conditions by regulating glycogen synthase kinase-3β through the cannabinoid CB1 receptor. Shih et al.[21] analyzed the recurrence of ischemic stroke with or without acupuncture and found that acupuncture may be effective in lowering the stroke recurrence rate even in patients on medications for stroke prevention. In a prospective randomized controlled trial, Shen et al.[19] showed that acupuncture intervention can significantly improve the clinical outcomes in patients with ischemic stroke. In the present study, we also found that treatment with acupuncture could significantly improve the clinical outcomes of patients with ischemic stroke.

Some studies have also demonstrated the efficacy of Buyang Huanwu decoction for ischemic stroke and other diseases. Mu et al.[22] demonstrated that Buyang Huanwu decoction has neuroprotective effects in patients with cerebral ischemia-induced neuronal damage. Chen et al.[23] showed that Buyang Huanwu decoction has therapeutic effects in patients with ischemic stroke through upregulation of the neurogenesis marker doublecortin and inhibition of the activity of glycogen synthase kinase 3 and tau. In the present study, we showed for the first time that Buyang Huanwu decoction can enhance the treatment efficacy of acupuncture for ischemic stroke.

In conclusion, we conducted a prospective study to investigate the effect of acupuncture combined with Buyang Huanwu decoction in patients with ischemic stroke. The results showed that acupuncture combined with Buyang Huanwu decoction can improve the clinical outcomes and reduce the recurrence rate of ischemic stroke. This study provides clinical evidence of the application of acupuncture and Buyang Huanwu decoction in the treatment of ischemic stroke.