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Annals of Cardiovascular Diseases

Meta-analysis of Acupuncture Safety in Post-stroke Dysphagia Treatment

Review Article | Open Access Volume 1 | Issue 3 |

  • 1. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong
  • 2. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong
  • 3. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong
  • 4. Department of Medicine, The Chinese University of Hong Kong, Hong Kong
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Corresponding Authors
Ching-Sum Chau, Stroke and Clinical Neurosciences Master Programme, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong Tel: +852-9772 3421; Fax: +852-2145 7237
ABSTRACT

Background: Post-stroke dysphagia may develop unfavorable outcomes. Acupuncture have been incorporated as one of the promising options to treat post-stroke dysphagia, however, there is no evidence to support the safety of it.

Objective: To identify and quantify the adverse effects associated with using acupuncture for treating post-stroke dysphagia.

Methods: Randomized controlled trials (RCTs) from MEDLINE, Embase, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, AMED, Database of Abstracts of Reviews of Effects, Health Technology Assessment, ACP Journal Club, PsycINFO, WanFang Data and CJN, were investigated. RCTs comparing acupuncture, non-acupuncture, and their combination were identified. Eligible studies with data about safety of acupuncture were extracted. Meta-analyses were performed for the outcomes of local effects (pain, petechia, mild bleeding, haematoma, dizziness) and systemic effects (infection, fainting, large scale bleeding, unbearable severe pain, aspiration pneumonia and death) by using clinical trials with Jadad score ≥ 3 and RevMan 5.3.5.

Results: Two studies were included. The most common adverse effects were local effects (pain, petechia, mild bleeding and haematoma). The metaanalyses of pain---risk difference (RD) = 42% (p< 0.001); petechia---RD = 11% (p = 0.004); mild bleeding---RD = 8% (p< 0.001); haematoma---RD = 5% (p = 0.005). No reports of severe systemic effects or deaths in the studies included.

Conclusions: Acupuncture for post-stroke dysphagia was safe. The main adverse effects related to acupuncture were with no severity, pain, petechia, mild bleeding and haematoma. It can conclude that acupuncture is a relatively safe strategy for rehabilitation in post-stroke dysphagia.

KEYWORDS

• Dysphagia

• Stroke

• Acupuncture

• Safety

• Adverse effects

CITATION

Chau CS, Chua KK, Lau AY (2016) Meta-analysis of Acupuncture Safety in Post-stroke Dysphagia Treatment. Ann Cardiovasc Dis 1(4): 1016.

ABBREVIATIONS

Rcts: Randomized controlled trials; TCM: Traditional Chinese Medicine; AMED: Allied and Complementary Medicine; CJN: China Journal Net; Revman 5.3.5: Cochrane Review Manager V.5.3.5; RD: Risk Difference.

INTRODUCTION

The second most common cause of death worldwide, stroke is the leading cause of disability in adult [1]. Dysphagia, deglutition disorder or swallowing difficulty, is a common manifestation after stroke. One study suggested that about 20% of stroke patients diagnosed with post-stroke dysphagia, in which, about 30% diagnosed with severe dysphagia [2]. Other studies indicated that patients with post-stroke dysphagia would be persisted on nasogastric tube, lengthened the hospitalization, increasing the chance of developing malnutrition and pulmonary complications such as aspiration pneumonia [3]. Therefore, unfavorable outcomes and mortality in post-stroke dysphagia increase the health-care consumptions which make us concern [2].

Currently, management of post-stroke dysphagia includes dietary and feeding posture modification, transcutaneous neuromuscular stimulation, thermal tactile stimulation, and exercising the swallowing musculature [4,5]. However, patients with severe disorders may need transient or long-term non-oral feeding mode, such as nasogastric feeding tube or percutaneous endoscopic gastrostomy, to bypass the oral cavity and pharynx entirely before recovery [6]. Therefore, post-stroke dysphagia becomes one of the problematic complications in managing rehabilitation. Acupuncture becomes an alternative treatment for post-stroke dysphagia, due to few efficient medical treatment options in the initial stage and treatment options are not always effective currently [7].

Acupuncture is a traditional therapy with complex mechanisms [8]. Studies showed that it is effective for rehabilitation in poststroke dysphagia [9]. Mechanism of it can be illustrated under the theory of Traditional Chinese Medicine (TCM). In TCM, Qi is body’s ‘vital energies’. Qi flows around human body through a network, called ‘meridians’. Qi is often disrupted when the disease onset [10]. Acupuncture is done by inserting needles at acupoints with required needling techniques along meridians [11]. It stimulates the cutaneous and/or muscular nerve fibers so as to induce the required somatomotor and autonomic responses [12].

Post-stroke dysphagia belongs to “Houbi” in TCM. It happens under the cause of liver, kidney, Qi, and blood deficiencies. This results in the blockage of meridians, phlegm stagnation, and dysphagia [13]. In the rehabilitation of swallowing reflex, acupuncture is functioned by reforming new synaptic connection and reconstructing the swallowing reflex arc [14]. Acupoints, such as Fengchi (GB 20), Wangu (GB 12), Yifeng (SJ 17), Lianquan (CV 23), Dicang (ST 4), Jiache (ST 6), Jinjin (EX-HN12), Yuye (EXHN13), Renying (ST 9), and some scalp acupoints and so on were conventionally used (15) in treating post-stroke dysphagia for regulating the function of the liver and kidney and tonifying the brain. Therefore, the flow of Qi and blood would be restored and the phlegm and turbidness would be eliminated as well [13].

Though the above mentioned acupoints are conventionally used for treating post-stroke dysphagia [15], they may be related to the higher incidence of severe adverse effects, such as subarachnoid haemorrhage and spinal epidural haematoma [16]. Besides, some studies have shown mild, local and transient acupuncture-related adverse events including local pain, slight bleeding or haematoma at needle points [17-20]. Moreover, serious adverse reactions, occasionally life-threatening, caused by acupuncture, such as pneumothorax, cardiac tamponade, organ trauma, spinal cord injury, and viral hepatitis that required specific treatments or hospitalization, have been recorded in previous studies [18,20-23].

Since acupuncture might be beneficial in the rehabilitation of patients with post-stroke dysphagia, [8] the knowledge of its possible local and systemic adverse effects required to be identified and quantified. This study is aimed to investigate the safety of acupuncture in the post-stroke dysphagia treatment.

METHODS

Search strategy

Search for publications was carried out in November 2015 in MEDLINE, Embase, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, AMED (Allied and Complementary Medicine), Database of Abstracts of Reviews of Effects, Health Technology Assessment, ACP Journal Club, PsycINFO, WanFang Data and China Journal Net (CJN), with no restrictions regarding date and language of publication. The keywords ‘acupuncture AND (dysphagia OR swallow disorder OR deglutition disorder) were used in the first stage of article selection. Journals were searched with no restrictions on date and language of publication. Search spectrum was also extended to the ‘related articles’. Only the most comprehensive paper was included if multiple publications were found from the same study group.

Inclusion and exclusion criteria

The inclusion criteria of the articles were: 1) only randomized controlled trials (RCTs) were included in this review; 2) all subjects included should meet the diagnostic criteria of post-stroke dysphagia; 3) included all RCTs that compared the acupuncture treatments including conventional, non-conventional or electric acupuncture with the non-acupuncture treatments [24], and 4) adverse effect(s) was/were reported in the studies.

The exclusion criteria of the articles were: 1) all review articles, case reports and editorials; 2) all RCTs that were not compared the acupuncture treatments with the non-acupuncture ones; 3) all Quasi-RCTs and case–control trials; and 4) all studies without the report of adverse effect(s).

Appraising the quality of published reports and study inclusion

First, all studies were analyzed by the C.S.Chau and L.H. Tsang independently. Titles and abstracts were scanned to obtain related publications. Moreover, full texts were obtained for the selected articles. First author’s surname year of publication, the number of cases and controls, and the adverse effects outcomes were extracted. Articles met the inclusion criteria were then classified according to the Jadad score [25]. Higher quality studies with Jadad score [26] ≥ 3 were included. The selection process is illustrated in Figure (1).

Article selection process.

Figure 1: Article selection process.

Statistical analysis

The statistical package Cochrane Review Manager V.5.3.5 (RevMan 5.3.5, Cochrane Library, UK) was used. The adverse effects were reported from the selected RCTs. Risk difference (RD) with fixed confidence interval of 95% and a statistical significance level with a maximum p = 0.05 (5%) . The statistical Mantel-Haenszel chi-square test was used to calculate the heterogeneity, and expressed as I2 . If I2 > 50% were considered as heterogeneous. Asymmetries were expressed in the funnel plot.

RESULTS

After searching the databases, 2 RCTs were included according to the inclusion and exclusion criteria and the Jadad score. All were conducted in mainland China. The 2 RCTs included 218 and 145 cases in treatment groups and control group respectively.

A total of 2 RCTs were included in this study Table (1) shows the adverse effects statistically associated with the intervention of acupuncture for post-stroke dysphagia patients, without necessarily establishing a causal relationship between acupuncture and those effects, showing how many of these studies reported them and the variations between prevalence rates.

Table 1: Frequency of identification (FI) and prevalence interval (PI) of adverse effects associated with acupuncture and identified in two selected randomized controlled trials.

Adverse effects

Frequency of identification

Prevalence interval (%)

Local

 

 

Local Pain

2

1.35-100

Petechia

1

11.43

Mild bleeding

2

5.41-11.43

Dizziness

2

-

Haematoma

2

0.68-11.43

Systemic

 

 

Infection

2

-

Fainting

2

-

Large scale bleeding

2

-

Unbearable severe pain

2

-

Aspiration pneumonia

1

1.43

Death

2

1.43

The selection of outcomes for the meta-analyses was carried out according to the frequency of appearance of adverse effects assessed in the selected publications, comparing their occurrence between subjects with and without acupuncture, emphasizing the local effects (pain, petechia, mild bleeding, haematoma, dizziness) and, as systemic effect (infection, fainting, large scale bleeding, unbearable severe pain, aspiration pneumonia, death). This analysis was performed with two studies with a Jadad score ≥3 [25]. All studies were without gender restriction for acupuncture, and one of them without age group restriction. Two studies were carried out in mainland China. The meta-analysis results for the ‘‘pain’’, ‘‘petechia’’, ‘‘mild bleeding’’, ‘‘dizziness’’, ‘‘haematoma’’, ‘‘infection’’, ‘‘fainting’’, ‘‘large scale bleeding’’, ‘‘unbearable severe pain’’, ‘‘aspiration pneumonia’’ and ‘‘death’’ outcomes are shown in Figure (2).

Meta-analysis of outcomes ‘‘pain’’, ‘‘petechia’’, ‘‘mild bleeding’’, ‘‘haematoma’’, ‘‘dizziness’’, ‘‘infection’’, ‘‘fainting’’, ‘‘large scale bleeding’’, ‘‘‘unbearable severe  pain’’, ‘‘respiration pneumonia’’ and ‘‘death’’ from the results provided by the selected RCTs. *M-H, Mantel-Haenszel; CI, confidence interval; in the forest plots, the  horizontal axis represents the CI of risk difference. The risk difference is represented by the points in each study. The dots located to the right of the median line  represents higher incidence of the outcome in the group that received acupuncture; the size of the dots indicates the relative weight of each study in the final outcome.  The diamond represents the final outcome of the meta-analysis; ** funnel plots show the heterogeneity between studies (horizontal axis = magnitude of the effect; vertical  axis = sample size).

Figure 2: Meta-analysis of outcomes ‘‘pain’’, ‘‘petechia’’, ‘‘mild bleeding’’, ‘‘haematoma’’, ‘‘dizziness’’, ‘‘infection’’, ‘‘fainting’’, ‘‘large scale bleeding’’, ‘‘‘unbearable severe pain’’, ‘‘respiration pneumonia’’ and ‘‘death’’ from the results provided by the selected RCTs. *M-H, Mantel-Haenszel; CI, confidence interval; in the forest plots, the horizontal axis represents the CI of risk difference. The risk difference is represented by the points in each study. The dots located to the right of the median line represents higher incidence of the outcome in the group that received acupuncture; the size of the dots indicates the relative weight of each study in the final outcome. The diamond represents the final outcome of the meta-analysis; ** funnel plots show the heterogeneity between studies (horizontal axis = magnitude of the effect; vertical axis = sample size).

For the ‘‘pain’’ outcome, the meta-analysis assessed 2 RCTs [27,28], totaling 363 participants, 218 acupunctured and 145 placebo-controlled. Of the acupunctured ones, 72 had pain at the acupuncture site, while 0 reported the same outcome with the placebo, resulting in an RD = 42% (95% CI: 0.40-0.44; I2 = 100%), therefore pain being significantly more common after the acupuncture (p < 0.001).

The ‘‘petechia’’ outcome was analyzed in one article [28]. These included 140 patients, of which 8 developed petechia at the acupuncture site in the treatment group, and 0 in the placebo group, resulting in an RD = 11% (95% CI, 0.04-0.19; p = 0.004), which was statistically significant for developing petechia after acupuncture (p < 0.05).

Of all patients acupunctured, [27,28] 16 developed ‘‘mild bleeding’’ outcome at the acupuncture site, while 0 ‘‘mild bleeding’’ outcome in the placebo group, with an RD = 8% (95% CI: 0.04-0.12, I2 = 54%, p < 0.001), therefore mild bleeding being significantly more common after the acupuncture (p < 0.05).

For the ‘‘haematoma’’ outcome, 2 RCTs [27,28] were under the meta-analysis. There were totaling 363 participants, including 218 in treatment group and 145 in placebo-control group. Nine out of 363 developed haematoma in treatment group, with an RD = 5% (95% CI: 0.02-0.09, p = 0.005), which was statistically significant for developing haematoma after acupuncture (p < 0.05).

In turn, the meta-analysis of the ‘‘dizziness’’ outcome involved two articles [27,28]. Of the 218 acupunctured patients and 145 in the placebo group, none of them had dizziness in both treatment group and placebo-controlled group. The RD = 0 (95% CI -0.02-0.02, I2 = 0, p= 1), which was not statistically significant for developing dizziness after acupuncture (p > 0.05).

No reports of acupuncture-related severe adverse effects or deaths were shown among the analyzed studies. The metaanalysis of the ‘‘infection’’, ‘‘fainting’’, ‘‘large scale bleeding’’ or ‘‘unbearable severe pain’’ outcome involved two articles [27,28]. Totaling 363 participants, including 218 participants assigned to acupuncture group and 145 assigned to placebo-control group. None of them had infection, fainting, large scale bleeding, or unbearable severe pain, in both treatment group and placebocontrolled group. For infection outcome, RD = 0% (95% CI -0.02-0.02, I2 = 0, p= 1), which was not statistically significant for developing infection after acupuncture (p > 0.05). For fainting outcome, RD = 0% (95% CI -0.02-0.02, I2 = 0, p= 1), which was not statistically significant for developing fainting after acupuncture (p > 0.05). For large scale bleeding outcome, RD = 0% (95% CI -0.02-0.02, I2 = 0, p= 1), which was not statistically significant for developing large scale bleeding after acupuncture (p > 0.05). For unbearable severe pain outcome, RD = 0% (95% CI -0.02-0.02, I 2 = 0, p= 1), which was not statistically significant for developing unbearable severe pain after acupuncture (p > 0.05).

For the ‘‘aspiration pneumonia’’ outcome, 1 RCTs was assessed by the meta-analysis [28]. There were totaling 140 participants, including 70 in treatment group and 70 in placebocontrolled group. One out of 70 developed aspiration pneumonia in treatment group, while 2 out of 70 in the placebo group, with an RD = -1% (95% CI: -0.06-0.03, p = 0.56), which was not statistically significant for developing aspiration pneumonia after acupuncture (p > 0.05).

The meta-analysis of the ‘‘death’’ outcome involved 2 articles [27,28], totaling 363 participants, one died in treatment group and two died in placebo-controlled group, with an RD = -1% (95% CI: -0.03-0.02, p = 0.62), which was not statistically significant for death happened after acupuncture (p > 0.05).

Besides, no reports of acupuncture-related severe adverse effects such as pneumothorax, cardiac tamponade, organ trauma, spinal cord injury, viral hepatitis [17,18,21-23,29], subarachnoid haemorrhage and spinal epidural haematoma [16], in previous studies were shown among the analyzed studies.

DISCUSSION

Dysphagia is a common manifestation after stroke which causes unfavorable outcomes. Acupuncture becomes an alternative treatment due to few efficient and effective medical treatment options nowadays [7]. Considering that there is good efficacy in treating post-stroke dysphagia demonstrated in several studies [7,8]. The knowledge of possible adverse reactions is crucial to ensure the safety and the success of acupuncture to treat post-stroke dysphagia, no matter with or without conventional therapy.

The present study selected the RCTs with comparison to control group, especially those using placebo, as studies with this design allow a clear association of adverse effects and acupuncture to establish, and the undesirable effect of confounding factors can be ruled out.

The clinical trials selected for this study recorded the existence of several adverse effects, local and systemic, severe and mild, and diseases onset during the experimental period reported by the affected patients. These clinical phenomena may not be interpreted as adverse reactions associated with the administration of the acupuncture unless their occurrence has been compared with control groups, and the causal association has been established.

For these 2 studies, local adverse effects, including pain, petechia, mild bleeding and haematoma are noteworthy, as they were the most frequently associated with acupuncture, when compared to control groups. No significant differences were found regarding the occurrence of dizziness among groups. In other words, there are four adverse effects statistically associated with the acupuncture for the treatment of post-stroke dysphagia, which shows the importance of safety analysis among the effects were pain, petechia, mild bleeding and haematoma.

Pain was identified in both articles and this was the most common adverse reaction, always associated with acupuncture when compared to the placebo group. Mild bleeding and haematoma were present in both articles and identified as effects that were directly related to the acupuncture treatment. Petechia was present in 1 out of the 2 articles and was regarded as a reaction directly associated to the acupuncture treatment.

Among the wide variety of systemic adverse effects considered in this study, none of them were related to acupuncture, including infection, fainting, large scale bleeding, unbearable severe pain, aspiration pneumonia and death. This result may become a reference to healthcare professionals who recommend acupuncture to their post-stroke dysphagia patients.

Other mentioned diseases in the drop-outs, such as acute myocardial infarction, pneumonia, fever, heart failure, cholecystitis, gastrointestinal bleeding and stress ulcers [27,28], were not included in these meta-analyses, as they were considered as the complications of stroke and post-stroke dysphagia [30].

The implementation of the meta-analysis aimed not only to confirm, but also to quantify the related adverse reactions. By using statistical methods, a joint assessment of trials that recorded the adverse effects is investigated. The metaanalyses performed in this study showed a higher probability of acupunctured post-stroke dysphagia patients to develop local effects, with significant difference of risk, especially regarding local pain, and to a lesser extent, mild bleeding, haematoma and petechia. On the contrary, among the wide variety of suspected severe systemic adverse reactions in this study, none of them was actually related to acupuncture, such as infection, fainting, large scale bleeding, unbearable severe pain, aspiration pneumonia and death. This result can be a reminder for healthcare professionals to recommend proper care after acupuncture for post-stroke dysphagia. Though the risk difference is statistically significant, it is not sufficient to contraindicate its use, based on its good efficacy and none of the systemic adverse effects were found in treating post-stroke dysphagia. By considering the incidence ofpost-stroke dysphagia, long-term hospitalization, development of pulmonary complications such as aspiration pneumonia [30], the risk/benefit ratio of the acupuncture shows to be completely acceptable, confirming its good efficacy and safety proposed by other authors [8], which contributes to the protocol of poststroke dysphagia rehabilitation.

n these 2 studies, acupoints Fengchi (GB 20), Wangu (GB 12), and Yifeng (SJ 17) were used. Fengchi (GB 20) locates at the nape laterally between the sternocleidomastoid muscle and the trapezius on both sides, below the occipital bone [15]. Wangu (GB 12) situates on the depression site posterior and inferior to the mastoid process [31]. Yifeng (SJ 17) locates posterior to the ear lobe, in the depression site between the mastoid process and the mandible [32]. They are all anatomically near the medulla oblongata and vertebral artery [15,31].

Junhua Zhang [16] suggest that needling on the acupoints, including Fengchi (GB20), Yamen (GV15), and Fengfu (GV16), may be related to the higher incidence of severe adverse effects, such as subarachnoid haemorrhage and spinal epidural haematoma. The role of the above mentioned acupoints are of the utmost importance to enhance the rehabilitation of poststroke dysphagia [31]. As this finding was exclusively found in the systematic review carried out by these authors, the above adverse reactions have not been mentioned in our studies, further studies are required to determine their causal relation. Moreover, one systematic review suggested that the reported adverse effects involved the usage of inappropriate techniques of acupuncture [16]. Hence, acupuncture applied by the well trained practitioners can truly minimize the occurrence of involving adverse reactions.

Other acupoints were also applied in our included studies, such as Lianquan (CV 23), Dicang (ST 4), Jiache (ST 6), Jinjin (EXHN12), Yuye (EX-HN13), Renying (ST 9), some scalp acupoints and so on [27,28]. Lianquan (CV 23) situates on the neck at the anterior midline above the laryngeal protuberance, which is the depression site above the upper border of the hyoid bone. Dicang (ST 4) locates on the face directly below the pupil at the corner of the mouth. Jiache (ST 6) locates on the prominence of the masseter muscle, which is one finger breadth anterior and superior to the mandible. Jinjin (EX-HN12) and Yuye (EX-HN13) situates in the mouth, locates on the left and right frenulum below the tongue respectively [32]. Renying (ST 9) locates on the neck, 1.5 cun lateral to the Adam’s apple, at the anterior border of the sternocleidomastoid muscle, where the pulsation of the common carotid artery can be found [15]. This shows that they are not near the major organs anatomically [31] and with no serious related adverse reactions were found in our studies.

Some related adverse reactions (such as traumatic complications, subarachnoid haemorrhage or infections) were identified in other analysis; they were believed to be resulted from inappropriate techniques, insufficient aseptic procedure and knowledge on the part of application. Using improper disinfected reusable acupuncture needles, improper manipulation in highrisk acupoints were the major reasons causing most adverse effects concerned. Therefore, the use of disposable sterile acupuncture needles with guide tubes, be aware of the depth of needle insertion and the condition of patients, are always be recommended [16]. Despite the results reported in this studies should be interpreted with caution, acupuncture may still be recommended as a relatively safe treatment under the operation by qualified Chinese Medicine practitioners.

The methodological divergence of this study is the results came from small sample population study. Moderate and high heterogeneity values (I2 > 50%) were showed in this metaanalysis, which reduces the degree of confidence in the results shown here. This indicated that the heterogeneity may come from some variables, such as age, gender and sample size, suggesting that the outcomes studied in the meta-analyses cannot depend on the acupuncture only, but also on the above factors. Moreover, due to the similarity of the results from the selected studies, the confidence intervals of the calculated risk differences were narrow, resulting in the increased rationalization in the observed magnified effect [33].

On the other hand, two articles have not demonstrated the information on the degree of the assessed adverse effects. This might impair the assessment on the severity of the related effects as our study did not consider the differences in severity of each effect. It is noteworthy when the studies are compared and the results show that adverse effects present, this finding is suggested to re-establish by performing further studies, so as to compare the degree of adverse reactions among studies.

The safety of treatment has been affected since different conventional rehabilitation therapies for post-stroke dysphagia, such as western drugs and rehabilitation therapy, different frequency and intensity of electro-acupuncture were applied at the same period of time. It is difficult to set a standardized protocol for treatment group due to the small sample size and small number of studies included.

In this meta-analysis, studies included were conducted in mainland China. The methodological quality of the relevant RCTs needs to be concerned. Though all the related and updated studies were tried to identify, most of them were without detailed randomization or blinding procedure. Moreover, the selected RCTs only recruited a limited number of subjects when compared with the incidence of post-stroke dysphagia. This feature prevents the inclusion of studies. Rare or unknown adverse reactions are avoided to pick out. Furthermore, some of the adverse reactions did not report the frequency of occurrence which made analysis difficult. Therefore, further high quality studies, including well blinded randomized controlled trials with sizable sample size, additional long-term studies, with similar outcome measures, would be recommended in carrying out advance studies in this area. Besides, the conclusion would be more valid unless more trials were included. Only two studies were included herein. There was bias unless non-Chinese studies were included. Moreover, the possibility of unfound studies with different unpublished findings cannot be excluded.

CONCLUSION

In this context, the results shown above suggest that the application of acupuncture for post-stroke dysphagia was potentially safe and well tolerated. The main adverse effects related to acupuncture for post-stroke dysphagia were local effects, such as pain, petechia, mild bleeding and haematoma. As there was no report of acupuncture-related severe systemic effects or deaths among the analyzed studies, it can conclude that acupuncture is a relatively safe strategy for rehabilitation in postdysphagia. This supports the persistent encouragement from health professionals to recommend acupuncture to the affected population.

AUTHOR ROLES

The authors’ contributions are as follows:

C.S Chau conceived the project and coordinated all efforts in this study; C.S Chau, A.Y.L Lau and K.K. Chua contributed to the design of the study; C.S Chau helped with data analysis; C.S Chau and K.K. Chua wrote the paper.

ACKNOWLEDGEMENT

This work is part of the thesis of Stroke and Clinical Neurosciences (CNS) Master Programme and supported by the CNS Master Programme Office, The Chinese University of Hong Kong. The authors would like to thank Prof. Vincent Mok and Prof. Adrian Wong from CUHK for their technical support and professional advice. Thanks L.H. Tsang monitored the trial and helped with data analysis.

REFERENCES
  1. Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V,  et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2013; 380: 2095-2128.
  2. Arnold M, Liesirova K, Broeg-Morvay A, Meisterernst J, Schlager M, Mono M, et al. Dysphagia in Acute Stroke: Incidence, Burden and Impact on Clinical Outcome. PloS one. 2016; 11: e0148424.
  3. Chai J, Chu FCS, Chow TW, Shum NC. Prevalence of malnutrition and its risk factors in stroke patients residing in an infirmary. Singapore Med J. 2008; 49: 290-296.
  4. Shaw GY, Sechtem PR, Searl J, Keller K, Rawi TA, Dowdy E. Transcutaneous Neuromuscular Electrical Stimulation (VitalStim) Curative Therapy for Severe Dysphagia: Myth or Reality? Ann Otol Rhinol Laryngol. 2007; 116: 36-44.
  5. Logemann JA. Approaches to management of disordered swallowing. Baillieres Clin Gastroenterol. 1991; 5: 269-280.
  6. Wong ISY, Ng KF, Tsang HWH. Acupuncture for dysphagia following stroke: A systematic review. European Journal of Integrative Medicine. 2012; 4: 141-150.
  7. Zhang J, Wang D, Liu M. Overview of Systematic Reviews and Meta-Analyses of Acupuncture for Stroke. Neuroepidemiology. 2014; 42: 50-58.
  8. Long Y, Wu X. A meta-analysis of the efficacy of acupuncture in treating dysphagia in patients with a stroke. Acupunct Med. 2012; 30: 291-297.
  9. Zhang S, Li N, Liu M. Use of acupuncture for stroke in China. Acupuncture in medicine: journal of the British Medical Acupuncture Society. 2009; 27: 146.
  10. Lundeberg T. To be or not to be: the needling sensation (de qi) in acupuncture. Acupunct Med. 2013; 31: 129-131.
  11. Kagitani F, Uchida S, Hotta H. Afferent nerve fibers and acupuncture. Auton Neurosci. 2010; 157: 2-8.
  12. Jian-wen Zhao, Zhi-yong Wang, Wen-zhong Cao, Yan-wei Zhang, Shu-chang Song, Wei-ge Kang, et al. Therapeutic efficacy of swallowing neuromuscular electrical stimulation combined with acupuncture for post-stroke dysphagia. World Journal of Acupuncture-Moxibustion. 2015; 25: 19-23.
  13. Cui-fang Fan, Hong-ying Jiang, Lian-zhong Wu. Clinical observations on acupuncture treatment of post-stroke dysphagia. Journal of Acupuncture and Tuina Science. 2007; 5: 297-300.
  14. Jie Yan. Skills with Illustrations of Chinese Acupuncture and Moxibustion . Human Science and Technology Press; 2006.
  15. Zhang J, Shang H, Gao X, Ernst E. Acupuncture-related adverse events: a systematic review of the Chinese literature. Bull World Health Organ. 2010; 88: 915-921.
  16. Endres HG, Molsberger A, Lungenhausen M, Trampisch HJ. An internal standard for verifying the accuracy of serious adverse event reporting: the example of an acupuncture study of 190,924 patients. Eur J Med Res. 2004; 9: 545-551.
  17. Witt CM1, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, et al. Safety of acupuncture: Results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009; 16: 91-97.
  18. Arne Johan Norheim, Vinjar Fønnebø. Acupuncture adverse effects are more than occasional case reports: Results from questionnaires among 1135 randomly selected doctors, and 197 acupuncturists. Complementary Therapies in Medicine. 1996; 4: 8-13.
  19. White A, Hayhoe S, Hart A, Ernst E.. Adverse events following acupuncture: prospective survey of 32 000 consultations with doctors and physiotherapists. BMJ. 2001; 323: 485-486.
  20. Ernst E, Sherman KJ. Is acupuncture a risk factor for hepatitis? Systematic review of epidemiological studies. J Gastroenterol Hepatol. 2003; 18: 1231-1236.
  21. Peuker ET, White A, Ernst E, Pera F, Filler TJ. Traumatic complications of acupuncture. Therapists need to know human anatomy. Arch Fam Med. 1999; 8: 553-558.
  22. Yamashita H, Tsukayama H, White AR, Tanno Y, Sugishita C, Ernst E. Systematic review of adverse events following acupuncture: The Japanese literature. Complement Ther Med. 2001; 9: 98-104.
  23. Wong ISY, Ng KF, Tsang HWH. Acupuncture for dysphagia following stroke: A systematic review. European Journal of Integrative Medicine. 2012; 4: 141-150.
  24. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials. 1996; 17: 1-12.
  25. Ping Wu, Fanrong Liang, Yang Li, Ling Yang, Yinlan Huang, Anyi Li, et al. Clinical Observation on Acupuncture plus Rehabilitation Training. Journal of traditional Chinese medicine. 2011; 52: 45-48.
  26. Xie Y, Liu H, Zhou W. Effect of Acupuncture on Dysphagia of Convalescent Stroke Patients. Chinese journal of integrated traditional and Western medicine. 2011; 31: 736-740.
  27. Norheim AJ. Adverse effects of acupuncture: a study of the literature for the years 1981-1994. J Altern Complement Med. 1996; 2: 291-297.
  28. Smithard DG, O'Neill PA, Parks C, Morris J. Complications and outcome after acute stroke: Does dysphagia matter? Stroke. 1996; 27: 1200-1204.
  29. Xue-min S. Acupuncture and Moxibustion. : Xin hua shu dian Beijing fa xing suo fa xing; 2007.
  30. De Shen W. Chinese Acupuncture and Moxibustion. : Shandong University of Traditional Chinese Medicine; 1992.
  31. Coelho PL, da Silva Calestini GL, Alvo FS, de Moura Freitas JM, Castro PM, Konstantyner T. Safety of human papillomavirus 6, 11, 16 and 18 (recombinant): systematic review and meta-analysis Rev Paul Pediatr. 2015; 33: 474-482.

Chau CS, Chua KK, Lau AY (2016) Meta-analysis of Acupuncture Safety in Post-stroke Dysphagia Treatment. Ann Cardiovasc Dis 1(4): 1016.

Received : 20 Jun 2016
Accepted : 01 Nov 2016
Published : 03 Nov 2016
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