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关于放射肿瘤学中使用针灸减轻副作用的现有证据和未来发展方向
来源:针灸最前沿 2019-07-31 [科技] [中国中医药]

Abstract

Several reports have shown that acupuncture is an effective method of complementary medicine.However, only a few of these reports have focused on oncological patients treated with radiation therapy. Most of these studies discuss a benefit of acupuncture for side-effect reduction, however, not all could demonstrate significant improvements. 

文摘

一些报告表明,针灸是一种有效的补充医学方法.然而,只有少数的这些报告都集中在肿瘤患者放射治疗方面 .大多数这些研究讨论针灸的减少副作用的好处,然而,并不是所有都能证明针灸显著改善治疗。

Thus, innovative trial designs are necessary to confirm that acupuncture can alleviate side effects related to radiation therapy.

In the present manuscript, we perform a broad review and discuss pitfalls and limitations of acupuncture in parallel with standard radiation therapy.

因此,证实针灸可以减轻放射治疗相关副作用的创新的试验设计是必要在目前的手稿,我们执行一个全面审查和讨论缺陷和局限性的针灸与标准的放射治疗.

Introduction

Complementary and alternative medicine (CAM), including acupuncture, homeopathy, naturopathy and special dietary concepts, is gaining more and more interest. Many patients ask for CAM methods, in order to enhance the efficacy of their cancer treatment, to boost their immune system as well as to reduce side effects and increase tolerability of conventional cancer care 1, 2 and 3. 

 

介绍

补充和替代医学(CAM),包括针灸、顺势疗法、物理疗法和特殊饮食概念,正在占有越来越多的分量。许多病人望借助替代医学以提高他们的癌症治疗的疗效,提高他们的免疫系统能力,以及减少副作用,增加传统癌症治疗的耐受性1、2和3。

Several methods of Traditional Chinese Medicine (TCM) are sub-classified as CAM, and acupuncture is one of the most frequently requested and offered treatments.

Thus, there is a need for solid data on the effects of acupuncture。

针灸和几种列为替代医学方法的中国传统医学(中医)是一种最频繁患者请求和要求提供的治疗。因此,需要可靠的数据在针灸的效果方面需要可靠的数据

Acupuncture is a well-established part of TCM and one of the oldest treatments. It has been practiced in China and other Asian countries for over 2000 years.Meanwhile reported clinical outcomes in scientific and non-scientific media have convinced at least subgroups of physicians about the positive effects.

中医针灸是一个不可或缺的组成部分和最古老的治疗方法之一。它已经在中国和其他亚洲国家存在2000多年了。同时临床结果在科学和非科学媒体报道相信其起到的积极作用。

According to the theory, "energy" (Qi) flows along predefined "pathways" (meridians) in our human body and influences health and well-being.

The total balance of this ”flowing energy” is defined as the optimal state, and characterized as being „healthy“. 

根据这一理论,“能量”(气)流在预定义的“通路”(穴位)在我们的人体是影响健康的福祉。总平衡的“能量流”被定义为最优状态,特点是„健康”。

Various stressors including sleeping disturbances, poor work-life-balance, illnesses such as infections, cancer or chronic diseases, can trigger an imbalance within these specified meridians.

From the classical acupuncturist’s point of view, achieving a healthy energy flow within the meridians is the starting point for every therapeutic intervention. The technique is based on stimulating predefined acupuncture points (acupoints) along these meridians using needles, slight pressure, ultrasound or laser, for a certain duration once or several times per week.

在这些指定的经脉,各种压力源包括睡眠障碍,可怜的适当平衡工作和生活,疾病,如感染、癌症或慢性疾病,可以触发不平衡。从古典针灸师的角度来看,实现健康的能量流在经络是每个治疗干预的起点。这项技术是基于在一定时间一周一次或几次,预定的穴位刺激(穴位)沿着这些经络使用针头,轻微的压力,在超声波或激光下传导。

There is strong knowledge about the location of these acupoints in correlation to the human anatomy, and experienced therapists not only require a solid repertoire of anatomical structures but need also manual experience in finding the respective acupoints and placing the needles.

有经验的治疗师不仅需要这些穴位的位置,和相关的人体解剖学对应的坚实的解剖结构,也需要手工经验找到相应的穴位,将针刺入。

In general, for certain targeted symptoms corresponding acupoints exist. By choosing the acupoints wisely and applying well-trained acupuncture, the idea is to restore the unbalanced energy, which can result in symptom reduction and/or relief of suffering.

一般来说,对于某些目标症状存在对应的治疗穴位。通过选择明智和应用训练有素的针灸穴位,这个想法是为了恢复能量不平衡,从而导致减少症状和/或缓解痛苦。

In the literature, for instance, comprehensive reviews on the effect of acupuncture on cancer-related fatigue exist 18, 19 and 20. Most reports only include few patients. Large randomized trials have not been initiated. Nevertheless, many practitioners are offering acupuncture to cancer patients receiving radiotherapy (RT) – independently of the lack of clinical data.

在文献中,例如,综合评价针灸的效果在癌症相关疲劳存在18,19和20。大多数报告只包括几个病人。大型随机试验尚未启动。然而,许多从业者提供针灸癌症患者接受放疗(RT)——独立于临床数据的缺乏。

We, therefore, reviewed in the present manuscript all existing data from prospective trials on acupuncture in radiation oncology and discuss potential benefits, downsides, and rationales for future prospective clinical trial designs.

因此,我们回顾了在目前的手稿前瞻性试验的所有现有数据在针灸放射肿瘤学和讨论潜在的好处,缺点,为未来的前瞻性临床试验设计和依据。

Materials and Methods

We identified 10 articles with the abovementioned terms. Of those two were feasibility studies for subsequent larger trials. All were from university-based centers with special institutions focusing on CAM treatments. Due to the small number of trials and subsequently the small number of patients included in these trials we chose a trial-by-trial comparison method.

我们确定了10篇文章与上述条款。这两个的可行性研究为后续更大的试验。所有来自大学校园中心与特殊机构专注于CAM治疗。由于小数量的试验,随后这些试验的患者包括我们选择trial-by-trial比较方法。

Results

Ten articles were found in the literature reporting on randomized acupuncture trials in the context of radiation oncology (table 1). Targeted symptoms and endpoints varied between trials.

结果

十篇文章被发现在文献中报道的上下文中随机针灸试验放射肿瘤学(表1),有针对性的症状和末端之间的各种试验。

Xerostomia

In five trials xerostomia was chosen as an endpoint. Patients with RT treatment in the head-and-neck region were included in these trials. Four of the five studies demonstrated a significant reduction of xerostomia by additional acupuncture. In one study xerostomia was also reduced in the control arm applying placebo acupuncture.

The study by Blom et al. [21] evaluated 38 patients with radiation-induced xerostomia, of which 20 were treated with classical acupuncture in the experimental arm and 18 patients received superficial acupuncture as placebo in the control arm. In both groups, patients showed significantly increased salivary flow rates after acupuncture treatment. 

 

口腔干燥

在五个试验口腔干燥被选为一个末端。RT患者治疗的头颈部区域包含在这些试验。4的5口腔干燥的研究表明显著减少额外的针灸。在布鲁姆的一项研究中针灸在口腔干燥方面也减少了安慰剂的使用[21]。评估患者38例患者放疗后口腔干燥中的20例与传统针灸治疗,在实验中18名患者接受表面针灸后起到了与安慰剂类似的作用。这两个组的患者显示针灸治疗后显著增加唾液流率显著增加

The results indicate that among the patients, who had increased salivary flow rates already after the first 12 acupuncture sessions, the majority had a high probability of continual improvement after the completion of acupuncture treatment. The improved salivary flow rates usually persisted during the observation year.

绝大多数的患者的结果表明,针刺前12次之后,,他们增加了唾液流速。完成针灸治疗后,这个高概率还在持续升高。改进的唾液流率通常保存观察一年。

Radiationduced xerostomia was also addressed in the study by Cho et al. [22] for head-and-neck cancer patients.

曹等人的研也在进行同样的研究。[22]有头颈部癌症患者参与实验。

Acupuncture was performed twice-weekly for six weeks. Needle points were chosen for the efficacy on the respective meridians in promoting salivary flow or water-like elements of the body. 

针灸每周执行了六个星期。针灸治疗选择了具有促进唾液分泌功能或中医中属水的穴位。

Results showed no statistical difference between both groups regarding saliva flow, however, real acupuncture increased saliva flow and showed improved symptoms in the xerostomia questionnaire (XQ) scores.

结果显示两组之间没有统计学差异对唾液流,然而,问卷显示针灸增加了唾液流量,改善了口腔干燥症状。

Since the data showed a significant increase in QoL and reduction of xerostomia, they launched a larger trial with the same acupoints (see table 1). In this trial, 86 patients were randomized into two groups, 40 in the acupuncture arm and 46 in the sham acupuncture arm.

Endpoints of the study were QoL assessed by the xerostomia questionnaire (XQ) and stimulated and unstimulated salivary flow rates. QoL revealed a significant improvement in the verum group compared to the sham group, and salivary flow measurements demonstrated a significantly higher rate in the acupuncture group in the early phase at week three and also during longer follow-up at one and six months。

Thus, the team from Fudan University could demonstrate that acupuncture works as an excellent strategy to alleviate side effects.

来自复旦大学的团队也证明了针灸是用来减轻副作用的有效医疗手段。

The research group from Sussex compared acupuncture to oral care in patients with chronic xerostomia after RT for head-and-neck cancer [25]. Seven oncology centers in the UK participated. Inclusion criteria consisted of prior RT (at least 18 months) with at least one parotid in the target volume (without any dose constraints. The study used a crossover design beginning four weeks after the end of the first intervention (acupuncture vs. oral care) was used.

Acupuncture was performed weekly for eight consecutive weeks with a duration of 20 minutes per session. Oral care included dietary approaches, symptomatic relief products such as artificial saliva, and oral hygiene advice. Primary and secondary endpoints were the patient-reported change in severity of xerostomia, xerostomia-related symptoms, stimulated and unstimulated saliva production and QoL. 

英国七个肿瘤中心提供的病人进行实验也得出了同样的结论。

Cancer-related fatigue

One study by the team of Balk and colleagues [20] performed a pilot study as a randomized modified, double-blinded, placebo controlled trial of acupuncture for cancer-related fatigue. A total of 54 patients were included who had surgery alone or in combination with chemotherapy with an indication for RT. 

易疲劳

共有54名患者接受了针灸在改善癌症患者易疲劳方面的研究,包括正在接受手术的病人。

The standard arm consisted of acupuncture once or twice per week during four weeks. Needles were placed uni- or bilaterally depending on the acupoints. The control arm consisted of sham acupuncture mimicking true acupuncture. Out of the 27 patients recruited and randomized into the verum arm, only 26 completed treatment. 

Results showed that patients’ fatigue in the verum acupuncture group had a better improvement than in the control arm. Other endpoints, including physical and mental distress and QoL, improved during treatment as well, however, not significantly between both groups.

结果表明,针灸组在患者改善疲劳方面更有成效。其他方面,包括身体和精神上的痛苦和生命质量,两组之间没有显著。

Nausea and emesis

恶心和呕吐

Endpoints were an emesis questionnaire, weekly “open questions” on different aspects such as mood, sleep or pain, as well as evaluation of the treatment protocol including patients’ sensations at needle insertion. Verum acupuncture was not proven to be more effective than sham acupuncture in reducing radiation-induced nausea, however, patients in both groups had a significant benefit in terms of nausea reduction.

最后是一个呕吐问卷,每周都设计“开放式问题”,分别从不同方面的情绪、睡眠或疼痛,包括针插入病人时的感觉。针灸没有被证明是比对照针灸治疗在减少辐射诱导恶心方面是更有效的,但是,两组针灸病人在减少恶心方面确有很大的好处。

Dysphagia

Dysphagia is a common side effect in patients treated with RT in the head-and-neck region. This symptom is very distressing for the patients, not only due to the pain but also due to the subsequent difficulty in eating, drinking and swallowing. One randomized, sham-controlled trial focused on dysphagia and the benefit of acupuncture on symptom reduction published by Lu et al. [29]. 

吞咽困难

吞咽困难是一种常见的副作用。病人是非常痛苦的,不仅由于疼痛,而且由于饮食吞咽的后续困难。一个随机,假对照试验集中在吞咽困难和针灸减少症状方面.[29]。

 The team examined patients after radiochemotherapy for head-and-neck cancer. A total of 42 patients were included. Endpoints of the included changes in the MD Anderson Dysphagia Inventory Score from baseline to 12 months. The secondary endpoint was QoL. 

共有42名头颈癌患者接受了实验,包括安德森吞咽困难量表得分的变化及生命质量是被考察的两点。

A subgroup of patients received testing for salivary flow rates and cytokines, including plasma transforming growth factor and interleukin, to identify a biological explanation for any changes observed. The final results of the study have not yet been published, however, the trial design is promising to support the use of acupuncture for relief of dysphagia in head-and-neck cancer patients.

病人进行了一些有关唾液流率和细胞因子,包括等离子体转化生长因子和白介素,识别生物解释的测试,观察到的任何更改将作为实验数据。这项研究的最终结果尚未公布,不过,试验设计承诺支持使用针灸缓解可头颈癌患者的吞咽困难。

Discussion and future trial design

The present article summarizes all relevant studies available on the effect of acupuncture to reduce radiation-related side effects. Since acupuncture is discussed controversially, several groups have designed such trials to define the value of acupuncture in in modern radiation oncology. 

讨论和未来的试验设计

本文总结了所有可用针灸的效果减少化疗辐射的副作用的相关研究。由于针灸疗效的争议性,这些试验无不证明了针灸在现代放射肿瘤学中的璀璨价值。

Explanations for this effect may be that sham acupuncture also releases some triggers and stimulates in spite of not being placed at dedicated acupoints. Activation of limbic regions by tactile stimulation is known, and sham needles have been observed to activate a variety of brain areas depending on the needle and stimulation used 32 and 33. Other explanations might be that some therapists talk to patients longer and have more body contact, which itself can reduce psychological distress 34, 35 and 36. 

解释这一效应的原因,可能是针灸也发布一些触发器和刺激,尽管没有在专用的穴位起作用,但已经被观察到激活不同的大脑区域如边缘区域的激活和刺激32和33。其他的解释可能是,有些治疗师和病人的时间更长,有更多的身体接触,这本身可以减少心理压力34、35和36

Since psychological distress can be a predictor of emesis, nausea or other symptoms, reduction of stress can lead to symptom improvement. Kaptchuk and co-workers have addressed this issue and confirmed that the patient-therapist interaction is more important than the needle stimulation itself 37, 38 and 39.

由于心理压力可以预测呕吐,恶心或其他症状,减少压力可以导致症状的改善。. Kaptchuk和同事已经解决了这个问题,确认医患交互比针刺激本身更重要37岁,38和39。

White et al. published a cumulative review on acupuncture-related side effects and reported serious side effects at 0.05 per 10,000 patients treated [40]. Most adverse events were related to improper use of the acupuncture needles or improper application, mostly in series where patient self-application were evaluated, although the studies assert that patients were trained by experienced therapists 41, 42 and 43. Leung et. al reported that most events observed are not adverse events, but treatment-related side effects due to wrong handling or application. Thus, the authors conclude, such events are clearly preventable 43 and 44.

针灸相关的副作用几乎可以忽略不计,累计发表评论报道严重副作用为0.05每10000患者[40]。大部分不良事件是由于针灸针的使用不当或不当的应用造成的41岁42和43。梁等人报道,大多数事件观察没有不良事件,但是治疗相关副作用时与错误的处理或应用有关。因此,作者总结说,这些事件显然是可预防的43和44。

searched for evidence focused on xerostomia reduction by acupuncture in head-and-neck cancer patients. From the data available, they concluded that insufficient evidence is available to judge whether acupuncture is safe and whether it is effective in preventing or treating radiation-induced xerostomia. Significant research remains to be done before acupuncture can be recommended for routine use in radiation-induced xerostomia [45]. 

寻找证据集中在减少口腔干燥,针灸在头颈部癌症患者。从可用的数据,他们得出的结论是,证据不足可以判断针灸是否安全、是否有效地预防或治疗放射性口腔干燥。重要的研究仍有待做过针灸可以在辐射诱导建议常规使用口腔干燥[45]。

As a comparator sham acupuncture was implemented. In those arms, every patient also received an acupuncture treatment, but the needles were not inserted as deep as in real acupuncture and the acupoints did not lay on the traditional given „pathways“.

在接受针灸治疗的患者与对照组患者的差别在于针刺深度有没有达到针灸的“通路”上。

A conclusion from all studies, independently of RT treatment, is that acupuncture is considered as a safe treatment without any severe side effects. Several reports including extensive reviews have confirmed this. Acupuncture has the potential to reduce side effects and enhance QoL when applied by an experienced therapist and in conjunction with high-end modern medicine.

从所有独立于RT治疗的针灸研究中得出,针灸治疗被认为是安全的,没有任何严重的副作用。几个报告包括广泛的评论也证实了这一点。针灸有可能降低副作用,提高生命质量,适用于有经验的治疗师和结合现代医学高端。

As a general rule of acupuncture in cancer care, the conclusion must be, that acupuncture is becoming more and more popular as an asset in oncology, even though there are many aspects that need to be addressed and standardized, ideally within prospective clinical trials [46]. For radiation oncology, we can support this conclusion, however, we must add that standardized parameters for RT as well as information on dose application need to be established.

一般来说针灸治疗癌症放化疗副作用,结论是肯定的,针灸是变得越来越流行,也在肿瘤治疗中作为一种资产,即使有很多方面需要解决和标准化,在前瞻性临床试验[46]中需要变得更理想。我们可以支持这一结论,然而,我们必须添加对RT的标准化参数以及剂量应用程序需要的信息。

Conclusion

A few small studies have assessed the benefit of acupuncture against radiation-related side effects. Most have shown a benefit, however, most of them include only small numbers of patients and a variety of endpoints. Keeping in mind that acupuncture has been used in TCM for thousands of years, some benefits can be expected, and it is our task in modern oncology to examine and prove this effects. Thus, innovative trial designs and selection of appropriate patient cohorts for CAM methods will help define the role of acupuncture in modern oncology.

结论

以上一些小研究评估针灸对缓解癌症放化疗辐射的副作用起到的好处。大多数研究只显示一个方面,然而,大多数人也只包含了很少数病人。记住,中医针灸已经使用了数千年,一些优点是可以预期的,我们的任务是在现代肿瘤学中检查和证明这个结果。因此,新颖的试验设计和选择合适的实验组,将帮助我们定义针灸在现代肿瘤学的角色和地位

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