随机对照研究中的中药汤剂的安慰剂

安慰剂的恰当使用是临床随机对照研究中的重要环节之一。由于中药汤剂具有特殊的气味、色泽和口感,在其安慰剂的制作上存在极大的困难。本文从安慰剂重要性、临床随机对照试验中使用状况出发,从安慰剂制备、安全性、合格性检测及伦理性四个方面进行论述,以期为医学研究人员在临床随机对照试验中合理选择中药汤剂安慰剂提供理论依据。     

针灸研究的复杂性与挑战性（英文）

With the growing popularity of acupuncture in western society in recent decades,many acupuncture researches and clinical studies have been conducted.These studies have significantly enhanced our understanding of acupuncture;nevertheless,very few findings obtained from acupuncture research have been transferred to acupuncture clinical practice,which has significantly hampered the development of acupuncture treatment.In addition,some crucial information,such as correct dosage of acupuncture,remains unknown,which further limits the interpretation of clinical trials testing the efficacy of acupuncture treatment.Future acupuncture research should try to fill these gaps and explore new ways to increase the clinical effectiveness of acupuncture treatment.     

安慰对照针灸方法的可信性测试

目的:寻找理想的安慰对照针灸方法.方法:11位健康志愿者,随机接受6种安慰对照针灸方法(简称安慰针法)及2种标准针法(即常规针法),每次针后,测量针感值(VAS Scale)及做真假针法判断.结果:6种安慰针法与2种标准针法针感比较,差别有统计学意义;而真假针法判别在初次接受针刺者及曾有针灸经历者之间,差异有统计学意义.结论:安慰针法针感(感觉)不同于标准针法,安慰针法可能失败于曾有针灸经历人士.     

安慰剂效应与安慰剂组学的研究与思考

安慰剂效应是指由安慰剂引起的,对疾病或症状起到缓解作用的心理生理效应。安慰剂效应与药物性质,临床应用背景,患者的个体差异及接触到的信息等多种因素相关,其中个体的基因差异会导致不同程度的安慰剂效应。介导安慰剂效应的神经递质通路有多巴胺通路、阿片受体信号通路、内源性大麻素及血清素等信号通路。疾病的精准治疗,有赖于对发病机制和药物作用机制的透彻了解,安慰剂效应作为药物效应的一个方面,对其深入研究有助于精准医学的发展。     

随机对照试验研究中各种假针刺的评价

目的:在随机对照试验(Randomized Controlled Trials,RCTs)研究中,不同的假针刺方法广泛地用于评价针刺对某种病症除安慰效应外是否具有内在的治疗作用.为使试验结果可信和更有可比性,有必要对假针刺方法做个统一的规范.方法:回顾了最近14年高质量的针刺RCT研究,评价其中的各种假针刺方法的恰当与否.结果:根据进针部位、破皮方式、所用仪器的不同,这些假针刺方法主要可以分为5类.结论:最常用的假针刺方法有穴位旁开针刺、远部非穴部位针刺和不破皮假针刺3种,其中远部非经非穴部位针刺可能是比较理想的假针刺对照.另外,对照的设立应结合考虑RCT研究的目的和设计,如非劣效性、等效性、优效性试验.     

腹针疗法治疗单纯性肥胖临床疗效观察

目的:观察腹针疗法对单纯性肥胖患者体质指数(BMI)及腰围比值的影响,了解腹针疗法对单纯性肥胖临床治疗的效果。方法:设立健康对照组、安慰针对照组和治疗组,以脐周2寸、3寸、4寸的部位围着脐部上、下、左、右、左上、左下、右上、右下取8个点刺入,针尖均斜向脐位;体针取两侧足三里和三阴交。比较安慰针组及治疗组治疗后BMI及腰围比值的变化,并与健康对照组比较。结果:经毫针针刺治疗后,单纯性肥胖患者的BMI及腰围比值与安慰针组比较明显降低(P<0·05和P<0·01),且其BMI与健康对照组相比无明显差异(P>0·05)。结论:腹针疗法对于单纯性肥胖的BMI有良好的调整作用。     

Placebokontrollierte Untersuchung zerebraler und vegetativer Effekte von Akupunktur an Di 4

Background and Aims

Many neurophysiologic effects have been observed during acupuncture. So far there is no placebo-controlled trial studying the correlation between changes in the central nervous system and vegetative effects. In consideration of a reliable blinding of the volunteers, the aim of this study was to examine specific cerebral and vegetative effects of verum-acupunture (VA) compared to placebo-acupuncture (PA).

Methods

Healthy volunteers received either VA at LI 4 (Hegu) with a verum-needle or PA at a non-acupuncture point with a placebo needle. EEG and ECG recordings were performed in parallel followed by an evaluation of pain, skin penetration and vegetative effects.

Results

The feeling of skin penetration was not significantly different (p = 0.057). Vegetative effects and Deqi occurred significantly more often during VA (p = 0.022). Pain was increased during VA-stimulation compared to PA (p > 0.01). Verum stimulation markedly increased occipital EEG power (p < 0.03). The increase in the fast alpha1 waves was accompanied by a decrease in the theta frequencies and the ratio alpha1/theta was shifted to the benefit of alpha1 (p < 0.04). This was paralleled by a short increase of the ECG ratio between low frequency (LF) and high frequency (HF) (p < 0.02), followed by an increase of HF-power (p < 0.04).

Conclusions

Volunteers were unable to distinguish between VA and PA. The EEG and ECG changes measured during VA stimulation are pointing towards a modulation of cerebral functions by vegetative acupuncture effects compared to PA.     

血脂康胶囊治疗血脂异常随机平行对照研究

[目的]观察血脂康胶囊治疗血脂异常疗效。[方法]使用随机平行对照方法,将70例门诊患者按随机数字表分为两组。对照组25例血脂康胶囊模拟剂,2粒/次,2次/d。治疗组45例血脂康胶囊,2粒/次,2次/d。连续治疗8周为1疗程。观测血脂水平TC(总胆固醇)、TG(甘油三脂)、HDL-C(高密度脂蛋白胆固醇)、LDL-C(低密度脂蛋白胆固醇):用药前2周、用药后当日、4周后及疗程结束后各检测1次。连续治疗2疗程,判定疗效。[结果]治疗组显效18例,有效20例,无效7例,总有效率84.44%。对照组显效2例,有效5例,无效18例,总有效率28.00%。治疗组疗效优于对照组(P0.05)。血脂水平对照组治疗前后无明显差异(P0.05);治疗组治疗前后有显著性差异(P0.05)。[结论]血脂康胶囊治疗血脂异常效果显著,值得推广。     

基于传统针灸理论刍议针刺临床研究中对照组的干预方法设计

针刺临床研究中对照组设计目前得到了国内相关研究者的广泛关注,其中关于对照组中安慰针的设计与具体操作的观点争议颇多,笔者追溯传统针灸起源,从传统针灸理论及手法操作出发,结合现代临床研究中安慰针的设计与具体操作,对针灸临床研究中对照组干预手法的设计提出创新性建议,以求为针刺临床研究提供参考。     

“山幕针”——一种双盲安慰针装置的设计与实践

为临床针刺双盲对照试验提供切实可行且科学的安慰针装置——"山幕针"。其特征是,真/假针具皆由毫针、针管及底座组成,假针具底座下端开口完全封闭,使毫针针尖无法与皮肤接触,从而不产生任何轻微刺激,而外形又与真针具完全相同。假针具内置的填充物可以模拟腧穴内软组织,同时结合试验前暗示诱导,起到降低破盲风险的作用,使针刺双盲试验成为可能。     

对国外偏头痛临床研究中针刺与伪针刺疗效无差异结论的思考

针对近年来国外偏头痛临床研究领域中出现的"针刺与伪针刺疗效无差异"这一结论,通过对伪针刺(安慰针刺)的定义和理想的安慰针刺需遵循的原则,浅刺的定义、部位、作用及临床效果几方面的论述,探讨浅刺能否作为针刺临床研究中的伪针刺(安慰针刺)对照方法.结果表明"用最小刺激量针刺皮肤表浅层经穴或非经穴"这种所谓的"伪针刺(安慰针刺)"对照方法,很可能是通过"浅刺皮部"这一途径激发了人体全身性的调整作用,从而发挥了治疗作用.故该法并非适宜的安慰针刺对照方法,不能作为针刺临床研究中的伪针刺(安慰针刺)对照方法,因此自然可以推翻用该法作为安慰针刺对照方法得出的"针刺与伪针刺的疗效无差异"这一结论.     

Mikrosystem-Akupunktur bei craniomandibulärer Schmerzsymptomatik: – eine randomisierte kontrollierte Studie

Background

Patients suffering from craniomandibular disorders describe their problems not only as toothache, but also as facial pain. Limitation of movement and a tense feeling in the temporomandibular joint as well as pain in the vertebra are also possible. To treat such symptoms, an interdisciplinary approach (myofascial, stomatognath, lymphatic system) is necessary. Relieving the patients' symptoms as quickly as possible helps to improve the compliance with the patient, thereby facilitating further therapies.

Aim

To assess the effects of acupuncture on the acute symptoms in patients with craniomandibular disorder in comparison to placebo laser treatment. Primary end points are pain intensity (quantified using Visual Analogue Scale [VAS]), functional muscle test, ability to open the mouth, axiographic evaluation as well as the palpation and treatment of sensitive acupuncture points.

Methods

23 patients with craniomandibular disorder were recruited for the randomised controlled double blind trial. They were divided into two groups: the verum group received acupuncture in the style of “very point”, as described by Gleditsch. The second group received treatment with a placebo laser on the same points as a control group. Before and after each session of treatment, the following diagnostic findings were recorded in each group: subjective pain (VAS), mouth opening ability (mm), pressure sensitivity of the face and neck muscles, and pressure sensitivity of the acupuncture areas (MAPS). The therapeutic intervention was not performed by the examiner.

Results

Muscle pain ranking from 0 (no pain) to 3 (very painful) in the acupuncture group (19,1 ± 11,9) was significantly reduced compared to the placebo group (6,2 ± 14,8): p = 0,03. Pressure- pain sensitivity of the neck and masticatory muscles was significantly reduced in most of the tested muscles (p < 0,05) among the acupuncture group. Patients in the acupuncture group showed a slight improvement of mandibular movement in comparison to the placebo group, but this observation remained without a statistical significance.

Conclusion

This RCT shows that acupuncture with the „very point” method can improve symptoms of craniomandibular disorders within a short period of time. Further studies are necessary and projected to prove the long term effect within a larger group of patients.     

Wirksamkeit der Akupunktur bei der Therapie von idiopathischen Schmeckstörungen: Eine randomisierte Placebo-kontrollierte Studie

Background

At present, the state-of-the-art medication in treating idiopathic taste disorder (gustatory dysfunction) is zinc. If zinc medication was unsuccessful, not tolerated or if it is contraindicated the persons affected can hardly be helped.

Objectives

In a randomized placebo-controlled clinical trial an attempt was made to determine the efficacy of acupuncture.

Methods

The treatment group was treated with acupuncture needles, the placebo group with an inactive acupuncture-laser. Endpoints of the study were changes in the taste test, the quality of life and the severity of symptoms of depression (BDI) as well as mood changes (ZMS). Satisfaction with the success of the respective therapy was also evaluated. Data were collected before and after therapy and again for the treatment group 10 weeks after completion of the treatment period.

Findings

Treatment with real acupuncture showed a significant improvement in gustatory function as well as a significant improvement in psychological symptoms. Greater satisfaction with the treatment results was evident in the treatment group. The treatment results of acupuncture remained stable over a period of ten weeks after completion of the treatment.

Conclusion

Acupuncture was effective in the therapy of idiopathic taste disorders and therefore it is an effective alternative when zinc medication is not tolerated or unsuccessful. But it is also suitable as a therapy of first choice. Acupuncture can be considered as an extension of the therapeutic spectrum in the difficult treatment of taste disorders.     

Needling Sensations following Real and Placebo Acupuncture – a randomised single-blinded two-period cross-over pilot study –

BackgroundPlacebo needles are accepted as the gold standard for the control in acupuncture research. Credibility is one of the essential factors which influence the placebo response. The needling sensations of the real and placebo needles may have a decisive influence on credibility. The aim of the study was therefore to test these sensations from a placebo needle compared to those of real acupuncture.Methods10 healthy volunteers were enrolled in this cross-over pilot study. In each period of the study 5 volunteers were treated with a placebo needle and 5 with a normal acupuncture needle. The LI 4 (Hegu) acupuncture point was selected for bilateral treatment and the needles stayed in place for 15 minutes. Placebo and real needles were manipulated for a short time by rotating the needles in both directions. The interval between the two periods of the study was one week. After each treatment session the volunteers had to guess which treatment condition they had received and filled in a questionnaire which assessed the pricking sensation (intensity), quality and spread of the deqi sensation. The extent of the different sensations was rated on a Verbal Rating Scale (1–10).ResultsThree volunteers receiving real acupuncture and two receiving placebo correctly identified the form of treatment. Four volunteers in the first session and five in the second session could not decide how they had been treated. No significant difference between placebo and real treatments was detected in any of the variables examined which were related to needle sensation (unpaired t-test, p-value > 0.05).ConclusionsBased on the findings of this trial, the tested placebo needle might be a suitable control condition for acupuncture trials.A study with a larger sample size is warrented to confirm the present findings.     

对临床研究中真假针灸的质疑及反思

从针灸临床实践及理论出发,对假针灸是否名副其实、真假针灸的命题是否成立以及针灸效应是否等同于安慰剂作用3个方面做了阐述,认为将针灸的生物学效用和心理学效用相互分离的研究方法不符合中医"身心合一"的传统,也违背了当今"生物—心理—社会"的医学新模式,没有理由继续在西方身心两分研究模式的困境中重蹈覆辙。假针灸作为对照方法尚不成熟,不宜作为针灸研究的标准模式,赞同《中国针灸》杂志提倡首选与现代医学疗法对照的做法,瞄准医学中公认的最有效、最先进的手段方法及结果作为对照,直接发现针灸的差距或优势,实际价值和意义更大。     

Agreement and meaning: rethinking consensus analysis

This study provides a critical perspective on "informant agreement (consensus) analysis" as it is used in ethnobotany and ethnopharmacology. It recasts the concept at a higher cultural level, and it describes the cultural agreement about reported medicinal plant use for the native peoples of North America. It examines some plant use categories around which there is significant cross cultural agreement, and some categories which lack such agreement. The study then proposes a theoretical approach to understanding the efficacy of plants lacking significant consensus in their usage. The study considers the implications of this second form of efficacy defined here as the "meaning response", but often referred to as the "placebo effect".     

西方对中国针灸临床科研的态度及引发的思考——从两个海外学者关于中风疗效的通信辩论看开来

从最近两个海外学者关于中风疗效的辩论引中出西方国家对中国针灸临床科研的怀疑甚至否定态度,认为针灸对于中风康复和疼痛的治疗是没有依据的.借此介绍了西方常用的针灸临床科研方法,尤其是盲法的设计:安慰针灸和假针灸.提出几点设想供国内的同行们参考,并呼吁国内的同行对此问题引起高度关注.     

Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine

In recent years, new preparations of traditional Chinese medicines (TCMs) have been developed, increasing the need for their clinical trials. Using placeboes rather than control drugs is increasingly popular in clinical trials of TCMs, as the therapeutic effects of the tested TCMs can be more properly judged. The basic attributes of TCM placeboes include similarity, safety, applicability and controllability. In particular, it is necessary to have similarities in appearance, color, smell and taste between the tested TCMs and placeboes. This is quite difficult for some TCMs due to their distinctive smell and taste. On the other hand, according to the TCM theory on homology of medicine and food, many foods also have certain bioactivities, potentially further complicating the selection of materials for TCM placeboes. In this review, firstly, studies on the special smell and taste of TCMs were introduced. Then, the preparation quality evaluation processes for TCM placeboes were summarized and discussed, based on the relevant literature published in recent years and the research results from our own lab. This review will facilitate the further research and development of TCM placeboes.