Einleitung
Wie es der Titel vermuten lässt, ist dieser Artikel auf Englisch und beleuchtet die Erkrankung Asthma und aktuelle Studien dazu. Diese Arbeit war Teil des ersten Trimesters der Nanjing University.
1. Introduction
Asthma is a chronic inflammatory lung disease which cause sporadic difficulties in breathing. The main symptoms are breathlessness, troublesome inhalation, dry cough and wheezing. The severity and the frequency can change during the seasons. Asthma is classified as atopic (extrinsic) or non-atopic (intrinsic) based on an allergic reaction to the environment (dust etc) or no allergic reaction. Another classification is according to the frequency and the strength of the lung to exhale in one second (FEV1) and by the peak expiratory flow rate (PEF, PEFR). During the acute stage the lung tissue is swollen, there is a bronchospasms and excess production of mucus inside of the bronchioles. In the chronic stages there is a chronic inflammatory response in the tissue. This inflammation will produce an airway remodeling, which give rise to a lasting tissue destruction (WHO Team, 2019). Worldwide more than 235 million people are suffering from this illness and it is the world most common chronic lung disease in children.
1.1. Chinese medicine and asthma
In the Chinese medicine asthma is called Xiao Bing (哮病- wheezing). The main cause for Xiao Bing is latent phlegm retention in the lung. The pathogenesis for phlegm is related to the invasion of external pathogenic factors, improper diet, emotional stimulus or weakness. Because of the phlegm the lung is not able to disperse and descend the Qi and fluids properly, which give rise to wheezing (Xinyue, 2006).
1.2. The WHO and the treatment of asthma
In the year 2002 the World Health Organization (WHO) published a review called “Acupuncture: Review And Analysis of Reports on Controlled Clinical Trials” (ARCT). This book was a landmark in the European countries for the question, which diseases can be treated with acupuncture. One indication was asthma. According to ARCT (2002) the majority of controlled trials suggest that acupuncture is effective in treating asthma and this effect is specific to points. Although there are some conflicting results. Limitations for acupuncture were the effect on acute cases and the weak effect on objective measurements. One criticism on ARCT is that it only includes nine clinical trials up to 1998 on asthma.
The aim of this paper is therefore, to critically review current studies and meta-analysis, to highlight new developments, trends, disadvantages and advantages. Only studies after 2000 were used and all of them are related to clinical trials about asthma. The measurement for the result will be the effect of acupuncture on the objective FEV1 and the general effect of acupuncture. Another point will be the effect on the life quality and the results of different points.
2. Current Clinical Trials
Is acupuncture an effective treatment for asthma? To answer this question efficacy trials are a good point to start. Those trials are very rigid in their design and have a high internal validity (MacPherson, 2008, p. 116).
2.1. Acupuncture in children and adolescents with bronchial asthma: a randomised controlled study
In this efficacy trial with 85 participants an acupuncture group with standard care (n = 43) was compared with a control group (N = 42) which received standard care alone. Medication was administered under the regulations of the actual guidelines for the treatment of asthma. The whole study was realized in a rehabilitation center and the study process was observed with a pre, post and 4-months later questioning. Data analysis was evaluated by the outcome on lung function, the medication, quality of life (PAQLQ) and state-trait anxiety inventory for children (STAIK). The acupuncture group received 12 treatments over four weeks with a standardized program (Bl 13, Ren 17, Lu 7). Beside from this points different other points were used in relation to the pattern of the patient diagnosis (St 40 = phlegm, Kid 6 = Qi deficiency, Li 11 = Lung Yin deficiency, St 41 = stomach heat, Bl 42 = fear, grief, sorrow). The acupuncture group had a better outcome than the control group in all measured fields, also the FEV1 improved. This shows that acupuncture can be a potentially supportive treatment in asthma. This analysis has some weaknesses, the study would have been more useful with a sham-control group. Without it is not clear if the acupuncture effect is specific or a placebo.
Another issue is the small sample size. Small sample sizes are useful for pilot studies but a valid study should have an adequate size (MacPherson, 2008, p. 138).
The positive effect on the quality of life increased also in other studies Shao et al. (2008), Reinhold et al. (2014) and Brinkhaus et al. (2017). Therefore this result seems to be substantial.
In relation to the FEV1 the outcome should be observed with caution. The systematic review from Liu and Chien (2015) analysed one further study. The result was that the FEV1 might increase but further research is necessary. The systematic review from Jian et al. (2019) about current studies found no significant improvement in this marker in chronic cases. Only in the acute stage the effect on the FEV1 was positive.
2.2. Which point is the best and does acupuncture points have a specific effect?
As a practitioner one important question is which point/point combination is the best suitable one for a given patient. To answer this from research a clear definition and understanding of the anatomical and physiological structures which defines a “point” is necessary. For Langevin et al (2018) the failure of using a clear definition and unclearness behind the acupuncture mechanism leads to the rejection that acupuncture is an evidence-based treatment. This statement has huge implications. As long as it is unclear what a point is, it is also unclear what acupuncture is. From that point of view its not possible to clarify which kind of treatment is a placebo. According to MacPherson (2008) a placebo should mimicry a tested treatment without using its specific and active elements. This illustrates as long as the mechanism of acupuncture is not ifully understand, it is impossible to do sham-acupuncture as a placebo-control. Without a placebo-control treatment the specific effect of a point cant be figured out (MacpPerson, 2008, p. 139-141).
For Charlotte Paterson and Rosa N. Schnyer (cited in MacPherson, 2008) it seems therefore clear that acupuncture should be evaluated „patient-centered“. The main question should be whether acupuncture improves peoples health because to highlight the holistic approach of acupuncture. From that point of view specific point effects can be differentiated.
2.3. Comparison between “five needles therapy” and conventional acupuncture for individual symptoms and signs of asthma of latent cold phlegm-fluid in the lung.
If there is a difference in the outcome when different points are selected was investigated by Zhang et al. in a RCT 2018.
210 patients were divided into one observation group and into a control group. The observation group received acupuncture at Bl12, Bl13 and GV 14.
In the control group different acupuncture points were used (Bl 12, Bl 13, Lu 1, CV 22, CV 17, Lu 6, EX-B 1, St 40 , Lu 9). The whole treatment plan covered one treatment for twelve days.
The outcome was measured before treatment and on the 3rd, 6th, 9th, 12th days on six clinical signs and symptoms. The symptoms were pant, wheezing, cough, cough with phlegm, fullness in the chest and diaphragm, and shortness off breath. All observed symptoms are “patient-centered” as suggested from Charlotte Paterson and Rosa N. Schnyer (MacPherson, 2008, p.77). In general the total effective rate in the observation group was 96,9% and in the control group 90,9%. Therefore this study shows that different styles of acupuncture are effective in the treatment of chronic asthma and effective rates depend on the used acupuncture points.
This result is supported from the results in Wei et al. (2018) literature review. Wei et al. (2018) describes that different acupuncture manipulations can produce different reactions in the human body even though the same point is used. For Cheung et al (2001) the effect of acupuncture depends on three aspects: the selected points, the used manipulation and the nervous system of the patient.
Regarding the point selection of the study from Zhang et al, it is striking that in the control and observation group the same points were used except some differents. If the technique remains the same, this would indicate that certain points have a specific effect. A sham-control group would still be necessary to falsify this hypothesis.
2.4. Acupuncture in Patients with Allergic Asthma: A Randomized Pragmatic Trial
This study was done in Germany with 1025 patients (130 acupuncture, 125 control, 770 non-randomized-acupuncture). Its length was 6 months.
The aim was to investigate the effectiveness of acupuncture in addition to routine care for asthma compared to treatment with routine care alone. As a pragmatic trial this study investigated the effectiveness of acupuncture in the clinic with different points regarding to the patients diagnosis (MacPherson, 2008, p. 116).
The acupuncture for the randomized acupuncture group and the non randomized acupuncture included 15 treatments during the first three months, followed by three months follow up with no acupuncture treatment. The control group received acupuncture in the 4th month of the study.
The outcome measurements were done in the baseline and 3 months later with the asthma quality of life questionnaire (AQLQ) and the Short-Form-36 (SF-36) questionnaire. The AQLQ is a asthma specific instrument to score the physical and emotional impact of asthma. It includes 32 questions with 4 subcategories all related to the severity of asthma (symptoms, activity limitation, emotional function and environmental stimuli). The SF-36 included question about the quality of life. This measurement is “patient-centered” and is a way to evaluate the effect of acupuncture (MacPherson, 2008, p. 243 -244).
The development of the AQLQ score was positive and increased in all groups. Interestingly the score for the control group increased more after the additional treatment with acupuncture. Consequently the conclusion from Brinkhaus et al (2017) suggests that the use of acupuncture as an supportive treatment in the routine care of asthma is valid treatment because it could be proofed that acupuncture was superior to routine care alone in improving specific symptoms and the quality of life. A question that need to be asked in this study is, if the training of the MD has an effect on the result. All MD had only 140 hours training. According to Birch the WHO developed regulations for a qualified acupuncturist. It should not be less than 1500 hours for a medical doctor who wants to work primary in this field (Birch, 2007, p. 14). In addition to this, the regulations about acupuncture training are different in Europe (Leung, 2006, p. 247-270). Therefore it might be possible that clinical trials from Europe can have a different outcome because of the lacking qualification of the MD. Unfortunately this subject is not investigated from any study.
2.5. Are systematic reviews and meta-analysis the gold standard
Meta-analysis are sometimes called the “gold standard” of science (Crocetti, 2015, p. 1). In researching acupuncture this is also a proper method but there are some major difficulties.
The heterogeneity of the RCTs in the field of acupuncture is very large. Therefore it is very hard to find comparable data (MacPherson, 2008, p. 214).
This is a problem with the non-existent definition about acupuncture. Sometimes the term is related to anatomical landmarks and sometimes it is related to the use of needles with or without electricity (Langevin, 2018, p. 201).
2.6. Efficacy of acupuncture in children with asthma: a systematic review
This systematic review focused RCTs about asthma and children under 18 years of age. The main task of this review was to clarify the efficacy of acupuncture. Liu and Chien did the data extraction from the sources MEDLINE, Embase and the Cochrane Library databases up to October 20, 2014. From 102 articles after a quality assessment only seven RCTs with totally 410 patients were used. The criterion for the quality assessment came from the Cochrane Collaboration to assessing risks of bias.
After watching these seven studies Liu and Chien came to the result, that the efficacy of acupuncture on other measurements than the PEF in children with asthma is unclear (Chi & Li, 2015, p. 8) The main argument against the efficacy was the heterogeneity of the studies because some studies used laser treatments, some used needles. The same problem was mentioned by Langevin et al (2018). Therefore this is a valid problem and for following RCTs it is necessary for to use comparable methods with existing RCTs in order to enable meta-analyzes.
2.7. Conventional Treatments plus Acupuncture for Asthma in Adults and Adolescent: A Systematic Review and Meta-Analysis
The aim of this systematic review by Jiang et al. (2019) was to investigate if acupuncture is a good choice for a supportive treatment in asthma. Studies who compared conventional care and conventional care plus acupuncture were used for the meta-analysis. Two reviewers collected 1242 studies from PubMed, EMBASE, the Cochrane Library, Web of Science, China National Knowledge Infrastructure and the Wanfang database from 1990 to 2018.
Only nine matched to the inclusion criteria (English/Chinese publication, patients with asthma, RCTs compared conventional treatment versus conventional treatment plus acupuncture, FEV1 was used). In total all studies included 472 patients with no significant heterogeneity. None of the study was double blinded. In all studies different medication was used for the conventional therapy. For acupuncture only traditional acupuncture was used.
Five studies were used to analysis the general response on both different treatments. It was possible to see that conventional care plus acupuncture had a significant better symptom response than conventional care alone.
For the analysis or Fev1 four studies were used and for FEV1/FCV five studies were used. The result was that supportive acupuncture had no effect on those parameters in the chronic stage but in the acute stage.
The meta-analysis further showed that the Interleukin-6 (IL-6) decreased significantly. The conclusion from Jiang et al was therefore that acupuncture as an adjunctive therapy is clinically and statistically useful (Jiang, 2019, p. 99). The result is advantage for acupuncture because this meta-analysis used comparable data. One limitation lies in the fact that none of the studies were double blinded. Therefore the risk of a bias is high (Kabisch 2011, p. 664-665), (MacPherson, 2008, p. 114). The negative outcome on the FEV1 might be a result of the medication. Fujita et al. (2017) showed in a animal study that caffeine reduces the efficacy of acupuncture. This is principally possible for all substances. As long as the mechanism of acupuncture is unclear, it is unclear how medication interfere with acupuncture. In this field further research is necessary.
2.8. Cost effectiveness
A new question that was not asked in the ARCT is the question of the cost effectiveness of acupuncture. The question is a very crucial one, especially with the rising costs in the healthcare system (MacPherson, 2008, p. 124-125). Because this question is a new development only a few studies are available for different disease.
2.9. Acupuncture in Patients Suffering from Allergic Asthma: Is It Worth Additional Costs?
In this 2012 study, the cost effectiveness of acupuncture and the quality-adjusted delivery years (QALYs) were examined.
A total of 306 patients, divided into an acupuncture group (n = 159) and a control group (n = 147), were examined over a period of 6 months. Both groups were allowed to use the standard medication. The acupuncture group was treated for three months and then interviewed for another three months. In the control group, the treatment was vice versa.
The SF-36 questionnaire was used as evaluations for the QALYs and the incremental cost effectiveness ratio (ICER) was used to calculate the cost effectiveness.
With this study Reinhold et al. they were able to show that acupuncture improves the QALY considerably but is also more cost-intensive, since acupuncture had no influence on the amount of used medication. However an important question regarding this result was not answered, was there an active attempt to reduce the medication to reduce the cost? The study has no concept of how far the medication can be reduced if the asthma disease improves. Therefore, this result should be used with caution.
The study also showed that the improvement in QALYs is specific to acupuncture. The improvement in QALYs was only evident during acupuncture in both groups. This result was also evident in the study by Brinkhaus et al (2017). However, it applies in both studies that they had no placebo control group. It is therefore not clear whether the effect of acupuncture is specific or not.
3. Conclusion
For the FEV1 it is unclear if acupuncture improves it. Single studies Scheewe et al (2011), Shao et al (2013) showed a significant effect but the meta-analysis from Jiang et al (2019) found no significant effect. One possible reason for this discrepancy could be the different medication. Further research would be necessary to investigate the impact of medication. A second reason could be the different acupuncture styles/point selection, therefore standardization would be essential for further research.
It seems that points has a specific impact on the symptoms. Zhang et al (2018) compared the “five needles” with conventional acupuncture. It would be interesting to do further investigations with a sham-control group to investigate the specific efficacy. This would also proof that points has an impact on the outcome as ARCT supported. Further studies should be done with a standardized manipulation method because studies showed that different manipulations produce an specific effect.
The question if verum-acupuncture is better than sham-acupuncture can not answered more deeply. All mentioned RCTs, except three studies in Liu and Chien systematic Review, were without a sham-control-group.
To improve the evidence of acupuncture further research with a placebo-control group is necessary. It is also indispensable to further investigate the mechanisms behind acupuncture. This is necessary for the differentiation between a placebo or acupuncture (Langevin, 2018).
This literature review showed that as long as the measurement for the outcome is “patient-centered” the results for acupuncture are positive in effectiveness and efficacy. That means not to neglect objective measurements just to change the focus for a better understanding of the complexity in this therapy.
The ARCT mentioned also a possible reduction in the medication during acupuncture. This statement can not verified by this review because none of the studies mentioned this kind of result but also no active attempt to investigate this during the study.
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