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Communications to the Editor |

Missing the (Acu) Point FREE TO VIEW

Opher Caspi; Elad Schiff
Author and Funding Information

Affiliations: University of Arizona, College of Medicine, Tucson, AZ,  Bnai-Zion Medical Center, Haifa, Israel,  Baylor College of Medicine, Houston, TX,  University of Pittsburgh Medical Center, Pittsburgh, PA,  Hadassah University Hospital, Jerusalem, Israel

Correspondence to: Opher Caspi, MD, MA, Research Assistant Professor, Program in Integrative Medicine, Department of Medicine, College of Medicine, The University of Arizona, Health Sciences Center, PO Box 245153, Tucson, AZ 85724-5153; e-mail: ocaspi@ahsc.arizona.edu



Chest. 2003;123(4):1312-1314. doi:10.1378/chest.123.4.1312
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To the Editor:

Varon et al (May 2002),1 in an editorial accompanying the study of acupuncture in asthma by Shapira et al (May 2002),2 commended the study for being “… important because it provides the rigor of Western scientific method to an alternative medical therapy.”1, p 1388 In what follows, we would like to call the reader’s attention to at least three potential critical flaws in the design and data analysis of that study that render its overall validity and generalizability questionable.

First, the fidelity and integrity of the study intervention rested entirely on the relative competency and proficiency of a single “certified and experienced”2, p 1397 acupuncturist who evaluated the study subjects, diagnosed their condition, and treated the study subjects according to the principles of traditional Chinese medicine (TCM). This, however, is an undesirable research practice since it poses plausible threats to both the construct and external validity of a study, particularly when it fails to reject the null hypothesis.3 Likewise, it would be inappropriate to draw any generalized causal inferences about the efficacy of a surgical procedure or a given method of psychotherapy by examining the outcomes of any single surgeon or therapist, respectively. Negative findings in such studies could arguably be explained as type II error (ie, concluding that there is no effect when in fact there really is an effect), especially when other research indicates opposite results. This is all the more so in TCM research, in which the diagnosis and treatment rests solely on the practitioners’ clinical skills. For this reason, it has been recommended recently4 that studies that evaluate traditional systems of medicine should involve multiple practitioners. Unfortunately, the inclusion of only one acupuncturist in this study also precludes the possibility of testing the hypothesis that the study failed due to suboptimal provision of care, since, from a generalizability standpoint, the assessment of the measurement error and variance associated with the therapist facet of the study requires multiple practitioners.5

Second, it may be argued that the negative findings of this study are a result of a significant threat to its internal validity, stemming from another unfortunate flaw in the study design, the intervention itself. The assertion that this study is more rigorous than other studies that have looked at the efficacy of acupuncture in asthma patients because it provided “personalized” (ie, individualized) treatment seems evidence-free, since all the patients received treatments according to fixed time schedules despite the fact that, according to TCM diagnosis, many of them have had different underlying pathologies. Likewise, giving “the first and last sessions … to treat acute attacks of asthma, while the second and third sessions … to treat the root”2, p 1397 inevitably depersonalizes the session design and lacks the flexibility of a tailored treatment plan. If true individualization were to occur, then session design, acupuncture point selection, manipulation technique, and treatment schedules should all have been tailored individually to the patient according to his or her underlying TCM etiology and pathophysiology. Of equal concern is the arbitrary length (3 weeks) of the washout period, which is completely evidence-free.

Third, a severe threat to the statistical conclusion validity of the study deserves attention.3 As the authors acknowledged, asthma as an intact Western clinical entity does not exist in TCM. Rather, in TCM, asthma can be diagnosed by the presence of more than five different syndromes. As Wiegant et al6 have suggested, to achieve homogeneity in study samples in complementary and alternative medicine research, ideal designs should involve a double selection procedure; that is, first, a specific conventional diagnosis should be selected, and second, a specific complementary and alternative medicine system diagnosis should be selected from among the multiple possibilities. Nonetheless, the data analysis in the study of Shapira et al2 was based on overall between-group (ie, either real or sham acupuncture) comparison of means rather than on subgroup (ie, the five TCM syndromes) analysis. Indeed, a quick look at the “family of lines” in Figures 2 and 3 in the study by Shapira et al,2 reveals relatively large variations in the individual responses to asthma that may be accounted for by subgroup differences. Given the five subgroups and the crossover design, we doubt whether the study was adequately powered,7 which is a concern that may raise some ethical considerations.8

In conclusion, we paradoxically agree that the study is important, but for exactly opposite reasons than those that the esteemed authors or the editorialists used to conclude that it was important. Confucius, the great Chinese philosopher, was quoted as saying: “Our greatest glory is not in never failing, but in rising every time we fail.” The study by Shapira et al2 offers an unusual opportunity to educate us all about research design and generalized causal inferences. If we sincerely intend to compare different systems of medicine, we should enable the equal application of each system. Failing to do so may lead us to draw inaccurate conclusions and may deprive us of the potential for additional therapeutics for our patients.

Varon, J, Fromm, RE, Jr, Marik, PE (2002) Acupuncture for asthma fact or fiction [editorial]?Chest121,1387-1388. [PubMed] [CrossRef]
 
Shapira, MY, Berkman, N, Ben-David, G, et al Short-term acupuncture therapy is of no benefit in patients with moderate persistent asthma.Chest2002;121,1396-1400. [PubMed]
 
Shadish, WR, Cook, TC, Campbell, DT. Experimental and quasi-experimental designs for generalized causal inference. 2002; Houghton Mifflin Company. Boston, MA:.
 
MacPherson, H, Sherman, K, Hammerschlang, R, et al The clinical evaluation of traditional East Asian systems of medicine.Clin Acupunct Oriental Med2002;3,16-19
 
Shavelson, RJ, Webb, NM. Generalizability theory: a primer. 1991; Sage Publications. Thousand Oaks, CA:.
 
Wiegant, FAC, Kraers, CW, van Wijk, R The importance of patient selection Lewith, GT Aldridge, D eds. Clinical research methodologies for complementary therapies. 1993; Hodder and Stoughton. London, UK:.
 
Cleophas, TJM, Zwinderman, AH Crossover studies with continuous variables: power analysis.Am J Ther2002;9,69-73. [PubMed]
 
Halpern, SD, Karlawish, JHT, Berlin, JA The continuing unethical conduct of underpowered clinical trials.JAMA2002;288,358-362. [PubMed]
 
To the Editor:

The use of alternative medicine techniques in patients with asthma remains unproven and poorly tested.1 In a recent article in CHEST, Shapira et al (May 2002)2 reported on their randomized, double-blind, sham-controlled, crossover study of short-term acupuncture in patients with moderate persistent asthma. Drs. Caspi and Schiff raise concerns about the methodology of this study, particularly the use of a single acupuncturist in the delivery of therapy. Certainly, this raises the concern of the generalized applicability of the conclusions of the study. However, the advantage of using one or a few experienced practitioners is that one can expect homogeneity and reproducibility in the treatment.

The correspondents are also concerned about the “personalized” treatment program. It is their contention that the use by Shapira et al2 of a fixed time schedule for treatment “depersonalized the session design,” which may have impacted the outcome of the trial. We will leave the defense of this particular design to the authors of the study. However, some structure is required for the practical implementation of any clinical trial.

We must be cautious in the interpretation of every clinical trial. The generalized ability of the conclusions is dependent on the clinical trial design. Despite its shortcomings, we believe that the study by Shapira et al is important because it brought the rigor of Western scientific methodology to alternative medical therapy.3 The randomized clinical trial (RCT) allows for the objective and unbiased evaluation of a treatment modality, and, while very few RCTs are flawless, we must guard against dismissing an RCT that does not agree with what we believe or practice. The study by Shapira et al has not answered all questions about the role, if any, of acupuncture in the treatment of patients with asthma. However, given its results, we remain skeptical and cannot recommend acupuncture for the treatment of asthma.

References
Blanc, PD, Trupin, L, Earnest, G, et al Alternative therapies among adults with a reported diagnosis of asthma or rhinosinusitis: data from a population-based survey.Chest2001;120,1461-1467. [PubMed] [CrossRef]
 
Shapira, MY, Berkman, N, Be-David, G, et al Short-term acupuncture therapy is of no benefit in patients with moderate persistent asthma.Chest2002;121,1396-1400. [PubMed]
 
Varon, J, Fromm, RE, Marik, PE Acupuncture for asthma: fact or fiction [editorial]?Chest2002;121,1387-1388. [PubMed]
 
To the Editor:

I would like to comment on the problems mentioned in the letter of Dr. Caspi.

Indeed, our study had a single acupuncturist. We welcome results from larger-scale studies.

As specified in the article, only the second and third sessions were designed to treat the root cause of the asthma, as diagnosed by traditional Chinese medicine. Interestingly, you haven’t mentioned the importance of the practitioner’s treatment intention. As Ch’i Po answers to the emperor in the Nei Ching:

Poor medical workmanship is neglectful and careless and must be therefore combated, because a disease that is not completely cured can easily breed new disease, or there can be a relapse of the old disease … the most important requirement in the art of healing is that no mistake or neglect occur.1

You claim that 3 weeks of washout are “evidence free.” In fact, there is no scientific basis for any length of washout. However, no washout was used in a crossover study of the effect of acupuncture on allergic rhinitis.2 Also to be noted is that Zhu and Polus3 used 3 weeks as a washout period and Malmstrom et al4 did not expect an effect of acupuncture on bronchial asthma 2 weeks after the termination of treatment. Our results show that no effect was seen after 3 weeks, thus supporting our choice of 3 weeks of washout.

You state that the “family of lines” in Figures 2 and 3 shows great variation that may be accounted for by subgroup variation. I call to your eyes the same variation in the placebo group.

Our results deal with acupuncture treatment for asthma as seen by “Western eyes,” eyes that have no ability to make traditional Chinese medicine diagnosis and thus cannot enjoy the subgrouping suggested by you, and so are inadequately powered. From your letter, I understand that you expect the common pulmonologists and general practitioners to make a Chinese diagnosis with subgrouping, then decide if there are chances of asthmatic relief with acupuncture.

By the way, I am not familiar with any Chinese literature that implies that there is a subgroup of asthma in which acupuncture does not help; could you open my eyes in this matter?

As a person dealing in complementary medicine for over a decade, I am as disappointed with negative results as you are. However, those results cannot be wiped out because of the technicalities you mention (and which we disagree with, as mentioned above).

As Sun Tzu says in the Art of War5 : “Fight, but know where there are sufficiencies and deficiencies.” Our study does give an answer to the limited question of the effect of short-term treatment on moderate persistent asthma.

References
Veith, I The yellow emperor’s classic of internal medicine.1982,150 Southern Materials Center. Taipei, Republic of China:
 
Xue, CC, English, R, Zhang, JJ, et al Effect of acupuncture in the treatment of seasonal allergic rhinitis: a randomized controlled clinical trial.Am J Clin Med2002;30,1-11. [CrossRef]
 
Zhu, XM, Polus, B A controlled trial on acupuncture for chronic neck pain.Am J Clin Med2002;30,13-28
 
Malmstrom, M, Ahlner, J, Carlsson, C, et al No effect of Chinese acupuncture on isocapnic hyperventilation with cold air in asthmatics, measured with impulse oscillometry.Acupunct Med2002;20,66-73. [PubMed]
 
Tzu, S. Art of war. 1993; William Morrow. New York, NY:.
 

Figures

Tables

References

Varon, J, Fromm, RE, Jr, Marik, PE (2002) Acupuncture for asthma fact or fiction [editorial]?Chest121,1387-1388. [PubMed] [CrossRef]
 
Shapira, MY, Berkman, N, Ben-David, G, et al Short-term acupuncture therapy is of no benefit in patients with moderate persistent asthma.Chest2002;121,1396-1400. [PubMed]
 
Shadish, WR, Cook, TC, Campbell, DT. Experimental and quasi-experimental designs for generalized causal inference. 2002; Houghton Mifflin Company. Boston, MA:.
 
MacPherson, H, Sherman, K, Hammerschlang, R, et al The clinical evaluation of traditional East Asian systems of medicine.Clin Acupunct Oriental Med2002;3,16-19
 
Shavelson, RJ, Webb, NM. Generalizability theory: a primer. 1991; Sage Publications. Thousand Oaks, CA:.
 
Wiegant, FAC, Kraers, CW, van Wijk, R The importance of patient selection Lewith, GT Aldridge, D eds. Clinical research methodologies for complementary therapies. 1993; Hodder and Stoughton. London, UK:.
 
Cleophas, TJM, Zwinderman, AH Crossover studies with continuous variables: power analysis.Am J Ther2002;9,69-73. [PubMed]
 
Halpern, SD, Karlawish, JHT, Berlin, JA The continuing unethical conduct of underpowered clinical trials.JAMA2002;288,358-362. [PubMed]
 
Blanc, PD, Trupin, L, Earnest, G, et al Alternative therapies among adults with a reported diagnosis of asthma or rhinosinusitis: data from a population-based survey.Chest2001;120,1461-1467. [PubMed] [CrossRef]
 
Shapira, MY, Berkman, N, Be-David, G, et al Short-term acupuncture therapy is of no benefit in patients with moderate persistent asthma.Chest2002;121,1396-1400. [PubMed]
 
Varon, J, Fromm, RE, Marik, PE Acupuncture for asthma: fact or fiction [editorial]?Chest2002;121,1387-1388. [PubMed]
 
Veith, I The yellow emperor’s classic of internal medicine.1982,150 Southern Materials Center. Taipei, Republic of China:
 
Xue, CC, English, R, Zhang, JJ, et al Effect of acupuncture in the treatment of seasonal allergic rhinitis: a randomized controlled clinical trial.Am J Clin Med2002;30,1-11. [CrossRef]
 
Zhu, XM, Polus, B A controlled trial on acupuncture for chronic neck pain.Am J Clin Med2002;30,13-28
 
Malmstrom, M, Ahlner, J, Carlsson, C, et al No effect of Chinese acupuncture on isocapnic hyperventilation with cold air in asthmatics, measured with impulse oscillometry.Acupunct Med2002;20,66-73. [PubMed]
 
Tzu, S. Art of war. 1993; William Morrow. New York, NY:.
 
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