Akupunkturtherapie für klinische Studien, Teil 2

von Gabriel Stux  

Wie soll man Akupunktur in klinischen Studien anwenden?

Diese Frage stellt sich zur Zeit für die drei Arbeitsgruppen, die für die gesetzlichen Krankenkassen kontrollierte Studien vorbereiten. Für den nicht-kontrollierten Teil dieser Studien werden keine Leitlinien formuliert.

Der kontrollierte Teil der Studien erfordert aber eine intensive Beschäftigung mit dieser Frage. Dazu liegt bereits seit einem Jahr eine Arbeit im "Clinical Acupuncture Scientific Basis", Springer-Verlag 2001, vor. Hier folgt der zweite Teil.

Proposed standards of acupuncture treatment for clinical studies ( Teil 2)

G. Stux, S. Birch

Proposals for systematizing the selection of acupuncture in clinical trials

Since many clinical trials of acupuncture use so-called sham or irrelevant acupuncture as the control treatment, the method used for selecting the appropriate and adequate acupuncture treatment could also be used for selecting this control treatment [5, 6]. Having a systematic method of ensuring that an appropriate control treatment is selected can be as important as having a method for selecting the test treatment. The following proposal provides a method for selecting both types of treatment.

In addition to selecting the test and control treatments, it may be possible to tackle the problem of generalizability of results. To date, the problem of the generalizability of results has not been well addressed. Is it possible to generalize the results from one study of acupuncture to other studies or to acupuncture as a whole? What do we need to do to ensure or enhance generalizability of results? There is a sufficiently broad range of therapeutic techniques and approaches in the field [8, 10, 23], that generalizing from the study of one of them to the rest of them can be problematic. However, it may be possible to develop a method that allows generalizability of results across methods or at least increased generalizability without committing the same logical error.

What is needed is a repeatable method for selecting both the test and control treatments. The following "BRITS" method is offered as a solution to this problem, which essentially seeks to establish treatment validity and to improve generalizability of results through extensive literature reviews [the term "BRITS" was coined by one of the authors and stands for the "Birch Relevant and Irrelevant Treatment Selection" method.] This method developed in early 1993, was first presented at the Second Symposium of the Society for Acupuncture Research, September, 1994 [5]. The method has since been adopted in major clinical trials of acupuncture in the U.S. These include a trial of acupuncture for chronic neck pain at Harvard Medical School [11], a trial of acupuncture for cocaine dependence at Yale University School of Medicine [49], a large multi-center trial of acupuncture for cocaine dependence through Columbia University, including the substance abuse treatment centers at the Universities of Yale, Minnesota, Miami, Washington and California at Los Angeles and San Francisco [50]. Other smaller studies in the U.S. have also utilized this method.

The BRITS method:

Purposes:

1. To develop an easily applied standardizable approach to selecting and validating relevant acupoints for the test treatment in needle controlled acupuncture studies, thereby helping ensure the appropriateness and adequacy of the test treatment.
2. To develop an easily applied standardizable approach to selecting and validating irrelevant acupoints for the control treatment.
3. To develop a pool of standardized irrelevant acupoints for specific conditions that can be used in future needle controlled studies testing acupuncture for those conditions.
4. To develop a method that allows for a broad generalization of the results of controlled acupuncture studies that use the method.
5. To aid in the development of assessment criteria that can be used to evaluate the quality and quantity of the test and control acupuncture treatments in published clinical trials.

The BRITS method for selecting and validating the test (relevant) treatment points:

1. Review treatment texts or papers directly related to the method or tradition of practice being tested. Confirm that all the acupoints to be treated are recommended for the condition being treated in at least 6 sources.
2. Review other treatment texts to confirm that the treatment points are generally indicated in these other texts for the condition being treated. This step enhances the potential generalizability of the results. This step is optional, but preferred.
3. Test the treatment in a pilot study before going to a full scale study. Data from the pilot study can help fine tune the design and size of the larger follow up studies. This step is preferred, but not always necessary.

The BRITS method for selecting and validating the control (irrelevant) treatment points:

1. Review the same treatment texts and papers used to validate the test acupoints, and pick out the same number of points as test points.
2. The selection criteria for these points should be:

1. that they are not at all or almost never mentioned as being good for the condition or related conditions as that being treated in the study.
2. that they are in similar regions of the body. The credibility of the control treatment will likely decrease if the treatment is perceived as being ridiculous or unrelated to the pain. Needling in the proximity of the pain will likely be more credible.
3. Always test the control treatment in a pilot study before going to a full scale study.

This method provides a greater guarantee of validity of the selected "active" and "control" treatment sites than previous methods, and by including a broad range of literature from diverse sources in the review, it increases the generalizability of the results. The more agreement there is about a particular concept or method across varied traditions of practice, the greater the generalizability of the results that can be made to the whole field about that concept or method.

If the literature review yields unclear results, as was found with the osteoarthritis review discussed above, the literature review should be augmented by practitioner surveys and a panel of relevant experts. These experts could use the findings of the literature review as a starting point for their considerations. Once a majority or consensus opinion develops this can be used for the particular study to outline the treatment protocols used in the study.

The following example illustrates how the BRITS method can be used. In their study of acupuncture in the treatment of chronic neck pain, Birch and Jamison reviewed twenty four classical Chinese, modern Chinese (including English language texts) and modern Japanese texts to determine what were the most commonly referenced local points for the treatment of neck pain and to validate the selection of the non-local points [7, 11]. The same texts were also reviewed to select points that were never cited in the treatment of neck pain, and which were used as the control or irrelevant treatment points. The review of these texts allowed for the derivation of treatment protocols that were supportable by a significant body of modern and historical literature. In addition, the treatment protocols had broad generalizability because of the selection of treatment points from a variety of schools and traditions of practice. The review also justified the selection of the specific treatment techniques used in the study.

The use of this method coupled with the broader literature reviews discussed above, allows one not only to ascertain the minimum adequate treatment (numbers of discrete sites and number of treatment sessions) for the condition to be studied, but also the choice of specific acupoints themselves. It is also possible to use this method for focussing on the specific techniques to be tested as well.

Extending this concept of minimum adequate treatment we can derive the "optimal treatment", that is the treatment that we think will produce optimal results. The BRITS method allows for a precise selection of the treatment points and associated methods. However, as we saw above, the literature does not usually specify much about numbers of treatment sessions needed. In 1995, Stux addressed the issue of optimal treatments. He recommended for example that for headaches or migraines, at least sixteen treatments should be administered [64]. Generally, it is very bad for a study to discover after the fact that an inadequate treatment or dose of treatment had been administered during the study. Thus, to compensate for this, we feel justified in recommending to guarantee an optimal treatment. Our recommendations for optimal treatments in clinical trials of acupuncture are as follows:

1. Since the reviews of the treatment of head, low back and neck pain found an average minimum of 10-11 treatment sites, and average maximum of 14-17 treatment sites, [see tables 2 and 4], we feel that it is better to use an average of 15 sites per treatment. Variations from this should be based on an extensive literature review, and if necessary, practitioner surveys complemented by expert panel reviews. However, if the goal of a particular study is to look only at palliative care, that is short-term symptom relief, the reviews for chronic pain suggest that six sites of stimulation in each of six treatment sessions appears to be a good cut off point for minimum adequate treatment [4]. In the treatment of asthma, our review suggests that the optimal treatment should involve the treatment of 17 sites [see table 4].
2. There has not been much discussion of numbers of treatment sessions needed. However, our reviews suggest that for the treatment of chronic pain a minimum of ten sessions is needed [see tables 2 and 4]. Thus for optimal treatment, we feel it better to err on the side of too much, thus at least fifteen treatment sessions should be administered (except as just mentioned for palliative care studies). For the treatment of asthma, it is probable that optimal treatment should involve more than 15 and possibly as many as 20 treatment sessions [see table 4].
3. The frequency of treatment is discussed with even less frequency than numbers of treatment sessions. However, we feel again that it is better to err on the side of the optimal treatment. We feel that treatment frequency should be at least twice per week (more for addictions for example), and cut back to once or less a week based on some algorithm.
4. Treatment techniques should match the model of practice being tested. If a TCM acupuncture model of practice is being used, "de qi" should be elicited at all points. If an electro-stimulation treatment is being tested, it is important to specifiy the machine used, intensity and frequency of stimulation, wave form used, etc. Each technique used should be justified through an appropriate literature review. The type and gauge of needles used, depths of insertion used should all be recorded as well.
5. Inserted needles are usually retained for some minimum length of time. This length is not always specified. We feel however it most appropriate to retain needles for at least 15-20 minutes, and longer as necessary. Since our approach is to recommend in favor of the optimal treatment, we feel that if the study is to retain needles less than the 15 minutes, it should justify the approach through an appropriate literature review.
6. A important issue that has been barely raised in the literature is that of adequacy of training of the person administering the acupuncture in the study. It is not enough to merely state that the person had some training, it is necessary to specify more about the training. Perhaps the safest standard to apply is that the person administering the acupuncture treatments should have completed an approved course. It is clearly not appropriate for a "surgeon from China" to administer the acupuncture, nor is the completion of a single weekend of training sufficient either. We discussed above the variation in training programs. Further work is necessary to establish an international standard for the training of the acupuncturist in clinical trials of acupuncture, but at least for now, ensuring that the acupuncturist satisfies the standards in the country of practice should be sufficient. Additionally it is probably advisable that the acupuncturist have a minimum number of years of experience practicing acupuncture.
7. Finally, it is evident that the methodology of most acupuncture studies has been poor. It is therefore recommended as a matter of course that any proposed study bring in the services of at least three different experts: an acupuncture expert (separate from the person administering the treatment), an expert in methodology, and a statistical expert. With appropriate advice, it is hoped that the methodology of future studies of acupuncture will improve.
     

Conclusions

It is apparent from above discussions that there is considerable variety in how acupuncture textbooks describe the treatment of a particular condition. This variety exists even among those texts purportedly describing the same tradition of practice. It is also apparent that the adequacy of treatment in clinical trials of acupuncture has been poor, raising yet more questions about how to interpret these trials. Further, with inadequate reporting of treatments and their origins, it is likely that idiosyncratic treatments have been tested, raising yet other questions about the generalizability of results from these studies. There is clearly a need for a method that helps guarantee adequacy of treatment in future studies, and which helps resolve the contradictions in the acupuncture literature itself. The authors have proposed methods for addressing these problems, given examples of how to apply them, and proposed minimum and optimum standards for future studies.
  

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