Rapid Responses to:

RESEARCH:
Lisa Li-Chen Hsieh, Chung-Hung Kuo, Liang Huei Lee, Amy Ming-Fang Yen, Kuo-Liong Chien, and Tony Hsiu-Hsi Chen
Treatment of low back pain by acupressure and physical therapy: randomised controlled trial
BMJ 2006; 332: 696-700 [Abstract] [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] Accupressure & Physical Therapy Design Flaw
Douglas M. White, DPT, OCS   (18 February 2006)
[Read Rapid Response] Re: Accupressure & Physical Therapy Design Flaw
Tony Hsiu-Hsi Chen   (20 February 2006)
[Read Rapid Response] Use of Cognitive re-structuring and Bio-feed back procedures for back pain
Dr S S RAIZ M ISMAIL   (20 February 2006)
[Read Rapid Response] Variability in physical therapy between countries
Andrew Walker   (24 February 2006)
[Read Rapid Response] A patients view
John Madura   (24 February 2006)
[Read Rapid Response] Re: Variability in physical therapy between countries
Tony Hsiu-Hsi Chen   (27 February 2006)
[Read Rapid Response] Re: Re: Accupressure & Physical Therapy Design Flaw
Douglas M. White   (27 February 2006)
[Read Rapid Response] Re: Re: Re: Accupressure & Physical Therapy Design Flaw
Tony Hsiu-Hsi Chen   (2 March 2006)
[Read Rapid Response] No standard PT treatment
Eric Allen   (29 June 2006)
[Read Rapid Response] US Validation of Treatment Program
Randolph J Wagner   (19 September 2006)
[Read Rapid Response] Comment regarding responses
Jay Defigh   (30 June 2007)

Accupressure & Physical Therapy Design Flaw 18 February 2006
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Douglas M. White, DPT, OCS,
Doctor of Physical Therapy - Private Practice
191 Blue Hills Pkwy, Milton, MA 02186

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Re: Accupressure & Physical Therapy Design Flaw

The study by Hsieh, LL et al compared subjects with low back pain with treatment by accupressure or physical therapy. The discussion and conclusion implied accupressure was more effective than physical therapy in reducing pain and disability.

In Table 3 of the study "satisfaction with previous treatment" was reported as a core outcome measure and related indicator[s.] The type of previous treatment was not described. In personal correspondence with Professor Tony Hsiu-Hsi Chen, the corresponding author, he replied that the previous treatment was physical therapy.

Thus the physical therapy group appears to have received the same treatment in the study as they has previously received and evidently failed. This presents a flaw in study design as the groups had prior unsuccessful experience with one of the variables in the study. Therefore as the methodology is flawed the results and conclusions are not supported as published. To compare acupressure to physical therapy in subjects with low back pain neither group should have prior experience with one of the variables.

Competing interests: None declared

Re: Accupressure & Physical Therapy Design Flaw 20 February 2006
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Tony Hsiu-Hsi Chen,
Professor
Institute of Preventive Medicine, College of Public Health, National Taiwan University, Taipei 100

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Re: Re: Accupressure & Physical Therapy Design Flaw

Dear Dr White,

Thank you for your concern about the type of previous treatment shown in Table 3 regarding "satisfaction with previous treatment". The two points raised by Dr White are not problems and do no exist in our study.

The first point, "Thus the physical therapy group appears to have received the same treatment in the study as they has previously received and evidently failed... had prior unsuccessful experience with one of variables in the study" is based on his premise. Participants in our study were recruited from existing patients who visited the orthopedic clinic for the service physical therapy for their persistent and/or recurrent low back pain (LBP), in other words the physical therapy is still effective to them. If previous treatment was failed they would not visit the clinics according to the habit of "hospital shopping" among Chinese people. In addition, the results of Table 2 regarding R&D score show the mean score in the physical therapy group also improved with follow-up time although the improvement in the physical therapy is smaller than the acupressure group. If they failed previously how such improvement came from? Similar situation was found in table 3 as well. Our eligible criteria for enrolling patients are based on those who had chronic LBP for more than four months (see Study Participants on eligibility of criteria) rather than newly diagnosed patients. The fact that they had received previous treatment for their pain was anticipated. Note that very few chronic LBP patients in our country had not received any treatment with chronic LBP more than four months. In reality, as LBP is prevalent it is unrealistic to seek patients free of any treatment for randomized controlled trial regarding the comparison between conventional therapy and alternative one. If this is true, why does the "core" set questions include this question as part of outcome measure as proposed in Deyo et al study (Spine 1998)?

The second point, "To compare acupressure to physical therapy in subjects with low back pain neither group should have prior experience .....", is pertinent to the selection criteria. As mentioned before and clearly defined in methodological section, one of our eligible criteria for study participants was based on those who had chronic low back pain for more than four months. The criterion for selecting patients free of treatment proposed by Dr Wright is unrealistic unless target population are derived from newly diagnosed LBP or untreated chronic LBP, which are difficult to obtain in clinics in the filed of chronic LBP. However, we reiterated, as our focus on population is targeted at chronic LBP, the inference or results made from our study may not be applied to newly diagnosed LBP or untreated chronic LBP as addressed by Dr Wright although we still think it is unrealistic for conducting a random trial using Dr. Wright's criteria.

Base on the above argument, we cannot see any flaw in the design in our study. We think the first statement written by White is not evidence- based criticism and the second one is unrelated to target population in our study.

Professor Tony Hsiu-Hsi Chen

Competing interests: None declared

Use of Cognitive re-structuring and Bio-feed back procedures for back pain 20 February 2006
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Dr S S RAIZ M ISMAIL,
clinical attache' in Psychiatry
St. Francis unit, Nottingham City Hospital, Nottingham-NG5 1PB

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Re: Use of Cognitive re-structuring and Bio-feed back procedures for back pain

Use of Cognitive re-structuring and Bio-feed back procedures for back pain.

Cognitive Re-structuring:

Our thoughts can have a profound effect on our mood and physical state- including our perception of physical pain. If you constantly tell yourself, "I don't see how this pain is ever going to get better," or "I can't take it anymore," as many pain patients do, you may exacerbate your pain in three ways.

1. It becomes hard to develop the sense of power and control necessary to fight the pain.
2. These self-defeating, stressful thoughts can further tense your muscles.
3. Such thoughts may alert the nervous system to widen the pain gate and increase the discomfort.

Cognitive restructuring revises the way you think about your problem by rewriting your internal "script." It has been successful in treating a number of psychological problems, most notably depression. In the treatment of chronic pain, cognitive restructuring is used as an adjunct to other approaches, such as relaxation.

Bio-feed back procedures:

Biofeedback procedures are also useful in managing back pain. The technique known as electromyographic (EMG) biofeedback alerts you to know thelectrical activity from muscle tension, thus helping you control it and diminish the pain it causes

Competing interests: None declared

Variability in physical therapy between countries 24 February 2006
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Andrew Walker,
Physiotherapist
Ilford, IG5

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Re: Variability in physical therapy between countries

Dear Professor Hsiu-Hsi Chen,

Thankyou for a thought provoking article. It is interesting to address the clinical skills and treatment techinques employed by physiotherapists/physical therapists in different countries.

In the United Kingdom and several other countries, many physical therapists take postgraduate courses in acupuncture (including: traditional, acupressure, laser acupuncture, electo-acupuncture) accredited by a special interest group of the chartered society of physiotherapy (AACP, 2006)

Do the physical therapists from your orthopaedic specialist clinic in Taiwan usually employ acupressure/acupuncture in their clinical caseload? If they do not practice acupuncture/acupressure, i would question how easily this study could be replicated in the UK, as acupressure may well be a treatment tool that a UK physiotherapist would use in the treatment of back pain.

I believe that acupuncture is an extremely useful treatment technique, but it should not be used exclusively of other physiotherapeutic techniques. Acupressure/Acupuncture as employed by physiotherapists in combination with other traditional techniques can be more powerful than either would be independently. This would certainly be an interesting further area for research, but would be country specific.

I await your comments with interest.

Many Thanks,

Andrew Walker BSc (Hons) MCSP

Ref:

1)AACP (2006) Accupuncture association of Chartered Phsyiotherapists. <http://www.aacp.uk.com/>

Competing interests: None declared

A patients view 24 February 2006
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John Madura,
Patient
08859

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Re: A patients view

The study and responses raise valid points. As a long term back pain patient, I continue to search for relief from pain. Over the last 11 years, I have repeatedly turned to physical therapists and Bio-feedback techniques for help rather than just take more medicines. In every case these techniques helped with varying degrees of relief retention. The skill and background of the therapist has a great deal to do with the results - some see repeated returns as a waste of their time whereas others are more comitted to helping. The ultimate problem is that continuing pain is poorly understood by all concerned and the inability to maintain sufferable levels does indeed effect the state of mind. I believe that once you and your medical team reach some level of trust- understanding, that the depressing aspects lessen.

Another reason for depression is the never ending requirement (at least in the U.S) to get new prescriptions monthly as refills are not allowed by law. This ties us down and imposes sometimes difficult restrictions that add to the problem. In the end I schedule my future around the rx cycle.

Competing interests: None declared

Re: Variability in physical therapy between countries 27 February 2006
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Tony Hsiu-Hsi Chen,
Professor
Institute of Preventive Medicine, National Taiwan Uni., Taipei 100

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Re: Re: Variability in physical therapy between countries

Dear Dr Walker,

Thank you for your comments on heterogeneity of clinical skills and treatment techniques related to low back pain across countries and your proposal for a perspective research area on the combined treatment with physical therapy and acupuncture/acupressure.

Your point on heterogeneity of treatment modalities for chronic low back pain (LBP) is very realistic. As a matter of fact, such variation may be observed not only across countries but also between different institutions in the same country. This point is exactly one of our motivations to do randomized trials for testing the efficacy of acupressure given variation as a result of different therapists and different characteristics of patients. This point has a significant clinical implication for the application of Western medicine /alternative medicine to LBP in countries where Western medicine and alternative medicine such as acupuncture and acupressure are potentially intermingled.

Different cultures in different areas may lead to heterogeneous clinical skills and treatments. In Asian countries like Taiwan, I think in addition to conventional physical therapy, alternative medicine such as acupuncture/acupressure is popular and accepted by folk people. Some Taiwanese people or physicians specialized in Chinese/alternative medicine have deep-rooted belief or a liking for seeking or using alternative medicine only and do not want take regular conventional therapy. The extreme case can be found in patients who had been diagnosed as liver cancer but only sought alternative medicine such as herbal medicine or mixed with Western medication. Similar situations were seen in chronic LBP treated with physical therapy or alternative medicine (acupuncture/acupressure) or both. As seen in China (Hesketh et al, BMJ 1997;315:115-117), there are two separate medical systems in Taiwan as well: Western medication and Chinese medication. The recent payment system of national health insurance was also distinct for two separate medical systems. In the past, it may not be practiced in orthopaedic specialist but in other settings characterized with alternative medicine. However, it has increasingly gained attention and has been gradually incorporated to become part of a single and independent entity in orthopaedic clinics in our health care system. Any medical practitioner is not allowed to practice both and only one can be chosen. However, technique skill and clinical treatment for LBP in our country is still fraught with variation and has been barely proved by evidence-based principle, particularly with randomized controlled trial. As different cultures and health beliefs may lead to different scenarios for the study, the comparison with randomized controlled design between acupressure and physical therapy. However, I think this design may be unnecessary for the country where physical therapy has become the mainstay and indispensable.

The viewpoint of combined therapy may also have a significant implication for the evolution of treatment pattern for LBP in different countries. Our emphasis on this article is by no means intended to replace or look down upon physical therapy, the mainstay for treating physical therapy and already known as an effective method for relieving LBP pain, or to suggest using acupressure exclusively. Instead, we give acupressure a challenge using a randomized trial. Following evidence-based principle and considering the ethical viewpoint, we have no choice but select the group receiving conventional physical therapy group as the comparison group because it is unethical to take people without treatment as the control group. Although our article concluded acupressure is more effective but it does not mean the same results would be anticipated if a similar trial is conducted in other places or therapists because the outcome still depends on the technique skill and variation of patients. As pointed out in our discussion, the use of a single therapist in our study may reduce internal validity but external application is still very limited. Whether acupressure can be standardized and performed well still varies from place to place. Since physical therapy has been demonstrated to be effective and is the mainstay treatment for LBP in the country such as USA and UK. There is no reason to dispense with this conventional therapy in countries where the majority of people has been accustomed to Orthodox medicine. Instead, the comparison between combined therapy and physical therapy as suggested should be addressed. To the great delight, the developed country like UK has already incorporated alternative medicine as adjunct therapy. From the patient perspective, we do hope Chinese people or providers who were impregnated with alternative medicine can also embrace effective Western medicine in the future in order to relieve pain from patients. After all, different therapies have their own merits. It is like coins used with different styles in different countries but having one character in common i.e."Head" and "Tail", corresponding to Western medicine and Chinese medicine, respectively. We have to own both sides of coin instead of only one side if it is useful for commercial interest. Doing so may really render patients receive more benefit compared with single and separate therapy. However, different cultures, beliefs, and health care systems may make things complicated and hard to reach consensus. We are therefore looking forward to seeing the perspective of maximizing the benefit for patients given the combined therapy covering conventional physical therapy, acupuncture/acupressure, cognitive re-structuring and bio-feed back, massage and other possible effective modalities. However, the optimal modalities may vary from country to country and need to have evidence-based data to support given the variability of different treatment modalities in different countries. Given scarce resources and increased demand for treatment, economic evaluation including quality of life of patients with LBP may also be required.

Tony Hsiu-Hsi Chen

Ref: 1) Hesketh T, Zhu WX. Health in China. Traditional Chinese medicine: one country, two systems. BMJ 315:115-7,1997.

Competing interests: None declared

Re: Re: Accupressure & Physical Therapy Design Flaw 27 February 2006
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Douglas M. White,
Doctor of Physical Therapy - Private Practice
191 Blue Hills Pkwy, Milton, MA USA 02186

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Re: Re: Re: Accupressure & Physical Therapy Design Flaw

Professor Chen:

Thank you for your response. I would be appreciative if you could clarify the methodology used in the study. Am I correct in that your design involved a cohort of subjects with chronic low back pain and that cohort had a previous trial of physical therapy (PT) prior to the study? Is it also correct that the previous trial of PT did not resolve their low back pain which is why they presented to the clinic for further treatment and were subsequently enrolled in your study?

If this is correct then I would offer the following comments:

To repeat PT for one cohort who had already a course of PT is at least a confounding variable. There is also the element of a Hawthorne effect. Repeating a treatment that has already been shown not to be beneficial is a major limitation to any study. It is logical to presume that if the first course of PT had been successful then the study participants would not have sought further treatment at the clinic where they were subsequently enrolled in the study. If the first course of PT was unsuccessful then the likelihood of a second course of PT being successful is remote.

To accurately compare PT and acupressure for individuals with chronic low back pain then the cohorts should not have prior experience with the two variables. That is not to say they cannot have had some other type of treatment such as medication or home exercise. If the study methodology is as I have described above then the study is biased in favor of acupressure and the discussion and conclusion should appropriately reflect this limitation in study design.

The specific PT interventions described in the study appear to have been individualized and decided by the physical therapist. There does not appear to be standardization of PT interventions across the cohort. Thus generalized statements as to the effectiveness of PT cannot be made nor can generalized statements as to the effectiveness of acupressure as compared to PT for individuals with chronic low back pain be made unless the PT is standardized. As noted by another respondent acupressure is a PT intervention. Given the variability of the PT interventions it would not be possible to replicate the study.

Competing interests: None declared

Re: Re: Re: Accupressure & Physical Therapy Design Flaw 2 March 2006
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Tony Hsiu-Hsi Chen,
Professor
Institute of Preventive Medicine, National Taiwan University, Taipei 100

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Re: Re: Re: Re: Accupressure & Physical Therapy Design Flaw

Dear Dr. White,

Thank you for your further enquiry. It is a pity that you misunderstand the background about the enrollment of study subjects in our study. Your question arise form your imaginative scenario rather than ours. The characteristics and enrollment process of our study subjects are not like your description. The following is my reply.

1. (Q) "Am I correct in that your design involved a cohort... with chronic pain?"

(A) Incorrect. I think you imagine the enrollment of study subjects in our study as cohort membership in the same clinics/hospital as perhaps seen in your private medical system. In our health care system, patients are free to visit any clinical/hospital for treatment. Patients may see different clinics/hospitals due to different episodes. It is therefore very difficult to enroll a cohort of subject with chronic LBP and that cohort had a previous trial of physical therapy in the same clinics before study. Study subjects selected into our study attended our study hospital at their discretion. Your description on our disproportional selection of failure therapy through repeated visits in the same cohort is therefore not correct. When you wrote e-mail to ask me about the question of "satisfaction with care" in Table 3, which actually is an optional question in core set developed by Deyo et al rather than our own developed question (see Deyo 1998 Spine) we gave you a reply with physical therapy because the mainstay treatment for LBP in most orthopaedic clinics in Taiwan is physical therapy. This does not mean they received physical therapy in the same hospital/clinic like a cohort. One may be concerned about selection bias caused by previous treatment history. To do objective evaluation, we therefore applied a randomized controlled trial, which has been regarded as the best method to avoid the selection bias (Roberts and Torgerson, BMJ, 1998).

2. (Q) "Is it also correct that the previous trial of PT did not resolve .......further treatment and were subsequently enrolled in your study"

(A) Incorrect. I have already answered this question in earlier response. Following the answer in question 1, the second argument is evidently not correct. From clinical viewpoint, this point even for the enrollment of subjects with the same cohort is also not adequate. For patients with chronic LBP it is frequently for them to have new episode or recurrence of LBP, prompting them to visit clinic. Note that chronic LBP is a recurrent chronic disease. Cure for patients with current episode does not guarantee no episode at all afterward. How does one define "success" or "failure"? Please read the rapid response in the accompanying series, a patient who has already 11 years of chronic LBP and she describe physical therapy help her. If you define this case as failure then the real reason according to her description is nothing to do with physical therapy but the aspect of depression due to pain. That's why our study subjects were targeted at chronic LBP more than four months because this group constitute of the majority of LBP in need of effective treatment.

Reference:

Roberts C, Torgerson D. Understanding controlled trials. Randomisation methods in controlled trials. BMJ 1998; 317:1301.

Competing interests: None declared

No standard PT treatment 29 June 2006
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Eric Allen,
PT, SCS, ATC, CSCS
Hammond Henry Hospital, Geneseo, IL 62154

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Re: No standard PT treatment

I notice that the PT intervention is described as follows: "The participants in the physical therapy group received the routine physical therapy offered by the orthopaedic specialist clinic, including pelvic manual traction, spinal manipulation, thermotherapy, infrared light therapy, electrical stimulation, and exercise therapy, as decided by the physical therapist." This is problematic siimply because the study variable becomes the individual therapist and treatment choice rather than any specific modality. The therapist could have chosen simply electrical stimulation, which in most cases would be less than the standard of care. I understand the difficulty in creating a method to study outcomes by using only one treatment, but the conclusions drawn certainly do not consider that the outcomes are more related to the therapist and the therapist treatment choices than "physical therapy" in general.

Competing interests: None declared

US Validation of Treatment Program 19 September 2006
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Randolph J Wagner,
Management
USA 20886

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Re: US Validation of Treatment Program

VIA ELECTRONIC MAIL AT WWW.BMJ.BMJJOURNALS.COM

Dear Sir or Madam,

After receiving some very beneficial treatment in acupressure, my wife and I decided to research the responses of those in the medical community towards this alternative method for treatment towards certain illnesses and physical pain. For your reference, I am a former United States Army Captain and graduate of the United States Military Academy at West Point, who suffered severe lower back and knee injury during my military service. I have tried numerous treatments from physical therapy, surgery, chiropractics, diet and lifestyle changes, to appropriate pain medications all of which produced relative results with negligible long term benefits.

We recently consulted with Hsieh, senior therapist and co-author of “Treatment of low back pain by acupressure and physical therapy: randomized controlled trial.” One of the primary reasons we visited with her was due to her complementary knowledge in Western medicine. She is also a medical doctor who specializes in both the Neurology and Internal Medicine Departments at Kaohsiung, Taiwan. And after receiving a concentrated series of acupressure from this senior therapist – twice daily for a period of ten days – I honestly feel a significant amount of pain relief and mobility in both my lower back and knees. In fact, the treatment occurred over two months ago, and I still feel a significant improvement from my original condition.

I am concerned over the questions posed in an Editorial from March 25, 2006 entitled, “Acupressure for low back pain: promising but not proved” by Helen Frost and Sarah Stewart-Brown. Although a healthy amount of skepticism encourages claimants to produce even more conclusive evidence to support their positions, I feel many of the questions posed are naïve, from someone who has very little understanding of oriental medicine and the Orient in general.

Frost questions the validity of the results by suggesting that if the success rate was as high and Hsieh purports, then why aren’t more Chinese medicine clinicians using acupressure over acupuncture? I feel there is a simple sociological explanation for this – as I am sure we can all agree, individuals are frequently reluctant to engage in change. It is quite possible that there are many clinicians practicing acupressure successfully – although most of which do not possess the knowledge or ability, or feel compelled to conduct randomized clinical trials such as Hsieh.

Frost also questions the validation of patients using the English language to describe their outcomes after treatment. Hsieh explained in detail the data compiled from her trial during my treatments and I found that these surveys were conducted in Mandarin (the main language in Taiwan); and then translated by one group of professional translators from Mandarin to English to ensure consistency. I assume Frost is insinuating that the Taiwanese patients and those conducting the trials lack the ability to properly understand and/or translate the surveys provided?

What about the cost effectiveness of acupressure over physical therapy? Physical therapy in the United States is entangled in our less than efficient healthcare system. And I have received physical therapy in the price range of $50-$150 USD per treatment for an average of three times a week for six weeks. The acupressure as mentioned in the study only requires six sessions (such sessions would have a general price range of $30 USD per treatment, although the study was conducted at no charge) for a period of one month.

We had no expectations, just some general skepticism, when we entered into this treatment with Hsieh because we have used Western medicine (sometimes supplemented with acupuncture) with little success. We are only pleasantly surprised and relieved by the amount of pain alleviated after treatment. My wife and I both agree that we are some of the fortunate few whom have received the specific acupressure treatment referenced by Hsieh. This limitation is largely due to logistics – as the senior therapist and orthopedic clinic both have a domicile in Kaohsiung, Taiwan. However, the fact that few residents in the United States and/or Europe have benefited from these treatments does not invalidate or diminish the tremendous success of this form of acupressure.

We do, however, agree with one point raised by Frost; that is, we need to know and locate those practitioners (Chinese or otherwise) who can achieve this level of success by acupressure. However, we strongly feel that Hsieh’s treatments are amplified because of her unique ability to provide a medical diagnosis and prognosis to the symptoms identified during her acupressure treatments – which should be fostered and encouraged by the medical community. We would ask that your community, rather than publish editorials which raise questions substantiated by little research and understanding for the oriental culture, encourage therapists such as Hsieh to effectively train practitioners so that we can have more researchers, therapists, publications, etc…in support of this highly effective means of alleviating physical pain and illness.

Very Truly Yours,

Mr. Randolph J Wagner, MBA, PMP Mrs. Jean Wagner, JD 12301 Falls Road Potomac, MD 20854

Competing interests: None declared

Comment regarding responses 30 June 2007
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Jay Defigh,
Spanish Interpreter
Home, 97232

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Re: Comment regarding responses

I have read over this thread, and I find the comments made by Tony Hsiu-Hsi Chen to be extremely biased. He obviously did not understand fully the statements made by Mr. White and thus did not address their implications. While he addressed the fact that the patients in the study did not receive care at the same facility (or would be difficult to determine), he made no mention of the major point Mt. White made: namely, that the patients had undertaken prior physical therapy-- and were perhaps treated with the same modalities in the study. If it did not work the first time, it probably won't the second time? It is a pity that Dr. Chen misses this obvoius point. This represents, in my mind, a major design flaw.

I do recognize your point, Dr. Chen, that you wanted to investigate treatment outcomes on those with chronic back pain, and precisely those patients would have most likely already undergone PT of some kind. However, at the very least, this issue (stated above) should have been acknowledged in your study.

In addition, the point raised by Mr. Allen is also a valid one. You did not standardize the control group treatment. Hello? Of course different patients may require different modalities based on presenting symptoms and signs. However, if you are to leave the treatment to the discretion of the therapist, then your control group is really not a control group at all. A better idea would be to recruit patients who require the same PT treatment, and use them as your control group.

Please learn to design a study better before conducting one.

Performing a study in this manner really serves no good, in my mind, as both sides (pro-acupressure and against acupressure) will silmultaneously arrive at opposite conclusions. You confuse the average person, perpetuate sub-par science, and do a disservice to the modality you are examining.

Competing interests: None declared