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HealthTronics et al respond to negative ESWT study in JAMA

Posted by Scott R on 1/07/03 at 18:01 (105048)

Here are letters to the editor of JAMA concerning the anti-ESWT article published some months ago:
http://jama.ama-assn.org/issues/v289n2/ffull/jlt0108-1.html

Re: tsk, tsk -- can't we just stick to the facts

Ed Davis, DPM on 1/07/03 at 23:12 (105074)

Scott:
It was a needed response. But why didn't the authors stick to the facts of the matter instead of an attempt to bash their low energy competitors. The study was flawed not because it used low energy but because the number of shocks provided was inadequate and because half of the study participants did not meet basic criterion for inclusion in most studies. Again, I use both low and high energy and welcome legitimate debate, comparing efficacies.
Ed

Re: tsk, tsk -- can't we just stick to the facts

Dr. Z on 1/08/03 at 06:03 (105083)

What scares me is that JAPMA is a well respected journal. There are many topics in this journal that are just not in my field of expertise but I read and assume that they are all quality studies by MD's. Knowing what I know about ESWT and reading this article I wonder how many other articles were written that are just done wrong and written for maybe other reason . I am going to have a totally different attitude with all journals that I read including our own.

Re: tsk, tsk -- can't we just stick to the facts

Scott R on 1/08/03 at 13:58 (105104)

I've known medical journals are 80% trash after first reading about heel pain years ago. Engineering and scientific journals wouldn't publish 95% of what gets published in medical journals. Every other sentence in many medical journals are claims without proof and the other half of the sentences use references that are also based on 50% speculation. 'More art than science' describes medicine well. Sometimes articles can be entirely factual and yet completely miss the mark. Here's an example ( my reviwe of another JAMA article, this time about vitamin C)
http://heelspurs.com/levine.htm

Re: tsk, tsk -- can't we just stick to the facts

Ed Davis, DPM on 1/08/03 at 14:41 (105105)

Dr. Z:

You are right in that a well respected journal should have a sufficiently high level of quality to maintain that respect. This area is 'new' enough that this one 'got away' from the editors. I would feel better if that journal could self-critique and acknowledge the error.

Readers of journals need to do more than reading just the abstracts but need to study the entire articles including the methodology used in the studies.
Ed

Re: tsk, tsk -- can't we just stick to the facts

Ed Davis, DPM on 1/08/03 at 14:50 (105106)

Scott:

Unfortunately, you are so right. It seems that those dealing in the pure sciences uphold a higher standard than those in the applied sciences.
The examples are too numerous to list. An interesting contraversy is the one concerning aspartame with 96% of the studies funded by the manufacturer being favorable and the majority of studies not funded by the manufacturer showing problems.

I place a lot of weight on the collective experiences of physicians, including my own experiences as we can share information based on the treatment of thousands of patients.
Ed

Re: Buchbinder's reply

BrianG on 1/08/03 at 16:38 (105115)

I think people should read these letter for what they are: 'Letters to the editor'. They are not scientific papers by any means. I've also included the 'response' leter from the people who ran the trials. I think it's important that everyone can see that the other side had a chance to defend himself / herself. I'm not saying the letters are right, or wrong, just that they are only 'letters to the editor'.

BrianG

In Reply: We agree with Dr Wheelock that the negative results of our trial do not rule out the possibility that other modes of delivery of ESWT may or may not be efficacious for this condition. In particular, our study does not provide any data about the efficacy of single-dose high-energy ESWT. However, the mean total dose that the active group received was 1401.7 mJ/mm2, which is higher than the 1300 mJ/mm2 total dose delivered to patients in the active groups of both previous trials of single-dose high-energy ESWT.1, 2 In our trial, the device energy was increased to the highest tolerable level of pain in the active group, aiming for a total dose of >1000 mJ/mm2, and, as we reported, our results were consistent irrespective of total dose of ESWT received. The same procedure was simulated in the placebo group.
We strongly disagree with Dr Theodore that the results of our study are a disservice to the future development of ESWT for the treatment of orthopedic conditions. On the contrary, the negative results of our trial highlight the need to determine the true value of therapeutic interventions by methodologically sound randomized clinical trials. The positive anecdotal experiences of Dr Miller are consistent with the results of our trialparticipants in both the active and placebo groups improved over time. Such clinical observations may be explained by placebo effects or by the self-limiting nature of the condition and serve to emphasize that without a control group it is not possible to definitely attribute any improvement over time to a specific intervention.
An experienced ESW therapist, who was very familiar with the technology, gave all treatments in our trial. In the absence of a requirement for local or regional anesthesia, this confirms that no specific medical skills are required. The shock wave focus was directed to the thickest portion of the plantar fascia in the region of the tendon abnormality. In our experience this is virtually always the point of maximal tenderness. In contrast, single-dose high-energy ESWT is blindly performed under regional or local anesthesia. Thus, it may not be possible to verify that treatment is specifically and continually directed at the predetermined point of maximal pain.
Wheelock asserts that our study supports observations that different physical characteristics of shock waves may produce significant different effects in human tissues. We wish to point out that our trial provides no comparative information whatsoever concerning the efficacy of one type of shock wave generation over another (active) type. As Ogden et al have recently noted, there are no published comparative data for musculoskeletal applications of shock wave therapy.3 Any theoretical differences are therefore speculative at present and need to be confirmed (or refuted) in head-to-head clinical trials.
 
Rachelle Buchbinder, MBBS, FRACP, MSc
Department of Clinical Epidemiology at Cabrini Hospital and Department of Epidemiology and Preventive Medicine
Andrew Forbes, PhD
Department of Epidemiology and Preventive Medicine
Monash University
Melbourne, Australia
Ronnie Ptasznik, MBBS, FRANZCR
Radiology Department
Latrobe University Medical Centre
Melbourne
 
 
1. Ogden JA, Alvarez R, Levitt R, Cross GL, Marlow M. Shock wave therapy for chronic proximal plantar fasciitis. Clin Orthop. 2001;387:47-59. MEDLINE
2. Dornier MedTech Inc. Dornier EposTM Ultra: Summary of Safety and Effectiveness Data. Kennesaw, Ga: Dornier MedTech Inc; 2002.
3. Ogden J, Alvarez R, Marlow M. Shockwave therapy for chronic proximal plantar fasciitis: a meta-analysis. Foot Ankle Int. 2002;23:301-308. MEDLINE
 
 
Letters Information  
 
Guidelines for Letters
 
 
Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor

Re: tsk, tsk -- can't we just stick to the facts

Carole C in NOLA on 1/11/03 at 08:18 (105245)

What I really hate are the articles in medical journals (even ones with good reputations) concerning multiple sclerosis. By its nature, MS is a condition that involves numerous remissions for no apparent reason at all, that often last from months to years. Thus if a treatment seems to work, it's not always clear if the improvement was due to the treatment or would have happened in any case. It seems only logical that because of this, a LOT of patients should be involved in any trial or study of a new treatment for MS.

And yet, most/many such studies involve not 1000 or 2000 patients, but fewer than 500 patients, and often fewer than 100 patients. My daughter used more bean sprouts than that in her fourth grade science fair project (and didn't win).

MS patients are NOT that hard to find. Anybody who says so is full of baloney. Nobody seems to attempt to contact MS patients either directly or indirectly for studies; the patients have to search them out. MS is no longer as rare a disease as in the past; everybody and his brother is getting diagnosed with MS now that MRI's are easily available. I think the continued publication of studies using (for example) 30-40 patients and trying to justify that practice statistically, is unconscionable.

Obviously I'm the only person on the face of the earth that thinks this, but I do.

Carole C

Re: more on the same pet peeve

Carole C in NOLA on 1/11/03 at 08:30 (105246)

Because of these poorly conceived studies, MS patients are treated to headlines about once a year, 'New Treatment Holds Promise for MS Patients'. After getting one's hopes up a dozen times or so, the tendency is to ignore such news releases.

This is the real tragedy... if a treatment is found that actually DOES work well and consistently, a lot of MS patients will not seek it out because they've seen it all before, again and again.

A lot of these studies seem to be motivated by greed, rather than by humanitarian considerations.

Carole C

Re: Buchbinder's reply

Bill on 1/11/03 at 09:00 (105249)

I don't understand is how they gave an average of 1401.7 mJ/mm2 to the treated patients without the treated patients feeling pain.

Looking at the numbers, they performed a total of 6000 shocks over three treatments. The average energy per shock was .23 mJ/mm2. This corresponds to a setting that is greater than level 5. In order to reach 1401 mJ/mm2 the treatments must have been on level 5 or 6 for most of the shocks.

Both of those levels are very painful. They need to explain how patients tolerated high energy without pain! They need to explain why the treated patients did not guess that they were receiving a treatment.

Dr Z. Based on your experience, would your patients feel pain if you
gave 6000 shocks at level 5 & 6 without a local?

Th Buchbinder results just don't make sense. 6000 shocks on level 5 & 6,
no pain, complete blinding. It just doesn't work.

Re: Buchbinder's reply

Dr. Z on 1/12/03 at 20:36 (105326)

Very good point.. There is no way that someone could take level 5-6 on the dornier with that amount of pulses. I agree that they don't make sense
I am going to read the original

Re: Buchbinder's reply

Don Scott on 1/13/03 at 03:00 (105334)

To All,
It will be interesting to see what result she puts forward with her trial on lateral elbow ESWT.

Don Scott
Australia

P.S. If any of the Podiatrist out there want to get together and pool their ideas on a protocol for treatment form my e-mail is (email removed)

Re: Buchbinder's reply

john h on 1/13/03 at 11:29 (105355)

Based on my personal exprience with the Orby which is a relative or mid range energy machine I had little to no pain after the first three shocks at a setting between 16-18. I either had 1500 or 3000 per foot. Dr. Z will remember that No shots.

Question: Did Healthtronics sort of create their own high cost problem by bringing their machine to the FDA with a hospital protocol? Does the manufacturer have a choice on what the protocol will be for what ever equipment they bring to FDA? Could they not go back to FDA and have testing done with the Ossatron performed in office?

Re: tsk, tsk -- can't we just stick to the facts

john h on 1/13/03 at 17:23 (105399)

Scott: Medicine is an art. Engineering/Math are not nearly so theoratical except when we get into some theoratical time space physics. I am sort of preaching to the choir here am I not. Those docs have got to publish or perish just like everyone in academia.

Re: tsk, tsk -- can't we just stick to the facts

Ed Davis, DPM on 1/07/03 at 23:12 (105074)

Scott:
It was a needed response. But why didn't the authors stick to the facts of the matter instead of an attempt to bash their low energy competitors. The study was flawed not because it used low energy but because the number of shocks provided was inadequate and because half of the study participants did not meet basic criterion for inclusion in most studies. Again, I use both low and high energy and welcome legitimate debate, comparing efficacies.
Ed

Re: tsk, tsk -- can't we just stick to the facts

Dr. Z on 1/08/03 at 06:03 (105083)

What scares me is that JAPMA is a well respected journal. There are many topics in this journal that are just not in my field of expertise but I read and assume that they are all quality studies by MD's. Knowing what I know about ESWT and reading this article I wonder how many other articles were written that are just done wrong and written for maybe other reason . I am going to have a totally different attitude with all journals that I read including our own.

Re: tsk, tsk -- can't we just stick to the facts

Scott R on 1/08/03 at 13:58 (105104)

I've known medical journals are 80% trash after first reading about heel pain years ago. Engineering and scientific journals wouldn't publish 95% of what gets published in medical journals. Every other sentence in many medical journals are claims without proof and the other half of the sentences use references that are also based on 50% speculation. 'More art than science' describes medicine well. Sometimes articles can be entirely factual and yet completely miss the mark. Here's an example ( my reviwe of another JAMA article, this time about vitamin C)
http://heelspurs.com/levine.htm

Re: tsk, tsk -- can't we just stick to the facts

Ed Davis, DPM on 1/08/03 at 14:41 (105105)

Dr. Z:

You are right in that a well respected journal should have a sufficiently high level of quality to maintain that respect. This area is 'new' enough that this one 'got away' from the editors. I would feel better if that journal could self-critique and acknowledge the error.

Readers of journals need to do more than reading just the abstracts but need to study the entire articles including the methodology used in the studies.
Ed

Re: tsk, tsk -- can't we just stick to the facts

Ed Davis, DPM on 1/08/03 at 14:50 (105106)

Scott:

Unfortunately, you are so right. It seems that those dealing in the pure sciences uphold a higher standard than those in the applied sciences.
The examples are too numerous to list. An interesting contraversy is the one concerning aspartame with 96% of the studies funded by the manufacturer being favorable and the majority of studies not funded by the manufacturer showing problems.

I place a lot of weight on the collective experiences of physicians, including my own experiences as we can share information based on the treatment of thousands of patients.
Ed

Re: Buchbinder's reply

BrianG on 1/08/03 at 16:38 (105115)

I think people should read these letter for what they are: 'Letters to the editor'. They are not scientific papers by any means. I've also included the 'response' leter from the people who ran the trials. I think it's important that everyone can see that the other side had a chance to defend himself / herself. I'm not saying the letters are right, or wrong, just that they are only 'letters to the editor'.

BrianG

In Reply: We agree with Dr Wheelock that the negative results of our trial do not rule out the possibility that other modes of delivery of ESWT may or may not be efficacious for this condition. In particular, our study does not provide any data about the efficacy of single-dose high-energy ESWT. However, the mean total dose that the active group received was 1401.7 mJ/mm2, which is higher than the 1300 mJ/mm2 total dose delivered to patients in the active groups of both previous trials of single-dose high-energy ESWT.1, 2 In our trial, the device energy was increased to the highest tolerable level of pain in the active group, aiming for a total dose of >1000 mJ/mm2, and, as we reported, our results were consistent irrespective of total dose of ESWT received. The same procedure was simulated in the placebo group.
We strongly disagree with Dr Theodore that the results of our study are a disservice to the future development of ESWT for the treatment of orthopedic conditions. On the contrary, the negative results of our trial highlight the need to determine the true value of therapeutic interventions by methodologically sound randomized clinical trials. The positive anecdotal experiences of Dr Miller are consistent with the results of our trialparticipants in both the active and placebo groups improved over time. Such clinical observations may be explained by placebo effects or by the self-limiting nature of the condition and serve to emphasize that without a control group it is not possible to definitely attribute any improvement over time to a specific intervention.
An experienced ESW therapist, who was very familiar with the technology, gave all treatments in our trial. In the absence of a requirement for local or regional anesthesia, this confirms that no specific medical skills are required. The shock wave focus was directed to the thickest portion of the plantar fascia in the region of the tendon abnormality. In our experience this is virtually always the point of maximal tenderness. In contrast, single-dose high-energy ESWT is blindly performed under regional or local anesthesia. Thus, it may not be possible to verify that treatment is specifically and continually directed at the predetermined point of maximal pain.
Wheelock asserts that our study supports observations that different physical characteristics of shock waves may produce significant different effects in human tissues. We wish to point out that our trial provides no comparative information whatsoever concerning the efficacy of one type of shock wave generation over another (active) type. As Ogden et al have recently noted, there are no published comparative data for musculoskeletal applications of shock wave therapy.3 Any theoretical differences are therefore speculative at present and need to be confirmed (or refuted) in head-to-head clinical trials.
 
Rachelle Buchbinder, MBBS, FRACP, MSc
Department of Clinical Epidemiology at Cabrini Hospital and Department of Epidemiology and Preventive Medicine
Andrew Forbes, PhD
Department of Epidemiology and Preventive Medicine
Monash University
Melbourne, Australia
Ronnie Ptasznik, MBBS, FRANZCR
Radiology Department
Latrobe University Medical Centre
Melbourne
 
 
1. Ogden JA, Alvarez R, Levitt R, Cross GL, Marlow M. Shock wave therapy for chronic proximal plantar fasciitis. Clin Orthop. 2001;387:47-59. MEDLINE
2. Dornier MedTech Inc. Dornier EposTM Ultra: Summary of Safety and Effectiveness Data. Kennesaw, Ga: Dornier MedTech Inc; 2002.
3. Ogden J, Alvarez R, Marlow M. Shockwave therapy for chronic proximal plantar fasciitis: a meta-analysis. Foot Ankle Int. 2002;23:301-308. MEDLINE
 
 
Letters Information  
 
Guidelines for Letters
 
 
Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor

Re: tsk, tsk -- can't we just stick to the facts

Carole C in NOLA on 1/11/03 at 08:18 (105245)

What I really hate are the articles in medical journals (even ones with good reputations) concerning multiple sclerosis. By its nature, MS is a condition that involves numerous remissions for no apparent reason at all, that often last from months to years. Thus if a treatment seems to work, it's not always clear if the improvement was due to the treatment or would have happened in any case. It seems only logical that because of this, a LOT of patients should be involved in any trial or study of a new treatment for MS.

And yet, most/many such studies involve not 1000 or 2000 patients, but fewer than 500 patients, and often fewer than 100 patients. My daughter used more bean sprouts than that in her fourth grade science fair project (and didn't win).

MS patients are NOT that hard to find. Anybody who says so is full of baloney. Nobody seems to attempt to contact MS patients either directly or indirectly for studies; the patients have to search them out. MS is no longer as rare a disease as in the past; everybody and his brother is getting diagnosed with MS now that MRI's are easily available. I think the continued publication of studies using (for example) 30-40 patients and trying to justify that practice statistically, is unconscionable.

Obviously I'm the only person on the face of the earth that thinks this, but I do.

Carole C

Re: more on the same pet peeve

Carole C in NOLA on 1/11/03 at 08:30 (105246)

Because of these poorly conceived studies, MS patients are treated to headlines about once a year, 'New Treatment Holds Promise for MS Patients'. After getting one's hopes up a dozen times or so, the tendency is to ignore such news releases.

This is the real tragedy... if a treatment is found that actually DOES work well and consistently, a lot of MS patients will not seek it out because they've seen it all before, again and again.

A lot of these studies seem to be motivated by greed, rather than by humanitarian considerations.

Carole C

Re: Buchbinder's reply

Bill on 1/11/03 at 09:00 (105249)

I don't understand is how they gave an average of 1401.7 mJ/mm2 to the treated patients without the treated patients feeling pain.

Looking at the numbers, they performed a total of 6000 shocks over three treatments. The average energy per shock was .23 mJ/mm2. This corresponds to a setting that is greater than level 5. In order to reach 1401 mJ/mm2 the treatments must have been on level 5 or 6 for most of the shocks.

Both of those levels are very painful. They need to explain how patients tolerated high energy without pain! They need to explain why the treated patients did not guess that they were receiving a treatment.

Dr Z. Based on your experience, would your patients feel pain if you
gave 6000 shocks at level 5 & 6 without a local?

Th Buchbinder results just don't make sense. 6000 shocks on level 5 & 6,
no pain, complete blinding. It just doesn't work.

Re: Buchbinder's reply

Dr. Z on 1/12/03 at 20:36 (105326)

Very good point.. There is no way that someone could take level 5-6 on the dornier with that amount of pulses. I agree that they don't make sense
I am going to read the original

Re: Buchbinder's reply

Don Scott on 1/13/03 at 03:00 (105334)

To All,
It will be interesting to see what result she puts forward with her trial on lateral elbow ESWT.

Don Scott
Australia

P.S. If any of the Podiatrist out there want to get together and pool their ideas on a protocol for treatment form my e-mail is (email removed)

Re: Buchbinder's reply

john h on 1/13/03 at 11:29 (105355)

Based on my personal exprience with the Orby which is a relative or mid range energy machine I had little to no pain after the first three shocks at a setting between 16-18. I either had 1500 or 3000 per foot. Dr. Z will remember that No shots.

Question: Did Healthtronics sort of create their own high cost problem by bringing their machine to the FDA with a hospital protocol? Does the manufacturer have a choice on what the protocol will be for what ever equipment they bring to FDA? Could they not go back to FDA and have testing done with the Ossatron performed in office?

Re: tsk, tsk -- can't we just stick to the facts

john h on 1/13/03 at 17:23 (105399)

Scott: Medicine is an art. Engineering/Math are not nearly so theoratical except when we get into some theoratical time space physics. I am sort of preaching to the choir here am I not. Those docs have got to publish or perish just like everyone in academia.