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Acupuncture appears to show results.
- Thread starter The Atheist
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Phytotherapist
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This is the reply I received from Prof. Facco on the 21st April 2008. I also had a long exchange of opinions with him. Here is his reply:
"Dear colleague, the criticism and discussion on our study is welcome and I'm pleased to answer, providing the information you asked for.
It seems to me that the comments may rise , at least partially, from some skepticism about acupuncture. I do believe that keeping a neutral stance is mandatory in the world of science, since both fideistic and skeptical stances, which have the same nature, may be a source of bias: both of them look like the two facets of the same medal, since they may favor an a priori position, increasing the risk of wrong judgement in a positive (fideistic) or negative (skeptical) way.
From the request, I received, it seems to me that the criticism includes contradictory elements and does not take into account the whole paper, but only focuses on a single aspect of methods. Of course, the item of blinding is essential, but a proper evaluation of the study calls for taking into account other relevant aspects, such as the problems of research in acupuncture (see Ceccherelli and Facco, as a review) and reappraising of the definition of the term "placebo".
Double blinding, as well as a truly inert placebo, can be performed with drug therapy only. Obviously, acupuncture does not allow double blinding, likewise surgery and behavioral therapies, but this is not a fault: one can partially overcome this problem by blinding who is charged for the data analysis (myself, as regards our study).
The aim of our study (for the first time in western literature, to my knoledge) was the attempt to merge Western Medicine and TMC in a whole, to check whether could be feasible studying TMC with the current scientific methods. The reason for such a choice was that too many papers dealing with acupuncture, used needles and acupoints without applying the TMC: it cannot be considered as true acupuncture, since it does ignore the diagnosis and appropriate treatment according to TMC, thus introducing a strong bias in the process of validation (or falsification) of acupuncture.
Understanding the meaning of results, besides checking methods, calls for a good knowledge of the topic: I believe that one may misunderstand the results of a scientific paper on pain and/or acupuncture, when pathophysiology of pain, its modulation in the CNS and the mechanisms of pain relief (both acupuncture and the so-called placebo) are not taken into account. Therefore, I shall provide the information you asked me for together with a few comments on placebo, hoping that they will provide some useful information:
1. The patients were randomized and allocated to each group using sealed envelopes.
2. The aim of the study was to check whether acupuncture according to TMC may be effective: it implied the use of a non scientific paradigm and a variable treatment according to TMC, which is not considered plausible by Western Medicine and, as a consequence, presumed to be meaningless. Since all the patients were administered a western attack treatment, they were not informed about true or mock acupuncture. They were informed that, according to different Chinese syndromes, they might have been submitted to a stronger or milder acupuncture treatment, the latter using a painless technique with superficial puncture (likewise abdominal acupuncture, a new almost painless technique). They were also informed that at the end of the treatment and follow-up (that is after T2), should they have no relief, they would have been submitted to re-evaluation of their migraine and a new treatment would have been administered accordingly, free of charge. In this way, no doubt about the type of applied acupuncture was introduced, while delivering an effective attack treatment to all patients and assuring a proper acupuncture treatment after placebo, if needed. Futhermore, the effects of mock acupuncture might not be easily told from those of Rizatriptan in the overall change of symptoms, contributing to the credibility of placebo. Thus, we do believe that patients were satisfactorilly blinded; futhermore there is no possibility of different credibility of RMA and SMA since they were performed in the same way; the only difference was in the more empathic, systemic approach according to the diagnostic process of TMC in group RMA, and the more standard , Western style of SMA. In our opinion, this was new relevant source of effects to be checked, related to different approach (and related changes of patient's feeling of being cared of and expectation), not to needles or acupoints.
3. We are aware that the study has some limitations, such as the lack of post-hoc analysis about placebo credibility: however, it was not possible since the patients ignored the placebo (the authors did not even know whether the TMC would have behaved better than placebo), but knew about different kinds of treatments according to TMC diagnosis.
4. Our main interest was to provide a preliminary estimate on the possibility of applying the paradigm of TMC, merging it with the scientific method, rather than showing which, if any, would be the best acupuncture treatment of migraine. This is a matter of futher study, which calls for facing the hard problem of fully understanding the Chinese classification and therapy of headache. This has been emphasized in this discussion.
The criticism to our study looks to me rather contradictory (perhaps I may have misunderstood the remarks) for the following reasons:
A. The significant effects of RMA on pain at T1, as a matter of facts, confirms the credibility of the mock acupuncture, despite it can be used by skeptics to claim to patients that TA is not effective.
B. The lack of effects of SMA, can lead skeptics to claim that patients were aware of placebo, but it was very unlikely, since needle applications was performed exactly in the same way as RMA.
C. The only difference between RMA and SMA was in the approach according to TMC, not in needle application: it allowed for checking whether TMC might provide a better feeling of being cared, thus improving patient's expectance and possible placebo effects.
D. The "placebo effect" of RMA was at T1 only (that is, at the end of treatment), but, unlike TA, these effects had dissapeared at the follow-up (T2).
E. The factorial ANOVA (taking into account group differences at any time) allowed to show that there is a specific significant effect of TA at T2: this is indeed specific effect of TA only, unrelated to placebo.
F. The significant effects of RMA at T1 do not allow for concluding that TA was ineffective; rather, they indicate that the overall effects of acupuncture, with its systemic approach, involve both specific, needle related effects, and subjective factors; in other words, acupuncture is much more than needles alone.
G. The conventioal concept of "placebo" may affect the criticism as well. In the discussion, I mentioned the concept of Iatroplacebogenesis: the real therapeutic potential of the so-called placebo is increasingly recognized in the literature of pain and its traditional, obsolete, meaning is no longer enough. The so-called placebo may account for both RMA and , partially, TA effects. Simply subtracting the true from placebo effects may be misleading, when dealing with non-pharmacological treatments, with the risk of taking the baby for the bath water. As fa as the problem of placebo is concerned, it is now time to deeply reappraise its definition, role and effects in order to avoid wrong conclusions.
Reference List:
1. Ceccherelli F. FAcco E: Methodological problems on acupuncture research in pain therapy. Capasso A (Ed.), Kerala, India., Research signpost, 2005, pp 217-28
2. Benedetti F: Placebo analgesia, Neurol. Sci, 2006; Suppl2: S100-S102
3. Diener HC: Placebo in headache trials, Cephalalgia 2003; 23:485-6
4. Kong J, Gollub RL, Rosman IS, Webb JM, Kirsch I, Kaptchuck TJ: Brain activity associated with expectancy-enhanced placebo analgesia as measured by functional magnetic resonance imaging. J Neurosci. 2006; 26: 381-8
5. PatersonC, Dieppe P: Characteristics and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005; 330: 1202-5"
"Dear colleague, the criticism and discussion on our study is welcome and I'm pleased to answer, providing the information you asked for.
It seems to me that the comments may rise , at least partially, from some skepticism about acupuncture. I do believe that keeping a neutral stance is mandatory in the world of science, since both fideistic and skeptical stances, which have the same nature, may be a source of bias: both of them look like the two facets of the same medal, since they may favor an a priori position, increasing the risk of wrong judgement in a positive (fideistic) or negative (skeptical) way.
From the request, I received, it seems to me that the criticism includes contradictory elements and does not take into account the whole paper, but only focuses on a single aspect of methods. Of course, the item of blinding is essential, but a proper evaluation of the study calls for taking into account other relevant aspects, such as the problems of research in acupuncture (see Ceccherelli and Facco, as a review) and reappraising of the definition of the term "placebo".
Double blinding, as well as a truly inert placebo, can be performed with drug therapy only. Obviously, acupuncture does not allow double blinding, likewise surgery and behavioral therapies, but this is not a fault: one can partially overcome this problem by blinding who is charged for the data analysis (myself, as regards our study).
The aim of our study (for the first time in western literature, to my knoledge) was the attempt to merge Western Medicine and TMC in a whole, to check whether could be feasible studying TMC with the current scientific methods. The reason for such a choice was that too many papers dealing with acupuncture, used needles and acupoints without applying the TMC: it cannot be considered as true acupuncture, since it does ignore the diagnosis and appropriate treatment according to TMC, thus introducing a strong bias in the process of validation (or falsification) of acupuncture.
Understanding the meaning of results, besides checking methods, calls for a good knowledge of the topic: I believe that one may misunderstand the results of a scientific paper on pain and/or acupuncture, when pathophysiology of pain, its modulation in the CNS and the mechanisms of pain relief (both acupuncture and the so-called placebo) are not taken into account. Therefore, I shall provide the information you asked me for together with a few comments on placebo, hoping that they will provide some useful information:
1. The patients were randomized and allocated to each group using sealed envelopes.
2. The aim of the study was to check whether acupuncture according to TMC may be effective: it implied the use of a non scientific paradigm and a variable treatment according to TMC, which is not considered plausible by Western Medicine and, as a consequence, presumed to be meaningless. Since all the patients were administered a western attack treatment, they were not informed about true or mock acupuncture. They were informed that, according to different Chinese syndromes, they might have been submitted to a stronger or milder acupuncture treatment, the latter using a painless technique with superficial puncture (likewise abdominal acupuncture, a new almost painless technique). They were also informed that at the end of the treatment and follow-up (that is after T2), should they have no relief, they would have been submitted to re-evaluation of their migraine and a new treatment would have been administered accordingly, free of charge. In this way, no doubt about the type of applied acupuncture was introduced, while delivering an effective attack treatment to all patients and assuring a proper acupuncture treatment after placebo, if needed. Futhermore, the effects of mock acupuncture might not be easily told from those of Rizatriptan in the overall change of symptoms, contributing to the credibility of placebo. Thus, we do believe that patients were satisfactorilly blinded; futhermore there is no possibility of different credibility of RMA and SMA since they were performed in the same way; the only difference was in the more empathic, systemic approach according to the diagnostic process of TMC in group RMA, and the more standard , Western style of SMA. In our opinion, this was new relevant source of effects to be checked, related to different approach (and related changes of patient's feeling of being cared of and expectation), not to needles or acupoints.
3. We are aware that the study has some limitations, such as the lack of post-hoc analysis about placebo credibility: however, it was not possible since the patients ignored the placebo (the authors did not even know whether the TMC would have behaved better than placebo), but knew about different kinds of treatments according to TMC diagnosis.
4. Our main interest was to provide a preliminary estimate on the possibility of applying the paradigm of TMC, merging it with the scientific method, rather than showing which, if any, would be the best acupuncture treatment of migraine. This is a matter of futher study, which calls for facing the hard problem of fully understanding the Chinese classification and therapy of headache. This has been emphasized in this discussion.
The criticism to our study looks to me rather contradictory (perhaps I may have misunderstood the remarks) for the following reasons:
A. The significant effects of RMA on pain at T1, as a matter of facts, confirms the credibility of the mock acupuncture, despite it can be used by skeptics to claim to patients that TA is not effective.
B. The lack of effects of SMA, can lead skeptics to claim that patients were aware of placebo, but it was very unlikely, since needle applications was performed exactly in the same way as RMA.
C. The only difference between RMA and SMA was in the approach according to TMC, not in needle application: it allowed for checking whether TMC might provide a better feeling of being cared, thus improving patient's expectance and possible placebo effects.
D. The "placebo effect" of RMA was at T1 only (that is, at the end of treatment), but, unlike TA, these effects had dissapeared at the follow-up (T2).
E. The factorial ANOVA (taking into account group differences at any time) allowed to show that there is a specific significant effect of TA at T2: this is indeed specific effect of TA only, unrelated to placebo.
F. The significant effects of RMA at T1 do not allow for concluding that TA was ineffective; rather, they indicate that the overall effects of acupuncture, with its systemic approach, involve both specific, needle related effects, and subjective factors; in other words, acupuncture is much more than needles alone.
G. The conventioal concept of "placebo" may affect the criticism as well. In the discussion, I mentioned the concept of Iatroplacebogenesis: the real therapeutic potential of the so-called placebo is increasingly recognized in the literature of pain and its traditional, obsolete, meaning is no longer enough. The so-called placebo may account for both RMA and , partially, TA effects. Simply subtracting the true from placebo effects may be misleading, when dealing with non-pharmacological treatments, with the risk of taking the baby for the bath water. As fa as the problem of placebo is concerned, it is now time to deeply reappraise its definition, role and effects in order to avoid wrong conclusions.
Reference List:
1. Ceccherelli F. FAcco E: Methodological problems on acupuncture research in pain therapy. Capasso A (Ed.), Kerala, India., Research signpost, 2005, pp 217-28
2. Benedetti F: Placebo analgesia, Neurol. Sci, 2006; Suppl2: S100-S102
3. Diener HC: Placebo in headache trials, Cephalalgia 2003; 23:485-6
4. Kong J, Gollub RL, Rosman IS, Webb JM, Kirsch I, Kaptchuck TJ: Brain activity associated with expectancy-enhanced placebo analgesia as measured by functional magnetic resonance imaging. J Neurosci. 2006; 26: 381-8
5. PatersonC, Dieppe P: Characteristics and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005; 330: 1202-5"
I've always wondered about the "placebo" effect, and more important, the nocebo effect. While it seems to be just shrugged off or ignored, often placebo is as effective as a drug, which is just damn interesting, much like sticking needles in somebody can cause them to feel better.
It is baffling. On the one hand, it is dismissed as meaningless, yet it means we accept the power of belief to actually alter symptoms of a disease. Or even to get rid of a disease.
That is some wild claims.
It is baffling. On the one hand, it is dismissed as meaningless, yet it means we accept the power of belief to actually alter symptoms of a disease. Or even to get rid of a disease.
That is some wild claims.
He is incorrect on this point. As outlined in "Why Most Published Research Findings are False", the probability of drawing valid conclusions is dramatically improved by considering prior odds rather than adopting any particular stance a priori (his "fideistic", "skeptical" and "neutral" merely represent assigning 'odds for', 'odds against' and 'even odds').
To be fair, his misunderstanding of this point is likely due to being presented (I suspect) with only a single post of mine, rather than all the information/criticism I had provided prior to that post.
The main concern that I raised with the lack of blinding was that there were several ways in which the various treatment groups could be led to have different expectations. And since we already know that expectation, regardless of the actual treatment received, leads to differences in subjective outcomes (continuous rather than binary), we can't tell how much (if any) of the differences in this study were due to the treatment because we can't tell how much was due to expectation. Blinding the person doing the data analysis does nothing to address this issue, since by then the horse has bolted from the barn.
I agree that his concern is reasonable (although I easily can find studies which use TCM, so I'm not sure how applicable his criticism is), which makes it even more mind-boggling that he failed to design a study that could address that issue (i.e. no comparison of TCM and non-TCM acupoints, and no separation of the effects of greater attention and accupoint selection).
I agree with these statements, but why bring them up when no indication has been given that they apply in this situation?
Yet nothing was done to check whether or not this was the case. And is it not foolish to assume that the only information available to patients about acupuncture was that information given to them during the course of the study? It would have taken very little effort on the part of everyone not receiving TA to discover that they were receiving a treatment that was different from others participating in the study, or different from the usual course of acupuncture.
My bold. Exactly my point. We already know that expectation changes subjective perceptions. What's the point of retesting this idea instead of the purported idea?
With further explanation of what information was provided to the patients, I agree that it would be difficult to use placebo credibility in order to understand expectation.
The effectiveness of acupuncture seems to be more strongly associated with expectation than with whether it corresponds to TCM (in the placement of the needles and as to whether the needles are inserted) (http://ehp.sagepub.com/cgi/content/abstract/28/1/9). How can we conclude that TCM adds something specific, when the results can be explained by non-specific effects, and there is otherwise no solid support for the ideas behind TCM?
I agree. Which is why I am puzzled by the conclusions drawn by the authors of this study.
Linda
As I said earlier, this is a misleading statement. It is no more a 'study on acupuncture' as injecting people with saline solution is a 'study on vaccination'.
Acupuncture is not just sticking needles into people in random places. It is a field of medicine which claims stimulation of key points on the body through the use of a needle will correct imbalances and heal various ailments. It is equally incorrect to state that chiropracty is the alleviation of pain through the manipulation of the spine - an example of what a medical field does is not the same as the fundamental underpinnings of the philosophy behind it.
That is not to say there is nothing useful behind this study. It has the potential to provide more information on how human biology works. Yet one thing this study does not do is support the practice of acupuncture.
It pays to keep that in perspective.
Athon
In comparisons of placebo to no treatment, placebo is unable to remove the symptoms or get rid of a disease, but it is able to alter our perception of the symptoms to some degree (http://content.nejm.org/cgi/content/short/344/21/1594). For a drug to be considered effective, it has to do more than that.
Linda
Skeptic Ginger
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I find it troubling that the researchers would conclude
The providers could diagnose the patient, prescribe the acupuncture treatments, then a second provider could administer the treatments and based on random assignments either use blunt needles not inserted, real needles inserted, or real needles inserted into inactive points, and a 4th group would not be treated. The patients could be masked from seeing if the needles were inserted or not. It is pretty hard to tell if a needle is inserted or you are just touched with a blunt needle if you are not looking.
I understand what he is saying that the provider cannot dispense a pill without knowing whether it is the real or placebo but I think this particular study did not even single blind the study as well as they could have.
Perhaps I am misunderstanding exactly how the placebo was administered but I think even people unaware of the specifics of acupuncture would know that taping foam over acupuncture points was not normal procedure. I admit this was very confusing to me reading the report.
The email reply does not address, nor did the paper address why there was such a large decrease in the untreated group.
And I await the study results being repeatable, a key point in an extraordinary claim.
I can think of a number of ways to double blind an acupuncture study.
The providers could diagnose the patient, prescribe the acupuncture treatments, then a second provider could administer the treatments and based on random assignments either use blunt needles not inserted, real needles inserted, or real needles inserted into inactive points, and a 4th group would not be treated. The patients could be masked from seeing if the needles were inserted or not. It is pretty hard to tell if a needle is inserted or you are just touched with a blunt needle if you are not looking.
I understand what he is saying that the provider cannot dispense a pill without knowing whether it is the real or placebo but I think this particular study did not even single blind the study as well as they could have.
Perhaps I am misunderstanding exactly how the placebo was administered but I think even people unaware of the specifics of acupuncture would know that taping foam over acupuncture points was not normal procedure. I admit this was very confusing to me reading the report.
The email reply does not address, nor did the paper address why there was such a large decrease in the untreated group.
And I await the study results being repeatable, a key point in an extraordinary claim.
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"Your honor, the defendant raised the topic, and I am allowed to challenge any of his assertions on cross-examination. It goes to the witness' claimed expertise in medicine."
Judge "Objection overruled. The witness will answer the question."
Again, Phyto, how could an Italian medical professional not know that chiropractors are now, or soon to be, licensed in Italy?
One, small point: those are not medical fields, they are fantasy fields.
That is an important point, not just for this study, but for all the alternative practices (as you pointed out). And I think the reason the authors failed in their aim to study the contribution of TCM to needling (i.e. acupuncture) was that they failed to take that issue into consideration when designing their study.
Linda
No, not when faced with obvious nonsense. I am not neutral about the Earth being flat, or hollow. After thousands of years in which acupuncture has failed to prove itself better than placebo, one must be biased against it being anything more than placebo. Someone has defined insanity as "doing the same thing over and over, and expecting a different result."
Yes. And this has actually been done. We (as in, there was a thread on the JREF forum about this) even had a discussion about a recent study where there were no differences found between real needles inserted into inactive points and active points.
People can tell the difference - not reliably, but enough to foil blinding. The more you make an effort to eliminate the opportunity to find these differences (using study participants who have never received acupuncture (so they're not sure what real acupuncture feels like), blinding providers or having them use scripts, masking the insertion point (with tape or foam blocks), using minimal insertion, etc.) the more likely you are to find no difference between sham acupuncture and real acupuncture.
Linda
Rules for a trial of acupuncture:
Use only two groups: active and control.
The active group receives true acupuncture by an experienced acupuncturist.
The control group receives sham acupuncure by an experienced acupuncturist.
True acupuncture is defined as inserting needles into the true acupuncture points for the condition under study, which we will call condition A.
Sham acupuncture is defined as inserting needles into the true acupuncture points for a different condition, which we will call condition B.
Of course both groups, active and control, actually have condition A
Double blinding can be achieved by:
- Choosing patients who are not familiar with the true acupuncture points for condition A or condition B. That should be easy.
- Telling the acupuncturist that half the patients are being treated for condition A, and the other half are being treated for condition B, and ensuring that they do not know which group is the active group and which is the control group. That might be a little more difficult
Use only two groups: active and control.
The active group receives true acupuncture by an experienced acupuncturist.
The control group receives sham acupuncure by an experienced acupuncturist.
True acupuncture is defined as inserting needles into the true acupuncture points for the condition under study, which we will call condition A.
Sham acupuncture is defined as inserting needles into the true acupuncture points for a different condition, which we will call condition B.
Of course both groups, active and control, actually have condition A
Double blinding can be achieved by:
- Choosing patients who are not familiar with the true acupuncture points for condition A or condition B. That should be easy.
- Telling the acupuncturist that half the patients are being treated for condition A, and the other half are being treated for condition B, and ensuring that they do not know which group is the active group and which is the control group. That might be a little more difficult
The problem is that Phytotherapist passed on a few of my comments, directed to Phytotherapist in the context of this discussion, to one of the authors of the study. As far as I can tell, he did not mention the other criticisms that have arisen in the course of this discussion, nor did he provide enough context to make the nature of my criticisms clear (unless the author was trying to be deliberately obfuscatory in his response to my comments).
Except that as it stands, not even this study supports the extraordinary claims made the authors.
Linda
You may see it that way. However, Phyto's argument was that the primary author of the article was highly qualified, and I addressed that argument:
See, I did not ignore Phyto's argument. But, he posts a lot of stuff that is difficult to believe.
Skeptic Ginger
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So what was not clear to me in this report was did they use the foam in the real study group and just insert the needles further than in the sham group or did they just use the foam in the sham group?
I still didn't get the impression the placebo control in this study was as good as it could have been.
Skeptic Ginger
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Did you all see the SWIFT article mentioning acupuncture? They likened it to evolution in that the people in China so invested in acupuncture working are going to have the same difficulty coming to terms with it being bogus despite the real scientific research as believers in Creation are having coming to terms with evolution evidence.
I have noticed this already when looking at the supporting research. Like this study, I fear they are seeing the effect they want to see. I'm willing to accept the evidence if it accumulates. But like the prayer studies, the research I read claiming positive results really isn't convincing.
I have noticed this already when looking at the supporting research. Like this study, I fear they are seeing the effect they want to see. I'm willing to accept the evidence if it accumulates. But like the prayer studies, the research I read claiming positive results really isn't convincing.
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