Sham interventions in randomized clinical trials of acupuncture: a review.

[Guest guest]

F. Dincer and K. Linde. Sham interventions in randomized clinical

trials of acupuncture—a review. Complementary Therapies in

Medicine, Dec 2003. Dept of Internal Medicine II, Centre for

Complementary Medicine Research, Technische Universität

München, Munich, Germany. Background and objectives: For non-

drug interventions such as acupuncture, it is difficult to establish

placebo or sham controls that are both inert and indistinguishable.

We reviewed sham-controlled clinical trials of acupuncture to

investigate (a) which types of sham interventions have been used in

the past; (b) in what respects true and sham interventions differed;

and © whether trials using different types of sham yielded different

results. Methods: 47 randomized controlled trials comparing true

and sham acupuncture interventions for pain and a variety of other

conditions were identified from systematic reviews and through a

search in PubMed. Details of patients, interventions, sham

interventions and outcomes were extracted in a standardized

manner. Results: In two trials the sham intervention consisted of

superficial needling of the true acupuncture points, four trials used

true acupuncture points which were not indicated for the condition

being treated, in 27 trials needles were inserted outside true

acupuncture points, five trials used placebo needles and nine trials

used pseudo-interventions such as switched off-laser acupuncture

devices. True and sham interventions often differed in a variety of

other variables, such as manipulation of needles, depth of insertion,

achievement of an irradiating needling sensation (de-chi), etc.

There was no clear association between the type of sham

intervention used and the results of the trials. Conclusion:

Randomized trials investigating the specific effects of acupuncture

have used a great variety of sham interventions as controls.

Summarizing all the different sham interventions as ‘placebo’

controls seems misleading and scientifically unacceptable.

 

Best regards,

 

Email: <

 

WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland

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Chinese Proverb: " Man who says it can't be done, should not interrupt man doing

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[Guest guest]

On 21/09/2004, at 8:54 PM, wrote:

 

> .......... Results: In two trials the sham intervention consisted of

> superficial needling of the true acupuncture points, four trials used

> true acupuncture points which were not indicated for the condition

> being treated, in 27 trials needles were inserted outside true

> acupuncture points, five trials used placebo needles and nine trials

> used pseudo-interventions such as switched off-laser acupuncture

> devices. True and sham interventions often differed in a variety of

> other variables, such as manipulation of needles, depth of insertion,

> achievement of an irradiating needling sensation (de-chi), etc.

> There was no clear association between the type of sham

> intervention used and the results of the trials. Conclusion:

> Randomized trials investigating the specific effects of acupuncture

> have used a great variety of sham interventions as controls.

> Summarizing all the different sham interventions as ‘placebo’

> controls seems misleading and scientifically unacceptable.

>

>

 

This is good to see Phil; perhaps more serious and valid controls will

be part of acupuncture research design in the future.

 

However, I have yet to see or hear of a truly inert placebo control

that is sufficient to obtain scientifically valid results. The idea of

a placebo control, let alone the " gold-standard " of a double-blinded

placebo controlled trial design is IMO a pipe-dream.

 

IMO the best option for assessing the clinical value of acupuncture

(and some forms of bodywork also) is comparing the generally accepted

current standard treatment to the therapy being tested. eg. aspirin vs.

acupuncture for headache.

 

I did my final paper in " research design and methods " on " placebo

design in acupuncture research " and argued that such " controls " were

not inert interventions when considering both:-

 

1) The points chosen for a particular patient or condition will vary

considerably from practitioner to practitioner and style to style.

 

2) The needling depth, manipulation, point location and need to obtain

" de qi " varied considerably from practitioner to practitioner and

style to style.

 

It would be interesting to hear the point of view of a non-TCM style

acupuncturist regarding the need for deep needling, the method of

locating of acu-points and the need for " de qi " . From my limited

knowledge in other schools of acupuncture, I believe that many previous

placebo designs can resemble a valid treatment method in some schools

of acupuncture. Thus the trial design is more closely comparing two

styles of acupuncture than comparing a placebo vs. acupuncture.

 

Best Wishes,

 

Steve

[Guest guest]

Hi All, & Hi Steve

 

1. I agree that it is difficult or impossible to use the so-called " gold-

standard " of randomised double-blind controls in AP research if the

groups to be compared are AP v sham-AP or " placebo needling " .

 

The " gold-standard " , however, could be used to compare real

(verum) INDIVIDUALISED AP v (say) standardised (cookbook) AP v

POSITIVE control (say " state-of-the-art " conventional therapy.

 

2. As Steve noted, the problem of comparing " real AP " with " sham-

AP " or " random points " is that there probably are thousands (if not

millions) of undocumented acupoints on the body; needling one of

those could possibly have the same effect as the verum points

 

Also, as Steve noted, some forms of AP do NOT require Deqi.

They involve very shallow needling, or no needling (as in certain

Japanese sytles, and in use of LLLT to activate the points.

 

That said, SOME trials have shown significant differences in favour

of verum AP, when compared with needling nearby points or sham

points. But IMO, a comparison of AP v positive control (the best of

WM therapy) is a far more useful design.

 

Best regards,

Phil

 

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

 

Re .... Randomized trials investigating the specific effects of AP

have used a great variety of sham interventions as controls.

Summarizing all the different sham interventions as ‘placebo’

controls seems misleading and scientifically unacceptable.... Steve

replied:

 

> Perhaps more serious and valid controls will be part of

acupuncture research design in the future. However, I have yet to

see or hear of a truly inert placebo control that is sufficient to

obtain scientifically valid results. The idea of a placebo control, let

alone the " gold-standard " of a double-blinded placebo controlled

trial design is IMO a pipe-dream. IMO the best option for assessing

the clinical value of acupuncture (and some forms of bodywork

also) is comparing the generally accepted current standard

treatment to the therapy being tested. eg. aspirin vs. acupuncture

for headache. I did my final paper in " research design and

methods " on " placebo design in acupuncture research " and argued

that such " controls " were not inert interventions when considering

both: (1) The points chosen for a particular patient or condition will

vary considerably from practitioner to practitioner and style to style.

(2) The needling depth, manipulation, point location and need to

obtain " de qi " varied considerably from practitioner to practitioner

and style to style. It would be interesting to hear the point of view of

a non-TCM style acupuncturist regarding the need for deep

needling, the method of locating of acu-points and the need for " de

qi " . From my limited knowledge in other schools of acupuncture, I

believe that many previous placebo designs can resemble a valid

treatment method in some schools of acupuncture. Thus the trial

design is more closely comparing two styles of acupuncture than

comparing a placebo vs. acupuncture.

 

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

Best regards,

 

Email: <

 

WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland

Mobile: 353-; [in the Republic: 0]

 

HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

Tel : 353-; [in the Republic: 0]

WWW : http://homepage.eircom.net/~progers/searchap.htm

 

Chinese Proverb: " Man who says it can't be done, should not interrupt man doing

it "

[Guest guest]

On 22/09/2004, at 3:06 AM, wrote:

 

> Hi All, & Hi Steve

>

> 1. I agree that it is difficult or impossible to use the so-called

> " gold-

> standard " of randomised double-blind controls in AP research if the

> groups to be compared are AP v sham-AP or " placebo needling " .

>

> The " gold-standard " , however, could be used to compare real

> (verum) INDIVIDUALISED AP v (say) standardised (cookbook) AP v

> POSITIVE control (say " state-of-the-art " conventional therapy.

>

 

Hi Phil,

 

We agree that this approach is the best; however is it really the

" gold-standard " ? What I mean is, would we be blinding both the patient

and therapist ie. double-blinded? I know this is a small point of

definition but it prevents the trials reaching " gold-standard " status.

 

Best Wishes,

 

Steve

[Guest guest]

Hi All, & Hi Steve

 

I wrote:

> 1. I agree that it is difficult or impossible to use the so-called

> " gold- standard " of randomised double-blind controls in AP

> research if the groups to be compared are AP v sham-AP or " placebo

> needling " . The " gold-standard " , however, could be used to compare

> real (verum) INDIVIDUALISED AP v (say) standardised (cookbook) AP v

> POSITIVE control (say " state-of-the-art " conventional therapy.

 

 

Steve replied:

> Hi Phil, We agree that this approach is the best; however is it

> really the " gold-standard " ? What I mean is, would we be blinding

> both the patient and therapist ie. double-blinded? I know this is

> a small point of definition but it prevents the trials reaching

> " gold-standard " status.

 

Steve, you are correct; my mistake!

 

I should have said: " IMO, the best design would be to compare real

(verum) INDIVIDUALISED AP v (say) standardised (cookbook) AP v

POSITIVE control (say " state-of-the-art " conventional therapy. "

 

That design, however, by its nature, could not qualify as a blinded

trial for the patient (except for the verum v cookbook comparison),

let alone for the therapist.

 

However, if the Clinical ASSESSOR(s) were unaware of the Tx

given, he/she(they) could be said to be blinded.

 

Best regards,

 

Email: <

 

WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland

Mobile: 353-; [in the Republic: 0]

 

HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

Tel : 353-; [in the Republic: 0]

WWW : http://homepage.eircom.net/~progers/searchap.htm

 

Chinese Proverb: " Man who says it can't be done, should not interrupt man doing

it "