Research studies into Placebo Needle

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New Sham Method in Auricular Acupuncture

 

We read with interest the randomized controlled trial by Avants et

al1 suggesting that auricular acupuncture may reduce cocaine

dependence. The authors made a laudable effort to develop adequate

controls for auricular acupuncture treatment in a series of trials.2-

4 We would like to suggest a sham acupuncture method that offers the

advantage of patient-blinding and avoidance of needle insertion

(which some authors believe has physiological effects and therefore

is an " unfair " placebo).5

 

The blunt telescoping sham needle method was introduced in body

acupuncture with 2 different methods for retaining the needle.5,6

One involves the purpose-designed Park tube and the other an Oring

and adhesive cover. The former method could also be used in

auricular acupuncture by shortening the needle and slightly

modifying the Park tube. We believe that a sham needle on sham

points is even less active than a real needle and therefore would

constitute a more appropriate control for needle insertion. We await

further credibility and validity tests.

 

Jongbae Park, KMD

Adrian R. White, MD

Edzard Ernst, MD

Exeter, England

 

1. Avants SK, Margolin A, Holford TR, Kosten TR. A randomized

controlled trial

of auricular acupuncture for cocaine dependence. Arch Intern Med.

2000;160:

2305-2312.

2. Margolin A, Avants SK, Chang P, Birch S, Kosten TR. A single-

blind investigations

of four auricular needle puncture configurations. Am J Chin Med.

1995;

23:105-114.

3. Margolin A, Avants SK, Birch S, Falk C, Kleber HD. Methodological

investigations

for a multisite trial of auricular acupuncture for cocaine

addiction: a study

of active and control auricular zones. J Subst Abuse Treat.

1996;13:471-

481.

4. Margolin A, Chang P, Avants SK, Kosten TR. Effects of sham and

real auricular

needling: implications for trials of acupuncture for cocaine

addiction. Am

J Chin Med. 1993;21:103-111.

5. Park J, White AR, Lee H, Ernst E. Development of a new sham

needle. Acupunct

Med. 1999;17:110-112.

6. Streitberger K, Kleinhenz J. Introducing a placebo needle into

acupuncture

research. Lancet. 1998;352:364-365.

 

 

From the manufacturer in Germany, web address: http://www.asia-

med.de/

 

Evaluation of a Placebo Needle for Acupuncture Research Background

A problem acupuncture research has to face is the concept of a true

placebo method. In the context of controlled trials a placebo can be

defined as a dummy treatment without the specific action of the real

treatment being investigated. In order to achieve single blinding

the dummy acupuncture treatment has to be indistinguishable from the

real treatment to the subject. Because of the nature of needle

acupuncture, it has been difficult to design a suitable placebo for

acupuncture trials.

 

Two primary methodologies have been used:

1) Applying needle acupuncture to the " wrong " points (invasive

placebo methods) Sham acupuncture: needling at non-acupoints

Needling at real but not indicated acupoints Superficial needling

From a neurophysiologic perspective, any penetration of the skin

will lead to some physiological responses like Neurally mediated

analgesic effects (e.g. endogenous opioid release and Diffuse

Noxious Inhibitory Controls) Effects on trigger points Local immune

function and microcirculation changes 2) Application of different

stimuli to the skin with various instruments (non-invasive placebo

methods) Mock TENS or mock laser (subjects are not blinded) Pressure

with the finger-nail (patient must not see the sites) Almost

pricking the skin with a blunt needle hard to mimic the length of

the procedure, possibly rather strong sensory stimulus) Tapping the

skin with a plastic guided tube and taping a needle in place (again

subject must not see the insertion points) Without penetration it

has been hard to elicit the patients' belief that he

or she has received real acupuncture. Therefore, psychological

effects still may be largely responsible for differences between

groups.

 

It was stated that an optimal placebo should:

Include a needle which looks like a real acupuncture needle Appear

as though the skin is being penetrated, even though it is not Be

applicable at every acupuncture point Be convincing to the patient

With these aspects in mind a new placebo needle was designed

following the concept of the theatrical stage dagger. The tip of

this telescopic needle is blunted to avoid penetration or injury to

the skin. The handle slides over the needle when it is compressed,

giving it the appearance of penetrating the skin. To retain the

needle in position, it is supported by a ring and adhesive dressing

It is important to note that this method control for the puncture of

the skin, which has been the main concern with the other primary

placebo using sham points.

 

Convincing placebo?

We tested our new device in a cross-over experiment to determine

weather the placebo needle felt any different from real acupuncture

in healthy volunteers.

 

Methods:

29 female and 31 male, normal healthy volunteers, aged 21-40 years,

were recruited from our hospital staff. Informed consent was

obtained for each participant. They were told that we were testing a

new needle to see if it was more or less painful than a traditional

needle. After randomisation they were needled in a cross-over design

with a real acupuncture needle and the placebo needle at acupoint

Hegu (LI 4). In both cases the point was disinfected with alcohol,

then marked with the plastic ring which was covered with plaster.

After puncturing the plaster the needle was depressed. In the case

of placebo acupuncture, the needle touched the skin and the handle

then slid over the needle, shortening the visible portion of the

needle, giving the same appearance as for the real acupuncture. In

the case of the real acupuncture the needle went through the skin to

the appropriate depth. After the needles were removed the volunteers

were asked if they felt the needle penetrate the skin, if the

penetration was painful on a visual analogue scale (VAS), and

whether they felt a dull pain (DEQI).

 

Results:

Of 60 volunteers, 47 reported that they felt a penetration with the

placebo needle and 54 felt it with the real acupuncture needle (Fig.

3). Difference in VAS was small (4.15) with large SD (11.57) and a

large range (0-51) demonstrating the large range of individual pain

perception. None of the subjects suspected that the needle had not

penetrated the skin. Practical use of the placebo in a clinical trial

We designed a randomised controlled trial comparing the effects of

acupuncture with the placebo needle for the treatment of rotator

cuff tendonitis in 52 sportsmen. The protocol was approved by the

Ethics Commission of the University of Heidelberg.

 

Methods:

Inclusion criteria

Rotator cuff disease due to sport

Diagnosis confirmed by clinical examination

Duration more than 4 weeks

Age greater than 18 years

No acupuncture during the last 6 months

Less than 81 (out of 100) points at Constant-Murley Score a score

assessing shoulder function with objective and subjective criteria)

Exclusion criteria

Operation on the shoulder, rupture of tendons or calcification

Pregnancy

Age greater than 50 years

Treatment

Acupuncture versus placebo acupuncture at up to 12 acupoints out of

20 (ST 38, SI 3, SI 6, SI 9, SI 11, SI 12, SI 14, LI 11, LI 14, LI

15, TE 3,

TE 14, TE 15, BL 44, GB 34, LR 2, HT 1, PC 2 and two extra-points).

Same standardized treatment procedure in both groups.

Primary outcome variable:

Change from baseline in the Constant-Murley score after 8

acupuncture sessions.

Assessed by orthopaedists not informed about treatment allocation.

 

Results:

After an initial assessment by an orthopaedist, 52 sportsmen and

women, ages 18-50 years, with rotator cuff tendinitis were included

into the study. Twenty seven (n=27) of them were randomised into the

placebo group. Baseline characteristics did not differ

significantly. The acupuncture group improved by 19.2 points (SD

16.1, range –13 to 50), the control group by 8.37 points (SD 14.56,

range –20 to 41), p = 0.014 (t-test), CI 2.3;19.4. A questionnaire

to ascertain the credibility of the therapeutic setting showed no

differences between the groups. After the first treatment all

patients felt confident that the treatment could alleviate their

complaint.

 

Discussion

Different mechanisms have been proposed for the potential effects of

needle acupuncture and it has not previously been possible to

differentiate the specific needle effects from non-specific effects.

The relevance of the response to skin penetration had previously not

been rigorously tested. Needle penetration produces a powerful

overall psychological and physiological response in many people.

Therefore we designed a placebo needle which does not penetrate the

skin. Two studies were performed to evaluate the questions of 1)

Whether or not the placebo needle is a convincing placebo 2) If it

is of practical use in a clinical trial and 3) If it duplicates the

needling effects of acupuncture in a defined condition. Our cross-

over experiment showed that the placebo needle is a convincing

simulation of real needle acupuncture treatment. In the second

study, treating rotator cuff injuries, we introduced the placebo

needle into a randomised clinical trial. The procedure was very well

accepted by the patients and none of them detected it as a placebo.

True needling was found to be superior to the placebo needling in

the treatment of rotator cuff disease. This suggests that actual

penetration

of the skin is an important component of acupuncture treatment. With

this placebo needle the needling effects of acupuncture can be

investigated now in other well defined conditions. For further

discussion there are still some problems in the application of the

placebo needle:

The adhesive plaster for fixing the needle makes it difficult to

apply in the scalp, ear, toes or fingers. The ring may introduce

some limitation in angle of insertion A patient`s previous

experience of acupuncture could lead to unmasking of the placebo, if

the patient expects the specific sensation (DEQI) Minimal sensory

stimulus by the blunted tip could be strong

enough to act on Ad nerve pathways Blinding of the acupuncture

practitioner is not possible with this device. Questions and

comments are very much welcome! Dr. med. Konrad Streitberger

Clinic of Anaesthesiology University of Heidelberg INF 110 69120

Heidelberg, Germany e-mail: konrad_streitberger

 

References:

Streitberger K, Kleinhenz J. Introducing a placebo needle into

acupuncture

research. Lancet 352 (1998): 364-365.

Kleinhenz J, Streitberger K, Windeler J, Güßbacher A, Mavridis G,

Martin E.

Randomised clinical trial comparing the effects of acupuncture and a

newly

designed placebo needle in rotator cuff tendinitis. Pain 83 (1999):

235-241.

Vincent C, Lewith G. Placebo controls for acupuncture studies.

J Royal Soc Med 1995; 88: 199-202.

Kaptchuk TJ. Placebo needle for acupuncture.

Lancet (1998) 352:992.

Kaptchuk TJ. Methodological issues in trials of acupuncture.

JAMA (2001) 285: 1015.

 

Attilio

 

Chinese Medicine , Musiclear@a...

wrote:

> In a message dated 8/24/2003 7:30:55 AM Eastern Daylight Time,

> attiliodalberto writes:

>

> > Streitberger's new placebo needle

>

> This is interesting. What is it?

>

> Thanks

> Chris

>

>

>