Point injection as an alternative acupuncture technique--an exploratory study of responses in...

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Introduction Two of the greatest problems encountered in acupuncture research relate to difficulties choosing appropriate controls, and uncertainties about the stimulation strength of different acupuncture techniques. ‘Sham’ points or minimally invasive techniques are often used as controls in randomised controlled trials (RCTs), yet it is accepted that both suffer inherent problems, not the least of which being the assumption that they have no, or at least minimal, effect. It is recognised that sham points may have a physiological effect, may induce the subjective needling sensation (de qi ), and may produce an overt clinical outcome. Araujo concludes that ‘sham’ acupuncture appears almost as active as ‘real’ acupuncture. 1 This conclusion is strengthened by functional magnetic resonance (fMRI) studies, such as that by Wu et al. 2 While some researchers have found substantial effects from sham acupuncture, other studies have found no ACUPUNCTURE IN MEDICINE 2007;25(4):166-174. 166 www.acupunctureinmedicine.org.uk/volindex.php Papers Point injection as an alternative acupuncture technique – an exploratory study of responses in healthy subjects Mark W Strudwick, Roderick C Hinks, S T Boris Choy Mark W Strudwick research officer Centre for Magnetic Resonance University of Queensland St Lucia Brisbane, Australia Roderick C Hinks head of faculty (acupuncture) Australian College of Natural Medicine Fortitude Valley Brisbane, Australia S T Boris Choy lecturer Department of Mathematical Sciences University of Technology Sydney Sydney, Australia Correspondence: Mark W Strudwick mark.strudwick @uq.edu.au Abstract Introduction Point injection as a therapeutic technique is well documented, but its physiological effects have not been formally compared with traditional acupuncture. One aim of this study was to compare the effects of the two techniques at one acupuncture point, as a step towards understanding the mode of action of point injection and validating its clinical use. A second aim was to explore whether repeated point injection at the same site might provide a way of increasing the dose of stimulation, in the hope of identifying a dose response curve which could be an alternative strategy to placebo control in demonstrating the biological effects of acupuncture. Methods Sixty nine healthy subjects (age range 18-56 years, mean 29.9; 48 females) completed the study, which employed a counterbalanced experimental design with two stimulation sessions of LI4 approximately one week apart. One half of the participants received point injection first, and the other half received traditional acupuncture first. Baseline physiological data were recorded, then measurements were made before, during and after stimulation; each subject also reported needle sensation (de qi). The measures were heart rate, derived pressure rate product and mean arterial pressure. Results Although stronger sensations of de qi were reported with point injection, no significant differences were found for mean heart rate (HR), pressure rate product (PRP) and mean arterial pressure (MAP) before and after stimulation by the two techniques. No subject gender or age bias was encountered and previous exposure to acupuncture had no effect on outcome. Power spectral analysis of heart rate variability (HRV) made on data from a small subset (n=10) of this cohort also showed no significant differences in autonomic response. Conclusion Point injection and traditional acupuncture seem to provoke similar physiological responses, although the greater needle sensation seen with point injection might indicate it could have more powerful clinical effects. Further studies of repeated point injection are necessary to indicate whether this technique may provide a method of increased strength of point stimulation, as an alternative to traditional needling in acupuncture research. Keywords Acupuncture, point injection, physiology, heart rate, mean arterial pressure, de qi. group.bmj.com on June 19, 2016 - Published by http://aim.bmj.com/ Downloaded from

Transcript of Point injection as an alternative acupuncture technique--an exploratory study of responses in...

IntroductionTwo of the greatest problems encountered in

acupuncture research relate to difficulties choosing

appropriate controls, and uncertainties about the

stimulation strength of different acupuncture

techniques. ‘Sham’ points or minimally invasive

techniques are often used as controls in randomised

controlled trials (RCTs), yet it is accepted that both

suffer inherent problems, not the least of which

being the assumption that they have no, or at least

minimal, effect. It is recognised that sham points

may have a physiological effect, may induce the

subjective needling sensation (de qi), and may

produce an overt clinical outcome. Araujo concludes

that ‘sham’ acupuncture appears almost as active

as ‘real’ acupuncture.1 This conclusion is

strengthened by functional magnetic resonance

(fMRI) studies, such as that by Wu et al.2 While

some researchers have found substantial effects

from sham acupuncture, other studies have found no

ACUPUNCTURE IN MEDICINE 2007;25(4):166-174.166 www.acupunctureinmedicine.org.uk/volindex.php

Papers

Point injection as an alternative acupuncturetechnique – an exploratory study of responses in healthy subjectsMark W Strudwick, Roderick C Hinks, S T Boris Choy

Mark W Strudwickresearch officerCentre for MagneticResonanceUniversity ofQueenslandSt Lucia Brisbane,Australia

Roderick C Hinkshead of faculty(acupuncture)Australian College ofNatural MedicineFortitude ValleyBrisbane, Australia

S T Boris ChoylecturerDepartment ofMathematical SciencesUniversity ofTechnology SydneySydney, Australia

Correspondence:Mark W Strudwick

[email protected]

AbstractIntroduction Point injection as a therapeutic technique is well documented, but its physiological effects

have not been formally compared with traditional acupuncture. One aim of this study was to compare the effects

of the two techniques at one acupuncture point, as a step towards understanding the mode of action of point

injection and validating its clinical use. A second aim was to explore whether repeated point injection at the

same site might provide a way of increasing the dose of stimulation, in the hope of identifying a dose response

curve which could be an alternative strategy to placebo control in demonstrating the biological effects of

acupuncture.

Methods Sixty nine healthy subjects (age range 18-56 years, mean 29.9; 48 females) completed the study, which

employed a counterbalanced experimental design with two stimulation sessions of LI4 approximately one week

apart. One half of the participants received point injection first, and the other half received traditional

acupuncture first. Baseline physiological data were recorded, then measurements were made before, during

and after stimulation; each subject also reported needle sensation (de qi). The measures were heart rate,

derived pressure rate product and mean arterial pressure.

Results Although stronger sensations of de qi were reported with point injection, no significant differences

were found for mean heart rate (HR), pressure rate product (PRP) and mean arterial pressure (MAP) before

and after stimulation by the two techniques. No subject gender or age bias was encountered and previous

exposure to acupuncture had no effect on outcome. Power spectral analysis of heart rate variability (HRV) made

on data from a small subset (n=10) of this cohort also showed no significant differences in autonomic

response.

Conclusion Point injection and traditional acupuncture seem to provoke similar physiological responses,

although the greater needle sensation seen with point injection might indicate it could have more powerful

clinical effects. Further studies of repeated point injection are necessary to indicate whether this technique may

provide a method of increased strength of point stimulation, as an alternative to traditional needling in

acupuncture research.

KeywordsAcupuncture, point injection, physiology, heart rate, mean arterial pressure, de qi.

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effects.3 Vincent concludes that the results of RCTs

using sham points as controls only show the

difference between sham and real acupuncture, not

the real effect of acupuncture.4 In light of this, the

conclusion reached by Ryan that acupuncture

researchers should cease using sham acupuncture

as a control in trials seems valid.5 Even the newer

Streitberger placebo needle has been demonstrated

to have shortcomings.6 Minimal acupuncture is

designed to produce just that – minimal effect. Yet,

this method may also produce distinct subjective

and objective effects, as noted by White et al.7

Marcus postulates that the effect of acupuncture is

the result of several factors that are operative during,

and very shortly after, the initial skin penetration:8

1) manipulation for longer than five seconds does

not appear to increase stimulus strength since the

initial tissue damage caused by skin penetration

leads to the release of inflammatory mediators that

sensitise local nerve endings; 2) the acupuncture

effect is a direct result of a cone of tissue damage

proportional to the depth of needling and the

diameter of the needle, this damage regulating the

dose of inflammatory mediators released; 3) the

needle may also cause direct nerve and muscle

stimulation. Skin penetration also induces

microcurrents that may have a local effect. 9 These

latter two mechanisms occur during the initial

penetration and settle quickly thereafter.

Acupuncture point injection (PI) of a small

amount of a drug, vitamin, saline, or plant extract is

a recent innovation of traditional acupuncture that

aims to enhance and prolong the effect of stimulation

of acupuncture points.10 One suggested advantage

of this technique is that it offers the opportunity to

standardise and replicate treatment, which is difficult

to achieve with classic acupuncture. PI is well

documented, and many standard texts contain

references to the use of PI.11-14 A PubMed search of

<acupuncture AND point injection> produced more

than 100 references, the earliest (reporting the

treatment of acute appendicitis by distilled water

injection to an acupuncture point) having been

published in Chinese in 1960.15 Belitskaia et al

concluded that the clinical response to PI was due

to the specificity of acupuncture stimulation by the

introduction of fluid, and not the composition of the

fluid itself.16 Yang and colleagues demonstrated that

PI to PC6 (Neiguan) controlled post surgical

vomiting, and thus lent support to the suggestion

that PI is simple, convenient, timesaving and

effective.17 We suggest that PI offers the opportunity

to titrate the dose of saline injected into an

acupuncture point, thus increasing the stimulus in a

controlled and measurable manner. Identifying a

dose response curve for acupuncture could be an

alternative strategy to comparing acupuncture with

‘placebo’ in the demonstration of biological effects of

acupuncture. One aim of this study, therefore, was to

explore the effects of titrated injections.

To date, the physiological effects of PI have not

been compared with those of traditional acupuncture

(TA). A comparison of the effects of two methods

applied at the same acupuncture point is a first step

in investigating PI and validating the technique for

clinical use. Previous studies of the physiological

response to acupuncture have used, in part, heart rate

(HR) and non-invasive (measurement of) blood

pressure (NIBP).18-21 Others have used invasive

measures such as microelectrode implant in muscle

or repeated blood sampling. Ballegaard also used

the derived pressure rate product (PRP) as an

outcome measure of cardiac workload, which Wright

et al had demonstrated to be a sensitive assessment

for even small cardiac workloads.22 The main aim

of this study, therefore, was to compare the

physiological responses to PI and TA, using non-

invasive measures (HR, MAP, and PRP) along with

self reported sensation of de qi, to facilitate a

comparison with published data.

MethodsVolunteers

An initial sample size calculation determined that

we would need a minimum of 63 subjects (assuming

a 50% difference between groups, with a power of

0.8, and 95% confidence level). With the approval of

the Human Research Ethics Committees of the

University of Queensland (UQ) and Australian

College of Natural Medicine (ACNM), 75 healthy

subjects were initially recruited. Healthy subjects

were chosen, as this was a laboratory study and not

a clinical trial. All gave written informed consent.

None had a history of psychiatric or neurological

disorders or head trauma with loss of consciousness.

Sixty nine (48 female) aged between 18 and 56 (mean

29.9) completed the study. Of these, 59 had

experienced acupuncture previously (they were either

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students or faculty in acupuncture school) and 10

were naïve to acupuncture.

Procedure

A counterbalanced experimental design was

employed to avoid order effects. Volunteers were

randomly assigned to one of two groups, the first

group received TA in the first session and PI in the

second, this being reversed for the second group.

Sessions were scheduled one week apart to allow

for washout of any effects. Prior to enrolment in the

study, personal details were collected. Physiologic

data (resting HR, NIBP, and respiration rate) were

obtained before entering the laboratory. These

parameters, as well as peripheral oxygen saturation

(SpO2) were then measured 10 minutes before and 10

minutes after point stimulation. During the

intervention, these parameters were measured

continuously at 2.5 second intervals. After each

session, volunteers scored their experience of the

stimulation (pain on insertion, pain at needle site, de

qi, and any unpleasant feeling) on an 11-point

numerical scale, where 0 signified no noticeable

sensation and 10 signified maximum tolerable

sensation. De qi was defined as any one of numbness,

heaviness, distension, soreness at the point, spreading

away from the point with time, or other sensation

that the subject may have related to the acupuncture

point stimulation.23

The laboratory was controlled for temperature

and humidity and each session was conducted at

approximately the same time of day and week for

each volunteer. During each session, the volunteer

rested comfortably on a standard treatment couch

facing away from the investigator and monitoring

apparatus.

Stimulation

The acupuncture point LI4 (Hegu), situated on the

dorsum of the left hand between the first and second

metacarpals at the midpoint of the second metacarpal

bone close to its radial border, was chosen for this

study. Being easy to identify and having only

pregnancy or possible pregnancy as its only described

traditional contraindication, it is one of the most

commonly studied points.12 As this study was

intended to compare two methods of acupuncture

point stimulation, it was appropriate to use only one

acupuncture point and not use a control point. An

acupuncturist with 30 years’ experience in traditional

needling techniques and four years’ experience in

PI (MWS) performed all stimulations. The selected

needle – either a solid 0.35 x 13mm sterile, single

use needle (Cathay Herbal Laboratories, Sydney,

2010, Australia) for TA or a hollow 0.50 x 16mm

sterile, single use hypodermic needle (Terumo Corp,

Elkton, MD, 21921, USA) for PI – was inserted to a

depth of 13mm.

At 30 seconds after needle insertion, LI4 was

stimulated for one second by needle rotation at 3Hz

(TA intervention) or by infusion of 0.5ml normal

physiological saline (PI intervention) repeated at 30

second intervals for five stimulation periods, a total

intervention time of 180 seconds (see Figure 1). A

purpose built, computer controlled syringe driver

(Figure 2) was used to perform precise saline

infusion; the fluid delivery line was connected by 3

way tap to a Baxter Uniflow pressure transducer

(Baxter Healthcare Corp, Irvine, CA) allowing

measurement and recording of intra acupuncture

point pressure at 2.5 second intervals, simultaneously

with the HR and SpO2 recordings. The

instrumentation has been previously reported.24

Heart rate variability (HRV)

Towards the end of the study, a recording

electrocardiograph (PowerLab 5, ADInstruments Pty

Ltd) became available. During both intervention

sessions, a subset (n=10) of the enrolled cohort

underwent continuous electrocardiograph (ECG)

recording from limb leads (I, II, or III) for later

analysis of HRV, with the aim of monitoring any

modulation of the autonomic nervous system (ANS)

activity resulting from acupuncture stimulation.25

Statistical analysis

Data were analysed with SPSS (Macintosh Version

11.0.4, SPSS Inc). Using paired samples t tests at a

significance level of 0.05 to determine any significant

differences between the baseline and endpoint of the

experiment, comparative analyses were made of self

reported de qi sensation, MAP, HR, and derived PRP,

all measured before and after stimulation. Repeated

measures ANOVA of peak pressure recordings was

made to determine any differences in acupuncture

point pressure from injection to injection. ECG

recordings were analysed in Chart 5 with HRV

extension (ADInstruments Pty Ltd) and the computed

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low frequency (LF) and high frequency (HF)

components (expressed in normalised units) and

LF/HF ratio were imported to SPSS for analysis of

any differences of the mean by paired samples t test.

Results

Of the original 75 volunteers enrolled, five were

unable to complete the second session within the

one week timeframe and a sixth experienced anxiety

during the first session and withdrew, leaving 69 to

complete the study. Separate analysis of the

acupuncture naïve group demonstrated no differences

when compared with the group that had prior

acupuncture experience. In addition, there were no

significant differences between the male and female

subjects, nor were there any age related differences.

Therefore data from all participants were analysed

together. Data are presented as means and standard

deviations, and P values of the paired samples t tests

are reported, where appropriate.

Table 1 presents the results of self reported

subjective data. In general, there were significant

differences in the in situ needle sensation (P<0.001),

de qi (P<0.001) and unpleasantness during

experiment (P<0.001) with subjects reporting that

TA provided a lower intensity in all three sensations.

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Figure 1 The trial protocol is shown: baseline measurements were taken 20 minutes before needle insertion,

with the subject settled comfortably on couch. Endpoint measurements were taken 10 minutes after removal

of needle and before the participant left the laboratory.

Figure 2 This is a schematic view of the basic layout of the saline delivery system: the trigger can be

provided by any mechanism delivering a 1V peak to peak signal. For this study, manual triggering was used

with activation of the system occurring 30 seconds after needle insertion.

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Table 1 Difference in sensation reported after TA and PI (n=69)

TA PI t* P (two tailed)

Pain on needle insertion 3.22 (2.28) 3.49 (2.34) 0.89 0.38

Pain at needle site during the scan 3.13 (2.22) 5.13 (2.40) 5.46 < 0.001

De qi (numbness, heaviness, distension,soreness, spreading away)

3.39 (2.49) 5.58 (2.54) 5.82 < 0.001

Unpleasantness 2.10 (2.57) 3.77 (2.88) 4.96 < 0.001

Values are mean (SD) scores on a 0-10 numerical scale; TA – traditional acupuncture; PI – point injection*Paired t test

Table 2 Physiological variables before and after TA and PI

TA PIPre-stimulation Post-stimulation Pre-stimulation Post-stimulation

SBP 110.04 (10.91) 112.28 (10.26) 110.61 (10.43) 112.58 (11.00)

DBP 63.75 (7.67) 67.49 (8.91) 63.51 (7.62) 65.81 (7.66)

MAP 79.25 (7.62) 82.49 (7.95) 79.25 (7.65) 81.42 (7.95)

HR 67.62 (10.75) 67.57 (10.33) 68.20 (11.24) 67.57 (9.66)

PRP 7.48 (1.59) 7.63 (1.61) 7.562 (1.57) 7.62 (1.43)

SpO2 97.67 (1.64) 97.94 (1.47) 97.29 (1.76) 97.75 (1.61)

All values are means (SD); SBP – systolic blood pressure (mmHg); DBP – diastolic blood pressure (mmHg);MAP – mean arterial pressure (mmHg); HR – heart rate (beats per minute); PRP – pressure rate product;SpO2 – peripheral oxygen saturation (%)

Table 3 Comparison of pre- v post-stimulation HR and PRP

Visit Pre-stimulation Post-stimulation Paired difference t* Df P (two tailed)

HR 1 72.36 (12.42) 67.91 (11.48) 4.45 4.81 68 <0.001

2 73.16 (11.49) 67.56 (8.78) 5.61 5.94 68 <0.001

PRP 1 8.09 (1.76) 7.64 (1.71) 0.14 3.25 68 0.002

2 8.28 (1.62) 7.55 (1.36) 0.729 5.17 68 <0.001

All values are means (SD); HR – heart rate (beats per minute); PRP – pressure rate product;Visit 1 = traditional acupuncture (TA); Visit 2 = point injection (PI)*Paired samples t test

Table 4 Analysis of HRV components before and after TA and PI

n TA PIBefore After Before After

LF 10 60.13 (14.26) 68.01 (13.78) 63.97 (16.03) 65.27 (16.31)

HF 10 47.01 (35.05) 29.72 (13.11) 32.70 (9.66) 31.91 (15.11)

LF/HF 10 2.52 (2.97) 3.09 (2.30) 2.46 (1.48) 2.88 (2.72)

Values are mean (SD) normalised units (ms2); HRV – heart rate variability; TA – traditional acupuncture; PI – point injection; LF– Low frequency (0.04-0.15Hz); HF – High frequency (0.15-0.4Hz)Note: normal values (in normalised units) for the LF and HF spectral components of HRV are given as: LF 54±4 ms2, HF 29±3 ms2;LF being seen as a measure of sympathetic tone while HF reflects parasympathetic tone and fluctuations caused by spontaneousrespiration. The LF/HF ratio (normal range 1.5-2.0) is used to indicate balance between sympathetic and parasympathetic tone, 25with a decrease in the score being a possible indication of either an increase in parasympathetic or decrease in sympathetic tone.

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There was no significant difference between TA and

PI (P=0.38) for the sensation associated with needle

insertion.

Results for the physiological variables are

presented in Table 2. No significant differences that

could be related to the method of acupuncture

stimulation were demonstrated. Although SpO2 was

measured throughout, there was no change from

measurement to measurement.

Repeated measures ANOVA was conducted

comparing the peak pressures recorded at LI4 from

each of the five injections, and the results are shown

in Table 3 as mean and standard deviation. Data were

also plotted, as shown in Figure 3. Although the

mean peak pressure steadily increases with each

injection, statistical analysis does not show any

significant differences.

For the subset of 10 volunteers in which HRV

analysis could be undertaken, the low frequency (LF)

and high frequency (HF) components of power

spectral analysis (PSA) are presented in Table 4 as in

normalised units, along with the ratio of LF/HF.

Comparative analyses using paired samples t tests

at a significance level of 0.05 demonstrate no

significant difference in autonomic response after

stimulation either within or between methods.

Discussion

As suggested by Marcus and by Pomeranz, it seems

reasonable to postulate that one main acupuncture

effect is brought about by the initial skin penetration.8;9

This causes both local tissue damage leading to

release of inflammatory mediators and also may

initiate a microcurrent that causes changes to cell

membrane function and set off afferent impulses

from local nerve endings. The initial effect is likely to

be proportional to both the needle diameter and the

depth of penetration, and further manual stimulation

beyond this seems unlikely to produce greater effects.

A number of functional imaging studies have

demonstrated the effects of acupuncture in the CNS,

but the reports do not mention whether these effects

are the result of the initial stimulation or are a

cumulative effect of repeated stimulations.2;26-30 Using

acupuncture point injection, once the initial needle

response has subsided, incremental stimulation should

produce parallel response differentials. Therefore,

simply changing the research technique may address

many of the current concerns surrounding controls for

acupuncture research. Additionally, comparing the

physiological effects of PI against TA would be a

first step in investigating the mode of action of PI

and its validation as a clinical tool.

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Figure 3 Mean pressure at the acupoint is shown during repeated saline injection, showing an overall

increase in pressure from injection to injection.

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For this correlational study of differing acupuncture

methods, a single point (LI4, Hegu) was chosen for

several reasons: 1) point location is easy and

reproducible; 2) Hegu has an excellent research track

record; and 3) it is relatively safe to use. Healthy

subjects were chosen in line with previously reported

research protocols.18;31;32

Although there were some differences between

needles used – Terumo hypodermic needles having

a low friction coating not obtainable with similar

sized acupuncture needles – we considered this might

have little effect on de qi. As no difference in skin

erythema was observed between sessions, our

conclusion appeared to be supported. However, the

needles were also of slightly differing diameters

(Terumo: 0.5mm, Cathay: 0.35mm), since needles

of comparable size were not commercially available.

Therefore the decision was taken to examine

subjective reports of any differences in needling

sensations as part of the study. It was noted that

sensations of de qi and unpleasantness were greater

with the hypodermic needle, an outcome that might

be related to the larger diameter or the cutting edge.

To test this relationship further would require the

manufacture of 0.5mm diameter acupuncture needles

at a cost beyond the scope of this study.

HR and NIBP are two of the most commonly

used physiological markers of acupuncture effect;

although we considered derived PRP a more sensitive

measure of physiological response.18;33;22 A comparison

of these data provided no significant differences that

could be related to the differing methods of acupoint

stimulation. Examining changes in autonomic

response with power spectral analysis of HRV or

non-linear measures (such as Poincaré plots) may

improve the statistical value of the physiologic

data.34;35 Although apparatus for measuring HRV only

became available towards the end of the data

collecting period, we used HRV to examine whether

this would provide further data to address our

hypotheses. Analysis of HRV in a small cohort of

volunteers likewise provided no demonstrable

difference in autonomic response, although this must

be interpreted with considerable caution as the sample

size was small and the time between final stimulation

and final ECG recording was only 10 minutes.

Interestingly, the stress induced increase in ANS

activity that may have been anticipated was not noted.

A previous study has considered the usefulness and

limitations of HRV analysis in neuroimaging using PI

as the method of acupuncture point stimulation.36

The one significant difference between PI and

TA appeared in the subjective response, de qi. De qi

is typically described as a response to insertion and

manipulation of a filiform acupuncture needle,

although it has also been described in connection

with electroacupuncture (EA).9;23;37-39 As there is a lack

of consensus on whether de qi is necessary to produce

clinical effects,7 it was deemed reasonable to accept

de qi as an outcome measure of subjective response.

Most subjects reported a more powerful stimulation

response with PI. This may be an anticipatory

response even though a counterbalanced design was

used and every effort was made to provide exactly the

same environment and stimulation at every

encounter.38 Since de qi is claimed to relate to clinical

outcome,14;23;40 these subjective differences may

indicate that PI provides a more powerful clinical

outcome; with stronger sensations being translated

into a stronger clinical response, as outlined by Wang

et al10 and Luo and Chen.41 Not all subjects adequately

reported the quality of de qi experienced; therefore

analysis of the qualitative results was not formally

undertaken. The increased sensation of unpleasantness

needs further exploration, as it was not adequately

defined in this study. ‘Unpleasantness’ is a very broad

term that includes responses to experiences or events

that are not pleasing or a situation that is not pleasing.

It was noted that a number of subjects had formed

preconceptions of the needlestick experience that

might have biased the results of this study.

Although the measured pressure at LI4

demonstrated a trend to increase from injection to

injection, these changes were not statistically

significant; therefore, this trend must be regarded as

inconclusive and worthy of further investigation.

Pressure measurement is mathematically one step

removed from actual compliance; although pressure

and volume were measurable, it does not follow that

compliance has been measured. When interstitial

fluid volume increases above control volume, the

interstitial volume pressure curve levels off; above

150-200% of the control volume, the interstitial

compliance is virtually infinite.42 Therefore it is

possible that an incremental response occurred but

could not be observed. This measure was still

valuable as it can be used as an objective measure of

stimulus delivery.

Papers

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We accept that there are limitations to the study, and

generalisable conclusions are difficult to make.

Different needle diameters were, of necessity,

employed. Although no subjective differences were

noted, and there did not appear any differences in

skin response on visual inspection, it may be possible

that slight differences could have occurred. Next,

the saline dose and rate were empirically determined

for this study as there have been no previous studies

using this methodology. Effects of different injectates

and rates of injection need further investigation. We

used only one form of TA needle manipulation, ie

rotation, and might have obtained different results

with other methods of needle manipulation. The

manipulation for this investigation was chosen as it

has been used in most of the previously reported

neuroimaging studies, for which PI was being

assessed as an alternative stimulatory model. Finally,

the questionnaire for subjective sensations was not

formally validated, although it was tested on

randomly chosen subjects before the study, and each

subject was also given the opportunity before and

after the actual experiment to discuss his or her

response prior to scoring, and any ambiguity was

clarified.

ConclusionsThis exploratory study was unable to detect any

differences between the physiological responses of

healthy volunteers to TA and PI. No subject gender

or age effects were encountered and previous

exposure to acupuncture had no effect on outcome.

The subjective perception of de qi is greater with PI,

as is the unpleasantness; PI may therefore produce a

better outcome clinically, if it is acceptable to patients.

Further research is justified into whether a titrated

response can be seen on repeated injection into the

same point, although no effect was seen in this study.

Measurement of injection pressure could prove

valuable as an objective measure of the actual

delivery of the stimulus.

Acknowledgements and FundingThe technical assistance and ongoing advice of Dr SJ

Wilson (School of Information Technology &

Electrical Engineering, UQ) and Dr GI de Zubicaray

(Centre for Magnetic Resonance, UQ) throughout

this project is gratefully acknowledged.

This work was partly funded from an External

Enabling Grant from the University of Queensland

and a Project Grant from Australian College of

Natural Medicine.

Conflict of interestNone declared.

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responses in healthy subjects an exploratory study of−technique

Point injection as an alternative acupuncture

Mark W Strudwick, Roderick C Hinks and S T Boris Choy

doi: 10.1136/aim.25.4.1662007 25: 166-174 Acupunct Med 

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