ALBERTA Re Scanned Acupuncture Evidence 2002
ALBERTA Re Scanned Acupuncture Evidence 2002
ALBERTA Re Scanned Acupuncture Evidence 2002
Acupuncture: Evidence
from Systematic Reviews
and Meta-analyses
March 2OO2
This Health Technolosr Report has been prepared on the basis of available information
of whtch the Foundatlon ls aware from public literatue and expert opinion and
attempts to be curent to the date of publication. It has been externally reviewed.
Additional information and comments relatlve to the report are welcome and should be
sent to:
ISBN l-896956-56-4
Alberta's health technolory assessment program has been established under the Health
Research Collaboration Agreement between tie Alberta Heritage Foundation for
Medical Research and the Alberta Health Ministry.
AcKNowLEDGMENTS
The Alberta Heritage Foundation for Medical Research is most grateful to the following
peFons for provision of information and comments on the draft report. The views
expressed in the final report are those ofthe Foundation.
Dr. Brian Berman, MD, Complementary Medicine Prog.am, Baltimore, MD
D!. Stephen Birch, Stichting (Foundation) for the Study for Traditional East Asian
Medicine (STEAM), Amsterdam Netherlands
Dr. Andrew Vickers, Memorial Sloan-Kettering Cancer Center, New York, New York
Dr. Harald Walach, Universitatsklinikum Freiburg, Institute fur Umweltmedizln und
Krankenhaushygiene, Fdeburg, I.BR
Dr. Adrian R. White, Department of Complementary Medicine, Unlversity of Exeter,
Exeter, UK
Tables:
Table 1: Conclusions and quality rating ofthe systematic reviews.................................... 13
Table 2: Data extraction and qualitv assessment ofincluded studies ,,,..................,,,,,,,....2g
DEFINITION
called laser acupuncture, Techniques of fire needles involve inserting red-hot needles
at an acupuncture point.
Staple puncture is the application ofa metal staple to an acupuncture point where it
remains lor a prolonged period of time. Cupping is a technique by which a vacuum
force is applied to acupuncture sites, Bloodletting refers to tie pricking ofthe skin for
the purpose of releasing blood. This may be aided with the application of a cup over
the site. A less lnvasive procedure is acupressure which refers to the stimulation ofa
point manually with pressure with the intention ofstimulating Qi flow. Intramuscular
stimulation is a technique of applying needles to areas of tenderness. There is debate in
the acupuncture community over which ofthese techniques fall under the classification
ofacupuncture.
'De qi' is the sensation ofnumbness, tingling, electrical sensation, fullness, distension.
soreness, warmth, and itching which may be felt subjectively around the acupuncture
point 8. The practitioner may have a sensation of tenseness or dragging to the needle 11.
This sensation may be sought by some practitioners through twirling, plucking, or
thrusting ofthe needles. In Western terms these are signs that A-delta fibers are
activated r0. In TCM this indicates that the Qi has affived. There is controversy
amongst practitioners ofacupuncture as to whether it is necessary to elicit this sensation
ro render the rreatment effective 8.
CoMPLICATIoNS oF AcUPUNCTURE
Acupuncture is a relatively safe procedure, but it can also lead to both minor and
se.ious adverse events. There is an increasing amount ofliterature on adverse effects of
acupuncture; however, there is still a concem about under reporting in the studies of
the more minor adverse effects ofacupuncture.
Norheim's study ofthe literature from 1981 to 1994 examined 78 case reports (N= 193
treatments) of adverse effects with needle acupuncture 12. He classified the
complications as mechanical organ injuries such as pneumothorax (n=23) and medulla
spinalis injury (n=13); infections such as hepatitis (n=100) and auricular chondritis
(n=16); and other effects such as argyria (n=5) and problems with implanted needles
(n=5). Many ofthe effects seem to be linked to practitioner competence, or patients'
ongoing health conditions.
White et al. and MacPherson et al. both examined the adverse events occurring with
acupuncturists in the U.K., in over 32,000 and 34,000 consultations respectively 13,1r. In
MacPherson et al, no serious adverse effects were reported, as defined as requiring
hospitalization, or leading to permanent disability or death. and there was a rate of
1.3/1000 consultation of minor adveEe events such as severe nausea and fainting.
White et al. also found no serious adverse events in theb study. Significant minor
events such as fainting, lost needles, and exacerbation of symptoms were reported at a
rate of l4l10,000 consultations. In addition, both studies reported on'minor events'or
FtNDtNGS
Of the thirty three studies selected, twenty-three systematic reviews met the inclusion
criteria, including five Cochrane Reviews (see Appendix A). A table of data extraction
and quality assessment ofincluded systematic reviews can be found in Appendix B.
Though there is growing debate as to whether the Cochrane Reviews should continue
to be a 'gold standard' for systematic review methodology, they curently have the
most rigorous methodology, and therefore, a quality assessment ofthese reviews was
not undertaken 20. The other reviews were assessed using criteria based on those set out
in Greenhalgh 21 (see Appendix D). Though this quality assessment may not be as
rigorous as initially intended by its authors, it has been consistent across the reviews.
Once agreed upon criteria have been developed for the assessment ofthe
methodological quality ofprimary studies in acupuncture, the same approach should
be taken for the assessment ofsystematic reviews.
Eleven studies indicated that acupuncture was effective and seven ofthese studies were
rated at a high level due to their methodological quality. Rosted concluded that most of
the studies suggest that acupuncture is effective in controlling dental and TMD,/facial
pain. He stated concerns, however, about the clinical relevancy ofthis treatment as a
surgical analgesic, as the time needed for acupuncture to take effect was much longer
than other analgesics.
Headache
Only one review met the inclusion criteria.al. This Cochrane Review addressed the
question whether acupuncture was more effective than no treatment. sham or other
treatments used for headache ol three types: mig.aine, tension. and mixed. The Jadad
Scale 40 was used to assess study quality (Appendix C) ofthe 26 RCTs (16 RCTs for
migraine headaches, six RCTS for tension type headaches, and four RCTs for various
Asthma
Two systematic reviews assessed the effectiveness of acupuncture in the treatment of
asthma, in addition to a Cochrane Review. Kleijnen and colleagues 28 reviewed 13 RCTs
that were based on needle acupuncture. They reported on the style ofacupuncture (all
but one were based on formula acupuncture) but did not evaluate the appropriateness
ofpoints chosen. The methodological quality of the 13 studies was rated on the
Kleijnen scoring system (see Appendix C). No studies of high enough quality were
found to conclude ifacupuncture was effective in the treatment ofasthma.
In 1996 Linde and his colleagues published a review 2e of 15 tials including all but two
ofthe studies included in the Kleijnen et al. review. These excluded studies were not
.andomized trials. They were concemed that there had been no evaluation as to the
appropriateness of point selection; therefore four physicians who also taught and
practiced acupuncture evaluated the appropriateness ofthe acupuncture points chosen.
There was vadability in the assessment of adequacy oftreatment choice, but none ofthe
studies were evaluated as being totally inadequate. Jadad's scale a0 was used as well as
Linde's own scale to assess methodological quality ratings and were compared to the
ratings obtained in the Kleijnen scoring system (Appendix C). More similarity was
found between the Linde and Kleijnen ratings than those of Jadad. They concluded that
there was insufficient research ofhigh enough quality to recommend to acupuncturists
to stop treating asthma patients, nor to recommend to non-acupuncturists to start its
use,
A Cochrane Review by Linde, Jobst and Patton {2 using similar inclusion criteria was
published in 2000. Seven studies matched the criteria and were evaluated using the
Jadad Scale. One ofthe authors was experienced in acupuncture and evaluated the
adequacy ofthe sham-acupuncture, but not the appropriateness ofthe acupuncture
treatment. Objective measurements for lung function were included as well as drug
use. Subjective results were also accounted for in these studies. They concluded that
the efficacy of acupuncture for asthma can not yet be determined.
Although there were avariety ofcriteria used to evaluate the methodological quality of
the studies, the results obtained were consistent in stating that the evidence did not
support or refute the use ofacupuncture in the treatment of asthma.
Stroke rehabilitation
A review by Park and colleagues 2s included nine RCTS comparing needle acupuncture
to standard medical and rehabilitative treatments or sham electro-acupuncture, The
search included more than one complementary database, and study quality was
assessed usingJadad's Scale {0 (Appendix C). They identified variability in treatment
schedules, types ofstimulation, time ofinitiation ofacupuncture, acupuncture sites, and
use of quality of life measures. Numerous different stroke assessment scales were used
in the primary studies to measure the outcome, challenging the ability to make
comparisons between the studies. No mention was made of the evaluation of the
appropriateness ofteatment, although the duration ofheatment and whether it was
manual or electroacupuncture was documented. The authors found the quality of
studies to be poor (only two studies obtained a Jadad score of 3 or more) and stated that
the evidence does not support the use ofacupuncture for stroke rehabilitation, though
the findings show some promise.
meta analysis 30 included 19 studies that evaluated post-operative nausea and vomiting
by comparing acupuncture andlor TENS to a control group receiving eitier sham
acupressure or treatment or a pharmacological intervention. No specific
complementary database rvas searched to locate primary studies nor was there a stated
search ofthe grey literature. Eleven ofthe 19 studies scored three or better onJadad's
Scale a0 (Appendix C). though there were many issues noted that hindered comparison,
including diversity of techniques used for stimulation of the point. Acupuncture was
not deemed effective in the control ofnausea and vomiting in the pediatric population.
P6 stimulations fo. early or late PONV compared to pharmaceutical treatments was
reported to have an equal effect, and when compared to sham or no treatment was
supedor in 20% to 25% ofadults within 6 hours oflaparoscopic and gynecological
procedures. There was inadequate data to determine effects oftreatment versus sham
for late PONV.
Vickers' review 31, which included a complementary database in the search strategy,
identified 33 studies and evaluated the methodological quality using the Vickerc Scale a0
(Appendix C). They divided the studies into nausea and vomiting post-operatively,
following cancer chemothe.apy, and morning sickness. A diveNity of treatments were
assessed in the primary studies such as acupressure, electroacupuncture. needle
acupuncture, TENS, and acupoint injections. Using acupuncture while under
anaesthesia was found to be ineffective at controlling emesis, in four studies. All but
two ofthe remaining 29 studies reported a positive effect for acupuncture in P6
anti-emesis. The author concluded that PO stimulation seems to be effective except
when it was administered under anaesthesia.
was compared to sham, needling. laser, or TENS, waiting lists, or standard clinical
therapy. Most of the studies on chronic neck and back pain found either no difference
between acupuncture and control treatments, or found an initial positive effect for
acupuncture, but often after 24 hours there was no significant difference between the
treatments. The two studies examining acute low back pain after a single treatment
were evaluated to have no benefit over sham or acupressure with anaesthetic spray.
The conclusion ofthe reviewerc was that there was no evidence to support the
treatment ofback or neck pain by acupuncture.
Using methodological cdteria adapted from Koes (see Appendix C), Strauss 26 reviewed
results from four controlled clinical trials for chronic low back pain (LBp). There was
no evaluation olthe appropriateness of the acupuncture treatment, although the
discussion did address many ofthe problems associated with the assessment of
acupuncture including the skill of the acupuncture provider. Three of the studies
reported positive results for acupuncture, however these were ofpoor methodological
quality. The heterogeneity of patients and treatment methods, and practitioner
qualifications, made drawing any conclusion regarding the effectiveness ofacupuncture
in chronic LBP difficult. Though the author believed that acupuncture was a safe and
popular treatment for LBP, he recommended that rigorous research was needed to
determine the most appropriate treatment methods for specific conditions ofLBp.
Ernst and White 36 included 12 RCTs (9 into the meta-analysis) on back pain.
Methodologically this review was rigorous, with good data integration and assessment
of trcatment adequacy. Acupuncture was shown to be superior to waiting list and
physiotherapy but was not found to be superior to placebo except in one study on
severe pain. Odds ratios for unblinded studies suggested a strong placebo effect. They
recommended that further studies explore the specific and non-specific effects of
acupuncture, as well as the adveme elfects and cost-effectiveness ofthe various
treatments for back pain. to assist in determining the usefulness ofthese therapies.
The Cochrane Review by van Tulder 8 examined l1 RCTS on the effect of acupuncture
in chronic and acute lower back pain. This review followed the Cochrane Back Review
Croup's rules for assessing methodological quality (see Appendix C). No assessment as
to appropriateness of trcatment was made. There was conflicting evidence from low
quality trials comparing acupuncture to no treatment, moderate evidence that
acupuncture was not more effective than TENS or trigger point injections. and limited
evidence that acupuncture was not more effective than sham for the treatment of
chronic LBP. Overall this review reports that the ellectiveness ofacupuncture in t1-re
treatment ofLBP was unclear and, since there are effective altematives, the authors do
not.ecommend acupuncture as a regular treatment for LBp.
Chronic pain
Two reviews focused on the effectiveness ofacupuncture for the treatment ofchronic
pain. The appropriateness of treatment was not evaluated in either review.
The review by Ezzo et al. 3a used the Jadad Scale (see Appendix C) to evaluate 51 RCTS
in which patients with pain longer than 3 months were treated with needle
acupuncture. The review assessed the number offieatments, number ofpoints needled,
eliciting of'de qi', and type of acupuncture (whether formula or individualized). On$
'number oftreatments' seemed to be co.related with a positive outcome. The authors
found that the control group participants in studies using sham acupuncture (needles
were inserted) as the control had a proportionally higher improvement rate compared
to the control group participants in studies using inert controls such as, TENS, sugar
pills, and mock acupuncture (in which needles were not inserted), This led the authors
to propose, amongst other possibilities, that sham acupuncture was not physiologically
inert. They stated that they found limited evidence that acupuncture was more
effective than waiting lists and the evidence was inconclusive on whether acupuncture
was more effective than physiologically inert controls, sham acupuncture, or standard
The ter Riet. Kleijnen and Knipschild's meta-analysis 3e also evaluated 51 studies using
needle acupuncture (excluded surlace electrodes or laser acupuncture). but these
studies included patients with chronic pain of at least 6 months duration. They
assessed methodological quality based on criteria developed by ter Riet and colleagues
(see Appendix C) and found that further research needed to be conducted with more
homogeneous study groups, and better methodological design. The reviewers stated
that there are no published studies ofhigh enough quality and that the efficacy of
acupuncture lor this condition remains inconclusive.
Fibromyalgia
One review addressed the use of acupuncture for the trcatment of fibromyalgia 27. The
reviewers used the Jadad Scale to rate the methodological quality ofthe studies (see
Appendix C). They did not, however, identify the style (eg. classical TCM or formula
acupuncture), appropriateness of treatment, or the qualifications of the acupuncture
practitioner. The authors based their conclusions on one high quality RCT, which
found signiffcant improvement in both subjective and objective pain measures
compared to sham acupuncture but the duration of benefit was unknown. A lew
patients had woNening of symptoms during the treatment with acupuncture. They
state that their review may provide some practical information for practitioners on
possible benefits and risks ofacupuncture. Based on limited evidence, acupuncture is
more effective than sham acupuncture for improving symptoms (pain relief. reducing
morning stiffness, increasing pain threshold, and improving global ratings) in patients
with fibromyalgia syndrome.
Obstetrics
A Cochrane Review was conducted by Smith and Crowther a3 to determine the effects
of acupuncture lor the induction of labour. The authors noted that there were limited
observation studies published that suggested acupuncture appeared safe and effective.
None ofthe published trials, however, met the inclusion c teria and the authors
suggest the need for a well-designed RCT.
Addictions
Ter Riet and colleagues 38 conducted a meta-analysis that included 2Z studies.
euality
of studies was assessed using criteria developed by the authors (see Appendix C). The
outcomes assessed, however, were not clearly defined in terms ofaddiction treatments,
as they were only stated as the cessation of smoking. use of heroin, or use of alcohol. In
addition, no biochemical vedfication of cessation,/abstinence was included.
Fifteen ofthe 22 studies examined the use ofacupuncture (excluded surface electrodes
or laser acupuncture) in smoking cessation and reported acupuncture as not effective in
comparison to placebo; however placebo treatment was not identified. Five studies
reviewed the use of acupuncture in hercin addiction. The methodological quality of all
five studies was rated as low and therefore it was difficult to draw any conclusions.
Two studies using acupuncture for the treatment ofalcohol addiction reported a
positive effect for acupuncture reatment but these studies suffered from high drop-out
rates. No mention was made ofthe appropriateness ofthe acupuncture points used in
any ofthese studies. though the practitioner and treatment description were assessed as
part of the quality assessment. The conclusion lrom this review was that the evidence
does not support the use ofacupuncture in the treatment ofaddictions.
Smoking cessation
Two reviews examined acupuncture in the treatment ofsmoking addiction; the
Cochrane Review by White and colleagues aa and a meta analyses by White et al. 35. The
Cochrane Review included 18 RCTs in which smoking cessation was the outcome.
Acupuncture was compared to sham acupuncture or an alternative form ofcessation
intervention or to no inteNention. There was no assessment of appropdateness of
acupuncture sites chosen, but the treatment regimen was descdbed in the primary
studies. Only four studies reported any form of biochemical validation of smoking
cessation. Three studies indicated strong positive results for acupuncture in the
treatment olsmoking addiction. In two ofthese studies prolonged auricular
acupuncture was applied. The authors proposed that perhaps more rigourous study
into the effects ofintensive and continuous treatment was warranted. As \a,ell. they
suggested the importance olstudying acupuncture effects during acute nicotine
withdmwal. The review concludes that acupuncture was not superior to sham
acupuncture. Compared with other anti-smoking interventions there was no difference
but early results indicated it was superior to no intervention.
The meta analysis 35of 14 RCTs (12 RCTs sham-controlled) was thorough and methods.
as well as limitations, were clearly stated. The authors came to the same conclusions as
the Cochrane Review that there was no evidence that acupuncture was more or less
effective than sham acupuncture or other smoking cessation interventions.
Weight loss
One systematic review on the eflectiveness of acupuncture and acupressure in weight
loss and hunger suppression was identified 37, Four sham-controlled clinical trials were
assessed by an "accepted instrument" used by Kleijnen, Knipschild, ter Riet (see
Appendix C), One study used an acupressure device. while all other studies used
varying auricular points. The conclusion of the reviewers was that fufther, well
designed research needs to be conducted to provide sufficient evidence regarding the
effectiveness ofacupuncture in appetite or weight reduction, but that there curently
was no convincing evidence to support the effectiveness of acupuncture for weight loss
or hunger suppression.
Summary
For the various conditions listed in Table 1, the respective reviews found that the
evidence supports acupuncture as an ellective treatment for dental pain, and
nausea./vomiting. Though the evidence for the other conditions such as idiopathic
headaches, back pain, chronic pain, and fibromyalgia was often inconclusive due to
methodological weaknesses, andlor conflicting results reported by the primary studies
included in the reviews, the results look promising. These reviews. the majority with a
good quality rating, found acupuncture to be as effective in the short term as the
conventional interventions or no t.eatment for these conditions. Many of the authon
noted that better quality studies provided negative results while poorer quality studies
tended to report positive results. Furthermore. they agreed that there appeared to be
insufficient evidence and that better quality research was needed.
OTHER REVIEwS
Systematic reviews are a synthesis and critical appraisal of p mary studies and
therefore play an important role in evidence-based decision making. Many of the
primary studies included in a systematic review may not be easily accessible to a
number ofpmctitione$ or busy practitioners may not have time to read all the
published research, hence the value of systematic reviews. A main limitation of this
systematic review ofsystematic reviews is that it did not take into account the evidence
from new research that may add to or change the conclusions. For example, since the
publication ofthe systematic review by Park and colleagues 25 on the eflectiveness of
acupuncture for stroke, a sham controlled study considered ofgood quality, indicated
negative results. The addition of this study to the systematic review would strengthen
the evidence to recommend against the use ofacupuncture for this indication.
In 1997 the National lnstitute of Health held a2 d,ay conference on acupuncture
^nd,1/2
specifically to evaluate the scientific data on the conditions, sks, and benefits. They
stated that there seemed to be potential usefulness based on the studies but, due to
flaws in design, sample size, and other factors, the results ofthe research were often
equivocal. The role of acupuncture in nausea and vomiting resulting f.om
chemotherapy as well as post-operative surgical and dental pain appeared to have some
of the best evidence. They also acknowledged that there are many other conditions for
which acupuncture may be useful as an alternative or adjunct treatment. Their
concluding comments focused on the issues oftraining and licensure, summadzing that
there was sufficient evidence to support further research and integration into
conventional medicine a5. Based on these results Medicare does not cover acupuncture
services. The coverage and analysis group, however, a.e open to receiving furthe.
evidence on the efficacy ofacupuncture (informed placement ofneedles with or
lvithout twirling, but not with electrical stimulation or moxibustion) for post operative
chemotherapy pain and nausea in adults and post-operative dental pain for dental
conditions covered by Medicare 46.
Ernst and White { reviewed seven systematic reviews on the effectiveness of
acupuncture for dental pain, low back pain, neck pain, osteoarthritis, stroke, smoking
cessation and weight loss. They concluded that there was strong evidence on the
efficacy of acupunctu.e for dental pain, low back pain, and nausea/vomiting. In
addition, they stated the need for .igorous research by experts in the field, and lunding
support to allow for the expansion of acupuncture .esearch.
Linde et al. a7 published a bibliography ofsystematic reviews in acupuncture. The
reviews they included were on the lollowing topicsr chronic pain, headaches,
dental/TMD pain, rheumatic diseases, addiction, nausea, asthma, tinnitus,
weight,/appetite reduction. and stroke rehabilitation. They only found convincing
evidence in support of acupuncture for postoperative nausea and against acupuncture
for smoking cessation. They also concluded that there were key issues around
methodological problems, lack ofresearch infrastructure and funding for research and
pointed to the complexities ofacupuncture as a group oftreatments for many and
vadous medical conditions.
A final review by Vickers as published in the fall of200I looked ar effectiveness in the
treatment ofacute pain. chronic pain, addiction, astima, nausea/vomiting, obesity,
stroke rehabilitation, tinnitus, and various other conditions. They found acupuncture to
be effective for postoperative and chemotherapy nausea/vomiting. and postoperative
dental pain. They also found that the evidence for acupuncture in obesity, sm;king
cessation and tinnitus suggested it is 'unlikely to be of benefit'. For the other
conditions, the evidence was insufficient to support any conclusions.
Comparison ofthese reviews with this report finds consistent support for the
effectiveness of acupuncture in the treatment ofpostoperative nausea,/vomiting, and
dental pain.
and acoustic signals similar to those found during active laser acupuncture ss. These
placebo or sham controls increase the patient's perception ofactually receiving
acupuncture treatment, and also enables double-blinding.
Placebo or 'sham' were defined in the studies included in the systematic reviews as
using non-traditional acupuncture points, superficial puncturing ofthe skin without
stimulation, introduction ofa sensation without puncturing (eg. acupresssure), or, in
the case of elechoacupuncture, the use ofelectro stimulators without connecting the
cables s. 'Sham' acupuncture, the most commonly used control in acupuncture studies,
is where needling is done at theoretically irelevant sites t3.50. It was initially believed
that acupuncture at these sites would have no effect, but many people now believe that
inserting a needle anywhere in the body or applying pressure to any site evokes a
response s2. s3, 57. This evocation of response can also be found with other placebo
controls mentioned. Others believe that there is a strict process to ensuring that'sham'
is truly placebo. based on where the needling is done in relation to the treatment
aCuPuncture 56.
The specific and nonspecific effects ofsham techniques are unclear. For example, ifthe
sham control group also shows benefits, the acupuncture featment may be deemed
ineffective in comparison to the 'control' group; however, this may be misleading ifthe
'sham' featment was actually evoking a physiological response similar to the
acupunctu.e treatment group. Though this does not clarify the issue around placebo
controls, it does illustrate the complexity, and the impact ofindividual trcatment styles.
Though the effects, both specific and non-specific, of acupuncture at various sites need
to be determined, the value ofsham acupuncture as a control is clear: the patients can
then be blinded to treatment, 'improving' the quality ofthe research study 58. The
choice ofcontrol group in acupuncture research. Iike in conventional medicine research,
needs to be guided by the research question. and the objectives ofthe research 52.
Complexities of acupuncture
Acupuncture is a complex 'umbrella' oftreatment apprcaches. Acupuncture includes
such a diverse constellation ofphilosophies and treatment styles. This means the most
accurate determination ofeffectiveness of acupuncture should include the evaluation of
each single, well-defined approach, versus evaluating the 'umbrella' oftreatments as a
single approach 58. However, the many types and methods of acupuncture are often
combined and compared in the systematic reviews. For example, manual stimulation
and electrostimulation have seldom been compared to each other as to their
effectiveness, but are considered the same in many systematic reviews.
As well, many microsystems are used in treating varying conditions. Ear acupuncture
is perhaps the most widely used, although other systems such as scalp, hand, foot, nose,
and abdominal acupuncture are also considered specialties. Formula and TCM
acupuncture are two diiferent styles. which are also often grouped together in reviews.
TCM focuses on a balanced system. It uses point selection based on symptoms, pulse,
and tongue diagnoses, and the choice of points used may vary from day to day as the
balance shifts. The "formula" or standardized approach in which the same prescription
ofpoints are used for each patient repeatedly is better suited for research, but perhaps
not reflective ofactual experience 5.7.
The individualization of diagnosis and treatment may be more similar to
psychotherapy or physiotherapy where the skill ofthe therapist and the bond with the
patient are as important in producing an elfect as the treatment strategies 7.ae. Thempy
is adjusted according to the subtle shifLs as they occur rather than continuing with a
standard pattern. There have not been studies to elucidate the effectiveness ofany one
ofthese acupuncture approaches over the other or whether they are equal in their effect.
yet they are compared against placebo or sham in studies.
There is also variability in the technique ofneedle insertion and manipulation that may
influence the efficacy but are often not reported in studies. Electrical or manual
stimulation may alter the outcome. Diameter. length, depth of insertion, duration of
retention, the number of needles pe. treatment, tempemture ofthe needles, the number
oftreatments, and materials ofthe needles may all be factors which influence the
OUtCOme 7,49.
Linde et al. 2e included four expert opinions in acupuncture to evaluate the adequacy of
the acupuncture treatments from a clinician's percpective. They were given a
questionnaire to evaluate the choice ofacupuncture points used in the studies. Linde et
al. found a low level olagreement bet$,een the four experts and posed questions of
clinical relevance.
Few researchers have investigated what adequate acupuncture treatment is, due to the
complexity described above, and little agreement has been reached for the various
conditions treated with acupuncture. Birch broke this challenge down into the
administration ofadequate treatments, and the adequacy ofthe repo.ting ofthe
treatments 5r. The difnculties in determining adequate treatment can be captured by the
following: Which sources,/evidence does one use? Can the treatments from a study be
standardized to a broader population, or is it specific to those individuals? How many
treatment points and sessions are the correct number for certain conditions? Is the
condition used alone or in conjunction with any other modes oftreatment? sr. The issue
ofinadequate reporting makes assessment ofthe research difftcult and makes the
gene.alizability impossible. The inclusion ofkey information is necessary to be able to
determine the adequacy ofthe treatment used.
positive outcomes 28 32 34 37. 38. This makes the determination of efficacy very difficult, as
it is hard to differentiate between true positive effects, and false positive effects due to
poor study quality, leading to inconclusive results.
There is also the issue ofassessing methodological quality ofstudies, not only for
acupuncture specifically, but for complementa.y medicine overall. Acupuncture is
based on differing philosophical models 4. 4e than Western Medicine. Using
methodological c te.ia validated in conventional clinical tdals, to evaluate acupuncture
trials may not be appropriate 4e. As in the determination of adequate treatment, one
needs to attempt to separate the quality ofthe research from the quality ofthe
reporting 60.
Many systematic reviews examined in this report used the Jadad Scale 40.61 as their
quality assessment tool, as it is 'the'validated tool among the assessment scales
available 61. This scale includes five criteria (see Appendix C), four ofwhich look at
randomization and blinding. Therefore, if a study does l1ot describe the randomization
process or blinding methodology, the quality is deemed to be poor, without considering
other criteria 5e. It also does not evaluate specifics important in acupuncture elficacy
research, such as the appropriateness oftreatment, the skill ofthe the.apist, and the
type and duration of treatment. Difficulties in blinding both practitioner and
patient a ae are intrinsic to acupuncture, and some criticism ofthe Jadad Scale has been
based on this 5e. Double blinding can, however, also be ofthe patient and the assessor
ofthe results, which means that acupuncture research could meet this c terion after all
6t. 62. This latter inclusion for double blinding is not known or understood by some
researchers. so studies may meet that criterion and be underscored in the quality
assessment.
Any quality scale should explore the clinical relevance ofthe question, the intemal and
extemal validity, the appropdateness ofthe methodologies, and the ethical
implications. There are many scales presently being used. though the key criteria to be
assessed have not been agreed upon. Experts debate whether five criteria, such as the
Jadad Scale, are enough to effectively determine quality of any research 5e and. on the
other hand, whether longer lists of criteda may be too unwieldy. There is also some
discussion whethe. scoring studies using set criteria is a useful tool for determining the
quality olthe research 60 61. The criteria are often used solely to present the study data
(10 trials were randomized. 12 were not) in a standard format, rather than to use it as a
tool to analyze the study. These issues also extend to the systematic reviews, as the
quality ofreviews varied f.om poor to good, and the review details provided were
minimal in some cases 28. 37, 3e. Associated with this is the lack of agreement on an
appropriate tool to assess the quality ofstudies in complementary medicine.
The continuing goal is the development ofstandardized and accepted criteria that are
effective in evaluating the quality ofstudies in complementary and alternative
mediajne 26,39,59.
DrscussroN
This project was undertaken to provide a critical appraisal ofthe scientific literature and
determine the status ofacupuncture as a treatment option for various conditions, to
assist health care decision-makers in Alberta, both rcgionally and provincially
regarding acupuncture services. Acupuncture has become increasingly popular,
especially for conditions of a chronic or recurring nature. Though the determination of
effectiveness of trcatment for each condition is the primary objective ofthe report, much
ofthe discussion has focused on the quality ofthe evidence and the issues in
acupuncturc treatment and research.
Just as there are methodological limitations ofthe prima.y research studies, there are
methodological limitations ofsystematic reviews, The quality ofthe systematic review
is impacted by the quality of the reporting of the studies included in the review. This is
even more ofan issue when critically appraising systematic reviews, which is further
removed lrom the primary rcsearch.
Overall. the systematic reviews examined (10 out of 18, excluding Cochrane Reviews,
had ratings ofpoor to satisfactor, were oflow quality methodologically, and reported
mixed findings with inconclusive results. Dental pain, and nausea,/vomiting are the
two conditions for which evidence supported the efficacy ofacupuncture as a
treatment.
For dental and TMD pain. two reviews both found that acupuncture can be effective as
a treatment, though there was no discussion as to the specific type and method of
acupuncture that would be the most appropriate 2?. 24. Rosted, finding most studies in
favour ofacupuncture, had concerns with the clinical relevancy ofsuch findings, as
there are other analgesics available, with simpler procedures 22.
A Cochrane Review oa headaches found that though the procedures seemed safe, there
were mixed results, and therefore the authoN made no statements regarding the
efficacy ofacupuncture for migraine or tension headaches a1.
The one review on tinnitus found that there was no difference between acupuncture
and sham, and that the evidence did not support ofthe use ofacupuncture 23.
Three reviews including a Cochrane Review on asthma reported inconclusive results,
and that claims of efficacy \ /ere not supported. One difference with the study by
Kleijnen et al. 28. however, is that they used only relative effectiveness as their
outcomes, meaning that acupuncture would have to be more, not equally effective to
the controls, to show results. Though the evidence was not strong enough to support
claims of efficacy. Linde et al. 2e concluded that the evidence was also not shong enough
to recommend to those using it, to discontinue. Overall, however, the use of
acupuncture was not supported for the treatment ofasthma.
The one review on st.oke rehabilitation found that though the evidence did not
support acupuncture effectiveness, the findings were promising enough to warrant
CoNcLUSIoNS
Growing demands on the health care system for public funding ofcomplementary
health seryices, the changes in legislation regarding the regulation ofhealth care
professionals, in conjunction with demand from the community for funding coverage
for acupuncture treatment underline the importance and timeliness of this review.
A large body of primary research exists in acupuncture, covering virtually every
symptom. Due to the breadth of this topic and the challenge of reviewing the extensive
body ofresearch on acupuncture, the approach of systematically assessing the available
reviews was chosen to evaluate the current evidence for the efficacy ofacupuncture. In
choosing this approach, it is acknowledged that there are limitations.
There are many issues in acupuncture research which are highlighted briefly in this
report that need to be explored and addressed in future studies. These issues range
from the assessment ofstudy methodology to the appropriateness ofan acupunctu.e
treatment regimen. The studies included in the reviews had many limitations and
variations. Variability among the studies included the technique of needle insertion
and manipulation, grouping of range ofacupuncture techniques, the number ofneedles
per treatment, temperature ofthe needles, material composition ofthe needles, and
selection ofconhol comparatoF. All ofthese factors may influence the study's
outcomes and the overall conclusions ofthe systematic reviews,
Many researchers concur that acupuncture is a relatively safe procedure howevet. it is
not without risk. Acupuncture can lead to both minor (drowsiness. nausea and
fainting) and serious (traumatic injury ofbody tissue) adverse events. There is an
increasing amount of literature published on adverse effects ofacupuncture, but there is
still a concern about under reporting.
Twenty-three systematic reviews on conditions such as dental pain/TMD, headaches,
tinnitus, asthma, stroke, nausea/vomiting. neck/back pain, chronic pain, ftbromyalgia,
labour, addictions, and obesity, were included in this appraisal ofsystematic reviews.
This systematic review confirms the findings from other reviews which indicate
consistent support for the effectiveness of acupuncture in the treatment ofpostoperative
nausea/vomiting. and dental pain. For other indicators the robustness ofthe effect of
acupuncture is debatable and its clinical value questionable for conditions such as
idiopathic headaches, chronic pain, smoking and fibromyalgia, ho'"'i,ever some reviews
indicated promising results. The results from these reviews 27 3136 ar, the majority of
which had a good quality rating, found acupuncture to be as effective as the alternative
interventions or no treatment in the short term.
Overall, in terms of the volume ofresearch that has been created in studying
acupuncture there is a paucity of good quality research with large sampie sizes,
randomization, and control for placebo effects. There was a lack of study detail
provided in the reviews in regards to descriptions ofthe practitioners inirolved, Hence
it was not possible to relate treatment effect or no effect to service provider.
APPENDx A: METHoDoloGy
Two searches were performed inJanuary andJuly 2001. The following outlines the
search strategy and the databases used. Effort was made to find criteri; accepted by the
acupuncture community as well as the scientific community for use in the critical
appraisal ofthe quality ofsystematic reviews for acupuncture. No quality assessment
tool specific to acupuncture was found.
Two ofthe co-authors (LB and CH) selected the arlicles based on the inclusion and
exclusion criteria while two co-authors (LB and pLT) extracted data lrom the re\,iews
and evaluated their methodological quality using criteria by Greenhalgh 2r as outlined
in Appendix B, The authors of the reviews were not contacted for misiing information.
Search Strategy
Databases Searched Subject headings (Bolded) and Textwords combinations
IVEDLiNE (Ovid) Acupuncture (exploded) OR acupuncture
1990-May2001 acupressure OR Electroacupuncture OR
and PTeMEDLINE electro-acupuncture OR staple acupuncture OR
to Ju v 21. 2001 staple-acupuncture OR stapleacupuncture OR staple puncture OR
HeahhSTAR (Ovrd) staple-puncture OR slaplepuncture OR moxibusiion
1991- Jan 2000 - database
disconlinued
Best evidence (Ovid)
Jan/Feb 2001
CINAHL (ovid)
1990-March 2001
EMBASE (Ovid)
199 2AA1
AMED (Ovid)
l\4av 2001
Cochaane Database of Acupunctur' OR acupressure OR eleciroacupuncture OR
Syslematic Reviews e ectro-acupuncture OR staple acupunct!re OR
1st Ouarter 2001
staple-acupuncture OR stapleacupuncture OR staple puncture OR
slap e-punciure OR stapleouncture OR nroxibusiion
CMA praclice guide lnes- acupuncture OR moxibustion
CPG lniobase
June 22,2aA1
National guide ine acupunclure OR moxibLtstiof
cearinghouse
June 22 2AA1
DARE HTA, EED AcLrp OR moxibustion
June.2001
Two other databases, ISTAHC. Psyclnfo (February 2001), were searched but there were
no relevant studies found. Articles were submitted by various people interested in
acupuncture. and access was gmnted to a private collection ofjournals ofacupuncture.
This 'grey literature'was hand searched for articles that complied with rhe inclusion
cdte.ia. Reference lists of retrieved reviews were search for systematic reviews and
meta analyses.
Publlcation type limirs (where available): meta-analysis, systematic review
"A systematic review is an oveNiew olprimary studies that use explicit and
reproducible methods" 21.
"A meta analysis is a mathematical synthesis ofthe results of two or more primary
studies that addressed the same hypothesis in the same way" 2r.
These publication types were searched as textwords and where publication type
Iimiting was not available by using this search stringr (Subject headings OR Textwords)
AND (systematic review OR meta analysis OR critical appraisal OR metaanaly$ OR
meta-analy$ OR metanalys OR critical$ apprais$ OR systematic$ review$)
Inclusion diteria: Articles were selected if they were systematic leviews, which
includes but is not limited to meta-analyses. The study must have human participants,
but with no restriction ofage group or nationality. Reviews were requi.ed to have an
intervention of acupuncture as being the primary treatment intervention in the study.
Studies addressing any medical indication were included if they were published within
the past ll years (1990 - 2001). Only reviervs available in English were evaluated.
Exclusion criteria: Reviews were excluded if the use ofa tool to evaluate the
methodological quality of the primary studies rvas not apparent. If reviews used the
same methodological c.iteda and had the majority of primary studies in common, the
older publications were excluded.
lncluded studies:
. Ernst E, Pitder MH. The elfectiveness ofacupuncture in treating acute dentalpain: a
systematic review 21
. Smith LA, Oldman AD, McQuay Hj, Moorc RA. Teasing apart quality and validity in
systematic feviews: an example from acupuncture trials in chnnic neck and back pain 32
. Strauss AJ. Acupuncture and the treatment of chronic low-back pain: a review of the
Iiterature26
. Berman BM, EzzoJ, Hadhazy V, SwyerslP. Is acupuncture ellective in the treatmert of
fibromyalgia? 27
. Ezzo J, Berman B, Hadhazy VA, Jadad AR, Lao L, Singh BB . Is acupuncture ellective
f1r the treatment ofchronic pain? A systematic review3a
r ter Riet G, Kleijnen J, Knipschild P. Acupuncture and chronic pain: a criteia-based meta
analysis 3s
. White AR, Resch KL, Ernst E. A meta-analysis of acupuncture techniques for smoking
cessation 3i
. ter Riet G, KleijnenJ, Knipschild P. A meta-analysis ofstudies into the ellect of
ac up u ncture on addic tio n 38
. Ernst E, White AR, Acupuncturc for back pain: a meta-analysis of nndomized contt,lled
trials 36
Excluded Studies:
. Ernst E, White AR. Acupuncturc as a treatment for temporomandibularjoint dydunction:
a systematic review of randomind trials63 - methodological quality was not discussed
I r'o,",v. I sludies.lrials
methods of lhe sludy
Difficuli lo glean the
l."uo".
lctscotr rr'.t
I
acupuncture techniques. praclical implications.
I
l",pu,r"in tn" I I acupunclure that is best
for denlal analgesia, and
I
I
I I oL,orrsrreo ano I I
I
wdl I
l _l
(15)
(6)
- mixed (1)
(1)
AMED and
Brilish Library
supported by evidence.
Stroke Rehabilitation
complementary dalabases
There was a siqnficant The qualily assessmenl
lale (G48 reducl on in early onset
PONV in adults versus supported by reliability
30 placebo or drugs, and in
1999
PONV late onset PONV versus
Clear oulcome measures
IGoodl
and strong quanlitative
showed acupuncture as
lhough lhe
Summary of lhe quality
and the resulls. minimal
dala inlegration of the
(includins
TENS, acupoint
acupunclule in lreating
Their ovemll conclusions
were robust. and rculdn l
be significantly allercd if
inclusion c teria were
adjusted lo include or
exclude cerlain sludies
Disability Scale,
Chn
Obje.tives and inclusion
outcomes assessmenl l.
deiine signficance but we€
not pEsented in lhe Ev eu
Dala Ms well Jnlegraled
across studies 5nd rhe use
oi stalislical melhodologies
makes lhe lindinqs more
tEatment examined. lhe
Auihors reporled lhe €sulls
methodological scores.
More research needs lo
be conducted wilh more Study oulcomes were
only lisled as positive or
Fibromyalgia
Objectives and inciusion
cnleda we€ clear, and the
acupuncture, which may be
claled to lhe etiology ol ihe
disease. Physicians should
Only three studies had any
MANTIS, number ofFMS palienls follow 0p per ods, and iew
used any endpoint measues
lhal we€n t self-repo.led.
Qua ily assessment uses lwo
lnduction of Labour
Need for a welldesigned
RCT lo evaluate the mle
N=0RCTS
Smalh CA,
a3
Review 2001
childbinh
Group lrials
bibliogmphies
The ulility of
acuPunclurc in heroin robust in that they saw a
common Pattern across
sludies. which wouldn t
have changed dmstically
ifa study was removed.
alcohol addiclion needs
English was
when the sludies are of
involving
significantly Acupunclure has not
prcven lo be efficacious
as a trealmenl for these
randomizalion prccess
N = 18 RCTS
smoking compared Io
sham, bul appeared lo
(less than 6
rclhing
12 monlhs. lf
Social
poinls (including
Smoking&
Heallh.
Biological
DRUG.
bibliographies.
melhodological aspecls,
biochemical validation of
cessaiion, longer follow scenarios ifa study was
rcmoved, or some sludies
delails, werc grouped rogether
and analyzed, rcsulls
efiective lhan sham. or
lhal one acupuncture
I igour.
Ernsl E 1997
37 ctscoM, = 100 design.
l. Adequate desc ption ofthe population from which the participants are drawn.
2. Sample size adequate.
3. Random allocation to the treatment arms.
4. P.ognostic vadables adequately assessed.
5. Full description oftest inteNention.
6. Where possible a credible, inactive placebo should be used. If no placebo is
available. standard care may be used (but should have been compared previously to
placebo).
7. The use ofappropriate outcome measures for the condition and the therapy.
8. Patients blind to treatment allocation and researchers blinded when assessing
outcome,
9. Withdrawal and no-respondents less than 20% of initial sample.
10. Appropriate use ofinference statistics.
A ranking of very good receives 4 points, good - 3, fair - 2, not satislactory - 1 and
poor 0.
Ve.y good reflects a study which has adequately met the criteria and the results may be
considered valid-
Good reflects that the major crite a were met and the results have not been affected
Fair reflects the criteria have not been met fully and that the results have probably not
been affected
Poor reflects that the criteria have not been met adequately and that the outcome ofthe
study has probably been influenced by this.
Criteria Weight
C omp arab ility of prognosis
A. Homogeneity (1) 3
B. Prestratification (2) 3
C. Randomization 12
D. Comparability of relevant baseline characteristics shown 2
E. U 50 patients per group l0
F. < 20% loss to follow-up (3) 5
Adequate interyention
G. Avoidance ofDNIC (4) 2
H. Adequate description ofacupuncture procedure (5) 10
L Mentioning good quality ofthe acupuncturist 15
J. Existing treatment modality in reference group 3
Data presentation
R, Reader is given opportunity to do inferential statistics 5
Patient selection
a. were the eligibility criteria specified
b. treatmentallocation
i. was the method of mndomization described and adequate
ii. was the treatment allocation concealed
c. were the groups similar at baseline regarding the most important prognostic
indicato$
lntervention
a. were therapeutic and control interventions operationalized
b. was the care provider blinded
c. was controlled for co-interventions which could explain the results
d. was the compliance mte (in each group) unlikely to cause bias
e. was the patient blinded
Outcome measurement
a. was the outcome assessor blinded
b. was at least one ofthe primary outcome measures applied
c. was there a description ofadverse effects
d. was the withdrawal/drop-out rate unlikely to cause bias
e. timing of follow-up measurement perfomed
i. was a short-term follow-up measurement performed
ii. was a long-term follow-up measurement pe.formed
f. was the timing of the outcome assessment in both groups comparable
Statistics
a. was the sample size for each group described
b. did the analysis include an intention-to treat analysis
c. were the point estimates and measures ofvadability presented for the pdmary
outcome measures
Study Population
a. Description ofinclusion and exclusion criteria (l point)
b. Similarity ofrelevant baseline characteristics: the duration olcomplaints, value of
outcome measures, age, recurence status, radiating complaints (1 point)
Adequate validity, accuracy, and reliability of diagnosis point)
(1
Interventions
g. Interventions included in protocol and described adequately: acupuncturc treatment
described (5 points)
h. Pragmatic study: comparison with an existing treatment modality (5 points)
i. Co-interventions avoided: other physical therapy modalities or medical
interventions are avoided in the design ofthe study except analgesics (5 points)
j. Placebo (or sham) contrclled: comparison with a placebo or sham therapy (3 points).
Adequate description and use ofan appropriate placebo or sham (2 points).
k. Good qualification of acupuncturist: mentioning of qualified education and work
expedence ofthe acupuncturist (5 points).
Measurement of Effect
i. Patients blinded: placebo controlled: Attempts for blinding (3 points), blinding
evaluated and fully successful (2 points).
m. Outcome measures relevant: use (measured and reported) of: pain. global measure
of improvement, functional status (activities of daily living). spinal mobility,
medicine consumption (1 point each). Validity and reliability olinstruments (1
Poin0.
n. Blinded outcome assessments: each blinded measurement mentioned under point
M. Earns 2 points. Control of observer and subject bias (1 point).
o. Follow-up period adequate: moment of measurement during orjust after trcatment
(2 points). Moment of measurement 3 months or longer (2 points)
This Scale is to be used with trials that are randomized and have an N ) 10. There are
five main categories with a possible score being between 0 and 16.
1 Blinding maximum 6 points)
2. Size oftrial groups (maximum 3 points)
3. Outcomes (maximum 2 points)
4. Baseline pain and internal sensitivity (maximum 1 point)
5. Data Analysis (maximum 4 points)
. Definition of outcomes
. Data presentation: location and dispersion
. Statistical testing
. Handling oldropouts
Papers that summarise other papers (systematic reviews and meta-analyses) by Trisha
Greenhalgh 2r:
L Can you find an important clinical question which the review addressed?
2. Was a thorough search done ofthe appropriate databases and were other potentially
important sources explored?
3. Was methodological quality assessed and the trials weighted accordingly?
4. How sensitive are the results to the way the review has been done?
5. Have the numerical results been interpreted with common sense and due regard to
the broader aspects ofthe problem?
l. Patient's posture
2. Number ofneedles*
3. Needle size, manufacturer
4. Rationale and justification for point selection (traditional, tenderness, formulae)
5. Points used (international nomenclature), nonstandard points carefully described
6. Laterality
7. Depth*
8. Stimulation (eg manipulation, electrical, omoxabustion) strength and duration
9. Needle sensation induced
10. Duration of needling*
11. Frequency and number of repetitions**
12. Other simultaneous interventions
13. Subsequent changes to treatment
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