Av: Dieter Melchart, Andrea Streng, Andrea Hoppe, Benno Brinkhaus, Claudia Witt, Stefan Wagenpfeil, Volker Pfaffenrath, Michael Hammes, Josef Hummelsberger, Dominik Irnich, Wolfgang Weidenhammer, Stefan N Willich, Klaus Linde
Paper published 29 July 2005 on BMJ, Ref: doi:10.1136/bmj.38512.405440.8.F (see www.bmj.com)
Acupuncture in patients with tension-type headache: Randomized controlled trial
Objective – To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache.
Design – Three armed randomised controlled multicentre trial.
Setting – 28 outpatient centres in Germany.
Participants – 270 patients (74%women, mean age 43 (SD 13)years)with episodic or chronic tension-type headache.
Interventions – Acupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or waiting list control.
Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks.
Main outcome measure – Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in
Results – The number of days with headache decreased by 7. 2 (SD 6. 5)days in the acupuncture group compared with 6. 6 (SD
6. 0)days in the minimal acupuncture group and 1. 5 (SD 3. 7) days in the waiting list group (difference:acupuncture v minimal acupuncture, 0. 6 days, 95%confidence interval -1. 5 to 2. 6 days, P =0. 58;acupuncture v waiting list, 5. 7 days, 3. 9 to 7. 5 days, P <0. 001). The proportion of responders (at least 50%
reduction in days with headache)was 46%in the acupuncture group, 35%in the minimal acupuncture group, and 4%in the waiting list group.
Conclusions – The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache.
Trial registration number ISRCTN9737659.
Tension-type headache is essentially defined as bilateral
headache of a pressing or tightening quality without a known
Tension-type headache is classified as episodic if
it occurs on less than 15 days a month and as chronic if it occurs
A survey from the United States found a one year
prevalence of 38%for episodic tension-type headache and 2%
for chronic tension-type headache.
Acupuncture is widely used
for the treatment of tension-type headache, but its effectiveness is
In the acupuncture randomised trial in tension-
type headache (ART-TTH), we investigated whether acupuncture
reduced the frequency of headache more effectively than did
minimal acupuncture (superficial needling at non-acupuncture
points)or no acupuncture in patients with tension-type
Protocol, design, and randomisation
ART-TTH was a randomised multicentre trial comparing
acupuncture, minimal acupuncture, and a no acupuncture wait-
ing list condition. Minimal acupuncture served as a sham
intervention;we included the additional no acupuncture waiting
list control because minimal acupuncture is not a physiologically
inert placebo. Patients were blinded to treatment in the acupunc-
ture and minimal acupuncture arms of the study. Two blinded
evaluators analysed headache diaries. The methods of the trial
have been described in detail elsewhere.
After a baseline phase of four weeks, we used a centralised
telephone randomisation procedure (random list generated with
sample size 2. 0 by the statistician)to randomise patients,
stratified by centre (block size 12 unknown to trial physicians), in
a 2:1:1 ratio (acupuncture:minimal acupuncture:waiting list). We
used the 2:1:1 ratio to facilitate recruitment and increase the
compliance of trial physicians. All study participants provided
written, informed consent, and the study conformed to common
guidelines for clinical trials (Declaration of Helsinki, ICH-GCP,
including certification by external audit).
Inclusion criteria were a diagnosis of episodic or chronic
tension-type headache according to the criteria of the
International Headache Society,
at least eight days with
headache a month in the previous three months and in the base-
line period, age 18-65 years, duration of symptoms at least 12
months, completed baseline headache diary, and written
informed consent. Main exclusion criteria were additional
migraine headache, secondary headaches, start of headaches
after age 50, use of analgesics on more than 10 days a month,
prophylactic headache treatment with drugs during the previous
four weeks, and any acupuncture treatment during the previous
12 months or at any time if done by the participating trial physi-
cian. Most participants were recruited through reports in local
newspapers;a minority were patients who spontaneously
contacted trial centres.
We developed the study interventions in a consensus process
with German acupuncture experts and societies.
trained (at least 140 hours, median 500 hours)and experienced
(median 10 years)in acupuncture delivered the interventions.
Both the acupuncture and minimal acupuncture treatments
consisted of 12 sessions of 30 minutes, given over eight weeks
(preferably two sessions in each of the first four weeks, followed
by one session a week in the remaining four weeks).
Acupuncture treatment was semistandardised. All patients
were treated at “basic ”points bilaterally unless explicit reasons
for not doing so were given;additional points could be chosen
individually (box 1). We instructed physicians to achieve “de qi ”
(an irradiating feeling considered to be indicative of effective
needling)if possible and to stimulate needles manually at least
once during each session. The total number of needles was lim-
ited to 25 per session.
The number, length, and frequency of the sessions in the
minimal acupuncture group were the same as for the
acupuncture group. In each session, physicians needled at least
five out of 10 predefined distant non-acupuncture points (box 2)
bilaterally (at least 10 needles)and superficially using fine
needles. Physicians avoided “de qi ”and manual stimulation of
Patients in the waiting list control group did not receive any
prophylactic treatment for their headaches for a period of 12
weeks after randomisation. After that time, they received 12 ses-
sions of the acupuncture treatment described above.
All patients were allowed to treat acute headaches as needed.
Treatment was supposed to follow current guidelines
and had to
be documented in the headache diary.
Patients were informed with respect to acupuncture and
minimal acupuncture as follows:“In this study, different types of
acupuncture will be compared. One type is similar to the
acupuncture treatment used in China. The other type does not
follow the principles of traditional Chinese medicine, but has
also been associated with positive outcomes in clinical studies. ”
All patients filled in headache diaries in the four weeks before
randomisation (baseline phase), the 12 weeks after randomisa-
tion, and weeks 21 to 24 after randomisation. In addition, we
asked patients to fill in a pain questionnaire before treatment,
after 12 weeks, and after 24 weeks.
This included the following
validated scales:the German version of the pain disability index,
a scale for assessing sensoric and affective aspects of pain
the ADS depression scale,
and the German version of the SF-36 to assess health related
quality of life.
The primary outcome measure was the
difference in number of days with headache between the four
weeks before randomisation (baseline phase)and weeks nine to
12 after randomisation.
To test blinding to treatment and assess the credibility of the
different treatment methods, patients filled in a credibility ques-
tionnaire after the third acupuncture session.
At the end of the
study, patients were asked whether they thought that they had
received acupuncture following the principles of Chinese medi-
cine or the other type of acupuncture.
We based confirmatory testing of the primary outcome measure
and all main analyses (with SPSS 11. 5)on the intention to treat
population and used all available data. We used SOLAS 3. 0 (Sta-
tistical Solutions, Cork, Ireland)to do sensitivity analyses for the
primary outcome measure, replacing missing data with baseline
values or multiple imputation. We tested a priori ordered two
sided null hypotheses by using Student ’s t test (significance level
0. 05). In the first step we investigated whether acupuncture
reduced the number of days with headache more than no treat-
ment, and in the second step (only if the first null hypothesis was
rejected)we investigated whether acupuncture was more
efficacious than minimal acupuncture. We give exploratory
analyses (analysis of covariance adjusting for baseline differences
and _ tests)for predefined secondary outcome measures. We
did an additional per protocol analysis including only patients
without major protocol violations until week 12.
We made the original sample size calculation for one sided
testing. Under this premise we planned the study to have 80%
power to detect a group difference of two days with headache
assuming a standard deviation of five days (thus an effect size of
0. 4)and a 20%dropout rate.
However, we later decided to use Box 1:Acupuncture points used in the trial
All physicians used sterile, disposable, single use needles but were
free in their choice of length and diameter of needle
•Gall bladder (GB)20
•Mainly frontal headache:large intestine (LI)4, Du Mai (DU)
23, extra points Yintang and Taiyang, stomach (ST)44, GB 2
•Headache mainly in the vertex:DU 20 or 23, extra point Si
•Mainly neck pain:bladder (BL)10, 60, or 62;DU 14 or 19;
small intestine (SI)3 or 6
•Holocephalic pain with fatigue:extra point Taiyang, spleen
(SP)6 or 9, ST 36 or 40, Ren Mai (REN)12
•Worse with wet or cold weather:LI 4, DU 14, GB 3, Sanjiao (SJ)
6, GB 39
•Modalities wind, dampness, cold:LI 4, DU 14, SJ 6, GB 34
•Modalities cold, wind:LI 4, lung (LU)7, SJ 5, DU 14
Box 2:Minimal acupuncture points used in the trial
•“Deltoideus ”—in the middle of the line insertion of M
deltoideus (LI 14)and acromion
•“Upper arm ”—2 cun laterally of LU 3
•“Forearm ”—1 cun ulnar of the proximal third of the line
between heart (HE)3 and HE 7
•“Scapula ”—1 cun laterally of the lower scapular edge
•“Spina iliaca ”—2 cun above spina iliaca anterior superior in
vertical line to the arch of left ribs
•“Back I ”—5 cun laterally of the spine of lumbar vertebrum IV
•“Back II ”—5 cun laterally of the spine of lumbar vertebrum V
•“Upper leg I ”—6 cun above the upper edge of the patella
(between the spleen and stomach meridians)
•“Upper leg II ”—4 cun above the upper edge of the patella
•“Upper leg III ”—2 cun dorsally of GB 31 (avoiding bladder
A cun is defined according to the rules of traditional
acupuncture as the width of the interphalangeal joint of the
patient ’s thumb
two sided testing to comply better with common standards.
Before starting the analysis, and on the basis of the recommen-
dation of the ethical review board, we decided to exclude the data
from one centre that had included 26 patients, owing to repeated
severe protocol deviations and the suspicion of data manipula-
tion in some patients. We decided to do a sensitivity analysis
including this centre ’s data.
Within the 24 weeks after randomisation a total of three serious
adverse events (two acupuncture, one waiting list)were
documented. All cases were hospital stays considered unrelated
to the study (two diagnostic interventions, one elective surgery).
Twenty three patients in the acupuncture group reported a total
of 30 side effects compared with 11 patients in the minimal acu-
puncture group reporting a total of 14 side effects. The most
commonly reported side effects were triggering of headache or
other pain, haematoma, and dizziness.
The acupuncture intervention tested in this study was
significantly more effective than no preventive treatment but not
significantly more effective than the minimal acupuncture inter-
vention in patients with tension-type headache.
Strength and weaknesses
Compared with available studies of acupuncture for tension-type
which included up to a maximum of 69 patients,
our study has a much larger sample size. Other advantages
include adherence to current guidelines for headache trials,
strictly concealed central randomisation, an assessment of the
credibility of interventions, blinded evaluation of diaries,
interventions based on expert consensus provided by qualified
and experienced medical acupuncturists, high follow-up rates,
and an external audit of the quality of data.
Although the groups were comparable for sociodemo-
graphic characteristics and headache outcomes at baseline,
differences existed for some scores on the pain questionnaire in
Table 3 (not complete on this website)
Secondary outcome measures after treatment
The credibility of acupuncture and mini-
mal acupuncture was rated very similarly by patients, but guesses
about treatment allocation at the end of the trial differed slightly
between the acupuncture and minimal acupuncture groups,
which might indicate some degree of unblinding. Trial
physicians could not be blinded. Therefore, the small
non-significant differences between acupuncture and minimal
acupuncture could be due to bias. It was not possible to blind
waiting list patients, so we cannot rule out that the difference
from acupuncture and minimal acupuncture is overestimated.
However, several arguments exist as to why the influence of bias
should be limited. A slight improvement over time occurred in
the waiting list group in the first 12 weeks;this was probably due
to the natural course of the disease. This improvement, however,
makes it unlikely that patients in the waiting list group reported
negatively biased data in their diaries. Use of analgesics was lower
in both the acupuncture and minimal acupuncture groups than
in the waiting list group, making an influence of effective
co-interventions unlikely. Follow-up data confirmed the
improvements observed after treatment. After completion of the
treatment, patients had no further contact with acupuncturists;
they received and sent diaries and questionnaires directly to the
study centre, decreasing the likelihood of positively biased diary
Interpretation of findings
The lack of significant differences between acupuncture and
minimal acupuncture in our study indicates that point location
and other aspects considered relevant for traditional Chinese
acupuncture did not make a major difference. Although our
treatment strategy was consensus based, we cannot rule out the
possibility that a different approach would have yielded a differ-
ent result. Our findings are similar to those of three of the avail-
12 13 16
whereas two found significant effects of
acupuncture over sham acupuncture.
A recent large,
pragmatic trial from the United Kingdom found that adding
acupuncture to general practitioners ’care for headache was
more effective than general practitioners ’care alone.
mainly included patients with migraine, however, and subgroup
analyses suggested that patients with tension-type headache
might benefit less.
An intriguing finding of our trial is the strong and lasting
response to minimal acupuncture. The improvement over, and
the differences compared with, the waiting list group are clearly
clinically relevant. The minimal acupuncture intervention in our
study was designed to minimise potential physiological effects by
needling superficially at points distant from classical sites as well
as by using fewer needles than in the acupuncture group. How-
ever, it cannot be considered completely inert. The physiological
effects of superficial needling distant from classical acupuncture
sites may include local alteration in circulation as well as a wide
range of neurophysiological and neurochemical responses such
as release of neurotransmitters or activation of segmental and
heterosegmental antinociceptive systems.
Another explanation for the improvements we observed
could be that acupuncture and minimal acupuncture are associ-
ated with particularly potent placebo effects. Some evidence
shows that complex medical interventions or medical devices
have higher placebo effects than placebo drugs.
treatment has characteristics that are considered relevant in the
context of placebo effects.
It has an “exotic ”conceptual frame-
work with emphasis on the “individual as a whole, ”it is associated
with frequent patient-practitioner contacts, and it includes the
repeated “ritual ”of needling. Finally, the high expectations of
participants and our way of informing patients might have been
a relevant factor.
A significant proportion of patients with tension-type headache
benefited from acupuncture. The size of the effect seems compa-
rable to those of accepted treatments for tension-type headache
and is larger than that found in most trials comparing placebo
interventions with no treatment.
Acupuncture was well toler-
ated, and improvements lasted several months after completion
of treatment. However, minimal acupuncture —the superficial
needling of non-acupuncture points —had a similar effect.
We thank the acupuncture experts who participated in the consensus proc-
ess to establish the trial interventions. Trial centres contributing to the main
analysis are listed on bmj. com. The trial was initiated after a request from
German health authorities (Federal Committee of Physicians and Social
Health Insurance Companies, German Federal Social Insurance Authority)
and sponsored by German Social Health Insurance Companies. The health
authorities had requested a randomised trial including a sham control con-
dition with an observation period of at least six months to decide whether
acupuncture should be included in routine reimbursement. All other deci-
sions on design, data collection, analysis, and interpretation, as well as pub-
lication, were the responsibility of the researchers.
Contributors: All authors participated in the planning of the protocol and
revision of manuscript drafts. DM, KL, AS, BB, and CW were responsible for
general trial coordination. AS and AH were responsible for monitoring trial
centres ’activities. SW, WW, and KL did the statistical analysis. SW was
responsible for randomisation. VP provided neurological expertise. MH,
JH, and DI developed the acupuncture intervention. SNW and DM had
general medical and scientific responsibility. DM, AS, BB, CW, SNW, and KL
Funding:Study activities at the Centre for Complementary Medicine
Research, Munich, were funded by the following social health insurance
funds:Deutsche Angestellten-Krankenkasse (DAK), Hamburg;Barmer
Ersatzkasse (BEK), Wuppertal;Kaufmännische Krankenkasse (KKH), Han-
nover;Hamburg-Münchener Krankenkasse (HaMü), Hamburg;
Hanseatische Krankenkasse (HEK), Hamburg;Gmünder Ersatzkasse
(GEK), Schwäbisch Gmünd;HZK Krankenkasse für Bau-und Holzberufe,
Hamburg;Brühler Ersatzkasse, Solingen;Krankenkasse Eintracht Heusen-
stamm (KEH), Heusenstamm;Buchdrucker Krankenkasse (BK), Hannover.
Study activities at the Institute for Social Medicine, Epidemiology and
Health Economics, Berlin were funded by the following social health insur-
ance funds:Techniker Krankenkasse (TK), Hamburg;Betriebskrankenkasse
(BKK)Bosch;BKK Daimler Chrysler;BKK Bertelsmann;BKK BMW;BKK
Siemens;BKK Deutsche Bank;BKK Hoechst;BKK Hypo Vereinsbank;
BKK Ford;BKK Opel;BKK Allianz;BKK Vereins-und Westbank;Handel-
Competing interests:MH, JH, and DI have received fees for teaching
acupuncture in courses of professional societies. All other authors:none
Ethical approval:The protocol was approved by all relevant local ethics
1 International Headache Society. ICH-10 guide for headaches. Cephalalgia
What is already known on the topic
Acupuncture is widely used in patients with tension-type
Available trials had small sample sizes and controversial
What this study adds
In this randomised trial, acupuncture had a significant and
clinically relevant effect over no treatment
However, minimal acupuncture (superficial needling distant
from traditional acupuncture points)had a similar effect
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(Accepted 27 May 2005)
doi 10. 1136/bmj. 38512. 405440. 8F
Centre for Complementary Medicine Research, Department of Internal Medicine
II, Technische Universität München, Kaiserstr 9, 80801 Munich, Germany
Dieter Melchart director
Andrea Streng researcher
Andrea Hoppe researcher
Wolfgang Weidenhammer biostatistician
Klaus Linde epidemiologist
Institute of Medical Statistics and Epidemiology, Technische Universität München
Stefan Wagenpfeil statistician
Department of Neurology, Technische Universität München
Michael Hammes neurologist
Institute of Social Medicine, Epidemiology, and Health Economics, Charité
University Medical Centre, Berlin, Germany
Benno Brinkhaus internist
Claudia Witt epidemiologist
Stefan N Willich professor
Private practice, Munich
Volker Pfaffenrath neurologist
Josef Hummelsberger internist
Department of Anesthesiology, University of Munich, Munich
Dominik Irnich anaesthetist
Division of Complementary Medicine, Department of Internal Medicine,
University Hospital Zurich, Switzerland
Dieter Melchart researcher
Correspondence to:K Linde Klaus. Linde@lrz. tu-muenchen. de