*Although 2 patients assigned to the acupuncture group came only to
the initial examination but did not return at the end of the baseline phase,
one of the large study centers erroneously registered them for randomization.
According to the analysis plan the intent-to-treat population comprised only
patients with baseline data.
Error bars indicate 95% confidence intervals.
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Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for Patients With MigraineA Randomized Controlled Trial. JAMA. 2005;293(17):2118–2125. doi:10.1001/jama.293.17.2118
Context Acupuncture is widely used to prevent migraine attacks, but the available
evidence of its benefit is scarce.
Objective To investigate the effectiveness of acupuncture compared with sham acupuncture
and with no acupuncture in patients with migraine.
Design, Setting, and Patients Three-group, randomized, controlled trial (April 2002-January 2003)
involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine
headaches, based on International Headache Society criteria. Patients were
treated at 18 outpatient centers in Germany.
Interventions Acupuncture, sham acupuncture, or waiting list control. Acupuncture
and sham acupuncture were administered by specialized physicians and consisted
of 12 sessions per patient over 8 weeks. Patients completed headache diaries
from 4 weeks before to 12 weeks after randomization and from week 21 to 24
Main Outcome Measures Difference in headache days of moderate or severe intensity between
the 4 weeks before and weeks 9 to 12 after randomization.
Results Between baseline and weeks 9 to 12, the mean (SD) number of days with
headache of moderate or severe intensity decreased by 2.2 (2.7) days from
a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease
to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture
group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting
list group. No difference was detected between the acupuncture and the sham
acupuncture groups (0.0 days, 95% confidence interval, −0.7 to 0.7 days; P = .96) while there was a difference between
the acupuncture group compared with the waiting list group (1.4 days; 95%
confidence interval; 0.8-2.1 days; P<.001). The
proportion of responders (reduction in headache days by at least 50%) was
51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in
the waiting list group.
Conclusion Acupuncture was no more effective than sham acupuncture in reducing
migraine headaches although both interventions were more effective than a
waiting list control.
Migraine is a common and disabling condition that typically manifests
as attacks of severe, pulsating, 1-sided headaches, often accompanied by nausea,
phonophobiaor or photophobia. Population-based studies suggest that 6% to
7% of men and 15% to 18% of women experience migraine headaches.1,2 Although
in most cases it is sufficient to treat acute headaches, many patients require
interval treatment as attacks occur often or are insufficiently controlled.
Drug treatment with β-blockers, calcium antagonists, or other agents
has been shown to reduce the frequency of migraine attacks; however, the success
of treatment is usually modest and tolerability often suboptimal.3
Acupuncture is widely used for preventing migraine attacks although
its effectiveness has not yet been fully established.4 Since
2001, German social health insurance companies have reimbursed accredited
physicians who provide acupuncture treatment for chronic pain. By December
2004 more than 2 million patients had been treated with acupuncture, about
a third of these had migraine or tension-type headaches. In this study, the
Acupuncture Randomized Trial (ART-Migraine), we investigated whether acupuncture
reduced headache frequency more effectively than sham acupuncture or no acupuncture
in patients with migraines.
The methods of this trial have been described in detail elsewhere.5 The ART-Migraine was a randomized, multicenter trial
comparing acupuncture, sham acupuncture, and a no-acupuncture waiting list
condition. The additional no-acupuncture waiting list control was included
because sham acupuncture cannot be substituted for a physiologically inert
placebo. Patients in the acupuncture groups were blinded to which treatment
they received. Analysis of headache diaries was performed by 2 blinded evaluators.
The study duration per patient was 28 weeks: 4 weeks before randomization,
the baseline; 8 weeks of treatment; and 16 weeks of follow-up. Patients allocated
to the waiting list received true acupuncture after 12 weeks and were also
followed up for 24 weeks after randomization (to investigate whether changes
were similar to those in patients receiving immediate acupuncture).
After the baseline period patients meeting the inclusion criteria were
randomly stratified by center (block size 12 not known to trial centers) in
a 2:1:1 ratio (acupuncture:sham acupuncture:waiting list) using a centralized
telephone randomization procedure (random list generated with Sample Size
2.0).6 The 2:1:1 ratio was used to facilitate
recruitment and increase the compliance of trial physicians. All study participants
provided written informed consent. The study was performed according to common
guidelines for clinical trials (Declaration of Helsinki, International Conference
on Harmonization–Good Clinical Practice including certification by external
audit). The protocol had been approved by all relevant local ethics review
To be included, patients had to have a diagnosis of migraine, with or
without aura, according to the criteria of the International Headache Society7; 2 to 8 migraine attacks per month during the last
3 months and during the baseline period; be aged 18 to 65 years; had had migraines
for at least 12 months; had completed baseline headache diary; and provided
written informed consent. Main exclusion criteria were interval headaches
or additional tension-type headache on more than 10 days per month; inability
to distinguish between migraine attacks and additional tension-type headache;
secondary headaches; start of headaches after age 50 years; use of analgesics
on more than 10 days per month; prophylactic headache treatment with drugs
during the last 4 weeks; and any acupuncture treatment during the last 12
months or at any time if performed by the participating trial physician.
Most participants were recruited through reports in local newspapers;
some patients spontaneously contacted the trial centers.
Study interventions were developed by consensus of acupuncture experts
and societies and were provided by physicians trained (at least 140 hours,
median 500 hours) and experienced (median 10 years) in acupuncture. Both the
acupuncture and sham acupuncture treatment consisted of 12 sessions of 30
minutes’ duration, each administered over a period of 8 weeks (preferably
2 sessions in each of the first 4 weeks, followed by 1 session per week in
the remaining 4 weeks).
Acupuncture treatment was semistandardized. All patients were treated
at what are called basic points (gallbladder 20, 40, or 41 or 42, Du Mai–governing
vessel 20, liver 3, San Jiao 3 or 5, extra point Taiyang) bilaterally unless
explicit reasons for not doing so were given. Additional points could be chosen
individually, according to patient symptoms.5 Sterile
disposable 1-time-use needles had to be used, but physicians could choose
needle length and diameter. Physicians were instructed to achieve “de
Qi” (in which patients experience an irradiating feeling considered
to be indicative of effective needling) if possible, and needles were stimulated
manually at least once during each session. The total number of needles was
limited to 25 per treatment.
Number, duration, and frequency of the sessions in the sham acupuncture
group were the same as for the acupuncture group. In each session, at least
5 out of 10 predefined distant nonacupuncture points (see Melchart et al5 for details) were needled bilaterally (at least 10
needles) and superficially using fine needles (ie, minimal acupuncture). “De
Qi” and manual stimulation of the needles were avoided. All acupuncturists
received oral instructions, a videotape, and a brochure with detailed information
on sham acupuncture.
Patients in the waiting list control group did not receive any prophylactic
treatment for their headaches for a period of 12 weeks after randomization.
After that period they received 12 sessions of the acupuncture treatment described
All patients were allowed to treat acute headaches as needed. Attack
treatment should follow the guidelines of the German Migraine and Headache
Society8 and had to be documented in the headache
Patients were informed with respect to acupuncture and sham acupuncture
in the study 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 these principles, but has also been
associated with positive outcomes in clinical studies.”
All patients completed headache diaries for 4 weeks before randomization
(baseline phase), during the 12 weeks after randomization, and during the
weeks 21 to 24 after randomization. In addition, patients were asked to complete
a modified version of the pain questionnaire of the German Society for the
Study of Pain9 before treatment, after 12 weeks,
and after 24 weeks. The questionnaire includes questions on sociodemographic
characteristics, numerical rating scales for pain intensity, questions on
workdays lost, global assessments, etc, as well as the following validated
scales: (1) the German version of the Pain Disability Index10;
(2) a scale for assessing emotional aspects of pain (Schmerzempfindungsskala
SES)11; (3) the depression scale Allgemeine
Depressionskalla12; (4) the German version
of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) to
assess health-related quality of life.13
Primary outcome measure was the difference in number of days with headache
of moderate or severe intensity between the 4 weeks before randomization (baseline
phase) and weeks 9 to 12 after randomization. Predefined secondary outcomes
included the number of migraine attacks (episodes of migraine headaches separated
by pain-free intervals of at least 48 hours), total number of headache days,
proportion of treatment responders, and days with medication.
To test blinding to treatment and to assess the credibility of the respective
treatment methods, patients completed a credibility questionnaire after the
third acupuncture session.14 At the end of
the study, patients were asked whether they thought that they had received
acupuncture following the principles of Chinese medicine or the other type
Physicians documented acupuncture treatment, serious adverse events
and adverse effects for each session. Adverse effects were also reported by
patients at the end of week 12.
Confirmatory testing of the primary outcome measure (using SPSS 11.5,
SPSS Inc, Chicago, Ill) was based on the intention-to-treat population, replacing
missing data by baseline values (thus, setting differences compared with baseline
to zero). A priori ordered 2-sided null hypotheses to be tested were (1) the
primary outcome measure in the acupuncture group = outcome in waiting
list; and (2) outcome in the acupuncture group = outcome in the
sham acupuncture group. For each of the hierarchical hypotheses, we used the t test with a significance level of P <.05,
thus testing in a first step whether acupuncture is more efficacious in reducing
the number of days with moderate or severe headache than no treatment and
in a second step (only if the first null hypothesis was rejected) whether
acupuncture is more efficacious than sham acupuncture. Moreover, an analysis
of covariance with additional covariates of age at randomization and sex was
performed to account for potential baseline differences. Exploratory analyses
(2-sided t tests and Fisher exact test for pairwise
comparisons of groups without adjustment for multiple testing) based on all
available data without replacing missing data are reported for secondary outcome
measures. An additional per-protocol analysis was performed including only
patients without major protocol violations until week 12.
Due to the positive previous evidence regarding acupuncture for headache4 and the nature of the question posed by the German
health authorities (See “Role of the Sponsor” in the Acknowledgment
section) original sample-size calculations were based on 1-sided testing.
Under this premise the study was planned to have a power of 80% to detect
a group difference of 1 day with moderate or severe headache with assumed
SDs of 2.5 days (thus an effect size of 0.4), assuming a 20% dropout rate.5 However, we later decided to use 2-sided testing to
comply better with common standards.
Between April 2002 and January 2003 approximately 2000 patients with
headaches expressed interest in participating in the study (Figure 1), 472 entered the 4-week baseline period, and 304 were
randomly assigned. At one of the large study centers, 2 patients were randomly
assigned erroneously because they had only come to the initial examination
and never returned for the end of the baseline phase. The intent-to-treat
population comprised all remaining 302 patients (145 acupuncture, 81 sham
acupuncture, 76 waiting list) recruited in 18 outpatient centers. Seven patients
(5%) in the acupuncture group, 3 (4%) in the sham acupuncture group, and 10
(13%) in the waiting list group withdrew or were lost to follow-up at week
12 (P = .03, χ2 test).
Another 10 patients (6 acupuncture, 2 sham acupuncture, 2 waiting list) did
not complete the headache diary in a manner that allowed extraction of the
primary outcome measure, so valid data at week 12 were available for 132 patients
(91%) in the acupuncture group, 76 (94%) in the sham acupuncture group, and
64 (84%) in the waiting list group. At week 24, headache diary data were available
for 131 (90%) of patients in the acupuncture group and 72 (89%) in the sham
Groups were comparable at baseline (Table
1). A significant difference was only found for the physical health
summary scale of the SF-36 (less impairment in the sham acupuncture group).
The mean (SD) number of needles used per session was 17 (5) in the acupuncture
group and 11 (3) in the sham acupuncture group. After 3 treatment sessions
patients rated the credibility of acupuncture and sham acupuncture very highly
and almost identically (Table 2). By
the end of the study, patients’ ability to guess correctly their allocation
status differed significantly between the groups.
Between baseline and week 9 to 12 the number of days with headache of
moderate or severe intensity decreased by a mean (SD) of 2.2 (2.7) days in
the acupuncture group vs 2.2 (2.7) days in the sham acupuncture group and
0.8 (2.2) days in the waiting list group (difference acupuncture vs sham acupuncture,
0.0 days; 95% confidence interval [CI], −0.7 to 0.7 days; P = .96; acupuncture vs waiting list, 1.4 days, 95% CI, 0.8
to 2.1 days; P<.001; 2-sided confirmatory testing,
intent-to-treat population with missing values replaced). The results were
similar if the analysis was restricted to patients providing diary data and
if baseline values were entered in the analysis of covariance as covariates.
Additionally, the per-protocol analysis showed similar results. The proportion
of responders (reduction of headache days with moderate or severe pain by
at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture
group, and 15% in the waiting list group.
Compared with the waiting list control group, patients receiving acupuncture
or sham acupuncture fared significantly better for most secondary outcome
measures; however, there were no significant differences between the acupuncture
group and the sham acupuncture group (Table 3). Response differences in the waiting list group became apparent
after the first 4 weeks of treatment and increased until week 12 (Figure 2).
The improvements observed in the acupuncture groups persisted during
the follow-up period (Table 4). Results
in the sham acupuncture group tended to be slightly better than those in the
acupuncture group, but the differences were not significant. The patients
in the waiting list group who received acupuncture in weeks 13 to 20 showed
similar improvements after treatment as those who had received immediate treatment
Within the 24 weeks after randomization, 7 participants experienced
serious adverse events (4 acupuncture, 1 sham acupuncture, 2 waiting list).
All cases were hospital stays considered unrelated to study condition and
intervention (3 had elective surgery, knee surgery after household injury,
salpingitis, hypertensive crisis, diagnostic procedures). Thirty-six of 144
(25%) patients who had received at least 1 acupuncture treatment reported
a total of 37 adverse effects, and 13 of 81 (16%) receiving sham acupuncture
reported a total of 14 adverse effects (P = .13,
Fisher exact test). Ten participants in the acupuncture vs 2 in the sham acupuncture
groups reported that the treatment triggered migraine attacks or headache,
6 vs 1 reported fatigue, and 4 vs 2 reported hematoma, respectively.
In this randomized trial, acupuncture was no more effective than sham
acupuncture in reducing migraine headaches although both interventions were
more effective than a waiting list control. Our study is, to date, one of
the largest and most rigorous trials on the efficacy of acupuncture. The advantages
to this study include a protocol based on current guidelines for migraine
trials,15 strictly concealed central randomization,
assessment of the credibility of interventions, blinded diary evaluation,
interventions based on expert consensus, and provision of care delivered by
qualified and experienced medical acupuncturists. Our study also had high
One potential limitation of the study is that participants probably
had a more positive attitude toward acupuncture than the typical patient with
migraines although experiences from ongoing reimbursement programs in Germany
show that a large number of patients with chronic pain seek acupuncture treatment.
Dropout rates in our study were low compared with other migraine prevention
trials.3 However, more patients in the waiting
list group discontinued participation in the study after randomization than
did those in the other 2 groups. This was probably due to disappointment about
having to wait another 12 weeks for treatment after the 4-week baseline phase.
When patients were asked at the end of the trial to guess to which group
they had been assigned, the patients’ answers differed significantly
between the acupuncture and sham acupuncture groups, which indicates some
degree of unblinding. However, the results of the credibility assessment and
overall findings of our trial make it unlikely that the comparison between
acupuncture and sham acupuncture has been severely biased by unblinding.
In this study, it was not possible to blind waiting list patients. Therefore,
we cannot rule out that the difference between acupuncture and sham acupuncture
is overestimated due to bias. However, there are several arguments that could
explain why the influence of bias should be limited. There was a significant
improvement over time in the waiting list group in the first 12 weeks. This
was probably due to the natural course of the disease or the general effect
of being in a study (Hawthorne effect). This improvement, however, makes it
unlikely that patients in the waiting list group reported negatively biased
data in their diary. Analgesic use was lower in the acupuncture group and
sham acupuncture group, thereby making an influence of effective cointerventions
unlikely. Follow-up data confirmed the improvements observed after treatment.
After completion of the treatment, patients had no further contact with acupuncturists.
In addition, patients received and sent diaries and questionnaires directly
to the study center, decreasing the likelihood of positively biased diary
The lack of differences between acupuncture and sham acupuncture in
our study indicates that point location and other aspects considered relevant
for acupuncture did not make a difference. To some extent, this finding contradicts
current evidence in the literature. A number of small, mostly single-center
trials have compared acupuncture with a variety of sham interventions.4 Although the results of these trials were not fully
consistent, they suggested that, overall, acupuncture is superior to sham
interventions. We cannot rule out that the acupuncture interventions used
in some of the older studies were more appropriate for the treatment of migraine.
Nevertheless, we are confident that the consensus-based, semistandardized
strategy in our multicenter trial represents a suitable intervention. Another
potential explanation for the discrepancy in findings could be an overestimation
of effects over sham controls in the smaller, older studies due to bias or
An interesting finding of our trial is the strong response to sham acupuncture.
The improvement over and the differences compared with the waiting list group
are clearly clinically relevant. The number of days with moderate or severe
headache and the frequency of migraine attacks were reduced by 50% or more
compared with baseline in half of the patients and the improvement persisted
over several months. This response rate is comparable with that observed during
treatment with medications proven to be effective migraine prophylaxis, whereas
response rates in placebo groups are typically around 30%.3,16- 18 Also,
the effect of sham acupuncture over waiting list in our trial is larger than
that found in a recent meta-analysis of pain trials including both a placebo
and a no treatment control.19 The strong response
to sham acupuncture in our trial could be a chance finding. It could also
be that the study patients with high expectations of acupuncture treatment
reported positively biased data. However, the validity of our results is supported
by the consistency of findings as judged by a variety of instruments including
a headache diary and validated questionnaires on quality of life, disability,
and emotional aspects of pain.
The sham acupuncture intervention in our study was designed to minimize
potential physiological effects by needling superficially at points distant
from the segments of “true” treatment points and by using fewer
needles than in the acupuncture group. However, we cannot rule out that this
intervention may have had some physiological effects. The nonspecific physiological
effects of needling may include local alteration in circulation and immune
function as well as neurophysiological and neurochemical responses.20,21 The question investigated in our
comparison of acupuncture and sham acupuncture was not whether skin penetration
matters but whether adherence to the traditional concepts of acupuncture makes
a difference. For this purpose, our minimal acupuncture intervention was clearly
an appropriate sham control although it might not be an inert placebo.
Another explanation for the improvements that we observed could be that
acupuncture and sham acupuncture are associated with particularly potent placebo
effects. There is some evidence that complex medical interventions or medical
devices have higher placebo effects than medication.22 Furthermore,
acupuncture treatment has characteristics that are considered relevant in
the context of placebo effects,23,24 including
exotic conceptual framework, emphasis on the “individual as a whole,”
frequent patient-practitioner contacts, and the repeated “ritual”
A recent large, pragmatic trial from the United Kingdom has shown that
patients receiving acupuncture for chronic headache in addition to care from
a generalist physician did significantly better than patients receiving care
from generalist physician alone at little additional cost.25,26 Preliminary
results of a large, clinical trial from Germany seem to confirm these findings.27 However, these studies did not include a sham control
group. Given the uncertainties regarding the potential physiological effects
of sham interventions and the question of enhanced placebo effects, it is
crucial that direct head-to-head comparisons of acupuncture and proven standard
drug treatments are conducted in addition to sham-controlled trials. Until
now, only 2 rigorous trials have been published that compared acupuncture
with metoprolol28 or flunarizine.29 Their
results suggest that acupuncture might be similarly as effective as medication.
Two other trials with head-to-head comparisons of acupuncture and standard
drug treatment are currently under way.30,31 Such
trials are also desirable to assess the aspects of safety and compliance.
In our study, only minor adverse effects were reported and no patient withdrew
due to adverse effects. This compares favorably to findings in trials studying
drug treatment. In the largest published randomized trial on migraine prevention,
the drop-out rate due to adverse effects was 6.7% for 160 mg of propranolol,
6.9% for 10 mg of flunarizine, and 8.0% for 5 mg of flunarizine.19 A
recent large randomized trial of topiramate reported a drop-out rate of more
In conclusion, in our trial, acupuncture was associated with a reduction
of migraine headaches compared with no treatment; however, the effects were
similar to those observed with sham acupuncture and may be due to nonspecific
physiological effects of needling, to a powerful placebo effect, or to a combination
Corresponding Author and Reprints: Klaus
Linde, MD, Centre for Complementary Medicine Research, Department of Internal
Medicine II, Technische Universität München, Kaiserstrasse 9, 80801
Munich, Germany (Klaus.Linde@lrz.tu-muenchen.de).
Author Contributions: Dr Linde had full access
to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analysis.
Study concept and design: Linde, Streng, Jürgens,
Brinkhaus, Witt, Wagenpfeil, Pfaffenrath, Hammes, Weidenhammer, Willich, Melchart.
Acquisition of data: Linde, Streng, Jürgens,
Analysis and interpretation of data: Linde,
Brinkhaus, Witt, Wagenpfeil, Weidenhammer, Willich, Melchart
Drafting of the manuscript: Linde.
Critical revision of the manuscript for important
intellectual content: Linde, Jürgens, Hoppe, Brinkhaus, Witt,
Pfaffenrath, Hammes, Weidenhammer, Willich, Melchart.
Statistical analysis: Linde, Streng, Wagenpfeil,
Obtained funding: Willich, Melchart.
Administrative, technical, or material support:
Streng, Jürgens, Hoppe, Brinkhaus, Witt, Hammes.
Study supervision: Streng, Wagenpfeil, Pfaffenrath,
Financial Disclosures: None reported.
Participating Trial Centers: Hospital outpatient
units: Centre for Complementary Medicine Research, Department of Internal
Medicine II, Technische Universität München, Munich (A. Eustachi,
N. Gerling, J. J. Kleber); Department Complementary Medicine and Integrative
Medicine, Knappschafts-Krankenhaus Essen (G. Dobos, A. Füchsel, I. Garäus,
C. Niggemeier, T. Rampp, L. Tan); Department of Anaesthesiology, Kreiskrankenhaus
Altötting (H. Bettstetter, N. Schraml); Hospital for Traditional Chinese
Medicine Kötzting (S. Hager, U. Hager, S. Ma, T. Yangchun); Pain Unit
Marien-Krankenhaus Lünen (A. Lux).
Private practices: G. Ahrens, Hausham; C. Ammann, Berlin; J. Bek, Berlin;
K. J. Driller, Dortmund; I. Eiswirth, Velbert; C. H. Hempen, J. Hummelsberger,
H. Leonhardy, and R. Nögel, München; A. Jung, Berlin; U. Kausch,
Bogen; B. Kersting, Hasbergen; V. Lerke, Prien; C. Luckas, Nussdorf; J. Schäfers,
Mönchengladbach; A. Wiebrecht, Berlin.
Funding/Support: Study activities at the Centre
for Complementary Medicine Research, Munich were funded by the following social
health insurance funds: Deutsche Angestellten-Krankenkasse, Hamburg; Barmer
Ersatzkasse, Wuppertal; Kaufmännische Krankenkasse, Hannover; Hamburg-Münchener
Krankenkasse, Hamburg; Hanseatische Krankenkasse, Hamburg; Gmünder Ersatzkasse,
Schwäbisch Gmünd; HZK Krankenkasse für Bau-und Holzberufe,
Hamburg; Brühler Ersatzkasse, Solingen; Krankenkasse Eintracht Heusenstamm,
Heusenstamm; Buchdrucker Krankenkasse, Hannover.
Study activities at the Institute for Social Medicine, Epidemiology
and Health Economics, Berlin were funded by the following social health insurance
funds: Techniker Krankenkasse, Hamburg; Betriebskrankenkasse, Bosch; Betriebskrankenkasse,
Daimler Chrysler; Betriebskrankenkasse, Bertelsmann; Betriebskrankenkasse,
BMW; Betriebskrankenkasse, Siemens; Betriebskrankenkasse, Deutsche Bank; Betriebskrankenkasse,
Hoechst; Betriebskrankenkasse, Hypo Vereinsbank; Betriebskrankenkasse, Ford;
Betriebskrankenkasse, Opel; Betriebskrankenkasse, Allianz; Betriebskrankenkasse,
Vereins-und Westbank; Handelskrankenkasse.
Role of the Sponsors: The trial was initiated
due to a request from German health care 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 randomized trial including a sham control
condition with an observation period of at least 6 months to decide whether
acupuncture should be included into routine reimbursement. All other decisions
on design, data collection, analysis, and interpretation, as well as publication
were the complete responsibility of the researchers.
Acknowledgment: We thank Joseph Hummelsberger,
MD, Munich, and Dominik Irnich, MD, Department of Anaesthesiology, Ludwig-Maximilians-University,
Munich, for developing the acupuncture treatment protocols together with Dr
Hammes, and for their input at various levels of the protocol development.
We would like to thank Albrecht Neiss, PhD, Institute of Medical Statistics
and Epidemiology, Technische Universität München, for statistical