The acupuncture randomised trial (ART) for tension-type headache details of the treatment

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1 The acupuncture randomised trial (ART) for tension-type headache details of the treatment Introduction Acomprehensive description of the treatment is crucial to allow practitioners an assessment of the intervention tested in a randomised trial of acupuncture. In 2001, the STRICTA(STandards for Reporting Interventions in Controlled Trials of Acupuncture) recommendations were published to provide guidance for more precise description of interventions in controlled trials of acupuncture. 1 The recommendations emphasise the need to report details of the rationale for the chosen acupuncture strategy, needling, treatment regimen, cointerventions, practitioner background and control interventions in the publication of a trial. While this is easily possible in single-centre trials or studies with standardised interventions it becomes difficult in multicentre trials with flexible treatment schemes. We performed a randomised multicentre trial to investigate whether a semi-standardised acupuncture intervention is more effective than no treatment and more effective than a standardised minimal acupuncture intervention in patients with tensiontype headache (Acupuncture Randomised Trial in Tension-Type Headache = ART TTH). Within the framework of larger research programmes, ART TTH was performed on the request of health authorities in Germany and sponsored by a group of statutory sickness funds to serve as a basis for the Papers Dieter Melchart, Andrea Streng, Andrea Hoppe, Benno Brinkhaus, Claudia Becker-Witt, Michael Hammes, Dominic Irnich, Josef Hummelsberger, Stefan N Willich, Klaus Linde Abstract Objective The goal of this paper is to describe the characteristics of physicians and their interventions in a large, multicentre randomised trial of acupuncture for tension-type headache known as ART TTH, in order to enable acupuncturists to assess the study interventions. Methods Participating physicians were recruited whose qualifications met or surpassed those of physicians currently accredited for providing acupuncture by state health funding agencies in Germany. Semi-standardised treatment strategies for acupuncture and minimal acupuncture were developed in a consensus process with acupuncture experts. Atotal of 270 patients suffering from episodic or chronic tension-type headache were randomised to 12 sessions of semi-standardised acupuncture (three predefined basic points, recommendations for additional points given, but individual choice of additional points possible), standardised minimal acupuncture (superficial needling of at least 5 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list. Forty two physicians, trained and experienced in acupuncture, from 28 centres in Germany participated in the trial. Results The median duration of acupuncture training of trial physicians was 500 hours (range 140 to 1350 hours). Physicians had 10 (<1 to 25) years acupuncture experience. The three basic points (GB20, GB21 and LR3) were treated in 96%, 82% and 97% of sessions, respectively. Frequently treated optional points included LI4 (67%), SP6 (50%) and ST36 (46%). Ten of the 42 physicians stated that they would have treated patients differently outside the trial. The trial found a significant effect of acupuncture over waiting list but not over minimal acupuncture. Conclusions In general, trial physicians complied well with the predefined interventions. Arelevant minority of participating trial physicians stated that they would have treated patients differently outside the trial. Keywords Acupuncture, tension-type headache, treatment standardisation, sham acupuncture. Dieter Melchart director Andrea Streng clinical researcher Andrea Hoppe clinical researcher Klaus Linde epidemiologist Centre for Complementary Medicine Research Technische Universität München, Munich, Germany Benno Brinkhaus specialist in internal medicine Claudia Becker-Witt epidemiologist Stefan N Willich professor Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany Michael Hammes specialist in neurology and medical acupuncturist Department of Neurology, Technische Universität München, Munich, Germany Dominic Irnich specialist in anaesthesiology and medical acupuncturist Department of Anesthesiology, Ludwig- Maximilians-Universität München, Munich, Germany Josef Hummelsberger specialist in internal medicine and medical acupuncturist International Society for Chinese Medicine, Munich, Germany Correspondence: Klaus Linde Klaus.Linde@lrz.tumuenchen.de 157

2 decision whether acupuncture should be reimbursed. The protocol and the main results have been published elsewhere. 2;3 This paper aims to describe in detail the characteristics of participating physicians and the acupuncture and minimal acupuncture intervention provided in the trial. Methods ARTTTH was a randomised, controlled multicentre trial comparing acupuncture with minimal acupuncture and with a no-acupuncture waiting list control. In the acupuncture and minimal acupuncture groups, patients were blinded with regard to treatment. Patients with a diagnosis of episodic or chronic tension-type headache according to the classification of the International Headache Society fulfilling predefined in- and exclusion criteria were centrally randomised (ratio 2:1:1) to the three groups. The trial was initiated by 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 condition with an observation period of at least six months. All other decisions on design, data collection, analysis, and interpretation, as well as publication, were completely the researchers responsibility. Physicians participating in the trial were recruited so as to ensure their qualifications equalled or surpassed those of physicians currently accredited for providing acupuncture by state health funding agencies in Germany. According to the study protocol trial physicians had to fulfil the following criteria: (1) acupuncture training at least equivalent to an A diploma from one of the major German acupuncture societies (140 hours of acupuncture training); (2) 50% of trial physicians had to have at least a B diploma (350 hours: at the start of current reimbursement programmes about 20% of physicians accredited to provide acupuncture had this qualification); 4 (3) 50% had to have experience working in clinical studies; (4) all physicians had to have at least three years of practical experience with acupuncture; (5) all physicians had to participate in study training sessions on the trial methods, the interventions tested, and standards for performing clinical trials as laid down by the International Conference on Harmonisation Good Clinical Practice (ICH-GCP). The selection of trial physicians was based on recommendations of the acupuncture experts in the team, or their responses to a questionnaire asking about qualifications, experiences and interest in research sent to all physicians participating in a programme for reimbursement of acupuncture by German statutory sickness funds. The treatment strategies for acupuncture and minimal acupuncture were developed in a consensus process with experienced acupuncture experts (MH, JH, DI) representing the following two major German societies for medical acupuncture: German Medical Acupuncture Association (Deutsche Ärztegesellschaft für Akupunktur, DÄGfA); International Society for Chinese Medicine (Societas Medicinae Sinensis, SMS). In the first step the three experts developed a proposal which was then presented for discussion to more than 30 experts from both acupuncture societies. The final strategies were defined by the three experts, together with the study team, and communicated to the external advisors. The final strategies were generally considered as a pragmatic compromise between the need for some standardisation and the need for individualisation. Both the acupuncture and minimal acupuncture treatments consisted of 12 sessions of 30 minutes duration, each administered over a period of eight weeks (preferably two sessions in each of the first four weeks, followed by one session per week in the remaining four weeks). Patients in the waiting list group did not receive acupuncture treatment for a period of 12 weeks after randomisation. All patients could treat acute headaches as needed according to current German guidelines for tension-type headache (oral acetyl-salicylic acid, naproxen, paracetamol, or ibuprofen). Acupuncture treatment was semi-standardised (see Box 1). All patients were treated at basic points bilaterally unless there were contraindications. In addition, physicians could treat at other points based on a traditional Chinese syndrome diagnosis, personal experience, localisation of pain or other symptoms. Recommendations for additional points (uni- or bi-laterally) were made, but acupuncturists were free to choose other points (including ear acupuncture points, other microsystem points or trigger points). The number and name of additional acupuncture points had to be 158

3 Box 1 Acupuncture points used in trial of acupuncture for tension-type headache basic points GB20 GB21 LR3 Optional points Mainly frontal headache: LI4, GV23, extra points Yin Tang and Tai Yang, ST44, GB2 In case of headache mainly in the vertex: GV20 or GV23, extra point Si Shen Cong In case of mainly neck pain: BL10, BL60 or BL62, GV14 or GV19, SI3 or SI6 In case of pain through whole head with fatigue: extra point Tai Yang, SP6 or 9, ST36 or ST40, CV12 Complaints worse with wet or cold weather: LI4, GV14, GB3, SJ6, GB39 Modalities Wind, Dampness, Cold: LI4, GV14, TE6, GB34 Modalities Cold, Wind: LI4, LU7, TE5, GV14 Box 2 Minimal acupuncture points used in trial of acupuncture for tension-type headache 1. MA-point Deltoideus : In the middle of the line between the insertion of deltoid muscle (LI14) and acromion 2. MA-point Upper Arm : 2 cun lateral (radial) to LU3 3. MA-point Forearm : 1 cun ulnar to the proximal third of the line between HT3 and HT7 4. MA-point Scapula : 1 cun lateral to the lower scapular edge 5. MA-point Spina Iliaca : 2 cun above anterior superior iliac spine in vertical line to the arch of left ribs 6. MA-point Back I : 5 cun lateral to the spine of 4th lumbar vertebra 7. MA-point Back II : 5 cun lateral to the spine of 5th lumbar vertebra 8. MA-point Upper Thigh I : 6 cun above the upper edge of the patella (between the spleen and stomach meridians) 9. MA-point Upper Thigh II : 4 cun above the upper edge of the patella 10. MA-point Upper Thigh III : 2 cun dorsal to GB31 (avoiding bladder meridian) One cun is defined according to the rules of traditional Chinese medicine as the width of the interphalangeal joint of patient s thumb. documented. A traditional Chinese syndrome diagnosis was requested, but not mandatory. Sterile single-use needles had to be used, but physicians were free in their choice of needle length and diameter. An irradiating needling sensation ( de qi) was achieved if possible. Needles were stimulated manually at least once in each session. The total number of needles was limited to 25. Number, duration and frequency of the sessions in the minimal acupuncture group were the same as for the acupuncture group. In each session at least 5 out of 10 points (see box 2) had to be needled bilaterally (at least 10 needles) and superficially using fine needles. De qi and manual stimulation of the needles was avoided. All acupuncturists received an oral instruction, a videotape and a brochure with detailed information on minimal acupuncture. Patients were told about the acupuncture and minimal 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 filled in headache diaries in the four weeks before randomisation (baseline phase), the 12 weeks after randomisation and in the weeks 21 to 24 after randomisation. In addition, patients were asked to fill in a pain questionnaire before treatment, after 12 weeks and after 24 weeks, 5 which included the German version of the Pain Disability Index (PDI); 6 a scale for assessing emotional aspects of pain (Schmerzempfindungs-Skala SES); 7 the depression scale Allgemeine Depressionsskala (ADS); 8 and the German version of the SF-36 to assess health-related quality of life. 9 The main outcome measure for confirmatory analysis was the difference in the number of headache days in the four weeks before randomisation (baseline phase) and in weeks 9 to 12 after randomisation. Before and after completion of the study a questionnaire was sent to all trial physicians. This questionnaire included questions on training and experience before trial participation, as well as questions on how the trial interventions were judged post hoc. Results Atotal of 270 patients were included in the trial. Of these, 132 were randomised to acupuncture, 63 to minimal acupuncture and 75 to waiting list. Seven hospital outpatient units and 21 private practices participated as study centres. Atotal of 43 physicians applied acupuncture in the trial, however, one provided only a single treatment session, substituting an absent trial physician, and was excluded from further analysis. The characteristics of the 42 trial physicians are summarised in Table 1. The number of acupuncture 159

4 Table 1 Characteristics of trial physicians (n=42) and minimal acupuncture treatments provided varied between five and 262 (median 53) per physician. Physicians had had a median of 500 hours (range 140 to 1350 hours) of acupuncture training before participating in the trial; 28 (67%) had the B Diploma. median (range) or n (%) Number of acupuncture sessions provided within the trial per physician 53 (5-262) Age in years 42 (29-65) Female sex 18 (43%) Postgraduate specialisation (for example, internal medicine) 29 (69%) Length of medical practice, years 15 (1-41) B diploma (at least 350 hours training) 28 (67%) Hours of acupuncture training 500 ( ) Teacher of acupuncture in accredited postgraduate courses 15 (36%) Duration of use of acupuncture, years 10 (<1-25) Membership of professional societies any 38 (91%) German Medical Acupuncture Association (DÄGfA) 16 (38%) International Society for Chinese Medicine (SMS) 13 (31%) Arbeitsgemeinschaft TCM (AGTCM) 5 (12%) German Society for Acupuncture and Neural Therapy (DGfAN) 4 (10%) German Acupuncture Society Düsseldorf 1 (2%) Research Group Acupuncture and Traditional Chinese Medicine (FATCM) 1 (2%) Patients treated with acupuncture in the year before the trial for any condition 150 (15->1000) patients with tension headache 30 (5-300) Percentage of patients treated with different therapies in the physician s everyday practice acupuncture 30 (5-100) other traditional Chinese therapies 10 (0-75) other complementary therapies 10 (0-60) conventional medicine 30 (0-95) Frequently/always make Chinese diagnosis before treatment 35 (83%) s e s s i o n s t r e a t m e n t o f P r o p o r t i o n 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 1 ( 7 3 ) 2 ( 5 7 ) 3(72) 4 ( 5 5 ) 5 ( 6 1 ) Centre (n treatments) Fifteen (36%) trial physicians taught acupuncture in accredited postgraduate courses. Physicians had used acupuncture in their practice for 10 (<1 to 25) years and had treated 150 (15 to >1000) patients with acupuncture in the year preceding trial participation. 6 ( ) 7 ( ) 8 ( ) o t h e r ( ) a l l ( ) all 3 points 2 points 1 point Figure 1 Compliance with the predefined acupuncture strategy is illustrated here: proportion of treatment sessions in which all 3, 2, 1 or none of the basic points were treated. Displayed are the eight centres (numbered 1 to 8) providing 50 treatments or more; all centres providing fewer treatments were pooled under other. The number in parentheses is the number of treatments performed in that centre. none 160

5 Table 2 Treatment in the acupuncture group Two physicians at a large centre with several highly experienced acupuncturists had an Adiploma but less than three years of practice in acupuncture (one less than one year and one two years). Thirty five (83%) physicians frequently or always differentiated symptoms according to traditional Chinese medicine before starting treatment. Patients in the acupuncture group were treated in a total of 1,507 sessions. On average, 15.2±4.3 (mean and standard deviation) needles were used per session. The three basic points (GB20, 21 and LR3) were treated in 96%, 82% and 97% of sessions, respectively (see Table 2). Most centres complied well with the predefined treatment strategy (Figure 1). However, in one centre the simultaneous treatment of GB20 and 21 was considered unnecessary for the majority of patients. The most All sessions Session 1 Session 5 Session 10 n=1507 n=131 n=127 n=123 Basic point GB20 96% 95% 96% 95% Basic point GB21 82% 81% 80% 84% Basic point LR3 97% 95% 96% 98% Optional point LI4 67% 66% 67% 65% Optional point SP6 50% 38% 54% 52% Optional point ST36 46% 61% 52% 54% Optional point GV20 44% 40% 44% 48% Optional point Tai Yang 43% 44% 43% 39% Optional point BL60 25% 21% 24% 29% Optional point BL10 20% 21% 21% 21% Optional point GB34 21% 14% 23% 27% Optional point GV23 20% 22% 21% 19% Optional point ST44 15% 15% 13% 16% Optional point SI3 14% 15% 15% 15% Optional point SP9 13% 11% 15% 13% Optional point GV14 11% 8% 10% 12% Optional point ST40 11% 11% 12% 11% Optional point GB2 10% 12% 10% 7% Other classical acupuncture points used 40% 35% 41% 40% Microsystem points used 16% 12% 17% 18% Ah-Shi points used 5% 4% 7% 5% Trigger points used 3% 2% 2% 2% Total number of needles (mean±sd) 15.2± ± ± ±4.3 Duration of session in minutes (mean±sd) 29.9± ± ± ±2.7 Length of needles used: <20mm 56% 56% 54% 53% 21 to 30mm 77% 76% 76% 80% 31 to 40mm 37% 32% 37% 38% >40mm 2% 2% 2% 2% Manual stimulation none 22% 22% 22% 22% once 66% 66% 65% 63% more than once 13% 12% 13% 15% de qi easy to elicit 91% 79% 92% 94% difficult to elicit 8% 21% 8% 6% could be not be elicited < 1% Figures are percentages where indicated or means and standard deviations. frequently treated optional points were LI4 (in 67% of sessions), SP6 (50%), ST36 (46%), GV20 (44%), and extra point Tai Yang (43%). Additional classical points not mentioned as basic or optional points in the treatment instructions were used in 40%, microsystem points in 16%, ah shi points in 5% and trigger points in 3% of sessions. In 79% of the sessions needles were stimulated once or more often. De qi could be elicited easily in 91% of sessions. Compliance with instructions in the minimal acupuncture group was very good. Table 3 shows the frequency of use for the single minimal points. Fewer than 10 needles were used in one session (0.1%), 10 needles in 73%, 12 in 17% and more than 12 in 10% of sessions. The duration of sessions was similar to that in the acupuncture group

6 Table 3 Treatment in the minimal acupuncture group All sessions Session 1 Session 5 Session 10 n=747 n=63 n=63 n=61 Point Deltoideus 88% 89% 89% 87% Point Upper Arm 80% 78% 79% 82% Point Forearm 49% 52% 49% 43% Point Scapula 29% 27% 27% 31% Point Back I 25% 22% 25% 31% Point Back II 21% 19% 22% 21% Point Spina iliaca 25% 24% 30% 21% Point Upper Thigh I 81% 84% 84% 82% Point Upper Thigh II 77% 78% 76% 75% Point Upper Thigh III 65% 64% 66% 66% Total number of needles (mean±sd) 11.0± ± ± ±2.5 Length of needles used* <20 mm 57% 59% 59% 59% 21 to 30mm 44% 40% 46% 46% 31 to 40mm 9% 11% 5% 8% >40mm 1% 2% 2% <1% Duration of sessions in minutes (mean±sd) 29.4± ± ± ±2.4 *Several answers were possible. Figures are percentages where indicated or means and standard deviations. Table 4 Responses to acupuncturists' questionnaire (n=42) How would you have applied acupuncture outside of the trial? in exactly the same way 3 (7%) similarly 28 (67%) differently 10 (24%) totally different no answer 1 (2%) Would you have used additional therapies outside of the trial? no 4 (10%) yes, in some patients 26 (62%) yes, almost in every case 11 (26%) no answer 1 (2%) Did you have problems with minimal acupuncture yes, on an ethical level 26 (62%) yes, technically 3 (7%) yes, during informed consent 18 (43%) I would participate again in ART TTH 35 (83%) n (%) Acupunct Med: first published as /aim on 1 January Downloaded from The responses of physicians to the questions about how they would treat patients outside of the trial (posed after completion of the trial but before results were available) are reported in Table 4. Thirty one (74%) would have applied acupuncture similarly or exactly in the same way outside of the trial, 10 (20%) differently (one did not answer the question). The most often raised criticism was that basic points might not apply to all patients according to traditional Chinese medicine. Outside the trial, most physicians would have used additional therapies in at least some patients. Agreat variety of treatments was mentioned here (most often Chinese herbs, homeopathy, relaxation, nutritional changes). More than half of the physicians had ethical problems with providing minimal acupuncture. Thirty five (83%) explicitly confirmed that they would participate again in the trial, two were undecided, and three would not participate again. Reasons were the amount of bureaucracy, the use of minimal acupuncture, and the restriction of individualisation. Compared to the waiting list group, patients receiving acupuncture did significantly better in the main outcome measure as well as in almost all secondary outcome measures. However, there were no significant differences compared to minimal acupuncture (Table 5). The detailed clinical results have been published elsewhere. 3 on 20 November 2018 by guest. Protected by copyright

7 Table 5 Clinical outcome measures Discussion Our analyses show that: (1) the participating trial physicians were a heterogeneous group whose overall qualification was above the average of physicians providing acupuncture within statutory reimbursement systems in Germany; (2) the consensus-based treatment protocol for acupuncture and minimal acupuncture was feasible and acceptable to physicians, however, a quarter of physicians would have applied acupuncture differently outside the trial and most would have used additional therapies; (3) in the trial the acupuncture intervention tested was significantly more effective than no treatment but there were no significant differences between patients receiving acupuncture and minimal acupuncture. Defining interventions in randomised controlled trials of acupuncture is a difficult task. From a strictly scientific point of view, standardised interventions are desirable to facilitate exact reproduction of the experiment. However, in routine practice acupuncture is provided in a highly variable manner, and the treatment is often tailored to the individual patient. Trials with strictly standardised acupuncture interventions, therefore, might not be adequate to guide healthcare policy decisions on acupuncture. We opted for an intervention which should achieve transparency of the treatment provided in the trial on the one hand, and allow some degree of individualisation in point selection on the other hand. The treatment protocol was developed in a consensus process involving leading experts from two medical Acupuncture Minimal Waiting list AC AC (AC) acupuncture (WL) vs vs (MA) MA WL n=132 n=63 n=75 mean (SD) mean (SD) mean (SD) P P Days with headache baseline 17.5 (6.9) 17.7 (6.7) 17.3 (6.9) na na weeks 9 to (8.7) 10.8 (8.3) 16.3 (7.4) <0.001 weeks 21 to (8.6) 11.2 (8.6) na na Days with medication baseline 4.0 (3.7) 4.2 (4.2) 4.7 (4.2) na na weeks 9 to (2.9) 2.6 (2.6) 4.4 (4.1) <0.001 weeks 21 to (4.0) 2.9 (3.5) na na Physical health (SF-36) baseline 42.9 (7.2) 44.3 (6.8) 43.0 (7.5) na na week (7.5) 49.0 (6.1) 42.5 (7.2) <0.001 week (6.9) 49.1 (5.4) na na Two-sided Pvalues from t tests; na = not applicable. Figures are means and standard deviations or Pvalues. acupuncture societies; however, it has to be emphasised that this treatment protocol was a compromise. While the experts involved considered it adequate in general this does not mean that everyone considered that the chosen points were optimal. The responses to our question whether they would apply acupuncture in the same manner outside the trial indicate that the treatment protocol reflects to some extent, but is not an exact match with, what the trial physicians do in regular practice. Compared to some other Western countries (such as United Kingdom or Sweden) the approach to medical acupuncture in Germany is traditional, that is, based on the theories of traditional Chinese medicine. We cannot rule out the conclusion that the results of our trial would have been different if another acupuncture intervention had been applied. Acupuncturists who criticise our treatment strategy should take into account the fact that compared to the waiting list control it proved highly effective. Even more difficult than the choice of an adequate acupuncture intervention is the choice of the control interventions. Due to the request of the German health authorities, our trial had to include some sort of sham acupuncture. We were not allowed to use controls such as inactive laser or TENS devices. We did not use placebo (non skinpenetrating) needles for practical reasons (difficult to use in hairy areas, at the head, hands and feet; costs; handling in a multicentre trial) and conceptual reasons (more physician-patient contact than in routine practice). We chose a strategy which deviates from 163

8 adequate acupuncture in several aspects: superficial needling, non-acupuncture points, in distant areas, no manual stimulation, and avoidance of de qi. Still, this strategy proved similarly effective to our acupuncture intervention. Any intervention involving skin penetration cannot be considered an inert placebo and superficial needling is common in Japan. 10 Although the non-acupuncture points were chosen carefully and physicians could choose between several non-acupuncture points to ensure that potentially active areas could be avoided, we cannot rule out completely that some of the points still might have had some specific activity. However, there cannot be any doubt that the minimal acupuncture protocol in our trial would not be considered an adequate strategy to treat patients with tension-type headache according to classical concepts of acupuncture. In conclusion, we believe that the treatment protocols for acupuncture and minimal acupuncture in ARTTTH were an adequate compromise in the specific situation and for the predefined purposes. Such compromises always have drawbacks. Without the inclusion of a no treatment control ART TTH would clearly have been interpreted as a negative trial. The additional comparison with the no treatment control group, however, made clear that the issue is complex. We recommend such an additional control group in sham controlled trials of acupuncture whenever possible. Acknowledgements We would like to thank the participating patients, trial physicians, and the acupuncture experts participating in the consensus process to establish the trial interventions. 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), Hannover; 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 Heusenstamm (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 insurance 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; Handelskrankenkasse (HKK). Conflict of interest MH, JH and DI have received fees for teaching acupuncture in courses of professional societies. All other authors report no conflicts of interest. Summary points Median duration of acupuncture training of trial physicians was 500 hours (range 140 to 1350 hours) Physicians had 10 (<1 to 25) years acupuncture experience Basic points (GB20, GB21 and LR3) were treated in 96%, 82% and 97% of sessions, respectively Optional points included LI4 (67%), SP6 (50%) and ST36 (46%) Ten of the 42 physicians stated that they would have treated patients differently outside the trial Acupuncture was significantly better than waiting list but not significantly better than minimal acupuncture Reference list 1. MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med 2001;9(4): Melchart D, Linde K, Streng A, Reitmayr S, Hoppe A, Brinkhaus B et al. Acupuncture randomized trials (ART) in patients with migraine or tension-type headache - design and protocols. Forsch Komplementärmed Klass Naturheilkd 2003;10: Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S et al. Acupuncture in patients with tensiontype headache - randomised trial. BMJ 2005;331(7513): Weidenhammer W, Streng A, Reitmayr S, Hoppe A, Linde K, Melchart D. Das Modellvorhaben Akupunktur der Ersatzkassen. Dtsch Z Akupunkt 2002;45: Nagel B, Gerbershagen HU, Lindena G, Pfingsten M. Entwicklung und empirische Überprüfung des Deutschen Schmerzfragebogens der DGSS. Schmerz 2002;16: Dillmann U, Nilges P, Saile E, Gerbershagen HU. Behinderungseinschätzung bei chronischen Schmerzpatienten. Schmerz 1994;8:

9 7. Geissner E, Schulte A. Die Schmerzempfindungsskala (SES). Weinheim: Beltz; Hautzinger M, Bailer M. Allgemeine Depressionsskala (ADS). Die deutsche Version des CES-D. Weinheim: Beltz; Bullinger M, Kirchberger I. SF-36 Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe; Birch S. Controlling for non-specific effects of acupuncture in clinical trials. Clinical Acupuncture and Oriental Medicine 2003;4: Acupunct Med: first published as /aim on 1 January Downloaded from on 20 November 2018 by guest. Protected by copyright