Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients with osteoarthritis of the knee

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1 Complementary Therapies in Medicine (2007) 15, Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients with osteoarthritis of the knee B. Brinkhaus a,, C.M. Witt a, S. Jena a, K. Linde a,b, A. Streng b, J. Hummelsberger c, D. Irnich d, M. Hammes e,d.pach a, D. Melchart b,f, S.N. Willich a a Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Humboldt University of Berlin, Berlin, Germany b Center for Complementary Medicine Research, Department of Internal Medicine II, Technische Universität, Munich, Germany c International Society for Chinese Medicine, Munich, Germany d Department of Anesthesiology, Ludwig Maximilians University, Munich, Germany e Department of Neurology, Technische Universität München, Munich, Germany f Division of Complementary Medicine, Department of Internal Medicine, Universitätsspital Zürich, Switzerland Available online 22 June 2006 KEYWORDS Acupuncture; Randomised controlled trial; Osteoarthritis; Treatment standardisation; Sham acupuncture Summary Objective: The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee. Design: Three-armed, randomised, controlled multicentre trial with 1-year followup. Setting: Twenty-eight outpatient centres in Germany. Interventions: A total of 294 patients with osteoarthritis of the knee were randomised to 12 sessions of semi-standardised acupuncture (at least 6 local and 2 distant points needled per affected knee from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), 12 sessions of minimal acupuncture (superficial needling of at least 8 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list control (2 months no acupuncture). Outcome: Participating trial physicians and interventions. Results: Forty-seven physicians specialised in acupuncture (mean age 43 ± 8 years, 26 females) provided study interventions in 28 outpatient centres in Germany. The median duration of acupuncture training completed by participating physicians was Corresponding author. Tel.: ; fax: address: benno.brinkhaus@charite.de (B. Brinkhaus) /$ see front matter 2006 Elsevier Ltd. All rights reserved. doi: /j.ctim

2 Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients h (range ). The total number of needles used was 17.4 ± 4.8 in the acupuncture group compared to 12.9 ± 3.3 in the minimal acupuncture group. In total, 39 physicians (83%) stated that they would have treated patients in either a similar or in exactly the same way outside of the trial, whereas 7 (15%) stated that they would have treated patients differently (1 missing). Conclusions: Our documentation of the trial interventions shows that semistandardised acupuncture strategy represents an acceptable compromise for efficacy studies. However, a substantial minority of participating trial physicians stated that they would have treated patients differently outside of the trial Elsevier Ltd. All rights reserved. Introduction Over the past decade an increasing number of randomised controlled trials have been conducted to determine the efficacy of acupuncture in patients with osteoarthritis of the knee. One recent systematic review of seven randomised controlled trials with a total of 393 patients found that acupuncture was more effective than sham acupuncture in reducing pain, whereas for joint function the results were inconclusive. 1 However, the limited methodological quality of acupuncture trials and, in particular, the inadequate descriptions of the study interventions were criticised. 2 In 2001 the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) recommendations were published to help encourage more precise descriptions of the interventions used in controlled trials of acupuncture and to improve the quality of these interventions. 3 The recommendations emphasise the need to provide details on the rationale for the chosen acupuncture strategy, as well as for needling, treatment regimen, cointerventions, practitioner background, and control interventions. In the randomised multicentre Acupuncture Randomised Trial (ART) in osteoarthritis, we investigated whether a semi-standardised acupuncture intervention was more effective than standardised minimal acupuncture or no treatment in patients with osteoarthritis of the knee. The ART osteoarthritis trial was part of two larger research programmes 4,5 developed upon the request of health care authorities in Germany and sponsored by a group of statutory health insurance funds. The goal of the programme was to determine whether acupuncture should be reimbursed as part of standard medical care in Germany. The protocol and primary results have been published elsewhere. 6,7 The aim of this paper is to provide details on the characteristics and background of the acupuncturists who participated, as well as on the trial interventions that were performed, in the ART osteoarthritis study. Methods The ART osteoarthritis trial 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 to treatment. Patients with osteoarthritis who fulfilled predefined inclusion and exclusion criteria were centrally randomised (ratio 2:1:1) to one of the three treatment groups. The participating physicians were recruited in a manner designed to ensure that their qualification was equal to, if not better, than the average qualification of physicians currently accredited for providing acupuncture by statutory health insurance funds 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 h of acupuncture training); (2) 50% of trial physicians had to have at least a B Diploma (350 h; approximately 20% of physicians accredited to provide acupuncture as part of current reimbursement programs outside the trials have this qualification) 5 ; (3) 50% had to have experience working in clinical studies; (4) all physicians had to have at least 3 years of practical experience with acupuncture; (5) all physicians were required to participate in study training sessions on the trial methods, the interventions tested, and standards for performing clinical trials (ICH-GCP). We developed the treatment strategies for acupuncture and minimal acupuncture in a consensus process with three acupuncture experts (MH, JH, and DI) representing two major German societies for medical acupuncture: the German Medical Acupuncture Association (Deutsche Ärztegesellschaft für Akupunktur, DÄGfA) and the International Society for Chinese Medicine (Societas Medicinae Sinensis, SMS). The first step involved three experts developing a proposal, which was followed by a discussion including more than 30 acupuncture experts from both acupuncture soci-

3 182 B. Brinkhaus et al. eties. The final intervention strategies were defined by the three experts together with the study team and subsequently communicated to the external advisors. Both the acupuncture and minimal acupuncture treatments consisted of 12 sessions of 30 min duration administered over a period of 8 weeks (preferably 2 sessions a week for the first 4 weeks, followed by 1 session per week for the remaining 4 weeks). Patients in the waiting list group did not receive acupuncture treatment during the first 8 weeks after randomisation; as of week 9, they received the acupuncture treatment described below. Acupuncture treatment was semi-standardised: all patients were treated with a selection of local and distant points chosen by the acupuncturists participating in the trial. Additional points included body acupuncture, ear acupuncture, and trigger points. Patients were treated using at least 6 of the following local acupuncture points 8 : stomach 34, 35, and 36; spleen 9 and 10; bladder 40; kidney 10; gall bladder 33 and 34; liver 8; extra points Heding, Xiyan. In addition, physicians selected and needled at least 2 distant points from the following selection: spleen 4, 5, and 6; small intestine 6; bladder 20, 57, 58, 60, and 62; kidney 3. Sterile disposable one-time needles were used. Needle length and diameter were not predefined, but had to be documented. Physicians were instructed to achieve the characteristic De qi needling sensation, if possible. Needles were to be stimulated manually at least once in each session. Minimal acupuncture treatment entailed superficially inserting fine needles (20 to 40 mm in length) at predefined, distant non-acupuncture points. These non-acupuncture points were not in the area of the knee, and the selection of at least 8 out of 10 points was left to the physician s discretion. Physicians were instructed to avoid manual stimulation of the needles and provocation of de qi in the minimal acupuncture group. In investigator meetings, all acupuncturists received instructions on performing minimal acupuncture, including a videotape and a brochure with detailed information on the intervention. Patients were allowed to use oral non-steroidal anti-inflammatory drugs, if required. Corticosteroids or pain-relieving drugs that act through the central nervous system, however, were prohibited. Any concomitant pain-medication had to be documented. Patients were informed about 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 completed standardised questionnaires at baseline, and after 8, 26, and 52 weeks. The primary outcome measure was the Western Ontario and McMasters Universities Osteoarthritis Index score. 9,10 In cases of bilateral osteoarthritis, the knee defined at baseline as more painful was the one assessed throughout the entire study. Furthermore, the patient questionnaire included a modified version of the German Society for the Study of Pain questionnaire (DGSS). 11 In addition to the German version of the Pain Disability Index (PDI), 12 the DGSS questionnaire includes a scale for assessing emotional aspects of pain (Schmerzempfindungs-Skala SES), 13 the depression scale ADS, 14 and the German version of the SF In addition to the DGSS, patients were asked a number of questions about sociodemographic characteristics and workdays lost, and were asked to rate the pain intensity on a numeral rating scale and complete a number of global assessments. The number of days with pain and medication were documented in a diary by the patients. We sent a questionnaire to all 47 trial physicians after study completion, but before the analysis of the data was performed. This questionnaire included queries on physician training and experience prior to trial participation, as well as questions on how the trial interventions were judged post hoc. Results A total of 294 patients (66% female, 64 ± 7 years) were included in the study between March 2002 and January Five hospital outpatient units and 23 private practices participated as study centres, and a total of 47 physicians provided acupuncture treatment in the trial. The characteristics of the 47 physicians providing acupuncture within the trial are summarised in Table 1. During the course of the trial, participating physicians had provided between 2 and 227 (median 69) acupuncture treatments in total. They also had a median of 350 h (range h) of acupuncture training before participating in the trial, and 33 physicians (70%) had a B Diploma. Nineteen (40%) trial physicians had taught acupuncture in accredited postgraduate courses. Physicians had used acupuncture in their respective practices for an average of 10 (<1 to 25) years and had treated a median of 250 ( ) patients with acupuncture in the year preceding trial participation. Forty-four physicians (93%) stated that they frequently or always make a

4 Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients 183 Table 1 ART osteoarthritis of the knee: characteristics of participating trial physicians and assessment of intervention (n = 47) Mean, median (range) or n (%) Number of acupuncture sessions provided in the trial 72; 69 (2 227) Age in years 43; 42 (29 65) Women 26 (55) Postgraduate specialisation ( Facharzt ) 29 (62%) In medical practice for X years (prior to study initiation) 17; 17 (1 41) B Diploma (at least 350 h of training) 33 (70%) Hours of acupuncture training 588; 350 ( ) Teacher of acupuncture in accredited postgraduate courses 19 (40%) Use of acupuncture for X years (prior to study initiation) 10; 10 (0 25) Participation in earlier clinical trials 22 (47%) Membership in professional societies - In total 41 (87%) - German Medical Acupuncture Association (DÄGfA) 15 (32%) - International Society for Chinese Medicine (SMS) 11 (23%) - German Association for Acupuncture and Neural Therapy (DGfAN) 6 (13%) - Research Association for Acupuncture (FATCM) 2 (4%) - Others 17 (36%) Patients treated with acupuncture in the year before the trial - In total 345; 200 ( ) - Patients with osteoarthritis of the knee 58; 20 (0 600) Therapies used in patients in everyday practice (percentages) - Acupuncture 44% (3 100%) - Other traditional Chinese therapies 18% (0 60%) - Other complementary therapies 14% (0 50%) - Conventional medicine 32% (0 87%) Rarely/frequently/always Chinese diagnosis before treatment 3 (6%)/17 (36%)/27 (57%) How would you have applied acupuncture outside of the trial? - In exactly the same way 7 (15%) - Similarly 32 (68%) - Differently 7 (15%) - Missing 1 (2%) Would you have used additional therapies outside of the trial? -No 10 (21%) - Yes, in some patients 33 (70%) - Yes, in almost all patients 3 (6%) - Missing 1 (2%) Did you have any problems with minimal acupuncture? - Yes, on an ethical level 23 (49%) - Yes, technically 2 (4%) - Yes, during informed consent 23 (49%) Chinese syndrome diagnosis before starting treatment. A Chinese syndrome diagnosis was reported for 151 (51%) of the 294 patients who started the intervention (Table 2). Altogether, 288 Chinese syndrome diagnoses were made by the physicians. The most frequently reported syndromes were Bi syndrome (26%) and Kidney deficiency (26%), followed by Other diagnosis (21%) and Qi and Blood stagnation (17%). Patients in the acupuncture group were treated in a total of 1754 sessions (11.8 sessions/patient) (Table 3). According to the protocol, all of the patients were treated at local and distant points. On average, 17.4 ± 4.8 (mean and standard deviation) needles were used per session and the mean duration of each acupuncture session was 28.6 ± 3.0 min. The number of needles per session remained stable over the course of treatment. In almost all patients (>99%), the de qi sensation

5 184 B. Brinkhaus et al. Table 2 ART osteoarthritis of the knee: TCM syndromes diagnoses TCM diagnosis in ART osteoarthritis patients n (%) Patients with at least 1 TCM diagnosis 151 (51) Patients with 1 TCM diagnosis 47 (31) Patients with 2 TCM diagnoses 71 (47) Patients with 3 TCM diagnoses 33 (22) Group Subgroup Syndrome diagnosis TCM diagnosis 1 (n = 151) n (%) TCM diagnoses (all) (n = 288) n (%) I Bi-syndrome (all) 39 (26) 64 (22) 1 Bi-syndrome a 8 (5) 10 (4) 1a Cold 14 (9) 24 (8) 1b Dampness 10 (7) 19 (7) 1c Heat 4 (3) 7 (2) 1d Wind 3 (2) 4 (1) II Qi and blood stagnation (all) 26 (17) 47 (16) 2 Qi and blood stagnation a 4 (3) 5 (2) 3 Blood stagnation 20 (13) 33 (11) 4 Qi stagnation 2 (1) 9 (3) III Kidney deficiency (all) 39 (26) 57 (20) 5 Kidney deficiency a 5 (3) 10 (3) 6 Kidney yang deficiency b 16 (11) 23 (8) 7 Kidney yin deficiency c 13 (9) 18 (6) 8 Kidney qi deficiency 5 (3) 6 (2) IV Liver and spleen qi deficiency (all) 15 (10) 41 (14) 9 Liver qi deficiency 3 (2) 8 (3) 10 Spleen qi deficiency 12 (8) 33 (11) V 11 Other diagnosis 32 (21) 79 (27) a General category, more specific diagnosis was not mentioned. b Yang deficiency was interpreted as kidney Yang deficiency. c Yin deficiency was interpreted as kidney Yin deficiency; in case of dampness cold and dampness heat, Bi-syndrome it was defined as cold and heat Bi-syndrome. could be elicited, and in most cases (60%) manual stimulation was performed once. Additional classical points not mentioned as local or distant points in the treatment instructions were used in 35%, microsystem points in 17%, and trigger points in 14% of the sessions. In 64% of the sessions, acupuncture was performed in the same way as in the previous session. The mean number of local needles was 11.8 ± 3.6. The most frequently treated local points were ST36, SP9, ST35, extra point Xiyan, and ST34 (Table 4). The mean number of distant needles was 3.7 ± 1.4. The most frequently treated distant points were KI3, SP6, BL60, and SP4. Between 6 and 12 local points were used in 54% of patients, and 4 6 distant points were used in 67% of patients. In 609 treatment sessions, the participating physicians used additional acupuncture points, the most frequent of which were LR3, LI4, GB31, BL23, and BL11. Patients in the minimal acupuncture group were treated in a total of 869 sessions (11.8 sessions/patient) (Table 5). In most cases, the needle length used was mm. The most frequently used minimal acupuncture points were Upper Thigh II, Upper Thigh I, Upper Arm, Deltoideus, and Lower Thigh. The responses of physicians to the question of whether they would treat patients outside of the trial in the same way are summarised in Table 1. Thirty-nine (83%) physicians reported that they would have applied acupuncture similarly, or in exactly the same way, outside of the trial. Seven (15%) physicians stated that they would have treated patients differently (one answer missing). However, the majority of physicians indicated that they would have used additional therapies outside of the trial, at least for some patients. When asked in these cases which additional therapies they would have used, physicians named a great variety of treatments (i.e. most often Chinese herbs, homeopathy, relaxation, and nutritional changes). Approximately half of the physicians felt that providing minimal acupuncture was ethically problem-

6 Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients 185 Table 3 ART osteoarthritis of the knee: treatment in the acupuncture group All sessions n = 1754 Session 1 n = 148 Session 5 n = 146 Session 10 n = 145 Total number of needles 17.4 ± ± ± ± 5.0 Duration of session (min) 28.6 ± ± ± ± 2.9 Other classical acupuncture points used (%) Other classical acupuncture points: 3.3 ± ± ± ± 2.8 number of needles Trigger points used (%) Trigger points: number of needles 2.0 ± ± ± ± 0.8 Microsystem points used (%) Microsystem points: number of needles 2.8 ± ± ± ± 1.0 Acupuncture used as in sessions before (%) Length of needles used (%) <20 mm mm mm >40 mm Manual stimulation (%) - None Once More than once De qi (%) - Easy to elicit Difficult to elicit Could not be elicited atic. However, from a technical standpoint, the majority of physicians had no difficulties performing the specified minimal acupuncture technique. Thirty-eight (81%) physicians explicitly confirmed that, were another such trial to be conducted, they would participate again. However, eight (17%) indicated that they would not participate again (one answer missing). In the latter 10 cases, physicians gave the following reasons for their answer: the use of minimal acupuncture, the lack of complete individualisation, and the amount of bureaucracy involved in the trial. The results of the ART osteoarthritis trial demonstrate that acupuncture was more effective after 8 weeks than minimal acupuncture and no acupuncture in patients with osteoarthritis (Table 6). 7 The baseline-adjusted WOMAC Index at week 8 was 26.9 (1.4) (mean (S.E.)) in the acupuncture group compared to 35.8 (1.9) in the minimal acupuncture group and 49.6 (2.0) in the waiting list group (treatment difference acupuncture versus minimal acupuncture 8.8, 95% CI 13.5 to 4.2, p = ; acupuncture versus waiting list 22.7, 95% CI 27.5 to 17.9, p < ). In the acupuncture and minimal acupuncture groups, the improvements persisted through 26 and 52 weeks of followup, respectively. After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p = 0.080). Discussion Our analyses show that the physicians who participated in the ART osteoarthritis trial were a heterogeneous group whose overall qualifications were higher than the average qualifications of physicians who provide acupuncture within the German system of statutory reimbursement. In addition, our data indicate that the consensus-based treatment protocol used for acupuncture and minimal acupuncture in the ART osteoarthritis trial was a feasible approach that found acceptance among participating physicians. Nevertheless, it should be noted that approximately 15% of the trial physicians would have applied acupuncture differently outside of the study, and most would have used additional therapies if they had been given the choice. Finally, the findings of the ART osteoarthritis trial show that patients in the acupuncture group experienced

7 186 B. Brinkhaus et al. Table 4 ART osteoarthritis of the knee: treatment in the acupuncture group All sessions n = 1754 Session 1 n = 148 Session 5 n = 146 Session 10 n = 145 Local point ST34 (right/left) 56/53 54/53 56/55 52/47 Local point ST35 (right/left) 61/60 59/58 64/64 59/56 Local point ST36 (right/left) 76/71 76/70 75/71 76/71 Local point SP9 (right/left) 64/58 62/54 62/54 67/61 Local point SP10 (right/left) 53/52 53/53 54/53 51/49 Local point BL40 (right/left) 16/18 16/16 15/17 17/18 Local point KID10 (right/left) 19/17 21/16 20/ Local point GB33 (right/left) 11/9 11/9 10/8 10/10 Local point GB34 (right/left) 53/51 52/49 51/ Local point LI8 (right/left) 30/27 34/30 30/29 28/26 Extra point ExPHeding (right/left) 49/48 43/43 53/48 53/51 Extra point ExPXiyan (right/left) 59/56 57/56 62/57 59/57 Local points: number of needles 11.8 ± ± ± ± 3.5 Local points used -< > Distant point SP4 (right/left) 11/13 11/12 12/13 10/13 Distant point SP5 (right/left) 3/2 2/1 3/3 4/4 Distant point SP6 (right/left) 55/54 56/54 57/53 55/53 Distant point SI6 (right/left) 6/7 5/6 6/7 6/8 Distant point BL20 (right/left) 1/2 1/2 1/2 1/1 Distant point BL57 (right/left) 2/3 3/3 1/2 3/3 Distant point BL58 (left) Distant point BL60 (right/left) 24/25 26/26 23/23 23/25 Distant point BL62 (right/left) 10/10 11/12 11/11 10/10 Distant point KI3 (right/left) 72/70 69/67 74/73 70/69 Distant points: number of needles 3.7 ± ± ± ± 1.5 Distant points used - < greater improvements in pain and joint function than those in the minimal acupuncture or waiting list control groups at 8 weeks. Randomised trials of acupuncture are urgently needed to evaluate the effectiveness of this widely used therapy. However, defining interventions in randomised controlled acupuncture studies represents a difficult task. From a strictly scientific point of view, standardised interventions are needed so that the findings of a trial can be reproduced. A review of acupuncture studies in the treatment of osteoarthritis of the knee shows that standardised interventions were indeed used in all of the studies, at least in the period reviewed up to A recently published study including 570 patients with osteoarthritis of the knee used a standardised acupuncture intervention and yielded positive results in favour of acupuncture versus sham acupuncture. 16 However, the extent to which these findings are generalisable to other forms of acupuncture is unknown. In everyday practice, acupuncture in Germany and elsewhere is applied in a highly variable manner, and treatment is often individualised, as many physicians and acupuncturists believe that this results in the greatest effectiveness. 17 Because of this, acupuncture trials that use strictly standardised interventions might not represent a suitable foundation for guiding health care policy decisions on acupuncture treatment. In the ART osteoarthritis trial, we opted for a compromise that would assure a fundamental degree of consistency while

8 Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients 187 Table 5 ART osteoarthritis: treatment in the minimal acupuncture group All sessions n = 869 Session 1 N =73 Session 5 n =73 Session 10 n =72 Point Deltoideus (right/left) 67/72 69/73 66/71 68/74 Point Upper Arm (right/left) 69/70 71/73 70/71 67/68 Point Lower Arm (right/left) 53/53 56/56 53/53 49/49 Point Scapula (right/left) 48/52 41/44 48/52 53/57 Point Back I (right/left) 60/64 52/55 58/62 64/68 Point Back II (right/left) 56/60 47/49 55/59 60/64 Point Spina iliaca (right/left) 54/53 58/53 53/53 51/51 Point Upper Thigh I (right/left) 76/78 78/81 75/77 76/78 Point Upper Thigh II (right/left) 87/91 88/90 86/90 88/92 Point Lower Thigh (right/left) 64/68 62/66 62/66 68/72 Total number of needles 12.9 ± ± ± ± 3.4 Length of needles used <20 mm mm mm >40mm Duration of sessions (min) 28.0 ± ± ± ± 3.4 Table 6 ART osteoarthritis: outcome measures at week 8 after randomisation (questionnaire) and at weeks 5 8 (diary) Acupuncture (mean ± S.E.) Minimal acupuncture (mean ± S.E.) Waiting list (mean ± S.E.) ACU vs. MA a p ACU vs. WL a p Questionnaire WOMAC score 26.9 ± ± ± 2.0 <0.001 <0.001 WOMAC pain 24.4 ± ± ± 2.1 <0.001 <0.001 WOMAC stiffness 32.7 ± ± ± <0.001 WOMAC physical function 27.0 ± ± ± 2.1 <0.001 <0.001 Disability (PDI) 16.4 ± ± ± 1.3 <0.001 <0.001 Physical health (SF-36) b 36.2 ± ± ± <0.001 Mental health (SF-36) b 53.6 ± ± ± Pain affective (SES, t standard 42.4 ± ± ± scores) Pain sensoric (SES, t standard 47.3 ± ± ± scores) Depression (ADS, t standard 47.9 ± ± ± scores) Days with limited function 16.3 ± ± ± <0.001 Diary Days with pain in week ± ± ± <0.001 (diary) Days with medication in weeks 5 8 (diary) 4.5 ± ± ± VAS, visual analogue scale; FFBH-R, back pain questionnaire (Funktionsfragebogen Hannover-Rücken); PDI, Pain Disability Index; SES, questionnaire for assessing the emotional aspects of pain (Schmerzempfindungsskala); ADS, depression scale (Allgemeine Depressionsskala). a Mean baseline-adjusted treatment difference between groups. b Higher values indicate better status.

9 188 B. Brinkhaus et al. at the same time allowing some level of individualisation with regard to point selection. The treatment protocol was developed as part of a consensus process involving leading experts from two German medical acupuncture societies. Compared to several other Western countries (such as Great Britain or Sweden), the approach to medical acupuncture in Germany is, in general, based more on the theories of traditional Chinese medicine. We cannot rule out that our trial may have resulted in different outcomes if we had used a different acupuncture intervention. The authors of one large study (GERAC trial) comparing acupuncture with both sham acupuncture and standard treatment in patients with osteoarthritis of the knee pre-published their methods. 18 Similar to our study, the GERAC trial used a semi-standardised acupuncture treatment, including the needling of at least six local points in the knee region. However, there were nevertheless several major differences between the GERAC and the ART osteoarthritis studies. In ART osteoarthritis, physicians were required to treat patients at a minimum of two distant points, and ear acupuncture was permitted, whereas in the GERAC trial, additional points, such as distant points, were not mandatory. A head-to-head comparison of the findings of the ART and GERAC trials would be useful. In the trials mentioned thus far, even the difference in the number of acupuncture sessions demonstrates how heterogeneous acupuncture treatment in this kind of study can be. The number of acupuncture sessions varied considerably, with 10 sessions (plus 5 additional sessions) in the study by Streitberger et al sessions in our own trial, and 23 sessions in the trial conducted by Berman et al. 16 Thus, it seems that the number of treatment sessions is based primarily on subjective experience rather than on scientific findings. Further research should also include trials using different numbers of needles, applying different amounts of needle manipulation, and involving a larger number of international experts in the consensus process for defining treatment strategies. Even more difficult than defining the acupuncture intervention itself is the choice of an appropriate sham control. The German health authorities requested that our trial include a sham or placebo condition to investigate whether the effects of acupuncture are specific. However, the concepts of placebo and specific effects are unclear in relation to acupuncture. 19 Although it is widely accepted in Chinese medicine that it is important to correctly locate points, it should be noted that this theory has yet to be proved. Indeed, other aspects of acupuncture treatment, such as skin penetration, depth of needling, manipulation of needles, etc., may also be relevant effect modifiers. In the absence of an inert and indistinguishable placebo, a wide variety of sham interventions have been used in acupuncture trials. Based on a systematic review of such interventions, 20 as well as on our consensus procedure with acupuncture experts, we decided to use minimal acupuncture 21 as a sham control. It differed from the full or true acupuncture intervention with regard to point location, needling depth, and the avoidance of de qi and manual needle stimulation. Similar interventions have been used in a variety of previously published trials and also in the other ART trials in patients with migraine and tension-type headache. 20,22,23 Because our trial was performed to help policy makers decide whether acupuncture services should be reimbursed, a pragmatic comparison between an acupuncture treatment lege artis and a form that is clearly suboptimal according to acupuncture theory appeared to be an acceptable compromise. In the ART osteoarthritis trial, we asked the physicians to make Chinese medicine syndrome diagnoses, although doing so was not obligatory. Because of this, syndrome diagnoses were defined and documented in only half of the patients, a fact that clearly limits the findings of these diagnoses. The most frequently reported Chinese diagnoses were Bi syndrome, Kidney deficiency and Qi and Blood stagnation. This distribution of syndromes in patients with knee pain corresponds well with the statements of available textbooks on the subject. 24,25 However, our results cannot be compared with those of other trials because earlier acupuncture trials on osteoarthritis of the knee have either not evaluated or published the Chinese syndrome diagnoses. In conclusion, we believe that the treatment protocols for acupuncture and minimal acupuncture in the ART osteoarthritis trial represent an acceptable compromise, especially in the light of the very specific purpose of our study. Acknowledgements We would like to thank all participating patients and trial physicians, as well as the acupuncture experts who took part in the consensus process for developing the trial interventions. Study activities at the Institute of Social Medicine, Epidemiology, and Health Economics, Berlin, were funded by the following social health insurance funds: Techniker Krankenkasse (TK), Hamburg; Betriebskrankenkasse (BKK) Bosch; Betri-

10 Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients 189 ebskrankenkasse (BKK) Daimler Chrysler; Betriebskrankenkasse (BKK) Bertelsmann; Betriebskrankenkasse (BKK) BMW; Betriebskrankenkasse (BKK) Siemens; Betriebskrankenkasse (BKK) Deutsche Bank; Betriebskrankenkasse (BKK) Hoechst; Betriebskrankenkasse (BKK) Hypo Vereinsbank; Betriebskrankenkasse (BKK) Ford; Betriebskrankenkasse (BKK) Opel; Betriebskrankenkasse (BKK) Allianz; Betriebskrankenkasse (BKK) Vereins- und Westbank; Handelskrankenkasse (HKK). 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. References 1. Ezzo J, Hadhazy V, Birch S, et al. Acupuncture for osteoarthritis of the knee: a systematic review. Arthritis Rheum 2001;44(4): Birch S. Clinical research on acupuncture. Part 2. Controlled clinical trials, an overview of their methods. J Altern Complement Med 2004;10(3): MacPherson H, White A, Cummings M, Jobst KA, Rose K, Niemtzow RC. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. J Altern Complement Med 2002;8(1): Witt C, Brinkhaus B, Jena S, Selim D, Löbel S, Willich SN. Modellvorhaben Akupunktur der Techniker Krankenkasse und der dem Modellvorhaben beigetretenen Krankenkassen. Zeitschrift für Ärztliche Fortbildung und Qualitätssicherung im Gesundheitswesen 2004;98: Weidenhammer W, Streng A, Reitmayr S, Hoppe A, Linde K, Melchart D. Das Modellvorhaben Akupunktur der Ersatzkassen. Dt Ztschr f Akup 2002;45: Brinkhaus B, Becker-Witt C, Jena S, et al. Acupuncture randomized trials (ART) in patients with chronic low back pain and osteoarthritis of the knee design and protocols. Forsch Komplementärmed Klass Naturheilkd 2003;10(4): Witt C, Brinkhaus B, Jena S, et al. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet 2005;366: Deadman P, Baker K, Al-Khafaji M. A manual of acupuncture. Eastland Press; Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988;15(12): Stucki G, Meier D, Stucki S, et al. Evaluation of a German version of WOMAC (Western Ontario and McMaster Universities) arthrosis index. Z Rheumatol 1996;55(1): Schmerzfragebogen. medizin uni-koeln de/ projekte/dgss/schmerzfragebogen html; Dillmann U, Nilges P, Saile H, Gerbershagen HU. Behinderungseinschätzung bei chronischen Schmerzpatienten. Schmerz 1994;8: Geissner E. Die Schmerzempfindungsskala (SES). Hogrefe: Göttingen; 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; Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med 2004;141(12): Lao L, Berman B, Hammerschlag R. Assessing clinical efficacy of acupuncture: considerations for designing future acupuncture trials. In: Stux G, Hammerschlag R, editors. Scientific basis of acupuncture. Berlin: Springer-Verlag; p Streitberger K, Witte S, Mansmann U, et al. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: a study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN ]. BMC Complement Altern Med 2004;4(1): Birch S. Controlling for non-specific effects of acupuncture in clinical trials. Clin Acupunct Oriental Med 2003;4(2 3): Dincer F, Linde K. Sham interventions in randomized clinical trials of acupuncture a review. Complement Ther Med 2003;11(4): Vincent C, Lewith G. Placebo controls for acupuncture studies. J R Soc Med 1995;88(4): Linde K, Streng A, Jürgens S, et al. Acupuncture in patients with migraine a randomized trial (ART migraine). JAMA 2005;293(17): Melchart D, Streng A, Hoppe A, et al. Acupuncture in patients with tension-type headache a randomised trial. BMJ 2005;331: Maciocia G. This translation of the practice of Chinese medicine: the treatment of diseases with acupuncture and Chinese herbs. London: Churchill Livingstone; Focks C, Hillenbrand N. Leitfaden: traditionelle Chinesische medizin. München, Jena: Urban & Fischer Verlag; 2001.