Semi-standardized Acupuncture Research Articles

Acupuncture in diabetic peripheral neuropathy\u2014protocol for the randomized, multicenter ACUDPN trial

BackgroundAcupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms.MethodsThis study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24.DiscussionThe results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture.Trial registrationClinicalTrials.gov NCT03755960. Registered on 11 August 2018.

Does the dose of Traditional Chinese Medicine acupuncture in addition to usual care affect outcomes for adults with chronic low back pain? Protocol for a randomized controlled feasibility study

Background: Acupuncture is considered a clinically effective and cost-effective treatment option for chronic low back pain. However, few clinical trials have evaluated the dose dependence of acupuncture for chronic low back pain based on the number of sessions. Conclusions are conflicting and there is little high-quality evidence to support the cumulative effects of repeated interventions. A randomized controlled trial to investigate the optimal number of sessions of acupuncture in addition to usual care for adults with chronic low back pain is required; a feasibility study to test the rationale and method for the full-scale trial is the first step in that process.Design: A pragmatic parallel three-armed randomized, controlled feasibility study.Methods: Forty-five participants with chronic low back pain will be recruited locally and randomized on a 1:1:1 basis to receive usual care plus 4 (n = 15), 7 (n = 15) or 10 sessions (n = 15) of semi-standardized acupuncture. Primary outcomes are acceptability of and adherence to different numbers of sessions of acupuncture, as well as the feasibility of the recruitment approach and completion of the specific outcome measures. Secondary outcomes include pain intensity and patient satisfaction. Follow-up questionnaires will be collected at discharge, 6, and 12 weeks after randomization.Discussion: Outcomes will inform the decision to conduct a full-scale trial to definitively test the dose dependence of acupuncture. Findings will add to the limited evidence available regarding the optimal number of sessions of acupuncture in the management of chronic low back pain, as well as being clinically relevant to clinicians, researchers and policy makers.

A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis – trial intervention including physician and treatment characteristics

BackgroundIn a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial’s participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians.MethodsACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each sessionResultsAcupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was ‘wind-cold invading the lung’ (37%) and ‘wind-heat invading the lung’ (37%), followed by ‘lung and spleen qi deficiency’ (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6).ConclusionsThe trial interventions were provided by well educated and experienced acupuncturists. The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients. For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles.Trial registrationClinicalTrials.gov: NCT00610584.

Akupunktur bei Patienten mit allergischer Rhinitis: Analyse der Studienintervention und Syndrommuster der randomisierten Multicenter Studie (ACUSAR)

BackgroundAcupuncture was efficient and superior to sham acupuncture and a control group in the ACUpuncture in Seasonal Allergic Rhinitis (ACUSAR) trial. The article aims to inform about the study intervention, the underlying therapeutic ideas and clinical consequences. DesignThree-armed, randomized, controlled multi-center-trial with a 16-week follow-up during the SAR season in the first trial year and an 8 week follow-up during the SAR season in the following year. SettingOutpatient or private clinics in Germany. Intervention422 Patients with seasonal allergic rhinitis on birch and grass pollen have been randomized to fall into 3 groups: 12 sessions of semi-standardised acupuncture plus rescue medication (RM, Cetirizine) or 12 sessions of sham acupuncture plus RM or RM alone during the initial two months of the study. Study intervention was defined in a Delphi consensus procedure including five experts from two major German acupuncture associations and three experts on trial methodology and statistics. A consensus between the need for standardisation and individualisation was defined using a semi-standardised treatment in the acupuncture group: 4 obligatory acupuncture points, ≥ 3 out of 8 facultative basic points and ≥ 3 facultative local or distant acupuncture points. Sham acupuncture consisted in superficial needling of at least 5 of 7 predefined, bilateral, distant non-acupuncture points. Needling characteristics such as point location, needling time, manipulation and achieved ‘De Qi' had to be documented after each session. ResultsCM syndrome diagnoss reported most frequently were Wind-Cold invading the lung' and ‘Wind-Heat invading the lung' (37 % each). In the acupuncture group all basic obligatory points were used in 97 % of cases (LI 4, LI 11, LI 20, EX-HN 3 Yintang). The most frequently used basic optional acupuncture points were GB 20, LIV 3, ST 36, LU 7 and SP 6. The total number of needles used was higher in the acupuncture group (15.7 ± 2.5) compared to the sham acupuncture group (10.0 ± 1.6). ConclusionsCM syndrome diagnoses and point selection in the acupuncture group of the trial corresponded to clinical experiences in CM treatment of SAR. Point location and a higher number of needles in the acupuncture group compared to the sham acupuncture group may have influenced the positive trial results.

Effects of acupuncture for cancer pain and quality of life - a case series.

BackgroundMany cancer patients seek complementary and alternative medicine (CAM) including acupuncture to manage their cancer-related symptoms or side effects of treatments. Acupuncture is used to manage cancer pain and improve quality of life (QoL). This study aimed to conduct a preliminary study on a case series to evaluate the feasibility of acupuncture for treating cancer pain and to collect preliminary data on the effectiveness of acupuncture in treating cancer pain and improving QoL.MethodsA semi-standardized acupuncture treatment comprising one to three treatment sessions (20–30 minutes per session) per week for 8 weeks was provided by four licensed acupuncturists, who had more than 5 years of clinical experience, at the University Health Center. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C3) and a visual analogue scale (VAS) for pain rating were used as the outcome measures to assess pain and QoL. Data were collected at baseline, immediately after 2, 4, 6, and 8 weeks of treatment and at 4 weeks after treatment completion (week 12).ResultsTwo males and five females with a median age of 66 years (range: 44–71 years) completed the study. For the VAS, the percentage of improvement ranged between 18% and 95%. The baseline mean raw score was reduced from 51 mm to 36 mm at the end of week 8 and to 23 mm at the end of week 12. The percentage of overall QoL improvement ranged between 20% and 100%. The mean raw score for QoL improved with time. The baseline score was increased from 55 to 69 at the end of treatment (week 8) and to 73 after the follow-up (week 12).ConclusionsThis pilot study on a case series showed that acupuncture might be beneficial for reducing pain and improving QoL in cancer patients.

Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) – Design and Protocol of a Randomised Controlled Multi-Centre Trial

Background: We report on the study design and protocol of a randomised controlled trial (Acupuncture in Seasonal Allergic Rhinitis, ACUSAR) that investigates the efficacy of acupuncture in the treatment of seasonal allergic rhinitis (SAR). Objective: To investigate whether acupuncture is non-inferior or superior to (a) penetrating sham acupuncture and (b) rescue medication in the treatment of SAR. Design: 3-armed, randomised controlled multi-centre trial with a total follow-up time of 16 weeks in the 1st year and 8 weeks in the 2nd year. Setting: 41 physicians in 37 out-patient units in Germany specialised in acupuncture treatment. Patients: 400 seasonal allergic rhinitis patients with clinical symptoms and test-positive (skin-prick test and/or specific IgE) to both birch and grass pollen. Interventions: Patients will be randomised in a 2:1:1 ratio to one of three groups: (a) semi-standardised acupuncture plus rescue medication (cetirizine); (b) penetrating sham acupuncture at non-acupuncture points plus rescue medication; or (c) rescue medication alone for 8 weeks (standard treatment group). Acupuncture and sham acupuncture will consist of 12 treatments per patient over 8 weeks. Main Outcome Measures: Average means of the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the Rescue Medication Score (RMS) between weeks 6 and 8 in the first year, adjusted for baseline values. Outlook: The results of this trial available in 2011 will have a major impact on the decision of whether acupuncture should be considered as a therapeutic option in the treatment of SAR.

Acupuncture in acute herpes zoster pain therapy (ACUZoster) – design and protocol of a randomised controlled trial

BackgroundAcute herpes zoster is a prevalent condition. One of its major symptoms is pain, which can highly influence patient's quality of life. Pain therapy is limited. Acupuncture is supposed to soften neuropathic pain conditions and might therefore act as a therapeutic alternative. Objective of the present study is to investigate whether a 4 week semi-standardised acupuncture is non-inferior to sham laser acupuncture and the anticonvulsive drug gabapentine in the treatment of pain associated with herpes zoster.Methods/DesignThree-armed, randomised, placebo-controlled trial with a total follow-up time of 6 months. Up to estimated 336 patients (interim analyses) with acute herpes zoster pain (VAS > 30 mm) will be randomised to one of three groups (a) semi-standardised acupuncture (168 patients); (b) gabapentine with individualised dosage between 900–3600 mg/d (84 patients); (c) sham laser acupuncture. Intervention takes place over 4 weeks, all patients will receive analgesic therapy (non-opioid analgesics: metamizol or paracetamol and opioids: tramadol or morphine). Therapy phase includes 4 weeks in which group (a) and (c) consist of 12 sessions per patient, (b) visits depend on patients needs. Main outcome measure is to assess the alteration of pain intensity before and 1 week after treatment sessions (visual analogue scale VAS 0–100 mm). Secondary outcome measure are: alteration of pain intensity and frequency of pain attacks; alteration of different aspects of pain evaluated by standardised pain questionnaires (NPI, PDI, SES); effects on quality of life (SF 36); analgesic demand; alteration of sensoric perception by systematic quantitative sensory testing (QST); incidence of postherpetic neuralgia; side effects and cost effectiveness. Credibility of treatments will be assessed.DiscussionThis study is the first large-scale randomised placebo controlled trial to evaluate the efficacy of acupuncture compared to gabapentine and sham treatment and will provide valuable new information about the clinical and physiological effects of acupuncture and gabapentine in the treatment of acute herpes zoster pain. The study has been pragmatically designed to ensure that the study findings can be implemented into clinical practice if acupuncture can be shown to be an effective treatment strategy in acute herpes zoster pain.Trial registrationNCT00885586

Efficacy of acupuncture for the treatment of non-specific acute low back pain: different components of the therapeutic effect

Background The aim of this study was to evaluate the efficacy of acupuncture in treating non-specific acute low back pain, and to identify the different components of the therapeutic effect of the technique. Methods Randomized controlled multicentre prospective study, with four Branches, aimed at comparing real semi-standardized acupuncture at specific Points Group A), acupuncture at non-specific points (Group B), placebo acupuncture (Group C) and conventional treatment (analgesics, antirugs, inflammatory drugs, myorelaxants, postural advice) (Group D). The patients were blinded for the specific, non-specific and placebo acupuncture treatments. Evaluation of the patients and analysis of the results were carried out by experts who were blinded as regards the allocation to the different treatment groups. The patients selected were of working age and presented symptoms of acute non-specific low back pain; they had been referred by their GPs at Primary Healthcare Clinics to one of the four clinics participating in the study, all of which belonged to the Andalusian Public Health System (Spain). The participants were evaluated before randomization and at the end of weeks 3, 12 and 48 from the start of treatment. The primary outcome measure was significant clinical improvement (SCI) at 3 weeks after randomization, defined as a reduction of 35% of more in the RMQ score. Results 275 patients were randomized; mean duration of 6 days of the low back pain episode. 59% were women, with a mean age of 42.7 years. 75% of the participants were in paid work, and over 50% of these said they were satisfied with it. The patients suffered a high mean baseline pain intensity level (70.4 mm on a scale of 100 mm), an index of fear and avoidance conduct related to physical activity of 18.8 (SD 5.6) and a corresponding work-related index of 24.3 (SD 9.8). For 44% of the patients, this was their first episode of back pain, while 61.7% were on sick leave due to the back pain being suffered at the outset of the study. Over half of the participants (57.8%) remarked that their pain was work related. By ITT analysis, the SCI at 3 weeks from the start of the treatment was obtained for 77.1% of the participants in Group A, for 73.5% of those in Group B, for 62.3% of those in Group C, and for 42.9% of those in Group D. The differences between Groups A, B and C with respect to Group D were statistically significant, as were those between Groups A and C (see table). Conclusion Acupuncture, both at specific points and at non-specific ones or as a placebo, achieves a rate of significant clinical improvement that is superior to that obtained by conventional treatment for acute non-specific back pain, and this difference is statistically significant. No differences were found between the different types of acupuncture, as regards specific or non-specific points, for this type of pain.

Tratamiento de acupuntura de preparación para una fertilización in vitro en un caso de infertilidad. Un estudio observacional

Background During the past years acupuncture has been increasingly used to assist in vitro fertilization (ivF). Objective To test whether success rates of acupuncture for ivF could be raised employing a semi-standardised acupuncture regimen with special emphasis on acupuncture point Ex-R8. Method During III/99 and III/06 261 female patients were treated with acupunctur directly before and after embryo transfer. Result 93 of 261 patients became pregnant (rise of β-HCG in the second week after transfer in 35,6 %). Discussion The success rate is especially impressive because the patients treated in my clinic had undergone at least one non successful ivF before. Conclusion There is no doubt that acupuncture is able to raise the success rate of ivF. I advise the scientific community to test my therapeutic regimen, especially including the utilisation of acupuncture point Ex-R 8.

Akupunkturbehandlung zur Vorbereitung auf eine In-vitro-Fertilisation bei unerfülltem Kinderwunsch – eine Anwendungsbeobachtung

BackgroundDuring the past years acupuncture has been increasingly used to assist in vitro fertilization (ivF). ObjectiveTo test whether success rates of acupuncture for ivF could be raised employing a semi-standardised acupuncture regimen with special emphasis on acupuncture point Ex-R8. MethodDuring III/99 and III/06 261 female patients were treated with acupunctur directly before and after embryo transfer. Result93 of 261 patients became pregnant (rise of b-HCG in the second week after transfer in 35,6 %). DiscussionThe success rate is especially impressive because the patients treated in my clinic had undergone at least one non successful ivF before. ConclusionThere is no doubt that acupuncture is able to raise the success rate of ivF. I advise the scientific community to test my therapeutic regimen, especially including the utilisation of acupuncture point Ex-R 8.

Interventions and Physician Characteristics in a Randomized Multicenter Trial of Acupuncture in Patients with Low-Back Pain

Descriptions of the interventions used in acupuncture studies are often incomplete. The aim of this paper is to describe participating trial physicians and interventions in a randomised trial of acupuncture for low back pain. Three-armed, randomized, controlled multicenter trial with 1-year follow-up. A total of 301 patients with low-back pain were randomized to 12 sessions of semistandardized acupuncture (at least six local and two distant points needled bilaterally from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), minimal acupuncture (superficial needling of at least 6 of 10 predefined, bilateral, distant nonacupuncture points), or a waiting list control (2 months no acupuncture followed by semistandardised acupuncture described above). Participating trial physicians and interventions. Forty-five (45) physicians specializing in acupuncture (mean age 44 +/- 7.8 years, 23 (51%) female) in 30 outpatient centers in Germany provided the interventions. The median duration of acupuncture training of trial physicians was 350 hours (range 140-2508). The most frequently reported Chinese diagnosis was Kidney deficiency (39%), followed by qi and Blood stagnation (24%), and bi syndrome (20%). The total number of needles used was 17.3 +/- 4.2 in the acupuncture group compared to 12.3 +/- 1.2 in the minimal acupuncture group. In total, 40 physicians (89%) stated that they would have treated patients similarly or in exactly the same way outside of the trial, whereas 5 (11%) stated that they would have treated patients differently. For most trial physicians, the semistandardized acupuncture strategy used in this trial was an acceptable compromise for an efficacy study. However, a relevant minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

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

The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee. Three-armed, randomised, controlled multicentre trial with 1-year follow-up. Twenty-eight outpatient centres in Germany. 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). Participating trial physicians and interventions. 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 350 h (range 140-2508). 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). Our documentation of the trial interventions shows that semi-standardised 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.

Acupuncture in Migraine Prophylaxis

The purpose of the present trial was to evaluate semi-standardized acupuncture efficacy in migraine prophylaxis. Twenty-eight subjects with migraine were randomized to the real or sham acupuncture groups. Semi-standardized and standardized minimal acupuncture were used, respectively, in the two groups of patients. They were all treated with 16 acupuncture sessions in 12 weeks. Both groups exhibited similar reductions in: percentage of patients with reduction of migraine>or=40% and >or=50% regarding frequency of migraine attacks, days with migraine, frequency of migraine attacks, average duration of a migraine attack, rate of rescue medication used, average headache severity rate and other parameters compared with the baseline period. Associated symptoms, such as nausea and vomiting, also showed equal estimates in both groups. These findings showed that semi-standardized acupuncture shows no difference from sham acupuncture in preventing migraine attacks.

Treatment in a Randomized Multicenter Trial of Acupuncture for Migraine (ART Migraine)

Background: This paper aims to describe the characteristics ofphysicians and interventions of a large, multicenter randomizedtrial of acupuncture for migraine (ART Migraine) in order to enableacupuncturists to assess the study interventions. Patients andMethods: 302 patients suffering from migraine were randomized to12 sessions of semi-standardized acupuncture (6 predefined basicpoints, recommendations for optional individual choice of additionalpoints given), standardized minimal acupuncture (superficialneedling of at least 5 of 10 predefined, distant non-acupuncturepoints) or a waiting list. 30 physicians trained and experienced inacupuncture from 18 centers in Germany participated in the trial.Results: The median duration of acupuncture training of trial physicianswas 500 h (range 140-1350). Physicians had acupuncture experiencefor 10 (<1 to 25) years and had treated 200 (60 to >1000)patients with acupuncture in the year preceding trial participation.The 6 basic points were needled in 76-93% of sessions. Compliancewith treatment instructions varied considerably among centers inthe acupuncture group. In contrast, compliance with the minimalacupuncture protocol was very good. 6 of the 30 physicians statedthat they would have treated patients somewhat differently outsidethe trial, 1 completely differently. The trial found a significant effectof those treated with acupuncture compared to those on the waitinglist for treatment, but minimal acupuncture was as effective asacupuncture. Conclusions: The treatment protocols for acupunctureand minimal acupuncture in ART Migraine appeared an adequatecompromise in the specific situation and for the predefined purposes.However, a relevant minority of participating physicians wouldhave treated patients differently outside the trial.

The Acupuncture Randomised Trial (Art) for Tension-Type Headache - Details of the Treatment

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. 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. A total 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. 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. In general, trial physicians complied well with the predefined interventions. A relevant minority of participating trial physicians stated that they would have treated patients differently outside the trial.

Acupuncture Randomized Trials (ART) in Patients with Chronic Low Back Pain and Osteoarthritis of the Knee – Design and Protocols

Background: We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively. Objective: To investigate whether acupuncture is more efficacious than (a) no treatment or (b) minimal acupuncture in the treatment of low back pain and osteoarthritis. Design: Two randomized, controlled, multicenter trials with three treatment arms and a total follow-up time of 52 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: 300 patients will be included in each study. In the low back pain trial, patients will be included according to clinical diagnosis. In the osteoarthritis pain trial, patients will be included according to the American College of Rheumatology criteria. Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) minimal acupuncture at non-acupuncture points (75 patients), or (3) no treatment for two months followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters: pain intensity as measured by a visual analogue scale (VAS; 0–100 mm) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis trial. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

Acupuncture Randomized Trials (ART) in Patients with Migraine or Tension-Type Headache – Design and Protocols

Background and Objective: We report the design and essentials of the protocols of two Acupuncture Randomized Trials (ART) investigating whether acupuncture is more efficacious than no treatment and minimal acupuncture in the interval treatment of migraine and tension-type headache. Design: Randomized controlled multicenter trials with three treatment arms and a total observation period of 28 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: Per study 300 patients with migraine and episodic or chronic tension-type headache, respectively (diagnosis according to the criteria of the International Headache Society). Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) standardized minimal acupuncture (75 patients), or (3) no interval treatment for 12 weeks followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: Main outcome measure in the migraine trial is the difference between the number of days with headache of moderate or severe intensity during the 4 weeks before randomization and weeks 9 to 12 after randomization. In the study on tension-type headache the main outcome measure is similar to that described above, but for the number of headache days regardless of intensity. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.