Hydrotherapy and acupressure in restless legs syndrome: A randomized, controlled, 3-armed, explorative clinical trial.

BACKGROUND: Restless legs syndrome (RLS) is a common neurological disease that has a significant impact on daily activities and quality of life, for which there is often no satisfactory therapy. Complementary medicine, such as acupressure and hydrotherapy, is used to treat patients with RLS; however, the clinical evidence is unclear. This study aims to investigate the effects and feasibility of self-administered hydrotherapy and acupressure in patients with RLS. METHODS: This is a randomized, controlled, open-label, exploratory, clinical study with 3 parallel arms, comparing both self-applied hydrotherapy (according to the German non-medical naturopath Sebastian Kneipp) and acupressure in addition to routine care in comparison to routine care alone (waiting list control) in patients with RLS. Fifty-one patients with at least moderate restless-legs syndrome will be randomized. Patients in the hydrotherapy group will be trained in the self-application of cold knee/lower leg affusions twice daily for 6 weeks. The acupressure group will be trained in the self-application of 6-point-acupressure therapy once daily for 6 weeks. Both interventions take approximately 20 minutes daily. The 6-week mandatory study intervention phase, which is in addition to the patient preexisting routine care treatment, is followed by a 6-week follow-up phase with optional interventions. The waitlist group will not receive any study intervention in addition to their routine care before the end of week 12. Outcome parameters including RLS-severity, disease and health-related quality of life (RLS-QoL, SF-12), Hospital Anxiety and Depression Score in German version, general self-efficacy scale, and study intervention safety will be measured at baseline and after 6 and 12 weeks. The statistical analyses will be descriptive and exploratory. CONCLUSION: In the case of clinically relevant therapeutic effects, feasibility, and therapeutic safety, the results will be the basis for planning a future confirmatory randomized trial and for helping to develop further RLS self-treatment concepts.

Acupressure in patients with seasonal allergic rhinitis: a randomized controlled exploratory trial.

BACKGROUND: Acupuncture has shown beneficial effects for seasonal allergic rhinitis (SAR); however, it is time and cost intensive. We investigated feasibility and effects of self-administered body acupressure as a self-care technique that stimulates acupuncture points with manual pressure in SAR patients. METHODS: We conducted a two-armed randomized controlled exploratory trial to compare effects of self-administered acupressure over 4 weeks at five acupuncture points plus rescue medication (RM) with cetirizine compared to RM alone in SAR patients. Among other outcome parameters, we assessed disease-related quality of life (Rhinitis Quality of Life Questionnaire [RQLQ]), overall SAR symptoms by a visual analogue scale (VAS) and a rescue medication score (RMS) after 4 and 8 weeks. RESULTS: Forty-one SAR patients (mean age 38.5 ± 10.0 years, n = 21, 51.2% women) were randomized. Compared to RM alone (n = 21), acupressure plus RM (n = 20) was associated with relevant improvements after 4 weeks, shown by the difference between groups in adjusted means of RQLQ: - 0.9 points (95% CI - 1.6 to - 0.2; p = 0.011) and VAS overall SAR symptoms: - 21.6 mm (95% CI - 36.3 to - 6.8; p = 0.005). The RMS was lower in the acupressure group than in the control group: 1.9 points (95% CI - 3.8 to - 0.1; p = 0.120). Group differences decreased slightly until week 8. The acupressure was feasible and safe. CONCLUSION: Results of this exploratory study indicate that self-applied acupressure is feasible, may improve disease-specific quality of life and reduce disease-related symptoms as well as anti-allergic medication intake in SAR patients. High-quality confirmatory studies including a sham-control group are needed in the future. Trial registration DRKS-ID: DRKS00014310. Date of registration in DRKS: 2018/04/24. Investigator sponsored/initiated trial (IST/IIT): yes. Ethics approval/approval of the ethics committee: Approved (leading) Ethics Committee No. EA1/033/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014310.

Corrigendum to "The Contribution of Complementary and Alternative Medicine to Reduce Antibiotic Use: A Narrative Review of Health Concepts, Prevention, and Treatment Strategies".

[This corrects the article DOI: 10.1155/2019/5365608.].

[Traditional Chinese medicine (TCM)-what is myth and what is the state of evidence today?] / Traditionelle Chinesische Medizin (TCM) ­ vom Mythos zur Evidenz.

Traditional Chinese medicine (TCM) is the most comprehensive and widely practiced system of medicine in the world.Originally, TCM appeared in our Western context as an unfathomable mythological doctrine. Once the linguistic barriers had been overcome, it became possible to understand and apply the terminological and physiological concepts, the method of diagnosis, and the clinical findings.Since the NIH consensus conference in 1998, our understanding of TCM has been the subject of methodologically robust studies. We now have evidence of the efficacy and effectiveness of acupuncture beyond its use in pain therapy and allergy treatment. Thanks to fMRI studies, among others, we also have a better understanding of the mechanisms underlying acupuncture.Meta-analyses and studies also confirm the efficacy of Chinese medicinal drugs and remedies in some fields, yet there is still extensive need for further research. But opportunities are also emerging for new medicines and prescriptions for (accompanying) treatments of infections, autoimmune diseases, cancer, metabolic illnesses, dermatological disorders, and gastrointestinal diseases.To enable further evaluation of TCM, but also to ensure an integrative, critical application in the practice of TCM, it is vital for doctors to have thorough training. Further institutionalisation is necessary to provide orientation and patient safety.The days of regarding TCM as some kind of mysticism are indeed long over and it can offer real opportunities for better patient care. In many fields, there is increasing evidence of TCM's effectiveness, yet further comprehensive research is essential. This should be encouraged unconditionally.

The Contribution of Complementary and Alternative Medicine to Reduce Antibiotic Use: A Narrative Review of Health Concepts, Prevention, and Treatment Strategies.

AIM: The aim of this narrative review was to explore the potential contributions of CAM to reduce antibiotic use. METHODS: We searched PubMed, Embase, and Cochrane Database of Systematic Reviews with a specific, limited set of search terms and collected input from a group of expert CAM researchers to answer the question: What is known about the contribution of CAM health and health promotion concepts, infection prevention, and infection treatment strategies to reduce antibiotic use? Results. The worldview-related CAM health concepts enable health promotion oriented infection prevention and treatment aimed at strengthening or supporting the self-regulating ability of the human organism to cope with diseases. There is some evidence that the CAM concepts of health (promotion) are in agreement with current conceptualization of health and that doctors who practice both CAM and conventional medicine prescribe less antibiotics, although selection bias of the presented studies cannot be ruled out. There is some evidence that prevention and some treatment strategies are effective and safe. Many CAM treatment strategies are promising but overall lack high quality evidence. CONCLUSIONS: CAM prevention and treatment strategies may contribute to reducing antibiotic use, but more rigorous research is necessary to provide high quality evidence of (cost-)effectiveness.

[Traditional Chinese Pharmacotherapy in Patients with Chronic Rhinosinusitis - an Observational Trial Considering the Origin of Medicinal Drugs]. / Traditionelle chinesische Arzneitherapie bei Patienten mit chronischer Rhinosinusitis − eine Therapiebeobachtung mit Berücksichtigung der Arzneimittelherkunft.

BACKGROUND: The use of Chinese medicinal drugs is becoming more common in Germany. However, the import from China results in aggravated quality controls and potentially jeopardized therapeutic safety. Therefore, in 1999 the Bavarian Department for Agriculture has initiated an interdisciplinary research project to cultivate and analyze important Chinese herbal plants. Currently 16 Bavarian-produced Chinese drugs are in use and distributed to patients by pharmacies. Despite a comparable quality of Bavarian pharmaceutical products, there are concerns remaining as the Bavarian medical drugs have been used for treatment purposes on patients since 2006, without their effect having been compared to the Chinese products. Therefore we performed an observational trial using a parallel group design on patients with chronic rhinosinusitis. METHODS: The duration of the trial was 4 weeks. After a 4-week follow-up, the patients were interviewed via telephone. During the trial the patients were given 2 × 50 ml of a decoction of Chinese medicinal herbs, either (a) from Bavarian controlled cultivation (Bavaria group) or (b) from Chinese production (China group). The therapeutic success was evaluated using numerical rating scales. RESULTS: In total, 64 patients completed the observational trial (31 Bavaria group, 33 China group). Both groups showed significant improvements in the main symptom scores of chronic rhinosinusitis as well as in secondary symptoms, such as the overall state of health or the tendency to catch a cold. There were no significant differences between the groups concerning the main symptoms scores. Overall the herbal decoctions had no severe side effects. CONCLUSION: This observational trial shows that Chinese herbal drugs from Bavarian cultivation are as effective as medicinal herbs imported from China, but the effects of concomitant therapies must be considered as well. The symptom score improvements during the treatment period were obvious and should stimulate further investigation on the efficacy of this herbal formula in the treatment of chronic rhinosinusitis.

Safety aspects of Chinese herbal medicine in pregnancy-re-evaluation of experimental data of two animal studies and the clinical experience.

INTRODUCTION: Chinese herbal medicine is an increasingly popular worldwide medical therapy which also has an impact in pregnancy. However, the question of its drug safety during pregnancy remains unresolved. Potential problems include teratogenicity, abortion, perinatal toxicity, pre- and postnatal developmental abnormalities, and eventually an increased risk for carcinomas in the offspring. Standard Materia Medica textbooks contain unreliable information when it comes to risks during pregnancy. Wang and co-workers conducted an experimental study (WS) on mice in which they investigated the effects of 17 Chinese medicinals regarding embryotoxicity and fetotoxicity. All these drugs seemed to exhibit multiple significant toxic effects. Another study by Li and co-workers (LS) investigated the reproductive toxicity of Atractylodis macrocephalae Rhizoma in mice, rats and rabbits. They described an increased pre- and postnatal mortality and, at high doses, congenital malformations. In an attempt to identify the risks of the tested medicinals during pregnancy, we analysed these two experimental studies and compared their results with possible safety data for humans from two reviews of clinical studies on threatened miscarriage (AR and CR). METHODS: We re-evaluated WS and LS in relation to accordance with internationally accepted rules, equivalence to human dose, biometric accuracy, plausibility, and coherence. Eligible studies of the two reviews on threatened miscarriage were evaluated for specific pregnancy risks concerning the 17 medicinals tested in WS and LS. RESULTS: We found that WS does not conform to international ICH guidelines and includes many inconsistencies, implausibilities and several severe biometrical flaws. It reported a total of 364 significant events out of which 145 false significant results are expected. The data-handling pointed to irregularities. Analysis of LS exhibited also many inconsistencies. The results regarding congenital malformations were statistically insignificant and are based on small case numbers. Insofar as the safety data of the 17 medicinals were documented by eligible studies of the two reviews, there was no indication of an increased abortion rate in humans. Fetal growth retardation was not observed in the human studies. For neonatal health and postnatal development, there were sufficient safety data only for a few medicinals in the human studies. As for teratogenicity, only small case numbers (0 to 109) were available from the human data. CONCLUSION: WS and LS are not reliable data sources for deriving pregnancy risks in humans for the tested Chinese medicinals. In addition, the results appear to contradict the outcomes observed in the treatment of humans. Regarding teratogenicity, for most Chinese medicinals, neither the safety nor the risk during pregnancy can be definitively ascertained. Further studies on the risks of Chinese medicinals during pregnancy are urgently needed.

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

BACKGROUND: In 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. METHODS: ACUSAR (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 session RESULTS: Acupuncture 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). CONCLUSIONS: The 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 REGISTRATION: ClinicalTrials.gov: NCT00610584.

Acupuncture in patients with seasonal allergic rhinitis: a randomized trial.

UNLABELLED: Chinese translation BACKGROUND: Acupuncture is frequently used to treat seasonal allergic rhinitis (SAR) despite limited scientific evidence. OBJECTIVE: To evaluate the effects of acupuncture in patients with SAR. DESIGN: Randomized, controlled multicenter trial. (ClinicalTrials.gov: NCT00610584) SETTING: 46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics. PATIENTS: 422 persons with SAR and IgE sensitization to birch and grass pollen. INTERVENTION: Acupuncture plus rescue medication (RM) (cetirizine) (n = 212), sham acupuncture plus RM (n = 102), or RM alone (n = 108). Twelve treatments were provided over 8 weeks in the first year. MEASUREMENTS: Changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMS) from baseline to weeks 7 and 8 and week 16 in the first year and week 8 in the second year after randomization, with predefined noninferiority margins of -0.5 point (RQLQ) and -1.5 points (RMS). RESULTS: Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score (sham vs. acupuncture mean difference, 0.5 point [97.5% CI, 0.2 to 0.8 point; P < 0.001]; RM vs. acupuncture mean difference, 0.7 point [97.5% CI, 0.4 to 1.0 point; P < 0.001]) and RMS (sham vs. acupuncture mean difference, 1.1 points [97.5% CI, 0.4 to 1.9 points; P < 0.001]; RM vs. acupuncture mean difference, 1.5 points [97.5% CI, 0.8 to 2.2 points; P < 0.001]). There were no differences after 16 weeks in the first year. After the 8-week follow-up phase in the second year, small improvements favoring real acupuncture over the sham procedure were noted (RQLQ mean difference, 0.3 point [95% CI, 0.03 to 0.6 point; P = 0.032]; RMS mean difference, 1.0 point [95% CI, 0.2 to 1.9 points; P = 0.018]). LIMITATION: The study was not powered to detect rare adverse events, and the RQLQ and RMS values were low at baseline. CONCLUSION: Acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.

Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone: using stakeholder engagement to design a pragmatic randomized trial and study protocol.

BACKGROUND: Self-care acupressure might be successful in treating menstrual pain, which is common among young women. There is a need for comparative effectiveness research with stakeholder engagement in all phases seeking to address the needs of decision-makers. Our aim was to design a study on the effectiveness of additional self-care acupressure for menstrual pain comparing usual care alone using different methods of stakeholder engagement. METHODS: The study was designed using multiple mixed methods for stakeholder engagement. Based on the results of a survey and focus group discussion, a stakeholder advisory group developed the study design. RESULTS: Stakeholder engagement resulted in a two-arm pragmatic randomized trial. Two hundred and twenty women aged 18 to 25 years with menstrual pain will be included in the study. Outcome measurement will be done using electronic questionnaires provided by a study specific mobile application (App). Primary outcome will be the mean pain intensity at the days of pain during the third menstruation after therapy start. CONCLUSION: Stakeholder engagement helped to develop a study design that better serves the needs of decision makers, including an App as a modern tool for both intervention and data collection in a young target group. TRIAL REGISTRATION: Clinicaltrials.gov identifier http://NCT01582724.

Cultivation and breeding of Chinese medicinal plants in Germany.

Chinese herbal medicine (CHM) is increasingly used in Germany and Europe. Due to the need for herbal drugs of consistent quality and reliable supply, methods for commercial field cultivation and post-harvest processing under south German conditions have been developed for selected plant species used in CHM since 1999. The project used an interdisciplinary approach covering all aspects from seed sourcing to medicinal application. This paper describes the outcome of the agricultural seed and field experiments, breeding program, botanical and chemical characterization of the experimental material, comparison of experimental and imported herbal material with respect to their pharmaceutical quality, transfer of production methods and plant material to specialized farmers, medicinal application and, finally, information for users along the chain of distribution about the benefits of the locally produced herbal material.

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.

Interventions and physician characteristics in a randomized multicenter trial of acupuncture in patients with low-back pain.

OBJECTIVE: 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. DESIGN: 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). OUTCOME MEASURES: Participating trial physicians and interventions. RESULTS: 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. CONCLUSIONS: 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.

Treatment in a randomized multicenter trial of acupuncture for migraine (ART migraine).

BACKGROUND: This paper aims to describe the characteristics of physicians and interventions of a large, multicenter randomized trial of acupuncture for migraine (ART Migraine) in order to enable acupuncturists to assess the study interventions. PATIENTS AND METHODS: 302 patients suffering from migraine were randomized to 12 sessions of semi-standardized acupuncture (6 predefined basic points, recommendations for optional individual choice of additional points given), standardized minimal acupuncture (superficial needling of at least 5 of 10 predefined, distant non-acupuncture points) or a waiting list. 30 physicians trained and experienced in acupuncture from 18 centers in Germany participated in the trial. RESULTS: The median duration of acupuncture training of trial physicians was 500 h (range 140-1350). Physicians had acupuncture experience for 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. Compliance with treatment instructions varied considerably among centers in the acupuncture group. In contrast, compliance with the minimal acupuncture protocol was very good. 6 of the 30 physicians stated that they would have treated patients somewhat differently outside the trial, 1 completely differently. The trial found a significant effect of those treated with acupuncture compared to those on the waiting list for treatment, but minimal acupuncture was as effective as acupuncture. CONCLUSIONS: The treatment protocols for acupuncture and minimal acupuncture in ART Migraine appeared an adequate compromise in the specific situation and for the predefined purposes. However, a relevant minority of participating physicians would have treated patients differently outside the trial.

Acupuncture in patients with tension-type headache: randomised controlled trial.

OBJECTIVE: To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. DESIGN: Three armed randomised controlled multicentre trial. SETTING: 28 outpatient centres in Germany. PARTICIPANTS: 270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type headache. INTERVENTIONS: Acupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or waiting list control. Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks. MAIN OUTCOME MEASURE: Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries. RESULTS: The number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture v minimal acupuncture, 0.6 days, 95% confidence interval -1.5 to 2.6 days, P = 0.58; acupuncture v waiting list, 5.7 days, 3.9 to 7.5 days, P < 0.001). The proportion of responders (at least 50% reduction in days with headache) was 46% in the acupuncture group, 35% in the minimal acupuncture group, and 4% in the waiting list group. CONCLUSIONS: The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache. TRIAL REGISTRATION NUMBER: ISRCTN9737659.

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

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. 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. 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. A relevant minority of participating trial physicians stated that they would have treated patients differently outside the trial.