Minimal Acupuncture Research Articles

Acupuncture for pain relief in labour: a systematic review and meta‐analysis

Acupuncture is frequently used for pain relief in labour, but the evidence is not clear. To critically evaluate the evidence for or against acupuncture for labour pain management. Nineteen electronic databases, including English, Korean, Japanese, and Chinese databases, were systematically searched. All randomised controlled trials (RCTs) involving women receiving acupuncture alone, or as an adjunct to conventional analgesia, for pain relief in labour were considered. Pain intensity on a 100-mm visual analogue scale (VAS; 0, no pain; 100, worst pain) and use of other analgesic methods were used as primary outcomes, and for statistical pooling. Maternal/fetal outcomes were secondary outcomes, and adverse events were also recorded. Risk of bias was assessed regarding randomisation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other biases. Ten RCTs involving 2038 women were included. VAS for pain intensity data were available in seven studies; the meta-analysis shows that acupuncture was not superior to minimal acupuncture at 1 hour (pooled mean difference -8.02; 95% CI -21.88, 5.84; I(2) = 94%) and at 2 hours (-10.15; 95% CI -23.18, 2.87; I(2) = 92%). Patients reported significantly reduced pain by 4 and 6% during electroacupuncture (EA) treatment at 15 (-4.09; 95% CI -8.05, -0.12) and 30 minutes (-5.94; 95% CI -9.83, -2.06), compared with placebo EA, but the effect was not maintained afterwards. Compared with no intervention, acupuncture reduced pain by only 11% for the first 30 minutes (-10.56; 95% CI -16.08, -5.03). In trials where acupuncture was compared with conventional analgesia, women receiving acupuncture required less meperidine (pooled risk ratio 0.20; 95% CI 0.12, 0.33) and other analgesic methods (0.75; 95% CI 0.66, 0.85). No acupuncture-related adverse events were reported. Most trials did not blind participants, care providers and/or evaluators. The evidence from RCTs does not support the use of acupuncture for controlling labour pain. The primary studies are diverse and often flawed. Further research seems warranted.

Contact-free Infrared Thermography for Assessing Effects during Acupuncture: A Randomized, Single-blinded, Placebo-controlled Crossover Clinical Trial

Although evidence of its effects is tentative, acupuncture has long been used in the treatment of multiple maladies. So far, it has not been possible to discriminate the effects of the venue from specific results of needling itself, thus physicians merely depend on patients' statements. The authors investigated the efficacy of infrared thermography in distinguishing response to true acupuncture as compared to nonacupoint cutaneous and muscular needling (sham or minimal acupuncture), as well as without manipulation. Thermographic imaging was performed in 50 healthy volunteers randomly assigned to four groups: Acupuncture of Hegu (LI 4), needling of a cutaneous and a muscular point where no acupuncture point has been described yet, and without manipulation. In a crossover protocol, each proband completed all four arms of the protocol in a random order. Infrared thermograms were gathered at defined points in each group. A significant increase in surface temperature occurred within 2 min after needling the acupuncture point Hegu (from 30.1 +/- 2.7 degrees C [SD] to 31.2 +/- 3.0 degrees C and to 31.9 +/- 2.5 degrees C after 10 min, P < 0.001), whereas needling of the cutaneous and muscular point, as well as without any manipulation resulted in a decrease of temperature in the monitored area. Contact-free infrared thermographic imaging is a reliable and easy-to-handle tool to distinguish between needling at Hegu and needling of a nonacupoint ("sham" acupuncture).

How Acupuncture May Relieve Infantile Colic Symptoms—melatonin, Serotonin and Circadian Rhythmicity

Reinthal et al ’s study of minimal acupuncture effects on infantile colic was a great support for paediatric acupuncture.1 Although acupuncture has long been used for infantile colic, there were no randomised controlled trials until Reinthal et al ’s study. Six years before that, Zhao2 had reported treatment of infantile morbid night crying with acupuncture at point PC9 in 100 cases, which were not referred to in Reinthal et al ’s study. In the Reinthal et al study, the effect of needling of the chosen point LI4 was attributed to …

La acupuntura superficial no es un placebo válido para los ensayos aleatorizados controlados sobre acupuntura: perspectiva de un fisiólogo

Placebo-control of acupuncture is used to evaluate and distinguish between the specific effects and the non-specific ones. During, true’ acupuncture treatment in general, the needles are inserted into acupoints and stimulated until deqi is evoked. In contrast, during placebo acupuncture, the needles are inserted into non-acupoints and/or superficially (so-called minimal acupuncture). A sham acupuncture needle with a blunt tip may be used in placebo acupuncture. Both minimal acupuncture and the placebo acupuncture with the sham acupuncture needle touching the skin would evoke activity in cutaneous afferent nerves. This afferent nerve activity has pronounced effects on the functional connectivity in the brain resulting in a “limbic touch response”. Clinical studies showed that both acupuncture and minimal acupuncture procedures induced significant alleviation of migraine and that both procedures were equally effective. In other conditions such as low back pain and knee osteoarthritis, acupuncture was found to be more potent than minimal acupuncture and conventional non-acupuncture treatment. It is probable that the responses to “true” acupuncture and minimal acupuncture are dependent on the aetiology of the pain. Furthermore, patients and healthy individuals may have different responses. In this paper, we argue that minimal acupuncture is not valid as an inert placebo-control despite its conceptual brilliance.

Ist die analgetische Wirkung der Akupunktur ein Placeboeffekt?

The German acupuncture trials ART and GERAC have shown that acupuncture and sham or minimal acupuncture were equally effective in the reduction of chronic pain symptoms. These results have prompted an ongoing discussion as to whether acupuncture exerts its effects through a placebo response. Increasing knowledge about the neurobiology of pain and its intrinsic control suggests a combination of acupuncture-specific neurophysiologic effects combined with effects that match those of expectation-induced placebo analgesia.

Minimal acupuncture is not a valid placebo control in randomised controlled trials of acupuncture: a physiologist's perspective

Placebo-control of acupuncture is used to evaluate and distinguish between the specific effects and the non-specific ones. During 'true' acupuncture treatment in general, the needles are inserted into acupoints and stimulated until deqi is evoked. In contrast, during placebo acupuncture, the needles are inserted into non-acupoints and/or superficially (so-called minimal acupuncture). A sham acupuncture needle with a blunt tip may be used in placebo acupuncture. Both minimal acupuncture and the placebo acupuncture with the sham acupuncture needle touching the skin would evoke activity in cutaneous afferent nerves. This afferent nerve activity has pronounced effects on the functional connectivity in the brain resulting in a 'limbic touch response'. Clinical studies showed that both acupuncture and minimal acupuncture procedures induced significant alleviation of migraine and that both procedures were equally effective. In other conditions such as low back pain and knee osteoarthritis, acupuncture was found to be more potent than minimal acupuncture and conventional non-acupuncture treatment. It is probable that the responses to 'true' acupuncture and minimal acupuncture are dependent on the aetiology of the pain. Furthermore, patients and healthy individuals may have different responses. In this paper, we argue that minimal acupuncture is not valid as an inert placebo-control despite its conceptual brilliance.

Studien zum Lingshu als Beitrag zur Bewertung klinischer Akupunkturstudien : – Punktlokalisation, Stichtiefe, De Qi

Background Clinical trials on acupuncture use a variety of control methods, such as sham acupuncture, minimal acupuncture, and placebo. Frequently, needle insertion on non-classical acupuncture points (“minimal acupuncture”) is employed for this purpose. The aim of such clinical trials is to evaluate specific effects of acupuncture. There is a controversial discussion regarding the appropriateness of comparing “true” acupuncture to “minimal acupuncture”. Minimal and verum acupuncture are distinguished by various criteria, such as “localisation”, “depth of needle insertion”, and “induction of de qi”. Aim This study is dedicated to the question of what information the Huang Di Neijing, specifically the Lingshu-compilation which extensively focuses on needling techniques, has to offer regarding the above mentioned criteria, and their importance for successful acupuncture. In relation to this, it will be discussed if the definition of “minimal acupuncture” as used in the German Acupuncture Trials, is feasible. Methods The entire original text of the Huang Di Neijing Lingshu was searched for information regarding “point localisation”, “insertion depth”, and “induction of “ de qi”. The paragraphs in question were compiled and probed on statements regarding the efficacy of treatment. These subsequently were compared to the technique of “minimal acupuncture” as in the German Acupuncture Trials (ART, GERAC). Results The analysis of the Lingshu shows that neither a specific point localisation, nor a certain insertion depth or the induction of de qi are clearly and in all cases relevant for a successful therapy. Rather, the Lingshu offers specific indications for superficial needling. Sites of acupoint localisation aren't clearly defined and the induction of de qi is not understood as mandatory for a successful therapy. Conclusion The criteria distinguishing „verum acupuncture” from „minimal acupuncture” as practiced in many clinical trials don't correspond to the early practice of acupuncture as documented in the Lingshu. This can be a possible explanation for the good clinical results of minimal acupuncture in a number of clinical trials. However, for further discussions of this problem the developments and the clinical evolution present-day acupuncture has undergone since the ancient times have to be held in account.

Effects of Minimal Acupuncture in Children with Infantile Colic – a Prospective, Quasi-Randomised Single Blind Controlled Trial

Colic causes crying in 10-30% of infants and is one of the primary reasons parents seek health care. Treatments are generally not totally effective and some cause side effects. In this study we aimed to test the effect of light needling (minimal acupuncture) on crying. Forty children (median six weeks of age) with excessive crying unresponsive to conventional therapies, were recruited from 21 Child Welfare Clinics within an area of western Sweden, and quasi-randomised to control or light needling treatment. Parents were unaware of which group their child was assigned to. Children were given light needling acupuncture on one point (LI4) on both hands for approximately 20 seconds on four occasions, or received the same care except needling. Parental assessment questionnaires were used pre- and post-treatment to assess crying intensity, frequency, duration of crying and pain related behaviour throughout the day in six hour periods. Light needling resulted in a significant reduction in the rated crying intensity (assessed by a numeric rating scale, 0 to 10). For example, during the morning time period 0600-1200 hours, the median (range) rated crying intensity changed from 6 (1 to 9) pre-treatment to 2 (0 to 5) post-treatment (P=0.002), in the light needling group. The corresponding ratings for the children in the control group was 6 (0 to 10) and 5 (0 to 10) respectively. The difference between the groups was significant (P=0.016). There were also significant differences between the groups for the afternoon (1200-1800 hours), and evening (1800-midnight) time periods. Pain related behaviour like facial expression, was also significantly less pronounced in the light needling group as compared to the control group post-treatment, (P=0.027). The parents rated the light needling as more effective in improving symptoms than the control group (P<0.001). Four treatments with light needling on one point in the hand may alleviate crying and pain related behaviour without any noted side effects.

P.2.a.009 Pooled analysis: 2 randomised clinical trials confirms superiority of escitalopram over paroxetine in treatment of major depressive disorder

The Impact of Patient Expectations on Outcomes in Four Randomized Controlled Trials of Acupuncture in Patients with Chronic PainLinde K, Witt CM, Streng A, Weidenhammer W, Wagenpfeil S, Brinkhaus B, Willich SN, Melchart D.Pain 2007;128:264–271In a pooled analysis of four randomized controlled trials of acupuncture in patients with migraine, tension-type headache, chronic low back pain, and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome.The 864 patients included in the analysis received either 12 sessions of acupuncture or minimal (i. e. sham) acupuncture (superficial needling of non-acupuncture points) over an 8 week period. Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment. After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving. Patients were classified as responders if the respective main outcome measure improved by at least fifty percent. Both univariate and multivariate analyses adjusted for potential confounders (such as condition, intervention group, age, sex, duration of complaints, etc.) consistently showed a significant influence of attitudes and expectations on outcome.After completion of treatment, the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 (95 % confidence interval 1.20-2.32). For personal expectations and confidence after the third session, odds ratios were 2.03 (1.26-3.26) and 2.35 (1.68-3.30), respectively. Results from the 6-month follow-up were similar.In conclusion, in our trials a significant association was shown between better improvement and higher outcome expectations.

Acupuncture in Migraine Prevention

To assess the efficacy of acupuncture in migraine prophylaxis. Thirty-seven patients with migraine were enrolled in a randomized control trial at the Headache clinic located in a University Hospital. Real and sham acupuncture groups received 16 acupuncture sessions over 3 months. Treatment was individualized in the real acupuncture group and minimal acupuncture was used in the sham group. The primary end point was the percentage of patients with a >or=50% reduction in their migraine attack frequency in the second, third, fourth, fifth, and sixth (months) compared with the first one (baseline period). Primary and secondary end points were measured comparing headache diaries. Real acupuncture group showed improvement with significant differences compared with the sham acupuncture group in the primary efficacy end point (P=0.021) at the second month of the treatment. Differences also appeared in 2 secondary end points: number of days with migraine per month (P=0.007) in the second month and the percentage of patients with >or=40% reduction in migraine attack frequency in the first (P=0.044) and second months (P=0.004) of the treatment. These differences disappeared in the third (last) month of the treatment as a consequence of the high improvement of the sham acupuncture group. Comparisons within each group showed that several migraine parameters evaluated improved significantly in both groups. Individualized treatment based on traditional Chinese medicine plays a role in preventing migraine attacks. Nevertheless, sham acupuncture had similar effects. Major conclusions were limited by the small sample sizes however the observed trends may contribute to design future trials.

Health-related quality of life in a trial of acupuncture, sham acupuncture and conventional treatment for chronic sinusitis

BackgroundAcupuncture is commonly used to treat chronic sinusitis, though there is little documentation on the effect. This study presents the health-related quality of life (HRQoL) outcomes in a trial comparing traditional Chinese acupuncture, sham acupuncture, and conventional treatment for chronic sinusitis.FindingsIn a three-armed single blind randomized controlled study, we recruited 65 patients with symptoms of sinusitis >3 months and signs of sinusitis on computed tomography (CT). Patients were randomized to one of three study arms: (1) 2–4 weeks of medication with antibiotics, corticosteroids, 0.9% sodium chloride solution, and local decongestants (n = 21), (2) ten treatments with traditional Chinese acupuncture (n = 25), or (3) ten treatments with minimal acupuncture at non-acupoints (n = 19). Change in HRQoL was assessed over 12 weeks using the Chronic Sinusitis Survey (CSS) and Short form 36 (SF-36) questionnaires.In the study, we found only a non-significant difference on the CSS symptom scale between conventional medical therapy and traditional Chinese acupuncture. On the SF-36 scale role-physical the change was larger in the conventional group than in the sham group (p = 0.02), and on the mental health scale the change in the conventional therapy arm was larger than in the traditional Chinese acupuncture group (p = 0.03). There was no difference in effect on HRQoL on any scale between the sham and traditional Chinese acupuncture groups.ConclusionThere was no clear evidence of the superiority of one treatment over another on short-term HRQoL outcomes, although there was a statistically non-significant advantage of conventional therapy in a few dimensions.

Las expectativas de los pacientes influyen sobre el efecto de la acupuntura

Objectives In a pooled analysis of four randomized controlled trials of acupuncture in patients with migraine, tension-type headache, chronic low back pain, and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome. Methods The 864 patients included in the analysis received either 12 sessions of acupuncture or minimal (i. e. sham) acupuncture (superficial needling of non-acupuncture points) over an 8 week period. Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment. After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving. Patients were classified as responders if the respective main outcome measure improved by at least fifty percent. Both univariate and multivariate analyses adjusted for potential confounders (such as condition, intervention group, age, sex, duration of complaints, etc.) consistently showed a significant influence of attitudes and expectations on outcome. Results After completion of treatment, the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 (95 % confidence interval 1.20-2.32). For personal expectations and confidence after the third session, odds ratios were 2.03 (1.26-3.26) and 2.35 (1.68-3.30), respectively. Results from the 6-month follow-up were similar. Conclusions In conclusion, in our trials a significant association was shown between better improvement and higher outcome expectations

Comparison of the effect of two types of acupuncture on quality of life in secondary progressive multiple sclerosis: a preliminary single-blind randomized controlled trial

Objective: To compare the effect of two types of acupuncture on the quality of life of individuals with secondary progressive multiple sclerosis and provide preliminary evidence regarding the safety of this intervention for this population. Design: Preliminary single-blind randomized controlled trial. Setting: Outpatient attendance at rehabilitation unit. Participants: Fourteen participants with secondary progressive multiple sclerosis. Interventions: Chinese medical acupuncture or minimal acupuncture. Participants received 10 treatments over five weeks. Measures: Multiple Sclerosis Impact Scale 29, Fatigue Severity Scale and General Health Questionnaire 12 were measured pre and post intervention. Adverse events and other responses during treatment were recorded prospectively. Results: Participants receiving minimal acupuncture demonstrated statistically significant greater improvement in the Multiple Sclerosis Impact Scale 29 psychological subscale compared with those receiving Chinese medical acupuncture in an intention-to-treat analysis (P=0.04), with mean change in Chinese acupuncture group of 6.0 (SD 13.9) and in minimal acupuncture group of 23.0 (SD 21.0). No other statistically significant difference between the groups was found. No major adverse events were noted. Minor adverse events such as lower limb muscle spasms or pain were noted in some participants in both intervention groups. Conclusion: Minimal acupuncture resulted in greater improvement of Multiple Sclerosis Impact Scale 29 psychological subscale compared with Chinese medical acupuncture. No other differences between the groups were found. In view of the small sample these results are not conclusive. This study provides preliminary evidence to suggest that acupuncture is safe for people with secondary progressive multiple sclerosis. A large-scale trial is required to provide more definitive evidence.

The effects of acupuncture during labour on nulliparous women: A randomised controlled trial

Acupuncture is as an ancient system of diagnosis and treatment. It is regarded as a complementary tool for pain management. To assess the effects of acupuncture on nulliparous women during labour with respect to pain, labour duration and maternal acceptability. One hundred and forty-four healthy nulliparous women in active phase were randomised into the study and control group, receiving real and minimal acupuncture, respectively. Visual analogue scale was used to assess pain. Objectives were to evaluate acupuncture effect on pain and labour duration and patients' willingness to receive acupuncture for subsequent pregnancies. Visual analogue scale pain score in the study group was lower after two hours. Active phase duration and the oxytocin units administered were lower in the study group. Study group patients had greater willingness to receive acupuncture again. No adverse effects were detected. Acupuncture could reduce pain experience, active phase duration and oxytocin units. Patients were satisfied and no adverse effects were noted.

The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain

In a pooled analysis of four randomized controlled trials of acupuncture in patients with migraine, tension-type headache, chronic low back pain, and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome. The 864 patients included in the analysis received either 12 sessions of acupuncture or minimal (i.e. sham) acupuncture (superficial needling of non-acupuncture points) over an 8 week period. Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment. After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving. Patients were classified as responders if the respective main outcome measure improved by at least fifty percent. Both univariate and multivariate analyses adjusted for potential confounders (such as condition, intervention group, age, sex, duration of complaints, etc.) consistently showed a significant influence of attitudes and expectations on outcome. After completion of treatment, the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 (95% confidence interval 1.20–2.32). For personal expectations and confidence after the third session, odds ratios were 2.03 (1.26–3.26) and 2.35 (1.68–3.30), respectively. Results from the 6-month follow-up were similar. In conclusion, in our trials a significant association was shown between better improvement and higher outcome expectations.

Erwartungen von Patienten beeinflussen Akupunktureffekt

The Impact of Patient Expectations on Outcomes in Four Randomized Controlled Trials of Acupuncture in Patients with Chronic Pain Linde K, Witt CM, Streng A, Weidenhammer W, Wagenpfeil S, Brinkhaus B, Willich SN, Melchart D. Pain 2007;128:264–271 Objectives In a pooled analysis of four randomized controlled trials of acupuncture in patients with migraine, tension-type headache, chronic low back pain, and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome. Methods The 864 patients included in the analysis received either 12 sessions of acupuncture or minimal (i. e. sham) acupuncture (superficial needling of non-acupuncture points) over an 8 week period. Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment. After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving. Patients were classified as responders if the respective main outcome measure improved by at least fifty percent. Both univariate and multivariate analyses adjusted for potential confounders (such as condition, intervention group, age, sex, duration of complaints, etc.) consistently showed a significant influence of attitudes and expectations on outcome. Results After completion of treatment, the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 (95 % confidence interval 1.20-2.32). For personal expectations and confidence after the third session, odds ratios were 2.03 (1.26-3.26) and 2.35 (1.68-3.30), respectively. Results from the 6-month follow-up were similar. Conclusions In conclusion, in our trials a significant association was shown between better improvement and higher outcome expectations.

The Programme for the Evaluation of Patient Care with Acupuncture (Pep-Ac) – a Project Sponsored by Ten German Social Health Insurance Funds

Objective The aim of the Programme for the Evaluation of Patient care with Acupuncture (PEP-Ac) was to investigate the efficacy, effectiveness and safety of acupuncture in patients with the following three indications: chronic headache, chronic low back pain and chronic osteoarthritic pain. This article provides an overview of the results of the whole programme. Methods The programme included five randomised trials, a large observational study, a survey of physicians providing acupuncture, and three systematic reviews. Results The results show that, for all three indications, acupuncture, when compared to no treatment, produces a clear benefit that lasts for at least several months. However the effects of point-specific acupuncture only offered a significant advantage over minimal acupuncture in the treatment of OA knee. Conclusions The evidence from these trials – on the one hand, a clear overall effect of acupuncture and on the other hand, the lack of evidence supporting its superiority over sham acupuncture for all indications except osteoarthritis of the knee – leaves a considerable amount of room for interpretation.

Safety of Acupuncture for Osteoarthritis of the Knee – a Review of Randomised Controlled Trials, Focusing on Specific Reactions to Acupuncture

In order to assess how many reported adverse reactions to acupuncture are truly associated with the physiological mechanisms of acupuncture, we performed a literature review of published RCTs of acupuncture for osteoarthritis of the knee. We searched for reports of RCTs using two data sources: PubMed and Japana Centra Revuo Medicina (Igaku Chuo Zasshi). Of the twelve RCTs located, seven included information on adverse events. No serious adverse events were reported. Joint swelling, local inflammation, haematoma and back pain occurred more frequently in the dummy electroacupuncture or minimal acupuncture group. We confirmed the possibility that many adverse reactions to acupuncture treatment reported in RCTs, at least for the knee OA, are non-specific, and that not all reported events should be attributed to the mechanism of action of acupuncture. It is likely this is also true for RCTs of acupuncture in other conditions, and for prospective surveys on adverse events of acupuncture.

Acupuncture was better than no acupuncture but did not differ from minimal (sham) acupuncture for chronic low back pain at 8 weeks

Acupuncture was better than no acupuncture but did not differ from minimal (sham) acupuncture for chronic low back pain at 8 weeks

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.