Effect of ear acupuncture on pregnancy-related pain in the lower back and posterior pelvic girdle: A multicenter randomized clinical trial.

INTRODUCTION: Ear acupuncture carried out in primary care by trained midwives, with no specialist training in acupuncture, may be effective in alleviating pregnancy-related lower back and/or posterior pelvic girdle pain (LBPGP). The objective of this study was to assess the effect of ear acupuncture associated with standard obstetric care, in the primary-care setting, on LBPGP experienced by pregnant women. MATERIAL AND METHODS: This four-group, multicenter, randomized controlled trial was conducted at 18 public primary care centers in three regions in Spain, with the participation of 220 pregnant women at 24-36 weeks of gestation, aged 18 years or more, diagnosed with pregnancy-related LBPGP and who had not previously received ear acupuncture. The trial was conducted from March 2014 to December 2016. Participants were randomly assigned (1:1:1:1) to receive standard obstetric care plus two sessions (over 2 weeks) of verum ear acupuncture, or nonspecific ear acupuncture, or placebo ear acupuncture, or standard obstetric care alone. The primary outcome was change in pain intensity, assessed using a visual analog scale (0-100 mm) from baseline to the end of treatment (T2). Secondary outcomes included change or presence of pain at 3 months (T3) and at 1 year (T4) postpartum, and changes in responses to the Roland-Morris disability questionnaire (RMDQ) and Short Form-12 Health Survey (SF-12) at the end of treatment. RESULTS: A total of 55 women were randomized to each group, and 205 completed the study. With respect to baseline values, the reduction in pain intensity among the verum ear acupuncture group vs standard obstetric care was significantly greater, both at T2 (65.8%, 95%CI 56.2-75.3 vs 25.1%, 95%CI 15.3-34.9) and at T3 (93.8%, 95%CI 88.7-99.0 vs 67.9%, 95%CI 55.3-80.5). Moreover, significant changes were found in the verum ear acupuncture group vs standard obstetric care at T2, in reduced RMDQ scores (70.9%, 95%CI 61.8-80.1 vs 21.2%, 95%CI 8.6-33.7) and in increased SF-12 scores on the physical scale (40.5%, 95%CI 31.5-49.4 vs 8.1%, 95%CI 0.8-15.5). CONCLUSIONS: After 2 weeks of treatment, ear acupuncture applied by midwives and associated with standard obstetric care significantly reduces lumbar and pelvic pain in pregnant women, improves quality of life and reduces functional disability.

Acupuncture treatment of shoulder impingement syndrome: A randomized controlled trial.

BACKGROUND: Shoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice, frequently causing significant functional impairment. The most common cause of shoulder pain is impingement syndrome. OBJECTIVE: To decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture. METHOD: Randomized controlled trial with two groups of participants: one group received true acupuncture (TA) and the other received acupuncture at sham points (SA). The treatment was carried out over 4 weeks, with the participants receiving a session every week. The results were measured immediately after the treatment (T1) and 3 months later (T2). To evaluate the results, we used the 100 mm Visual Analogue Scale (VAS), and to assess the functionality of the shoulder we employed the UCLA questionnaire (0-35 points). RESULTS: A total of 68 participants were included in the analysis (TA, n=35; SA, n=33), with a mean age of 33.4 years (SD 12.53). We found significant differences in the analyzed results between the two groups, as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 (CI 95% 36.7; 51.5) and 87.58 mm at T2 (CI 95% 28.32; 46.81), while the decrease in the FA group was of 19.84 mm at T1 (CI 95% 12.2; 27.4) and 20 mm at T2 (CI 95% 10.9; 29.09). When the UCLA scores were analyzed, the results were clinically meaningful in support of TA in terms of functional assessment of the shoulder. No adverse effects were reported. CONCLUSIONS: The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services.

Acupuncture for fibromyalgia in primary care: a randomised controlled trial.

OBJECTIVES: To evaluate the efficacy of an individualised acupuncture protocol for patients with fibromyalgia. METHODS: Randomised controlled multicentre trial, blinded to participants and to data analysts. Conducted in three primary care centres in southern Spain. A total of 164 participants aged over 17 years and diagnosed with fibromyalgia were enrolled in this trial; 153 participants completed the study. Participants were randomly assigned to either the real intervention (individualised acupuncture, IA) or the sham intervention (sham acupuncture, SA). In both the IA and SA groups, one session per week (lasting 20 min) was provided, in addition to usual pharmacological treatment. The primary outcome was change in pain intensity at 10 weeks. RESULTS: Intention-to-treat analysis revealed that the decrease in pain intensity at 10 weeks was greater (p=0.001) in the IA group (-41.0%, 95% CI -47.2% to -34.8%) than in the SA group (-27.1%, 95% CI -33.2% to -20.9%). During the follow-up period, significant differences (p<0.01) in favour of the IA group persisted at 12 months (IA: -19.9%, 95% CI -24.6% to -15.1%; vs SA: -6.2%, 95% CI -11.2% to -1.2%). CONCLUSIONS: Individualised acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualised acupuncture in patients with fibromyalgia is recommended. TRIAL REGISTRATION NUMBER: ISRCTN60217348.

Cost effectiveness of using moxibustion to correct non-vertex presentation.

AIMS: To analyse the cost effectiveness of using the moxibustion technique to correct non-vertex presentation and to reduce the number of caesarean sections performed at term. METHOD: A deterministic model of decision analysis has been developed to analyse the cost of treatment in which heat is applied by moxibustion (the combustion of Artemisia vulgaris) at acupuncture point BL67 for pregnant women with non-vertex fetal position at 33-35 weeks' gestation. This approach was compared with conventional treatment recommendations based on the knee-chest posture technique. The costs were obtained mainly from data provided by the Andalusian Public Health System. Effectiveness data for the baseline analysis were taken from a previous clinical study. A secondary analysis was performed based on a meta-analysis conducted using random effects analysis, by reference to studies published in recent systematic reviews of moxibustion versus conventional treatment, in order to make the results generalisable to other healthcare settings. Deterministic and probabilistic sensitivity analyses were performed under diverse assumptions to assess the uncertainty of the result. RESULTS: The baseline analysis shows that the application of moxibustion prevents 8.92% of deliveries with non-vertex presentation compared with conventional treatment, with an average cost saving of €107.11 per delivery, mainly due to the cost saving from avoiding the need for caesarean section. The meta-analysis revealed a relative risk of the version of non-vertex presentation at term of 0.34 (95% CI 0.16 to 0.76). The sensitivity analysis showed that moxibustion can avoid 0.34 caesarean sections, with an incremental cost per delivery ranging from €68 to -€640 for moxibustion versus conventional treatment. CONCLUSIONS: Moxibustion treatment applied at acupuncture point BL67 can avoid the need for caesarean section and achieve cost savings for the healthcare system in comparison with conventional treatment.

Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy: study protocol for a multicentre randomised placebo-controlled trial.

BACKGROUND: About 45% of all pregnant women suffer low back pain and/or pelvic girdle pain (LBPGP). This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and with standard obstetric care in the field of primary health care. METHODS AND DESIGN: This study will be a four-parallel-arm, multicentre, randomised, placebo-controlled trial. A total of 212 pregnant women (24 to 36 weeks' gestation), aged at least 17 years, with LBPGP, will be randomly assigned to the verum auricular acupuncture plus standard obstetric care group (VAAc), to the non-specific auricular acupuncture plus standard obstetric care group (NSAAc), to the non-specific placebo auricular acupuncture plus standard obstetric care group (PAAc), or the standard obstetric care group (SOC). The VAAc, NSAAc, and PAAc groups will receive treatment at three auricular acupuncture points (specific points for the VAAc group or non-specific ones for the NSAAc and PAAc groups), once a week for 2 weeks; the SOC group will receive only standard obstetric care during the same period. The primary outcome will be the reduction in pain intensity, according to the visual analogue scale (iVAS), at 2 weeks after the start of treatment. The secondary outcomes will be functional status with respect to LBPGP (according to the Roland-Morris disability questionnaire), health-related quality of life (SF12) at 2 weeks after the start of treatment, and iVAS at 12 and 48 weeks postpartum. DISCUSSION: This trial will implement a high-quality methodology and may provide evidence for the efficacy, safety, and specificity of auricular acupuncture as a treatment for pregnant women with LBPGP. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41033073 (date 20/03/2014).

Efficacy and safety of auriculopressure for primary care patients with chronic non-specific spinal pain: a multicentre randomised controlled trial.

BACKGROUND: Chronic uncomplicated musculoskeletal pain in the spine (cervical, thoracic or lumbar) is highly prevalent and may severely limit the daily activities of those affected by it. OBJECTIVE: To evaluate the efficacy and safety of treatment with auriculopressure applied to patients with non-specific spinal pain. METHODS: A multicentre randomised controlled trial with two parallel arms (true auriculopressure (TAP) and placebo auriculopressure (PAP)) was performed. The intervention phase lasted 8 weeks and outcomes were measured 1 week after the last intervention (T1) and 6 months after baseline (T2). The primary outcome measure was change in pain intensity according to a 100 mm visual analogue scale (pain VAS) at T1. Secondary outcome measures were the Lattinen index, the McGill Pain Questionnaire and the SF-12 health-related quality of life scale (Spanish version in every case). RESULTS: There were 265 participants (TAP group, n=130; PAP group, n=135). Pain was most frequently located in the upper back (55.1%, n=146), followed by the lower back (25.3%, n=67) and the dorsal area (12.5%, n=33). Nineteen patients (7.2%) reported pain affecting the entire spine. There were statistically significant differences between TAP and PAP in the change in the pain VAS at T1 of 10 mm (95% CI 2.8 to 17.3, p=0.007) and in the change in the pain VAS at T2 of 7.2 mm (95% CI 0.02 to 14.3, p=0.049) in favour of TAP. We also observed a statistically significant difference of 3.4 points in the physical component of the SF-12 in favour of TAP at T2 (95% CI 0.45 to 6.3, p=0.024). No severe adverse effects were detected or reported during treatment. CONCLUSIONS: The application of auriculopressure in patients with non-specific spinal pain in primary healthcare is effective and safe, and therefore should be considered for inclusion in the portfolio of primary healthcare services. TRIAL REGISTRATION NUMBER: ISRCTN01897462.

Using moxibustion in primary healthcare to correct non-vertex presentation: a multicentre randomised controlled trial.

OBJECTIVE: To compare the effectiveness of additional moxibustion at point BL67 with moxibustion at a non-specific acupuncture point and with usual care alone to correct non-vertex presentation. METHODS: This was a multicentre randomised controlled trial in which 406 low-risk pregnant women with a fetus in ultrasound breech presentation, with a gestational age of 33-35 weeks, were assigned to (1) true moxibustion at point BL67 plus usual care; (2) moxibustion at SP1, a non-specific acupuncture point (sham moxibustion) plus usual care; or (3) usual care alone. The primary outcome was cephalic presentation at birth. Women were recruited at health centres in primary healthcare. RESULTS: In the true moxibustion group, 58.1% of the full-term presentations were cephalic compared with 43.4% in the sham moxibustion group (RR 1.34, 95% CI 1.05 to 1.70) and 44.8% of those in the usual care group (RR 1.29, 95% CI 1.02 to 1.64). The reduction in RR of the primary outcome in women allocated to the true moxibustion group compared with the usual care group was 29.7% (95% CI 3.1% to 55.2%) and the number needed to treat was 8 (95% CI 4 to 72). There were no severe adverse effects during the treatment. CONCLUSIONS: Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10634508.

Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial.

Reviews of the efficacy of acupuncture as a treatment for acute low back pain have concluded that there is insufficient evidence for its efficacy and that more research is needed to evaluate it. A multicentre randomized controlled trial was conducted at 4 primary-care centres in Spain to evaluate the effects of acupuncture in patients with acute nonspecific low back pain in the context of primary care. A total of 275 patients with nonspecific acute low back pain (diagnosed by their general practitioner) were recruited and assigned randomly to 4 different groups: conventional treatment either alone or complemented by 5 sessions over a 2-week period of true acupuncture, sham acupuncture, or placebo acupuncture per patient. Patients were treated from February 2006 to January 2008. The primary outcome was the reduction in Roland Morris Disability Questionnaire scores of 35% or more after 2weeks' treatment. The patients in the 3 types of acupuncture groups were blinded to the treatments, but those who received conventional treatment alone were not. In the analysis adjusted for the total sample (true acupuncture relative risk 5.04, 95% confidence interval 2.24-11.32; sham acupuncture relative risk 5.02, 95% confidence interval 2.26-11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21-5.46), as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were better than conventional treatment alone, but there was no difference among the 3 acupuncture modalities, which implies that true acupuncture is not better than sham or placebo acupuncture.

A pilot feasibility study of a questionnaire to determine European Union-wide CAM use.

BACKGROUND: No questionnaire specifically measuring the core components of complementary and alternative medicine (CAM) use has been validated for use across European Union (EU) countries. We aimed to determine the face validity, acceptability and the participants' comprehension of a pre-existing questionnaire designed to measure 'CAM use', to provide a comparative, standardised questionnaire for use by health care providers, policy makers and purchasers throughout Europe. METHODS: Established procedures were employed to translate the questionnaire into 4 EU languages. The translated questionnaires were piloted on 50 healthy adults from each country who may never have used CAM. 10 participants per country also took part in audio-recorded think aloud interviews about the questionnaire. The interviews were transcribed and analysed in the language in which they were conducted; findings were summarised in English. Questionnaire data were pooled across countries, and patterns of completion and missing data were analysed. RESULTS: The questionnaire was translated into Italian, Spanish, Dutch and Romanian. The mean age of the participants was 43.6 years. 34% were male, 87.4% were either light or heavy CAM users, and 12.6% were non-users. Qualitative analysis identified common problems across countries including a 'hard-to-read' layout, misunderstood terminology and uncertainty in choosing response options. Quantitative analysis confirmed that a substantial minority of respondents failed to follow questionnaire instructions and that some questions had substantial rates of missing data. CONCLUSIONS: The I-CAM-Q has low face validity and low acceptability, and is likely to produce biased estimates of CAM use if applied in England, Romania, Italy, The Netherlands or Spain. Further work is required to develop the layout, terms, some response options and instructions for completion before it can be used across the EU.

Towards a pan-European definition of complementary and alternative medicine--a realistic ambition?

BACKGROUND: The terms used for defining complementary and alternative medicine (CAM) including the methods, procedures and therapies vary greatly. The task of the CAMbrella working group on terminology was to explore the existing CAM terminologies and to develop a pragmatic definition of CAM that is acceptable Europe-wide. This can then be used to systematically research, e.g., its prevalence and legal status and to investigate the citizens' demands on CAM and the perspectives of providers of CAM in Europe. METHODS: Terms and definitions were collected from both scientific and non-scientific sources. The terms and definitions identified were analysed and discussed among the CAMbrella working group participants on several occasions with the aim of arriving at a consensus. RESULTS: We developed a proposal for a pragmatic European definition of CAM: 'Complementary and alternative medicine (CAM) utilised by European citizens represents a variety of different medical systems and therapies based on the knowledge, skills and practices derived from theories, philosophies and experiences used to maintain and improve health, as well as to prevent, diagnose, relieve or treat physical and mental illnesses. CAM has been mainly used outside conventional health care, but in some countries certain treatments are being adopted or adapted by conventional health care.' CONCLUSION: Developing a uniform, pragmatic pan-European definition of CAM was complicated by a number of factors. These included the vast diversity of existing definitions, systems, disciplines, procedures, methods and therapies available within the EU.

A systematic literature review of complementary and alternative medicine prevalence in EU.

BACKGROUND: Studies suggest that complementary and alternative medicine (CAM) is widely used in the European Union (EU). We systematically reviewed data, reporting research quality and the prevalence of CAM use by citizens in Europe; what it is used for, and why. METHODS: We searched for general population surveys of CAM use by using Ovid MEDLINE (1948 to September 2010), Cochrane Library (1989 to September 2010), CINAHL (1989 to September 2010), EMBASE (1980 to September 2010), PsychINFO including PsychARTICLES (1989 to September 2010), Web of Science (1989 to September 2010), AMED (1985 to September 2010), and CISCOM (1989 to September 2010). Additional studies were identified through experts and grey literature. Cross-sectional, population-based or cohort studies reporting CAM use in any EU language were included. Data were extracted and reviewed by 2 authors using a pre-designed extraction protocol with quality assessment instrument. RESULTS: 87 studies were included. Inter-rater reliability was good (kappa = 0.8). Study methodology and quality of reporting were poor. The prevalence of CAM use varied widely within and across EU countries (0.3-86%). Prevalence data demonstrated substantial heterogeneity unrelated to report quality; therefore, we were unable to pool data for meta-analysis; our report is narrative and based on descriptive statistics. Herbal medicine was most commonly reported. CAM users were mainly women. The most common reason for use was dissatisfaction with conventional care; CAM was widely used for musculoskeletal problems. CONCLUSION: CAM prevalence across the EU is problematic to estimate because studies are generally poor and heterogeneous. A consistent definition of CAM, a core set of CAMs with country-specific variations and a standardised reporting strategy to enhance the accuracy of data pooling would improve reporting quality.

Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial.

BACKGROUND: Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. METHODS/DESIGN: Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. DISCUSSION: This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. TRIAL REGISTRATION: ISRCTN trial number ISRCTN60217348 (19 October 2010).

Correction of nonvertex presentation with moxibustion: a systematic review and metaanalysis.

We searched systematically for randomized controlled trials, comparing moxibustion with a nonmoxibustion control group or other methods such as external cephalic version, postural methods, and acupuncture in databases, both Western and Chinese, up to June 2007. Six studies, with 1087 subjects and a high degree of heterogeneity, compared moxibustion vs observation or postural methods and reported a rate of cephalic version among the moxibustion group of 72.5% vs 53.2% in the control group (relative risk, 1.36; 95% confidence interval, 1.17-1.58); the number needed to treat was 5 (95% confidence interval, 4-7). In terms of safety, no significant differences were found in the comparison of moxibustion with other techniques. Moxibustion at acupuncture point BL67 has been shown to produce a positive effect, whether used alone or in combination with acupuncture or postural measures, in comparison with observation or postural methods alone, for the correction of nonvertex presentation, although these results should be viewed with caution, given the considerable heterogeneity found among studies.

Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocol.

BACKGROUND: Uncomplicated chronic rachialgia is a highly prevalent complaint, and one for which therapeutic results are contradictory. The aim of the present study is to evaluate the effectiveness and safety of treatment with auriculopressure, in the primary healthcare sector, carried out by trained healthcare professionals via a 30-hour course. METHODS/DESIGN: The design consists of a multi-centre randomized controlled trial, with placebo, with two parallel groups, and including an economic evaluation. Patients with chronic uncomplicated rachialgia, whose GP is considering referral for auriculopressure sensory stimulation, are eligible for inclusion. Sampling will be by consecutive selection, and randomised allocation to one of the two study arms will be determined using a centralised method, following a 1:1 plan (true auriculopressure; placebo auriculopressure). The implants (true and placebo) will be replaced once weekly, and the treatment will have a duration of 8 weeks. The primary outcome measure will be the change in pain intensity, measured on a visual analogue scale (VAS) of 100 mm, at 9 weeks after beginning the treatment. A follow up study will be performed at 6 months after beginning treatment. An assessment will also be made of the changes measured in the Spanish version of the McGill Pain Questionnaire, of the changes in the Lattinen test, and of the changes in quality of life (SF-12). Also planned is an analysis of cost-effectiveness and also, if necessary, a cost-benefit analysis. DISCUSSION: This study will contribute to developing evidence on the use of auriculotherapy using Semen vaccariae [wang bu liu xing] for the treatment of uncomplicated chronic rachialgia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN01897462.

Effectiveness of acupuncture, special dressings and simple, low-adherence dressings for healing venous leg ulcers in primary healthcare: study protocol for a cluster-randomized open-labeled trial.

BACKGROUND: Venous leg ulcers constitute a chronic recurring complaint that affects 1.0-1.3% of the adult population at some time in life, and which corresponds to approximately 75% of all chronic ulcers of the leg. Multilayer compression bandaging is, at present, the only treatment that has been proved to be effective in treating this type of ulcer. There is no consensus, however, about the dressings that may be applied, beneath the compression, to promote the healing of this type of ulcer, as there does not seem to be any added benefit from using special dressings rather than simple, low-adherence ones. As well as analgesia, acupuncture provokes peripheral vasodilation, in skin and muscles - which has been demonstrated both experimentally and in clinical practice - probably due to the axon reflex, among other mechanisms. The aim of the present study is to measure the effectiveness and cost of compression treatment for venous leg ulcers combined with special dressings, in comparison with low-adherence ones and acupuncture. METHODS/DESIGN: Cluster-randomized open-labeled trial, at 15 primary healthcare clinics in the Sevilla-Sur Healthcare District, with a control group treated with compression bandaging and low-adherence dressings; the experiment will consist, on the one hand, of the compression treatment applied in combination with special dressings (Treatment 1), and on the other, the compression treatment applied in association with low-adherence dressings, together with acupuncture (Treatment 2). DISCUSSION: The results will be measured and recorded in terms of the median time elapsed until complete healing of the ulcer, and the rate of complete healing at 3 months after beginning the treatment. An economic analysis will also be made. This study, carried out in the context of real clinical practice, will provide information for decision-taking concerning the effectiveness of special dressings. Moreover, for the first time a high-quality study will evaluate the effectiveness of acupuncture in the process of healing venous leg ulcers. TRIAL REGISTRATION: Current Controlled Trials ISRCTN26438275.

Correcting non cephalic presentation with moxibustion: study protocol for a multi-centre randomised controlled trial in general practice.

BACKGROUND: Non cephalic presentation in childbirth involves various risks to both the mother and the foetus. The incidence in Spain is 3.8% of all full-term pregnancies. The most common technique used to end the gestation in cases of non cephalic presentation is that of caesarian section, and although it provokes a lower rate of morbi-mortality than does vaginal delivery in such situations, there remains the possibility of traumatic injury to the foetal head and neck, while maternal morbidity is also increased. The application of heat (moxibustion) to an acupuncture point, in order to correct non cephalic presentation, has been practised in China since ancient times, but as yet there is insufficient evidence of its real effectiveness. METHODS/DESIGN: The experimental design consists of a multi-centre randomised controlled trial with three parallel arms, used to compare real moxibustion, sham moxibustion and the natural course of events, among pregnant women with a non cephalic presentation and a gestational duration of 33-35 weeks (estimated by echography). The participants in the trial will be blinded to both interventions. The results obtained will be analyzed by professionals, blinded with respect to the allocation to the different types of intervention. In addition, we intend to carry out a economic analysis. DISCUSSION: This trial will contribute to the development of evidence concerning moxibustion in the correction of non cephalic presentations. The primary outcome variable is the proportion of cephalic presentations at term. As secondary outcomes, we will evaluate the proportion of cephalic presentations at week 38 of gestation, determined by echography, together with the safety of the technique, the specificity of moxibustion and the control of the blinding process. This study has been funded by the Health Ministry of the Andalusian Regional Government. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10634508.

Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine.

BACKGROUND: Migraine is a chronic neurologic disease that can severely affect the patient's quality of life. Although in recent years many randomised studies have been carried out to investigate the effectiveness of acupuncture as a treatment for migraine, it remains a controversial issue. Our aim is to determine whether acupuncture, applied under real conditions of clinical practice in the area of primary healthcare, is more effective than conventional treatment. METHODS/DESIGN: The design consists of a pragmatic multi-centre, three-armed randomised controlled trial, complemented with an economic evaluation of the results achieved, comparing the effectiveness of verum acupuncture with sham acupuncture, and with a control group receiving normal care only. Patients eligible for inclusion will be those presenting in general practice with migraine and for whom their General Practitioner (GP) is considering referral for acupuncture. Sampling will be by consecutive selection, and by randomised allocation to the three branches of the study, in a centralised way following a 1:1:1 distribution (verum acupuncture; sham acupuncture; conventional treatment). Secondly, one patient in three will be randomly selected from each of the acupuncture (verum or sham) groups for a brain perfusion study (by single photon emission tomography). The treatment with verum acupuncture will consist of 8 treatment sessions, once a week, at points selected individually by the acupuncturist. The sham acupuncture group will receive 8 sessions, one per week, with treatment being applied at non-acupuncture points in the dorsal and lumbar regions, using the minimal puncture technique. The control group will be given conventional treatment, as will the other two groups. DISCUSSION: This trial will contribute to available evidence on acupuncture for the treatment of migraine. The primary endpoint is the difference in the number of days with migraine among the three groups, between the baseline period (the 4 weeks prior to the start of treatment) and the period from weeks 9 to 12. As a secondary aspect, we shall record the index of laterality and the percentage of change in the mean count per pixel in each region of interest measured by the brain perfusion tomography, performed on a subsample of the patients within the real and sham acupuncture groups. TRIAL REGISTRATION: Current Controlled Trials ISRCTN98703707.

Evidence from RCTs on optimal acupuncture treatment for knee osteoarthritis--an exploratory review.

There are many differing opinions on what constitutes an optimal acupuncture dose for treating any particular patient with any particular condition, and only direct comparisons of different methods in a clinical trial will provide information on which reliable decisions can be made. This article reviews the recent research into acupuncture treatment for osteoarthritis of the knee, to explore whether any aspects of treatment seem more likely to be associated with good outcome of treatment. Among four recent, high quality RCTs, one showed a much greater treatment response than the other three, and the possible factors are discussed. A recent systematic review included 13 RCTs, and this article discusses the possible explanations for differences in their outcomes. It is speculated that optimal results from acupuncture treatment for osteoarthritis of the knee may involve: climatic factors, particularly high temperature; high expectations of patients; minimum of four needles; electroacupuncture rather than manual acupuncture, and particularly, strong electrical stimulation to needles placed in muscle; and a course of at least 10 treatments. These factors offer some support to criteria for adequate acupuncture used in the recent review. In addition, ethnic and cultural factors may influence patients' reporting of their symptoms, and different versions of an outcome measure are likely to differ in their sensitivity - both factors which may lead to apparent rather than real differences between studies. The many variables in a study are likely to be more tightly controlled in a single centre study than in multicentre studies.

Effectiveness of acupuncture and related techniques in treating non-oncological pain in primary healthcare--an audit.

BACKGROUND: Pain is one of the principal symptoms for which the general public seeks medical attention, and it is frequently treated by GPs. Although acupuncture is mainly practised in the private field, it enjoys growing acceptance in the public system too, which helps bring down the high cost of its use. The aim of the present study is to evaluate the effectiveness of acupuncture and related techniques in treating non-oncological pain during nine years of activity at the Pain Treatment Unit (PTU) within the Andalusian Public Health System (Spain) in the field of primary healthcare. METHODS: Retrospective review of 5981 electronically stored case histories of patients who sought treatment for non-oncological pain and were seen at the PTU between June 1997 and July 2006. We excluded from this review those patients who had on any occasion been recruited for clinical trials at the PTU. The primary result measure applied was the success rate, defined as an improvement of least 50% on the Global Assessment Index, which is made up of five variables: pain intensity, as measured on a numerical scale of 0-10, pain frequency, consumption of analgesics, level of incapacity and sleep disorders caused by pain (the latter four variables were measured on a 5-point Likert scale of 0-4). RESULTS: The majority (84.5%) of the patients treated were women, with a mean age of 58.8 years (range 8-93), and they attended the healthcare clinic because of pain present for over three months (88.8%) and mainly affecting the lower back (58.8%). In the 5690 patients who completed treatment, the mean success rate was 79.7%, with highest rates (93%) being achieved in patients with cephalalgia. The mean reduction in pain intensity was 5.5 (SD 2.5) points amounting to 67% fall from the baseline. There was a reduction of euro7.1 in the mean weekly expenditure on analgesics per patient. From the regression model, we conclude that the patients who suffered acute or sub-acute pain presented higher success rates than did those with chronic pain (OR, 1.94; 95% CI, 1.53-2.48). CONCLUSIONS: Acupuncture seems to be effective in treating musculoskeletal pain, and presents no severe adverse events. With acupuncture treatment, the consumption of analgesic and anti-inflammatory drugs is considerably reduced.