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.

A personalized intervention to prevent depression in primary care: cost-effectiveness study nested into a clustered randomized trial.

BACKGROUND: Depression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care. METHODS: Cost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months. RESULTS: With a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results. CONCLUSIONS: Compared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01151982. Registered on June 29, 2010.

Intervention to Prevent Major Depression in Primary Care: A Cluster Randomized Trial.

BACKGROUND: Not enough is known about universal prevention of depression in adults. OBJECTIVE: To evaluate the effectiveness of an intervention to prevent major depression. DESIGN: Multicenter, cluster randomized trial with sites randomly assigned to usual care or an intervention. (ClinicalTrials.gov: NCT01151982). SETTING: 10 primary care centers in each of 7 cities in Spain. PARTICIPANTS: Two primary care physicians (PCPs) and 5236 nondepressed adult patients were randomly sampled from each center; 3326 patients consented and were eligible to participate. INTERVENTION: For each patient, PCPs communicated individual risk for depression and personal predictors of risk and developed a psychosocial program tailored to prevent depression. MEASUREMENTS: New cases of major depression, assessed every 6 months for 18 months. RESULTS: At 18 months, 7.39% of patients in the intervention group (95% CI, 5.85% to 8.95%) developed major depression compared with 9.40% in the control (usual care) group (CI, 7.89% to 10.92%) (absolute difference, -2.01 percentage points [CI, -4.18 to 0.16 percentage points]; P = 0.070). Depression incidence was lower in the intervention centers in 5 cities and similar between intervention and control centers in 2 cities. LIMITATION: Potential self-selection bias due to nonconsenting patients. CONCLUSION: Compared with usual care, an intervention based on personal predictors of risk for depression implemented by PCPs provided a modest but nonsignificant reduction in the incidence of major depression. Additional study of this approach may be warranted. PRIMARY FUNDING SOURCE: Institute of Health Carlos III.

Is there a case for mental health promotion in the primary care setting? A systematic review.

OBJECTIVES: To evaluate the effectiveness of mental health promotion (MHP) interventions by primary health care professionals in the adult population. METHODS: Systematic review of literature in English and Spanish for randomized controlled trials (RCTs) and observational studies evaluating the impact of interventions carried out by primary care professionals explicitly to promote and improve the overall mental health of adult patients. PubMed, PsycINFO, and Web of Science were independently searched by two investigators to identify all MHP articles from inception to October 2013 (no restrictions). RESULTS: We retrieved 4262 records and excluded 4230 by a review of title and abstract. Of 32 full-text articles assessed, 3 RCTs were selected (2 in USA, 1 in UK); two focused on the mental health of parents whose children have behavioral problems, the other on older people with disabilities. One study reported a MHP intervention that improved participants' mental health at 6-month follow-up. All studies had low-moderate quality (2 of 5 points) on the Jadad Scale. CONCLUSION: There is a lack of implementation and/or evaluation of mental health promotion activities conducted by primary care professionals. More research is needed to clearly understand the benefits of promoting mental health in this setting.

Preventing the onset of major depression based on the level and profile of risk of primary care attendees: protocol of a cluster randomised trial (the predictD-CCRT study).

BACKGROUND: The 'predictD algorithm' provides an estimate of the level and profile of risk of the onset of major depression in primary care attendees. This gives us the opportunity to develop interventions to prevent depression in a personalized way. We aim to evaluate the effectiveness, cost-effectiveness and cost-utility of a new intervention, personalized and implemented by family physicians (FPs), to prevent the onset of episodes of major depression. METHODS/DESIGN: This is a multicenter randomized controlled trial (RCT), with cluster assignment by health center and two parallel arms. Two interventions will be applied by FPs, usual care versus the new intervention predictD-CCRT. The latter has four components: a training workshop for FPs; communicating the level and profile of risk of depression; building up a tailored bio-psycho-family-social intervention by FPs to prevent depression; offering a booklet to prevent depression; and activating and empowering patients. We will recruit a systematic random sample of 3286 non-depressed adult patients (1643 in each trial arm), nested in 140 FPs and 70 health centers from 7 Spanish cities. All patients will be evaluated at baseline, 6, 12 and 18 months. The level and profile of risk of depression will be communicated to patients by the FPs in the intervention practices at baseline, 6 and 12 months. Our primary outcome will be the cumulative incidence of major depression (measured by CIDI each 6 months) over 18 months of follow-up. Secondary outcomes will be health-related quality of life (SF-12 and EuroQol), and measurements of cost-effectiveness and cost-utility. The inferences will be made at patient level. We shall undertake an intention-to-treat effectiveness analysis and will handle missing data using multiple imputations. We will perform multi-level logistic regressions and will adjust for the probability of the onset of major depression at 12 months measured at baseline as well as for unbalanced variables if appropriate. The economic evaluation will be approached from two perspectives, societal and health system. DISCUSSION: To our knowledge, this will be the first RCT of universal primary prevention for depression in adults and the first to test a personalized intervention implemented by FPs. We discuss possible biases as well as other limitations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01151982.

[Validity of smoking measurements during pregnancy: specificity, sensitivity and cut-off points]. / Validez de distintas medidas de consumo de tabaco durante el embarazo: especificidad, sensibilidad y puntos de corte dónde y cuándo.

BACKGROUND: Non-disclosure by pregnant women smokers of their smoking habit questions the validity of self-declarations. The purpose of this research is to determine the rate of Non disclosure and to establish the validity of exhaled CO as a method of biochemical validation. METHOD: Data obtained in a Randomised Clinical Trial in 12 Health Centres in Malaga. 454 pregnant women smokers, of whom 104 declared that they had stopped smoking at the start. Measurement of the habit: self-declaration, carbon monoxide (CO) and cotinine in the urine in those subjects who declared that they no longer smoked. The ROC curve was obtained for the CO, calculating the area under the curve and the sensitivity and specificity for different cut-off points. Using the CO as the gold standard, the validity of the self-declarations was determined in terms of sensitivity and specificity. RESULTS: Cotinine/self-declaration comparison: rate of Non disclosure 15.4% (IC 95% 9.3-24.1). Cotinine/CO comparison: Area under the ROC curve of 0.838 (IC 95% 0.740-0.935). For a cut-off point of 9, recommended in the relevant bibliography, we achieved 100% specificity with 12.5% sensitivity. CO/self-declaration comparison (cut-off point 9): False negations 0.8%, prevalence of spontaneous abandonment of smoking habit 58.1%. CONCLUSIONS: A percentage of Non disclosure similar to other studies and the validity of CO as a method for the identification of women smokers are confirmed. At cut-off point 9, the validity of CO and self-declaration would be similar, with the prevalence of spontaneous abandonment increasing up to unreal figures. At the present time, the evidence is not sufficient in order to recommend 9 as the CO cut-off point. The results suggest that this should be lower. More extensive research is necessary in pregnant women who state that they do not smoke, using an appropriate methodology.

Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467].

BACKGROUND: Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60-70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis. METHODS/DESIGN: Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points), placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study. In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI) at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results. DISCUSSION: This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain and to isolate the specific and non-specific effects of the treatment.

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).

[Smoking prevalence and associated factors during pregnancy in Andalucía 2007-2012]. / Prevalencia de tabaquismo durante el embarazo y factores asociados en Andalucía 2007-2012 (*).

BACKGROUND: Smoking during pregnancy is the most important preventable perinatal health problem. The aim of this research is to determine smoking prevalence in pregnant women at different times of pregnancy in Andalucía, using biochemical validation methods and to explore factors associated with it. METHODS: Cross-sectional study. The study population was pregnant women followed in andalusian public health centers. A random sample of 40 health centers, stratified by number of pregnancies was collected, with 1813 pregnant enrolled in 3 independent samples (beginning and end of pregnancy, postpartum). The smoke exposure was measured by urinary cotinine, self-report and carbon monoxide in exhaled air. Control variables were socio-demographic, obstetric and related to smoking habit. A logistic regression was performed to explore factors associated with pregnancy smoking. RESULTS: The mean prevalence in the whole sample was 21.6%, which was lower at the end of pregnancy (15.6%) and postpartum (16.7%) than at the beginning (30.3%). Daily smokers fell from 56.3% before pregnancy to 14% at the end (according to selfreport). Most of the quitters gave up before pregnancy (21.8%) or when they noticed they were pregnant (23.6%). Deception rate was 19.6%, varying according to gestational age and the amount of tobacco consumed. Younger age (OR: 0.956, CI 0.92-0.99), be exposed to second hand smoke at home (OR: 3.48, CI 2.6 to 4.7), a higher level of consumption before pregnancy (6-10 OR 13.1 CI 3 to 56.9,> 10 OR 25.1 CI 5.8 to 109.6), greater gestational age at measurement (end OR: 0.5 CI: 0.4-0.8; immediate postpartum OR 0.4 CI 0.3-0.6) and lower educational level (no education and first grade compared to university OR: 1.98, CI 1.22 to 3.22) were identified as factors associated. CONCLUSION: Consumption variations with gestational age compel to indicate the time of measurement in prevalence studies. The profile of the pregnant smoker was being young, poorly educated, exposed to tobacco smoke at home and with a previous history of heavy smoking.

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.