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.

Topical treatment with oleocanthal extract in reducing inflammatory reactions after photodynamic therapy: a prospective quasi-experimental pilot study.

OBJECTIVE: Photodynamic therapy (PDT) is an effective treatment against skin field cancerization. Its main side effect is local inflammation in the treated area. The phenolic compound oleocanthal (decarboxy methyl ligstroside aglycone), which is present in extra virgin olive oil (EVOO), has anti-inflammatory properties. The purpose of this study was to evaluate the topical efficacy of an oily fluid enriched with oleocanthal (OC) extract, in comparison with a conventional oily fluid, in reducing the degree of inflammatory reaction after conventional PDT. METHODS: Quasi-experimental pilot study, before-after with a control group, performed with a cohort of consecutive patients diagnosed with actinic keratosis/field cancerization (AK/FC) in the forehead and/or scalp, treated by PDT. The study was carried out from April 2016 to November 2017 at a speciality hospital in southern Spain. A group of 24 consecutive patients received the topical application, three times daily for one week, of an emollient oily fluid in the area treated with PDT. Subsequently, another group, of 23 consecutive patients, received the same treatment pattern with an oily fluid enriched with OC extract. The post-PDT inflammatory reaction was measured by an independent member of the hospital's dermatology department, using the following visual scale of erythema (from 0 to 4).The assessment was conducted at 30 min and at 48 h post-PDT. RESULTS: In the assessment at 48 h after treatment, the inflammation had improved more among the patients treated with OC (median: 25%, 95%CI: -5.3 to 28.5) than in the non-OC group (median: 0%; 95%CI: -45.2 to -6.2). The difference was statistically significant (p<0.01), and the Cohen's d value was 0.89 (large effect). At three months after PDT, a complete response had been obtained by 60.9% of the patients treated with OC compared to 29.2% of the non-OC group, and the difference was close to statistical significance (p=0.059). CONCLUSIONS: The topical application of an oily fluid enriched with OC extract achieved a greater reduction in post-PDT cutaneous inflammation and a better treatment response, in comparison with the application of a conventional oily fluid.

Discrepancias entre el empleo de las ecuaciones MDRD-4 IDMS y CKD-EPI en vez de la de Cockcroft-Gault en la determinación de la posología de los anticoagulantes orales directos en pacientes con fibrilación auricular no valvular / Discrepancies between the use of MDRD-4 IDMS and CKD-EPI equations, instead of the Cockcroft-Gault equation, in the determination of the dosage of direct oral anticoagulants in patients with non-valvular atrial fibrillation

Fundamento y objetivo: Los anticoagulantes orales directos (ACOD) precisan ajuste de dosis según el estimated clearance creatinine (eClCr, «aclaramiento de creatinina estimado») por la ecuación de Cockcroft-Gault (CG). Existen discrepancias entre las ecuaciones que estiman el filtrado glomerular (FGe). Analizamos cómo afecta a la posología recomendada para los ACOD el empleo de las ecuaciones CKD-EPI y MDRD-4 IDMS. Pacientes y métodos: Estudio retrospectivo de pacientes con fibrilación auricular no valvular atendidos en una consulta de cardiología entre noviembre de 2012 y agosto de 2014. Se reclasifican los pacientes según la posología recomendada para dabigatrán, rivaroxabán, apixabán y edoxabán en función de la ecuación de FGe empleada. Se tienen en cuenta otros factores clínicos, según ficha técnica. Analizamos el porcentaje de discordancia. Resultados: Se estudian 454 pacientes, 53,3% hombres, con una edad media de 68,7±13,8 años. La media de las diferencias intraindividuales registradas respecto a la ecuación de GC fue de 3,9ml/min/1,73m2 con MDRD-4 IDMS (IC 95% 1,4-6,4; p=0,003) y 11,3ml/min/1,73m2 con CKD-EPI (IC 95% 8,9-13,7; p<0,001). Se observa un gradiente en la discordancia de la posología (apixabán 1,1%, dabigatrán 3,5%, edoxabán 5,7%, rivaroxabán 8,4% con MDRD-4 IDMS). Las diferencias se limitaron a los pacientes con eClCr<60ml/min y fueron más manifiestas en≥75 años, en los que las ecuaciones de FGe sobreestiman la función renal. Conclusiones: En pacientes con fibrilación auricular no valvular, especialmente con insuficiencia renal y en ancianos, las ecuaciones de FGe tienden a sobreestimar la función renal respecto a CG y, por ello, a recomendar una sobredosificación de los ACOD (AU)

Background and objective: Direct oral anticoagulants (DOACs) require dose adjustment according to estimated clearance creatinine (eClCr) using the Cockcroft-Gault (CG) equation. There are discrepancies with the equations that estimate glomerular filtration rate (eGFR). We analyse how the use of the CKD-EPI and MDRD-4 IDMS equations affect the recommended dosage for ACODs. Patients and methods: Retrospective study of patients with non-valvular atrial fibrillation seen at a cardiology clinic between November 2012 and August 2014. Patients were reclassified according to the recommended dosage for dabigatran, rivaroxaban, apixaban and edoxaban, based on the eGFR equation used. Other clinical factors are taken into account, according to the product label. We analysed the percentage of discordance. Results: Four hundred and fifty-four patients, 53.3% men, with a mean age of 68.7±13.8 years were studied. The mean intra-individual differences recorded for the CG equation were 3.9ml/min/1.73m2 with MDRD-4 IDMS (95% CI 1.4-6.4, P=.003) and 11.3ml/min/1.73m2 with CKD-EPI (95% CI 8.9-13.7, P<.001). A gradient is observed in the discordance of the posology (apixaban 1.1%, dabigatran 3.5%, edoxaban 5.7%, rivaroxaban 8.4% with MDRD-4 IDMS). Differences were limited to patients with eClCr<60ml/min and were more evident in≥75 years in which the eGFR equations overestimate renal function. Conclusions: In patients with non-valvular atrial fibrillation, especially with renal failure and in the elderly, eGFR equations tend to overestimate renal function relative to CG and therefore suggest an overdose of DOACs (AU)

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.

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).

New therapeutic approach to Tourette Syndrome in children based on a randomized placebo-controlled double-blind phase IV study of the effectiveness and safety of magnesium and vitamin B6.

BACKGROUND: Tourette Syndrome (TS) is a neurological condition presenting chronic motor and phonic tics, and important degree of comorbidity. Considered an uncommon illness, it first becomes apparent during childhood. Current standard treatment only achieves partial control of the condition, and provokes frequent, and sometimes severe, side effects. METHODS AND DESIGN: Main aim: To show that, with respect to placebo treatment, the combination of 0.5 mEq/Kg magnesium and 2 mg/Kg vitamin B6 reduces motor and phonic tics and incapacity in cases of exacerbated TS among children aged 7-14 years, as measured on the Yale Global Tic Severity Scale (YGTSS). Secondary aims: Assess the safety of the treatment. Describe metabolic changes revealed by PET. Measure the impact of the experimental treatment on family life. METHODOLOGY: Randomized, blinded clinical trials. Phase IV study (new proposal for treatment with magnesium and vitamin B6). SCOPE: children in the geographic area of the study group. Recruitment of subjects: to include patients diagnosed with TS, in accordance with DSM-IV criteria (307.23), during a period of exacerbation, and provided none of the exclusion criteria are met. INSTRUMENTATION: clinical data and the YGTSS score will be obtained at the outset of a period of exacerbation (t0). The examinations will be made after 15 (t1), 30 (t2), 60 (t3) and 90 days (t4). PET will be performed at the t0 and t4. We evaluated decrease in the overall score (t0, t1, t2, t3, t4), PET variations, and impact made by the treatment on the patient's life (Psychological General Well-Being Index). DISCUSSION: Few clinical trials have been carried out on children with TS, but they are necessary, as current treatment possibilities are insufficient and often provoke side effects. The difficulty of dealing with an uncommon illness makes designing such a study all the more complicated. The present study seeks to overcome possible methodological problems by implementing a prior, phase II study, in order to calculate the relevant statistical parameters and to determine the safety of the proposed treatment. Providing a collateral treatment with magnesium and vitamin B6 could improve control of the illness and help reduce side effects. This protocol was approved by the Andalusian Government Committee for Clinical Trials (Spain). This study was funded by the Health Department of the Andalusian Regional Government and by the Healthcare Research Fund of the Carlos III Healthcare Institute (Spanish Ministry of Health). TRIAL REGISTRATION: Current Controlled Trials ISRCTN41082378.