Francisco Rivas-Ruiz

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

Summary Each of the acupuncture modalities (true, sham, and placebo) associated with conventional treatment achieved a clinical improvement after 3 weeks that was greater than that achieved by conventional treatment alone in patients with acute low back pain, although there were no significant differences among the different forms of stimulus. Abstract 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 2 weeks’ 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.

Efficacy of rifabutin-based triple therapy as second-line treatment to eradicate helicobacter pylori infection

BackgroundRifabutin has been found to be effective in multi-resistant patients after various treatment cycles for Helicobacter pylori (HP) infection, but it has not been analysed as a second-line treatment. Therefore, we seek to compare the effectiveness of a treatment regimen including rifabutin versus conventional quadruple therapy (QT).MethodsOpen clinical trial, randomised and multi-centre, of two treatment protocols: A) Conventional regime -QT- (omeprazole 20 mg bid, bismuth citrate 120 mg qid, tetracycline 500 mg qid and metronidazole 500 mg tid); B) Experimental one -OAR- (omeprazole 20 mg bid, amoxicillin 1 gr bid, and rifabutin 150 mg bid), both taken orally for 7 days, in patients with HP infection for whom first-line treatment had failed. Eradication was determined by Urea Breath Test (UBT). Safety was determined by the adverse events.Results99 patients were randomised, QT, n = 54; OAR, n = 45. The two groups were homogeneous. In 8 cases, treatment was suspended (6 in QT and 2 in OAR). The eradication achieved, analysed by ITT, was for QT, 38 cases (70.4%), and for OAR, 20 cases (44.4%); p = 0.009, OR = 1.58. Of the cases analysed PP, QT were 77.1%; OAR, 46.5%; p = 0.002. Adverse effects were described in 64% of the QT patients and in 44% of the OAR patients (p = 0.04).ConclusionA 7-day rifabutin-based triple therapy associated to amoxicillin and omeprazole at standard dose was not found to be effective as a second-line rescue therapy. The problem with quadruple therapy lies in the adverse side effects it provokes. We believe the search should continue for alternatives that are more comfortably administered and that are at least as effective, but with fewer adverse side effects.Trial RegistrationCurrent Controlled Trials ISRCTN81058036

Geographic variability of fatal road traffic injuries in Spain during the period 2002-2004: an ecological study

BackgroundThe aim of the present study is to describe the inter-province variability of Road Traffic Injury (RTI) mortality on Spanish roads, adjusted for vehicle-kilometres travelled, and to assess the possible role played by the following explicative variables: sociodemographic, structural, climatic and risk conducts.MethodsAn ecological study design was employed. The mean annual rate of RTI deaths was calculated for the period 2002–2004, adjusted for vehicle-kilometres travelled, in the 50 provinces of Spain. The RTI death rate was related with the independent variables described above, using simple and multiple linear regression analysis with backward step-wise elimination. The level of statistical significance was taken as p < 0.05.ResultsIn the period 2002–2004 there were 12,756 RTI deaths in Spain (an average of 4,242 per year, SD = 356.6). The mean number of deaths due to RTI per 100 million vehicle-kilometres (mvk) travelled was 1.76 (SD = 0.51), with a minimum value of 0.66 (in Santa Cruz de Tenerife) and a maximum of 3.31 (in the province of Lugo). All other variables being equal, a higher proportion of kilometres available on high capacity roads, and a higher cultural and education level were associated with lower death rates due to RTI, while the opposite was true for the rate of alcohol consumers and the road traffic volume of heavy vehicles. The variables included in the model accounted for 55.4% of the variability in RTI mortality.ConclusionAdjusting RTI mortality rates for the number of vehicle-kilometres travelled enables us to identify the high variability of this cause of death, and its relation with risk factors other than those inherent to human behaviour, such as the type of roads and the type of vehicles using them.

Estimation of the real population and its impact on the utilisation of healthcare services in Mediterranean resort regions: an ecological study

BackgroundThe demographic structure has a significant influence on the use of healthcare services, as does the size of the population denominators. Very few studies have been published on methods for estimating the real population such as tourist resorts. The lack of information about these problems means there is a corresponding lack of information about the behaviour of populational denominators (the floating population or tourist load) and the effect of this on the use of healthcare services. The objectives of the study were: a) To determine the Municipal Solid Waste (MSW) ratio, per person per day, among populations of known size; b) to estimate, by means of this ratio, the real population in an area where tourist numbers are very significant; and c) to determine the impact on the utilisation of hospital emergency healthcare services of the registered population, in comparison to the non-resident population, in two areas where tourist numbers are very significant.MethodsAn ecological study design was employed. We analysed the Healthcare Districts of the Costa del Sol and the island of Menorca. Both are Spanish territories in the Mediterranean region.ResultsIn the two areas analysed, the correlation coefficient between the MSW ratio and admissions to hospital emergency departments exceeded 0.9, with p < 0.001. On the basis of MSW generation ratios, obtained for a control zone and also measured in neighbouring countries, we estimated the real population. For the summer months, when tourist activity is greatest and demand for emergency healthcare at hospitals is highest, this value was found to be double that of the registered population.ConclusionThe MSW indicator, which is both ecological and indirect, can be used to estimate the real population in areas where population levels vary significantly during the year. This parameter is of interest in planning and dimensioning the provision of healthcare services.

Prevalence of Primary Resistance of Helicobacter pylori to Clarithromycin and Levofloxacin in Southern Spain

Background: The eradication of Helicobacter pylori (HP) using clarithromycin (CLA)-based triple therapy depends on the resistance of HP to antibiotics. The Maastricht III conference recommends the implementation of locoregional surveillance programmes for primary resistance of HP to CLA. In Andalusia, there are no previous data in this respect. The aim of this study was to determine the prevalence of the primary resistance of HP to CLA and levofloxacin (LF) in southern Spain. Methods: Multicentre cross sectional study was carried out in 6 hospitals in Andalusia. Patients of both sexes numbering 401 were included (male 48%), aged 18-80 years and naïve to HP eradication. Resistance of HP to CLA (CLAr) and LF (LFr) was assessed by determining mutations by PCR: mutations of the 23S rRNA gene define CLAr and mutations of the gene gyrA define LFr. Four hundred one gastric samples were collected. CLAr was detected in 72 patients (17.9%) and LFr was detected in 56 patients (13.9%). Heteroresistance was detected for both antibiotics: CLA 37/72 (51.3%) and LF 28/56 (50%). Variability for CLAr was detected among the centres, ranging from 11.5% to 24.7% without statistical significance (p = 0.12). Female sex was related to CLAr. Conclusions: In Andalusia, there is a high rate of primary CLAr and LFr. CLA-based triple therapy should be avoided as the primary eradication regimen in this region. There is a wide variability in the rate of CLAr among centres.

Hepatic steatosis and severity-related factors in obese children.

Obesity is an important health‐care problem in developed countries. It is considered a multisystemic disease, but it may also affect the liver, thus provoking non‐alcoholic fatty liver disease. This disease has been less extensively studied among children than among adults. We propose to analyze the prevalence of hepatic steatosis among a pediatric population within an area in southern Europe besides the variables associated with its development and severity.

Ethnic differences in the use of intrapartum epidural analgesia

BackgroundObstetric epidural analgesia (EA) is widely applied, but studies have reported that its use may be less extensive among immigrant women or those from minority ethnic groups. Our aim was to examine whether this was the case in our geographic area, which contains an important immigrant population, and if so, to describe the different components of this phenomenon.MethodsCross-sectional observational study. Setting: general acute care hospital, located in Marbella, southern Spain. Analysis of computer records of deliveries performed from 2004 to 2010. Comparison of characteristics of deliveries according to the mothers’ geographic origins and of vaginal deliveries noting whether EA was received, using univariate and bivariate statistical analysis and multiple logistic regression (MLR).ResultsA total of 21,034 deliveries were recorded, and 37.4% of these corresponded to immigrant women. EA was provided to 61.1% of the Spanish women and to 51.5% of the immigrants, with important variations according to geographic origin: over 52% of women from other European countries and South America received EA, compared with around 45% of the African women and 37% of the Asian women. These differences persisted in the MLR model after adjusting for the mothers age, type of labor initiation, the weight of the neonate and for single or multiple gestation. With the Spanish patients as the reference category, all the other countries of origin presented lower probabilities of EA use. This was particularly apparent for the patients from Asia (OR 0.38; 95%CI 0.31-0.46), Morocco (OR 0.49; 95%CI 0.43-0.54) and other Africa (OR 0.55; 95%CI 0.37-0.81).ConclusionsWe observed a different use of EA in vaginal deliveries, according to the geographic origin of the women. The explanation for this involves a complex set of factors, depending both on the patient and on the healthcare staff.

Distribución y tendencia de los fallecimientos en el medio hospitalario en España durante el periodo 1997-2003

Fundamento: El lugar en que se produce la muerte de una persona depende de circunstancias de naturaleza demografica, socioeconomica, cultural y asistencial El objetivo del estudio fue describir las variaciones en el porcentaje de muertes en hospitales entre las comunidades autonomas de Espana, diferenciando las que ocurrieron en urgencias y hospitalizacion, y explorar su relacion con posibles variables explicativas. Metodos: El estudio fue ecologico. Se estudio la tendencia del porcentaje de muertes en hospitales entre 1997 y 2003. Se calcularon los porcentajes de muertes en hospitales de cada comunidad autonoma en los anos 2000-2002 a partir del Movimiento Natural de la Poblacion y de la Encuesta de Establecimientos Sanitarios con Regimen de Internado que incluye informacion de todos los hospitales publicos y privados. Mediante regresion lineal simple se analizo su relacion con variables demograficas, socioeconomicas, y asistenciales. Resultados: El 53% de los fallecimientos ocurrieron en hospitales (variando entre 37,3 y 68,4% en las distintas comunidades). El 10,7% de ellos en el area de urgencias (variando entre 6 y 14,5%) y el resto en hospitalizacion. Conclusiones: El porcentaje de muertes en hospitales fue mayor en las comunidades con menos poblacion anciana y rural, mas poblacion extranjera y mayor frecuentacion de urgencias. El porcentaje de muertes hospitalarias en urgencias fue mayor en las comunidades con peores indicadores socioeconomicos. La tendencia en los 7 anos estudiados fue al aumento del porcentaje de muertes en hospitales.

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

BackgroundTourette 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 designMain 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.MethodologyRandomized, 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 patients life (Psychological General Well-Being Index).DiscussionFew 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 RegistrationCurrent Controlled Trials ISRCTN41082378

Oral oxybutynin for the treatment of hyperhidrosis: outcomes after one-year follow-up.

Although many treatments are available to address hyperhidrosis, the results are not always satisfactory. The aim of the study was to assess the effectiveness, optimal dosage regimen and long‐term safety of oral oxybutynin in the treatment of hyperhidrosis.