Hepatic steatosis and severity-related factors in obese children.

BACKGROUND AND AIM: 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. METHODS: Cross-sectional study carried out on a population of children aged 6-14 years inclusive, using abdominal ultrasound as a method to determine the presence and severity of hepatic steatosis; in addition, anthropometric and blood-tested parameters were examined to determine which of these were associated with steatosis. RESULTS: One hundred forty-four children were analyzed, 84 male (58.3%). Steatosis was detected in 50 children (34.7%; 95% confidence interval [CI]: 26.0-42.0%). In six of these cases (12%), elevated aminotransferase levels were recorded. Factors found to be associated with steatosis were body mass index ≥ 99th percentile (odds ratio [OR] 3.58, 95% CI 1.16-15.6) and the level of alanine aminotransferase (ALT) (OR 1.08, 95% CI 1.03-1.13), while its severity was associated with ALT (OR 1.17, 95% CI 1.09-1.28). A level of ALT < 23.5 UI/dL predicted lack of severe steatosis with an area under receiver operating characteristic curve of 0.805 (95% CI 0.683-0.927). CONCLUSIONS: Non-alcoholic fatty liver disease is common in the obese pediatric population in our geographical area. High levels of ALT are associated with severe steatosis, although having ALT above the normal range is not common. Also, the lack of severity of steatosis can be predicted in a subgroup of children with obesity.

Development and validation of clinical scores for visual outcomes after cataract surgery.

PURPOSE: To develop and validate a clinical score to predict visual acuity (VA) and functional changes after phacoemulsification on the basis of readily obtainable preoperative history data and patient assessment. DESIGN: Prospective follow-up study. PARTICIPANTS: A sample of 5512 patients on waiting lists for phacoemulsification at 17 hospitals in Spain. METHODS: Data were obtained at the baseline examination from the 5512 patients. The patients were divided randomly into 2 subgroups: derivation (n = 3285; 60%) and validation (n = 2227; 40%). The preoperative predictors of postoperative gains in VA and visual function index 14 (VF-14) were determined by multivariate logistic regression analysis and implemented using a prediction score. MAIN OUTCOME MEASURES: Probability of postoperative improvement in VA and VF-14 scores. The cutoff points were established for each outcome on the basis of the minimal clinically important difference values. RESULTS: The predictive variables for VA gain were the baseline VA, patient age, ocular comorbidity, and surgical complexity. Regarding the VF-14, the predictive factors were the preoperative VF-14, the eye with the better VA, and the surgical complexity. In the multivariate logistic model in the derivation sample, the final VA and VF-14 scores ranged from 0 to 44 and from 0 and 24, respectively. Receiver operating characteristic curves were developed in the derivation and validation samples, and no statistical significance was found when their areas under the curve were compared. Areas under the curve ranged from 65% to 80%. Both scores had a positive predictive value from 74% to 85%. CONCLUSIONS: Newly developed and validated clinical prediction scores may assist physicians and patients in decision making about the expected outcomes and benefits of cataract surgery.

Complications in immediate breast reconstruction after mastectomy.

OBJECTIVES: Immediate post-mastectomy breast reconstruction (IBR) is a procedure that has proven advantages, but it also entails risks. The aim of this study was to identify risk factors for reconstruction failure. METHODS: A review was made of all the IBR carried out at a general hospital from 2002 to 2009. Retrospective information was obtained about postoperative complications and the characteristics of patients and treatments applied. The minimum follow-up period was 9 months. Cox's regression analysis was performed on the variables related to the reconstruction failure requiring the removal of the prosthesis, with an explanatory model in which all the study variables were introduced and a predictive model that contained only the variables known before the intervention. RESULTS: A total of 115 IRB interventions carried out on 112 women with breast cancer were analyzed. The mean follow-up period was 25.5 months. In sixty cases (52.2 percent), there were no complications; in sixteen cases (13.9 percent) minor complications appeared, and in 39 (33.9 percent) the complications were moderate. In twenty-six cases (22.6 percent), a reconstruction failure occurred. Cox's regression model revealed that the reconstruction failures were related to the patient's age (Hazard Ratio 1.08), to neoadjuvant chemotherapy (HR 6.24) and to postoperative tamoxifen (HR 3.10). The predictive model included the age of the patient (HR 1.05) and the use of neoadjuvant chemotherapy (HR 5.11). CONCLUSIONS: A significant proportion of the patients receiving IBR developed reconstruction failure. Multivariate analysis identified three variables related to this complication, two of which were known before the intervention.

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.

Prognostic implications of emergency admission and delays in patients with breast cancer.

INTRODUCTION: This study evaluates clinical-pathological characteristics and survival rates associated with emergency admission and delays in diagnosis and treatment of 411 consecutive breast cancer patients. MATERIALS AND METHODS: Emergency admission and first symptom-first hospital visit delay were significantly associated with advanced tumor stages but only in the former case with short disease-free survival (RR 2.5, CI 95% 1.5-4.2). RESULTS: Brief diagnostic delays were significantly associated with advanced disease stage and poor survival rates (RR 2.04; CI 95% 1.08-3.82) probably because sicker patients receive prompt medical attention.

Ankle-brachial index in HIV infection.

Prognosis for patients with the human immunodeficiency virus (HIV) has improved with the introduction of highly active antiretroviral therapy (HAART). Evidence over recent years suggests that the incidence of cardiovascular disease is increasing in HIV patients. The ankle-brachial index (ABI) is a cheap and easy test that has been validated in the general population. Abnormal ABI values are associated with increased cardiovascular mortality. To date, six series of ABI values in persons with HIV have been published, but none was a prospective study. No agreement exists concerning the risk factors for an abnormal ABI, though its prevalence is clearly higher in these patients than in the general population. Whether this higher prevalence of an abnormal ABI is associated with a higher incidence of vascular events remains to be determined.

Pre-hospital antibiotic treatment and mortality caused by invasive meningococcal disease, adjusting for indication bias.

BACKGROUND: Mortality from invasive meningococcal disease (IMD) has remained stable over the last thirty years and it is unclear whether pre-hospital antibiotherapy actually produces a decrease in this mortality. Our aim was to examine whether pre-hospital oral antibiotherapy reduces mortality from IMD, adjusting for indication bias. METHODS: A retrospective analysis was made of clinical reports of all patients (n = 848) diagnosed with IMD from 1995 to 2000 in Andalusia and the Canary Islands, Spain, and of the relationship between the use of pre-hospital oral antibiotherapy and mortality. Indication bias was controlled for by the propensity score technique, and a multivariate analysis was performed to determine the probability of each patient receiving antibiotics, according to the symptoms identified before admission. Data on in-hospital death, use of antibiotics and demographic variables were collected. A logistic regression analysis was then carried out, using death as the dependent variable, and pre-hospital antibiotic use, age, time from onset of symptoms to parenteral antibiotics and the propensity score as independent variables. RESULTS: Data were recorded on 848 patients, 49 (5.72%) of whom died. Of the total number of patients, 226 had received oral antibiotics before admission, mainly betalactams during the previous 48 hours. After adjusting the association between the use of antibiotics and death for age, time between onset of symptoms and in-hospital antibiotic treatment, pre-hospital oral antibiotherapy remained a significant protective factor (Odds Ratio for death 0.37, 95% confidence interval 0.15-0.93). CONCLUSION: Pre-hospital oral antibiotherapy appears to reduce IMD mortality.

[Use and evaluation of the health care services and the antirretroviral medication in HIV diagnosed people]. / Uso y valoración de los servicios sanitarios y de la medicación antirretroviral en personas diagnosticadas de infección por el virus de la inmunodeficiencia humana.

AIM: To analyze the use or not of antirretrovirals (ART) human inmunodeficiency virus (HIV) diagnosed people in relation to the utilization and evaluation of the health care services and sociodemographic profiles. METHODS: The data was collected with a questionnaire to 108 HIV people, in the city of Granada (Spain) between July and September 2005. Participants were contacted from three sources: infectious diseases service, HIV's nongovernmental association and from the street through peers. RESULTS: The mean age was 40 years, and the participants knew that they were seropositives since a mean of 12 years ago. At the moment of the interview, 55.6% consumed illegal drugs (cannabis not included), and 63.9% were former injecting drug users. In relation to ART, 25% did not take it, 15.7% were totally adherent, and 59.3% were in treatment but failed in the intake of the medication as prescribed. In general, participants have a positive and accurate perception of ART. The group of the adherents showed the best scores and those who do not take ART the lowest, in almost the totality of the studied variables. CONCLUSION: The present study suggests that is important continuing to improve the access to the health and social resources, to implement strategies of motivation for patients who have been many years in HIV treatment and to integrate in the health care system social excluded HIV positive people.

Association between long travel and venous thromboembolic disease: a systematic review and meta-analysis of case-control studies.

The term "economy-class syndrome" defines an infrequent episode of venous thromboembolism (VTED) related to a long travel, namely by plane. However, this relation has not clearly been demonstrated by investigators. We carried out a systematic review and a meta-analysis of cases-control studies that had studied this topic. We realised a systematic review of the literature and selected all the case-control studies published. Two authors carried out a methodological evaluation according to the Scottish Intercollegiate Guidelines Network items (concordance was analysed by weighted kappa index), and a systematic analysis of the potential biases of each study was assessed. We carried out the meta-analysis with the data extracted from the studies. We recovered eight cases-control studies. The relation between the antecedent of a long travel and subsequent VTED varied from OR = 1.1 to OR = 4.0 and was found to be significant in four studies. The studies were highly heterogeneous in methodology and so the results obtained about the relation between the long travel and the VTED and the score at SIGN50. Two meta-analysis were carried out: only with travels by plane in which the relation was not significant (OR = 1.21; CI 95%, 0.95-1.55) and with all types of transport, with a slightly significant relation (OR = 1.46; CI95%, 1.24-1.72). We may deduce from this systematic review that there does exist a weak association between episodes of VTED and a long travel, but not by plane specifically. The heterogeneity and the methodological quality of the studies published preclude of more robust conclusions.

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.

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.

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.

[An open study evaluating the efficacy and security of magnesium and vitamin B(6) as a treatment of Tourette syndrome in children]. / Estudio piloto sin grupo control del tratamiento con magnesio y vitamina B(6) del síndrome de Gilles de la Tourette en niños.

BACKGROUND AND OBJECTIVE: We intended to ascertain the effectiveness and safety of oral solutions of magnesium and vitamin B(6) in alleviating the symptoms emerged during clinical exacerbations in children aged 7-14 years suffering from Tourette syndrome (TS). We also aimed to determine the mean and the standard deviation of such an improvement in order to estimate sample sizes in future assays with a control group. PATIENTS AND METHOD: The treatment under investigation was administered to children diagnosed with TS, in accordance with Diagnostic and Statistical Manual of Mental Disorders, fourth edition -IV, under conditions of clinical exacerbation. The effects were scored on the Yale Global Tics Severity Scale (YGTSS) at 0, 15, 30, 60 and 90 days. RESULTS: The total tics score decreased from 26.7 (t0) to 12.9 (t4) and the total effect on the YGTSS was a reduction from 58.1 to 18.8. Both results were statistically significant. With respect to the application of conventional treatment or otherwise, no significant differences were observed. No side effects were seen. CONCLUSIONS: The treatment assayed is safe and effective in reducing the harmful effects of TS in children. Further studies are needed, with a control group, and evaluation of different doses of the drugs.

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

BACKGROUND: Rifabutin 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). METHODS: Open 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. RESULTS: 99 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). CONCLUSION: A 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 REGISTRATION: Current Controlled Trials ISRCTN81058036.

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

BACKGROUND: The 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. METHODS: An 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. RESULTS: In 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. CONCLUSION: Adjusting 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.

BACKGROUND: The 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. METHODS: An 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. RESULTS: In 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. CONCLUSION: The 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.

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.

[Incidence and clinico-epidemiological aspects of ulcerative colitis in the area of the Hospital Costa del Sol]. / Incidencia y aspectos clinicoepidemiológicos de la colitis ulcerosa en el área de influencia del Hospital Costa del Sol.

INTRODUCTION: The incidence of inflammatory bowel disease, and of ulcerative colitis in particular, varies widely according to geographical area and has been reported to have increased in the last few years, although some of the differences observed may be due to the methodology employed. OBJECTIVES: To determine the incidence of ulcerative colitis in our area and to compare it with that described in other areas of Spain and Europe, as well as to describe certain clinico-epidemiological aspects of this disease. MATERIAL AND METHODS: A descriptive, prospective, population-based study was performed from 2000-2001 in patients diagnosed with ulcerative colitis in the catchment area of the Hospital Costa del Sol, with a population of 210,384 inhabitants. The crude incidence rate was adjusted by the direct method, using the European standard population (EU-25, 2000) as the reference population; 95% confidence intervals were calculated. RESULTS: Forty-three patients (23 men [53.5%] and 20 women [46.5%], with a mean age of 35.23 years [SD=15.42]) were included. Thirty-three percent were residents of the Hospital Costa del Sol's catchment area and were included in the calculation of incidence. The crude incidence was 7.84 and the incidence adjusted by age and sex to the European population was 7.26 per 100,000 inhabitants/year. CONCLUSIONS: The incidence of ulcerative colitis in the area of the Hospital Costa del Sol is higher than that found in other studies performed in the autonomous community of Andalusia as well as that observed in some studies performed in the north of the Peninsula.

Controlled trial of prescribed heroin in the treatment of opioid addiction.

AIM: This study aimed to assess the efficacy of the prescription of intravenous diacetylmorphine (DAM) versus oral methadone with medical and psychosocial support, with a view of improving physical and mental health as well as social integration among socially excluded, opioid-dependent individuals for whom standard treatments have failed. DESIGN: This study used an open, randomized controlled trial. SETTING: This study took place in Granada, Spain. PARTICIPANTS: Sixty-two opioid-dependent participants were randomized, 31 in each treatment group, and 50 of them were analyzed. The participants were recruited directly from the streets, through peer outreach, in well-known meeting places for drug-addicted individuals. INTERVENTIONS: Participants in the experimental group received injected DAM, twice a day, plus oral methadone, once a day, for 9 months. The control group received only oral methadone, once a day. The two groups received an equivalent opioid dosage. The average DAM dosage was 274.5 mg/day (range: 15-600 mg), and an average methadone dosage was 42.6 mg/day (range: 18-124 mg). The daily methadone dosage in the control group was 105 mg/day (range: 40-180 mg). Comprehensive clinical, psychological, social, and legal support was given to both groups. MEASUREMENTS: The following were measured in this study: general health, quality of life, drug-addiction-related problems, nonmedical use of heroin, risk behavior for HIV and HCV, and psychological, family, and social status. FINDINGS: Both groups improved with respect to the total domain assessed. Those in the experimental group showed greater improvement in terms of physical health (the improvement was 2.5 times higher; p = .034) and risk behavior for HIV infection (the improvement was 1.6 times higher; p = .012). In addition, this group decreased its street heroin use from 25 days/month to 8 days/month as seen on the Addiction Severity Index (p = .020), as well as the number of days free from drug-related problems (the improvement was 2.1 times higher; p = .004) or involvement in crime (from 11 days/month to <1 day/month; p = .096 between groups). CONCLUSIONS: These findings support the hypothesis that, under the same conditions, DAM could be safely delivered, in our context. Also, in physical health, HIV risk behavior, street heroin use, and days involved in crime, DAM plus methadone was more efficacious than methadone alone. This implies that this treatment could provide an effective alternative for the treatment of socially excluded, opioid-dependent patients with severe physical and mental health problems because of drug addiction, when all available previous treatments have failed.