[Study of the relationship between adherence to back school and coping with pain in patients with chronic low back pain]. / Estudio de la relación entre adherencia a la Escuela de la Espalda y afrontamiento del dolor en pacientes con lumbalgia crónica.

INTRODUCTION: Back School (BS) is a treatment modality for patients with chronic low back pain with educational contents associated with other therapeutic measures such as exercise. If followed, it is effective but it is well known that it is difficult to make changes to daily habits. This study evaluated whether patients completing BS had a predominance of active strategies in coping with pain, as they adhered better to the recommendations of BS. MATERIAL AND METHOD: Prospective observational study to evaluate BS adherence in patients with chronic low back pain. Adult patients attending BS were included in the study. Patients whose educational level, concomitant pathology or personal situation prevented them from completing the study were excluded. The patients were evaluated at the beginning and after the third session of BS. The variables studied were adherence to exercises and recommendations, coping with pain, pain intensity, functional disability and other sociodemographic characteristics. RESULTS: A total of 67.2% of the 116 included patients acknowledged that they did not perform the exercises and recommendations of BS every day. No relationship was established between patients with active strategies for coping with pain and adherence to BS. Functional capacity and pain intensity did not differ between adherent and non-adherent patients. CONCLUSIONS: This study did not demonstrate that adherence to the exercises and habits taught in BS is related to coping with pain strategies, pain intensity and functional capacity in patients with chronic low back pain.

Fluticasone in mild to moderate atopic dermatitis relapse: A randomized controlled trial.

BACKGROUND: The long-term efficacy of corticosteroids to prevent atopic dermatitis (AD) relapses has partially been addressed in children. This study compared an intermittent dosing regimen of fluticasone propionate (FP) cream 0.05% with its vehicle base in reducing the risk of relapse in children with stabilized AD. METHODS: A randomized controlled, multicentric, double-blind trial was conducted. Children (2-10 years) with mild/moderate AD (exclusion criteria: >30% affected body surface area and/or head) were enrolled into an Open-label Stabilization Phase (OSP) of up to 2 weeks on twice daily FP. Those who achieved treatment success entered the Double-blind Maintenance Phase (DMP). They were randomly allocated to receive FP or vehicle twice-weekly on consecutive days for 16 weeks. The primary study endpoint was relapse rate; time to relapse and severity of disease were also studied. Kaplan-Meier estimates were calculated. RESULTS: Fifty-four patients (29 girls) entered the OSP (23 mild AD) and 49 (26 girls) continued into the DMP. Mean age was 5.5 (SD: 2.8) and 5.1 (SD: 2.3) yrs for FP and vehicle groups, respectively. Four patients withdrew from the DMP (two in every group). Patients treated with FP twice weekly had a 2.7 fold lower risk of experiencing a relapse than patients treated with vehicle (relative risk 2.72, SD: 1.28; p=0.034). FP was also superior to vehicle for delaying time to relapse. Both treatment therapies were well tolerated. CONCLUSION: This long-term study shows that twice weekly FP provides an effective maintenance treatment to control the risk of relapse in children with AD.

Alternate-day dosing of atorvastatin: effects in treating type 2 diabetic patients with dyslipidaemia.

An analysis is made of the effect of alternateday dosing of atorvastatin and standard once-daily dosing, based on mean low-density lipoprotein (LDL) reduction from baseline in type 2 diabetics. Forty-four type 2 diabetics were enrolled in the study. In compliance with American Diabetes Association (ADA) and National Cholesterol Education Program Expert Panel (NCEP-III) guidelines, LDL-C<100 mg/dl was chosen as the treatment target. Patients were assigned to 10 mg atorvastatin as an initial dose every day. The atorvastatin dose was doubled every 6 weeks if the patients failed to reach the treatment target. After achieving LDL<100 mg/dl, the patients were assigned to the corresponding atorvastatin dose every other day for 12 weeks. Thirty-three patients correctly completed the study. LDL-C decreased 39% after the every-day period and 23% after the alternate-day atorvastatin dosing period (p<0.05). The target LDL-C concentration of <100 mg/dl was maintained in 19 patients (57.6%) in the alternate-day period. None of the 33 patients showed elevations in liver enzymes or creatine kinase during the alternate-day dosing period. Alternate-day dosing of atorvastatin could be an effective and safe alternative to daily-dosing in some type 2 diabetic patients.

[Quality of the publication of adverse drug reactions in the letters to the editor section of four Spanish internal medicine and general medicine journals]. / Calidad de la publicación de reacciones adversas a medicamentos en la sección de Cartas al Director de cuatro revistas españolas de medicina interna y medicina general.

OBJECTIVE: To assess the quality and relevance of adverse drug reactions (ADRs) published as Letters to the Editor (LE) in Spanish medical journals. DESIGN: Observational study. PARTICIPANTS: LE on adverse drug reactions published over 5 years (1994-98). SETTING: Four Spanish medical journals (Medicina Clínica, Revista Clínica Española, Atención Primaria and Anales de Medicina Interna). MAIN MEASUREMENTS: Patient characteristics, drugs, ADR, causality algorithm, minimum criteria, and publication relevance. RESULTS: Out of 2244 LE, 204 (9.1%) reported ADRs, which included 235 cases. The therapeutic subgroups most commonly implicated were anticoagulants and antiplatelet drugs, antibiotics, and antineoplastic agents; 20.4% of the drugs were recently marketed. ADRs most commonly involved the nervous system (13.6%), liver (10.2%), skin and appendages (9.8%), general reactions (9.8%), and the digestive system (8.1%). The reactions were moderate in 50.2% of cases and severe/fatal in 34%. The mean causality algorithm value (5.9+/-2.2) was similar among journals. Of the ADRs, 28 (11.9%) were definitive, 182 (77%) possible or probable, and 26 (11.1%) improbable or conditional; 10.2% were unknown. There were no differences in the mean minimum publication criteria (9.5+/-1.2). Publication relevance was 3.2+/-1.6 points, and higher in Medicina Clínica. CONCLUSIONS: ADRs constitute an important part of LE in the journals studied. The causal relationship is acceptable, the documentation quality is high, with few unknown reactions and ADRs to recently marketed drugs. Relevance is generally low, although greater in Medicina Clínica.

Drug utilisation in outpatient children. A comparison among Tenerife, Valencia, and Barcelona (Spain), Toulouse (France), Sofia (Bulgaria), Bratislava (Slovakia) and Smolensk (Russia).

INTRODUCTION: Scarce information about comparative diagnostic and therapeutic patterns in paediatric outpatients of different countries is found in the literature. OBJECTIVE: To describe the similarities and differences observed in diagnosis and therapeutic patterns of paediatric patients of seven locations in different countries. DESIGN: Cross-sectional, prospective, international comparative, descriptive study. PATIENTS AND METHODS: A randomly selected sample of 12,264 paediatric outpatients seen in consultation rooms of urban and rural areas and attended by paediatricians or general practitioners of the participating locations. Data on patient demographic information, diagnosis and pharmacological treatment were collected using pre-designed forms. Diagnoses were coded using the ICD-9 and drugs according to the ATC classification. RESULTS: Among the ten most common diagnoses, upper respiratory tract infections are in the first position in all locations; asthma prevalence is highest in Tenerife (8.4%). Tonsillitis, otitis, bronchitis and dermatological affections are the most common diagnoses in all locations. Pneumonia is only reported in Sofia (3.8%) and Smolensk (2.3%). The average number of drugs prescribed per child varied from 1.3 in Barcelona to 2.9 in Smolensk. There are no great differences in the profile of pharmacological groups prescribed, but a considerable range of variations in antibiotic therapy is observed: prescription of cephalosporins is low in Smolensk (0.7%) and higher in the other locations, from 16.5% (Bratislava) to 28% (Tenerife). Macrolides prescriptions range from 12.6% (Toulouse) to 24.7% (Smolensk), except in Sofia where they drop to 5.6%. Trimethoprim and its combinations are used in Smolensk (23.3%), Sofia (11.8%) and Bratislava (8.7%). Check-up consultations are not recorded in Smolensk and Bratislava, whereas in Toulouse these visits account for 16.2% of all consultations and in the other locations the percentage varies from 6.1% (Tenerife) to 1.9% (Sofia). Homeopathic treatments are registered only in Toulouse. CONCLUSION: Except in asthma prevalence, there are no great differences in diagnostic maps among locations. Significant variations in the number of drugs prescribed per child and antibiotic therapies are observed. Areas for improvement have been identified.

Pharmacological treatment of acute otitis media in children. A comparison among seven locations: Tenerife, Barcelona and Valencia (Spain), Toulouse (France), Smolensk (Russia), Bratislava (Slovakia) and Sofia (Bulgaria).

OBJECTIVE: To describe patterns observed in the treatment of acute otitis media (AOM) in several locations of five countries. PATIENTS AND METHODS: Cross-sectional, descriptive study. Random sample of 12,264 paediatric outpatients seen by paediatricians or general practitioners (GPs). Data on patient demographics, diagnoses and treatment were collected. Diagnoses were coded by ICD-9 and drugs by ATC classification. Patients diagnosed with AOM (ICD-9 codes: 381 and 382) were selected for analysis. RESULTS: Cases of AOM (873) accounted for 7.1% of the sample. There is a clear variation in the percentage of children diagnosed with AOM and treated with antibiotics in the different locations, antibiotic prescriptions being higher in Barcelona (93% of children), and lowest in Smolensk (56.4 % of children were treated without antibiotics). The antibiotics used varied widely: ampicillin use is almost limited to Smolensk (26.7%) and Bratislava (13.8%), whereas amoxicillin plus clavulanic acid is the choice in Toulouse (33.8%), Valencia (30.2%) and Barcelona (28.9%), and cephalosporins are more frequently prescribed in Tenerife (51.7%). Finally, macrolides are used in Barcelona (18.3%), Valencia (17.5%) and Tenerife (13.6%), but not prescribed in Toulouse or Sofia. Prescriptions of anti-inflammatory drugs were only relevant in Valencia (31.7%), Tenerife (27.2%) and Toulouse (17.4%) and of otological preparations in Sofia, where almost each child received ear drops (91.9%). Nasal preparations are commonly used only in Sofia (41.9%), Bratislava (65.5%) and Smolensk (68.6%). CONCLUSION: Despite the general agreement of most guidelines, wide differences in the treatment of uncomplicated AOM in children are observed. Non-antibiotic therapy for AOM and the use of first-choice antibiotics should be more actively encouraged in the primary care centres. Studies to measure prevailing rates of antibiotic resistance in these populations are needed.

[Influence of patient's sex on the quality of medicine taken]. / Influencia del sexo del paciente en la calidad de los medicamentos consumidos.

OBJECTIVE: To analyse the relationship between patient's sex and quality of medicine taken by monitoring the most pertinent predictive variables. DESIGN: Observational cross-sectional study. SETTING: Thirteen Health Centres in the Community of Valencia. PARTICIPANTS: Adult users, selected by consecutive sampling. MAIN MEASUREMENTS: A semi-structured questionnaire collected the following variables: social and personal details, use of medicines for health problems, frequency of use of services, and place where prescription was issued. The quality of the medication was measured by its intrinsic value (IV). RESULTS: 412 of the 812 patients were women. Men took more medication with a high IV, and women more with an unacceptable IV. Women over 45 took more medication with a not-high IV. Multivariate analysis showed: a) women took one and a half times more medicines with a not-high IV than men, with differences not significant, and b) in the 45-64 age-group, being a woman operated as a modifier of effect, increasing prevalence of consumption of not-high IV to two and a half times more than men. This was adjusted for frequency of attendance, health problems and where the prescription was issued. CONCLUSIONS: The study helped clarify the influence of gender on the quality of medicine, by pointing to the greater likelihood of women between 45 and 64 taking lower-quality medication. In addition, it showed the effect of where the prescription was issued and of health problems on explaining this difference in consumption.

Characteristics of histamine tachyphylaxis in rat uterine smooth muscle.

OBJECTIVE AND DESIGN: To study both the desensitisation induced by short-term exposure to histamine and the mechanism responsible in the isolated rat uterus. MATERIAL: Precontracted isolated uterus (37 mM KCl) from oestrogenised Wistar rats were used. TREATMENT: Repetitive responses to histamine (10(-6), 10(-5), 10(-4), 10(-3) M), dimaprit and clonidine (10(-4) M) were tested at 15, 30, 45 and 105 min., with their modifications by (5 mg/kg, 24 h before sacrifice) reserpine, 10(-7) M propranolol, 10(-8) M atropine, and 10(-6) M indomethacin. Dose-response curves for adrenaline were carried out as standard protocol. METHODS: In vitro techniques (de Jalon's solution, 31 degrees C, carbogen, isotonic registration, resting tension 1 g). Levels of cAMP were studied in response to histamine, adrenaline and isoproterenol by radioassay. RESULTS: Repeated histamine produced a rapid loss of inhibitory uterine response depending on the number of exposures and increase in concentration. The tachyphylaxis phenomenon is not modified by the different pretreatments used. Dimaprit, but not clonidine or adrenaline, produced tachyphylaxis. The second exposition to 10(-3) M histamine produced a 38.8% reduction in cAMP production. CONCLUSION: Histamine appears to induce homologous and probably cAMP-dependent desensitisation of H2-receptors.

[Consumption of medicinal herbs and medicines]. / Consumo de hierbas medicinales y medicamentos.

OBJECTIVE: Given the possibility of adverse side-effects, interactions with medicines and poisoning by contaminants among herbal medicine consumers (HM), we aimed to describe the consumption of HM by health centre users being treated with medicines. DESIGN: Cross-sectional, observational study.Setting. Thirteen health centres in the Community of Valencia. PATIENTS AND OTHER PARTICIPANTS: Users of either sex, over 14, chosen for a study of use of medicines to find differences between the sexes. MEASUREMENTS AND MAIN RESULTS: The study variables, age, gender, education, consumption of medicines and use of HM, were gathered from the clinical records, the long-treatment card and an ad hoc structured survey. 801 out of 812 users took medicines. 159 took HM (19.6%; 95% CI, 16.9-22.3); average age 55.8 (SD, 16.5); women 58.5% (95% CI, 50.8-66.1). They took 226 HM (mean of 1.42; 95% CI, 1.32-1.52). Men consumed more HM (p < 0.05). There were no differences in consumption of HM for age, educational background or number of medicines taken. 42.8% (95% CI, 35.1-50.2) of those who took HM attended for consultation over 10 times in the previous year. 96.9% (95% CI, 93.7-98.4) of HM were taken by self-medication. They were consumed: <> by 36.7% (95% CI, 30.4-43.0); stomach problems, 19.5% (95% CI, 14.3-24.6); nerves/depression, 12.8% (95% CI, 8.5-17.2); intestinal disorders, 10.6% (95% CI, 6.6-14.6); insomnia 5.8% (95% CI, 3.1-9.6). 49.1% (95% CI, 42.6-52.6) were manufactured HM. CONCLUSIONS: One of every five patients being treated with medicines is also taking HM by self-medication. The health authorities and doctors should advise of the risks to health and of the counter-indications of these products.

[Compliance of hormone replacement therapy in menopausal women]. / Cumplimiento del tratamiento hormonal sustitutivo en mujeres menopáusicas.

BACKGROUND: The effectiveness of a given treatment is only achieved with a due compliance. Our objective was to know the compliance degree of hormone replacement therapy (HRT) in menopausal women. METHOD: A descriptive observational study was carried out in three hospitals in the Valencia Community (Spain). We included menopausal patients who were visited in a menopause unit from 1989 to 1999 and who were administered HRT. We analyzed age, age at menopause, type of menopause, age at starting HRT, education level, prescription reason, treatment duration, information level, side effects, and causes leading to withdrawal. RESULTS: The study was performed in 363 women. There were 75% probabilities that women fulfilled the therapy for 5 years. The median of fulfillment was 11 years. Those women who had side effects were more prone to withdraw the treatment. By contrast, women who experienced benefits were less prone to withdraw it. Risk of withdrawal was also lower in cases of postsurgery menopause and in women who were younger than 55 years when they started HRT. CONCLUSIONS: In our study, the compliance level was high and it was determined either by treatment benefits or side effects, type of menopause and age at starting HRT.

Adverse drug reactions in children reported by means of the yellow card in Spain.

OBJECTIVE: To analyze the case reports concerning children (14 years or younger) in the Spanish Pharmacovigilance System over a 10-year period (1982-1991). FINDINGS: The study of 1419 reports of adverse drug reaction (9.8% of all those received) showed the most commonly involved organs and systems to be the skin, digestive tract, and nervous system (62.8%). The most commonly involved pharmacological groups were antibiotics, respiratory medications, and vaccines (69%). The absolute number of reports is higher in children between 1 and 4 years of age (37.9%). There were more reports among males than in females. Less than 5% of the reports notified directly life-threatening or fatal reactions. CONCLUSIONS: Adverse drug reaction are not common in pediatric patients, and most are mild. However, due to limitations of clinical trials in children, pharmacoepidemiological studies may be the only source of information on the benefit-risk profile of drugs received by these patients, and as such require special attention.