Scielo RSS <![CDATA[Revista médica de Chile]]> http://www.scielo.cl/rss.php?pid=0034-988720060007&lang=es vol. 134 num. 7 lang. es <![CDATA[SciELO Logo]]> http://www.scielo.cl/img/en/fbpelogp.gif http://www.scielo.cl <![CDATA[<strong>¿Por qué demoran en publicarse los manuscritos en la <i>Revista Médica de Chile</i>?</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700001&lng=es&nrm=iso&tlng=es <![CDATA[<strong>Autoevaluación de fortalezas, debilidades y confianza de los médicos de atención primaria en el abordaje de enfermedades reumatológicas</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700002&lng=es&nrm=iso&tlng=es Background: Rheumatologic diseases are common and frequently managed by primary care physicians. Aim: To assess strengths, weaknesses and self confidence of primary care physicians in the management of rheumatic diseases. Material and methods: A self assessment and anonymous questionnaire was mailed to primary care physicians of two Chilean regions. Using a 10 points Likert scale, they were asked about personal interest, undergraduate training, continuous medical education, availability of medical literature, complementary laboratory tests and consultation with a rheumatologist. Medical skills, knowledge, therapeutic approach and performance of rheumatologic procedures were evaluated under the item confidence. Results: Three hundred forty seven out of 763 physicians (45%) answered the questionnaire. Their age range extended from 25 to 75 years, 59% were male, 58% were Chilean and 74% worked in the Metropolitan region. The worst evaluated parameters were availability of literature with a score of 2.2±2, access to consultation with a rheumatologist (3.8±2.2) and to continuous medical education (4.3±2.7). Physicians had a better confidence in their knowledge (6.7±1.5) and in their therapeutic approach (6.1±1.5). The worst confidence score was for shoulder injection therapy (3.4±2.6). Continuous medical education correlated with knowledge but not with clinical skills. Conclusions: Primary care physicians perform a bad assessment of their skills in rheumatology. They have a low level of confidence in their clinical skills to perform rheumatologic procedures. Continuous medical education improves confidence in knowledge but not in skills <![CDATA[<strong>Efectividad de la terapia con leuprolide acetato de depósito cada tres meses en pubertad precoz central</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700003&lng=es&nrm=iso&tlng=es Background: Precocious puberty may reduce final adult height, and affected children may suffer social and emotional problems. The efficacy of treatment with a long acting agonist analogue of the gonadotropin releasing hormone (aLHRH) has been well demonstrated. Aim: To evaluated the efficacy of a new formulation of aLHRH (leuprolide, Lupron®) for the suppression of gonadotropin activation and clinical signs of puberty. Material and methods: Eleven children (ten females) with idiopathic central precocious puberty, with a mean chronological age of 7.5±1.8 years and a bone age of 9.7±1.8 years were recruited. Testicular volume in the male was 15 ml. In females, Tanner stage for breast development was between 2-4 and mean ovarian volume was 2.3±0.8 ml. They were treated during 18 months with aLHRH, 11.25 mg administered intramuscularly every three months. Results: Clinical, hormonal and ultrasonographic signs of puberty regressed in all patients. The degree of suppression of LH was 87.7±5.1% at the end of the 18 months. No significant changes in bone mineral content were observed during the treatment period. Conclusions: Leuprolide (aLHRH) 11.25 mg, injected every three months, is effective for the control of central precocious puberty and allows to reduce the number of yearly injections from 12 to 4 <![CDATA[<strong>Tratamiento endovascular del síndrome de vena cava superior</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700004&lng=es&nrm=iso&tlng=es Background: Superior vena cava syndrome (SVCS) is caused by the obstruction of venous drainage from the upper portion of the body. Common clinical findings are headache and cervical, facial and upper limb edema. Occasionally, clouding of consciousness appears. Aim: to report our experience with endovascular treatment of SVCS. Material and methods: Retrospective review of all patients with SVCS subjected to endovascular treatment between 1999 and 2005. Results: Eight patients were treated, all of them with malignancies. Six had a benign obstruction due to the presence of a chemotherapy catheter located in the superior vena cava, one had obstruction secondary to radiation therapy and one a tumor compression of the superior vena cava. Two patients underwent thrombolytic therapy. Angioplasty and stenting was performed in all patients. The chemotherapy catheter was removed to all patients and installed again in one. One patient had a hemothorax secondary to a simultaneous needle lung biopsy under video thoracoscopy. No patient died in relation to the procedure. Congestive signs and symptoms subsided in all patients within 24 hours after the procedure. During follow up, only one patient had symptoms related to vena cava obstruction and three died due to their malignant tumor. Conclusions: Endovascular treatment of SVCS has a low rate of complications and provides immediate and mid-term symptom relief <![CDATA[<strong>Caracterización molecular de alelos ABO*O del locus de grupo sanguíneo ABO en tres poblaciones chilenas</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700005&lng=es&nrm=iso&tlng=es Background: Among the allelic variants of blood groups, the molecular characterization of ABO blood group has clinical and anthropological importance. Aim: To perform a characterization of the molecular variants of the allele ABO*O of the ABO blood group. Material and methods: Eighty four subjects of Aymara origin, living in Northern Chile, 75 individuals of Huilliche origin, living in Southern Chile and 82 subjects living in Santiago (Central Chile), were studied. All individuals were of group O, homozygotes for G261- deletion, that defines O¹ alleles. Mutations G188A, G261-, G542A, T646A and C771T, described for alleles O¹, O1variant and G542A were determined by PCR-RFLP (polymerase chain reaction-restriction fragment lenght polymorphism). Results: Allele O1variant has frequencies of 0.65, 0.81 and 0.6 in Aymara, Huilliche and Santiago subjects, respectively. The figures for allele O¹ are 0.35, 0.19 and 0.4, respectively and those for the allele with G542A mutation are 0.119, 0.113 and 0.079, respectively. Conclusions: These results are concordant with the reported higher frequency of allele O1variant in South American aboriginal populations. The frequencies of G542A allele in these Chilean individuals are lower than those described for Amazon aborigines <![CDATA[<strong>Cáncer colorrectal hereditario</strong>: <strong>análisis molecular de los genes APC y MLH1</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700006&lng=es&nrm=iso&tlng=es Background: Among colorectal cancer hereditary variants, two syndromes show a predisposition to the disease based on germline mutations: Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC). Aim: To screen mutations in FAP and HNPCC families in Chile. Materials and Methods: Two FAP and one HNPCC families were studied. The APC gene (for FAP patients) and the MLH1 gene (for HNPCC patients), were screened for mutations on genomic DNA. The molecular analysis was performed through polymerase chain reaction, Single Strand Conformer Polymorphism (SSCP) and DNA sequencing. Mutations were defined as changes in the DNA sequence leading into a stop codon and a truncated protein. Results: In the two FAP families the analysis revealed a mutation consisting in the deletion of five nucleotides named c.3927_3931delAAAGA. The genetic study of the HNPCC family demonstrated the insertion of one adenine in codon 168 of exon 6, named c.504insA. Discussion: Germ-line mutations were identified in the three families. The relevance of these studies in a better knowledge of cancer susceptibility, and the possibility of identifying in relatives in risk by molecular diagnosis <![CDATA[<strong>Riesgo perioperatorio del <i>bypass</i> gástrico reseccional en pacientes con obesidad mórbida</strong>: <strong>Estudio prospectivo de 684 pacientes</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700007&lng=es&nrm=iso&tlng=es Background: Bariatric surgery is a complex procedure not exempt of complications. Aim: To assess mortality and complications of excisional gastric bypass among morbidly obese subjects. Material and methods: Prospective analysis of 684 morbid obese patients (age range 14-70 years, 525 females) subjected to an excisional gastric bypass. Major postoperative complications and mortality were registered. Results: Mean body mass index (BMI) of the subjects was 43.7 kg/m². One hundred sixty two patients had a BMI between 35 and 39.9 kg/m², 419 had a BMI between 40 and 49.9 kg/m² and 103 had a BMI over 50 kg/m². Two patients with a BMI of 52 and 56 kg/m² respectively, died in the postoperative period (0.3%). Thirty six patients had major complications. Anastomotic fistula was the most common complication in 12 patients (1.7%). Fourteen patients required a new operation due to complications. None of these died. The mean operative volume of the surgical team was 124 patients per year. Conclusions: Excisional gastric bypass has a low rate of mortality and complications, if the surgical team operates a large volume of patients <![CDATA[<strong>El consumo de <i>Lycopersicum esculentum </i>podría aumentar lipoproteínas de alta densidad (HDL) y disminuir el estrés oxidativo a corto plazo</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700008&lng=es&nrm=iso&tlng=es Background: Tomato has a high antioxidant capacity due to its high content of vitamin C, vitamin E and lycopene that is a powerful free radical scavenger. However, the effects of tomato on plasma lipoproteins is not well known, and there is little evidence about the relationship between tomato consumption and oxidative state changes in humans. Aim: To assess in vivo the effects of dietary supplementation with pure concentrated tomato juice on short term changes in oxidative state and plasma lipoproteins in healthy volunteers. Subjects and methods: Seventeen healthy volunteers were studied. They received a supplement of pure tomato juice during 7 days. At baseline, at the end of the supplementarion period and eight days after the end of the supplementation, a blood sample was drawn to measure total antioxidant capacity (TRAP), enzymatic antioxidants (catalase and superoxide dismutase), non-enzimatic antioxidants (lycopene and a-tocopherol) and plasma lipoproteins. Results: Lycopene level increased early and significantly in comparison with basal levels (48%; p <0.05). TRAP, catalase and superoxide dismutase did not change significantly. HDL cholesterol increased significantly in 5.6±4.3 mg/dL (p <0.002) on the second sampling period, improving the ratio cholesterol/HDL. It returned to baseline in the third period. Conclusions: Dietary supplementation of concentrated tomato juice significantly increases lycopene levels and HDL cholesterol. Non significant changes observed in TRAP, catalase and superoxide dismutase were observed during the supplementation period <![CDATA[<strong>Prevalencia de anticuerpos contra <i>Bartonella henselae</i> en niños, en adolescentes y en una población de riesgo ocupacional en Chile</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700009&lng=es&nrm=iso&tlng=es Background: Bartonella henselae is the causative agent of cat-scratch disease. Aim: To study the seroepidemiology of Bartonella henselae in healthy Chilean children and in a population with occupational risk. Material and methods: Serum IgG antibodies were determined by indirect fluorescence technique in 181 children and adolescents and in 107 technical and professional workers involved in the care of cats. Samples with titers equal to or greater than 64 were considered positive. Results: Twenty four (13.3%) children and 11 (10.3%) occupational risk subjects were seropositive. No significant differences by age and gender were observed. Conclusions: Assuming that seroprevalence indicates level of exposure to Bartonella henselae, these results suggest that this infection is endemic in Chile and, for this reason, the best antibody titer to diagnose acute cat-scratch disease should be higher than the figure recommended by the Centers for Disease Control in the in United States <![CDATA[<strong>Identificación rápida de micobacterias no tuberculosas mediante análisis de patrones de restricción</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700010&lng=es&nrm=iso&tlng=es Background: The frequency of diseases caused by non tuberculous mycobacteria has increased in the last years. Their clinical diagnosis is difficult, mainly in immunocompromised patients. The identification of these mycobacteria by traditional methods is based on phenotypic characteristics and the results are obtained two to four weeks after their isolation in primary cultures. Aim: To report a new identification method for non tuberculous mycobacteria. Material and methods: The restriction pattern analysis method was implemented. It is based on the amplification, using polymerase chain reaction (PCR), of a polymorphic region of 440 base pairs that codifies Hsp65 protein, followed by a digestion with BstE II and Hae III restriction enzymes. The results were compared with patterns established for each strain. Results: Sixty four strains of mycobacteria obtained from clinical samples and seven reference mycobacteria, were identified using the traditional methods and restriction pattern analysis. The latter method identified the same strain as the former in 87.5% of cases. In the remainder 12.5% of cases there was no agreement between both methods. In these, the sequencing of a fragment of a gene that codifies 16S ribosomal RNA, confirmed the correct identification by restriction patterns. Conclusions: Restriction pattern analysis is a rapid identification method for non tuberculous mycobaterial strains <![CDATA[<strong>Eficacia del infliximab en pacientes con síndrome de Behçet portadores de úveo-retinitis grave</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700011&lng=es&nrm=iso&tlng=es The efficacy and safety of repeated administration of infliximab was evaluated in five patients (two men, three women) with Behçet syndrome accompanied by severe uveoretinitis. Ocular and extra ocular inflammation was suppressed in all patients during the observation period without any serious adverse reactions. The results in these patients suggests that TNF-á blockade is effective in patients with severe ocular Behçet syndrome <![CDATA[<strong>Encefalomielitis aguda diseminada de presentación atípica</strong>: <strong>utilidad de la biopsia estereotáctica para su diagnóstico. Caso clínico</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700012&lng=es&nrm=iso&tlng=es We report a 15 year-old female presenting with behavioral disturbances, headache, left hemiparesis and paresis of the vertical gaze. CAT scan and magnetic resonance showed an involvement of right thalamus, third ventricle and medial temporal lobe suggesting an encephalitis or lymphoma. 201Thalium SPECT suggested a lymphoma. A stereotaxic biopsy showed a subacute demyelinizing lesion, compatible with an acute disseminated encephalomyelitis. The patient was treated with Methylprednisolone with resolution of symptoms. She remains in good condition after one year of follow-up <![CDATA[<strong>Pérdida de resincronización biventricular</strong>: <strong>Causa inhabitual. Caso clínico </strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700013&lng=es&nrm=iso&tlng=es Cardiac resynchronization therapy is a non-pharmacological treatment for patients with dilated cardiomyophaty and congestive heart failure. The success of this therapy depends of permanent biventricular stimulation. We report an 84 year-old man, with intermittent loss of biventricular pacemaker stimulation despite having adequate sensing and stimulation thresholds in the right atrium and both ventricles. The problem was solved after correcting some programming parameters <![CDATA[<strong>Levodopa en la enfermedad de Parkinson</strong>: <strong>¿Qué hemos aprendido?</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700014&lng=es&nrm=iso&tlng=es Parkinson's disease (PD) is the second most common neurodegenerative disease in the world. Dopamine deficit is the cornerstone of its clinical manifestations. Levodopa, the main treatment for this condition, was first used for PD more than 40 years ago and today it still is the most powerful treatment for this disease. In recent years many advances have been made for understanding of the neurochemical mechanisms of this drug. Furthermore, new insights about the genesis of motor complications secondary to its use are known, specially related with the mode of its administration. This article updates the pharmacology of levodopa and its implications for the pathophysiology and treatment of PD. The new available presentations of levodopa are also reviewed. The implications of these advances for the treatment of this disease are commented <![CDATA[<strong>Actualización en el diagnóstico y terapéutica en hipertensión pulmonar arterial</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700015&lng=es&nrm=iso&tlng=es Pulmonary Arterial Hypertension includes a heterogeneous group of disorders with a common genetic, pathological and hemodinamyc origin. It is characterized by a high pulmonary artery pressure due to a primary vascular disease, as a consequence of genetic and environmental factors. The common pathway is a vascular imbalance towards vasoconstriction and proliferation inside the small vessels. According to the World Health Organization, 2003, Pulmonary Arterial Hypertension is classified as idiopathic, familiar or associated to connective tissue diseases, HIV, drugs, porto-pulmonary hypertension, congenital intracardiac shunts and others. The diagnosis is based in hemodynamics. Echocardiogram is a non invasive and right ventricular catheterization is an invasive diagnostic tool. Follow up is based on a clinical and functional assessment through functional class classification, dyspnea scores and 6-minute walking test. The prognosis is historically devastating but new therapies are changing the natural history of the disease. New treatments have demonstrated improvement in symptoms, hemodynamic profiles and survival. Intravenous, subcutaneous or inhaled prostanoids such as Epoprostenol, Treprostinil or Iloprost respectively have been approved for Pulmonary Arterial Hypertension treatment as well as oral endothelial receptor blockers. They are all considered first line treatments for arterial pulmonary hypertensive patients with even better benefits than lung transplantation. Phosphodiesterase inhibitors (Sildenafil), have been recently approved for the treatment of pulmonary arterial hypertension <![CDATA[<strong>Utilidad de la deoxiglucosa marcada con flúor-18 (FDG) en el manejo de los linfomas</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700016&lng=es&nrm=iso&tlng=es Positron emission tomography (PET) with fluorine-18 labeled deoxyglucose (FDG) is useful in the management of lymphomas. In this review, some general concepts of this metabolic test are defined. It has an excellent diagnostic yield in Hodgkin disease as well as in most non Hodgkin lymphomas. Staging, restaging residual mass evaluation and the control of therapy are the main indications for FDG-PET. Images with FDG have a high diagnostic and prognostic value, that is superior to anatomical images and conventional staging techniques. They are also helpful for the assessment of tumor activity in abnormal lymph nodes or large masses that have been treated and reduce their size slowly or show an incomplete resolution. Currently, the resolution of dedicated PET equipments is 6 mm and bigger lesions can easily be detected. The main differences and advantages of FDG versus gallium-67 in lymphoma are also discussed, as well as the initial local experience with the technique in lymphoma patients <![CDATA[<strong>Calidad metodológica de un artículo de tratamiento de cáncer gástrico adoptado como protocolo por algunos hospitales chilenos</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700017&lng=es&nrm=iso&tlng=es Background: Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC. Aim: To determine methodological quality and internal and external validity of the Macdonald study. Material and method: Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales: MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology. Results: The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis. Conclusion: The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the <![CDATA[<strong>Controversia en la revisión editorial y en las publicaciones científicas</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700018&lng=es&nrm=iso&tlng=es Background: Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC. Aim: To determine methodological quality and internal and external validity of the Macdonald study. Material and method: Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales: MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology. Results: The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis. Conclusion: The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the <![CDATA[<strong>FE DE ERRATUM</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700019&lng=es&nrm=iso&tlng=es Background: Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC. Aim: To determine methodological quality and internal and external validity of the Macdonald study. Material and method: Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales: MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology. Results: The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis. Conclusion: The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the <![CDATA[<strong>Revisión por pares en la <i>Revista Médica de Chile</i>, año 2005</strong>]]> http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872006000700020&lng=es&nrm=iso&tlng=es Background: Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC. Aim: To determine methodological quality and internal and external validity of the Macdonald study. Material and method: Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales: MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology. Results: The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis. Conclusion: The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the