Indomethacin for preventing post-endoscopic retrograd cholangiopancreatography pancreatitis by rectal administration: a Meta-analysis of randomized controlled trial / 中国基层医药

Objective@#To assess the effectiveness and safety of indomethacin in preventing post-endoscopic retrograd cholangiopancreatography pancreatitis(PEP) by rectal administration.@*Methods@#Retrieved from PubMed, Cochrane Library, CNKI, VIP, CBM and Wanfang database, randomized blinding placebo-controlled trails about indomethacin for preventing PEP by rectal administration were included from establishment to December 2017 and comprehensively evaluated.Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, assessed the risk bias of included studies, and then Meta-analysis was performed using the RevMan 5.3 software.@*Results@#A total of 8 RCTs involving 3240 patients were included.The results of Meta-analysis showed that indomethacin could reduce the incidence of PEP(OR=0.57, 95% CI: 0.45-0.73, P<0.00 001) and moderate or severe PEP(OR=0.51, 95% CI: 0.30-0.85, P=0.010). The adverse reactions of indomethacin was gastrointestinal bleeding, and there was no statistically significant difference between indomethacin and placebo(OR=0.63, 95% CI: 0.25-1.52, P=0.300).@*Conclusion@#Indomethacin is safe and effective in reducing the incidence of PEP by rectal administration.

Indomethacin for preventing post-endoscopic retrograd cholangiopancreatography pancreatitis by rectal administration: a Meta-analysis of randomized controlled trial / 中国基层医药

Objective To assess the effectiveness and safety of indomethacin in preventing post-endoscopic retrograd cholangiopancreatography pancreatitis (PEP) by rectal administration.Methods Retrieved from PubMed,Cochrane Library,CNKI,VIP,CBM and Wanfang database,randomized blinding placebo-controlled trails about indomethacin for preventing PEP by rectal administration were included from establishment to December 2017 and comprehensively evaluated.Two reviewers independently screened literature according to the inclusion and exclusion criteria,extracted data,assessed the risk bias of included studies,and then Meta-analysis was performed using the RevMan 5.3 software.Results A total of 8 RCTs involving 3240 patients were included.The results of Meta-analysis showed that indomethacin could reduce the incidence of PEP(OR =0.57,95％ CI:0.45-0.73,P ＜ 0.00 001) and moderate or severe PEP(OR =0.51,95 ％ CI:0.30-0.85,P =0.010).The adverse reactions of i ndomethacin was gastrointestinal bleeding,and there was no statistically significant difference between indomethacin and placebo(OR =0.63,95％ CI:0.25-1.52,P =0.300).Conclusion Indomethacin is safe and effective in reducing the incidence of PEP by rectal administration.

A Randomized Double-blind Placebo-controlled Trial on the Effect of Magnesium Oxide in Patients With Chronic Constipation

BACKGROUND/AIMS: Magnesium oxide (MgO) has been frequently used as a treatment for chronic constipation (CC) since the 1980s in Japan. The aim of this study is to evaluate its therapeutic effects of MgO in Japanese CC patients. METHODS: We conducted a randomized, double-blind placebo-controlled study. Thirty-four female patients with mild to moderate constipation were randomly assigned to either placebo (n = 17) or MgO group (n = 17) 0.5 g × 3/day for 28 days. Primary endpoint was overall improvement over the 4-week study period. Secondary endpoints were changes from baseline in spontaneous bowel movement (SBM), response rates of complete spontaneous bowel movement (CSBM), stool form, colonic transit time (CTT), abdominal symptom, and quality of life. RESULTS: One patient failed to complete the medication regimen and was omitted from analysis: data from 16 placebo and 17 MgO patients were analyzed. The primary endpoint was met by 25.0% of placebo vs 70.6% of MgO group (P = 0.015). MgO significantly improved SBM changes compared to placebo (P = 0.002). However, MgO did not significantly improved response rates of CSBM compared to placebo (P = 0.76). In addition, MgO significantly improved Bristol stool form scale changes (P < 0.001) and significantly improved CTT compared to the placebo group (P < 0.001). MgO significantly improved the Japanese version of the patient assessment of constipation quality of life (P = 0.003). CONCLUSION: Our placebo-controlled study demonstrated that MgO was effective treatment for improving defecation status and shortened CTT in Japanese CC patients with mild to moderate symptoms.

Low-dose intravenous ketamine versus intravenous ketorolac in pain control in patients with acute renal colic in an emergency setting: a double-blind randomized clinical trial / 대한통증학회지

BACKGROUND: This study was conducted to compare the effectiveness of low-dose ketamine versus ketorolac in pain control in patients with acute renal colic presenting to the emergency department (ED). METHODS: This is a double-blind randomized clinical trial. The initial pain severity was assessed using the numerical rating scale (NRS). Then, ketamine or ketorolac was administered intravenously at a dose of 0.6 mg/kg and 30 mg respectively. The pain severity and adverse drug reactions were recorded 5, 15, 30, 60, and 120 min thereafter. RESULTS: The data of 62 subjects in the ketamine group and 64 patients in the ketorolac group were analyzed. The mean age of the patients was 34.2 ± 9.9 and 37.9 ± 10.6 years in the ketamine and ketorolac group, respectively. There was no significant difference in the mean NRS scores at each time point, except for the 5 min, between the two groups. Despite a marked decrease in pain severity in the ketamine group from drug administration at the 5 min, a slight increase in pain was observed from the 5 min to the 15 min. The rate of adverse drug reactions, including dizziness (P = 0.001), agitation (P = 0.002), increased systolic blood pressure (> 140 mmHg), and diastolic blood pressure (> 90 mmHg) was higher in the ketamine group. CONCLUSIONS: Low dose ketamine is as effective as ketorolac in pain management in patients with renal colic presenting to the ED. However, it is associated with a higher rate of adverse drug reactions.

Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: a double-blind placebo-controlled randomized clinical trial / 中西医结合学报

<p><b>BACKGROUND</b>Lipid-lowering effect of Rhus coriaria L. (Rhus) has been investigated in multiple animal studies with promising results. Nonetheless, its clinical efficacy has not been adequately examined.</p><p><b>OBJECTIVE</b>The aim of this study was to evaluate the lipid-lowering effects of Rhus among patients with hyperlipidemia.</p><p><b>DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS</b>The study was designed as a two-arm, double-blind placebo-controlled randomized clinical trial, using a parallel design. Eighty patients with primary hyperlipidemia were randomly assigned to receive Rhus capsules or placebo for 6 weeks.</p><p><b>MAIN OUTCOME MEASURES</b>The serum lipid levels, apolipoprotein-A1 (Apo-A1) and apolipoprotein-B (Apo-B) were measured.</p><p><b>RESULTS</b>Mean serum high-density lipoprotein cholesterol (HDL-C) and Apo-A1 levels were significantly increased in the Rhus group, compared with the placebo group, after 6 weeks of intervention (P = 0.001). The analysis of covariance test including age, gender, body mass index (BMI), and smoking as co-variables revealed that the increase in HDL-C and Apo-A1 levels remained significant, and increases in HDL-C were dependent on the increase in Apo-A1 levels. No significant difference was observed between Rhus and placebo groups in terms of mean reductions in total cholesterol, low-density lipoprotein cholesterol and triglyceride levels; however, more significant improvement was observed among obese patients (BMI ≥ 30 kg/m).</p><p><b>CONCLUSION</b>The study showed significant increases in HDL-C and Apo-A1 levels in response to Rhus supplementation in patients with hyperlipidemia.</p><p><b>TRIAL REGISTRATION</b>ClinicalTrials.gov ID: NCT02295293.</p>

Patient blinding with blunt tip placebo acupuncture needles: comparison between 1 mm and 2 mm skin press / 中西医结合学报

<p><b>OBJECTIVE</b>To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter.</p><p><b>METHODS</b>Forty healthy volunteers were enrolled as subjects for patient blinding. Four acupuncturists applied the following needles randomly at three points in each forearm: 0.18 mm and 0.25 mm diameter penetrating needles inserted to a depth of 5 mm, and 0.18 mm and 0.25 mm diameter skin-touch needles depressing the skin at the acupoint to a depth of 1 mm and 2 mm from the skin surface. The subjects reported their guesses at the nature of needles they received, and rated needle pain and de qi. A blinding index was calculated to define the success of blinding for subjects.</p><p><b>RESULTS</b>The blinding status of subjects for 1 mm press needles of 0.18 mm diameter was "random guess", but "unblinded" for 1 mm press needles of 0.25 mm diameter. For 2 mm press needles of both diameters, the blinding status was "opposite guess" and the blinding status for penetrating needles of both diameters was "unblinded." The percentages of "felt pain" with 2 mm press needles of both diameters were similar to that with penetrating needles, but those were not similar for 1 mm press needles. The frequency of de qi occurrence with 2 mm press needles of 0.18 mm diameter was similar to that of penetrating needles of both diameters.</p><p><b>CONCLUSION</b>Placebo needles of 2 mm press made more subjects guess that the needles penetrated the skin than 1 mm press needles. The use of small diameter needles increased patient blinding.</p>

Effect of continuous femoral nerve block combined with periarticular local infiltration analgesia on early operative functional recovery after total knee arthroplasty: a randomized double-blind controlled study / 北京大学学报(医学版)

Objective:To investigate the effects of early rehabilitation training after total knee arthroplasty surgery by continuous femoral nerve block (CFNB) with or without periarticular local infiltration analgesia (PLIA).Methods:In this randomized,double-blind,controlled study,100 patients undergoing primary unilateral total knee arthroplasty in patients with knee osteoarthritis were enrolled.All the patients received CFNB for postoperative analgesia before combined spinal epidural anesthesia.They were randomly divided into 2 groups (n =50 each):CFNB group,CFNB combined with PLIA group (PLIA group).Group PLIA received periarticular local infiltration analgesia with 20 mL ropivacaine (5 g/L),while the equal volume of normal saline was used instead of ropivacaine in group CFNB.Postoperative pain during rest and passive exercises including front and rear portions of knees,the time of ability to perform an active straight leg raise,the time of ability to reach 90° knee flexion,and preoperative and postoperative hospital for special surgery knee score (HSS) were evaluated.Results:Compared with group CFNB,the visual analogue scores (VAS) of front of knees at rest time in group PLIA had no significant difference (P ＞ 0.05);there were significant differences at 4,8,12,24 h postoperation in portions of knees at rest time (P ＜ 0.05);the VAS had significant differences at 24 h in passive exercises of knees (P ＜ 0.05);the VAS had significant differences at 12,24 h in portions of knees at passive exercises of the knees (P ＜ 0.05);the time of ability to perform an active straight leg raise had significant differences in the two groups (P ＜ 0.05).Conclusion:Compared with CFNB postoperative analgesia alone,CFNB with PLIA could relieve rest pain and pain during passive movement after total knee arthroplasty.CFNB with PLIA could shorten the time to perform an active straight leg raise and the time of ability to reach 90° knee flexion.And so some patients could improve postoperative rehabilitation training.

Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren's Syndrome: a Double-Blind Randomized Control Study

The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028).

Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study

BACKGROUND/AIMS: The therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC). METHODS: In a multicenter, double-blind, randomized study, 110 patients with moderately active UC were assigned to two groups after treatment with a constant dose of mesalamine. Fifty-five patients were treated with a pH-dependent release formulation of 3.6 or 4.8 g/day for 8 weeks. The primary endpoint was a decrease in the UC disease activity index (UCDAI) adjusted by covariates. RESULTS: In the full analysis set (n=110), the mean decrease in UCDAI was 3.1 in the 3.6 g/day group and 3.4 in the 4.8 g/day group (P>0.05). In a subgroup analysis, the effectiveness of the 4.8 g/day dose was greater in particular populations, such as those who had been previously treated with a lower dose of mesalamine and those with more severe disease. The safety was comparable between the two groups. CONCLUSIONS: The results suggest that treatment with pH-dependent release mesalamine at either 3.6 or 4.8 g/day was effective and safe for the induction of remission in patients with moderately active UC. However, the patients receiving mesalamine at 2.4 g/day but in whom the therapeutic effect is not sufficient and having more severe symptoms (UCDAI 9-10), benefit from higher doses of mesalamine compared to others.

Clinical Trials on Zhenjujiangya Tablets Combined with Long-acting Antihypertensive Drugs in the Treat-ment of Hypertension / 中国药师

To determine the efficacy and safety of Zhenjujiangya tablets combined with long-acting antihypertensive drugs in the patients with hypertension. Methods:A controlled study was carried out among 220 patients meeting the inclusion / ex-clusion criteria. All the patients were randomly divided into the experimental group and the control group. Both groups were treated with long-acting antihypertensive drugs as usual. The 110 patients in the experimental group were orally treated with Zhenjujiangya tab-lets ( bid) , while the other 110 patients in the control group were orally treated with Zhenjujiangya simulated tablets ( bid) , and the treatment course was 4 weeks. The efficacy was assessed using the reduction range of blood pressure, the clinical symptom score of hy-pertension and the indicators of ambulatory blood pressure monitoring as the indices, and the safety was assessed by the symptoms, signs and laboratory tests. Results:After the four-week treatment, the systolic blood pressure, diastolic blood pressure and hyperten-sion clinical symptom score were significantly decreased in the two groups, and the changes in the experimental group were more signifi-cant than those in the control group (P0. 05). After the treatment, the changes in average systolic blood pres-sure in 24h and daytime in the experimental group showed statistically significant difference (P0. 05), and the number of abnormal blood pressure in 24h and daytime in the experimental group exhibited reduction trend. There were no significant difference in the incidence of adverse events between the two groups (P>0. 05). Conclusion:Long-acting antihypertensive drugs combined with Zhenjujiangya tablets can further improve the antihypertensive efficacy without significant adverse reactions, which is suitable for clinical application.

Efeito do ácido graxo ômega 3 no tratamento da esteatohepatite não alcoólica (EHNA): estudo randomizado placebo controlado / Effects of omega-3 fatty acids (PUFA) on treatment nonalcoholic steatohepatitis (NASH)

Introdução: Existem poucas estratégias de intervenção medicamentosa que se mostraram eficazes na doença hepática gordurosa não alcoólica (DHGNA). Os ácidos graxos poliinsaturados (AGPI) Ômega-3 parecem ser eficazes no tratamento da esteatose hepática de modelos experimentais, mas poucos estudos randomizados em humanos foram realizados. O objetivo deste estudo foi avaliar prospectivamente a eficácia de AGPI Ômega-3 provenientes do óleo de linhaça e peixe na esteatohepatite não alcoólica (pacientes com EHNA). Métodos: Sessenta pacientes com biópsia confirmando EHNA foram incluídos no estudo duplo cego, randomizado, placebo controlado. Os pacientes foram randomizados em dois grupos. Grupo Ômega-3 (n = 32) recebeu três cápsulas contendo no total 945 mg de AGPI Ômega-3 (63% ácido alfa linolênico (ALA), 21% ácido eicosapentaenóico (EPA) e 16% do ácido docosahexaenóico (DHA)) e Grupo Placebo (n = 28) recebeu três cápsulas contendo óleo mineral. A intervenção foi realizada por seis meses, quando os pacientes foram novamente submetidos à biópsia hepática. O desfecho primário foi a mudança histológica hepática de acordo com o escore de atividade EHNA (NAS) no início (pré intervenção) e seis meses (após intervenção). Desfecho secundário compreendeu análise das aminotransferases séricas, perfil lipídico e glicemia em jejum, parâmetros antropométricos e nível sérico de IL6 em 0, 3 e 6 meses e dosagem de Ômega-3 plasmático, como prova de tratamento, em 0 e 6 meses. Resultados: Dos 60 pacientes avaliados, 10 não terminaram o estudo (5 no grupo Ômega-3, e 5 no grupo placebo). Analisando os resultados primários, a atividade NAS melhorou ou se manteve estável em 78,26% dos pacientes do grupo placebo e em 55,56% do grupo Ômega-3, sem diferença significativa entre os grupos (p = 0,978), a inflamação lobular reduziu ou se manteve estável em 91,3% no grupo de placebo e em 66,67% no grupo Ômega-3, também sem diferença entre os grupos (p = 0,994). Ômega-3 não...

Introduction: There is a limited number of effective drug treatments available for the treatment of nonalcoholic steatohepatitis (NASH). Polyunsaturaturated fatty acid (PUFAs) Omega 3 seems to be effective in treating hepatic steatosis in experimental animal models, however there is a limited number of humans randomized studies available in the literature. The purpose of the present study is to prospectively evaluate the treatment efficacy of the PUFAs Omega 3 from flaxseed and fish in patients with NASH disease. Methods: A total of sixty biopsy confirmed NASH patients were included in a double blind, randomized, placebo controlled study. They were randomized into two groups: Omega 3 group (n = 32) where patients received a total of 945mg of PUFAs Omega 3 and Placebo group (n = 28) where patients received only mineral oil. After a 6 month treatment all patients underwent a new liver biopsy. Primary goal was to evaluate and compare liver histologic changes, according to Nonalcoholic fatty liver disease (NAFLD) activity score (NAS), between pre and post treatment biopsies. Secondary goal was to evaluate serum transaminases, lipid profile and serum non fasting glucose, anthropometric parameters and serum IL6 at 0, 3 and 6 month treatment. A serum Omega 3 dosage was performed at 0 and 6 month as treatment proof. Results: A total of 50 patients finished the study, 25 from each original group. NAS score improved or was unaltered in 78.26% of the placebo group and in 55.56% of the Omega 3 group (p = 0,978). Lobular liver inflammation was reduced or unaltered in 91.3% and in 66.67% respectively of the placebo and Omega 3 groups (p = 0,994). Omega 3 alone was not able to reduce liver steatosis, hepatocelular balonization or fibrosis. Biochemical analysis revealed reduction on serum triglycerides after 3 month treatment for the Omega 3 group patients, when compared to placebo (p=0,011). Serum transaminases, total cholesterol and fractions, non fasting...

Avaliação e tratamento de pacientes com dor facial atípica através da estimulação magnética transcraniana repetitiva / Assessment and treatment of patients with atypical facial pain patients that underwent repetitive transcranial magnetic stimulation

Dor facial atípica (DFA) é uma condição álgica crônica destacada pela etiopatogenia ainda desconhecida e pela característica rebelde aos tratamentos vigentes. O objetivo deste estudo é avaliar o limiar e padrões de excitabilidade cortical de doentes com DFA através de Estimulação Magnética Transcraniana (EMT) e compará-los a controles saudáveis, além de avaliar a eficácia terapêutica da EMT repetitiva (EMTr) ativa em doentes com DFA comparados à EMTr placebo. Durante o período de março de 2010 a dezembro de 2013 foram avaliados 29 doentes com DFA - os quais preencheram os critérios segundo a classificação proposta pela Associação Internacional de Cefaleia (2004) - e 28 controles saudáveis. A avaliação foi iniciada com a investigação da excitabilidade cortical bilateral. Em seguida, os doentes foram aleatorizados em dois grupos (ativo e placebo) para o tratamento com EMTr sobre o córtex motor primário na área de representação da face, esquematizado da seguinte forma: cinco sessões consecutivas para a fase de indução, e uma sessão semanal (pelo período de oito semanas) para a de manutenção; frequência excitatória de 10Hz; 80% do limiar motor de repouso; e 3000 pulsos no total por sessão. Os doentes foram avaliados quanto às características dolorosas no momento basal, no dia sete após a semana de indução, e nos dias 21, 30 e 60 para acompanhamento na fase de manutenção. Em todas as avaliações, utilizou-se os seguintes questionários validados para a língua portuguesa: Inventário Breve de Dor; DN4, Inventário de Sintomas de Dor Neuropática, Questionário de descritores breve de dor McGill e Questionário de qualidade de vida SF-36. Os doentes do grupo ativo e placebo apresentaram excitabilidade cortical inicial diferenciada em relação aos controles nos padrões de inibição e facilitação intracortical (p < 0,001). Ao final da última avaliação, os doentes do grupo ativo apresentavam padrões de excitabilidade cortical mais próximos dos controles do que os doentes...

Atypical facial pain (AFP) is a chronic condition with unknown physiopathology and refractory characteristics to the gold standard treatment. The aim this study was to compare the patterns of cortical excitability between AFP and health subjects (HS), and to assess the analgesic effect of repetitive transcranial magnetic stimulation (rTMS) in AFP patients. Twenty-eight HS and 29 patients with AFP were included according to the IHS criteria (2004). Participants underwent a cortical excitability battery bilaterally in the primary motor cortex (M1) representation of the masseter muscle. They were then randomized into active and sham rTMS groups. rTMS was performed over the contralateral motor cortex in the representation area of the face daily for a week and weekly for eight weeks in a total of 13 sessions (5 induction and 8 maintenance sessions). All participants received 10 Hz rTMS, at 80% of the rest motor threshold (total of 3000 pulses per session). Sham rTMS was performed with an identical sham coil that emitted a similar sound to the active one. Patients were clinically assessed at baseline, after the induction phase (one week) and after 21, 30 and 60 days after the beginning of the study. Evaluations included the following validated questionnaires to the Brazilian Portuguese language: brief pain inventory; DN-4; Neuropathic pain symptoms inventory, McGill pain questionnaire brief version and quality of life questionnaire SF-36. At the baseline assessment, patients with AFP showed defective intracortical excitability inhibition and facilitation (p < 0.001) compared to HS. After the final evaluation, the patients from the active group had cortical excitability patterns closer to HS than the patients from the sham group, although there was no significant difference. There was no difference between patients that underwent active and sham rTMS about their pain characteristics and quality of life; both had pain improvement...

Randomized prospective study evaluating addition of corticoid to viscosupplementation: three months of follow-up / Estudo prospectivo e randomizado que avalia a adição de corticoide a viscossuplementacao: três meses de seguimento

OBJECTIVE: To assess if the initial results of viscosupplementation are improved by the addition of corticosteroid. DESIGN: We evaluated 104 patients receiving usual care for knee osteoarthritis at the Universidade de São Paulo Medical Center. Patients were randomized to receive either a single intra-articular injection of 6 mL of Hylan GF-20 (Group 1) or a single intra-articular injection of 6 mL of Hylan GF-20 plus 1 mL (20 mg) of Triamcinolone Hexacetonide (Group 2). VAS, WOMAC and Lequesne questionnaires were applied at weeks zero (prior the injection), and after one, four, and 12 weeks. RESULTS: The baseline measurements of the two groups with 52 patients each were not statistically different. At week one, WOMAC and VAS showed significantly better results for Group 2 compared to Group 1 (p < 0,05). At week four the scores did not show a statistically significant differences. The groups showed similar results at week 12. CONCLUSION: The addition of Triamcinolone Hexacetonide improves the short term symptom/functional scores of viscosupplementation. .

OBJETIVO: Avaliar se há melhora dos resultados iniciais da viscossuplementação com a adição de corticosteroide. MÉTODOS: Foram avaliados 104 pacientes em tratamento para osteoartrite do joelho no Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. Os pacientes foram distribuídos aleatoriamente para receber uma única injeção intra-articular de 6 mL de Hylan GF-20 (Grupo 1) ou uma injeção intra-articular de 6 mL de Hylan GF-20, mais 1 mL (20 mg) de hexacetonido de triancinolona (Grupo 2). Foram aplicados a escala visual analógica de dor (VAS) e os questionários de WOMAC e Lequesne antes da infiltração e após uma, quatro e 12 semanas. RESULTADOS: As medidas basais dos dois grupos com 52 pacientes cada não apresentaram diferença estatística. Após uma semana, o WOMAC e a VAS mostraram resultados significativamente melhores para o Grupo 2 em relação ao Grupo 1 (p < 0,05). Com quatro semanas os resultados não apresentaram diferenças estatisticamente significativas entre os grupos. Os grupos apresentaram resultados semelhantes na 12ª. semana. CONCLUSÃO: A adição de hexacetonido de triancinolona melhora os resultados de curto prazo da viscossuplementação. .

L-isoleucine-supplemented Oral Rehydration Solution in the Treatment of Acute Diarrhoea in Children: A Randomized Controlled Trial.

Antimicrobial peptides represent an important component of the innate immune defenses of living organisms, including humans. They are broad-spectrum surface-acting agents secreted by the epithelial cells of the body in response to infection. Recently, L-isoleucine and its analogues have been found to induce antimicrobial peptides. The objectives of the study were to examine if addition of L-isoleucine to oral rehydration salts (ORS) solution would reduce stool output and/or duration of acute diarrhoea in children and induce antimicrobial peptides in intestine. This double-blind randomized controlled trial was conducted at the Dhaka Hospital of ICDDR,B. Fifty male children, aged 6-36 months, with acute diarrhoea and some dehydration, attending the hospital, were included in the study. Twenty-five children received L-isoleucine (2 g/L)-added ORS (study), and 25 received ORS without L-isoleucine (control). Stool weight, ORS intake, and duration of diarrhoea were the primary outcomes. There was a trend in reduction in mean±standard deviation (SD) daily stool output (g) of children in the L-isoleucine group from day 2 but it was significant on day 3 (388±261 vs 653±446; the difference between mean [95% confidence interval (CI) (-)265 (-509, -20); p=0.035]. Although the cumulative stool output from day 1 to day 3 reduced by 26% in the isoleucine group, it was not significant. Also, there was a trend in reduction in the mean±SD intake of ORS solution (mL) in the L-isoleucine group but it was significant only on day 1 (410±169 vs 564±301), the difference between mean (95% CI) (-)154 (-288, -18); p=0.04. The duration (hours) of diarrhoea was similar in both the groups. A gradual increase in stool concentrations of ß-defensin 2 and 3 was noted but they were not significantly different between the groups. L-isoleucine-supplemented ORS might be beneficial in reducing stool output and ORS intake in children with acute watery diarrhoea. A further study is warranted to substantiate the therapeutic effect of L-isoleucine.

Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database / Avaliação do risco de viés de ensaios controlados randomizados de odontologia indexados na base de dados Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde)

CONTEXT AND OBJECTIVE: Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. DESIGN AND SETTING: This was a methodology study conducted at Universidade Federal de São Paulo (Unifesp) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. RESULTS: Out of the 4,503 articles classified, only 10 studies (0.22 percent) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. CONCLUSION: The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.

CONTEXTO E OBJETIVO: Ensaios controlados randomizados (ECRs) bem conduzidos representam o mais alto nível de evidência quando a pergunta de pesquisa é sobre o efeito de intervenções terapêuticas ou preventivas. No entanto, o grau de controle de viés entre os ECRs apresenta grande variabilidade entre estudos. Por esta razão, com o aumento do interesse e produção das revisões sistemáticas e metanálises, foi necessário desenvolver metodologia suportada por evidência empírica, para incentivar e valorizar a produção de ECRs válidos e com baixo risco de viés. O objetivo deste trabalho foi realizar uma análise metodológica da área de odontologia quanto ao risco de viés de ECRs de acesso aberto, disponibilizados no banco de dados do Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde). TIPO DE ESTUDO E LOCAL: Trata-se de um estudo sobre metodologia conduzido na Universidade Federal de São Paulo (Unifesp) que avaliou o risco de viés dos ECRs, utilizando as seguintes dimensões: geração da sequência de alocação, sigilo da alocação, cegamento e dados sobre desfechos incompletos. RESULTADOS: Dos 4.503 artigos classificados somente 10 (0,22 por cento) estudos foram considerados verdadeiros ECR e, destes, somente um estudo foi classificado como sendo de baixo risco de viés. Os itens mais frequentemente controlados pelos autores dos ECR foram cegamento e dados sobre desfechos incompletos. CONCLUSÃO: A presença efetiva de viés enfraqueceu seriamente a confiança nos resultados dos estudos de odontologia avaliados, sendo pouco úteis para clínicos e gestores como suporte a processos de decisão.

A Randomized, Double-blinded, Open Label Study of the Efficacy and Safety of Cefcapene Pivoxil and Amoxicillin, Clavulanate in Acute Presumed Bacterial Rhinosinusitis

OBJECTIVES: Currently established first line therapy of acute (presumed bacterial) rhinosinusitis (ARS) consists of 10 to 14 days of oral amoxicillin or cephalosporins. This study compared the clinical efficacy and tolerance of cefcapene pivoxil (CP) and amoxicillin-clavulanate (AMC) in patients with ARS. METHODS: A randomized, open labeled, double-blinded trial of ARS patients over 15 years of age was performed. Patients diagnosed with ARS received paranasal sinus X-rays and nasal endoscopies and 2 weeks of either CP (150 mg, 3 times/ day) or AMC (625 mg, amoxicillin 500 mg, 3 times/day). All patients revisited the clinic on days 7, 14, and 28 for evaluation of changes in symptoms, endoscopy, and monitoring of any adverse reactions. Demographics, clinical characteristics and drug efficacy were also compared between the two groups. RESULTS: Among the 60 initially enrolled patients (CP 30, AMC 30), 5 patients in the CP group and 6 in the AMC group were excluded due to poor compliance. There were no significant differences in demographic data including age, sex, initial signs and symptoms, endoscopic and X-ray findings between the two groups. Rates of improvement after 2 weeks were 96% and 95.8% in the CP and AMC group, respectively. Sinus symptoms were changed significantly after 2 and 4 weeks, however, there was no difference between groups (P=0.41). The most common adverse reaction was gastrointestinal complication, diarrhea occurred in 1 patient in the CP group and 6 in the AMC group (P=0.04). CONCLUSION: CP and AMC were both effective in treating ARS. The difference of treatment outcome was not found between the two groups, however, gastrointestinal complications were less prevalent in the CP group.

Zinc Deficiency: Descriptive Epidemiology and Morbidity among Preschool Children in Peri-urban Population in Delhi, India.

Community-based data relating to factors influencing zinc deficiency among preschool children in India are inadequate. Data of a large, double-blinded, randomized, controlled zinc-supplementation trial were used for assessing the descriptive epidemiology of zinc deficiency among children aged 6-35 months (n=940). In total, 609 children were followed up for 120 days for information on morbidity. Of these children, 116 from the control group belonging to the upper and the lower 25th quartile of plasma zinc status at baseline were selected for assessing the association of zinc deficiency with prospective morbidity. At baseline, demographic, socioeconomic and dietary information was collected, and anthropometric measurements and levels of plasma zinc were assessed. At baseline, 73.3% of the children were zinc-deficient (plasma zinc <70 μg/dL), of which 33.8% had levels of plasma zinc below 60 μg/dL. A significantly higher risk of morbidity was prevalent among the subjects with lower plasma zinc compared to those with higher levels of plasma zinc.

Effect of Prenatal Zinc Supplementation on Birthweight.

Although iron and zinc deficiencies are known to occur together and also appear to be high in Ghana, a few supplementation studies addressed this concurrently in pregnancy. In a double-blind, randomized controlled trial, 600 pregnant women in Ghana were randomly assigned to receive either a combined supplement of 40 mg of zinc as zinc gluconate and 40 mg of iron as ferrous sulphate or 40 mg of elemental iron as ferrous sulphate. Overall, there was no detectable difference in the mean birthweight between the study groups, although the effect of iron-zinc supplementation on the mean birthweight was masked by a strong interaction between the type of supplement and the iron status of participants [F (1,179)=5.614, p=0.019]. Prenatal iron-zinc supplementation was effective in increasing the mean birthweight among anaemic and iron-deficient women but not among women with elevated iron stores in early pregnancy.

Avaliação de um novo enxaguatório na formação de cáseos amigdalianos / Evaluation of a new mouthwash on caseous formation

Os cáseos amigdalianos afetam uma significativa porcentagem da população. As cirurgias, conservadoras ou não, têm sido as únicas alternativas viáveis de tratamento. Entretanto, ainda hoje não há um método econômico e não-invasivo de tratamento que apresente resultados satisfatórios. OBJETIVOS: Os objetivos deste estudo são avaliar a eficiência de um enxaguatório, cujos ingredientes ativos associam substâncias oxigenantes e antimicrobianas, na diminuição da formação dos cáseos amigdalianos e da saburra lingual, cuja etiologia é semelhante à dos cáseos, e avaliar a redução da concentração dos compostos sulfurados voláteis (CSVs). FORMA DE ESTUDO: Estudo clínico e experimental, randomizado, duplo-cego, placebo-controlado. MATERIAL E MÉTODO: Foi utilizada uma amostra de 50 voluntários, com queixa de tonsilite crônica caseosa há mais de um ano. A pesquisa foi realizada em 2005, nas cidades de São Paulo e Campinas. RESULTADOS: Para o grupo que utilizou a solução placebo, não houve correlação entre as variáveis nem significância estatística nos resultados. Para o grupo que utilizou o enxaguatório, os resultados foram significativos em todos os quesitos analisados. CONCLUSÕES: O novo enxaguatório demonstrou ser uma alternativa conservadora viável para o tratamento da tonsilite crônica caseosa, sendo eficiente também na redução da formação de saburra lingual e concentração dos CSVs.

Tonsil caseous affects a significant percentage of the population. Surgeries, conservative or not, have been the only viable alternatives of treatment. However, today there is still not, up to now, an economical and non-invasive treatment that presents satisfactory results. AIMS: The objectives of this study are to evaluate the efficiency of a mouthwash, with active ingredients that associate oxygenating and antimicrobial substances, in the reduction of caseous and tongue coating formation, whose etiology is similar to caseous, and to evaluate the reduction of the volatile sulfur compounds (VSCs) concentration. STUDY DESIGN: Double blind, placebo-controlled, randomized, clinical and experimental study. MATERIAL E METHODS: A sample of 50 volunteers with more than one year of chronic caseous tonsillitis complaint used it. The research was carried out in 2005, in the cities of São Paulo and Campinas. RESULTS: For the group that used the placebo solution, there was no correlation between the variables or statistical significance in the results. For the group that used the mouthwash, the results were significant in all analyzed questions. CONCLUSIONS: This new mouthwash proved to be a viable conservative alternative for the treatment of tonsil caseous, being also efficient in the reduction of tongue coating formation and VSCs concentration.

Economic and Clinical Benefits of Galantamine in the Treatment of Mild to Moderate Alzheimer's Disease in a Korean Population: A 52-Week Prospective Study

To evaluate the impact of galantamine treatment on the function, caregiver time, and resource used in the treatment of patients with mild to moderate Alzheimer's disease (AD), costs and outcomes were evaluated during a 52-week prospective, randomized, double-blind, community-controlled trial of galantamine. Patients received either galantamine treatment (n=72) or no treatment (n=66). The analysis was performed from a societal perspective. Galantamine treatment reduced time spent caring for the patients and maintained improved functional capacity, whereas, when no treatments were given, a great increase in caregiver time and progressive functional deteriorations were observed. Saved caregiver time was equivalent to 113 working days per year. After 52 weeks, mean total annual costs per patient were 14,735,000 Korea Won (KRW) (USD 12,315) for patients with galantamine treatment and 25,325,000 KRW (USD 21,166) for patients without treatment. Adjusted annual cost saving of galantamine treatment was 6,428,000 KRW (USD 5,372) when compared to no treatment (p=0.0089). Galantamine had a beneficial effect not only to slow functional decline in patients with mild to moderate AD, but also to save a substantial amount of costs, closely related to reduction in caregiver burden and decrease in caregiver time.