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A randomized controlled trial (RCT) to evaluate the effectiveness of hydroxichloroquine (HC) in symptomatic knee osteoarthritis (KOA)
CARE
5s
OF ADULTS
“A RANDOMIZED CONTROLLED TRIAL (RCT) TO EVALUATE THE EFFECTIVENESS OF HYDROXICHLOROQUINE (HC) IN SYMPTOMATIC KNEE OSTEOARTHRITIS (KOA).” ?&&OS Bosi Ferra?, and the Brazilian KOA Research Group. CEU, Escola Paulista de Medicina, SHo Paula, Brazil. c lmed at the evaluation of the effectiveness of HC Objective: This study ‘1 in the treatment of KOA. Design: Multicenter double-blind RCT. Setting: Seven tertiary health care centers located m S;Jo Paula and Rio de Janeiro, Brazil. Participants: Patients with KOA, as defined hy the American College of Rheumatology criteria, who have failed to respond to adequate doses of analgesics, were consecutively selected from the rheumatic disease unit outpatient clinics of 7 participating centers. Interventions: Patients were randomized hy center to receive HC 400 mg/ day or placebo (PLA) 1 tablet/day for a period of 6 months. Acetaminophen (AC) was allowed to he used (and recorded) during the trial. Main Outcome Measure(s): The outcome measures were evaluated at 0, 2, 4 and 6 months. Pam on movement was defined as the primary outcome. Functional ability was assessed by the Lequesne Index and the HAQ. Comphance was evaluated by pill count. Results: One hundred and nine patients were randomized, 89 pxlents completed the 6-month follow-up perloci and data from 97 patients were included in the intent-to-treat analysis. The groups were comparable at haseImc. The mean (SD) age and disease duration were: PLA: 59(6) and 6(6) years and HC: 59( 7) and 5(5) years, respectively. The group comparison [mean( at 6 months showed: Outcome
measure
Pain on movement (0.3) Ntght pain (0,3) Pain at rest (0,3) Lequesne index (0,24) HAQ (‘A31 Patient opinion (-2,+2) Compliance (W,)
PLA
HC
0.
3.52 (2.48) 2.17 2.75) 1.13 1.88j 7.34 4.88) 0.63 0.57) I.11 1.04) 92.91
2.58 (2.49) 1.49 (2.25) 0.62 (1.19j 5.54 (4.74) 0.47 (0.48) 1.50 (0.90) 88.13
0.068 0.182 0.116 0.069 0.138 0.056
“THERAPEUTIC EFFECT OF SINGLE ORAL 200,000 I.U. OF VITAMIN A IN ACUTE SHIGELLOSIS: A DOUBLE-BLIND PLACEBO CONTROLLED CLINICAL TRIAL.” S. Hossain, M. J. Dibley, 1. Kubir, R. Biswas, S. Snrker, D. H&e, and D. Mahulanubis. International Centre for Diarrhea1 Disease Research, Bangladesh. Objective: The objective of the study was to see the therapeutic efficacy of vitamin A in the treatment of acute shigellosis in children where suhclinical vitamin A deficiency is a major public health problem. Design: A randomized double-blind placebo controlled clinical trial. Setting: Dhaka hospital of the International Center for Diarrhea1 Disease Research, Bangladesh. Participants: Ninety-one children, aged 13 to 84 months, with a history ofdysentery of 5 72 hours, without any clinical signs of vitamin A deficiency and weight for age > 70% of NCHS standard without any systemic complication and stool pus cells 2 20 / High Power Field were recruited. Eighty three children with shigella positive stool culture were the final study suhjects. Intervention: Children were randomly assigned to a single oral dose of 200,000 1.U of vitamin A along with an antibiotic or antibiotic alone and followed for 5 days. Main Outcome Measure(s): Cumulative stool frequencies for the whole study period, fecal excretion of shqella species and clinical cure. Results: Median stool frequencies for the study period were 64 vs. 76 in the treatment and placebo group respectively. On last day 76% in treatment group and 68% in the placebo group had shigella free stools and clinical cure as defined by 5 3 formed stool with no blood, no fever, no abdominal tenderness and no shigella pathogen in the stool, was significantly higher in treatment group (45%~ vs. 20% in placeho group; Relative Risk 2.32; 95% Cl: 1.15 to 4.69). Conclusion: Vitamin A has an adluvant effect m the treatment of acute shigellosis in reducing the severity of disease in children among vitamm A deficient populations.
The total number of AC tahlets taken by PLA and HC groups were 293 and 276, reqxxtlvely. Few and m&l adverse effects were slrnilarly reported in both gnxlps. c one I usion: All r,utcome measures favored HC at 6 months. Although marginally not reaching statistical significance, the data suggest that HC may he more effective than PLA in the treatment of KOA.
“ASSOCIATED RISK FACTORS TO DEPRESSIVE SYNDROME AMONG COLOMBIAN POPULATION.” Carlos Gchez and Nelcy Rodriguez. CEU, Pontificia Universidad Javeriana, Bogotri, Colombia. Objective: To &scribe and determine the risk factors associated with depressive syndrome among the Colombian population. Depression has become one of the most important and prevalent mental health problems in Colombia. As a consequence, there is an increase in health services requirements and costs derived from its attention. This study will provide information to nnplement prevention campaigns in the community. Design: Cross-sectional survey among Colombian populatmn. Setting: This study is a secondary analysis of a data set from the First National Mental Health and Substance Abuse Research in a community-based study between 1993-1994. Participants: 25,134 persons, aged 12 to 60 years were included, 57.2% females and 42.8% males. Main Outcome Measure(s): Depression measured by Zung Scale in persons 16 to 60 years (N = 22020). 1n f ormation about all variables was collected on standardized form hy trained non-medical interviewers. 200 independent variables were measured. Results: 84.2% of the population did not present depression, 11.8% has mild depression, 3.4% moderate and 0.6% severe depression. Bivariate analysis found that age, stratum, anxiety, family perception, health perception, general self perception, sex, and suicide attempts were associated with depression. With ordinal logistic regression technique we found an association between depression and the following factors: had health perception OR = 2.1 (95% Cl: 1.8-2.6), females OR = 1.3 (1.2-1.4), low family cohesion OR = 6.1 (2.0-18) , low anxiety OR = 12.9 (11.7-14.3), suicide attempt in the whole life OR = 2.0 (1.7-2.4) , in the last year OR = 3.8 (2.8-5.1) and low satisfaction with achievements OR = 1.7 (1.5-2.9). Conclusions: Depression is a prevalent and important mental health problem in Colombia. Anxiety, suicide attempts, satisfaction with achievements, family and self perception are important associated fixtors to be studied in our country in order to improve management and Implement prevention campaigns.
“EFFECT OF PARENTERAL NUTRITION (PN) AND CHEMOTHERAPY (CT) IN GASTROINTESTINAL (GI) CANCER PATIENTS.” Da-Yonglin and M. R. Phillips. CEU, Shanghai Medical University, Shanghai, China. Objective: To compare the changes m cell phase composition of the Cl cancer patients after four different interventions and to determme the best preoperative intervention for patients with Cl cancer. Design: Prospective randomized controlled trial. Any Cl cancer patients entermg the study were divided into four groups randomly: control, PN, CT, PN+CT group. The intervention was instituted from the 4th to 10th day. Pre and post-intervention assessments were made. Setting: A tertiary general hospital. Participants: Ninety-two patients were enrolled and completed the study. There were twenty-three cases randomly allocated to each group. Interventions: Patients were given PN with 25kcal/Kg nonprotein energy and 0.15 gN/kg amino acid per day; and CT with methotrexate 8mg IV on the 4th day and 5-Fu lg per day from 4th to the 10th day. Main Outcome Measure(s): The DNA contents, DNA indices and the cell cycle phase of GI cancer cells were detected by Image Cytometry technique. The serum albumin, prealhumin, transferrin and nitrogen balance were also detected. Results: More effective improvement in the nutritional status in PN(P < 0.005) and PN + CT (P < 0.01) group than the other group, and deterioration in CT group. PN would increase tumor cells proliferation (P < O.OOOl), but PN + CT did not produce an increase in tumor cells proliferation. More wound infection, poor wound healing and mortahty occurred in CT group, but did not occur in PN and PN + CT groups. Conclusion: The best preoperative interventmn for Cl cancer patients would be to give PN + CT.
5s
OF ADULTS
“A RANDOMIZED CONTROLLED TRIAL (RCT) TO EVALUATE THE EFFECTIVENESS OF HYDROXICHLOROQUINE (HC) IN SYMPTOMATIC KNEE OSTEOARTHRITIS (KOA).” ?&&OS Bosi Ferra?, and the Brazilian KOA Research Group. CEU, Escola Paulista de Medicina, SHo Paula, Brazil. c lmed at the evaluation of the effectiveness of HC Objective: This study ‘1 in the treatment of KOA. Design: Multicenter double-blind RCT. Setting: Seven tertiary health care centers located m S;Jo Paula and Rio de Janeiro, Brazil. Participants: Patients with KOA, as defined hy the American College of Rheumatology criteria, who have failed to respond to adequate doses of analgesics, were consecutively selected from the rheumatic disease unit outpatient clinics of 7 participating centers. Interventions: Patients were randomized hy center to receive HC 400 mg/ day or placebo (PLA) 1 tablet/day for a period of 6 months. Acetaminophen (AC) was allowed to he used (and recorded) during the trial. Main Outcome Measure(s): The outcome measures were evaluated at 0, 2, 4 and 6 months. Pam on movement was defined as the primary outcome. Functional ability was assessed by the Lequesne Index and the HAQ. Comphance was evaluated by pill count. Results: One hundred and nine patients were randomized, 89 pxlents completed the 6-month follow-up perloci and data from 97 patients were included in the intent-to-treat analysis. The groups were comparable at haseImc. The mean (SD) age and disease duration were: PLA: 59(6) and 6(6) years and HC: 59( 7) and 5(5) years, respectively. The group comparison [mean( at 6 months showed: Outcome
measure
Pain on movement (0.3) Ntght pain (0,3) Pain at rest (0,3) Lequesne index (0,24) HAQ (‘A31 Patient opinion (-2,+2) Compliance (W,)
PLA
HC
0.
3.52 (2.48) 2.17 2.75) 1.13 1.88j 7.34 4.88) 0.63 0.57) I.11 1.04) 92.91
2.58 (2.49) 1.49 (2.25) 0.62 (1.19j 5.54 (4.74) 0.47 (0.48) 1.50 (0.90) 88.13
0.068 0.182 0.116 0.069 0.138 0.056
“THERAPEUTIC EFFECT OF SINGLE ORAL 200,000 I.U. OF VITAMIN A IN ACUTE SHIGELLOSIS: A DOUBLE-BLIND PLACEBO CONTROLLED CLINICAL TRIAL.” S. Hossain, M. J. Dibley, 1. Kubir, R. Biswas, S. Snrker, D. H&e, and D. Mahulanubis. International Centre for Diarrhea1 Disease Research, Bangladesh. Objective: The objective of the study was to see the therapeutic efficacy of vitamin A in the treatment of acute shigellosis in children where suhclinical vitamin A deficiency is a major public health problem. Design: A randomized double-blind placebo controlled clinical trial. Setting: Dhaka hospital of the International Center for Diarrhea1 Disease Research, Bangladesh. Participants: Ninety-one children, aged 13 to 84 months, with a history ofdysentery of 5 72 hours, without any clinical signs of vitamin A deficiency and weight for age > 70% of NCHS standard without any systemic complication and stool pus cells 2 20 / High Power Field were recruited. Eighty three children with shigella positive stool culture were the final study suhjects. Intervention: Children were randomly assigned to a single oral dose of 200,000 1.U of vitamin A along with an antibiotic or antibiotic alone and followed for 5 days. Main Outcome Measure(s): Cumulative stool frequencies for the whole study period, fecal excretion of shqella species and clinical cure. Results: Median stool frequencies for the study period were 64 vs. 76 in the treatment and placebo group respectively. On last day 76% in treatment group and 68% in the placebo group had shigella free stools and clinical cure as defined by 5 3 formed stool with no blood, no fever, no abdominal tenderness and no shigella pathogen in the stool, was significantly higher in treatment group (45%~ vs. 20% in placeho group; Relative Risk 2.32; 95% Cl: 1.15 to 4.69). Conclusion: Vitamin A has an adluvant effect m the treatment of acute shigellosis in reducing the severity of disease in children among vitamm A deficient populations.
The total number of AC tahlets taken by PLA and HC groups were 293 and 276, reqxxtlvely. Few and m&l adverse effects were slrnilarly reported in both gnxlps. c one I usion: All r,utcome measures favored HC at 6 months. Although marginally not reaching statistical significance, the data suggest that HC may he more effective than PLA in the treatment of KOA.
“ASSOCIATED RISK FACTORS TO DEPRESSIVE SYNDROME AMONG COLOMBIAN POPULATION.” Carlos Gchez and Nelcy Rodriguez. CEU, Pontificia Universidad Javeriana, Bogotri, Colombia. Objective: To &scribe and determine the risk factors associated with depressive syndrome among the Colombian population. Depression has become one of the most important and prevalent mental health problems in Colombia. As a consequence, there is an increase in health services requirements and costs derived from its attention. This study will provide information to nnplement prevention campaigns in the community. Design: Cross-sectional survey among Colombian populatmn. Setting: This study is a secondary analysis of a data set from the First National Mental Health and Substance Abuse Research in a community-based study between 1993-1994. Participants: 25,134 persons, aged 12 to 60 years were included, 57.2% females and 42.8% males. Main Outcome Measure(s): Depression measured by Zung Scale in persons 16 to 60 years (N = 22020). 1n f ormation about all variables was collected on standardized form hy trained non-medical interviewers. 200 independent variables were measured. Results: 84.2% of the population did not present depression, 11.8% has mild depression, 3.4% moderate and 0.6% severe depression. Bivariate analysis found that age, stratum, anxiety, family perception, health perception, general self perception, sex, and suicide attempts were associated with depression. With ordinal logistic regression technique we found an association between depression and the following factors: had health perception OR = 2.1 (95% Cl: 1.8-2.6), females OR = 1.3 (1.2-1.4), low family cohesion OR = 6.1 (2.0-18) , low anxiety OR = 12.9 (11.7-14.3), suicide attempt in the whole life OR = 2.0 (1.7-2.4) , in the last year OR = 3.8 (2.8-5.1) and low satisfaction with achievements OR = 1.7 (1.5-2.9). Conclusions: Depression is a prevalent and important mental health problem in Colombia. Anxiety, suicide attempts, satisfaction with achievements, family and self perception are important associated fixtors to be studied in our country in order to improve management and Implement prevention campaigns.
“EFFECT OF PARENTERAL NUTRITION (PN) AND CHEMOTHERAPY (CT) IN GASTROINTESTINAL (GI) CANCER PATIENTS.” Da-Yonglin and M. R. Phillips. CEU, Shanghai Medical University, Shanghai, China. Objective: To compare the changes m cell phase composition of the Cl cancer patients after four different interventions and to determme the best preoperative intervention for patients with Cl cancer. Design: Prospective randomized controlled trial. Any Cl cancer patients entermg the study were divided into four groups randomly: control, PN, CT, PN+CT group. The intervention was instituted from the 4th to 10th day. Pre and post-intervention assessments were made. Setting: A tertiary general hospital. Participants: Ninety-two patients were enrolled and completed the study. There were twenty-three cases randomly allocated to each group. Interventions: Patients were given PN with 25kcal/Kg nonprotein energy and 0.15 gN/kg amino acid per day; and CT with methotrexate 8mg IV on the 4th day and 5-Fu lg per day from 4th to the 10th day. Main Outcome Measure(s): The DNA contents, DNA indices and the cell cycle phase of GI cancer cells were detected by Image Cytometry technique. The serum albumin, prealhumin, transferrin and nitrogen balance were also detected. Results: More effective improvement in the nutritional status in PN(P < 0.005) and PN + CT (P < 0.01) group than the other group, and deterioration in CT group. PN would increase tumor cells proliferation (P < O.OOOl), but PN + CT did not produce an increase in tumor cells proliferation. More wound infection, poor wound healing and mortahty occurred in CT group, but did not occur in PN and PN + CT groups. Conclusion: The best preoperative interventmn for Cl cancer patients would be to give PN + CT.