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Zinc adjunct therapy reduces case fatality in severe childhood pneumonia: a randomized double blind placebo-controlled trial
Maheswari G Srinivasan, Grace Ndeezi, Cordelia Mboijana, Sarah Kiguli, Gabriel S Bimenya, Victoria Nankabirwa, James K Tumwine
BMC Medicine , 2012, DOI: 10.1186/1741-7015-10-14
Abstract: Few studies have examined the impact of zinc adjunct therapy on the outcome of childhood pneumonia. We determined the effect of zinc as adjunct therapy on time to normalization of respiratory rate, temperature and oxygen saturation. We also studied the effect of zinc adjunct therapy on case fatality of severe childhood pneumonia (as a secondary outcome) in Mulago Hospital, Uganda.In this double blind, randomized, placebo-controlled clinical trial, 352 children aged 6 to 59 months, with severe pneumonia were randomized to zinc (20 mg for children ≥12 months, and 10 mg for those < 12 months) or a placebo once daily for seven days, in addition to standard antibiotics for severe pneumonia. Children were assessed every six hours. Oxygen saturation was normal if it was above 92% (breathing room air) for more than 15 minutes. The respiratory rate was normal if it was consistently (more than 24 hours) below 50 breaths per minute in infants and 40 breaths per minute in children above 12 months of age. Temperature was normal if consistently below 37.5°C. The difference in case fatality was expressed by the risk ratio between the two groups.Time to normalization of the respiratory rate, temperature and oxygen saturation was not significantly different between the two arms.Case fatality was 7/176 (4.0%) in the zinc group and 21/176 (11.9%) in the placebo group: Relative Risk 0.33 (95% CI 0.15 to 0.76). Relative Risk Reduction was 0.67 (95% CI 0.24 to 0.85), while the number needed to treat was 13. Among HIV infected children, case fatality was higher in the placebo (7/27) than in the zinc (0/28) group; RR 0.1 (95% CI 0.0, 1.0).Among 127 HIV uninfected children receiving the placebo, case fatality was 7/127 (5.5%); versus 5/129 (3.9%) among HIV uninfected group receiving zinc: RR 0.7 (95% CI 0.2, 2.2). The excess risk of death attributable to the placebo arm (Absolute Risk Reduction or ARR) was 8/100 (95% CI: 2/100, 14/100) children. This excess risk was substantially greater am
Ritanserin as an adjunct to lithium and haloperidol for the treatment of medication-naive patients with acute mania: a double blind and placebo controlled trial
Shahin Akhondzadeh, Hassan Mohajari, Mohammad Mohammadi, Homayoun Amini
BMC Psychiatry , 2003, DOI: 10.1186/1471-244x-3-7
Abstract: 45 patients aged between 21–43 were eligible to participate as they met the DSM-IV criteria for a current manic episode, on the basis of a clinical interview by an academician psychiatrist. In addition, a score of at least 20 points on the Young Mania rating Scale was required representing moderate to severe mania. Patients were randomly allocated lithium (1–1.2 mEq/L) + haloperidol (10 mg/day)+ ritanserin (10 mg/day) (Group A) or lithium (1–1.2 mEq/L)+ haloperidol (10 mg/day) + placebo (Group B) for a 6-week, double-blind, placebo-controlled study. Patients were assessed by a third year psychiatry resident at baseline and 3, 7, 14, 21, 28 and 42 days after the medication started. All patients entered the hospital were not previously under any medication. The mean decrease in the Young Mania Rating Scale score from baseline was used as the main outcome measure of response of mania to treatment. The extrapyramidal symptoms were assessed using the Extrapyramidal Symptoms Rating Scale. Side effects were systematically recorded throughout the study and were assessed using a checklist.Young Mania Rating Scale total scores improved with ritanserin. The difference between the two protocols was significant as indicated by the effect of group and the between-subjects factor (F = 5.02, d.f. = 1, P = 0.03). The means Extrapyramidal Symptoms Rating Scale scores for the placebo group were higher than the ritanserin group and the difference was significant in day 42. The difference between the two groups in the frequency of side effects was not significantThe efficacy of ritanserin to obtain a better improvement in patients with mania seems to support the 5-HT hypothesis of bipolar disorder.Bipolar disorder is a lifelong episodic condition characterized by mood swings between mania and depression. The lifetime prevalence of bipolar disorder to be 0.8. The 1 month point prevalence for bipolar disorder has been estimated as 0.4%. Acute manic episodes can have devastating consequenc
Short-Term effect of COX-2 selective inhibitor as an adjunct for the treatment of periodontal disease: a clinical double-blind study in humans
Pinho, Márcia de Noronha;Pereira, Leonardo Bíscaro;Souza, Sérgio Luís Scombatti de;Palioto, Daniela Bazan;Grisi, Márcio Fernando de Moraes;Novaes Jr., Arthur Belém;Taba Jr., Mario;
Brazilian Dental Journal , 2008, DOI: 10.1590/S0103-64402008000400007
Abstract: adjunctive therapeutic strategies that modulate the inflammatory mediators can play a significant role in periodontal therapy. in this double-blind, placebo-controlled study, 60 subjects diagnosed as periodontitis patients were evaluated for 28 days after periodontal treatment combined with selective cyclooxygenase-2 (cox-2) inhibitor. the experimental group received scaling and root planning (srp) combined with the loxoprofen antiinflammatory drug (srp+loxoprofen). the control group received srp combined with placebo (srp+placebo). plaque index (pi), probing pocket depth (pd) and bleeding on probing (bop) were monitored with an electronic probe at baseline and after 14 and 28 days. both groups displayed clinical improvement in pd, pi and bop. they also showed statistically similar values (p>0.05) of pd reduction on day 14 (0.4 mm) and on day 28 (0.6 mm). at the baseline, few deeper sites (>7 mm) from srp+loxoprofen group were responsible and most pd reduction was observed after 14 days (p<0.05). the percentage of remaining deep pockets (>7 mm) after 14 days in the srp+loxoprofen group was significantly lower (p<0.05) than in the srp+placebo group. loxoprofen presents potential effect as an adjunct of periodontal disease treatment, but long-term clinical trials are necessary to confirm its efficacy.
Maintenance N-acetyl cysteine treatment for bipolar disorder: A double-blind randomized placebo controlled trial  [cached]
Berk Michael,Dean Olivia M,Cotton Sue M,Gama Clarissa S
BMC Medicine , 2012, DOI: 10.1186/1741-7015-10-91
Abstract: Background N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder. Method The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes. Results There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures. Conclusions There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. Trial Registration The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493).
SINGLE BLIND PLACEBO CONTROLLED STUDY OF ISPAGHULA IN HYPERLIPIDEMIA
Shah Murad
International Journal of Pharmaceutical Research and Development , 2010,
Abstract: Study was planned to examine the effects of ispaghula on Serum Total Cholesterol and LDL-Cholesterol the design used is Single blind placebo controlled study, The study was to be conducted at department of Pharmacology and therapeutics at Basic Medical Sciences Institute , Jinnah Postgraduate Medical Centre, Karachi, from January 2006 to July 2006. In this Forty hyperlipidemic patients to be included, among which 20 patients were on placebo as control group, and 20 were on ispaghula, 3 gram daily, in divided doses for the period of three months. Patients with peptic ulcer, renal disease, hepatic disease, hypothyroidism, diabetes mellitus, and alcoholism were excluded from the study. Serum total cholesterol was calculated by enzymatic calorimeter method. Serum LDL-cholesterol was calculated by formula: LDL-Cholesterol = Total Cholesterol-(Triglycerides/5 +HDL-Cholesterol described by Delong et al (1986)12 and Beamount et al (1970).13 Data were expressed as the mean ± SD and “t” test was applied to determine statistical significance as the difference. A probability value of <0.05 was the limit of significance, the expected conclusion of study is that the ispaghula decreases the serum total cholesterol and LDL-Cholesterol in hyperlipidemic patients
A randomised, double-blind, placebo controlled cross-over study to determine the gastrointestinal effects of consumption of arabinoxylan-oligosaccharides enriched bread in healthy volunteers
Gemma E Walton, Congyi Lu, Isabel Trogh, Filip Arnaut, Glenn R Gibson
Nutrition Journal , 2012, DOI: 10.1186/1475-2891-11-36
Abstract: A double-blind, placebo controlled human intervention study was undertaken with 40 healthy adult volunteers to assess the impact of consumption of breads with in situ produced AXOS (containing 2.2?g AXOS) compared to non-endoxylanase treated breads. Volatile fatty acid concentrations in faeces were assessed and fluorescence in situ hybridisation was used to assess changes in gut microbial groups. Secretory immunoglobulin A (sIgA) levels in saliva were also measured.Consumption of AXOS-enriched breads led to increased faecal butyrate and a trend for reduced iso-valerate and fatty acids associated with protein fermentation. Faecal levels of bifidobacteria increased following initial control breads and remained elevated throughout the study. Lactobacilli levels were elevated following both placebo and AXOS-breads. No changes in salivary secretory IgA levels were observed during the study. Furthermore, no adverse effects on gastrointestinal symptoms were reported during AXOS-bread intake.AXOS-breads led to a potentially beneficial shift in fermentation end products and are well tolerated.
Human lactobacilli as supplementation of clindamycin to patients with bacterial vaginosis reduce the recurrence rate; a 6-month, double-blind, randomized, placebo-controlled study
Per-G?ran Larsson, Babill Stray-Pedersen, Kjeld R Ryttig, Stig Larsen
BMC Women's Health , 2008, DOI: 10.1186/1472-6874-8-3
Abstract: Women (n = 100) with bacterial vaginosis diagnosed by Amsel criteria were after informed consent offered vaginal clindamycin therapy followed by vaginal gelatine capsules containing either 109 freeze-dried lactobacilli or identical placebo capsules for 10 days during 3 menstrual cycles in a double-blind, randomized, placebo-controlled trial.The initial intent to treat (ITT) analysis for the one-month cure rate was 64% in the lactobacilli group and 78% in the placebo group (p > 0.05). However, any patient with missing or unclassified smears at the initial visit who continued the study and whose next smear indicated a cure was included in the cured group; the study also excluded two of the patients in the lactobacilli group who reported that they did not take any vaginal capsules. With consideration to these population changes, the initial cure rate would be 77% in the lactobacilli group. The 76 cured women were followed for 6 menstrual cycles or until relapse within that time span. At the end of the study, 64.9% (24/37) of the lactobacilli treated women were still BV-free compared to 46.2% (18/39) of the placebo treated women. Comparison of the two groups regarding "Time from cure to relapse" was statistically significant (p = 0.027) in favour of the lactobacilli treatment. Adjuvant therapy with lactobacilli contributed significantly to avoidance of relapse with a proportional Hazard Risk ratio (HR) of 0.73 (0.54–0.98) (p < 0.05)The study shows that supplementary treatment combining two different strains of probiotic lactobacilli does not improve the efficacy of BV therapy during the first month of treatment, but for women initially cured, adjunct treatment of lactobacilli during 3 menstrual cycles lengthens the time to relapse significantly in that more women remained BV free at the end of the 6-month follow up.ISRCTN62879834Bacterial vaginosis (BV) is a disease with unknown aetiology, characterized by loss or reduction of lactobacilli and increased overgrowth of ot
Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial
Fran?ois Piette, Jo?l Belmin, Hélène Vincent, Nicolas Schmidt, Sylvie Pariel, Marc Verny, Caroline Marquis, Jean Mely, Laurence Hugonot-Diener, Jean-Pierre Kinet, Patrice Dubreuil, Alain Moussy, Olivier Hermine
Alzheimer's Research & Therapy , 2011, DOI: 10.1186/alzrt75
Abstract: A randomised, placebo-controlled, phase 2 study was performed in patients with mild-to-moderate Alzheimer's disease, receiving masitinib as an adjunct to cholinesterase inhibitor and/or memantine. Patients were randomly assigned to receive masitinib (n = 26) (starting dose of 3 or 6 mg/kg/day) or placebo (n = 8), administered twice daily for 24 weeks. The primary endpoint was change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog) to assess cognitive function and the related patient response rate.The rate of clinically relevant cognitive decline according to the ADAS-Cog response (increase >4 points) after 12 and 24 weeks was significantly lower with masitinib adjunctive treatment compared with placebo (6% vs. 50% for both time points; P = 0.040 and P = 0.046, respectively). Moreover, whilst the placebo treatment arm showed worsening mean ADAS-Cog, Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory, and Mini-Mental State Examination scores, the masitinib treatment arm reported improvements, with statistical significance between treatment arms at week 12 and/or week 24 (respectively, P = 0.016 and 0.030; P = 0.035 and 0.128; and P = 0.047 and 0.031). The mean treatment effect according to change in ADAS-Cog score relative to baseline at weeks 12 and 24 was 6.8 and 7.6, respectively. Adverse events occurred more frequently with masitinib treatment (65% vs. 38% of patients); however, the majority of events were of mild or moderate intensity and transitory. Severe adverse events occurred at a similar frequency in the masitinib and placebo arms (15% vs. 13% of patients, respectively). Masitinib-associated events included gastrointestinal disorders, oedema, and rash.Masitinib administered as add-on therapy to standard care during 24 weeks was associated with slower cognitive decline in Alzheimer's disease, with an acceptable tolerance profile. Masitinib may therefore represent an innovative avenue of treatme
A double-blind placebo needle for acupuncture research
Nobuari Takakura, Hiroyoshi Yajima
BMC Complementary and Alternative Medicine , 2007, DOI: 10.1186/1472-6882-7-31
Abstract: We designed a double-blind non-penetrating placebo needle, the needle tip of which simply presses against the skin, and a matched penetrating needle. The needles are encased inside an opaque guide tube and the appearance and feel of the pair are designed to be indistinguishable. To validate the masking effect for the practitioner, 10 acupuncturists each applied 23 non-penetrating needles and 17 penetrating needles to the Large Intestine-4 point. After removing each needle, they judged whether the needle was 'penetrating', 'non-penetrating' or 'unidentifiable'. For the validation of patient masking, an acupuncturist randomly applied a non-penetrating/penetrating needle pair to the bilateral Sanjiao-5 points in 60 volunteers. When both applications were completed, we asked them to write down anything that they noticed regarding the needle application and associated sensations.The mean ± SD of correct/unidentifiable/incorrect answers given by the 10 acupuncturists were 17.0 ± 4.1/6.4 ± 3.6/16.6 ± 3.0, respectively. Regarding patient masking, none of the subjects commented in the questionnaire that they had received a non-penetrating needle. Of 60 penetrating and 60 non-penetrating needle applications, 48 (80.0%) and 25 (41.7%) applications elicited skin penetration sensation and 48 (80.0%) and 20 (33.3%) applications elicited de qi, respectively.These needles have the potential to mask both practitioners and patients from the type of needle used in acupuncture research.The strongest evidence supporting the efficacy of acupuncture has been obtained using single-blind methods [1-4], which fail to meet the methodological standards for study blinding in conventional medicine [5-8]. As a result, the effectiveness of acupuncture has remained controversial, even though studies of the highest possible quality have been published in leading medical journals [8]. The reason for this is that study subjects/patients are still exposed to possible bias due to the expectations, enthu
Clinical Effects of Systemic Azithromycin as an Adjunct to Scaling and Root Planing in the Treatment of Chronic Periodontitis: A Randomized Placebo-Controlled Clinical Trial
International Journal of Stomatological Research , 2012, DOI: 10.5923/j.ijsr.20120103.02
Abstract: Antibiotics are used adjunctively to scaling and root planing (SRP) for treatment of periodontal disease. The aim of this study was to evaluate the clinical effects of systemic Azithromycin (AZM) as an adjunct to SRP in the treatment of patients with chronic periodontitis. This study was a double-blinded, randomized clinical trial in which 49 patients with chronic periodontitis participated. Patients were randomly divided into 2 groups: The test group which received SRP plus AZM and the control group which received SRP plus placebo with the same dose. Clinical indices including Probing Pocket Depth (PPD), clinical Loss of Attachment (LOA), Gingival Index (GI),and Plaque Index (PI) were measured at the baseline and 3, 13, and 25 weeks after treatment.The mean LOA and PPD in the test group were significantly less than the control group after 25 weeks from baseline. Over all, the mean LOA and PPD were less in the test group than the control group at all times. All four mentioned indices showed further reduction in the test group during time.The adjunctive use of systemic azithromycin show significant clinical benefit in the treatment of chronic periodontitis.
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