Placebo controlled studies in acute schizophrenia – an issue of concern

1994 ◽  
Vol 9 (4) ◽  
pp. 165-173 ◽  
Author(s):  
A Delini-Stula ◽  
D Berdah-Tordjman
Keyword(s):  
Scientific Evidence ◽  
A Priori ◽  
Term Treatment ◽  
Drop Out ◽  
Assessment Instruments ◽  
Duration Of Treatment ◽  
Short Term Treatment ◽  
Improvement Rate ◽  
Acute Schizophrenia ◽  
Reported Data

SummaryPlacebo controlled studies in patients suffering from exacerbation eg acute productive episode of schizophrenia and performed in the period between 1963-1993 are reviewed and analysed with respect to study designs; size of studies; improvement rate under placebo and drop-outs due to inefficacy under placebo. The aim of the analysis was to find out if the reported data permit some realistic estimates for a priori assumptions needed for proper planning of such studies, particularly in view of the numerous ethical and other difficulties which their performance encounters in the practice. Literature research revealed a rather limited number of rigorous, placebo-controlled, monotherapy studies (without intermittent or concomitant additional neuroleptics) in acute schizophrenia. Across comparison of findings from these studies was difficult due to differences in duration of treatment, assessment instruments and criteria of efficacy which illustrated a lack of methodological standards for studies in this indication. The improvement rate under placebo, if measured by Clinical Global Assessment (CGI) appeared, however, not to exceed 25%, whereas BPRS score reduction as efficacy criterion mostly provided higher response rates (up to 40%). Of interest however, is the finding that the response rate to conventional neuroleptics at the end of 4-6 weeks of treatment in some studies hardly exceeded 40%. The most sensitive measure of placebo effect seemed to be the drop-out rate due to inefficacy (up to 100%) and it is suggested to consider this measure and the survival analysis approach in designing future studies. The review demonstrated many unresolved methodological problems in testing antipsychotic drugs in acute schizophrenia and, particularly, the need of scientific evidence of validity and sensitivity of measures of antipsychotic efficacy. The findings reported up to now do not offer cues for rational estimates of the effect size differences between placebo and active drugs after short-term treatment in acute schizophrenia.

scholarly journals Microscopic colitis: A literature review

2016 ◽  
Vol 62 (9) ◽  
pp. 895-900 ◽  
Author(s):  
ANA PAULA HAMER SOUSA CLARA ◽  
FLÁVIA DRAGO MAGNAGO ◽  
JULIANA NEVES FERREIRA ◽  
THAIS GAGNO GRILLO
Keyword(s):  
Scientific Evidence ◽  
Collagenous Colitis ◽  
Gastrointestinal Disorder ◽  
Normal Mucosa ◽  
Term Treatment ◽  
Diagnostic Methods ◽  
Microscopic Colitis ◽  
Older Individuals ◽  
Short Term Treatment ◽  
Pubmed Database

SUMMARY Microscopic colitis (MC) refers to chronic inflammation of the colon which is characterized by histologic changes at the level of a radiologically and endoscopically normal mucosa. It is a common cause of chronic non-bloody diarrhea that occurs primarily in older individuals; however, there are few studies in the literature with strong scientific evidence compared to other inflammatory bowel diseases (IBD), which limits the knowledge of physicians and pathologists. This article aims to review the information on MC, describing diagnostic methods and drugs available for treatment. We conducted a search of the Pubmed database and CAPES Portal using the keywords “microscopic colitis”, “collagenous colitis”, “lymphocytic colitis”, and “review” for selection of articles published between 1996 and 2015 related to the topic. Based on the studies discussed in this review, we conclude that MC is a relatively new gastrointestinal disorder, most studies are incipient particularly with respect to pathophysiology and immunology, and budesonide is the best documented short-term treatment. However, further studies are needed to elucidate the best strategy for treatment in the long term.

BISTABILITY AND LONG-TERM CURE IN A WITHIN-HOST MODEL OF HEPATITIS C

2011 ◽  
Vol 19 (04) ◽  
pp. 533-550 ◽  
Author(s):  
SWATI DEBROY ◽  
BENJAMIN M. BOLKER ◽  
MAIA MARTCHEVA
Keyword(s):  
Hepatitis C ◽  
Term Treatment ◽  
Clinical Settings ◽  
Duration Of Treatment ◽  
Short Term Treatment ◽  
Biologically Relevant ◽  
Ode Models ◽  
Permanent Cure ◽  
Extinction Threshold ◽  
Parameter Values

Treatment of hepatitis C virus (HCV) is lengthy, expensive and fraught with side-effects, succeeding in only 50% of treated patients. In clinical settings, short-term treatment response (so-called sustained virological response (SVR)) is used to predict prolonged viral suppression. Although ordinary differential equation (ODE) models for within-host HCV infection have illuminated the mechanisms underlying treatment with interferon (IFN) and ribavirin (RBV), they have difficulty producing SVR without the introduction of an external extinction threshold. Here we show that bistability in an existing ODE model of HCV, which occurs when infected hepatocytes proliferate sufficiently faster than uninfected hepatocytes, can produce SVR without an external extinction threshold under biologically relevant conditions. The model can produce all clinically observed patient profiles for realistic parameter values; it can also be used to estimate the efficacy and/or duration of treatment that will ensure permanent cure for a particular patient.

scholarly journals A Comparison of Short-Term Treatment Effects of Intravenous Sodium Amytal-Methedrine and LSD in the Alcoholic

1970 ◽  
Vol 15 (5) ◽  
pp. 493-497 ◽  
Author(s):  
F.G. Johnson
Keyword(s):  
Term Treatment ◽  
Short Term ◽  
Short Term Treatment ◽  
Improvement Rate ◽  
Treatment Conditions ◽  
Affective Experiences ◽  
One Year ◽  
Pronounced Reduction

Lysergic acid diethylamide (L.S.D.), given with and without a therapist present, is compared with sodium amylobarbitone-methedrine (S.A.M.), given with á therapist present, as abreactive agents in the treatment of alcoholism. Somatic, cognitive and affective experiences under the different treatment conditions are compared. L.S.D. produced a different quality of response from S.A.M. in many respects, but approximately half the patients in all categories noted a pronounced reduction of tension and depression following the experience. This short-term effect is contrasted with long-term (one year) absence of a significantly greater improvement rate with these drugs than with routine clinic treatment. The significance of these findings is discussed.

Shortened Treatment in a Child Guidance Clinic: The Results in 119 Cases

1966 ◽  
Vol 112 (487) ◽  
pp. 613-616 ◽  
Author(s):  
Marjorie K. Hare
Keyword(s):  
Term Treatment ◽  
Short Term ◽  
Short Term Treatment ◽  
Improvement Rate ◽  
Child Guidance ◽  
Child Patients ◽  
Diagnostic Work ◽  
Work Up ◽  
Methods Of Treatment ◽  
Intensive Psychotherapy

Conventional Child Guidance treatment includes a diagnostic “work-up” of five to ten hours and then weekly psychotherapeutic and casework interviews for the child and mother which last for months or years and are very expensive of professional time. There have been few reports of evaluation of such treatment, though Levitt (1963) combined the results of a number of studies to include nearly 10,000 child patients. Of those who received treatment, between two-thirds and three-quarters were improved, but a similar improvement rate occurred in those who were not treated. Eisenberg and Gruenberg (1961) found short-term treatment as effective as intensive psychotherapy, and Phillips and Johnston (1954) and Phillips (1960) claimed better results with short than with conventional treatment. Among the few reports from Britain is that of Barbour and Beedell (1955). They found no difference in outcome between treated and untreated cases or between short and long methods of treatment.

scholarly journals TIMP-1 and MMP-9 expressions in COPD patients complicated with spontaneous pneumothorax and their correlations with treatment outcomes

2019 ◽  
Vol 36 (2) ◽  
Author(s):  
Hang Li ◽  
Kaihu Shi ◽  
Yang Zhao ◽  
Jin Du ◽  
Dinghui Hu ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Spontaneous Pneumothorax ◽  
Term Treatment ◽  
Control Group ◽  
Chronic Obstructive ◽  
Short Term Treatment ◽  
Improvement Rate ◽  
Arterial Blood Gas ◽  
Arterial Blood ◽  
Copd Patients

Objective: To study the expressions of TIMP-1 and MMP-9 in patients with chronic obstructive pulmonary disease (COPD) complicated with spontaneous pneumothorax, and their correlations with treatment outcomes. Methods: A total of 80 COPD patients complicated with spontaneous pneumothorax treated in our hospital from December 2015 to December 2017. The serum expressions of TIMP-1 and MMP-9 in 80 COPD patients complicated with spontaneous pneumothorax (COPD group) and 52 healthy volunteers (control group) were detected by ELISA. The correlations of TIMP-1 and MMP-9 expressions with arterial blood gas parameters as well as scores of MRC breathlessness scale and St. George’s Respiratory Questionnaire (SGRQ) were analyzed. Results: The serum expressions of TIMP-1 and MMP-9 of COPD group were significantly higher than those of control group (P<0.05), but the two groups had similar MMP-9/TIMP-1 ratios (P>0.05). For COPD group, TIMP-1 expression, MMP-9 expression, MMP-9/TIMP-1, Sa(O2) and p(O2) were not correlated (P>0.05). TIMP-1 expression was significantly positively correlated with MRC scale and SGRQ scores (P<0.05). Sa(O2), p(O2) and MRC scale score of low MMP-9 expression, low TIMP-1 expression and low MMP-9/TIMP-1 group were significantly improved compared with those of high MMP-9 expression, high TIMP-1 expression and high MMP-9/TIMP-1 group (P<0.05). MMP-9 expression, TIMP-1 expression or MMP-9/TIMP-1 was not correlated with improvement of SGRQ score. Pulmonary function improvement (Sa(O2) improvement rate ≥5% and/or p(O2) improvement rate ≥10%) was correlated with serum MMP-9 expression, baseline Sa(O2) and p(O2). Conclusion: Increase of serum TIMP-1 and MMP-9 expressions in COPD patients was correlated with symptoms and scores of quality of life, and the expressions were also correlated with short-term treatment reactivity. doi: https://doi.org/10.12669/pjms.36.2.1244 How to cite this:Li H, Shi K, Zhao Y, Du J, Hu D, Liu Z. TIMP-1 and MMP-9 expressions in COPD patients complicated with spontaneous pneumothorax and their correlations with treatment outcomes. Pak J Med Sci. 2020;36(2):---------. doi: https://doi.org/10.12669/pjms.36.2.1244 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

scholarly journals Comparison of antihyperglycemic effects of creatine and metformin in type II diabetic patients

2009 ◽  
Vol 32 (6) ◽  
pp. 322 ◽  
Author(s):  
B Rocic ◽  
N Bedernjak Bajuk ◽  
P Rocic ◽  
D S Weber ◽  
J Boras ◽  
...  
Keyword(s):  
Term Treatment ◽  
Type Ii ◽  
Short Term ◽  
Duration Of Treatment ◽  
Short Term Treatment ◽  
C Peptide ◽  
Study Results ◽  
Type Ii Diabetics ◽  
Upper Level

Purpose: To compare the antihyperglycemic effects of metformin and creatine in recently detected type II diabetics in a short-term clinical study. Methods: In a 14 day simmetrically randomized crossover study, recently detected type II diabetics received either creatine (2x3 g/day) or metformin (2x500 mg/day) for five days, followed by two days of washout, followed by cross-over to the opposite treatment for the next five days. Fasting and post-prandial (-15, 60, 90, 120, 180 and 240 min) blood glucose, insulin, c-peptide, creatine and lactate were measured every other day for the duration of treatment, and HbA1c only at the begining and at the end of the study. Results: Both creatine and metformin decreased glucose concentrations to similar levels at all time points vs. basal glucose values [-15, 60, 90, 120, 180, and 240 min]: 11.1±0.75 vs 9.1±0.55a vs 8.8±0.59b, 14.4±0.6 vs 12.9±0.47a vs 13.1±0.55a, 14.8±0.58 vs 13.0±0.46b vs 13.3±0.55a, 14.1±0.6 vs 11.9±0.42b vs 12.5±0.51a, 12.2±0.6 vs 9.6±0.36c vs 9.9±0.38c, and 10.1±0.47 vs 7.8±0.36c vs 8.4±0.4b; (aP < 0.05; bP < 0.01; cP < 0.001 vs. basal glucose values). Neither treatment altered insulin, c-peptide, or HbA1c. Lactate varied during the day, but never reached the upper level of the safety reference range. Conclusion: Short-term treatment with creatine and metformin elicits similar glucose lowering effects in recently detected type II diabetics. Further studies are necessary to determine the effect of creatine on long-term glucose and insulin regulation. Purpose: To compare the antihyperglycemic effects of metformin and creatine in recently detected type II diabetics in a short-term clinical study. Methods: In a 14 day simmetrically randomized crossover study, recently detected type II diabetics received either creatine (2x3 g/day) or metformin (2x500 mg/day) for five days, followed by two days of washout, followed by cross-over to the opposite treatment for the next five days. Fasting and post-prandial (-15, 60, 90, 120, 180 and 240 min) blood glucose, insulin, c-peptide, creatine and lactate were measured every other day for the duration of treatment, and HbA1c only at the begining and at the end of the study. Results: Both creatine and metformin decreased glucose concentrations to similar levels at all time points vs. basal glucose values [-15, 60, 90, 120, 180, and 240 min]: 11.1±0.75 vs 9.1±0.55a vs 8.8±0.59b, 14.4±0.6 vs 12.9±0.47a vs 13.1±0.55a, 14.8±0.58 vs 13.0±0.46b vs 13.3±0.55a, 14.1±0.6 vs 11.9±0.42b vs 12.5±0.51a, 12.2±0.6 vs 9.6±0.36c vs 9.9±0.38c, and 10.1±0.47 vs 7.8±0.36c vs 8.4±0.4b; (aP < 0.05; bP < 0.01; cP < 0.001 vs. basal glucose values). Neither treatment altered insulin, c-peptide, or HbA1c. Lactate varied during the day, but never reached the upper level of the safety reference range. Conclusion: Short-term treatment with creatine and metformin elicits similar glucose lowering effects in recently detected type II diabetics. Further studies are necessary to determine the effect of creatine on long-term glucose and insulin regulation.

Sustained Response After Short-Medium-Term Treatment With Eltrombopag In Patients With ITP

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2323-2323 ◽  
Author(s):  
Tomás José González-López ◽  
José Ramón González-Porras ◽  
Maryam Arefi ◽  
Erik De Cabo ◽  
Blanca Sanchez Gonzalez ◽  
...  
Keyword(s):  
Platelet Count ◽  
Disease Onset ◽  
Term Treatment ◽  
Additional Treatment ◽  
Concomitant Treatment ◽  
Short Term ◽  
Duration Of Treatment ◽  
Short Term Treatment ◽  
Platelet Counts ◽  
Specific Subset

Abstract Introduction Eltrombopag is an oral, non-peptide thrombopoietic receptor-agonist (TPO-RA). In chronic immune thrombocytopenic purpura (ITP) randomized–controlled trials proved to be effective, safe and well tolerated with reported response rates of 59%-88%. When eltrombopag is discontinued, platelet counts usually return to baseline within 2 weeks. However, certain patients may be able to discontinue TPO-RA and still maintain platelet counts above baseline without additional treatment. We report here 12 patients who presented sustained responses after discontinuing eltrombopag without substituting additional anti-ITP therapy. Patients and Methods Primary ITP was defined as a platelet count < 100 x 109/L in the absence of other causes or disorders that may be associated with thrombocytopenia. Patients received daily oral eltrombopag, at a starting dose of 50 mg/day adjusting the dose as needed up to a maximum of 75 mg/day based on the patient’s platelet count. Successful discontinuation of eltrombopag treatment was defined as a platelet count of 30,000/μl and 20,000/μl above initial baseline for at least 6 months off eltrombopag without substituting additional anti-ITP therapy. Results Our patients were 4 males and 8 females, with a mean disease onset age of 55 years (range, 28–79 years). The median time from diagnosis to eltrombopag start was 24 months (range, 1-480). 5 cases had ITP since less than 1 year. The median prior number of therapies was 5 (range, 1-7). All patients were refractory to corticosteroids. Six patients had received rituximab: Patient (P) 1, P2, P3, P6, P7 and P8. Seven patients were splenectomized. Three patients (P2, P6 and P8) who failed to respond to romiplostim were switched to eltrombopag. One romiplostim responder (P12) switched to eltrombopag because patient request. The median platelet count before starting treatment was 7 x 109/L (range, 1-97 x 109/l). At start, concomitant treatment was administered in 4 patients: P2, P3 and P9 corticosteroids. P5, intravenous immunoglobulin. The median maximum platelet count during treatment was 482 x109/l (range, 251-858 x109/l). One patient had a transient increase in leukocyte count reaching 12x109/L. The median duration of treatment was 5 months (range, 1-13) (Fig 1A): only one month in three patients. Nine patients stopped treatment due to platelets higher than 250 x 109/l. Initial stop of eltrombopag in P2 was failed because of low platelet counts and eltrombopag was reinitiated. After 8 months of re-treatment, eltrombopag could be stopped with no other treatments needed for over 6 months. In P1, P10 and P11 eltrombopag was stopped at 140, 178 and 138 x109/L platelets, respectively. After a median follow-up of 7 months (range, 6 – 20 months), ten patients maintain a platelet count greater than 100 x 109/L (Fig 1B) without any anti-ITP treatment. Discussion The possibility of eltrombopag cessation in a specific subset of patients has emerged. Recently, a prospective ongoing study has demonstrated that approximately 1/3 of patients (5 of 15) appear able to successful elective discontinuation of eltrombopag after 2 or more years of treatment. Nevertheless we have showed that the remission of ITP is feasible after short term treatment with eltrombopag (3 patients treated for only 1 month). Repeated short-term use of eltrombopag in chronic ITP has been reported. Patient P2 could succesfully reintroduce eltrombopag after initial treatment stop. In our data no factors predict which patients may discontinue eltrombopag. Disclosures: San Miguel: Jansen, Celgene Corporation, Onyx, Novartis, Millenium: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees.

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