Flunarizine vs. Pizotifen in Migraine Prophylaxis: A Review of Comparative Studies

Cephalalgia ◽  
1988 ◽  
Vol 8 (8_suppl) ◽  
pp. 27-30 ◽  
Author(s):  
Egilius LH Spierings ◽  
Harley B Messinger
Keyword(s):  
Standard Deviation ◽  
Comparative Studies ◽  
Statistical Significance ◽  
Secondary Analysis ◽  
Migraine Prophylaxis ◽  
Attack Frequency ◽  
Double Blind ◽  
Number Of Patients

Six double-blind studies have been published in which the efficacy of flunarizine and pizotifen were compared. In none of the studies were differences of statistical significance revealed for attack frequency. Secondary analysis of the three studies in which the same protocol was employed, using parametric tests on transformed data gave similar results. Pooling of the data in an attempt to enhance the power by enlarging the number of patients, actually decreased the power due to an increase in standard deviation.

scholarly journals Efficacy of an Oral Rehydration Solution Enriched with Lactobacillus reuteri DSM 17938 and Zinc in the Management of Acute Diarrhoea in Infants: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2018 ◽  
Vol 10 (9) ◽  
pp. 1189 ◽  
Author(s):  
Maria Maragkoudaki ◽  
George Chouliaras ◽  
Antonia Moutafi ◽  
Athanasios Thomas ◽  
Archodoula Orfanakou ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Lactobacillus Reuteri ◽  
Oral Rehydration Solution ◽  
Statistical Significance ◽  
Acute Diarrhoea ◽  
Controlled Study ◽  
Double Blind ◽  
Oral Rehydration ◽  
Number Of Patients ◽  
Rehydration Solution

The efficacy of oral rehydration solution (ORS) enriched with Lactobacillus reuteri DSM 17938 and zinc in infants with acute gastroenteritis, is poorly defined. The aim of this double-blind, randomized, placebo-controlled study, was to assess the efficacy of an ORS enriched with Lactobacillus reuteri DSM 17938 and zinc (ORS+Lr&Z) in well-nourished, non-hospitalized infants with acute diarrhoea. Fifty one infants with acute diarrhoea were randomly assigned to receive either ORS+Lr&Z (28 infants, mean ± SD age 1.7 ± 0.7 years, 21 males), or standard ORS (ORS−Lr&Z; 23 infants, mean ± SD age 1.8 ± 0.7 years, 16 males). Stools volume and consistency were recorded pre- and posttreatment using the Amsterdam Infant Stool Scale and were compared between the two groups, as well as lost work/day care days, drug administration and need for hospitalization. Both groups showed reduction in the severity of diarrhoea on day two (p < 0.001) while, all outcomes showed a trend to be better in the ORS+Lr&Z group, without reaching statistical significance, probably due to the relatively small number of patients. No adverse effects were recorded. In conclusion, both ORS were effective in managing acute diarrhoea in well-nourished, non-hospitalized infants. ORS enriched with L. reuteri DSM 17938 and zinc was well tolerated with no adverse effects.

Double-Blind Randomized Placebo-Controlled Study of Homoeopathic Prophylaxis of Migraine

Cephalalgia ◽  
1997 ◽  
Vol 17 (5) ◽  
pp. 600-604 ◽  
Author(s):  
TE Whitmarsh ◽  
DM Coleston-Shields ◽  
TJ Steiner
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Migraine Prophylaxis ◽  
Controlled Study ◽  
Attack Frequency ◽  
Double Blind ◽  
Over The Counter ◽  
Ihs Criteria ◽  
The Uk

Homoeopathic remedies for migrane are widely available over the counter, statutorily offered by the national health service in the UK, and apparently popular with patients. Do they work? Sixty-three outpatients with migraine with or without aura b IHS criteria entered a 4-month randomized placebo-controlled, double-blind, parallel-groups trial of individualized homoeopathic prophylaxis, the first month being baseline with all patients on placebo. Three patients (4.8%) dropped out, leaving 30 in each treatment group. There were chance differences in attack frequency and severity between the groups at baseline (attacks were more frequent but less severe in the placebo group). Both groups improved on therapy but neither to a great extent on the primary outcome measure of attack frequency (verum: —19%; placebo: -16%). Reduction was mostly in mild attacks on placebo, more in moderate and severe attacks on homoeopathy. Few adverse events were reported. Overall, there was no significant benefit over placebo of homoeopathic treatment. The course of change differed between groups, and suggested that improvement reversed in the last month of treatment on placebo. On this evidence we cannot recommend homoeopathy for migraine prophylaxis, but cannot conclude that it is without effect.

Use of Gabapentin in Pain Management

1997 ◽  
Vol 31 (9) ◽  
pp. 1082-1083 ◽  
Author(s):  
Charles H Wetzel ◽  
Julie F Connelly
Keyword(s):  
Pain Management ◽  
Case Reports ◽  
Migraine Prophylaxis ◽  
Radiation Myelopathy ◽  
Limited Data ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Number Of Patients ◽  
Adequate Evaluation ◽  
Therapeutic Alternatives

There have been many proposed uses for gabapentin, including midscapular pain secondary to radiation myelopathy, RSD, neuropathic pain, postherpetic neuralgia, and migraine prophylaxis. However, the published reports consist of a small number of patients and limited data. Limited data provided in published case reports do not allow adequate evaluation of expected adverse effects or efficacy. It is unclear whether gabapentin is more effective for a specific type of pain and how gabapentin may compare with placebo or other therapeutic alternatives. Therefore, randomized, double-blind, placebo-controlled, prospective studies are warranted to further elucidate gabapentin uses beyond what is recommended by the Food and Drug Administration. Gabapentin should only be considered for pain management after well-established therapies have failed to produce desired outcomes.

Randomized phase III trial of sorafenib in advanced renal cell carcinoma (RCC): Impact of crossover on survival

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4524-4524 ◽  
Author(s):  
T. Eisen ◽  
R. M. Bukowski ◽  
M. Staehler ◽  
C. Szczylik ◽  
S. Oudard ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Secondary Analysis ◽  
Phase Iii ◽  
Rank Test ◽  
Double Blind ◽  
The Usa ◽  
Level Of Significance ◽  
Improvement In Survival

4524 Background: Sorafenib was approved for advanced RCC in the USA December 2005. A Phase III randomized double-blind, placebo-controlled trial demonstrated an estimated 39% improvement in survival for patients receiving sorafenib versus placebo (HR= 0.72, p = 0.018) (ECCO 2005). These data supported independently reviewed doubling of PFS to 24 weeks in RCC patients receiving sorafenib compared with placebo (12 weeks) (p < 0.000001) (ASCO 2005). Based on the statistical significance and magnitude of PFS benefit, patients were unblinded and placebo patients allowed to crossover to sorafenib in April 2005. A prospectively planned interim OS analysis reflecting impact of crossover of placebo patients is presented. Methods: OS data up to November 30, 2005, were analyzed in this interim analysis using a stratified log-rank test comparing the two treatment groups. In order to examine the effect of crossover on OS, a secondary analysis was performed censoring data from patients randomized to placebo at June 30, 2005. Results: A total of 903 patients were randomized (451 to sorafenib, 452 to placebo) and >200 placebo patients crossed over to sorafenib. Baseline characteristics were similar between treatment arms. There were 367 deaths. The median OS was 19.3 months for sorafenib versus 15.9 months for placebo (HR = 0.77; 95% CI 0.63, 0.95; p = 0.015); although this did not attain the level of significance specified for the interim analysis (α = 0.009), a continued favorable trend in survival benefit was observed. With censoring of crossover data, the median OS was 19.3 months for sorafenib versus 14.3 months for placebo (HR = 0.74, 95% CI 0.58, 0.93; p = 0.010). Conclusion: Sorafenib is the first novel, oral approved treatment for advanced RCC in more than a decade. Previous information on the effect of crossover on OS in randomized oncology studies is limited. The lower HR observed after censoring placebo patients crossed over to sorafenib suggests a continued beneficial effect of sorafenib. Final results await more mature data. [Table: see text]

Evaluation of daily breakthrough chemotherapy-induced nausea and vomiting (CINV) rates in a phase III study of NEPA versus an aprepitant (APR)/granisetron (GRAN) regimen.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 120-120 ◽  
Author(s):  
Eric Roeland ◽  
Gary Binder ◽  
Joseph Ma ◽  
Corinna Lanzarotti ◽  
Li Zhang
Keyword(s):  
Statistical Significance ◽  
Secondary Analysis ◽  
Complete Response ◽  
Phase Iii ◽  
Double Blind Study ◽  
Close Monitoring ◽  
Double Blind ◽  
Treatment Groups ◽  
The Difference ◽  
Delayed Phase

120 Background: Antiemetic trials typically evaluate CINV control during acute (Day 1), delayed (Days 2-5), and overall (Days 1-5) phases post-chemotherapy; the daily course of events is often unstudied in the delayed phase. In a head-to-head study evaluating NK1RA-containing regimens, a single dose of NEPA, an oral fixed combination of the NK1RA netupitant and 5-HT3RA palonosetron, was non-inferior to a 3-day regimen of APR and GRAN for overall complete response (no emesis/no rescue use) rates (74% NEPA vs 72% APR/GRAN) in 828 patients receiving cisplatin-based highly emetogenic chemotherapy (HEC). This secondary analysis explores daily rates of breakthrough CINV in this study. Methods: This was a double-blind study in chemotherapy-naïve patients with solid tumors. Daily rates of breakthrough CINV, defined as the % of patients with emesis and/or rescue use were calculated with differences between treatment groups evaluated by the Cochran-Mantel-Haenszel method stratified by sex. Results: While daily rates of patients with breakthrough CINV remained stable between 13%-15.1% for APR/GRAN, they declined from 15.5% to 8% over the 5 days for NEPA, with the difference between groups reaching statistical significance on Day 5 (Table). Percent of total patient days with CINV events were 11.7% [NEPA] and 14.0% [APR/GRAN]. The % of patients with ≥ 3 days of breakthrough CINV were 8.5% and 12.3%, respectively. Conclusions: In this study evaluating guideline-recommended antiemetic regimens for HEC, CINV was prevented in most patients during the overall phase yet breakthrough CINV on individual days differed between treatment groups. APR/GRAN showed a relatively constant rate over time, while NEPA rates decreased and patients had fewer total days with breakthrough. This suggests the need for close monitoring of CINV events during the delayed phase. [Table: see text]

scholarly journals The Statistical Fragility of Single-Bundle vs Double-Bundle Autografts for ACL Reconstruction: A Systematic Review of Comparative Studies

2021 ◽  
Vol 9 (12) ◽  
pp. 232596712110646
Author(s):  
Cooper B. Ehlers ◽  
Andrew J. Curley ◽  
Nathan P. Fackler ◽  
Arjun Minhas ◽  
Ariel N. Rodriguez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Comparative Studies ◽  
Statistical Significance ◽  
Double Bundle ◽  
Single Bundle ◽  
Bundle Versus ◽  
P Values ◽  
Number Of Patients ◽  
Lost To Follow Up

Background: The statistical significance of a given study outcome can be liable to small changes in findings. P values are common, but imperfect statistical methods to convey significance, and inclusion of the fragility index (FI) and fragility quotient (FQ) may provide a clearer perception of statistical strength. Purpose/Hypothesis: The purpose was to examine the statistical stability of studies comparing primary single-bundle to double-bundle anterior cruciate ligament reconstruction (ACLR) utilizing autograft and independent tunnel drilling. It was hypothesized that the study findings would be vulnerable to a small number of outcome event reversals, often less than the number of patients lost to follow-up. Study Design: Systematic review; Level of evidence, 2. Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, the authors searched PubMed for comparative studies and randomized controlled trials (RCTs) published in select journals, based on impact factor, between 2005 and 2020. Risk-of-bias assessment and methodology scoring were conducted for the included studies. A total of 48 dichotomous outcome measures were examined for possible event reversals. The FI for each outcome was determined by the number of event reversals necessary to alter significance. The FQ was calculated by dividing the FI by the respective sample size. Results: Of the 1794 studies screened, 15 comparative studies were included for analysis; 13 studies were RCTs. Overall, the mean FI and FQ were 3.14 (IQR, 2-4) and 0.050 (IQR, 0.032-0.062), respectively. For 72.9% of outcomes, the FI was less than the number of patients lost to follow-up. Conclusion: Studies comparing single-bundle versus double-bundle ACLR may not be as statistically stable as previously thought. Comparative studies and RCTs are at substantial risk for statistical fragility, with few event reversals required to alter significance. The reversal of fewer than 4 outcome events in a treatment group can alter the statistical significance of a given result; this is commonly less than the number of patients lost to follow-up. Future comparative study analyses might consider including FI and FQ with P values in their statistical analysis.

A Quantification of the Placebo Response in Migraine Prophylaxis

Cephalalgia ◽  
2002 ◽  
Vol 22 (4) ◽  
pp. 265-270 ◽  
Author(s):  
P-HM van der Kuy ◽  
JJHM Lohman
Keyword(s):  
Migraine Attack ◽  
Meta Analysis ◽  
Placebo Response ◽  
Migraine Prophylaxis ◽  
Prophylactic Therapy ◽  
Attack Frequency ◽  
Open Label ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Total Analysis

To quantify the placebo response of prophylactic therapy in migraine, a meta-analysis of prophylactic, double-blind, placebo controlled migraine studies was performed. The total analysis included 22 studies testing 19 different products, including 2013 patients, of which 828 were treated with placebo. A reduction in migraine attacks of 50% or more (responders) was seen in 23.5% ± 8.0 (95% C.I. 18.3-28.8%) of the patients in the placebo groups and 45.5% ± 15.5 (95% C.I. 37.4-53.6%) in the active groups. A reduction in migraine attacks of 16.8% ± 12.7 (95% C.I. 10.9-22.6%) was observed in the placebo groups and 41.8% ± 11.7 (95% C.I. 36.9-46.6%) in the active groups. We propose that if the percentage of responders in an open-label prophylactic trial in migraine is above 35-40%, or if a reduction in migraine attack frequency is found of 40% or more, further studies are indicated to determine the prophylactic activity of the drug. In all studies included in this analysis, no placebo response was seen above these limits.

The Statistical Fragility of Hamstring Versus Patellar Tendon Autografts for Anterior Cruciate Ligament Reconstruction: A Systematic Review of Comparative Studies

2020 ◽  
pp. 036354652096997
Author(s):  
Cooper B. Ehlers ◽  
Andrew J. Curley ◽  
Nathan P. Fackler ◽  
Arjun Minhas ◽  
Edward S. Chang
Keyword(s):  
Anterior Cruciate Ligament ◽  
Anterior Cruciate Ligament Reconstruction ◽  
Comparative Studies ◽  
Ligament Reconstruction ◽  
Cruciate Ligament ◽  
Statistical Significance ◽  
Number Of Patients ◽  
Anterior Cruciate ◽  
Lost To Follow Up

Background: Evidence-based medicine utilizes data to inform clinical decision making, despite the ability of a small number of outcome reversals to change statistical significance. P values are common measurements of statistical significance that possess inherent flaws. The inclusion of the fragility index (FI) and fragility quotient (FQ) may provide a clearer conveyance of statistical strength. Purpose/Hypothesis: The purpose was to examine the statistical stability of studies comparing hamstring tendon and bone–patellar tendon–bone autografts in primary single-bundle anterior cruciate ligament reconstruction with independent tunnel drilling. We hypothesized that the findings of these studies are vulnerable to a small number of outcome event reversals, often fewer than the number of patients lost to follow-up. Study Design: Systematic review. Methods: Comparative studies and randomized controlled trials (RCTs) published in 10 leading orthopaedic journals between 2000 and 2020 were analyzed. Statistical significance was defined as a P value ≤.05. FI for each outcome was determined by the number of event reversals necessary to alter significance. FQ was calculated by dividing the FI by the respective sample size. Results: Of the 1803 studies screened, 643 met initial search criteria, with 18 comparative studies ultimately included for analysis, 8 of which were RCTs. A total of 114 outcomes were examined. Overall, the mean (interquartile range) FI and FQ were 3.77 (2-4) and 0.040 (0.016-0.055), respectively. The FI was less than the number of patients lost to follow-up for 76.3% of outcomes. Conclusion: Studies examining graft choice for anterior cruciate ligament reconstruction may not be as statistically stable as previously thought. Comparative studies and RCTs are at substantial risk for statistical fragility, with few event reversals required to alter significance. The reversal of <4 outcome events in a treatment group can alter the statistical significance of a given result; this is commonly fewer than the number of patients lost to follow-up. Future comparative study analyses might consider including FI and FQ with P values in their statistical analysis.

Diclofenac (Voltaren®) for the Treatment of Osteo-Arthrosis: A Double-Blind Comparison with Naproxen

1977 ◽  
Vol 5 (3) ◽  
pp. 169-174 ◽  
Author(s):  
P Siraux
Keyword(s):  
Side Effects ◽  
Statistical Significance ◽  
Comparative Trial ◽  
Double Blind ◽  
Number Of Patients ◽  
Daily Dose ◽  
The Difference ◽  
Blind Comparison

A double-blind, between-patient, comparative trial of diclofenac (Voltaren) and naproxen was carried out in 30 patients suffering from osteo-arthrosis of the hip or the knee. The drugs were given twice daily, morning and evening, during a period of two weeks. The daily dose was 100 mg for Voltaren and 500 mg for naproxen. The results indicate that Voltaren brought relief of pain and stiffness in a greater number of patients than did naproxen. The same finding was made regarding the influence on the range of joint movements, the difference reaching statistical significance. Voltaren appeared also to be better tolerated since the number of patients reporting side-effects was smaller and the complaints of less severity.

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