Improvement of Walking Distance by Defibrotide in Patients with Intermittent Claudication

2000 ◽  
Vol 83 (05) ◽  
pp. 672-677 ◽  
Author(s):  
E. Marubini ◽  
S. Coccheri ◽  
G. G. Nenci ◽  
F. Violi
Keyword(s):  
Intermittent Claudication ◽  
Walking Distance ◽  
Controlled Study ◽  
Double Blind ◽  
Intention To Treat ◽  
Term Administration ◽  
One Year ◽  
Present Trial

SummaryDefibrotide is an antithrombotic drug which enhances prostacyclin production and activates fibrinolytic system. The aim of this study was to investigate the improvement of walking distance in patients with intermittent claudication treated with defibrotide.DICLIS was a double blind, placebo-controlled study which included patients with walking distance autonomy at a standardized treadmill test ≤350 ≥100 meters. A total of 310 patients were randomly allocated to placebo (n = 101), defibrotide 800 mg/day (n = 104) or defibrotide 1200 mg/day (n = 105).During a one year follow-up, the Absolute Walking Distance (AWD) was measured six times (0, 30, 60, 90, 180, 360 days).Similar improvement in walking distance was found in the three groups until the 90th day; thereafter placebo group showed no further increase, while AWD continued to increase in the defibrotide groups. Between the 180th and 360th day visits, AWD was significantly higher (P <0.01) in patients given defibrotide than in patients given placebo. No difference in efficacy was observed between the two dosages of defibrotide. No differences in side effects were observed among the three groups.The results of the present trial suggest that long-term administration of defibrotide improves walking distance in patients with intermittent claudication. Abbreviations: DICLIS = Defibrotide Intermittent CLaudication Italian Study, AWD = Absolute Walking Distance, IC = Intermittent Claudication, PVD = Peripheral Vascular Disease, LVOCF = Last Valid Observation Carried Forward, ITT = Intention-To-TreatAppendix, please see p. 676.

The long-term effects of homeopathic treatment of chronic headaches: one year follow-up and single case time series analysis

2001 ◽  
Vol 90 (02) ◽  
pp. 63-72 ◽  
Author(s):  
H Walach ◽  
T Lowes ◽  
D Mussbach ◽  
U Schamell ◽  
W Springer ◽  
...  
Keyword(s):  
Time Series ◽  
Single Case ◽  
Double Blind Study ◽  
Long Term Effects ◽  
Double Blind ◽  
Homeopathic Treatment ◽  
Chronic Headaches ◽  
One Year

AbstractLittle is known about long-term effects of homeopathic treatment. Following a double-blind, placebo controlled trial of classical homeopathy in chronic headaches, we conducted a 1-year observational study of 18 patients following the double-blind phase, and a complete follow-up study of all trial participants. Eighteen patients received free treatment for daily diary data (frequency, intensity, duration of headaches) over the course of 1 y. All patients enrolled in the double-blind study were sent a 6-week headache diary, a follow-up questionnaire, a personality inventory and a complaint list. Eighty-seven, of the original 98 patients enrolled returned questionnaires, 81 returned diaries. There was no additional change from the end of the trial to the one-year follow-up. The improvement seen at the end of the 12-week trial was stable after 1 y. No differential effects according to treatment after the trial could be seen. Patients with no treatment following the trial had the most improvement after 1 y. Five of 18 patients can be counted responders according to ARIMA analysis of single-case time-series. Patients with double diagnoses and longer treatment duration tended to have clearer improvements than the rest of the patients. Approximately 30% of patients in homeopathic treatment will benefit after 1 y of treatment. There is no indication of a specific, or of a delayed effect of homeopathy.

Long-Term Survival Is Comparable between Palifermin-Treated and Placebo-Treated Patients (Pts) with Hematologic Malignancies (HM) Undergoing High-Dose Chemotherapy and Total Body Irradiation Followed by Autologous Hematopoietic Stem Cell Transplantation (HSCT).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2925-2925 ◽  
Author(s):  
Ricardo Spielberger ◽  
Christos Emmanouilides ◽  
William Bensinger ◽  
Alan Rong ◽  
Alessandra Cesano ◽  
...  
Keyword(s):  
Controlled Study ◽  
Secondary Malignancies ◽  
Double Blind ◽  
Term Survival ◽  
Hematopoietic Stem ◽  
Double Blind Placebo ◽  
Disease Outcomes ◽  
Long Term Follow Up

Abstract Oral mucositis (OM) is a severely debilitating side effect of chemoradiotherapy that often causes significant pain, diminished quality of life, and increased risk of infections. Palifermin decreases the incidence and duration of severe OM in HM pts receiving myelotoxic therapy and HSCT. Palifermin safety and efficacy have not been established in the non-HM setting. Since the rHuKGF receptor is not expressed by HM, palifermin is not expected to interfere with long-term disease outcomes in this pt population. Aim: We assessed palifermin’s effects on the long-term disease outcomes (survival, disease progression, secondary malignancies) in pts with HM. Methods: Long-term follow-up data were pooled from a 1998 phase 2, double-blind, placebo-controlled study (n=86) and a 2000 double-blind, placebo-controlled phase 3 study (n=212). The analysis included 152 pts treated with palifermin and 146 pts treated with placebo. Pts were assessed at 6-month intervals during the first year and annually thereafter until death or loss to follow-up. The Kaplan-Meier (K–M) method provided estimates of the safety endpoints. Data reported here are as of August 2004. Results: There were 298 pts (152 palifermin: 146 placebo) monitored for long-term follow-up. The median follow-up period was 23.3 months for palifermin and 23.5 months for placebo. The overall survival and progression-free survival curves (p=0.474 and p=0.253, respectively) are similar between the palifermin and placebo groups. Secondary malignancies occurred in only 6 of 152 (3%) palifermin and 5 of 146 (4%) placebo pts. All secondary malignancies were myelodysplastic syndromes: 9 patients with diagnoses of Non-Hodgkin’s lymphoma and 2 patients of Hodgkin’s Disease. The number of deaths was similar between the groups (30% palifermin; 27% placebo); most deaths occurred within 12 months of randomization and were attributable to the underlying HM disease. Conclusion: Use of palifermin for the prevention of severe OM has shown no negative impact on long-term disease outcomes, including survival, in the HSCT setting for patients with HM.

Treatment of aggression with topiramate in male borderline patients, part II: 18-month follow-up

2008 ◽  
Vol 23 (2) ◽  
pp. 115-117 ◽  
Author(s):  
Marius K. Nickel ◽  
Thomas H. Loew
Keyword(s):  
Weight Loss ◽  
Anger Expression ◽  
Controlled Study ◽  
Term Therapy ◽  
Significant Weight Loss ◽  
Double Blind ◽  
Long Term Treatment ◽  
Borderline Patients

AbstractObjectiveWe previously tested topiramate, an anticonvulsant, in the treatment of aggression in men with borderline personality disorder (BPD) (Nickel M, Nickel C, Kaplan P, Lahmann C, Mühlbacher M, Tritt K, et al. Treatment of aggression with topiramate in male borderline patients: a double-blind, placebo-controlled study. Biol Psychiatry 2005;57:495–9), and found significant changes on most scales of the state–trait anger expression inventory (STAXI) and significant weight loss eight weeks later. The aim of this trial was to assess topiramate's efficacy in the long-term therapy for aggression in men with BPD.MethodsThis 18-month follow-up observation, in which the previous patients (topiramate group: n = 22; former placebo group: n = 22) were examined bianually, was carried out.ResultsAccording to the intent-to-treat principle, significant changes on all scales of the STAXI were observed in the subjects treated with topiramate. Additional significant weight loss was observed. All subjects tolerated topiramate relatively well.ConclusionsTopiramate appears to be an effective, relatively safe agent in the long-term treatment of patients with BPD. Mild, non-transient weight loss can be expected.

Long-Term Neurodevelopmental Outcome of Children Treated with Tri-Iodothyronine after Cardiac Surgery: Follow-Up of a Double-Blind, Randomized, Placebo-Controlled Study

2015 ◽  
Vol 84 (2) ◽  
pp. 130-136 ◽  
Author(s):  
Janna Mittnacht ◽  
Daniela Choukair ◽  
Carolin Kneppo ◽  
Romuald Brunner ◽  
Peter Parzer ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Neurodevelopmental Outcome ◽  
Controlled Study ◽  
Double Blind

Double-Blind, Randomized Clinical Trial on the Effect of Interferon-Beta in the Treatment of Condylomata Acuminata

1994 ◽  
Vol 5 (3) ◽  
pp. 182-185 ◽  
Author(s):  
L Olmos ◽  
J Vilata ◽  
A Rodríguez Pichardo ◽  
A Lloret ◽  
A Ojeda ◽  
...  
Keyword(s):  
Interferon Beta ◽  
Complete Response Rate ◽  
Controlled Trial ◽  
Condylomata Acuminata ◽  
Complete Response ◽  
Treated Group ◽  
Double Blind ◽  
One Year

A randomized, double-blind, placebo-controlled trial was conducted to assess interferon-beta efficacy and safety in the treatment of anogenital condylomatous lesions. One hundred patients received a daily intramuscular injection of either interferon-beta (IFN-β) (2 MIU/day) or placebo for 10 days. Of 94 evaluable patients, the complete response rate observed 8 weeks after treatment was significantly higher in the group receiving IFN-β, as compared to the placebo-treated group (51% vs 28.9%, P<0.05). After one year, 24 patients (100%) out of 24 complete responders to IFN-β who attended for follow-up remained free of lesions. Twelve of 13 patients with complete response to placebo (92.3%) remained free of lesions after one year. Side effects were mild and no significant analytical changes were observed. In conclusion, interferon-beta is an effective and safe treatment for long-term eradication of anogenital condylomatous lesions.

Naftidrofuryl kann die Lebensqualität von Patienten mit Claudicatio intermittens verbessern

VASA ◽  
1999 ◽  
Vol 28 (3) ◽  
pp. 207-212 ◽  
Author(s):  
Spengel ◽  
Brown ◽  
Poth ◽  
Lehert
Keyword(s):  
Quality Of Life ◽  
Intermittent Claudication ◽  
Analysis Of Covariance ◽  
Walking Distance ◽  
Claudicatio Intermittens ◽  
Controlled Study ◽  
Double Blind ◽  
Specific Questionnaire ◽  
Disease Specific

Background: Using a disease specific questionnaire, the CLAU-S, we undertook a double blind, placebo controlled study in patients with intermittent claudication to determine whether the increase in the pain-free walking distance, previously demonstrated with naftidrofuryl, is reflected as an improvement in the patients’ quality of life. Patients and methods: 287 patients, with stable intermittent claudication for at least 3 months were entered into the study. Following an initial one month placebo run-in, patients were randomised to either naftidrofuryl, at a dosage of 200 mg three times daily, or matching placebo, for 6 months. All patients completed the self-administered CLAU-S questionnaire which is divided into 6 dimensions, before the start of treatment, at 3 and 6 months. Statistical analysis was undertaken on an intention-to-treat (ITT) basis which included all patients know to have taken at least one dose of the drug and to have provided key data on at least one occasion after baseline. For each of the CLAU-S dimensions the two groups were compared with respect to difference between the initial and final values. Results: 255 patients (133 naftidrofuryl, 122 placebo) were eligible for the ITT analysis. Significant improvements, in favour of the active medication, were seen for the dimensions “daily living”, “pain”, “disease specific anxiety” and “mood”. A multivariate analysis of covariance, which took into account such factors as initial score, age and sex confirmed the global superiority of naftidrofuryl (p = 0.004). Conclusions: In this placebo controlled study, using a disease specific questionnaire, naftidrofuryl has been shown to significantly improve several aspects of the quality of life of patients with intermittent claudication.

scholarly journals One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients’ Depression: A Randomized, Single-Blinded, Controlled Study

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Kai-Jo Chiang ◽  
Tsai-Hui Chen ◽  
Hsiu-Tsu Hsieh ◽  
Jui-Chen Tsai ◽  
Keng-Liang Ou ◽  
...  
Keyword(s):  
Group Therapy ◽  
Rating Scale ◽  
Intervention Group ◽  
Automatic Thoughts ◽  
Controlled Study ◽  
Control Group ◽  
Cognitive Behavioral Group Therapy ◽  
One Year

The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention(P<0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended(P<0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up.

Sign in / Sign up

Export Citation Format

Share Document