Effect of Fish Oil on Appetite and Other Symptoms in Patients With Advanced Cancer and Anorexia/Cachexia: A Double-Blind, Placebo-Controlled Study

2003 ◽  
Vol 21 (1) ◽  
pp. 129-134 ◽  
Author(s):  
Eduardo Bruera ◽  
Florian Strasser ◽  
J. Lynn Palmer ◽  
Jie Willey ◽  
Kathryn Calder ◽  
...  
Keyword(s):  
Nutritional Status ◽  
Fish Oil ◽  
Advanced Cancer ◽  
Caloric Intake ◽  
Well Being ◽  
Controlled Study ◽  
Double Blind ◽  
Baseline Weight ◽  
High Doses ◽  
And Function

Purpose: To determine whether high doses of fish oil, administered over 2 weeks, improve symptoms in patients with advanced cancer and decreased weight and appetite. Patients and Methods: Sixty patients were randomly assigned to fish oil capsules or placebo. Appetite, tiredness, nausea, well-being, caloric intake, nutritional status, and function were prospectively assessed at days 1 and 14. Results: The baseline weight loss was 16 ± 11 and 16 ± 8 kg in the fish oil (n = 30) and placebo (n = 30) group respectively, whereas the baseline appetite (0 mm = best and 10 mm = worst) was 58 ± 24 mm and 67 ± 19 mm, respectively (P = not significant). The mean daily dose was 10 ± 4 (fish oil group) and 9 ± 3 (placebo group) capsules, which provided 1.8 g of eicosapentaenoic acid and 1.2 g of docosahexaenoic acid in the fish oil group. No significant differences in symptomatic or nutritional parameters were found (P < .05), and there was no correlation between changes in different variables between days 1 and 14 and the fish oil doses. Finally, the majority of the patients were not able to swallow more than 10 fish oil capsules per day, mainly because of burping and aftertaste. Conclusion: Fish oil did not significantly influence appetite, tiredness, nausea, well-being, caloric intake, nutritional status, or function after 2 weeks compared with placebo in patients with advanced cancer and loss of both weight and appetite.

Effect of Fish Oil on Appetite and Other Symptoms in Patients with Advanced Cancer and Anorexia/Cachexia: A Double-Blind, Placebo-Controlled Study

2003 ◽  
Vol 18 (6) ◽  
pp. 524-524 ◽  
Author(s):  
E Bruera ◽  
F Strasser ◽  
JL Palmer ◽  
J Willey ◽  
K Calder ◽  
...  
Keyword(s):  
Fish Oil ◽  
Advanced Cancer ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

Effects of Hypericum Extract on the Sleep EEG in Older Volunteers

1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 39-43 ◽  
Author(s):  
H. Schulz ◽  
M. Jobert
Keyword(s):  
Tricyclic Antidepressants ◽  
Visual Analysis ◽  
Well Being ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Older Volunteers ◽  
Washout Phase ◽  
High Doses ◽  
Hypericum Extract

The effects of treatment with high doses (300 mg three times daily) of hypericum extract LI 160 on sleep quality and well-being were investigated over a 4-week period. The double-blind, placebo-controlled study was conducted with 12 older, healthy volunteers in a cross-over design, which included a 2-week washout phase between both treatment phases. A hypostatic influence of the REM sleep phases, which is typical for tricyclic antidepressants and MAO inhibitors, could not be shown for this phytopharmacon. Instead, LI 160 induced an increase of deep sleeP during the total sleeping period. This could be shown consistently in the visual analysis of the sleeping phases 3 and 4, as well as in the automatic analysis of slow-wave EEG activities. The continuity of sleep was not improved by LI 160; this was also the case for the onset of the sleep, the intermittent wake-up phases, and total sleep duration.

Comparative effects of low and high doses of clomipramine and placebo in panic disorder: a double-blind controlled study

1999 ◽  
Vol 99 (1) ◽  
pp. 51-58 ◽  
Author(s):  
V. Caillard ◽  
F. Rouillon ◽  
J. F. Viel ◽  
S. Markabi
Keyword(s):  
Panic Disorder ◽  
Controlled Study ◽  
Double Blind ◽  
High Doses

Effects of dehydroepiandrosterone on fatigue and well-being in women with quiescent systemic lupus erythematosus: a randomised controlled trial

2009 ◽  
Vol 69 (6) ◽  
pp. 1144-1147 ◽  
Author(s):  
A Hartkamp ◽  
R Geenen ◽  
G L R Godaert ◽  
M Bijl ◽  
J W J Bijlsma ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Controlled Trial ◽  
Well Being ◽  
Controlled Study ◽  
Systemic Lupus ◽  
Double Blind ◽  
Female Patients ◽  
General Fatigue ◽  
Mental Well Being

ObjectiveDehydroepiandrosterone (DHEA) has been reported to improve fatigue and reduced well-being. Both are major problems in patients with systemic lupus erythematosus (SLE), even with quiescent disease. Low serum DHEA levels are common in SLE. The present work investigates the effects of DHEA administration on fatigue, well-being and functioning in women with inactive SLE.MethodsIn a double-blind, randomised, placebo-controlled study, 60 female patients with inactive SLE received 200 mg oral DHEA or placebo. Primary outcome measures were general fatigue, depressive mood, mental well-being and physical functioning. Assessments were made before treatment, after 3, 6 and 12 months on medication, and 6 months after cessation of treatment.ResultsPatients from the DHEA and placebo group improved on general fatigue (p<0.001) and mental well-being (p=0.04). There was no differential effect of DHEA. The belief that DHEA had been used was a stronger predictor for improvement of general fatigue than the actual use of DHEA (p=0.04).ConclusionsThe trial does not indicate an effect of daily 200 mg oral DHEA on fatigue and well-being, and therefore DHEA treatment is not recommended in unselected female patients with quiescent SLE.Clinical Trials Registration Number NCT00391924

scholarly journals Efficacy of Lactobacillus paracasei HA-196 and Bifidobacterium longum R0175 in Alleviating Symptoms of Irritable Bowel Syndrome (IBS): A Randomized, Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1159 ◽  
Author(s):  
Erin D. Lewis ◽  
Joseph M. Antony ◽  
David C. Crowley ◽  
Amanda Piano ◽  
Renu Bhardwaj ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Irritable Bowel Syndrome ◽  
Bifidobacterium Longum ◽  
Well Being ◽  
Lactobacillus Paracasei ◽  
Controlled Study ◽  
Double Blind ◽  
Gi Symptoms ◽  
Irritable Bowel

Specific probiotic strains can alleviate the gastrointestinal (GI) symptoms and psychiatric comorbidities of irritable bowel syndrome (IBS). In this randomized, double-blind, placebo-controlled study, the efficacy of Lactobacillus paracasei HA-196 (L. paracasei) and Bifidobacterium longum R0175 (B. longum) in reducing the GI and psychological symptoms of IBS was evaluated in 251 adults with either constipation (IBS-C), diarrhea (IBS-D), or mixed-pattern (IBS-M). Following a 2-week run-in period, participants were randomized to one of three interventions: L. paracasei (n = 84), B. longum (n = 83) or placebo (n = 81). IBS symptoms, stool frequency and consistency and quality of life were assessed by questionnaires. The differences from baseline in the severity of IBS symptoms at 4 and 8 weeks were similar between groups. Participants in this study were classified, after randomization, into subtypes according to Rome III. Within the L. paracasei group, complete spontaneous and spontaneous bowel movement frequency increased in participants with IBS-C (n = 10) after 8 weeks of supplementation (both p < 0.05) and decreased in participants with IBS-D (n = 10, p = 0.013). Both L. paracasei and B. longum supplementation improved the quality of life in emotional well-being and social functioning compared with baseline (all p < 0.05). In conclusion, L. paracasei and B. longum may reduce GI symptom severity and improve the psychological well-being of individuals with certain IBS subtypes.

scholarly journals Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised clinical trial

2020 ◽  
pp. annrheumdis-2020-217259
Author(s):  
Paula Dakin ◽  
Alan J Kivitz ◽  
Joseph S Gimbel ◽  
Nebojsa Skrepnik ◽  
Stephen J DiMartino ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Phase Ii ◽  
Chronic Low Back Pain ◽  
Randomised Clinical Trial ◽  
Controlled Study ◽  
Low Back ◽  
Efficacy And Safety ◽  
Double Blind ◽  
And Function

ObjectivesTo study the efficacy and safety of fasinumab in moderate-to-severe, chronic low back pain (CLBP).MethodsIn this phase II/III, double-blind, placebo-controlled study, patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids were randomised to fasinumab 6 or 9 mg subcutaneous every 4 weeks (Q4W), 9 mg intravenous every 8 weeks (Q8W) or placebo. Primary endpoint was change from baseline to week 16 in average daily low back pain intensity (LBPI) numeric rating score. Key secondary efficacy variables included Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA). The results are based on a modified intent-to-treat analysis of 563/800 planned patients when enrolment was stopped early given emerging signals of joint risk in other osteoarthritis (OA) studies at doses being tested here.ResultsSignificant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) −0.7 (0.3); both nominal p<0.05), but not 6 mg (–0.3 (0.3); p=0.39). RMDQ and PGA improvements to week 16 were greatest for fasinumab 9 mg intravenous. Numerically greater efficacy occurred in patients with, versus those without, peripheral OA (pOA) over 16 weeks. Treatment-emergent adverse events (AEs) occurred in 274/418 (65.6%) patients in the combined fasinumab groups and 94/140 (67.1%) placebo patients. Joint AEs, mostly rapid progressive OA type 1, were more frequent in the combined fasinumab groups (19 events in 16 patients (3.8%) vs 1 event in 1 patient (0.7%) for placebo); all except one occurred in pOA patients.ConclusionsFasinumab highest doses, but not lower dose, improved both CLBP pain and function. Most joint AEs occurred in pOA patients, consistent with earlier findings in symptomatic OA. Further study is needed of patients with CLBP with and without pOA to determine optimal benefit–risk.

Dexamethasone (DM) for cancer-related fatigue: A double-blinded, randomized, placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9002-9002 ◽  
Author(s):  
Sriram Yennurajalingam ◽  
Susan Frisbee-Hume ◽  
Marvin Omar Delgado-Guay ◽  
Janet Bull ◽  
Alexandria T. Phan ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Symptom Assessment ◽  
Primary Objective ◽  
Controlled Study ◽  
Advanced Cancer Patients ◽  
Double Blind ◽  
Cancer Related Fatigue ◽  
Significant Difference ◽  
Edmonton Symptom Assessment Scale

9002 Background: Cancer-related-fatigue (CRF) is the most common and distressing symptoms in patients with advanced cancer. Currently, there is no standard treatment for CRF. Although corticosteroids have been used in the treatment of CRF, there are no well-powered placebo-controlled trials that used a validated CRF outcome measure. The primary objective of this prospective, randomized, double-blind, placebo-controlled study is to compare the effect of DM versus placebo on CRF. Methods: Advanced cancer patients with fatigue ≥ 4/10 on the Edmonton Symptom Assessment Scale (ESAS) and at least 2 other CRF-related symptoms (pain, nausea, appetite, depression, anxiety or sleep disturbance ≥ 4/10), normal cognition, no infections and hemoglobin ≥ 9 g/L were eligible for enrollment. Patients were randomized to either receive dexamethasone 4 mg orally twice a day for 15 days (primary end point) or matching placebo. The primary outcome was the day 15 change in Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores. Differences in the group means (normal distribution) were analyzed using the two-sample t-test. Results: In 83 evaluable patients (43 DM and 40 placebo), median age was 60 years, 61% were white, and 53% were female. There was no difference in the demographics and fatigue (FACIT-F subscale) between DM and placebo groups except for sex (p=0.02). The mean (SD) FACIT-F subscores at baseline and at day 15 for DM were 18 (11) and 27 (11) (p<0.001) and for placebo were 21 (9) and 24 (12) (p=0.06), respectively. Mean improvement in FACIT-F subscale was significantly higher in the DM group compared to placebo (9.6 (11) vs. 3.1 (9.7), p=0.005). We found a significant difference in ESAS physical distress (p=0.02), but no differences in ESAS overall symptom distress (p=0.11) and ESAS psychological distress (P=0.88) between DM and placebo. There were insignificantly higher numbers of grade ≥3 toxicities in patients who received DM than in patients who received placebo (20/42 vs. 18/47, p=0.37). Conclusions: Dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer. Long-term safety studies are needed.

Dose-remission of pulsating electromagnetic fields as augmentation in therapy-resistant depression: a randomized, double-blind controlled study

2014 ◽  
Vol 26 (5) ◽  
pp. 272-279 ◽  
Author(s):  
Birgit Straasø ◽  
Lise Lauritzen ◽  
Marianne Lunde ◽  
Maj Vinberg ◽  
Lone Lindberg ◽  
...  
Keyword(s):  
Electromagnetic Fields ◽  
Depression Scale ◽  
Well Being ◽  
Dose Effect ◽  
Controlled Study ◽  
Hamilton Depression Scale ◽  
Self Administration ◽  
Double Blind ◽  
Resistant Depression ◽  
Active Dose

ObjectiveTo evaluate to what extent a twice daily dose of Transcranial Pulsating ElectroMagnetic Fields (T-PEMF) was superior to once daily in patients with treatment-resistant depression as to obtaining symptom remission after 8 weeks of augmentation therapy.MethodsA self-treatment set-up of the T-PEMF device was used allowing self-administration by patients in own homes. All patients were treated for 30 min per T-PEMF session. The antidepressant medication the patients were receiving at baseline remained unchanged during the trial. The patients were randomised to either one T-PEMF dose (active dose in the morning and sham in the afternoon) or two T-PEMF doses (active dose both morning and afternoon) in a double-blind procedure. A score of 7 or less on the Hamilton Depression Scale (HAM-D17) was the criterion of remission.ResultsIn total 34 patients received active T-PEMF once a day and 31 patients twice daily. After 5 weeks of therapy remission was obtained in 26.5% and 32.3% on one dose and two doses of T-PEMF, respectively. After 8 weeks the rate of remission was 73.5% and 67.7%, respectively. The side effects as measured by the Udvalget for Kliniske Undersøgelser scale showed a better toleration of the antidepresssive medication in both treatment groups, which was reflected by the WHO-5 well-being scale with increased scores in both groups of patients.ConclusionThe high remission rate obtained by the T-PEMF augmentation was not a dose effect (one versus two daily T-PEMF sessions) but was explained by the extension of the treatment period from 5 to 8 weeks.

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