An urgent need to include risk–benefit analysis in clinical trials investigating conjugated linoleic acid supplements in cancer patients

2011 ◽  
Vol 32 (1) ◽  
pp. 69-73 ◽  
Author(s):  
Reza Rastmanesh
Keyword(s):  
Clinical Trials ◽  
Linoleic Acid ◽  
Conjugated Linoleic Acid ◽  
Cancer Patients ◽  
Benefit Analysis ◽  
Risk Benefit Analysis

scholarly journals Applying a Risk-benefit Analysis to Outcomes in Tuberculosis Clinical Trials

2019 ◽  
Vol 70 (4) ◽  
pp. 698-703 ◽  
Author(s):  
Sachiko Miyahara ◽  
Ritesh Ramchandani ◽  
Soyeon Kim ◽  
Scott R Evans ◽  
Amita Gupta ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Systematic Approach ◽  
Composite Outcome ◽  
Efficacy And Safety ◽  
Benefit Analysis ◽  
Prevention Study ◽  
Design Considerations ◽  
The Mean ◽  
Risk Benefit Analysis ◽  
Noninferiority Margin

Abstract Although it is common to analyze efficacy and safety separately in clinical trials, this could yield a misleading study conclusion if an increase in efficacy is accompanied by a decrease in safety. A risk-benefit analysis is a systematic approach to examine safety and efficacy jointly. Both the “rank-based” and “partial-credit” methods described in this paper allow researchers to create a single, composite outcome incorporating efficacy, safety, and other factors. The first approach compares the distribution of rankings between arms. In the second approach, a score can be assigned to each outcome category, considering its severity and comparing the mean or median scores of arms. The methods were applied to the A5279/Brief Rifapentine-Isoniazid Efficacy for TB Prevention study, and design considerations for future clinical trials are discussed, including the challenge of arriving at a consensus on rankings/scorings. If well designed, a risk-benefit analysis may allow for a superiority comparison and, therefore, avoid setting a noninferiority margin. Clinical Trials Registration. NCT01404312 (A5279).

Conjugated Linoleic Acid Content in Breast Adipose Tissue of Breast Cancer Patients and the Risk of Metastasis

2003 ◽  
Vol 45 (1) ◽  
pp. 17-23 ◽  
Author(s):  
Véronique Chajès ◽  
Flore Lavillonnière ◽  
Virginie Maillard ◽  
Bruno Giraudeau ◽  
Marie-Lise Jourdan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adipose Tissue ◽  
Linoleic Acid ◽  
Conjugated Linoleic Acid ◽  
Cancer Patients ◽  
Acid Content ◽  
Linoleic Acid Content ◽  
Breast Cancer Patients ◽  
Breast Adipose Tissue ◽  
Breast Adipose

Effects of conjugated linoleic acid supplementation on serum leptin levels, oxidative stress factors and tumor marker in rectal cancer patients undergoing preopeatrive chemoradiotherapy

2021 ◽  
pp. 1-9
Author(s):  
Elnaz Faramarzi ◽  
Mohammad Mohammadzadeh ◽  
Sarvin Sanaie ◽  
Vibeke Andersen ◽  
Reza Mahdavi
Keyword(s):  
Rectal Cancer ◽  
Placebo Group ◽  
Linoleic Acid ◽  
Conjugated Linoleic Acid ◽  
Cancer Patients ◽  
Total Antioxidant Status ◽  
Serum Levels ◽  
Stress Factors ◽  
Serum Leptin ◽  
Major Factors

BACKGROUND: Inflammation is considered as one of the major factors in chemoradiotherapy toxicity. It has been reported that conjugated linoleic acid (CLA) has anti-inflammatory properties. OBJECTIVE: The aim of this study was to assess the effect of CLA supplementation on serum levels of leptin, interleukin 8 (IL-8), malondialdehyde (MDA), total antioxidant status (TAS), and carcinoembryonic antigen (CEA) in rectal cancer patients treated with chemoradiotherapy. METHODS: In this study, 34 rectal cancer patients were allocated to either the CLA group, who received four 1000 mg capsules (each capsule containing 760 mg CLA; 4 capsules providing 3 g CLA) 3 times/day, or the placebo group, who received 4 placebo capsules 3 times/day, for 6 weeks. RESULTS: The mean serum leptin level insignificantly increased in both groups; however, this elevation was remarkable in the CLA group. CLA supplementation reduced IL-8 by –0.62 pg/mL while placebo supplementation decreased it by –0.44 pg/mL. CEA levels were decreased by CLA supplementation, while its reduction in the placebo group was negligible compared to the CLA group. The elevation of MDA levels after CLA supplementation was about half of the placebo group in the CLA group. CONCLUSION: Since this study was the first to assess the effect of CLA supplementation on a small number of cancer patients, it is suggested further studies are conducted on larger sample size with various doses of CLA to obtain more clear results.

scholarly journals Conjugated Linoleic Acid Isomers Affect Profile of Lipid Compounds and Intensity of Their Oxidation in Heart of Rats with Chemically-Induced Mammary Tumors—Preliminary Study

Nutrients ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 2032 ◽  
Author(s):  
Małgorzata Białek ◽  
Agnieszka Białek ◽  
Marian Czauderna
Keyword(s):  
Breast Cancer ◽  
Linoleic Acid ◽  
Conjugated Linoleic Acid ◽  
Cancer Patients ◽  
High Performance ◽  
Cardiac Tissue ◽  
Cardiac Risk ◽  
Female Rats ◽  
Breast Cancer Patients ◽  
Shared Risk

Breast cancer and cardiovascular diseases (CVD) have shared risk factors and mechanisms of pathogenicity, as proven by increased cardiac risk in breast cancer patients receiving anticancerogenic therapies and in cancer survivors. A growing mammary tumor may cause heart injury in cancer patients who have not yet been treated. This study aimed to evaluate the effect of conjugated linoleic acid (CLA) supplementation of female rats with 7,12-dimethylbenz(a)anthracene (DMBA)-induced cancerogenesis on fatty acids (FAs), conjugated FAs (CFAs), malondialdehyde (MDA), cholesterol and oxysterols content in cardiac tissue. FAs, cholesterol and oxysterols contents were determined by gas chromatography coupled with mass spectrometry, while the contents of CFAs and MDA were determined by high performance liquid chromatography with photodiode detection. Our results indicate that both CLA supplementation and the presence of tumors influence the lipid biomarkers of CVD. A significant interaction of both experimental factors was observed in the content of polyunsaturated FAs (PUFAs), n-6 PUFAs and CFAs. CLA supplementation significantly inhibited PUFA oxidation, as evidenced by the lower content of MDA in rats’ hearts, while the cancerous process intensified the oxidation of cholesterol, as confirmed by the elevated levels of 7-ketocholesterol in DMBA-treated rats. These results may significantly expand knowledge about CLA properties in terms of the prevention of co-existing non-communicable diseases.

High-Dose Neuroleptics: Uncontrolled Clinical Practice Confirms Controlled Clinical Trials

1984 ◽  
Vol 144 (1) ◽  
pp. 25-27 ◽  
Author(s):  
Paola Bollini ◽  
Amato Andreani ◽  
Fabio Colombo ◽  
Cesario Bellantuono ◽  
Paola Beretta ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
General Hospital ◽  
Adverse Reactions ◽  
Complete Recovery ◽  
Psychiatric Ward ◽  
High Dose ◽  
Benefit Analysis ◽  
Controlled Clinical Trials ◽  
Risk Benefit Analysis

SummaryThe strategy of high-dose intramuscular haloperidol as routinely applied in a general hospital psychiatric ward to 74 successive patients, 33 of whom stayed only up to seven days, and a further 34 up to 15 days, led to a complete recovery in only six, and complete lack of change in 23. Adverse reactions were recorded in 42, severe enough to stop treatment in eight; there were three deaths. In view of this risk-benefit analysis, systematic application of this high dose strategy to get a more rapid turnover of patients is unjustified.

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