scholarly journals Placebo and nocebo effects in the neurological practice

2015 ◽  
Vol 73 (1) ◽  
pp. 58-63 ◽  
Author(s):  
Caroline Bittar ◽  
Osvaldo J.M. Nascimento
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Gold Standard ◽  
Neurological Diseases ◽  
Nocebo Effect ◽  
Double Blind ◽  
Positive Effects ◽  
Specific Effects ◽  
Randomized Clinical Study ◽  
Nocebo Effects

Knowledge of placebo and nocebo effects is essential to identify their influence on the results in clinical practice and clinical trials, and thereby properly interpret their results. It is known that the gold standard of clinical trials research is the double-blind, placebo-controlled, randomized clinical study. The objective of this review is to distinguish specific from non-specific effects, so that the presence of positive effects in the group that received placebo (placebo effect) and the presence of adverse effects in the group receiving placebo (nocebo effect) lead to confounding in interpreting the results. Placebo and nocebo effects have been considered in neurological diseases such as depression, pain, headache, multiple sclerosis, epilepsy. As placebo and nocebo effects are also present in clinical practice, the purpose of this review is to draw attention to their influence on neurological practice, calling attention to the development of measures that can minimize them.

scholarly journals Unethical informed consent caused by overlooking poorly measured nocebo effects

2020 ◽  
pp. medethics-2019-105903
Author(s):  
Jeremy Howick
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Natural History ◽  
Adverse Events ◽  
Placebo Effect ◽  
Nocebo Effect ◽  
Control Groups ◽  
Nocebo Effects ◽  
Negative Outcome

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

scholarly journals Medicinal herbs with anti-depressant effects

2020 ◽  
Vol 9 (4) ◽  
pp. 309-317 ◽  
Author(s):  
Mahbubeh Setorki
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Complete Recovery ◽  
Medicinal Herbs ◽  
Double Blind ◽  
Synthetic Drugs ◽  
Positive Effects ◽  
Antidepressant Effects ◽  
Life Threatening ◽  
Echium Amoenum

Depression is a life-threatening chronic illness which affects people worldwide. Drugs used to treat this disease have multiple side effects and may cause drug-drug or drug-food interactions. Additionally, only 30% of patients respond adequately to the existing drugs and the remaining do not achieve complete recovery. Thus, finding effective treatments that have adequate efficacy, fewer side effects and lower cost seem to be necessary. The purpose of this study was to review animal and double-blind clinical studies on the anti-depressant effects of medicinal herbs. In this study, validated scientific articles indexed in PubMed, SID, Web of Science and Scopus databases were reviewed. A database search was performed using the following terms: clinical trials, depression, major depressive disorder, essential oil, extract and medicinal plant. Positive effects of a number of herbs and their active compounds such as St John’s-wort, saffron, turmeric, ginkgo, chamomile, valerian, Lavender, Echium amoenum and Rhodiola rosea L. in improvement of symptoms of mild, moderate or major depression have been shown in clinical trials. The above plants show antidepressant effects and have fewer side effects than synthetic drugs. Hence, they have the potential to treat patients with depression.

Designing a clinical trial for neurorehabilitation

2020 ◽  
pp. 47-60
Author(s):  
Bruce Dobkin ◽  
Clarisa Martinez
Keyword(s):  
Clinical Trials ◽  
Gold Standard ◽  
Trial Design ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Neurological Diseases ◽  
Parallel Group ◽  
Study Participants ◽  
Parallel Group Trial ◽  
Group Trial

The design, implementation, and analysis of clinical trials for the types of complex therapies needed to lessen impairments and disabilities that result from neurological diseases are reviewed. A multistep progression from feasibility testing in small groups of selected participants to the demonstration of efficacy in large-scale, multicentre randomized clinical trials is presented. Designs other than the ‘gold standard’ parallel-group trial can be used to optimize the contents of a new therapeutic strategy. Emphasis is placed on defining clinical characteristics and establishing a stable functional baseline for study participants. How the choices of outcome measure and comparison intervention affect the statistical and clinical significance of trial results are highlighted. Discussion of methodological concerns about randomization and blinded outcome assessment is followed by a review of common statistical confounders in neurorehabilitation trials. The use of consensus standards about trial reporting provides a valuable checklist for basic decisions in trial design.

scholarly journals Registration of clinical trials submitted for publication in International Psychogeriatrics

2006 ◽  
Vol 18 (2) ◽  
pp. 191-193 ◽  
Author(s):  
David Ames
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Gold Standard ◽  
Trial Design ◽  
Treatment Guidelines ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Or Management ◽  
Multifaceted Interventions

When we manage our patients both they and we would like to know that the interventions we prescribe have been tested and shown to be safe and effective for the uses to which they are put. The most powerful tool to determine the utility of specific interventions in the discipline of medicine is the double-blind placebo-controlled randomized clinical trial (RCT). Some of the complex problems encountered in psychogeriatrics do not lend themselves to straightforward yes or no outcomes, and some of the multifaceted interventions developed for the management of common psychogeriatric syndromes are difficult to test using standard RCT design, especially with regard to effective blinding and appropriate control conditions (Llewellyn-Jones et al. 1999; Haynes, 1999; Ames, 1999). Nevertheless, there are specific interventions for which RCT data have been very useful in refining treatment guidelines and advice (e.g. Doody et al., 2001) and, where this is the appropriate trial design, RCTs comprise the “gold standard” by which to assess the efficacy of a treatment or “management package”.

Comparative nocebo effects in older patients enrolled in cancer therapeutic trials: Observations from a 446-patient cohort—NCCTG 97-24-51 and ACOSOG Z9001 (Alliance A151602).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21545-e21545
Author(s):  
Jennifer Le-Rademacher ◽  
Jared C. Foster ◽  
Josephine Louella Feliciano ◽  
Ajeet Gajra ◽  
Drew K. Seisler ◽  
...  
Keyword(s):  
Adverse Event ◽  
Cancer Therapy ◽  
Adverse Events ◽  
Older Patients ◽  
Nocebo Effect ◽  
Double Blind ◽  
Inert Substance ◽  
Therapeutic Trials ◽  
Nocebo Effects ◽  
Event Rates

e21545 Background: A nocebo is an inert substance that causes adverse events. Although previous studies have examined the favorably positive (placebo) effects of an inert substance, few studies have examined negative (nocebo) effects, particularly in older patients who sometimes experience frequent and severe adverse events from cancer therapy. Methods: This study focused on placebo/nocebo-exposed patients who participated in two double-blind, placebo-controlled, cancer therapeutic studies, namely, North Central Cancer Treatment Group (NCCTG) 97-24-51 and American College of Surgeons Oncology Group (ACOSOG) Z9001, with the goal of reporting comparative, age-based adverse event rates. Results: Among the 446 patients who received placebo/nocebo exclusively, 161 were 65 years of age or older at the time of respective trial entry; 5234 adverse events occurred. Unadjusted adverse event rates did not differ significantly between patients 65 years of age or older and those younger: rate ratio (99% confidence intervals (CI): 1.01 (0.47, 2.02) with similar findings for grade 2 or worse adverse events and for all symptom-driven adverse events (for example, pain, loss of appetite, anxiety). Adjustment for sex, ethnicity, baseline performance score, and trial resulted in no significant age-based rate differences in adverse event rates. Similar findings were observed with an age threshold of 70. Conclusions: A nocebo effect appears to occur irrespective of age. This observation suggests that adverse events should be taken no less seriously in older than in younger cancer patients and that education to manage patients’ expectations from cancer therapy might improve tolerability. [Table: see text]

scholarly journals Advances in Molecular Characterization and Targeted Therapy in Dermatofibrosarcoma Protuberans

Sarcoma ◽  
2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Piotr Rutkowski ◽  
Agnieszka Wozniak ◽  
Tomasz Switaj
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Targeted Therapy ◽  
Gold Standard ◽  
Kinase Inhibitor ◽  
Fusion Gene ◽  
Dermatofibrosarcoma Protuberans ◽  
Residual Tumor ◽  
Significant Percentage ◽  
Molecular Events

The molecular pathogenesis of dermatofibrosarcoma protuberans (DFSP) involves distinctive rearrangement of chromosomes 17 and 22 leading to formation of theCOL1A1-PDGFBfusion gene. The knowledge of molecular events underlying development of DFSP resulted in the implementation of targeted therapy with imatinib—a tyrosine kinase inhibitor (TKI), to the clinical practice. The striking efficacy of imatinib in advanced cases of DFSP has been demonstrated in a few clinical trials. Thus, imatinib is currently considered the gold standard in the treatment of inoperable and/or metastatic and/or recurrent cases of DFSP. Therapy with imatinib may potentially facilitate resection or decrease possible disfigurement related to radical surgical procedure. Following partial response on imatinib significant percentage of patients may be rendered free of the disease by surgery of the residual tumor.

scholarly journals The Challenge: Finding the Most Appropriate Statin and Dose for Each Patient

2021 ◽  
Vol 70 (6 Supplement) ◽  
Author(s):  
Lillo
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Cardiovascular Risk ◽  
Patient Education ◽  
Statin Therapy ◽  
Common Reason ◽  
Nocebo Effect ◽  
Statin Intolerance

KEY TAKEAWAYS • Discontinuing statin therapy results in increased cardiovascular risk. • The nocebo effect is a common reason for perceived statin intolerance. • Statin intolerance is much less commonly reported in clinical trials than in clinical practice, suggesting that patient education and other safeguards employed in clinical trials are important to include in clinical practice. • Several strategies are available that can enable continuation of statin therapy in patients who are truly statin-intolerant.

scholarly journals Existing and Emerging Approaches to Treating Chronic Inflammatory Demyelinating Polyneuropathy

US Neurology ◽  
2019 ◽  
Vol 15 (1) ◽  
pp. 33
Author(s):  
Brannagan III Thomas H ◽  
Khosro Farhad ◽  
Inna Kleyman ◽  
Megan Leitch ◽  
Rebecca Traub ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Randomized Clinical Trials ◽  
Chronic Inflammatory Demyelinating Polyneuropathy ◽  
Neurological Diseases ◽  
Demyelinating Polyneuropathy ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Inflammatory Demyelinating Polyneuropathy

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare disabling disease with an incompletely understood autoimmune etiology. Differentiating the condition from other neurological diseases can be challenging and appropriate treatment is often delayed. Intravenous immunoglobulin (IVIg), plasmapheresis, corticosteroids and subcutaneous immunoglobulin (SCIg) have all been demonstrated to be beneficial in placebo-controlled, randomized clinical trials. Corticosteroids, including methylprednisolone and dexamethasone are effective and frequently used in CIDP but their long-term use is limited by side effects. One of the most commonly prescribed treatments for CIDP is IVIg which diminishes inflammatory processes and prevents disease progression. Treatment with IVIg has proven effective in randomized, double blind, placebo controlled, clinical trials and the results support its use in CIDP. For some patients, the benefit of IVIg, is limited by the frequency of infusions and systemic side effects such as flu-like symptoms, headache, and nausea. Other effective treatments for CIDP include corticosteroids that are associated with serious side effects in long-term use and plasmapheresis which requires specialized facilities. More recently, SCIg has been demonstrated in double blind, placebo-controlled studies to be effective for maintenance use in CIDP in patients whose disease has been controlled by IVIg. In a large clinical trial, 0.2 g/kg and 0.4 g/kg body weight doses of 20% SCIg equivalent to 1 mL/kg or 2 mL/kg, respectively, administered weekly, demonstrated efficacy in CIDP and were well tolerated. Immunomodulating treatments such as cyclophosphamide, mycophenolate mofetil and rituximab have also shown efficacy in select populations with CIDP.

Double-Blind Clinical Trials of Oral Triptans Vs Other Classes of Acute Migraine Medication — A Review

Cephalalgia ◽  
2004 ◽  
Vol 24 (5) ◽  
pp. 321-332 ◽  
Author(s):  
RB Lipton ◽  
ME Bigal ◽  
PJ Goadsby
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Acute Treatment ◽  
Statistical Power ◽  
Inclusion Criteria ◽  
Double Blind ◽  
Practice Experience ◽  
Primary Endpoints ◽  
Migraine Medication ◽  
Comparative Trials

Although the migraine clinical trials literature is enormous, we identified only nine published double-blind studies which compare an oral triptan with a non-triptan acute treatment. Of the nine comparative trials that met inclusion criteria for this review, six compared sumatriptan with other drugs, zolmitriptan was studied in two trials and eletriptan in one trial. In seven of the nine studies reviewed herein, differences between active treatments on the primary endpoints were not dramatic. Experience in clinical practice suggests that, for many patients, oral triptans are superior to non-specific acute treatments, creating a discrepancy between clinical trials results and clinical practice experience. Four possible explanations for the disparities between clinical trials and clinical practice are likely: (i) statistically significant differences may not have emerged because the studies lack adequate statistical power; (ii) patients treated with triptans in clinical practice may be relatively more responsive to triptans and relatively less responsive to other agents than those who participate in clinical trials (patient selection); (iii) headache response at 2 h, as measured in clinical trials, may not fully capture the benefits of triptans relative to other therapies, as assessed in clinical practice; (iv) waiting until pain is moderate or severe, as required in clinical trials, may disadvantage triptans relative to comparators.

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