scholarly journals Equity in vaccine trials for higher weight people? Protocol for a rapid review of inclusion and exclusion criteria for higher weight people in clinical trials for COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e050114
Author(s):  
Jessica Campbell ◽  
Matthew Hobbs ◽  
Lily O’Hara ◽  
Angela Ballantyne ◽  
Anita Heywood ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Weight Status ◽  
Vaccine Trial ◽  
Risk Of Bias ◽  
Rapid Review ◽  
Vaccine Platform ◽  
Exclusion Criteria ◽  
Vaccine Trials ◽  
Increased Risk ◽  
Trial Protocols

IntroductionVaccination is a public health strategy that aims to reduce the burden of viral illness, especially important for populations known or likely to be at increased risk for inequitable outcomes due to the disease itself or disparities in care accessed and received. The role of weight status in COVID-19 susceptibility and disease burden remains unclear. Despite this, higher weight is frequently described as a definitive risk factor for both susceptibility and disease severity. Therefore, COVID-19 vaccine trials should recruit a study group representative of the full weight spectrum, and undertake appropriate subgroup analysis by weight status to evaluate response and titrate dose regimes where indicated to ensure equitable outcomes for higher weight people.Methods and analysisWe aim to review inclusion and exclusion criteria of clinical trial protocols registered with ClinicalTrials.gov, ISRCTN Register, the WHO official vaccine trial register, and ‘The COVID-19 Vaccine Tracker’. To determine the number of trials including higher weight (body mass index >30 kg/m2) individuals and the number of trials conducting efficacy subgroup analyses by weight status. Screening, data extraction and quality appraisal of trial protocols will be completed independently by a minimum of two reviewers. Clinical trials will be assessed for risk of bias using the Risk of Bias-2 tool. We will conduct a descriptive analysis of extracted data. The following subsets are proposed: participation of higher weight people in COVID-19 vaccine trials by trial phase, country and vaccine platform.Ethics and disseminationEthical approval was not required for this review. The results of this rapid review will be presented at appropriate conferences and published in a suitable peer reviewed journal.PROSPERO registration numberCRD42020226573

scholarly journals Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1466
Author(s):  
Jessica Campbell ◽  
Juliet Sutherland ◽  
Danielle Bucknall ◽  
Lily O’Hara ◽  
Anita Heywood ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Weight Status ◽  
Health Inequities ◽  
Phase Iii ◽  
Rapid Review ◽  
Exclusion Criterion ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Vaccine Trials ◽  
Trial Protocols

Higher weight status, defined as body mass index (BMI) ≥ 30 kg/m2, is frequently described as a risk factor for severity and susceptibility to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (known as COVID-19). Therefore, study groups in COVID-19 vaccine trials should be representative of the weight spectrum across the global population. Appropriate subgroup analysis should be conducted to ensure equitable vaccine outcomes for higher weight people. In this study, inclusion and exclusion criteria of registered clinical trial protocols were reviewed to determine the proportion of trials including higher weight people, and the proportion of trials conducting subgroup analyses of efficacy by BMI. Eligibility criteria of 249 trial protocols (phase I, II, III and IV) were analysed; 51 protocols (20.5%) specified inclusion of BMI > 30, 73 (29.3%) specified exclusion of BMI > 30, and 125 (50.2%) did not specify whether BMI was an inclusion or exclusion criterion, or if BMI was included in any ‘health’ screenings or physical examinations during recruitment. Of the 58 protocols for trials in phase III and IV, only 2 (3.4%) indicated an intention to report subgroup analysis of vaccine efficacy by weight status. Higher weight people appear to be significantly under-represented in the majority of vaccine trials. This may result in reduced efficacy and acceptance of COVID-19 vaccines for higher weight people and exacerbation of health inequities within this population group. Explicit inclusion of higher weight people in COVID-19 vaccine trials is required to reduce health inequities.

scholarly journals Key Barriers to Clinical Trial Enrolment: A Survey of Clinical Trial Staff at an NCI Designated Cancer Center

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5864-5864
Author(s):  
Amany R. Keruakous ◽  
Adam S. Asch
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cultural Bias ◽  
Cancer Center ◽  
Exclusion Criteria ◽  
Strict Inclusion ◽  
Trial Protocols ◽  
Trial Staff ◽  
Disease Site ◽  
Patient Enrolment

Background: Clinical trials, key elements of the processes that account for many of the recent advances in cancer care, are becoming more complex and challenging to conduct. The Stephenson Cancer Center (SCC) has been the lead accruer to NCI-LAP trials over the past three years, and in addition, fields investigator initiated and industry sponsored trials. To identify opportunities for continued improvement in clinical trial enrolment, we sought to identify the obstacles encountered by our clinical trial staff in these activities. Method: We conducted a survey of our research staff including all research nurses and disease site coordinators who participate in recruitment, screening, consenting, data collection and compliance. The survey, sent by email to the clinical trial list-serve at SCC (90 staff member), invited respondents to enumerate obstacles to patient participation in clinical trials. We then performed a follow up meeting with our research coordinators to clarify responses. A total of 26 responses from 90 respondents were received and tabulated by disease site. Results: The most commonly reported obstacles to enrolment were, in descending order: communication/language barriers, cultural bias, time/procedure commitment, and complexity of the trial protocol, financial logistics, comorbidities, and stringent trial criteria. Respondents identified 83 obstacles as frequently encountered obstacles to enrolment. The 83 reported obstacles were classified into 9 categories and organized by disease site as presented in tabular format (below). The most commonly identified obstacles to patient enrolment were communication and language barriers. In patients for whom Spanish is the primary language this was a universal obstacle, as there is a lack of consistent Spanish consents across the clinical trial portfolio. Cultural bias, as an obstacle was manifested as a general mistrust by prospective trial participants of experimental therapies and clinical trials. After communication and cultural bias as barriers, travel requirements and the associated expenses playing a role in patients from rural areas were identified as the most commonly encountered barrier. The complexity of trial protocols and the associated large number of clinic visits, frequent laboratory and imaging tests were also identified as common obstacles. Clinical trial complexity with strict inclusion and exclusion criteria and trial-specified biopsies were frequently cited. Implications: In this descriptive study, common barriers to patient enrolment in clinical trials were identified by clinical trial staff. Assessing barriers encountered by clinical trial staff is infrequently used as a metric for improving clinical trial enrolment, but provides important perspective. In our study, some obstacles are inherent in our patient populations, others appear to be actionable. Development of Spanish language consents and specific programs to overcome negative bias regarding clinical trials are potential areas for improvement. The complexity of clinical trial protocols and the increasingly strict inclusion/exclusion criteria, are issues that will require consideration and action at the level of the cooperative groups and industry. Disclosures No relevant conflicts of interest to declare.

Bleeding in patients receiving vitamin K antagonists who would have been excluded from trials on which the indication for anticoagulation was based

Blood ◽  
2008 ◽  
Vol 111 (9) ◽  
pp. 4471-4476 ◽  
Author(s):  
Marcel Levi ◽  
G. Kees Hovingh ◽  
Suzanne C. Cannegieter ◽  
Marinus Vermeulen ◽  
Harry R. Büller ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Careful Consideration ◽  
Exclusion Criterion ◽  
Exclusion Criteria ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Risk Of Hemorrhage ◽  
Control Study

Abstract Vitamin K antagonists (VKAs) are effective antithrombotic agents and advocated in guidelines for the management of cardiovascular disease. However, in the trials underlying these guidelines, many patients were excluded. We performed a case-control study in 993 patients receiving VKAs, who required hospitalization for bleeding, and contrasted them to 993 matched control patients on VKAs, who were hospitalized for an infection. We analyzed whether patients and controls would have been eligible for the clinical trials on which their indication for anticoagulation was based, and estimated the risk of hemorrhage associated with exclusion criteria as applied in those trials. Approximately one quarter (23% [95% CI: 21%-26%]) of controls had one or more exclusion criteria for the trials, supporting the use of anticoagulation for their condition. Forty percent of patients presenting with bleeding had one or more exclusion criteria (95% CI: 37%-43%). Having one exclusion criterion resulted in a 2.9-fold increased risk of bleeding (95% CI: 2.2-3.9), and this risk increased sharply when more than one exclusion criterion was present. VKAs are often prescribed to patients who would not have qualified for clinical trials, and in these patients a careful consideration should be made regarding the expected efficacy and the risk of bleeding.

scholarly journals COVID-19 Vaccination for Cancer Patients, What Oncologists and Cancer Patients Need to Know?

2020 ◽  
pp. 1-4
Author(s):  
Humaid O Al-Shamsi ◽  
◽  
Mona Abdullah Alfares ◽  
Sadir Alrawi ◽  
◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Vaccine Trial ◽  
Current Evidence ◽  
Cell Transplant ◽  
Current Time ◽  
Global Regulators ◽  
Vaccine Trials ◽  
Inactivated Vaccines ◽  
The Uk

As the current evidence is accumulating in support of multiple COVID-19 vaccine in general population while the final regulatory approvals are still pending, multiple vaccine candidates have already received temporary authorization for emergency use. The mRNA vaccines are new to the clinical practice and global regulators must balance the lack of medium to longer-term data on these novel mRNA COVID-19 vaccines.The inactivated vaccines have been used in cancer patients in the past with excellent safety profile and they may be theoretically the safest vaccine for cancer patients. Currently there are no formal COVID-19 vaccine trial designed specifically for cancer patients. Some of the current major trials excluded cancer patients while others did not explicitly excluded malignancies. Early reports indicate that some cancer patients were able to enroll in some of the vaccine trials, yet no clear information if these patients were on active systemic therapies or surveillance. There is a need for a dedicated COVID-19 vaccine trials for cancer patients. The UK Independent report by the “ Joint Committee on Vaccination and Immunisation for the Priority groups for coronavirus (COVID-19) vaccination” recommended “bone marrow and stem cell transplant recipients and people with specific cancers” to receive priority vaccination, without further clarification which “specific cancers” were referred to. Until further data are available, recommendations for vaccination for COVID-19 for cancer patients cannot be routinely recommended. At the current time evaluation of cancer patients who wish to consider COVID-19 vaccination should be done in the context of clinical trials, if there is no access to clinical trials; This should be addressed “case by case” basis with clear discussion about potential benefits, risks and uncertainties surrounding COVID-19 vaccination for cancer patients at the current time.

scholarly journals Drug-drug interactions in subjects enrolled in SWOG trials of oral chemotherapy

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lauren A. Marcath ◽  
Colin M. Finley ◽  
Siu Fun Wong ◽  
Daniel L. Hertz
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Interactions ◽  
Data Accuracy ◽  
Exclusion Criterion ◽  
Cancer Trial ◽  
Oncology Clinical Trial ◽  
Increased Risk ◽  
Trial Protocols ◽  
Trial Subject

Abstract Background Patients with cancer are at increased risk of drug-drug interactions (DDI), which can increase treatment toxicity or decrease efficacy. It is especially important to thoroughly screen DDI in oncology clinical trial subjects to ensure trial subject safety and data accuracy. This study determined the prevalence of potential DDI involving oral anti-cancer trial agents in subjects enrolled in two SWOG clinical trials. Methods Completed SWOG clinical trials of commercially available agents with possible DDI that had complete concomitant medication information available at enrollment were included. Screening for DDI was conducted through three methods: protocol-guided screening, Lexicomp® screening, and pharmacist determination of clinical relevance. Descriptive statistics were calculated. Results SWOG trials S0711 (dasatinib, n = 83) and S0528 (everolimus/lapatinib, n = 84) were included. Subjects received an average of 6.6 medications (standard deviation = 4.9, range 0–29) at enrollment. Based on the clinical trial protocols, at enrollment 18.6% (31/167) of subjects had a DDI and 12.0% (20/167) had a DDI that violated a protocol exclusion criterion. According to Lexicomp®, 28.7% of subjects (48/167) had a DDI classified as moderate or worse, whereas pharmacist review indicated that 7.2% of subjects (12/167) had a clinically relevant interaction. The majority of clinically relevant DDI identified were due to the coadministration of acid suppression therapies with dasatinib (83.3%, 10/12). Conclusions The high DDI prevalence in subjects enrolled on SWOG clinical trials, including a high prevalence that violate trial exclusion criteria, support the need for improved processes for DDI screening to ensure trial subject safety and trial data accuracy.

P1434ALDOSTERONE ANTAGONISTS FOR PATIENTS UNDERGOING DIALYSIS: A SYSTEMATIC REVIEW AND META-ANALYSIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Takeshi Hasegawa ◽  
Hiroki Nihiwaki ◽  
Erika Ota ◽  
William Levack ◽  
Hisashi Noma
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Standard Care ◽  
Meta Analysis ◽  
Left Ventricular ◽  
Risk Of Bias ◽  
Marginal Effect ◽  
Aldosterone Antagonists ◽  
Risk Of Death ◽  
Increased Risk

Abstract Background and Aims Patients with chronic kidney disease (CKD) requiring dialysis are at a particularly high risk of cardiovascular mortality and morbidity. Several clinical trials suggested that aldosterone antagonists would be a promising treatment option for patients undergoing dialysis. However, the clinical efficacy and potential harm of aldosterone antagonists for patients with CKD on dialysis have yet to be determined. This review aimed to evaluate the benefits and harms of aldosterone antagonists, both non-selective (spironolactone) and selective (eplerenone), in comparison to control (placebo or standard care) in patients with CKD requiring haemodialysis or peritoneal dialysis. Method We searched the Cochrane Kidney and Transplant Register of Studies up to 29 July 2019 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register Search Portal and ClinicalTrials.gov. We included individual and cluster randomised controlled trials (RCTs), cross-over trials, and quasi-RCTs that compared aldosterone antagonists with placebo or standard care in patients with CKD requiring dialysis. Two review authors independently extracted data and assessed risk of bias for included studies. We used a random-effects model meta-analysis to perform a quantitative synthesis of the data. We used the I statistic to measure heterogeneity among the trials in each analysis. We indicated summary estimates as a risk ratio (RR) for dichotomous outcomes, mean difference (MD) for continuous outcomes, or standardised mean differences (SMD) if different scales were used, with their 95% confidence interval (CI). We assessed the certainty of the evidence for each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach. Results We included 14 trials (12 parallel RCTs and two cross-over trials) involving a total of 1,375 participants. Most included studies had an unclear or high risk of bias. Compared to control, aldosterone antagonists reduced the risk of all-cause death for patients with CKD requiring dialysis (9 trials, 1,119 participants: RR 0.45, 95% CI 0.30 to 0.67; I=0%; moderate certainty of evidence). Aldosterone antagonist also decreased the risk of death due to cardiovascular disease (6 trials, 908 participants: RR 0.37, 95% CI 0.22 to 0.64; I=0%; moderate certainty of evidence) and cardiovascular and cerebrovascular morbidity (3 trials, 328 participants: RR 0.38, 95% CI 0.18 to 0.76; I=0%; moderate certainty of evidence). While aldosterone antagonists had an apparent increased risk of gynaecomastia compared with control (4 trials, 768 participants: RR 5.95, 95% CI 1.93 to 18.3; I=0%; moderate certainty of evidence), the elevated risk of hyperkalaemia (9 trials, 981 participants: RR 1.41, 95% CI 0.72 to 2.78; I=47%; low certainty of evidence) and increase in serum potassium (7 trials, 519 participants: MD 0.21, 95% CI -0.06 to 0.47; I2=84%) due to aldosterone antagonists was uncertain. Aldosterone antagonists had a marginal effect on left ventricular mass among participants undergoing dialysis (7 trials, 562 participants: SMD -0.33, 95% CI -0.72 to 0.05; I2=76%). Conclusion Based on moderate certainty of the evidence, aldosterone antagonists could reduce the risk of all-cause and cardiovascular death and morbidity due to cardiovascular and cerebrovascular disease but increase the risk of gynaecomastia in patients with CKD requiring dialysis. Two ongoing studies will provide better certainty of evidence in the future.

scholarly journals Clinical Surveillance and Evaluation of Suspected Ebola Cases in a Vaccine Trial During an Ebola Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola

2018 ◽  
Vol 217 (suppl_1) ◽  
pp. S33-S39 ◽  
Author(s):  
Muhammad-Abbas Conteh ◽  
Susan T Goldstein ◽  
Haja R Wurie ◽  
Jane Gidudu ◽  
Durodami Radcliffe Lisk ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Case Management ◽  
Sierra Leone ◽  
Vaccine Trial ◽  
Case Definition ◽  
Case Definitions ◽  
Early Symptoms ◽  
Management Algorithm ◽  
Increased Risk ◽  
Common Diagnosis

Abstract The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE), an Ebola vaccine trial conducted during the 2014–2016 Ebola epidemic, coordinated with the Sierra Leone national response to identify Ebola cases among trial participants. The early symptoms of Ebola are similar to common vaccine reactions, so it was important to differentiate these to avoid unnecessary referral to an Ebola facility and an increased risk of Ebola exposure. STRIVE developed a modified version of the national case definition and case management algorithm to distinguish between symptoms associated with both Ebola and vaccination with the candidate Ebola vaccine (rVSV∆G-ZEBOV-GP) from those typically associated only with Ebola. For participants who presented ≤48 hours after vaccination, we used the more stringent modified case definition to trigger referral for Ebola evaluation. Participants whose symptoms did not meet case definitions could also be referred to an Ebola facility, based on clinical judgment. No Ebola cases were diagnosed among the 8651 STRIVE participants. Fifty participants were evaluated for Ebola, of whom 34 (68%) were tested after vaccination; 22 deceased participants, all of whom underwent postmortem Ebola testing, as required during the Ebola epidemic, and had negative test results, were excluded from analysis. Seven of 34 participants (21%) had symptom onset ≤48 hours after vaccination, of whom 3 met the modified case definition. The most common diagnosis among those evaluated for Ebola was malaria. STRIVE demonstrates the feasibility of conducting Ebola surveillance among persons vaccinated with rVSV-ZEBOV during an Ebola epidemic and introduces a modified case definition and case management algorithm to distinguish vaccine reactions from early symptoms of Ebola that may be useful for reducing unnecessary Ebola evaluations among persons vaccinated during Ebola outbreaks. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

A Review on Repurposed Drugs and Vaccine Trials for Combating SARS CoV-2

2021 ◽  
Vol 13 ◽  
Author(s):  
Nikita Khanna ◽  
Sandip V. Pawar ◽  
Anil Kumar
Keyword(s):  
Clinical Trials ◽  
Mechanism Of Action ◽  
World Health Organisation ◽  
World Health ◽  
Vaccine Platform ◽  
Vaccine Trials ◽  
Investigational Drugs ◽  
Repurposed Drugs ◽  
Novel Coronavirus ◽  
Investigational Agents

Background: The novel coronavirus disease 2019 (COVID-19), emerged in Wuhan, China in December 2019 and then spread worldwide rapidly. The records from World Health Organisation (WHO), Centres of Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) backup the fact that no medications have proven to be completely effective for prevention or treatment of SARS-CoV-2. The clinical trials are underway for many repurposed, investigational drugs and vaccine candidates. BioNTech and Pfizer Inc, Moderna, Gamaleya institute and University of Oxford (collaboration with AstraZeneca) announced positive results in the Phase 3 interim analyses of vaccine trials in November 2020. Twelve countries have approved Pfizer- BioNTech COVID-19 vaccine for emergency use, as of December 2020. Objectives: The objective was to summarize the repurposed/investigational drugs, their mechanism of action, and rationale for their use in COVID-19 treatment. The article also aimed to summarize the vaccine trials that are currently undergoing across the globe. Methods: In order to find the content for review, studies defining COVID-19 chronology, repurposed drugs along with their mode of action and potential vaccine trials were studied and summarized. Results and Conclusion: The article summarizes potential therapeutic candidates (repurposed and investigational agents) for SARS-CoV-2, their possible mechanism of action and discussion related to their involvement in recent clinical trials. Innovative vaccine platform technologies are also highlighted that are recently being used in the vaccine production pipeline.

scholarly journals Emotional Eating in Adolescence: Effects of Emotion Regulation, Weight Status and Negative Body Image

Nutrients ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 79
Author(s):  
Lenka H. Shriver ◽  
Jessica M. Dollar ◽  
Susan D. Calkins ◽  
Susan P. Keane ◽  
Lilly Shanahan ◽  
...  
Keyword(s):  
Body Image ◽  
Emotion Regulation ◽  
Emotional Regulation ◽  
Emotional Eating ◽  
Weight Status ◽  
Normal Weight ◽  
Linear Regression Models ◽  
Obesity Risk ◽  
Negative Body Image ◽  
Increased Risk

Emotional eating is associated with an increased risk of binge eating, eating in the absence of hunger and obesity risk. While previous studies with children and adolescents suggest that emotion regulation may be a key predictor of this dysregulated eating behavior, little is known about what other factors may be influencing the link between emotional regulation and emotional eating in adolescence. This multi-method longitudinal study (n = 138) utilized linear regression models to examine associations between childhood emotion regulation, adolescent weight status and negative body image, and emotional eating at age 17. Emotion regulation predicted adolescent emotional eating and this link was moderated by weight status (β = 1.19, p < 0.01) and negative body image (β = −0.34, p < 0.01). Higher engagement in emotional eating was predicted by lower emotional regulation scores among normal-weight teens (β = −0.46, p < 0.001) but not among overweight/obese teens (β = 0.32, p > 0.10). Higher scores on emotion regulation were significantly associated with lower emotional eating at high (β = −1.59, p < 0.001) and low (β = −1.00, p < 0.01) levels of negative body image. Engagement in emotional eating was predicted by higher negative body image among overweight/obese teens only (β = 0.70, p < 0.001). Our findings show that while better childhood emotion regulation skills are associated with lower emotional eating, weight status and negative body image influence this link and should be considered as important foci in future interventions that aim to reduce emotional eating in adolescence.

scholarly journals Effects of open-label placebos in clinical trials: a systematic review and meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Melina von Wernsdorff ◽  
Martin Loef ◽  
Brunna Tuschen-Caffier ◽  
Stefan Schmidt
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medical Condition ◽  
Data Extraction ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Open Label ◽  
Cancer Related Fatigue ◽  
Promising Treatment ◽  
Irritable Bowel

AbstractOpen-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and thirteen studies were included into the systematic review. Eleven trials were eligible for meta-analysis. These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. Risk of bias was moderate among all studies. We found a significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions but the respective research is in its infancy. More research is needed, especially with respect to different medical and mental disorders and instructions accompanying the OLP administration as well as the role of expectations and mindsets.

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