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Acute gastroenteritis is a common illness, and treatment with probiotics is common. In a double-blind, placebo-controlled trial, treatment with Lactobacillus rhamnosus GG was found to afford no benefit in reducing symptoms associated with acute gastroenteritis in children.

Restoring intestinal flora may improve outcomes in children with acute gastroenteritis. In this multicenter trial, the administration of lactobacillus for 5 days in children with acute gastroenteritis was not associated with clinical benefit.

Background: Chemotherapy-induced nausea and vomiting is a common problem in patients undergoing chemotherapy, influencing quality of life (QoL) and daily activities. This study will investigate whether therapists’ positive communication may strengthen positive treatment expectations and induce antiemetic effects during antiemetic treatment using standard care, sham acupuncture, or verum acupuncture, compared to neutral communication. It will also investigate whether a variety of patient, therapist and treatment components modify the treatment outcomes. Methods: This is a trial protocol for a randomized, sham-controlled, patient- and evaluator-blinded clinical trial. Patients (n = 198 patients according to a sample size calculation) with breast, colorectal, or bladder cancer undergoing neo-/adjuvant moderately to highly emetogenic chemotherapy are being randomized in 2 × 3 factorial design to the following conditions: 1. neutral or 2. positive communication style regarding expected treatment effects, during the antiemetic treatment types: A) standard care only (including antiemetics, no acupuncture), or, in addition to standard care, B) sham acupuncture with telescopic non-penetrating needles, or C) verum, penetrating acupuncture. The 2 communication styles 1 and 2 are carried out during the antiemetic treatments given by an intervention therapist immediately pre and post (20 minutes × 2) an intravenous chemotherapy session. Data are being collected at baseline on the day before the chemotherapy session, daily for 10 days, at a 10-day follow-up, and at a follow-up after completing the entire chemotherapy period, lasting about 6 months. Primary outcome is mean score Visual Analog Scale nausea grading for the first 5 days of the chemotherapy session period. Secondary outcomes are for example, vomiting, treatment expectations, QoL, daily and physical activity, and physiological measures. Treatment effect modifiers will be analyzed, for example, blinding success, treatment expectations, and previous nausea experiences. Conclusions: This trial will expand integrative cancer care’s understanding of the effects of communication for strengthening treatment expectations and thus alleviating chemotherapy-induced nausea and vomiting. If proven effective, the communication model of strengthening positive treatment expectations in patients with risk for nausea and vomiting can be implemented in routine clinical care as part of side-effect management for patients with cancer. Trial registration: US National Institutes of Health, https://clinicaltrials.gov/study/NCT03232541?term=NCT03232541&rank=1), # NCT03232541.

Background Nausea and vomiting are frequent complaints during pregnancy, which can be accompanied by marital discord and sexual dissatisfaction, in addition to the hospitalization of pregnant women. Given the potential side effects of pharmaceutical treatments on both the mother and fetus, many women prefer non-pharmacological interventions. This study will assess the impact of an educational program based on the Ottawa Nutritional Guide on symptoms in pregnant women and explore sexual satisfaction as a secondary outcome. Methods In this randomized controlled clinical trial, a total of 60 pregnant women aged between 15 and 45 years, who scored 3–16 on the Rhodes Index of Nausea, Vomiting and Retching (RINVR), will be selected via convenience sampling. They will be then divided into two intervention and control groups through block randomization. Data will be collected using a demographic and obstetric checklist, the RINVR, and the Hudson’s Index of Sexual Satisfaction (ISS). The intervention group will be received training on the Ottawa Nutritional Guide in two 60-min sessions, conducted in groups of two to five people. The control group, on the other hand, received routine care. The collected data will be analyzed using SPSS Version 22. Discussion Several studies have reported the effectiveness of the Ottawa Nutritional Guide in managing nausea and vomiting in pregnant women, as well as its positive impact on their quality of life and marital satisfaction. However, further research is required to validate these findings before considering it as a potential alternative to pharmaceutical methods during pregnancy. Trial registration This study was registered in the Iranian Registry of Clinical Trials (IRCT20180218038783N5, registered 03/09/2023). Plain English summary Nausea and vomiting are common issues that many pregnant women face, and these symptoms can also lead to relationship problems and dissatisfaction with sexual life. Since medical treatments can have risks for both mothers and their babies, many women prefer to explore non-drug options. Ottawa Nutritional Guide may help manage nausea and improve the quality of life and marital happiness for pregnant women.

Postoperative nausea and vomiting are typical postsurgical complications. Drug therapy is only partially effective. The goal of our meta-analysis is to systematically evaluate the efficacy and safety of electrical acupoint stimulation for postoperative nausea and vomiting and to score the quality of evidence supporting this concept. PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov were searched from inception to March 19, 2020. Twenty-six studies (2064 patients) were included. Compared with control treatment, electrical acupoint stimulation reduced the incidence of postoperative nausea and vomiting (RR 0.49, 95% CI 0.41 to 0.57, P < 0.001), postoperative nausea (RR 0.55, 95% CI 0.47 to 0.64, P < 0.001) and postoperative vomiting (RR 0.56, 95% CI 0.45 to 0.70, P < 0.001). Electrical acupoint stimulation also reduced the number of patients requiring antiemetic rescue (RR 0.60, 95% CI 0.43 to 0.85, P = 0.004). No differences in adverse events were observed. Subgroup analysis showed that both electroacupuncture (RR 0.58, 95% CI 0.46 to 0.74, P < 0.001) and transcutaneous electrical acupoint stimulation (RR 0.44, 95% CI 0.34 to 0.58, P < 0.001) had significant effects. Electrical acupoint stimulation was effective whether administered preoperatively (RR 0.40, 95% CI 0.27 to 0.60, P < 0.001), postoperatively (RR 0.59, 95% CI 0.46 to 0.76, P < 0.001), or perioperatively (RR 0.50, 95% CI 0.37 to 0.67, P < 0.001). The quality of evidence was moderate to low. Electrical acupoint stimulation probably reduce the incidence of postoperative nausea and vomiting, postoperative nausea, postoperative vomiting, and reduce the number of patients requiring antiemetic rescue, with few adverse events.

Background Auricular acupressure (AA) has been viewed as a promising approach to managing chemotherapy-induced nausea and vomiting (CINV) but relevant research evidence has been inconclusive. This study aimed to examine the effects of AA on CINV in breast cancer (BC) patients undergoing chemotherapy. Methods A preliminary randomized controlled trial was conducted in 114 BC patients. Participants were randomly allocated to a true AA group ( n  = 38), a sham AA group ( n  = 38), and a standard care group ( n  = 38). All the participants were provided with standard antiemetic treatment and care, while the true AA group and the sham AA group received an additional 5-day true AA and a 5-day sham AA, respectively. Acute and delayed CINV were assessed by using the MASCC Antiemesis Tool (MAT), anticipatory nausea and vomiting were measured by the Index of Nausea, Vomiting, and Retching (INVR), and patients’ quality of life (QoL) was evaluated by the Functional Assessment of Cancer Therapy-Breast (FACT-B). Results Both the true and sham AA groups reported improved CINV outcomes than the standard care group, with the true AA demonstrating larger effects than the sham comparison. The true and sham AA groups had higher complete response (CR) rates of CINV when compared with the standard care group, with the difference in the CR of acute CINV achieving statistical significance ( p  = 0.03). Both the true and sham AA groups demonstrated lower incidence and severity of acute CINV compared with the standard care group with the among-group difference reaching statistical significance for the occurrence ( p  = 0.04) and severity ( p  = 0.001) of acute nausea. No significant differences in anticipatory CINV and QoL were found among the groups. Conclusion The use of AA plus standard antiemetic treatment and care was superior to the use of standard antiemetic treatment and care alone in managing CINV among BC patients receiving chemotherapy. The antiemetic effects of AA were identified to be more profound in improving acute CINV, particularly acute nausea. The antiemetic effects of AA were deemed to be a mixture of specific treatment effects and placebo effects, and the placebo effects were very large and even reached clinical significance. Trial registration ClinicalTrials.gov; NCT02403037 ; Registered March 31, 2015.

Purpose Nausea and vomiting complicating chemotherapy (CINV) remain side effects despite preventive and curative treatments. We hypothesize that acupuncture (ACU), auriculotherapy (AUR), and their combination (ACU-AUR), could decrease, compared to usual treatment (UT), the intensity of acute nausea in patients already treated according to the antiemetic guidelines and presenting nausea with or without vomiting in the earlier cycle. Methods In this multicenter study, patients were treated just before chemotherapy according to randomization. ACU consisted of implanting bilaterally on each forearm, one semi-permanent needle at point P6. AUR consisted of implanting bilaterally on each pavilion of the ear, one semi-permanent needle at point O. All patients received systematic preventive drug treatment according to antiemetic guidelines. Main outcome was intensity of nausea at 24 h after chemotherapy using a numeric scale ranging from 0 (no nausea) to 10 (maximum symptoms). Results One hundred and fifteen patients were included. Baseline characteristics were similar between groups at inclusion. Intensity of nausea at 24 h after chemotherapy, was statistically different between the groups (covariance intergroup analysis, p  = 0.005) and was significantly lower for the all-treatment groups vs UT group ( p  = 0.007 for AUR, p  = 0.008 for ACU, and p  = 0.0009 for AUR-ACU). AUR-ACU also decreased intensity of delayed nausea when compared to UT ( p  = 0.023). AUR, ACU and AUR-ACU had no effect on acute and delayed vomiting episodes. No serious adverse event due to the studied treatments was reported in our study. Conclusion AUR or ACU reduce intensity of acute and delayed nausea in patients treated by optimal antiemetic treatment. Trial Registration Number. Clinicaltrials.gov identifier NCT02767791, registered on May 10, 2016.

To evaluate the safety and efficacy of aromatherapy on symptom burden and associated outcomes. 92 inpatients who underwent hematopoietic stem cell transplantation on hematology-oncology units in an academic hospital. Participants in this pilot randomized controlled trial received essential oil-infused or blank aromatherapy patches and completed a symptom journal. Mixed-model analysis of variance was used to analyze chemotherapy-induced nausea, vomiting, and retching (CINVR) and anxiety symptoms. A t test was used to analyze medications administered for CINVR. Descriptive statistics were used to analyze additional study aims. There was no significant difference in mean symptom scores or medications administered between the intervention and control groups. On a 1-10 rating scale (10 = extremely satisfied/extremely likely), aromatherapy was rated 8 or higher for satisfaction (n = 50) and likeliness to use again (n = 53). Aromatherapy can be used for holistic symptom management to improve the patient experience.

ObjectiveCancer treatment is a particularly stressful period for the patient. The reasons vary and include fear of treatment outcome as well as treatment induced side effects. The patient frequently experiences simultaneously various side effects resulting in a diminishing of the patient’s health-related quality of life (HRQoL). The study provides evidence on the co-occurrence and inter-relations between pain, anxiety, depression and fatigue in patients with breast and prostate cancer.DesignThis paper presents a secondary analysis of the data from a randomised control trial designed to test the effectiveness of guided imagery and progressive muscle relaxation on pain, fatigue, anxiety and depression. Non-parametric bootstrapping analyses were used to test the mediational model of anxiety, fatigue and depression as parallel mediators of the relationship between pain and HRQoL.SettingThe study was undertaken at the home setting.ParticipantsIn total 208 patients were included in the study (assigned equally in two groups), referred at the outpatient clinics of the three participating cancer care centres.ResultsThe three mediators fully mediate the relationship between pain and HRQoL indirect effect (IEoverall=−0.3839, 95% CI: lower limit (LL)=−0.5073 to upper limit (UL)=−0.2825) indicating that patients with increased pain are likely to have higher levels of anxiety, fatigue and depression. Gender significantly moderated the mediational effect of Fatigue Index of Moderated Mediation (IMM=−0.2867 SE=0.1526, LL=−0.6127, UL=−0.0226) but did not moderate mediational effect of anxiety (IMM=−0.0709, SE=0.1414, LL=−0.3459, UL=+0.2089). The results show that the three mediators in a serial causal order fully mediate the relationship between pain and HRQoL (IEoverall=−0.384, 95% CI: LL=−0.51 to UL=−0.284) and the ratio of the overall indirect effect to the total effect is 0.8315 (95% CI: LL=0.5683 to UL=1.1718).ConclusionThis work provides evidence that targeting fatigue, anxiety and depression may have a meaningful effect on pain as a related symptom and potentially have a positive impact on HRQoL of patients with breast and prostate cancerTrial registration number NCT01275872; Post-results.

Background While clinical pathways have the potential to improve patient outcomes and reduce healthcare costs, their true impact has been limited by variable implementation strategies and suboptimal research designs. This paper explores a comprehensive set of factors perceived by emergency department staff and administrative leads to influence clinical pathway implementation within the complex and dynamic environments of community emergency department settings. Methods This descriptive, qualitative study involved emergency health professionals and administrators of 15 community hospitals across Ontario, Canada. As part of our larger cluster randomized controlled trial, each site was in the preparation phase to implement one of two clinical pathways: pediatric asthma or pediatric vomiting and diarrhea. Data were collected from three sources: (i) a mediated group discussion with site champions during the project launch meeting; (ii) a semi-structured site visit of each emergency department; and (iii) key informant interviews with an administrative lead from each hospital. The Theoretical Domains Framework (TDF) was used to guide the interviews and thematically analyze the data. Domains within each major theme were then mapped onto the COM-B model—capability, opportunity, and motivation—of the Behaviour Change Wheel. Results Seven discrete themes and 58 subthemes were identified that comprised a set of barriers and enablers relevant to the planned clinical pathway implementation. Within two themes, three distinct levels of impact emerged, namely (i) the individual health professional, (ii) the emergency department team, and (iii) the broader hospital context. The TDF domains occurring most frequently were Memory, Attention and Decision Processes, Environmental Context and Resources, Behavioural Regulation, and Reinforcement. Mapping these barriers and enablers onto the COM-B model provided an organized perspective on how these issues may be interacting. Several factors were viewed as both negative and positive across different perspectives. Two of the seven themes were limited to one component, while four involved all three components of the COM-B model. Conclusions Using a theory-based approach ensured systematic and comprehensive identification of relevant barriers and enablers to clinical pathway implementation in ED settings. The COM-B system of the Behaviour Change Wheel provided a useful perspective on how these factors might interact to effect change. Trial registration ClinicalTrials.gov, NCT01815710 .