A randomized feasibility trial of medium chain triglyceride-supplemented ketogenic diet in people with Parkinson's disease.

BACKGROUND: A ketogenic diet (KD) may benefit people with neurodegenerative disorders marked by mitochondrial depolarization/insufficiency, including Parkinson's disease (PD). OBJECTIVE: Evaluate whether a KD supplemented by medium chain triglyceride (MCT-KD) oil is feasible and acceptable for PD patients. Furthermore, we explored the effects of MCT-KD on blood ketone levels, metabolic parameters, levodopa absorption, mobility, nonmotor symptoms, simple motor and cognitive tests, autonomic function, and resting-state electroencephalography (rsEEG). METHODS: A one-week in-hospital, double-blind, randomized, placebo-controlled diet (MCT-KD vs. standard diet (SD)), followed by an at-home two-week open-label extension. The primary outcome was KD feasibility and acceptability. The secondary outcome was the change in Timed Up & Go (TUG) on day 7 of the diet intervention. Additional exploratory outcomes included the N-Back task, Unified Parkinson's Disease Rating Scale, Non-Motor Symptom Scale, and rsEEG connectivity. RESULTS: A total of 15/16 subjects completed the study. The mean acceptability was 2.3/3, indicating willingness to continue the KD. Day 7 TUG time was not significantly different between the SD and KD groups. The nonmotor symptom severity score was reduced at the week 3 visit and to a greater extent in the KD group. UPDRS, 3-back, and rsEEG measures were not significantly different between groups. Blood ketosis was attained by day 4 in the KD group and to a greater extent at week 3 than in the SD group. The plasma levodopa metabolites DOPAC and dopamine both showed nonsignificant increasing trends over 3 days in the KD vs. SD groups. CONCLUSIONS: An MCT-supplemented KD is feasible and acceptable to PD patients but requires further study to understand its effects on symptoms and disease. TRIAL REGISTRATION: Trial Registration Number NCT04584346, registration dates were Oct 14, 2020 - Sept 13, 2022.

The effect of manual therapy on ankle dorsiflexion range of motion: A pilot crossover randomized trial.

INTRODUCTION: Restricted ankle dorsiflexion is common after lower limb injury. The aim of this pilot study was to investigate the effect of passive ankle joint mobilization and calf muscle massage on ankle dorsiflexion range of motion in adults with residual restricted dorsiflexion. The secondary aim was to assess the methodology of the pilot study to inform a larger clinical trial. METHOD: The study design was a randomized crossover trial with assessor blinding. Twenty-five healthy participants with a history of lower limb injury were included in the study. Ankle joint mobilization and calf muscle massage were applied for 5 min in a random order, one to two weeks apart. Ankle dorsiflexion was measured by using the weight-bearing lunge pre- and post-intervention (cm). Paired t-tests were used to analyze the effect of the manual therapy interventions on restricted ankles. A minimal detectable difference 95% (MMD95) was calculated. The pilot study was analyzed for suitability of inclusion criteria, blinding of assessors and the manual therapist, and the washout period. RESULTS: A significant increase in dorsiflexion was demonstrated for ankle joint mobilization (change score = 0.51 ± 0.76, p = 0.003) and calf muscle soft tissue massage (change score = 0.91 ± 1.07, p < 0.001). There was no difference in change scores between manual therapy techniques (mobilization 0.51 ± 0.76, massage 0.91 ± 1.07, p = 0.12). Evaluation of the pilot study revealed limitations to be modified in future studies. CONCLUSION: These preliminary data indicate ankle joint mobilization and calf muscle soft tissue massage had similar effects on increasing ankle dorsiflexion range of motion in ankles with residual dorsiflexion restriction.

Effectiveness of a kinesio-taping-based treatment in stage IV sacral pressure ulcers in older patients: a pilot study.

OBJECTIVE: As reduced tissue vascularity is one of the mechanisms that prevent skin ulcers from healing, treatments that can improve local circulation could accelerate their clinical resolution. Given that kinesio-taping (KT) can improve tissue blood circulation and lymphatic drainage, we aimed to determine whether applying KT close to stage IV pressure ulcers (PUs) could improve their healing. METHOD: Older patients with stage IV sacral PUs, and impaired mobility and functional dependency who were consecutively admitted in a six-month period to the Home Care service of Galliera Hospital (Genoa, Italy) were screened for participation in this pilot clinical trial. Patients' PUs were divided into two treatment areas-in the experimental intervention, KT was applied close to a portion of the PU, while the contralateral portion of the same lesion was treated according to the standard protocol ('control'). The surface reduction of both portions was measured every four days, for a total of five examinations (timepoints (T2-T6) after the baseline evaluation (T1). RESULTS: A total of 12 patients (male=5, female=7; mean age 78.83±8.94 years) fulfilled the inclusion criteria and were enrolled in the study. At all timepoints (T2-T6), the mean percentage reduction was significantly greater in KT-treated areas than in control areas: T2=20.66% versus 6.17%, respectively; p<0.001; T3=37.33% versus 17.31%, respectively; p<0.001; T4=57.01% versus 30.06%, respectively; p<0.001; T5=69.04% versus 40.55%, respectively; p<0.001; and T6=80.34% versus 51.91%, respectively; p<0.001. Furthermore, from T3 onwards, a significantly higher number of KT-treated areas than control areas had halved in size, the maximum difference being recorded at T5 (10 versus two, respectively; p=0.002). CONCLUSION: From the findings of this pilot study, KT would seem to be an effective, rapid, low-cost therapy for advanced sacral PUs in older patients with impaired mobility and functional dependency. Declaration of interest: The authors have no conflicts of interest to declare.

Effect of traditional Chinese medicine combined group psychotherapy on psychological distress management and gut micro-biome regulation for colorectal cancer survivors: a single-arm phase I clinical trial.

OBJECTIVE: To evaluate the efficacy and feasibility of utilizing Traditional Chinese Medicine (TCM) combined group psychotherapy intervention on psychological distress management and gut micro-biome regulation for colorectal (CRC) survivors. METHODS: A single-arm phase I clinical trial was conducted between December 2020 and December 2021 in Xiyuan Hospital and Beijing Cancer Hospital in China. Inclusion criteria included stage I-III CRC survivors after radical surgery with age between 18 and 75. The intervention was a 6-week online TCM combined group psychotherapy intervention including 90-min communication, TCM lifestyle coaching, self-acupressure guidance, and mindfulness practice led by TCM oncologist and psychiatrist each week. Outcomes were measured by Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Fear of Cancer Recurrence Inventor (FCRI), and Quality of Life Questionnaire (QLQ-C30). Fecal samples before and after intervention were collected for 16Sr RNA analysis. RESULTS: We recruited 40 CRC survivors and 38 of them finally completed all interventions with average age of 58±13 years' old. Paired t-test showed that SAS at week 2(35.4±5.8), week 4 (37.9±10.5) and week 6 (31.3±6.4) during the intervention was significantly lower than baseline (42.1±8.3, p<0.05 respectively). SDS score also declined substantially from baseline (38.8±10.7) to week 2 (28.3±8.8, p<0.001) and week 6 (25.4±7.7, p<0.001). FCRI decreased from 19.4±7.2 at baseline to 17.5±7.1 at week 4 (p=0.038) and 16.3±5.8 at week 6 (p=0.008). Although changes of QLQ-C30 were not statistically prominent, symptom burden of insomnia and fatigue significantly alleviated. The abundances of gut microbiota Intestinibacter, Terrisporobacter, Coprobacter, and Gordonibacter were all significantly elevated after intervention. CONCLUSIONS: TCM combined group psychotherapy intervention is feasible and effective to reduce CRC survivors' psychological distress and modulate certain gut bacteria which might be associated with brain-gut axis effect. It is necessary to carry out with phase II randomized controlled clinical trial.

Evaluating the efficacy of auricular acupuncture for chemotherapy-induced taste alterations: A pilot randomized controlled trial.

PURPOSE: Irrespective of the development of acupuncture-based interventions, clinical evidence regarding their efficacy remains controversial owing to issues with the study design and an unclear risk of bias. This study aimed to evaluate the efficacy of auricular acupuncture in managing taste alterations in patients with cancer undergoing platinum-based chemotherapy. METHODS: We conducted a pilot randomized controlled trial involving 73 patients randomly assigned to an auricular acupuncture or a control group. The primary outcome was the severity of chemotherapy-induced taste alterations, and the secondary outcomes included quality of life and negative emotions of the patients. RESULTS: A total of 49 participants completed the study. Compared to the control group, patients in the auricular acupuncture group showed significant reductions in discomfort, general taste alterations, and total scores on the Chemotherapy-induced Taste Alteration Scale (all p < 0.05). Furthermore, we observed significant improvements in quality of life, including physical function (p = 0.007), role function (p = 0.006), emotional function (p = 0.016), nausea and vomiting (p = 0.021), appetite loss (p = 0.046), and significant improvements in anxiety and depression (p < 0.01). CONCLUSIONS: Our findings suggest that auricular acupuncture may be a beneficial intervention for managing chemotherapy-induced taste alterations in patients with cancer receiving platinum-based chemotherapy. It may also contribute to improvements in quality of life and negative emotions. However, these results are preliminary, and further evaluation with larger randomized controlled trials is necessary.

Hematinic Potential of Olive Leaf Extract: Evidence from an In Vivo Study in Mice and a Pilot Study in Healthy Human Volunteers.

Natural resources have recently received considerable attention as complementary or alternative hematinic agents. In this regard, olive leaf extract, which is rich in bioactive phenolic compounds, has been reported to induce erythroid differentiation in human hematopoietic stem cells. Therefore, in the present study, we aimed to explore the potential hematinic properties of aqueous olive leaf extract (WOL) in vivo. After 24 days of administering WOL to healthy mice orally, red blood cell (RBC), hematocrit, reticulocyte, and reticulocyte hemoglobin content (CHr) showed a significant increase. Additionally, WOL promoted plasma iron levels and the expression of splenic ferroportin (Fpn), an iron transporter. Additionally, a single-arm pilot study involving a limited number of healthy volunteers was conducted to assess WOL's feasibility, compliance, and potential benefits. Following an 8-week intervention with WOL, RBC count and hemoglobin level were significantly increased. Notably, there were no significant changes in the safety measures related to liver and kidney functions. Furthermore, we identified oleuropein and oleuroside as the active components in WOL to induce erythroid differentiation in the K562 cell line. Altogether, our study presents evidence of the hematinic potential of WOL in the in vivo studies, opening up exciting possibilities for future applications in preventing or treating anemia.

Meditation attenuates default-mode activity: A pilot study using ultra-high field 7 Tesla MRI.

OBJECTIVES: Mapping the neurobiology of meditation has been bolstered by functional MRI (fMRI) research, with advancements in ultra-high field 7 Tesla fMRI further enhancing signal quality and neuroanatomical resolution. Here, we utilize 7 Tesla fMRI to examine the neural substrates of meditation and replicate existing widespread findings, after accounting for relevant physiological confounds. METHODS: In this feasibility study, we scanned 10 beginner meditators (N = 10) while they either attended to breathing (focused attention meditation) or engaged in restful thinking (non-focused rest). We also measured and adjusted the fMRI signal for key physiological differences between meditation and rest. Finally, we explored changes in state mindfulness, state anxiety and focused attention attributes for up to 2 weeks following the single fMRI meditation session. RESULTS: Group-level task fMRI analyses revealed significant reductions in activity during meditation relative to rest in default-mode network hubs, i.e., antero-medial prefrontal and posterior cingulate cortices, precuneus, as well as visual and thalamic regions. These findings survived stringent statistical corrections for fluctuations in physiological responses which demonstrated significant differences (p < 0.05/n, Bonferroni controlled) between meditation and rest. Compared to baseline, State Mindfulness Scale (SMS) scores were significantly elevated (F(3,9) = 8.16, p < 0.05/n, Bonferroni controlled) following the fMRI meditation session, and were closely maintained at 2-week follow up. CONCLUSIONS: This pilot study establishes the feasibility and utility of investigating focused attention meditation using ultra-high field (7 Tesla) fMRI, by supporting widespread evidence that focused attention meditation attenuates default-mode activity responsible for self-referential processing. Future functional neuroimaging studies of meditation should control for physiological confounds and include behavioural assessments.

Virtual adjunctive gut-directed hypnotherapy for people with Crohn's disease: A randomized controlled pilot and feasibility trial.

BACKGROUND: Gut-directed hypnotherapy appears to be a promising adjunctive treatment for people with Crohn's disease. The primary objective of this pilot trial was to evaluate feasibility and acceptability of virtually delivered hypnotherapy to determine the parameters for a future definitive trial. METHODS: This prospective, single-site, randomized controlled pilot and feasibility trial compared a 7-week course of virtually delivered adjunctive gut-directed hypnotherapy to standard medical treatment only for adults with Crohn's disease. Primary outcomes were study feasibility and intervention acceptability. Secondary outcomes were objective disease activity and patient-reported outcomes. Assessments took place at five time-points: baseline, post-intervention, and follow-up three-, six-, and 12-months post-intervention. KEY RESULTS: Recruitment took place between July 2020 and August 2021 at a tertiary hospital. Recruitment was initially slow and subsequently expanded to community settings. Thirty-seven participants were enrolled in the trial: 95% were retained at post-intervention and 76% at 12-months. Completion of online assessments was high (97-100% across all time-points) whilst objective data collection was low (34-44%). Most intervention participants completed all hypnotherapy sessions (88%) and reported being extremely satisfied (73%), despite 60% experiencing technical issues. CONCLUSION & INFERENCES: Virtually delivered hypnotherapy was acceptable to participants. Certain aspects of the trial including online assessment were feasible, while recruitment and objective data collection were challenges. Undertaking a future definitive trial will require broader recruitment scope and significant funding for widespread objective data collection. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ANZCTR#1260000348954.

Domestication of a magic therapeutical wine glass fungus (Podoscypha petalodes) from Pakistan.

The Podoscypha is a recognized therapeutically significant genus of mushrooms. A Podoscypha species under a Morus sp. Was found from the largest man-made forest Changa-Manga, Kasur during the exploration of fungal flora of Pakistan. Detailed morpho-anatomical and phylogenetic analysis identified it as P. petalodes, a part of common native flora of many regions of the world like Pakistan. The culturabilty and cultivation potential of this fungus was assessed for the first time using different media and substrates. Maximum cultural growth was observed on the Compost Extract Agar (CEA) medium at 28 °C. Mycelium of cultured strains on CEA medium was used for the spawn production on wheat, sorghum and barley grains. Cultivation potential in the form of spawn running period, harvesting time duration and yield was investigated on variety of substrates. A mixed substrate of sawdust and tea waste at 28 °C showed the optimum yield. Tea-waste was used as the casing material in all substrates and proved very effective. These results depicted that Podoscypha petalodes possesses the cultivation potential. Its cultivation on large scale can solve the major health concerns of the growing population. It would provide the people easy accessibility of economical, effective and natural medicine throughout the year that restrict in case of only natural production at specific time of the year.

Multi-omics analyses reveal relationships among polyphenol-rich oolong tea consumption, gut microbiota, and metabolic profile: A pilot study.

Convincing evidence has suggested the health potentials of oolong tea (OT) on gut microbiota homeostasis; however, limited population-based studies exist regarding the effect of OT consumption on human gut microbial and metabolic profile. This pilot study explored gut microbial and metabolic changes in healthy adults with a 3-week oolong tea intake. Our findings showed that OT treatment significantly altered gut microbial diversity (Shannon index, 5.4±0.1 vs. 5.7±0.1 pre- and post-OT treatment), reorganized gut microbiota composition, enriched Bacteroides and Prevotella, decreased Megamonas, and improved gastrointestinal function. Also, gut microbes from overweight subjects with BMI >23.9 exhibited greater responses to OT treatment compared with normal-weight counterparts. Metabolomic analysis identified OT intake-induced 23 differential metabolites and 10 enriched metabolic pathways. This study may provide new insights into the association among OT intervention, host gut microbiome and metabolic profile, and improve the knowledge of clinical strategies and personalized nutrition.

Usability Testing of a New Digital Integrated Health Ecosystem (PainRELife) for the Clinical Management of Chronic Pain in Patients With Early Breast Cancer: Protocol for a Pilot Study.

BACKGROUND: Chronic pain (CP) and its management are critical issues in the care pathway of patients with breast cancer. Considering the complexity of CP experience in cancer, the international scientific community has advocated identifying cutting-edge approaches for CP management. Recent advances in the field of health technology enable the adoption of a novel approach to care management by developing integrated ecosystems and mobile health apps. OBJECTIVE: The primary end point of this pilot study is to evaluate patients' usability experience at 3 months of a new digital and integrated technological ecosystem, PainRELife, for CP in a sample of patients with breast cancer. The PainRELife ecosystem is composed of 3 main technological assets integrated into a single digital ecosystem: Fast Healthcare Interoperability Resources-based cloud platform (Nu platform) that enables care pathway definition and data collection; a big data infrastructure connected to the Fast Healthcare Interoperability Resources server that analyzes data and implements dynamic dashboards for aggregate data visualization; and an ecosystem of personalized applications for patient-reported outcomes collection, digital delivery of interventions and tailored information, and decision support of patients and caregivers (PainRELife app). METHODS: This is an observational, prospective pilot study. Twenty patients with early breast cancer and chronic pain will be enrolled at the European Institute of Oncology at the Division of Medical Senology and the Division of Pain Therapy and Palliative Care. Each patient will use the PainRELife mobile app for 3 months, during which data extracted from the questionnaires will be sent to the Nu Platform that health care professionals will manage. This pilot study is nested in a large-scale project named "PainRELife," which aims to develop a cloud technology platform to interoperate with institutional systems and patients' devices to collect integrated health care data. The study received approval from the Ethical Committee of the European Cancer Institute in December 2021 (number R1597/21-IEO 1701). RESULTS: The recruitment process started in May 2022 and ended in October 2022. CONCLUSIONS: The new integrated technological ecosystems might be considered an encouraging affordance to enhance a patient-centered approach to managing patients with cancer. This pilot study will inform about which features the health technological ecosystems should have to be used by cancer patients to manage CP. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41216.

Person-Centered Navigator Program for People with Parkinson's Disease: A Pilot Study.

There are limited Parkinson's disease (PD)-specific navigator programs, although PD is chronic and requires life-long comprehensive care. As most patient navigation literature focuses on oncology and is based in the West, this study aimed to develop a person-centered navigator program for PD and evaluate its preliminary outcomes and feasibility in the Korean context. The program was developed using the "analysis, design, development, implementation, and evaluation" model, and "professional navigation framework." Initially, 28 participants were recruited to participate in an 8-week navigator program. The retention rate was 82%. Social function was significantly improved 12 weeks after baseline. Participants reported high satisfaction with the program, suggesting that it was well-accepted. This study systematically developed a navigator program based on PD-specific needs and the Korean context. Future models should focus on personal and participatory attributes. Navigator programs for people with PD represent appropriate and evolving healthcare interventions.

Establishing a baseline for multilingual capabilities of medical students at the Michigan State University College of Osteopathic Medicine.

CONTEXT: The language proficiencies of Michigan State University College of Osteopathic Medicine (MSUCOM) medical students are unknown. As of 2015, approximately 8% (or roughly 25 million) of the US population over the age of five were considered "limited English proficient". Research indicates, however, that it is valuable to patients to be able to communicate in their primary language with their primary care physician. If medical students' language proficiencies were known, the medical school curriculum could be adapted to leverage or enhance a student's language proficiencies, preparing students to serve in communities where their patients language proficiencies align. OBJECTIVES: The aim of this pilot study was to survey MSUCOM medical students in order to assess their language proficiencies with two goals in mind: first, to develop medical school curriculum that would leverage student's language proficiencies, and second, to encourage student placement within diverse communities throughout the state of Michigan where these physicians-in-training speak or understand the primary language of the local community to better serve patients. METHODS: For this cross-sectional descriptive pilot study, a short, author-created survey was sent to 1,226 osteopathic medical students (OMS-I to OMS-IV) at MSUCOM. Participants were asked questions pertaining to language proficiency, number of languages spoken, prior exposure to education abroad, and demographic information. All participant data were only reported in grouped, collective, de-identified terms. Descriptive statistical analyses (frequencies, percentages) were calculated utilizing SPSS Version 25 software. RESULTS: Over the course of several months, 698 (58.7%) current MSUCOM medical students participated in the study. Of those students, 382 (54.7%) responded that they were multilingual. The top three second languages reported spoken were: English 332 (47.6%), Spanish 169 (24.2%), and Arabic 64 (9.2%). In addition, 249 (37.2%) said they had prior exposure to education abroad, and 177 (26.4%) said they had lived in another country for more than 6 months. CONCLUSIONS: The majority, 382 (54.7%), of the MSUCOM students who participated in the survey have some degree of multilingual capabilities. The student population at MSUCOM may benefit from completing primary care rotations in diverse communities within the state of Michigan. Likewise, the communities throughout Michigan may benefit from having bilingual and multilingual medical students serve in their medical facilities. Further research on the efficacy of leveraging language skills in various communities, as well as broadening the population sample, is warranted to refine and validate the observed pilot study results.

Feasibility of a New Model of Care for Allogeneic Stem Cell Transplantation Recipients Facilitated by eHealth: The MY-Medula Pilot Study.

The use of allogeneic stem cell transplantation (allo-SCT) for the treatment of hematologic diseases is steadily increasing; however, allo-SCT has the downside of causing considerable treatment-related morbidity and mortality. Mobile technology applied to healthcare (mHealth) has proven to be a cost-effective strategy to improve care and offer new services to people with multimorbidity, but there are little data on its usefulness in allo-SCT recipients. Here we describe a new integrated healthcare model facilitated by an mHealth platform, EMMASalud-MY-Medula, and to report the results of a feasibility and usability pilot study. The MY-Medula platform was developed in 4 phases. First, patient and healthcare professional needs were identified, and technological development and pretesting tests were conducted (phases 1 to 3, January 2016 to March 2021). Then a nonrandomized, prospective, observational, single-center pilot study was conducted (October 2021 to January 2022) at the adult SCT unit of a tertiary university hospital. Twenty-eight volunteer allo-SCT recipients were included in the pilot study, of whom one-half were outpatients in the first-year post-SCT and one-half were affected by steroid-dependent graft-versus-host disease (SR-GVHD). All patients used the MY-Medula app during the 2-month follow-up period, with a median number of visits to the app of 143 (range, 6 to 477). A total of 2067 self-monitoring records were created, and 205 text messages were received, most of them related to symptoms description (47%) and doubts about medication (21%). In 3.4% of the cases, drug dosage was adjusted by the pharmacist because of dosing errors or interactions. At the end of the study, a 6-question Likert-type questionnaire for patients and a 22-question test for healthcare professionals showed a high degree of satisfaction (95% and 100%, respectively) with the new healthcare pathway. Reengineering the follow-up of allo-SCT recipients into an integrated, multidisciplinary model of care facilitated by mHealth tools is feasible and has been associated with high usability and a high degree of satisfaction by patients and healthcare professionals. A randomized trial aiming to determine the cost-effectiveness of MY-Medula-based follow-up post-SCT is currently enrolling participants.

Assessing feasibility and acceptability of yoga and group CBT for adolescents with depression: A pilot randomized clinical trial.

PURPOSE: Given increasing rates of depression in adolescents, there is a clear need for innovative treatments. In this pilot randomized clinical trial, we assessed acceptability and feasibility of two group-based interventions: yoga and cognitive-behavioral therapy (CBT). The goal of this work is to prepare for a future fully powered randomized trial to test the hypothesis that yoga is not inferior to an established adolescent depression treatment, namely, group CBT. METHODS: We enrolled 42 adolescents with elevated depression symptoms. Participants were randomly assigned to a 12-week group-based intervention, yoga or CBT. We had a priori feasibility and acceptability targets, including for recruitment rate, retention rate, expectancy, credibility, program satisfaction, class attendance, engagement in home practice, and instructor/leader manual adherence. We assessed adverse events, and within-subject changes in outcomes (depression, anxiety, impairment, sleep disturbance) and possible mediators (mindfulness, self-compassion). RESULTS: Both interventions met most acceptability and feasibility targets. The only target not met related to low engagement in home practice. Participants within each study arm showed decreased depression symptoms over time and increased self-compassion. CONCLUSIONS: A yoga intervention appears to be acceptable and feasible to adolescents with depression. However, it may be challenging for this group to engage in unstructured home practice.

A Comparison of the Timing of Hand Expressing of Human Milk With Breast Massage to Standard Care for Mothers of Preterm Infants: An Exploratory Pilot Using a Randomized Controlled Design.

BACKGROUND: Globally, 10% of all births are preterm. Access to human milk via manual breast expression is required to reduce the incidence of adverse outcomes related to prematurity. However, there is little evidence to recommend optimum timing to commence breast expression in mothers of preterm infants or the most effective method. RESEARCH AIMS: (1) To test feasibility of recruitment and compliance to the protocol and (2) to determine influence of using hand expressing and breast massage on milk production, engorgement, mastitis, and breastfeeding status at 3 months. METHODS: This study was an exploratory parallel two-group, pilot randomized controlled trial. Mothers of preterm infants at a metropolitan maternity hospital in Queensland Australia (N = 31) were randomized to receive either hand expressing and breast massage within the 1st hr of birth or standard care, hand expressing within 6 hr of birth, to determine the influence on milk production, engorgement, mastitis, and breastfeeding status at 3 months. RESULTS: Feasibility targets were not met; however, valuable learning from this trial uncovered barriers facing midwives in the birth suite to commencing expressing in the 1st hr of birth. There was no difference in occurrence of secondary outcomes, although trends support future study. CONCLUSIONS: Overall, unpredictability of preterm birth influenced our ability to recruit participants. Important directions for future study design would benefit from incorporating expressing times up to 6 hr with a replicable breast massage.

Effectiveness of light therapy as adjunctive treatment in bipolar depression: A pilot study.

BACKGROUND: About 1 and 4 % of people suffering from depression is affected by bipolar disorder. Few patients respond to the first-line antidepressants, and a 4-week latency pharmacological treatment period has been observed. This pilot study aimed to evaluate the effectiveness and safety of bright light therapy (BLT) in accelerating and increasing therapeutic response in patients with bipolar depression. METHODS: A pilot study was conducted. Patients with bipolar depression, already treated with antidepressants, were included. The treatment group was composed of patients treated with antidepressants combined with BLT (30 min/4 days a week at 10,000 lx for eight weeks). The control group included patients treated with antidepressants with exposure to red light (30 min/4 days a week at a red light for eight weeks). MADRS, HAMD-17, CGI-S, FSS, and QoLS were collected at the baseline and after 4 and 8 weeks of treatments. RESULTS: Forty-one patients (18 males and 23 females; mean age 49.1 ± 15 years) were included in the study. After four weeks, MADRS and HAMD-17 scores in treatment groups were significantly lower than those reported in the control group (p < 0.001). After eight weeks, all scales except FSS reported significantly lower values in patients treated with BLT (p < 0.0001). LIMITATIONS: Small sample size and significant heterogeneity in the antidepressant treatments. CONCLUSION: BLT has shown reliable effectiveness and safety in treating patients with bipolar depression and should be considered a clinically relevant approach in accelerating patients' therapeutic response and reducing the impact of long-lasting therapy.

Immediate neural effects of acupuncture manipulation time for stroke with motor dysfunction: a fMRI pilot study.

Introduction: Acupuncture is widely utilized as a beneficial intervention for the treatment of motor dysfunction after stroke, and its effectiveness depends on the stimulation dose. Manipulation time is an important factor affecting the dose. This trial aimed use fMRI to explore the immediate neural effects in stroke patients with motor dysfunction by different acupuncture manipulation times, to reveal the neural mechanism of acupuncture manipulation. Methods: Thirty participants were divided into three groups according to different acupuncture times. Each group received the same acupoint prescription, although the continuous manipulation time of each acupoint in three groups was 1-min, 2-min, and 3-min, respectively. The NIHSS, FMA and fMRI-BOLD in each participant we obtained before and after acupuncture manipulation. Then, we used the regional homogeneity (ReHo) algorithm to analyze the changes of brain function and to compare the neural effects at different acupuncture manipulation times. Results: There were no significant differences in NIHSS and FMA scores between and within groups. Longitudinal analysis of ReHo values indicated that the right inferior frontal gyrus was activated in the 1-min group, the right insula in the 2-min group, and the right inferior temporal gyrus in the 3-min group. Compared with the 1-min group, the 2-min group showed the ReHo values of the right precentral gyrus was decreased, and the 3-min group showed the left cerebellum posterior lobe was increased, the right posterior cingulate gyrus and the right anterior cingulate gyrus were decreased. Compared with the 2-min group, the 3-min group showed the ReHo values of the right cerebellum anterior lobe was increased. Conclusion: Our findings suggest that acupuncture at different manipulation times caused different changes of the neural effects in stroke patients, and the volume of activated voxel clusters is positively correlated with the manipulation time. Longer acupuncture manipulation could drive SMN and DMN in stroke patients, which may be the potential neurological mechanism of acupuncture manipulation affecting the recovery of motor dysfunction.

The Effect of Black Cohosh on Ki67 expression and Tumor Volume: A Pilot Study of Ductal Carcinoma in Situ Patients.

BACKGROUND: Black cohosh (BC) (Cimicifuga racemosa) may prevent and treat breast cancer through anti-proliferative, pro-apoptotic, anti-estrogenic, and anti-inflammatory effects. This study sought to evaluate the effect of BC on tumor cellular proliferation, measured by Ki67 expression, in a pre-operative window trial of ductal carcinoma in situ (DCIS) patients. METHODS: Patients were treated pre-operatively for 2 to 6 weeks with BC extract. Eligible subjects were those who had DCIS on core biopsy. Ki67 was measured using automated quantitative immunofluorescence (AQUA) pre/post-operatively. Ki67, tumor volume, and hormone changes were assessed with 2-sided Wilcoxon signed-rank tests, α = .05. RESULTS: Thirty-one patients were treated for an average of 24.5 days (median 25; range 15-36). Ki67 decreased non-significantly (n = 26; P = .20; median pre-treatment 1280, post-treatment 859; range pre-treatment 175-7438, post-treatment 162-3370). Tumor volume, estradiol, and FSH did not change significantly. No grade 3 or 4 adverse events were reported. CONCLUSIONS: BC use showed no significant impact on cellular proliferation, tumor volume, or invasive disease upgrade rates in DCIS patients. It was well-tolerated, with no observed significant toxicities. Further study is needed to elucidate BC's role in breast cancer treatment and prevention.ClinicalTrials.gov Identifier: NCT01628536https://clinicaltrials.gov/ct2/show/NCT01628536.

Antihistamine promotes electroacupuncture analgesia in healthy human subjects: A pilot study.

Background and aim: We have previously reported that histamine H1 receptor antagonists facilitate electroacupuncture (EA) analgesia in experimental animals. In this pilot study, we sought to determine whether the histamine H1 receptor antagonist dexchlorpheniramine (DCPA) facilitates EA analgesia in healthy human subjects. Experimental procedure: Forty healthy subjects aged 20-30 years were randomly allocated to 1 of 4 groups: (1) sham EA at acupoints Zusanli (ST36) and Yanglingquan (GB34) (sham EA; n = 10); (2) EA at ST36 and GB34 (n = 10); (3) EA at ST36 and GB34 plus low-dose DCPA (2 mg, n = 10); (4) EA at ST36 and GB34 plus high-dose DCPA (4 mg, n = 10). Before and after acupuncture treatment, pain thresholds were determined by transcutaneous electrical stimuli on the glabrous skin of the left upper arm. Results: After the acupuncture session, subjects in the EA plus high-dose DCPA group had a significantly higher pain threshold elevation compared with the other 3 study groups. The change from baseline in pain threshold in the EA plus high-dose DCPA group was significantly greater than the change in pain threshold with EA only, indicating that DCPA 4 mg facilitated EA analgesia. Conclusion: The results suggest that combining H1 receptor antagonist treatment with EA appears to relieve pain to a greater extent compared with EA alone. This study is registered with ClinicalTrials.gov (https://clinicaltrials.gov/), number NCT03805035 (https://clinicaltrials.gov/ct2/show/NCT03805035).