A Feasibility Study of Valerian Extract for Sleep Disturbance in Person With Arthritis

Objectives: To present a pilot study of valerian to explore issues of feasibility and efficacy in studies of sedative herbs for arthritis-related sleep disturbance. Methods: Fifteen persons with arthritis and mild sleep disturbance were randomized to receive 600 mg valerian ( Valeriana officinalis, n = 7) or placebo ( n = 8) for five nights. Results: Protocol adherence (dosing and data collection) was high. Allocation concealment was successful using a novel approach for matching the placebo on the distinctive odor of valerian. Nonsignificant differences between the groups were found on all sleep outcomes, measured by daily diaries and wrist actigraphy. Conclusion: The study methods were feasible, except for recruitment issues (addressed in the discussion), and may guide the testing of other sedative herbs for persons with arthritis. Although efficacy outcomes were inconclusive due to the small sample size of this study, recent evidence from larger trials of valerian also does not support its efficacy.

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Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19)

10.21203/rs.3.rs-861831/v1 ◽

2021 ◽

Author(s):

Marvin R. McCreary ◽

Patrick M. Schnell ◽

Dale A. Rhoda

Keyword(s):

Pulmonary Embolism ◽

Adverse Events ◽

Small Sample Size ◽

Primary Outcome Measure ◽

Small Sample ◽

Double Blind ◽

Phase 2 Study ◽

Clinically Significant ◽

Low Incidence ◽

To Receive

Abstract Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N=105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol. Both groups received a single dose of Vitamin D3 which was used as an adjunct. The primary outcome measure was hospitalization within 21 days of symptom onset; secondary measures were ER visits, incidence of pneumonia and pulmonary embolism. Five patients chose not to participate after randomization. Twenty-one day outcome was determined of all one hundred participants (mean [SD] age 55.6 [8.8] years; 61% female) (or their surrogates). There were no clinically significant adverse events attributed to resveratrol. Outpatients in this phase 2 study treated with resveratrol had a lower incidence compared to placebo of: hospitalization (2% vs. 6%, RR 0.33, 95% CI 0.04-3.10), COVID-related ER visits (8% vs. 14%, RR 0.57, 95% CI 0.18-1.83), and pneumonia (8% vs. 16%, RR 0.5, 95% CI 0.16-1.55). One patient (2%) in each group developed pulmonary embolism (RR 1.00, 95% CI: 0.06-15.55). This underpowered study was limited by small sample size and low incidence of primary adverse events. A larger trial could determine efficacy.TRIAL REGISTRATIONS: ClinicalTrials.gov NCT04400890 26/05/2020; FDA IND #150033 05/05/2020

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What People with Newly Diagnosed MS (and their Families and Friends) Need to Know

International Journal of MS Care ◽

10.7224/1537-2073-2.3.29 ◽

2000 ◽

Vol 2 (3) ◽

pp. 29-39 ◽

Cited By ~ 25

Author(s):

Judy Wollin ◽

Helen Dale ◽

Nancy Spenser ◽

Anne Walsh

Keyword(s):

Multiple Sclerosis ◽

Small Sample Size ◽

Cross Sectional Study ◽

Small Sample ◽

Newly Diagnosed ◽

Cross Sectional ◽

Wide Range ◽

Study Participants ◽

To Receive ◽

Depth Interviews

Abstract The aim of this retrospective study was to determine from people with multiple sclerosis (MS) and their families what information would assist a person with newly diagnosed MS — in which format, when, and from whom it should be delivered. Thirty-four Queensland, Australia, residents with MS and 18 family members and friends participated in the main study. Participants were self-selected for this purposive, statewide, cross-sectional study. Nine of the respondents answered open-ended questions in addition to the standard questionnaires, and seven respondents gave in-depth interviews. The respondents recommended that people with a recent MS diagnosis and their families be given a wide range of information reflective of their personal needs. The information should be provided in person (in both group and individual sessions). They preferred to receive the information from their physicians and the staff of the Multiple Sclerosis Society. Research aimed at cures and therapies, as well as counseling and support services, should be discussed early in the course of the disease. Because of the small sample size and retrospective design, additional studies with larger populations are suggested to confirm these results and their cross-cultural applicability.

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Effectiveness of Ondansetron versus Metoclopramide in Hyperemesis Gravidarum

Nepal Journal of Obstetrics and Gynaecology ◽

10.3126/njog.v9i2.11753 ◽

2014 ◽

Vol 9 (2) ◽

pp. 27-32

Author(s):

M Chhetry ◽

A Thakur ◽

P Basnet ◽

R Joshi ◽

H Sangraula ◽

...

Keyword(s):

Hyperemesis Gravidarum ◽

Small Sample Size ◽

Supportive Therapy ◽

Small Sample ◽

Controlled Study ◽

P Value ◽

Weight Changes ◽

Randomized Controlled ◽

To Receive ◽

Intravenous Medication

Aims: The aim was to evaluate the effectiveness of intravenous ondansetron as compared to intravenous metoclopramide in hyperemesis gravidarum. Methods: Sixty-eight patients with hyperemesis gravidarum were randomized to receive either intravenous ondansetron or intravenous metoclopramide according to randomization group, till they started tolerating orally along with supportive therapy and various treatment parameters were compared. Results: No statistically significant differences were found in the number of doses of intravenous medication used (three doses of ondansetron vs four doses of metoclopramide; p value 0.77), weight changes (ondansetron - 0 kg vs. metoclopramide – 1 kg; p value 0.11) during treatment, duration of intravenous fluids (ondansetron – 24 hours vs. metoclopramide- 24 hours; p value 0.48) in the two groups. The duration of hospital stay of the patients in the two groups was comparable (ondansetron - 3 days vs. metoclopramide - 3 days; p value 0.83).Conclusions: Metoclopramide and ondansetron appear to be equally effective to treat hyperemesis gravidarum. Although this was a prospective randomized controlled study, it had a small sample size and the results should be confirmed in a larger and powered study.DOI:http://dx.doi.org/10.3126/njog.v9i2.11753

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Does Adjunctive Tigecycline Improve Outcomes in Severe-Complicated, Nonoperative Clostridium difficile Infection?

Open Forum Infectious Diseases ◽

10.1093/ofid/ofw264 ◽

2017 ◽

Vol 4 (1) ◽

Cited By ~ 11

Author(s):

Mary T. LaSalvia ◽

Westyn Branch-Elliman ◽

Graham M. Snyder ◽

Monica V. Mahoney ◽

Carolyn D. Alonso ◽

...

Keyword(s):

Clostridium Difficile ◽

Clostridium Difficile Infection ◽

Surgical Intervention ◽

Small Sample Size ◽

Severity Of Illness ◽

Small Sample ◽

High Rate ◽

Limited Power ◽

Severe Clostridium Difficile Infection ◽

To Receive

Abstract Severe Clostridium difficile infection is associated with a high rate of mortality; however, the optimal treatment for severe- complicated infection remains uncertain for patients who are not candidates for surgical intervention. Thus, we sought to evaluate the benefit of adjunctive tigecycline in this patient population using a retrospective cohort adjusted for propensity to receive tigecycline. We found that patients who received tigecycline had similar outcomes to those who did not, although the small sample size limited power to adjust for comorbidities and severity of illness.

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Pilot study comparing telephone to in-person delivery of cognitive-behavioural therapy for trauma-related insomnia for rural veterans

Journal of Telemedicine and Telecare ◽

10.1177/1357633x17732366 ◽

2017 ◽

Vol 24 (9) ◽

pp. 629-635 ◽

Cited By ~ 6

Author(s):

C Laurel Franklin ◽

Jessica L Walton ◽

Amanda M Raines ◽

Jessica L Chambliss ◽

Sheila A Corrigan ◽

...

Keyword(s):

Cognitive Behavioural Therapy ◽

Small Sample Size ◽

Meta Analysis ◽

Mode Of Delivery ◽

Behavioural Therapy ◽

Small Sample ◽

Post Treatment ◽

Cognitive Behavioural ◽

To Receive

Introduction It is estimated that 70% of patients with posttraumatic stress disorder (PTSD) have chronic insomnia. A recent meta-analysis examined cognitive-behavioural therapy for insomnia (CBT-I) in veterans with and without PTSD, and suggested that most studies had questionable methodology, but generally supported its effectiveness in this population. Further, while CBT-I via telehealth (i.e. using telecommunication and information technology to deliver health services) has shown effectiveness for primary insomnia, it has not been applied to PTSD-related insomnia. Methods Veterans with insomnia who were diagnosed with PTSD ( n = 12) or having significant subthreshold PTSD symptoms ( n = 6) on the Clinician Administered PTSD Scale were randomly assigned to receive CBT-I in-person ( n = 7) or by telephone ( n = 11), to pilot test the potential effectiveness, acceptability, and feasibility of administering CBT-I in rural veterans. A six-week CBT-I protocol was delivered, and the veteran’s insomnia was assessed at post-treatment and follow-up. Results Given the small sample size, Cohen’s d was used to detect group differences, finding large effect sizes favouring the in-person delivery, until three-months post-treatment when this difference diminished. Most veterans found the treatment acceptable, regardless of mode of delivery. Based on the results, a larger project is feasible. Feasibility for a larger project is favourable. Discussion In summary, our findings uphold and extend previous research. Specifically, current pilot data suggest that telephone-delivered CBT-I may be able to reduce trauma-related insomnia symptoms. Future trials are needed to assess the effectiveness of CBT-I delivered to rural veterans with posttraumatic insomnia.

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P336 Association between the prior duration of remission and efficacy outcomes in patients with Ulcerative Colitis treated with tofacitinib 10 mg twice daily who were in stable remission and either dose-reduced to tofacitinib 5 mg twice daily or remained on 10 mg twice daily: 6-month data from the double-blind, randomised RIVETING study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.460 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S361-S362

Author(s):

M C Dubinsky ◽

G R D’Haens ◽

W J Sandborn ◽

S C Ng ◽

J Panés ◽

...

Keyword(s):

Ulcerative Colitis ◽

Dose Reduction ◽

Small Sample Size ◽

Small Sample ◽

Open Label ◽

Double Blind ◽

Treatment Groups ◽

Mayo Score ◽

Remission Duration ◽

To Receive

Abstract Background Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). RIVETING (NCT03281304) is an ongoing, double-blind, randomised, parallel-group study designed to evaluate the efficacy and safety of dose reduction to tofacitinib 5 mg twice daily (BID) vs remaining on 10 mg BID in patients (pts) with UC in stable remission on tofacitinib 10 mg BID maintenance therapy. Eligible pts had received tofacitinib 10 mg BID for ≥2 consecutive years in an open-label, long-term extension study (NCT01470612), and had been in stable remission for ≥6 months (M) and corticosteroid-free for ≥4 weeks prior to enrolment.1 We aimed to evaluate the association between the duration of remission prior to enrolment into RIVETING and the efficacy of tofacitinib 5 and 10 mg BID. Methods Pts who were in partial Mayo score (PMS) remission (a PMS of ≤2 with no individual subscore >1, and a rectal bleeding subscore of 0) at RIVETING baseline were included in this analysis. Pts were randomised to dose-reduce to tofacitinib 5 mg BID or remain on 10 mg BID. We evaluated efficacy endpoints at Month 6 in RIVETING, stratified by duration of PMS remission (0–12, 12–24, 24–36, 36–48, >48 M) at RIVETING baseline. Results At RIVETING baseline, 139 of 140 pts were in PMS remission: 69 pts dose-reduced to tofacitinib 5 mg BID and 70 pts remained on tofacitinib 10 mg BID. In both treatment groups, compared with pts with <24M of PMS remission, baseline modified Mayo and total Mayo scores were numerically lower in pts with a PMS remission duration of >24M; these pts also generally had a numerically lower change from baseline modified Mayo and total Mayo scores at Month 6 (Table). At Month 6, following dose reduction to tofacitinib 5 mg BID, PMS remission was maintained in 66.7%, 60.0%, 82.4%, 75.0% and 90.0% of pts with baseline PMS remission durations of 0–12M, 12–24M, 24–36M, 36–48M and >48M, respectively. Corresponding values for pts who continued to receive tofacitinib 10 mg BID were 80.0%, 88.9%, 91.7%, 100.0% and 100.0%. At Month 6, the proportion of pts achieving modified Mayo remission, remission and modified PMS remission was generally higher in pts with baseline PMS remission of >24M vs pts with PMS remission of <24M across treatment groups (Table). Conclusion Following dose reduction from tofacitinib 10 to 5 mg BID, rates of modified Mayo remission, remission and PMS remission were numerically higher in pts with a PMS remission duration of >24M vs pts with <24M of PMS remission duration. The same trend was observed in pts who continued to receive tofacitinib 10 mg BID. These analyses are post hoc and limited by the small sample size. Reference

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Cost, Quality, and Access of Healthcare in Piura, Peru

American Journal of Undergraduate Research ◽

10.33697/ajur.2019.020 ◽

2019 ◽

Vol 16 (2) ◽

pp. 17-30 ◽

Cited By ~ 1

Author(s):

Julia Griffin ◽

Elaina Osterbur

Keyword(s):

Health Care ◽

Health Care Services ◽

Small Sample Size ◽

Healthcare Services ◽

Small Sample ◽

Medical Providers ◽

Care Services ◽

Care Workers ◽

The Cost ◽

To Receive

The aim of the study is to investigate the patient perceptions on the cost, quality, and access of health care services in Piura, Peru. Although one of the largest cities in Peru, Piura has one of the lowest densities of health care workers in the country which greatly impacts the population’s ability to receive medical treatment. Lack of financial resources and health literacy, among other health disparities exist. Modeled after CAHPS Health Plan Adult Commercial Survey 5.0 and the Patient Satisfaction Survey, a forty-four question English and Spanish survey was created with questions to study healthcare variables. As a correlational study with convenience sampling, the survey was administered to both patients and medical providers in eight city health centers. Over a period of twelve days, 107 surveys were collected. After eliminating subjects who did not meet the study criteria, 92 patients and 13 medical providers were included in the study. Findings from medical providers are not reported because of the small sample size. The results of this study suggests that 32% of subjects do not have health insurance, 24% of subjects rated their healthcare received as average, 18% of participants rated their healthcare as the best possible on a scale of zero to ten, and 29% of subjects had to wait an average of seven days for access to healthcare services when care is urgent. The results of this analysis can be used to better understand the Peruvian healthcare system and educate the Piura community and the Parish Santísimo Sacramento as they continue to improve and expand their health care services. KEYWORDS: Cost; Quality; Access; Healthcare; Piura; Peru; Satisfaction; Parroquia Santísimo Sacramento; EsSalud; SIS; MINSA

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Including young children in their food allergy care: A pilot study

Journal of Food Allergy ◽

10.2500/jfa.2020.2.200034 ◽

2020 ◽

Vol 2 (2) ◽

pp. 161-163

Author(s):

Jodi Shroba ◽

Susan McElroy

Keyword(s):

Food Allergy ◽

Pilot Study ◽

Parental Education ◽

Small Sample Size ◽

Active Role ◽

Small Sample ◽

Food Allergies ◽

Allergic Reactions ◽

Knowledge Questionnaire ◽

To Receive

Rationale: Food allergy education is often directed toward adult caregivers. However, once children go to school, they must participate in their food allergy care to remain safe. The purpose of this study was to assess food allergy knowledge and test an educational intervention targeted toward the child. We hypothesized that child-based teaching will be equal in safety and knowledge outcomes compared with standard parental education. Methods: Twenty-nine children between the ages of 5‐11 years and their caregivers were enrolled. Child subjects completed a food allergy knowledge questionnaire. Each caregiver/child dyad was randomized to receive parent-targeted education (control) or child-targeted education (treatment) and was given an educational booklet. Six weeks later, the child completed the same knowledge questionnaire. At the end of the semester, the caregivers were asked to report allergic reactions that occurred at school. Results: There were no differences between the groups on age or type of school attended. All the subjects demonstrated a statistically significant increase in allergy knowledge from time 1 (completion of survey 1) to time 2 (completion of survey 2) (t = ‐6.301; p < 0.001) There was no difference in knowledge between the groups at time 2 (t = ‐1.782; p = 0.089) and no difference between the groups on allergic reactions during the study period (χ2 = 2.33; p = 0.13). Conclusion: This pilot study, with a small sample size, demonstrated that child-based education was comparable with education targeted toward caregivers, with no difference in allergic events. Children can take an active role in education and management of their food allergies at school.

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Investigating Physician-Directed Chemotherapy Handouts to Improve Patient Knowledge of Chemotherapy

Blood ◽

10.1182/blood.v126.23.5575.5575 ◽

2015 ◽

Vol 126 (23) ◽

pp. 5575-5575

Author(s):

George Zacharia ◽

Ali M. Ameri

Keyword(s):

Side Effects ◽

Conflicts Of Interest ◽

Small Sample Size ◽

Symptom Control ◽

Chemotherapeutic Agents ◽

Small Sample ◽

Cancer Drug ◽

Chemotherapy Patients ◽

To Receive ◽

Improve Patient

Abstract Background: One of the basic goals of an oncologist is to educate patients as to the purpose of treatment and possible side effects of chemotherapy. Evidence suggests that patients who gain knowledge perform better self-care, cope better, and have better symptom control (Dodd, Res Nurs Health 1984; Williams et al, Oncol Nurs Forum 2004). However, we have found that in our clinic, patients frequently misunderstand the information presented to them regarding cancer treatment. This can lead to difficulties on both ends of the patient-physician spectrum. In our institution, it is standard policy for patients commencing chemotherapy as an outpatient to have a lengthy discussion with their oncologist regarding their diagnosis, type of chemotherapy, and side effects of chemotherapy 1-2 weeks before treatment. These patients then receive a handout in our outpatient infusion center from a nurse which contains the names of all the chemotherapeutic agents and possible side effects. The nurse also personally reviews the medications with the patients prior to administration. We have observed that despite receiving verbal and written education, cancer patients often cannot recall the names of the chemotherapeutic agents and side effects of treatment. We are investigating whether physician-directed handouts (PDH), in addition to education provided by nurses, prior to commencement of chemotherapy compared to our current practice could improve cancer drug education in our patients. Methods: We randomized 13 patients starting chemotherapy to receive either PDH or no PDH. The PDH included the name of the chemotherapy as well as 3-5 major and common side effects, which were highlighted. The handouts also contained the patient's chemotherapy cycle (i.e. how often they would be receiving chemotherapy). Patients then continued to receive handouts and education from the nurses at the outpatient infusion center as previously described. Four to six weeks after starting chemotherapy, patient took a multiple choice quiz which tested knowledge in three areas: names of the chemotherapeutic drugs or regimen they received, major side effects, and how often they were receiving chemotherapy. Eight to ten weeks after starting chemotherapy, patients again took the same quiz. Results: Of 13 patients randomized (6 to PDH and 7 to no PDH), 12 completed the study (5 PDH patients, 7 no PDH patients). Demographics: median age 63 years (20-89 years); 5 male; 8 female. At 4-6 weeks, patients in the PDH group and in the no PDH group scored 86% and 77%, respectively. At 8-10 weeks, patients in the PDH group and in the no PDH group scored 84% and 77%, respectively. With the exception of knowledge of chemotherapy cycles at 8-10 weeks (80% vs 100%), patients in the PDH group scored the same or better across all three of the main areas tested in the quizzes (first quiz: chemotherapy names 83% vs 73%, side effects 82% vs 71%, chemotherapy cycles 100% vs 100%; second quiz: chemotherapy names 91% vs 81%, side effects 78% vs 64%, chemotherapy cycles 80% vs 100%). Conclusions: Patients receiving PDH scored higher overall compared to patients that did not receive PDH. Dedicated education by physicians with handouts highlighting the most important aspects of treatment, in addition to education provided by chemotherapy nurses, may be beneficial to patients undergoing chemotherapy. Given the limitations of this small sample size, larger studies are warranted to evaluate these findings. Figure 1. Patients were either given a physician-directed handout (PDH) or no PDH prior to commencement of chemotherapy. Four to six weeks after starting chemotherapy, they took their first quiz. Eight to ten weeks after initiation of chemotherapy, patients took a second quiz. Figure 1. Patients were either given a physician-directed handout (PDH) or no PDH prior to commencement of chemotherapy. Four to six weeks after starting chemotherapy, they took their first quiz. Eight to ten weeks after initiation of chemotherapy, patients took a second quiz. Disclosures No relevant conflicts of interest to declare.

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