A Unique Strategy to Address Nurse Leader Fatigue.

A quality improvement process was implemented within a large, tertiary healthcare organization to develop and implement a roundtable culture as part of a fatigue risk management system focused on mitigating nurse leader fatigue and stress. Strategies to form trusting collaboration and reduce leader attrition were initiated and assessed for effectiveness. Results show measurable decreases in reported levels of stress and attrition. Acute, chronic, and persistent fatigue continue to challenge those in leadership roles.

Specialist foragers in forest bee communities are small, social or emerge early.

Individual pollinators that specialize on one plant species within a foraging bout transfer more conspecific and less heterospecific pollen, positively affecting plant reproduction. However, we know much less about pollinator specialization at the scale of a foraging bout compared to specialization by pollinator species. In this study, we measured the diversity of pollen carried by individual bees foraging in forest plant communities in the mid-Atlantic United States. We found that individuals frequently carried low-diversity pollen loads, suggesting that specialization at the scale of the foraging bout is common. Individuals of solitary bee species carried higher diversity pollen loads than did individuals of social bee species; the latter have been better studied with respect to foraging bout specialization, but account for a small minority of the world's bee species. Bee body size was positively correlated with pollen load diversity, and individuals of polylectic (but not oligolectic) species carried increasingly diverse pollen loads as the season progressed, likely reflecting an increase in the diversity of flowers in bloom. Furthermore, the seasonal increase in pollen load diversity was stronger for bees visiting trees and shrubs than for bees visiting herbaceous plants. Overall, our results showed that both plant and pollinator species' traits as well as community-level patterns of flowering phenology are likely to be important determinants of individual-level interactions in plant-pollinator communities.

Monosomy 18p is a risk factor for facioscapulohumeral dystrophy.

BACKGROUND: 18p deletion syndrome is a rare disorder caused by partial or full monosomy of the short arm of chromosome 18. Clinical symptoms caused by 18p hemizygosity include cognitive impairment, mild facial dysmorphism, strabismus and ptosis. Among other genes, structural maintenance of chromosomes flexible hinge domain containing 1 (SMCHD1) is hemizygous in most patients with 18p deletions. Digenic inheritance of a SMCHD1 mutation and a moderately sized D4Z4 repeat on a facioscapulohumeral muscular dystrophy (FSHD) permissive genetic background of chromosome 4 can cause FSHD type 2 (FSHD2). OBJECTIVES: Since 12% of Caucasian individuals harbour moderately sized D4Z4 repeats on an FSHD permissive background, we tested if people with 18p deletions are at risk of developing FSHD. METHODS: To test our hypothesis we studied different cellular systems originating from individuals with 18p deletions not presenting FSHD2 phenotype for transcriptional and epigenetic characteristics of FSHD at D4Z4. Furthermore, individuals with an idiopathic muscle phenotype and an 18p deletion were subjected to neurological examination. RESULTS: Primary fibroblasts hemizygous for SMCHD1 have a D4Z4 chromatin structure comparable with FSHD2 concomitant with DUX4 expression after transdifferentiation into myocytes. Neurological examination of 18p deletion individuals from two independent families with a moderately sized D4Z4 repeat identified muscle features compatible with FSHD. CONCLUSIONS: 18p deletions leading to haploinsufficiency of SMCHD1, together with a moderately sized FSHD permissive D4Z4 allele, can associate with symptoms and molecular features of FSHD. We propose that patients with 18p deletion should be characterised for their D4Z4 repeat size and haplotype and monitored for clinical features of FSHD.

Peer-to-Peer Feedback: A Novel Approach to Nursing Quality, Collaboration, and Peer Review.

This article describes how an acute care organization in Texas, a peer review mandated state, created a nonpunitive peer feedback structure and process for nursing staff. Strategies were targeted to improve patient outcomes. A peer feedback committee designed, implemented, and evaluated the feedback model to coexist with the state-required formal peer review committee structure. Peer feedback provided opportunities to advance skill development, enhance quality improvement, improve patient outcomes, and support a culture of safety within the healthcare environment.

A Spoonful of (Added) Sugar Helps the Constitution Go Down: Curing the Compelled Speech Commercial Speech Doctrine with FDA's Added Sugars Rule.

On May 27, 2016, the Food and Drug Administration (FDA) announced that it was adopting a new rule that requires food manufacturers to list­on the already mandated Nutrition Facts label­how many grams of sugar have been added to a food product. Many opponents have criticized this "added sugars" rule on First Amendment grounds, arguing that the rule violates the commercial speech rights of food manufacturers. Whether the rule would survive constitutional scrutiny or not is an open question because the compelled commercial speech doctrine is anything but clear. Courts are split over whether Zauderer's rational basis test, Central Hudson's intermediate scrutiny, or some combination of the two should apply to a mandated disclosure like FDA's added sugars rule. This Paper explains that the added sugars rule is unique in the history of mandated nutrition labeling in that the rule is motivated largely by public health concerns and backed by reports that assert that consumers should limit their intake of added sugars. In contrast, correcting and preventing consumer deception has been a major driving force behind the remainder of FDA's mandated nutrition labeling. Because of this distinct rationale, the added sugars rule does not fit neatly into any currently existing compelled commercial speech test. This Paper uses the added sugars rule to highlight the deficiencies in the existing tests. Finally, this Paper proposes a new compelled commercial speech test that would adequately balance the interest of all of the effected parties: the government, the public, and food manufacturers.

Hemizygosity for SMCHD1 in Facioscapulohumeral Muscular Dystrophy Type 2: Consequences for 18p Deletion Syndrome.

Facioscapulohumeral muscular dystrophy (FSHD) is most often associated with variegated expression in somatic cells of the normally repressed DUX4 gene within the D4Z4-repeat array. The most common form, FSHD1, is caused by a D4Z4-repeat array contraction to a size of 1-10 units (normal range 10-100 units). The less common form, FSHD2, is characterized by D4Z4 CpG hypomethylation and is most often caused by loss-of-function mutations in the structural maintenance of chromosomes hinge domain 1 (SMCHD1) gene on chromosome 18p. The chromatin modifier SMCHD1 is necessary to maintain a repressed D4Z4 chromatin state. Here, we describe two FSHD2 families with a 1.2-Mb deletion encompassing the SMCHD1 gene. Numerical aberrations of chromosome 18 are relatively common and the majority of 18p deletion syndrome (18p-) cases have, such as these FSHD2 families, only one copy of SMCHD1. Our finding therefore raises the possibility that 18p- cases are at risk of developing FSHD. To address this possibility, we combined genome-wide array analysis data with D4Z4 CpG methylation and repeat array sizes in individuals with 18p- and conclude that approximately 1:8 18p- cases might be at risk of developing FSHD.

The course and outcome of pregnancy in women with nondystrophic myotonias.

INTRODUCTION: Nondystrophic myotonias (NDM) are muscle channelopathies characterized by clinical and electrical myotonia. Little is known about pregnancy in NDM. The aim of this work was to assess pregnancy outcomes in women with NDM. METHODS: In this investigation, we utilized a cross-sectional approach and obtained questionnaire data and medical record review information. Pregnancy outcomes were compared with U.S. national data. RESULTS: Twenty-five women completed the study. There were 63 pregnancies with 53 live births, 8 miscarriages, 4 terminations, and 1 stillbirth. The infertility rate was 28% (above the U.S. average). Fetal distress was reported in 11.7% (U.S. average 3.6%) of the patients. NDM symptoms worsened in 62% of pregnancies. In those who worsened, symptoms usually resolved completely (66%) or partially (32%) after delivery in 2 days to 12 months, the majority (76%) within 3 months. CONCLUSIONS: Most pregnancy outcomes were favorable. NDM worsened in nearly two-thirds of pregnancies, but usually improved shortly after delivery. Incidences of infertility and fetal distress were higher than overall U.S. rates.

Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.

Restrictive lung involvement in facioscapulohumeral muscular dystrophy.

INTRODUCTION: Few studies have evaluated the frequency or predisposing factors for respiratory involvement in facioscapulohumeral muscular dystrophy type 1 (FSHD1) and type 2 (FSHD2). METHODS: We performed a prospective cross-sectional observational study of 61 genetically confirmed FSHD participants (53 FSHD1 and 8 FSHD2). Participants underwent bedside pulmonary function testing in sitting and supine positions, a standard clinical history and physical assessment, and manual muscle testing. RESULTS: Restrictive respiratory involvement was suggested in 9.8% (95% confidence interval 2.4-17.3): 7.5% FSHD1 and 25.0% FSHD2 (P = 0.17). Participants with testing suggestive of restrictive lung involvement (n = 6) were more severely affected (P = 0.005), had weaker hip flexion (P = 0.0007), and were more likely to use a wheelchair (P = 0.01). CONCLUSIONS: Restrictive respiratory involvement should be considered in all moderate to severely affected FSHD patients with proximal lower extremity weakness. The higher frequency of restrictive lung disease in FSHD2 seen here requires confirmation in a larger cohort of FSHD2 patients.

Predictors of successful transition to registered nurse.

AIM: To identify predictors of successful transition from undergraduate student to registered nurse and to identify whether any particular pre-registration paid employment choice impacted on transition. BACKGROUND: Nursing students in Australia and internationally, engage in a variety of paid employment whilst completing their university studies. However, there is little empirical evidence about the different types of employment chosen by students and any relationship to graduate nurse transition. DESIGN: A descriptive questionnaire survey. METHOD: This cross-sectional study was conducted with newly graduated nurses throughout Australia. The survey data were collected over 4 months in 2011, with 392 registered nurses completing a questionnaire. RESULTS: Respondents were categorized into four groups, according to their chosen work type (hospitality/retail, enrolled nurse, other healthcare worker, and non-worker) and transition scores were identified. Transition scores were significantly higher for undergraduates who were employed compared with non-workers. Postregistration institutional work factors appeared to be stronger predictors of successful transition than pre-registration employment factors. Assistance in dealing with complex patients, orientation to a new environment, and respect from colleagues were the best predictors for successful transition. CONCLUSIONS: Engaging in some form of paid employment in the final year of undergraduate university study is beneficial. However, it is not pre-registration employment choice per se that is the best predictor of successful transition, but the influence of work factors which new graduates experience in their first year of practice.

Regional plant abundance explains patterns of host use by pollen-specialist bees in eastern North America.

Specialist insect herbivores make up a substantial fraction of Earth's biodiversity; however, they exploit a minority of plant lineages. For instance, in the eastern United States and Canada, ~25% of bee species are pollen specialists, but they are hosted by a small fraction of the native, animal-pollinated angiosperms in the region: Only 6% of plant genera and 3% of families support pollen-specialist bees. It is unclear why some plant lineages host specialist bees while others do not. We know that at least some specialist bees use plant taxa that are avoided by generalists, suggesting that specialist bees favor plants with low-quality pollen, potentially as a strategy to escape competition or obtain protection from natural enemies. There is also evidence that specialist bees prefer superabundant host plants. Here we investigate whether pollen quality and plant abundance predict patterns of host use by specialist bees in eastern North America. Through field observations, we find that plants hosting specialist bees are frequent sources of pollen for generalists, suggesting that their pollen is not generally avoided by bees due to poor pollen quality. In addition, our analysis of a large citizen-science data set shows that regional abundance strongly predicts which plant genera in the eastern United States host pollen-specialist bees. Our results show that bees specialize on regionally abundant-but not necessarily low-quality-plant lineages. These plant lineages may provide more opportunities for the evolution of specialists and lower likelihood of specialist extinction.

Applying Learning Principles Within Parent Education: Exploring Nurses' Practice and Parents' Experiences.

Purpose: In parent-education practice nurses use Learning Principles (LPs) when helping parents to develop the knowledge and skills required to care for their children. LPs are basic precepts of learning, comprising people's beliefs, behaviors and reasoning processes. LPs underpin parents' active engagement, confidence building and decision-making, as information provided becomes usable knowledge. However, the ways nurses apply LPs in parent-education practice are poorly explained in healthcare. Likewise, descriptions of parents' learning experiences, associated with the use of LPs in nurse/parent-education interactions, are lacking. This study aimed to explore and describe nurses' perceptions and use of LPs, and parents' learning experiences in one healthcare organization. Participants and Methods: Using an action research design, 25 nurses and 18 parent participants were purposively recruited across metropolitan Adelaide, Australia. Data were collected through observations and semi-structured interviews and thematically analyzed simultaneously June-December 2017. Results: The LPs nurses used, and those important to parents' learning experiences created three overarching themes: 1) collaborative relationships, 2) deepening learning insights, 3) the learning environment. Despite their apparent use, nurses struggled to explicitly describe how they perceived LPs, believing their knowledge and use was sub-conscious - tacit. However, tacit knowledge hinders communication and explanation of LPs used within parent-education to other nurses. The member-checking of interview data helped to stimulate the nurses' metacognition (thinking about their thinking), unlocking their LPs awareness. Conclusion: Nurses used LPs in practice but their knowledge was tacit. Through metacognition, nurses started to recognize the ways LPs influenced their practice and parents' learning capabilities. Increasing healthcare constraints, including time allowed for parent-education, require nurses to optimize their use of LPs. Future research should identify ways nurses can communicate their use of LPs, potentially enhancing parents' active learning experiences and concordance with health recommendations.

Ginseng and Ginseng Herbal Formulas for Symptomatic Management of Fatigue: A Systematic Review and Meta-Analysis.

Objectives: Ginseng has been widely used in fatigue management. However, its efficacy on fatigue remains unclear. This study aimed to assess the efficacy and safety of ginseng and ginseng herbal formulas for fatigue in randomized clinical trials (RCTs). Methods: The authors searched PubMed, Embase, Cochrane, Web of Science, and Allied and Complementary Medicine Database (AMED) databases from inception to July 6, 2022. Outcomes included fatigue severity, quality of life (QoL), and adverse events (AEs). Quality of evidence was assessed using the Cochrane Risk of Bias Tool. They pooled all included data and performed subgroup analysis by fatigue type, assessment instrument, and ginseng type. Results: The authors included 19 RCTs. Pooled analyses found no significant reduction in fatigue severity with ginseng versus controls (standardized mean difference [SMD]: -0.36, 95% confidence interval [CI]: -0.82 to 0.11, p = 0.13). In subgroup analysis, there was significant fatigue reduction with the ginseng herbal formula (SMD: -0.39, 95% CI: -0.66 to -0.13, p = 0.004) and chronic fatigue (CF) (SMD: -0.30, 95% CI: -0.56 to -0.03, p = 0.03) compared to controls. Ginseng produced significant reductions in general (i.e., non-disease-specific) fatigue compared to controls (SMD: -0.48, 95% CI: -0.71 to -0.25, p < 0.0001). Ginseng was associated with a trend toward QoL improvement (p = 0.05) and did not increase AEs compared with controls. Effect sizes were small. Conclusion: Ginseng herbal formulas improved fatigue severity compared to controls, especially among patients with CF, but with a small effect size. Rigorous RCTs as well as guidelines for standard ginseng usage are needed to further evaluate the effects of ginseng for fatigue and ensure proper use.

The effectiveness of simulation activities on the cognitive abilities of undergraduate third-year nursing students: a randomised control trial.

AIMS AND OBJECTIVES: To provide evidence on the effectiveness of simulation activities on the clinical decision-making abilities of undergraduate nursing students. Based on previous research, it was hypothesised that the higher the cognitive score, the greater the ability a nursing student would have to make informed valid decisions in their clinical practice. BACKGROUND: Globally, simulation is being espoused as an education method that increases the competence of health professionals. At present, there is very little evidence to support current investment in time and resources. METHODS: Following ethical approval, fifty-eight third-year undergraduate nursing students were randomised in a pretest-post-test group-parallel controlled trial. The learning environment preferences (LEP) inventory was used to test cognitive abilities in order to refute the null hypothesis that activities in computer-based simulated learning environments have a negative effect on cognitive abilities when compared with activities in skills laboratory simulated learning environments. RESULTS: There was no significant difference in cognitive development following two cycles of simulation activities. Therefore, it is reasonable to assume that two simulation tasks, either computer-based or laboratory-based, have no effect on an undergraduate student's ability to make clinical decisions in practice. However, there was a significant finding for non-English first-language students, which requires further investigation. CONCLUSIONS: More longitudinal studies that quantify the education effects of simulation on the cognitive, affective and psychomotor attributes of health science students and professionals from both English-speaking and non-English-speaking backgrounds are urgently required. It is also recommended that to achieve increased participant numbers and prevent non-participation owing to absenteeism, further studies need to be imbedded directly into curricula. RELEVANCE TO CLINICAL PRACTICE: This investigation confirms the effect of simulation activities on real-life clinical practice, and the comparative learning benefits with traditional clinical practice and university education remain unknown.

An innovative strategy in evaluation: using a student engagement framework to evaluate a role-based simulation.

Online role-play has the potential to actively engage students in authentic learning experiences and help develop their clinical reasoning skills. However, evaluation of student learning for this kind of simulation focuses mainly on the content and outcome of learning, rather than on the process of learning through student engagement. This article reports on the use of a student engagement framework to evaluate an online role-play offered as part of a course in Bachelor of Nursing and Bachelor of Midwifery programs. Instruments that measure student engagement to date have targeted large numbers of students at program and institutional levels, rather than at the level of a specific learning activity. Although the framework produced some useful findings for evaluation purposes, further refinement of the questions is required to be certain that deep learning results from the engagement that occurs with course-level learning initiatives.

Herbal Formula Shenling Baizhu San for Chronic Diarrhea in Adults: A Systematic Review and Meta-analysis.

BACKGROUND: Shenling Baizhu San (SBS), a well-known Chinese medicine herbal formula, has been widely used for treating chronic diarrhea for thousands of years. However, the efficacy and safety of SBS in treating chronic diarrhea have not been fully assessed. OBJECTIVE: This study evaluates the efficacy and safety of the herbal formula SBS in symptomatic relief of chronic diarrhea. METHODS: English and Chinese language databases (PubMed, Cochrane Library, China National Knowledge Infrastructure, China Science and Technology Journal Database, Wanfang Data, and SinoMed electronic databases) were searched through April 2020 for relevant randomized controlled trials (RCTs). The outcomes in these RCTs included stool frequency, stool consistency, patient-reported satisfaction of chronic diarrhea treatment, quality of life and adverse events. Paired reviewers independently extracted data and conducted qualitative and quantitative analyses. The Cochrane revised risk of bias RoB-2 tool was applied to assess the risk of bias for each trial whereas the RevMan 5.3 software was used for outcomes data synthesis and meta-analysis. Mean difference (MD) and the 95% confidence interval (CI) were used to measure continuous data. The dichotomous data were analyzed via the relative risk (RR) with 95% CIs. RESULTS: Fourteen RCTs including 1158 participants (54% males) with chronic diarrhea were included. Shenling Baizhu San combined with or without conventional medicine (CM) was associated with greater patient-reported satisfaction than CM alone. There was no increased risk of adverse events (AEs) during treatment. CONCLUSION: Treatment with SBS was associated with significant improvement in patient-reported satisfaction, irrespective of conventional medicine use. Rigorous and powered RCTs with objective outcome measures are needed to confirm the effects of SBS in specific gastrointestinal disease populations with chronic diarrhea symptoms. SYSTEMATIC REVIEW REGISTRATION NUMBER (PROSPERO): CRD42020178073.

Hospital-wide cardiac arrest in situ simulation to identify and mitigate latent safety threats.

BACKGROUND: Cardiac arrest resuscitation requires well-executed teamwork to produce optimal outcomes. Frequency of cardiac arrest events differs by hospital location, which presents unique challenges in care due to variations in responding team composition and comfort levels and familiarity with obtaining and utilizing arrest equipment. The objective of this initiative is to utilize unannounced, in situ, cardiac arrest simulations hospital wide to educate, evaluate, and maximize cardiac arrest teams outside the traditional simulation lab by systematically assessing and capturing areas of opportunity for improvement, latent safety threats (LSTs), and key challenges by hospital location. METHODS: Unannounced in situ simulations were performed at a city hospital with multidisciplinary cardiac arrest teams responding to a presumed real cardiac arrest. Participants and facilitators identified LSTs during standardized postsimulation debriefings that were classified into equipment, medication, resource/system, or technical skill categories. A hazard matrix was used by multiplying occurrence frequency of LST in simulation and real clinical events (based on expert opinion) and severity of the LST based on agreement between two evaluators. RESULTS: Seventy-four in situ cardiac arrest simulations were conducted hospital wide. Hundreds of safety threats were identified, analyzed, and categorized yielding 106 unique latent safety threats: 21 in the equipment category, 8 in the medication category, 41 in the resource/system category, and 36 in the technical skill category. The team worked to mitigate all LSTs with priority mitigation to imminent risk level threats, then high risk threats, followed by non-imminent risk LSTs. Four LSTs were deemed imminent, requiring immediate remediation post debriefing. Fifteen LSTs had a hazard ratio greater than 8 which were deemed high risk for remediation. Depending on the category of threat, a combination of mitigating steps including the immediate fixing of an identified problem, leadership escalation, and programmatic intervention recommendations occurred resulting in mitigation of all identified threats. CONCLUSIONS: Hospital-wide in situ cardiac arrest team simulation offers an effective way to both identify and mitigate LSTs. Safety during cardiac arrest care is improved through the use of a system in which LSTs are escalated urgently, mitigated, and conveyed back to participants to provide closed loop debriefing. Lastly, this hospital-wide, multidisciplinary initiative additionally served as an educational needs assessment allowing for informed, iterative education and systems improvement initiatives targeted to areas of LSTs and areas of opportunity.

A mixed method pilot study: the researchers' experiences.

AIM: This paper reports on the outcomes of a small well designed pilot study. BACKGROUND: Pilot studies often disseminate limited or statistically meaningless results without adding to the body knowledge on the comparative research benefits. METHOD: The design a pre-test post-test group parallel randomised control trial and inductive content analysis of focus group transcripts was tested specifically to increase outcomes in a proposed larger study. OUTCOMES: Strategies are now in place to overcome operational barriers and recruitment difficulties. Links between the qualitative and quantitative arms of the proposed larger study have been made; it is anticipated that this will add depth to the final report. CONCLUSION: More extensive reporting on the outcomes of pilot studies would assist researchers and increase the body of knowledge in this area.

Tibetan herbal pain-relieving plaster for low back pain: A systematic review and meta-analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Tibetan traditional medicine CheeZheng Pain-Relieving Plaster (CZPRP) is frequently used as an over-the-counter external analgesic for musculoskeletal pain; however, its evidence for low back pain (LBP) has not been evaluated. AIM OF THE STUDY: This study aims to assess the efficacy and safety of CZPRP for both acute, subacute and chronic LBP through a systematic review and meta-analysis of clinical trials. MATERIALS AND METHODS: PubMed, CENTRAL, CNKI, CQVIP, and Wanfang databases were searched through April 20, 2020 for randomized controlled trials of CZPRP for LBP. Eligible comparators were placebo, active treatment, or usual care. Clinical outcomes included pain severity, lower back function score, pain-free rate, and adverse events (AEs). Qualitative evaluations were conducted using the Cochrane risk of bias assessment tools. Quantitative analyses were conducted using a random-effects model. RESULTS: This study includes 1674 LBP patients from nine clinical studies. Pooled analyses among subjects with acute LBP show 1) significant pain reductions (mean difference -0.84, 95% confidence interval[CI] -1.31, -0.37) in CZPRP plus diclofenac versus diclofenac, 2) significant improvements in lower back function (standard mean difference -1.50, 95% CI -2.16, -0.85) in CZPRP versus diclofenac, and 3) a higher pain-free rate in CZPRP alone (risk ratio 1.48, 95% CI 1.16, 1.89; I2 = 61%) or CZPRP plus nonsteroidal anti-inflammatory drugs (NSAIDs) (risk ratio 1.66, 95% CI 1.14, 2.40; I2 = 0%) versus NSAIDs. However, in a heterogeneous population with mixed LBP subtypes, there was no significant difference in pain outcomes between CZPRP and diclofenac. Additionally, CZPRP use did not increase AEs compared with no CZPRP (p = 0.40). All nine studies are associated with moderate to high risk of bias. CONCLUSIONS: The use of CZPRP is associated with improved acute LBP outcomes compared to diclofenac. However, due to the moderate to high risk of bias of the studies, future rigorous randomized controlled trials are needed to evaluate the effects of CZPRP for acute and chronic LBP.

Herbal formula MaZiRenWan (Hemp Seed Pill) for constipation: A systematic review with meta-analysis.

BACKGROUND: There is growing interest in using herbal supplements to treat constipation; however, little evidence exists for their use. PURPOSE: This study evaluates the efficacy and safety of herbal formula MaZiRenWan (Hemp Seed Pill, HSP) in patients with functional or non-functional constipation. STUDY DESIGN: Systematic review and meta-analysis METHODS: PubMed, CENTRAL, Embase, CNKI, and Wanfang were searched through April 20, 2020 for randomized trials of HSP versus placebo or medications for all types of constipation. The primary outcomes were complete response rate, complete spontaneous bowel movement (CSBM), patient-reported satisfactory treatment rate (prSTR), and adverse events (AEs). Clinical data were analyzed using a random-effects model, and the quality of evidence was evaluated with the GRADE system. RESULTS: This review includes 1681 constipation patients from 17 moderate-to-high risk of bias trials that were conducted in east Asia. Two high-quality trials showed that HSP compared with placebo significantly increased weekly CSBM (mean difference, 0.95; 95% CI: 0.56, 1.35) and had a higher complete response rate (risk ratio [RR], 1.43; 95% CI: 1.20, 1.71) in patients with functional constipation. Low-quality evidence showed significant improvement in prSTR in HSP compared with conventional medications (RR, 1.79; 95% CI: 1.42, 2.25). Additionally, HSP use did not increase AEs compared with no HSP (p = 0.99). CONCLUSIONS: This study found that HSP was effective among Asian patients with functional constipation. Rigorous trials need to be conducted in clinical populations outside of east Asia and in those with non-functional constipation to increase the generalizability of the evidence.