A Mediterranean-like dietary pattern with vitamin D3 (10 µg/d) supplements reduced the rate of bone loss in older Europeans with osteoporosis at baseline: results of a 1-y randomized controlled trial

ABSTRACT Background The Mediterranean diet (MD) is widely recommended for the prevention of chronic disease, but evidence for a beneficial effect on bone health is lacking. Objective The aim of this study was to examine the effect of a Mediterranean-like dietary pattern [NU-AGE (New Dietary Strategies Addressing the Specific Needs of the Elderly Population for Healthy Aging in Europe)] on indexes of inflammation with a number of secondary endpoints, including bone mineral density (BMD) and biomarkers of bone and collagen degradation in a 1-y multicenter randomized controlled trial (RCT; NU-AGE) in elderly Europeans. Design An RCT was undertaken across 5 European centers. Subjects in the intervention group consumed the NU-AGE diet for 1 y by receiving individually tailored dietary advice, coupled with supplies of foods including whole-grain pasta, olive oil, and a vitamin D3 supplement (10 µg/d). Participants in the control group were provided with leaflets on healthy eating available in their country. Results A total of 1294 participants (mean ± SD age: 70.9 ±4.0 y; 44% male) were recruited to the study and 1142 completed the 1-y trial. The Mediterranean-like dietary pattern had no effect on BMD (site-specific or whole-body); the inclusion of compliance to the intervention in the statistical model did not change the findings. There was also no effect of the intervention on the urinary biomarkers free pyridinoline or free deoxypyridinoline. Serum 25-hydroxyvitamin D significantly increased and parathyroid hormone decreased (P < 0.001) in the MD compared with the control group. Subgroup analysis of individuals with osteoporosis at baseline (site-specific BMD T-score ≤ −2.5 SDs) showed that the MD attenuated the expected decline in femoral neck BMD (n = 24 and 30 in MD and control groups, respectively; P = 0.04) but had no effect on lumbar spine or whole-body BMD. Conclusions A 1-y intervention of the Mediterranean-like diet together with vitamin D3 supplements (10 µg/d) had no effect on BMD in the normal age-related range, but it significantly reduced the rate of loss of bone at the femoral neck in individuals with osteoporosis. The NU-AGE trial is registered at clinicaltrials.gov as NCT01754012.

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Exercise Training as a Treatment for Cardiometabolic Risk in Sedentary Adults: Are Physical Activity Guidelines the Best Way to Improve Cardiometabolic Health? The FIT-AGEING Randomized Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm8122097 ◽

2019 ◽

Vol 8 (12) ◽

pp. 2097 ◽

Cited By ~ 2

Author(s):

Francisco J. Amaro-Gahete ◽

Alejandro De-la-O ◽

Lucas Jurado-Fasoli ◽

Borja Martinez-Tellez ◽

Jonatan R. Ruiz ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Exercise Training ◽

Cardiometabolic Risk ◽

Controlled Trial ◽

Whole Body ◽

Control Group ◽

Middle Aged ◽

Randomized Controlled ◽

Middle Aged Adults

This 12-week randomized controlled trial investigates the effects of different training modalities on cardiometabolic risk in sedentary, middle-aged adults, and examines whether alterations in cardiometabolic risk are associated with changes in those health-related variables that are modifiable by exercise training. The study subjects were 71 middle-aged adults (~54 years old; ~50% women) who were randomly assigned to one of the following treatment groups: (1) no exercise (control group), (2) concurrent training based on international physical activity recommendations (PAR group), (3) high intensity interval training (HIIT) group, or (4) HIIT plus whole-body electromyostimulation (HIIT+EMS group). A cardiometabolic risk score was calculated based on the International Diabetes Federation’s clinical criteria. A significant reduction in cardiometabolic risk was observed for all exercise training groups compared to the control group (all p < 0.05), which persisted after adjusting potential confounders (all p < 0.05). However, the HIIT+EMS group experienced the most significant reduction (p < 0.001). A significant inverse relationship was detected between the change in lean mass and the change in cardiometabolic risk (p = 0.045). A 12-week exercise training programs-especially the HIIT+EMS program-significantly reduced cardiometabolic risk in sedentary, middle-aged adults independent of sex, age, and cardiorespiratory fitness.

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Does trans fatty acid affect low birth weight? A randomized controlled trial

10.21203/rs.3.rs-61709/v1 ◽

2020 ◽

Author(s):

Parvin Mirmiran ◽

Masoumeh Simbar ◽

Parvaneh Mirabi ◽

Golaleh Asghari ◽

Seideh Hanieh Alamolhoda

Keyword(s):

Randomized Controlled Trial ◽

Birth Weight ◽

Prenatal Care ◽

Low Birth Weight ◽

Dietary Pattern ◽

Controlled Trial ◽

Intervention Group ◽

Hazard Ratio ◽

Control Group ◽

Randomized Controlled

Abstract Objective: To evaluate the effect of low trans fatty acids (TFAs) dietary pattern during pregnancy on risk of low birth weight (LBW).Methods: All pregnant women who received prenatal care with gestational age <8 weeks and aged ≤35 years were included in this randomized controlled trial study that took place in Tehran from December 2014 to August 2016. Women in the intervention group received individualized dietary pattern with TFAs content of < 1%; those in control group had dietary intake with no change on TFAs content. Dietary intakes were assessed by 3 non-consecutive 24-hour recalls at first prenatal care visit and at gestation age 13, 25 and 35 week. Hazard ratio was calculated using Cox proportional‐hazards models. Incidence and hazard ratio (95% CI) for low birth weight based on multivariable adjusted models were calculated.Result: Of the 800 women (n=407 in control and n=393 in intervention groups), 108 (13.5%) women were diagnosed with low birth weight. The incidence of LBW in intervention group was 12% and in control group was 19%. After multivariable adjustment for confounders, the hazard ratios for incident low birth weight in intervention group were 0.65 (0.44-0.96). Kaplan-Meier plot showed significant difference between two groups in incidence of LBW.Conclusion: Intake of low TFAs dietary pattern during pregnancy reduced risk of LBW.Trial registration The trial has been registered in the Iranian Registry of Clinical. Registration number: IRCT2016092729902N3. Registered 8 November 2016, https://en.irct.ir/trial/23919

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Passive exercise in a multisensory environment in order to manage adverse effects in physically inactive patients with dementia: a randomized controlled trial

10.21203/rs.2.10379/v1 ◽

2019 ◽

Author(s):

Marelle Heesterbeek ◽

Eddy van der Zee ◽

Anselm Fuermaier ◽

Marieke van Heuvelen

Keyword(s):

Randomized Controlled Trial ◽

Adverse Effects ◽

Physical Function ◽

Outcome Measures ◽

Controlled Trial ◽

Whole Body ◽

Control Group ◽

Passive Exercise ◽

Randomized Controlled ◽

Multisensory Environment

Abstract Background Since pharmacological treatments to manage dementia remain controversial, development of non-pharmacological alternatives to limit adverse effects of dementia is urgently needed. Passive exercise in a multisensory environment (Therapeutic Motion Simulation (TMSim, Whole Body Vibration (WBV) and a combination (TMSim + WBV)) is proposed to be such a non-pharmacological alternative. This study primarily aimed to investigate the effects of these different forms of passive exercise on Quality of Life (QoL) and Activities of Daily Living (ADLs) of inactive institutionalized patients with dementia. The secondary aim was to assess the effects on cognitive and physical function. Methods In this randomized controlled trial 120 inactive institutionalized persons with dementia (age 85.3 ± 6.8 years, 64.5% female, 59.2% walking aid/wheelchair users, mini mental state examination 12.9 ± 6.6) were assigned to TMSim, WBV, TMSim + WBV or a control group (regular care) The passive exercise groups followed a six-week intervention program consisting of four 4–12 minute sessions a week. QoL, ADLs (proxy-report questionnaires), cognitive and physical function (performance based tests) were measured at baseline, after 6 weeks of intervention, and 2 weeks after the intervention had ended. Results Outcome measures did not differ between groups at baseline. No consistent effects of passive exercise on QoL, ADLs, cognitive and physical function were observed after six weeks of intervention or during follow-up. Conclusion In the current setting passive exercise did not affect any of the outcomes measures. This may be due to the short intervention period, limited sensitivity to change of the assessment instruments in this specific vulnerable population or short lasting effects of the interventions. Future research into passive exercise should consider measuring acute and short term effects as well as longer intervention periods looking into alternative outcome measures (e.g. seated balance and behavioral and psychological symptoms of dementia).

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Clinico-biochemical relation of Vitamin D3 with the severity of atopic dermatitis and response to supplementation of Vitamin D3: A randomized controlled trial

Indian Journal of Child Health ◽

10.32677/ijch.v8i12.3227 ◽

2022 ◽

Vol 8 (12) ◽

pp. 412-415

Author(s):

Narayan Prasad Modi ◽

Arun Kumar Dash

Keyword(s):

Randomized Controlled Trial ◽

Atopic Dermatitis ◽

Vitamin D3 ◽

Urban Areas ◽

Controlled Trial ◽

Intervention Group ◽

Serum Vitamin ◽

Control Group ◽

Baseline Serum ◽

Randomized Controlled

Background: Atopic dermatitis (AD), also known as eczema, is one of the most common skin disorders among children and adults, with a steep rise in diagnoses among children. Many studies have investigated the relationship between Vitamin D3 (Vit D3) and AD. Methods: A randomized controlled trial was conducted among 60 children at SCB Medical College, Cuttack from August 2014 to November 2016. Children were randomly assigned to an intervention group that received 60,000 IU of Vit. D3 every week for 6 weeks in addition to regular treatment for AD and a control group that received same treatment of AD except for Vit. D3. Both the groups were followed up at 4 weeks and 8 weeks. Results: In 60 cases of moderate to severe AD, 70% of the patients were male. About 81.7% of patients were from urban areas and 56.7% belonged to a middle socioeconomic class. In 76.6% of cases, family history of atopy was present. At baseline, mean SCORAD was 47.8±7.5 in the intervention group, and 49.2±10.3 in the control group. At baseline, serum Vitamin. D3 level (ng/ml) was 17.6±1.8 in intervention and 17.3±3.5 in control group. After Vitamin. D3 supplementation, the SCORAD improved to 12.8±5.1 (75% reduction) at 4 weeks, and 3.6±2.1 (92% reduction) at 8 weeks in the intervention group. In the control group, the mean SCORAD was 18.8±9.1 (61% reduction) at 4 weeks, and 7.3±4 (85% reduction) at 8 weeks. Discussion: The improvement of serum 25-hydroxy Vit. D3 was 134% and 366% in the intervention group compared to 78% and 121% in the observation group after 4 weeks and 8 weeks respectively. The p-values at both the time points were significant (<0.05) for the intervention group as compared to the control group. Conclusion: Short-term therapeutic supplementation of Vitamin. D3 in children with moderate to severe AD improves the clinical score. There is an inverse relationship between serum Vitamin. D3 level and severity of AD.

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Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

10.2196/preprints.13973 ◽

2019 ◽

Author(s):

Sarah Dineen-Griffin ◽

Victoria Garcia Cardenas ◽

Kylie Williams ◽

Shalom Isaac Benrimoj

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Self Care ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Community Pharmacies ◽

Randomized Controlled ◽

Minor Ailments ◽

Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

Journal of Reconstructive Microsurgery ◽

10.1055/s-0041-1724465 ◽

2021 ◽

Author(s):

Ronnie L. Shammas ◽

Caitlin E. Marks ◽

Gloria Broadwater ◽

Elliot Le ◽

Adam D. Glener ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Breast Reconstruction ◽

Controlled Trial ◽

Depression Scale ◽

Control Group ◽

Lavender Oil ◽

Entire Cohort ◽

Randomized Controlled ◽

Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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Water exchange-assisted vs. carbon dioxide-insufflated single-balloon enteroscopy: randomized controlled trial

Endoscopy ◽

10.1055/a-1459-4571 ◽

2021 ◽

Author(s):

Shaopeng Liu ◽

Tao Dong ◽

Yupeng Shi ◽

Hui Luo ◽

Xianmin Xue ◽

...

Keyword(s):

Carbon Dioxide ◽

Randomized Controlled Trial ◽

Adverse Events ◽

Water Exchange ◽

Controlled Trial ◽

Control Group ◽

Balloon Enteroscopy ◽

Randomized Controlled ◽

Single Balloon ◽

Single Balloon Enteroscopy

Background and study aims Single-balloon enteroscopy (SBE) is a valuable but difficult modality for the diagnosis and treatment of small-bowel diseases. The water exchange (WE) method has the advantage of facilitating intubation during colonoscopy. Here, we evaluated the effects of WE on procedure-related variables related to SBE. Patients and methods This randomized controlled trial was conducted in a tertiary-care referral center in China. Patients with attempt at total enteroscopy (ATE) were randomly allocated to undergo WE-assisted (WE group) or carbon dioxide-insufflated enteroscopy (CO2 group). All patients were planned to undergo both antegrade and retrograde procedures. The primary outcome was the total enteroscopy rate (TER). Secondary outcomes included maximal insertion depth, positive findings, procedural time and adverse events. Results In total, 110 patients were enrolled, with 55 in each group. Baseline characteristics between the two groups were comparable. TER was achieved in 58.2% (32/55) of the WE group and 36.4% (20/55) of the control group (p=0.022). The estimated intubation depth was 521.2±101.4 cm in the WE group and 481.6±95.2 cm in the CO2 group (p=0.037). The insertion time was prolonged in the WE group compared with CO2 group (178.9±45.1 min vs. 154.2±27.6 min, p<0.001). Endoscopic findings and adverse events were comparable between the two groups. Conclusions The WE method improved TER and increased intubation depth during SBE. The use of WE did not increase complications of enteroscopy. Clinical trial registation: https://clinicaltrials.gov/， NCT01942863.

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