Randomization List Research Articles

Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial

ObjectivesTo determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these...

Clinical Efficacy on Severe Acute Radiation Dermatitis Treated by Topical Compound Danxiong Granules in Patients Receiving Radiation: A Prospective Randomized Trial

<h3>Purpose/Objective(s)</h3> Radiation dermatitis (RD) is one of the most common acute toxicities induced by radiation therapy (RT). The preliminary study demonstrated the Compound Danxiong Granules (CDG), a traditional Chinese medicine, had promising outcome in RD. To evaluate the efficacy of topical CDG in the treatment of ≥ grade 3 acute radiation dermatitis. <h3>Materials/Methods</h3> This prospective, randomized, open-label phase 2 clinical trial (ChiCTR1900021339) enrolled patients who had histologically proven malignant tumor, with grade 3 acute RD in the radiation field within 30 days after radiotherapy, in accordance with the CTCAE 4.0 version. We randomly assigned patients (2:1) to receive either CDG treatment (CDG group), or standard of care of recombinant human epidermal growth factor (Gene Time, control group), using a computer-generated randomization list. Application of the CDG via topical washes lasted 20 minutes, twice daily. Grading of RD was performed by independent radiation oncologist every day. The primary endpoint was the recovery time from grade 3 dropped to grade 1. <h3>Results</h3> 90 patients in our institution were randomized between January 2019 and December 2021. Of 90 patients, 58(64.4%) were assigned to the CDG group and 32(35.6%) to the control group. One (1.7%) patient in the CDG group did not receive allocated treatment and withdrew from the trial. The median recovery time was 11 days in the CDG group versus 26 days in the control group (p<0.001). Significant differences in compliance with RT were observed between the groups (p<0.001). The CDG regimen was well tolerated and did not cause any adverse effects. <h3>Conclusion</h3> Topical application of CDG can effectively relieve severe acute radiation dermatitis rapidly and shorten recovery time significantly compared to traditional treatment.

The Efficacy and Safety of the Zhuyun Formula and Auricular Acupressure for the Infertile Women with Recurrent Implantation Failure: A Randomized Controlled Trial.

Background Recurrent implantation failure (RIF), a clinical disorder characterized by failure to achieve pregnancy after repeated (≥3) embryo transfer, is a challenge for reproductive demands worldwide. In our preliminary work, the Zhuyun formula (ZYF) with auricular acupressure, a complementary and alternative medicine (CAM) with a small sample size for RIF, can improve the clinical pregnancy rate (41.2% vs. 26.7%, treatment group vs. control group, p < 0.05). Based on the toxicological and pregnancy-related pharmacological analysis of ZYF for RIF, the T-cell receptor signaling pathway might be involved in the pharmacological activity. This study aimed at evaluating the efficacy and safety of the CAM therapy according to pregnancy outcomes and maternal and child health and investigating the changes of T-helper (Th) cells in the peripheral blood of unexplained RIF women. Materials and Methods We conducted a prospective, two-arms, randomized, nonblinded study. All eligible women were randomly assigned to the treatment group (TG) and the control group (CG) according to a computer-generated randomization list in sealed opaque envelopes. Blood samples were collected from the two groups, and serum Th1, Th2, and Treg were detected by flow cytometry. The cytokines were detected by an enzyme-linked immunosorbent assay (ELISA). The TG was administrated with ZYF and auricular acupressure for three months before ovarian stimulation, while the control group was on a waiting list for the same period. The primary outcome was CPR. The second outcomes were the serum levels of immune parameters. For the safety evaluation, the perinatal outcomes of maternal and child were obtained by follow-up. Post-hoc sensitivity analyses were performed to assess the effect of missing data. Results One hundred and twenty-three women were randomized into the TG (n = 62) and CG (n = 61). The CPR was increased significantly in the TG (45.2%) than CG (26.2%) (p = 0.029). Twenty blood samples were collected, and the Th2/Th1 and Treg expression level was significantly higher in the TG than in the CG. IL-2, IL-10, and Foxp3 were higher significantly in the TG than in the CG. The maternal and child perinatal outcomes were not significantly different between the two groups. Conclusions The ZYF with auricular acupressure was effective and safe in improving the pregnancy outcomes of RIF. It might be related to balancing the level of cytokines related to the immune tolerance of the maternal-fetal interface to protect the embryo from the maternal immune system. Clinical Trial Registration: Clinical Trial Registry; date: 14/Dec/2013; no. NCT03078205.

Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomised, double-blind, placebo-controlled trial

Clostridioides difficile infection is an urgent antibiotic-associated health threat with few treatment options. Microbiota restoration with faecal microbiota transplantation is an effective treatment option for patients with multiple recurring episodes of C difficile. We compared the efficacy and safety of faecal microbiota transplantation compared with placebo after vancomycin for first or second C difficile infection. We did a randomised, double-blind, placebo-controlled trial (EarlyFMT) at a university hospital in Aarhus, Denmark. Eligible patients were aged 18 years or older with first or second C difficile infection (defined as ≥3 watery stools [Bristol stool chart score 6-7] per day and a positive C difficile PCR test). Patients were randomly assigned (1:1) to faecal microbiota transplantation or placebo administered on day 1 and between day 3 and 7, after they had received 125 mg oral vancomycin four times daily for 10 days. Randomisation was done by investigators using a computer-generated randomisation list provided by independent staff. Patients and investigators were masked to the treatment group. The primary endpoint was resolution of C difficile-associated diarrhoea (CDAD) 8 weeks after treatment. We followed up patients for 8 weeks or until recurrence. We planned to enrol 84 patients with a prespecified interim analysis after 42 patients. The primary outcome and safety outcomes were analysed in the intention-to-treat population, which included all randomly assigned patients. The trial is registered with ClinicalTrials.gov, NCT04885946. Between June 21, 2021, and April 1, 2022, we consecutively screened 86 patients, of whom 42 were randomly assigned to faecal microbiota transplantation (n=21) or placebo (n=21). The trial was stopped after the interim analysis done on April 7, 2022 for ethical reasons because a significantly lower rate of resolution was identified in the placebo group compared with the faecal microbiota transplantation group (Haybittle-Peto boundary limit p<0·001). 19 (90%; 95% CI 70-99) of 21 patients in the faecal microbiota transplantation group and seven (33%, 95% CI 15-57) of 21 patients in the placebo group had resolution of CDAD at week 8 (p=0·0003). The absolute risk reduction was 57% (95% CI 33-81). Overall, 204 adverse events occurred, with one or more adverse events being reported in 20 of 21 patients in the faecal microbiota transplantation group and all 21 patients in the placebo group. Diarrhoea (n=23 in the faecal microbiota transplantation group; n=14 in the placebo group) and abdominal pain (n=14 in the faecal microbiota transplantation group; n=11 in the placebo group) were the most common adverse events. Three serious adverse events possibly related to study treatment occurred (n=1 in the faecal microbiota transplantation group; n=2 in the placebo group), but no deaths or colectomies during the 8-week follow-up. In patients with first or second C difficile infection, first-line faecal microbiota transplantation is highly effective and superior to the standard of care vancomycin alone in achieving sustained resolution from C difficile. Innovation Fund Denmark.

New models for symbolic data analysis

Symbolic data analysis (SDA) is an emerging area of statistics concerned with understanding and modelling data that takes distributional form (i.e. symbols), such as random lists, intervals and histograms. It was developed under the premise that the statistical unit of interest is the symbol, and that inference is required at this level. Here we consider a different perspective, which opens a new research direction in the field of SDA. We assume that, as with a standard statistical analysis, inference is required at the level of individual-level data. However, the individual-level data are unobserved, and are aggregated into observed symbols—group-based distributional-valued summaries—prior to the analysis. We introduce a novel general method for constructing likelihood functions for symbolic data based on a desired probability model for the underlying measurement-level data, while only observing the distributional summaries. This approach opens the door for new classes of symbol design and construction, in addition to developing SDA as a viable tool to enable and improve upon classical data analyses, particularly for very large and complex datasets. We illustrate this new direction for SDA research through several real and simulated data analyses, including a study of novel classes of multivariate symbol construction techniques.

Efficacy and immunogenicity of R21/Matrix-M vaccine against clinical malaria after 2 years' follow-up in children in Burkina Faso: a phase 1/2b randomised controlled trial

Malaria is a leading cause of morbidity and mortality worldwide. We previously reported the efficacy of the R21/Matrix-M malaria vaccine, which reached the WHO-specified goal of 75% or greater efficacy over 12 months in the target population of African children. Here, we report the safety, immunogenicity, and efficacy results at 12 months following administration of a booster vaccination. This double-blind phase 1/2b randomised controlled trial was done in children aged 5-17 months in Nanoro, Burkina Faso. Eligible children were enrolled and randomly assigned (1:1:1) to receive three vaccinations of either 5 μg R21/25 μg Matrix-M, 5 μg R21/50 μg Matrix-M, or a control vaccine (the Rabivax-S rabies vaccine) before the malaria season, with a booster dose 12 months later. Children were eligible for inclusion if written informed consent could be provided by a parent or guardian. Exclusion criteria included any existing clinically significant comorbidity or receipt of other investigational products. A random allocation list was generated by an independent statistician by use of block randomisation with variable block sizes. A research assistant from the University of Oxford, independent of the trial team, prepared sealed envelopes using this list, which was then provided to the study pharmacists to assign participants. All vaccines were prepared by the study pharmacists by use of the same type of syringe, and the contents were covered with an opaque label. Vaccine safety, efficacy, and a potential correlate of efficacy with immunogenicity, measured as anti-NANP antibody titres, were evaluated over 1 year following the first booster vaccination. The population in which the efficacy analyses were done comprised all participants who received the primary series of vaccinations and a booster vaccination. Participants were excluded from the efficacy analysis if they withdrew from the trial within the first 2 weeks of receiving the booster vaccine. This trial is registered with ClinicalTrials.gov (NCT03896724), and is continuing for a further 2 years to assess both the potential value of additional booster vaccine doses and longer-term safety. Between June 2, and July 2, 2020, 409 children returned to receive a booster vaccine. Each child received the same vaccination for the booster as they received in the primary series of vaccinations; 132 participants received 5 μg R21 adjuvanted with 25 μg Matrix-M, 137 received 5 μg R21 adjuvanted with 50 μg Matrix-M, and 140 received the control vaccine. R21/Matrix-M had a favourable safety profile and was well tolerated. Vaccine efficacy remained high in the high adjuvant dose (50 μg) group, similar to previous findings at 1 year after the primary series of vaccinations. Following the booster vaccination, 67 (51%) of 132 children who received R21/Matrix-M with low-dose adjuvant, 54 (39%) of 137 children who received R21/Matrix-M with high-dose adjuvant, and 121 (86%) of 140 children who received the rabies vaccine developed clinical malaria by 12 months. Vaccine efficacy was 71% (95% CI 60 to 78) in the low-dose adjuvant group and 80% (72 to 85) in the high-dose adjuvant group. In the high-dose adjuvant group, vaccine efficacy against multiple episodes of malaria was 78% (95% CI 71 to 83), and 2285 (95% CI 1911 to 2568) cases of malaria were averted per 1000 child-years at risk among vaccinated children in the second year of follow-up. Among these participants, at 28 days following their last R21/Matrix-M vaccination, titres of malaria-specific anti-NANP antibodies correlated positively with protection against malaria in both the first year of follow-up (Spearman's ρ -0·32 [95% CI -0·45 to -0·19]; p=0·0001) and second year of follow-up (-0·20 [-0·34 to -0·06]; p=0·02). A booster dose of R21/Matrix-M at 1 year following the primary three-dose regimen maintained high efficacy against first and multiple episodes of clinical malaria. Furthermore, the booster vaccine induced antibody concentrations that correlated with vaccine efficacy. The trial is ongoing to assess long-term follow-up of these participants and the value of further booster vaccinations. European and Developing Countries Clinical Trials Partnership 2 (EDCTP2), Wellcome Trust, and NIHR Oxford Biomedical Research Centre. For the French translation of the abstract see Supplementary Materials section.

Comparison of Two Radiofrequency Vessel-Sealing Device for Laparoscopic Ovariectomy in African Lionesses (Panthera Leo).

Simple SummaryThis study evaluated two vessel-sealing devices for dissecting ovaries in adult obese African lionesses undergoing laparoscopic ovariectomy. We evaluated the surgery time the intra- and postoperative complications. The results of our study confirmed the significant advantages of employing the Caiman 12 vessel-sealing device in comparison with the LigaSure Atlas in terms of the time needed to complete ovariectomy, although both instruments could be considered safe. The use of the Caiman 12 is recommended when performing laparoscopic ovariectomies in adults with obesity.To evaluate two vessel-sealing devices with different jaw lengths for dissecting ovaries in adult obese African lionesses undergoing laparoscopic ovariectomy. Twelve lionesses (n = 12) were recruited. The surgical procedures were performed through three portals, with a retractor platform positioned at the umbilical port and cannulas placed 3–4 cm cranial and caudal to the device at the level of the midline. Ovariectomy was performed using a vessel-sealing device according to a randomization list. We evaluated the surgery time the intra- and postoperative complications. The total surgery time was 49.3 min (range 40–61 min) in the Atlas group and significantly lower in the Caiman group (mean 31.8 min, range 26–51 min). The installation phase was similar between the groups. The ovariectomy time was significantly lower in the Caiman group (mean 7.8 min, range 4–11 min) than in the Atlas group (mean 20 min, range 16–30 min). Controlled bleeding was observed at the tip of the uterine horn in two cases in the Atlas group. No other complications were noted. The results of our study confirmed the significant advantages of employing the Caiman 12 vessel-sealing device in comparison with the LigaSure Atlas in terms of the time needed to complete ovariectomy, although both instruments could be considered safe. The use of the Caiman 12 is recommended when performing laparoscopic ovariectomies in adults with obesity.

A cluster randomized controlled trial to evaluate the efficacy of esophageal and gastric cancer screening in mortality reduction in a non-high-incidence area: methodology and initial results.

BackgroundA cluster randomized controlled trial of endoscopy-based screening for esophageal cancer (EC) and gastric cancer (GC) was conducted to evaluate the efficacy and feasibility of this strategy in a non-high-incidence rural area of China. The trial design and baseline findings are presented here.MethodsA total of 33 eligible villages in Luoshan County in Henan Province were assigned randomly to the intervention or control group in a 1:1 ratio by a computer-generated randomization list. Local residents aged 40 to 69 years were enrolled from the villages. Participants in the intervention group were risk-stratified with a questionnaire, and high-risk individuals were subsequently screened by endoscopy. The primary outcomes were EC and GC mortality. The secondary outcomes comprised the detection rate, stage distribution, and the treatment rate. In this study, baseline characteristics were assessed by a questionnaire. Multivariate logistic regression analysis was performed to explore factors associated with endoscopy compliance.ResultsTrial recruitment was completed in 2017, and ultimately, there were 12,475 and 11,442 participants allocated to the intervention (17 clusters) and the control group (16 clusters), respectively. We included 23,653 participants in the analysis, with 12,402 in the intervention group and 11,251 in the control group. A total of 6,286 (50.7%) participants in the intervention group were estimated as high-risk individuals, and 2,719 (43.3%) underwent endoscopy. Multivariate logistic regression analysis demonstrated that some factors including age, gender, education, personality and mental health, and upper gastrointestinal diseases or symptoms might affect endoscopy compliance. The detection rates for positive cases of EC and GC were 0.22% and 0.55%, respectively. The rates for esophageal and gastric precancerous lesions were 0.70% and 2.35%, respectively. The early detection rates for EC and GC were 50.0% and 33.3%, respectively. Additionally, the overall treatment rate for positive cases was 90.0%.ConclusionsThe diagnostic yield of endoscopy-based screening for EC and GC was relatively low in a non-high-incidence rural area. The study may offer clues for the improvement of endoscopy compliance and the optimization of screening strategies for upper gastrointestinal cancer in non-high-incidence areas.Trial RegistrationChinese Clinical Trial Registry ChiCTR-EOR-16008577.

COMPARISON OF ORAL MIDAZOLAM,ORAL DEXMEDETOMIDINE AND ORAL MIDAZOLAM KETAMINE COMBINATION FOR PREMEDICATION IN PAEDIATRIC SURGERY

Background: Children especially age group &lt;10years undergoing operation may experience preoperative anxiety &amp; may be uncooperative.This uncooperative behavior of children may be observed at the time of separation from parents, venipuncture or mask application. Untreated anxiety may lead to difficult induction, greater rescue analgesic needs, emergence delirium (ED), behavioural &amp; postoperative psychological effects. An atraumatic premedication, calm separation from parents can minimize these problems and a smooth induction of anaesthesia can be achieved.Method : Prospective randomized double blind active controlled study was conducted in Government medical college &amp; hospital, Aurangabad from 2018 to 2020 after Institution Ethics Committee approval. 75 ASA I &amp; II subjects aged between 2 to 5 year weighing less than 15 Kg posted for elective paediatric surgery under general anaesthesia at tertiary care centre were selected. They were randomly allocated into 3 groups Group M ,Group M K &amp; Group D with 25 subjects in each group using computer generated randomization list. Oral premedication was given in each group 30 minutes before surgery.Baseline heart rate,SBP and RR measured before administering premedication and at 10 minutes intervals up to 30 to 45 minutes after premedication. Results: Sedation &amp; anxiolysis score at induction[S1] was significant higher in Group M K&amp; Group D [p Value &lt;0.05] compared to Group M. Sedation at the time of separation from parents [S2] was better in Group M K &amp; Group D compared to Group M[p Value &lt;0.05].Sedation during Mask Acceptance[S3] was better in Group M K &amp; Group D compared to Group M[p Value &lt;0.05].Wake up Behaviour [when the patient recovers from anaesthesia at end of surgery [S4] ] was assessed &amp; Subjects were more Sedated[post anaesthesia] in Group D when compared to Group m &amp; Group M K[p Value &lt;0.05]. Time taken for maximum change in vital parameters was more in Group D followed by Group M K and Group M respectively p Value 0.001].There was significant changes in Vital parameters in Group D compared to Group M &amp; Group M K .Bradycardia p Value 0.00044] &amp; Hypotension [p Value 0.01]was more significant in Group D when compared to Group MK &amp;Group M Conclusion: Oral Midazolam (0.2mg/kg) &amp; Ketamine (2mg/kg) combination &amp; oral Dexmedetomidine (0.5 g/kg) both provide satisfactory sedation levels &amp; offers significant ease of separation from parents with satisfactory mask acceptance in children&lt;10 years compared to oral Midazolam alone.

A randomized double blind comparison of atosiban in patients with recurrent implantation failure undergoing IVF treatment

BackgroundPatients with recurrent implantation failure (RIF) may have more uterine contractions. Several observational studies suggested that atosiban administration around embryo transfer resulted in higher pregnancy rates in RIF patients. This study aimed to evaluate the effect of atosiban given before fresh embryo transfer on pregnancy outcomes of women with RIF.MethodsA prospective, randomized, double-blind controlled clinical trial was performed in IVF center of Shanghai First Maternity and Infant Hospital. According to a computer-generated randomization list, 194 infertile women with RIF received fresh embryo transfer between July 2017 and December 2019 were randomly allocated into the atosiban (n = 97) and the placebo (n = 97) groups. Women in the treatment group received atosiban intravenously about 30 min before embryo transfer with a bolus dose of 6.75 mg over one minute. Those in the placebo group received only normal saline infusion for the same duration.ResultsThere was no significant difference in the live birth rate between the atosiban and placebo groups (42.3% vs 35.1%, P = 0.302, RR = 1.206 (0.844–1.723)). No significant differences were found between the two groups in the positive pregnancy test, clinical pregnancy, ongoing pregnancy, miscarriage, multiple pregnancy, ectopic pregnancy and implantation rates. Similar results were found when stratified by the number of embryos previously transferred, number of previous failed embryo transfers, frequency of endometrial peristalsis on embryo transfer day (≥ 3 waves/min) or serum estradiol (E2) on the day of hCG above the median level. And, there was no correlation between the serum E2 level on the day of hCG and the frequency of endometrial peristalsis on embryo transfer day. The frequency of endometrial peristalsis on embryo transfer day, total FSH/HMG dosage and duration were the significant factors which independently predicted the likelihood of a live birth.ConclusionsThese results suggested that atosiban treatment before fresh embryo transfer might not improve the live birth rate in RIF patients.Trial registrationThe study had been approved by the Institutional Review Board of the hospital (2017 ethics No.43) and was registered under Clinicaltrials.gov with an identifier NCT02893722.

Iranian EFL Learners’ Perceptions towards Demotivation in Learning English

Demotivation in learning English has always been challenging for teachers, parents and researchers and they sought ways to discover its roots and solve it. One important source of solutions to learners’ demotivation is their own perceptions. However, such a rich resource of information on demotivation has received little attention. Therefore, inspired by such a gap, the present study investigated Iranian high school EFL students’ perceptions of demotivation in learning English. Following quantitative survey research, a questionnaire was designed both inspired by demotivation questionnaires of Sakai and Kikuchi (2009) and Falout and Maruyama (2004) and teachers’ focus group on attitudes. It was created based on the Likert Scale and composed of three phases including 54 statements about teachers, textbooks and classroom conditions. The questionnaire was sent to 300 volunteer high school students selected from a random list of public and private high schools across the country. After completion, the questionnaire data were controlled and entered into SPSS. Then, descriptive statistics were computed and Pearson correlation and Runs Test were carried out. However, analysis of the learners’ perceptions revealed that students attributed their demotivation to teachers, classroom conditions, and textbooks respectively. It was found that in Iran, teachers were deemed not qualified enough to motivate students. Apart from that, the classroom conditions and English textbooks were in poor conditions and did not manage to attract and motivate learners.

A comparison of three different modalities in improving oral hygiene in adult orthodontic patients – An open label randomized controlled trial

The objective of the study was to compare outcomes in terms of Bleeding index (BI), Gingival Index (GI) and Orthodontic Plaque Index (OPI) with videographic and plaque disclosing tablets (PDT) versus verbal instructions in adult orthodontic patients undergoing fixed appliance treatment (FAT). Adult orthodontic patients were recruited form outpatient orthodontic clinic who fulfilled the inclusion criteria and were randomly allocated to three groups i.e., video, PDT AND VERBAL GROUPS: Subjects who had gingivitis as assessed by the Bleeding Index (BI), Gingival Index (GI) and Orthodontic Plaque Index (OPI) were recruited. Pre- and post-interventional measurements were taken at two intervals only for BI, GI and OPI. The primary outcome was to evaluate mean change in the BI, GI and OPI in the three study groups after six weeks. A computer-generated randomization list was used to allocate subjects to one of the three study groups using a random permuted block sampling of 6 and 9 to randomize the samples. A total of 99 subjects were assessed for eligibility out of which 96 participants were randomized as three of the participants declined to be part of this trial. The mean change in the oral hygiene indices score were assessed and we found no statistically significant difference among the three interventional groups. Pre- and postinterventional results showed statistically significant improvement in the oral hygiene indices for video and PDT group. No statistically significant difference for age, gender and education level on oral hygiene indices. Simple linear regression showed that video group produced significantly higher mean OPI change as compared to other groups. Visual aids performed better than verbal instructions. Gender, age, and education level did not have a statistically significant impact on oral hygiene indices.

EVALUATION OF WEIGHT REDUCTION EFFICACY AND SAFETY OF SIBUTRAMIN-CONTAINING DRUGS IN PATIENTS WITH ALIMENTARY OBESITY

The article presents clinical study results of the efficacy and safety of combination therapy with sibutramine and metformin (fixed combination) in comparison with sibutramine therapy with microcrystalline cellulose in patients with alimentary obesity.The aim is to evaluate the efficacy and safety of using the sibutramine+metformin fixed dose combination (Reduxin® Forte) and compare it with the sibutramine + microcrystalline cellulose combination (Reduxin®) in patients with alimentary obesity in the course of the obesity therapy.Materials and methods. Male and female patients (240 people) aged 18 to 65 years inclusive with alimentary obesity, meeting the inclusion criteria and not meeting the non-inclusion criteria, were randomized into 2 groups in a 1:1 ratio. One group (n=120) received sibutramine+ metformin p. o., 1 tablet (850 mg + 10 mg) once per day, the second group (n=120) received sibutramine+ microcrystalline cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days. The randomization list was generated by the factory method of random numbers. The efficacy and safety were assessed by anthropometric, clinical and laboratory parameters and the SF-36 questionnaire. The proportion of patients who achieved a decrease in body weight by more than 5% in 6 months, the magnitude and dynamics of changes in body weight and body mass index, waist and hip measurements, their ratios, changes in lipid profile, blood pressure, as well as the total number of adverse events, their frequency and nature of occurrence were analyzed.Results. The both drugs have demonstrated efficacy in all parameters of the obesity therapy. At the same time, in a comparative analysis, a statistically significant advantage of therapy with sibutramine + metformin was demonstrated in relation to the proportion of patients who had achieved more than 5% weight loss (body weight dynamics). Significant benefits were shown in terms of the magnitude of the change in body mass index (BMI); there was a statistically significant increase in the proportion of the patients who had switched from one category of BMI to another. By the end of the study, the vast majority of patients had no longer met the criteria for the diagnosis of “Obesity”. There was also a statistically significant benefit of sibutramine + metformin in terms of lowering triglycerides and low-density lipoprotein levels. The analysis of the safety parameters of sibutramine + metformin confirms a high safety profile of the drug, a comparative statistical analysis of adverse events in terms of their presence, severity, causal relationship with therapy and outcome have not revealed intergroup differences. Adverse events were transient and did not require discontinuation of therapy.Conclusion. The results of the study showed that therapy with Reduxin® and Reduxin® Forte provides a pronounced decrease in body weight. However, the use of a fixed combination has a more effective positive effect on the lipid profile and patients’ quality of life, which, combined with a high safety profile, proves the possibility and expediency of using Reduxin® Forte for the treatment of obesity and restoring metabolic health, even in patients without additional carbohydrate metabolism disorders.

Prophylactic Moxibustion in Preventing Postoperative Urinary Retention of Hemorrhoidectomy: A Study Protocol for a Randomized Controlled Trial.

BackgroundsPostoperative urinary retention (POUR) is one of the most common complications after hemorrhoidectomy. The best treatment for POUR is prevention and should be involved in the whole perioperative period. Moxibustion has been used to treat urinary retention for thousands of years, and clinical studies have also proved its effects. We try to carry out a randomized, controlled, prospective study to observe whether prophylactic moxibustion could effectively reduce the incidence of POUR of hemorrhoidectomy in 24 h.MethodsThis study is a single-center, evaluator-blinded, randomized, and controlled trial. Participants who meet the inclusion and exclusion criteria in this RCT will be randomly assigned to either the treatment group (moxibustion) or the control group (tamsulosin hydrochloride) in a 1:1 ratio according to a computer-generated randomization list. Both moxibustion and tamsulosin will be used 1, 10, and 24 h after operation, respectively. The outcomes of occurrence of POUR, time to first urination, catheterization rate, urinary tract infection, length of hospitalization, and adverse effects will be recorded.DiscussionThe findings of the study will help to explore the preventive efficacy of prophylactic moxibustion against POUR of hemorrhoidectomy in 24 h.Trial RegistrationCHiCTR, CHiCTR2000039350, registered 24 October, 2020, http://www.chictr.org.cn/showproj.aspx?proj = 63204.

A Study on the Health and Socioeconomic Impact of COVID-19 Pandemic and Barriers to Self-management of Diabetes during the Lockdown among Rural Residents of South India

Aim: To study the health and socioeconomic impact of the COVID-19 pandemic and to assess the barriers to self-management of diabetes during the lockdown, in rural South India. Materials and Methods: Details of demographic, social, economic, migration and health status were collected using a structured questionnaire from participants aged ≥18 years belonging to the 21 villages of Chengalpattu and Kancheepuram districts of Tamil Nadu state in south India as part of the Telemedicine pRoject for screENing Diabetes and its complications in rural Tamil Nadu (TREND) study. From the 11,249 TREND participants, a random list of 25% (n = 2812) was system-generated using random numbers and 2812 participants were contacted for the study, of whom 2511 individuals participated. Telephonic interviews were conducted during the lockdown from June to August 2020. Further, qualitative interviews(Focus group discussions) were conducted among 27 individuals with diabetes between September and December 2020. Data were analyzed using thematic analysis. Results: The mean age of the study population was 43 ± 14 years and 50.4% were women. Diabetes was present in 14.7%, hypertension in 31.9%, generalized and abdominal obesity in 33.3% and 46.5% respectively. When the lockdown was implemented in March 2020, 37% had migrated from urban to rural areas. Lack of daily wage jobs (68%), price of essential commodities (41.7%), social distancing/curfew (34.8%), mental fatigue/depression (14.7%), and loss of job (7.1%) were some reasons stated for their adverse social and financial circumstances. People with diabetes stated that they had to avoid or cut down their regular hospital visits due to travel restrictions. Many of the patients took the same medications for almost a year. Conclusion: Unemployment, poor mental health, and reduced household income were the most significant negative impacts faced by rural residents during the lockdown due to COVID-19. People with diabetes experienced disruptions in diabetes management due to the pandemic.

Intra-articular botulinum toxin A injection for painful base-of-thumb osteoarthritis: a double-blind, randomised, controlled, phase 3 trial (RHIBOT).

Intra-articular botulinum toxin A injection might have analgesic effects in patients with joint diseases. We aimed to compare the effects of intra-articular botulinum toxin A injection with those of intra-articular saline injection for patients with painful base-of-thumb osteoarthritis. RHIBOT was a double-blind, randomised, controlled, phase 3 trial conducted at Cochin Hospital, Paris, France. We recruited adult patients with x-ray evidence of trapeziometacarpal osteoarthritis who fulfilled the 1990 American College of Rheumatology criteria for hand osteoarthritis and reported a pain intensity score of at least 30 on an 11-point numeric rating scale (0: no pain to 100: maximal pain). Participants were randomly assigned (1:1), using a computer-generated randomisation list with permuted blocks of variable size (4 or 6), to receive an ultrasound-guided injection of either botulinum toxin A (50 Allergan units) in 1 mL of saline (experimental group) or 1 mL of saline alone (control group) in the trapeziometacarpal joint, in addition to custom-made rigid splinting. The primary outcome was the mean change from baseline in base-of-thumb pain in the previous 48 h on a numeric rating scale at 3 months after injection, analysed by intention to treat. This study is registered with ClinicalTrials.gov, NCT03187626. Between Nov 2, 2018, and Nov 3, 2020, we assessed 370 individuals for eligibility and recruited 60 (16%) participants (mean age 64·9 years [SD 9·4], 47 [78%] women and 13 [22%] men), of whom 30 (50%) participants were randomly assigned to the experimental group and 30 (50%) to the control group. At baseline, base-of-thumb pain score was 60·0 of 100·0 (SD 15·9). At 3 months, the mean reduction in base-of-thumb pain was -25·7 (95% CI -35·5 to -15·8) in the experimental group and -9·7 (-17·1 to -2·2) in the control group (absolute difference -16·0 [-28·1 to -3·9]; p=0·043). Overall, 51 adverse events were reported in both groups: 27 (53%) in the experimental group and 24 (47%) in the control group. During follow-up, 14 (47%) participants in the experimental group and two (7%) participants in the control group reported mild transient motor deficit of the thenar muscle. No serious adverse events were reported. Botulinum toxin A could be considered as a fast-acting, intra-articular therapy targeting chronic pain in individuals with base-of-thumb osteoarthritis. Future studies are needed to investigate the potential mechanism of the effects observed in this trial, to replicate our findings, and to assess the effects of repeated injections over time and their clinical effectiveness, including an analysis of cost-effectiveness. Assistance Publique-Hôpitaux de Paris.

Prevention of Polymorphic Light Eruption Afforded by a Very High Broad-Spectrum Protection Sunscreen Containing Ectoin.

IntroductionPolymorphic light eruption (PLE) is the most common idiopathic, acquired photodermatosis. The pathophysiology of PLE is not yet fully understood but seems to involve immunological mechanisms, UVA-induced oxidative stress, and the subsequent elicitation of a cellular stress response affecting keratinocyte gene expression and skin immune function. In the present study, a high broad-spectrum sunscreen medical device (MD), containing a very high protection complex of UVB and UVA filters and ectoin, was investigated for its ability to protect against UVA-induced PLE.MethodsThe study was carried out as a monocentric, double-blinded, randomized, untreated controlled design. The test MD was applied (2 mg/cm2) on one side of the chest according to a randomization list of 15 patients with a typical history of PLE, and the contralateral area remained untreated. After product application, the test areas were exposed daily to increasing doses of UVA radiation (from 40 to 60 J/cm2) until a PLE reaction was detected or for a maximum of five consecutive days. Evaluations of induced PLE included clinical scoring and chromametry for erythema and pigmentation.ResultsOverall, no positive PLE reaction was observed on the side of the chest treated by the test MD, whereas positive PLE reactions were triggered on the untreated side of 13 subjects. Subjective sensations were very rare on the MD-treated side but were numerous and more severe on the untreated side. Chromametry and clinical visual inspection indicated that the skin color was unchanged on the MD-protected side, whereas high increased values of erythema and pigmentation were observed on the untreated chest side.ConclusionThis MD sunscreen based on a complex of UVA–UVB filters and 1% of ectoin may be effective in preventing UVA-induced PLE. New studies comparing this MD sunscreen versus the same product without ectoin should be conducted.ClinicalTrials.gov identifier: NCT05320315 (retrospectively registered 09/17/2021).Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-022-00755-5.

Human papillomavirus (HPV) vaccination intent and its associated factors: a study of ethnically diverse married women aged 27 to 45 in Malaysia, a Southeast Asian country

ABSTRACT Introduction: This study aimed to investigate HPV vaccination intention among adult married women aged 27 to 45 years and its associated factors, and their spouse/partner’s influence on HPV vaccination decision-making. Methods: This is a cross-sectional, questionnaire-based study. Study participants were recruited through simple random sampling of patients attending obstetrics and gynecology outpatient clinics in a university teaching hospital. Participants were selected based on a computer-generated list of a random list of patients attending the clinic. Results: A total of 794 complete responses were received (response rate 88.2%). The mean age of the respondents was 32.2 years with a standard deviation (SD) of ±3.9 years.The vast majority (85.3%) would communicate with their spouse/partner with regard to HPV vaccination decision-making. Nearly 30% (over half were of the Malay ethnic group) perceived their spouse/partner would not consent to their HPV vaccination. Over half (54.9%) reported joint decision-making, and 9.1% (the majority of whom were Malay) reported that HPV vaccination was dependent on their spouse/partner’s decision. Intention to vaccinate against HPV was high (74.5%). Factors influencing HPV vaccination intention were spouse/partner’s consent to HPV vaccination (odds ratio [OR] = 4.51; 95% confidence interval [CI], 3.08–6.62), being a postgraduate student (OR = 4.55; 95% CI, 2.13–9.72 vs. unemployed/housewife), average household income MYR2000–4000 (OR = 2.09; 95%CI, 1.16–3.78 vs. below MYR2000), and an HPV-related knowledge score of 9–20 (OR = 1.60; 95% CI, 1.10–2.32 vs. score 0–8). Conclusion: Findings highlight the importance of culture-centered interventions to enhance male partner’s awareness and support for the HPV vaccination of married women.

Students’ Inattention Symptoms and Psychological Need Satisfaction During the Secondary School Transition: The Protective Role of Teachers’ Involvement

Objective: This study examined the prospective relationship from student inattention symptoms to changes in their psychological need satisfaction (PNS) during their transition to secondary school. In doing so, it has explored whether this temporal association was moderated by teachers’ involvement (TI). Method: A sample of 688 students (46% male; Mage = 11.82) followed in Grade 6 and Secondary 1 was selected from a stratified random list. Results: Inattention symptoms predicted a decrease in autonomy and competence need satisfaction, after adjusting for gender, anxiety, aggression, and PNS at baseline. In addition, TI in Secondary 1 attenuated the association between inattention and autonomy need satisfaction decline. TI also predicted a smaller decrease in competence need satisfaction, over and above the contribution of inattention. Conclusions: Results support the importance of TI in PNS of students who are struggling with inattention throughout a critical transition. Implications for educational practices and research are discussed.

Efficacy and Safety of Granulocyte-Colony Stimulating Factor Therapy in Chagas Cardiomyopathy: A Phase II Double-Blind, Randomized, Placebo-Controlled Clinical Trial.

AimPrevious studies showed that granulocyte-colony stimulating factor (G-CSF) improved heart function in a mice model of Chronic Chagas Cardiomyopathy (CCC). Herein, we report the interim results of the safety and efficacy of G-CSF therapy vs. placebo in adults with Chagas cardiomyopathy.MethodsPatients with CCC, New York Heart Association (NYHA) functional class II to IV and left ventricular ejection fraction (LVEF) 50% or below were included. A randomization list using blocks of 2 and 4 and an allocation rate of 1:1 was generated by R software which was stratified by functional class. Double blinding was done to both arms and assessors were masked to allocations. All patients received standard heart failure treatment for 2 months before 1:1 randomization to either the G-CSF (10 mcg/kg/day subcutaneously) or placebo group (1 mL of 0.9% saline subcutaneously). The primary endpoint was either maintenance or improvement of NYHA class from baseline to 6–12 months after treatment, and intention-to-treat analysis was used.ResultsWe screened 535 patients with CCC in Salvador, Brazil, of whom 37 were randomized. Overall, baseline characteristics were well-balanced between groups. Most patients had NYHA class II heart failure (86.4%); low mean LVEF was 32 ± 7% in the G-CSF group and 33 ± 10% in the placebo group. Frequency of primary endpoint was 78% (95% CI 0.60–0.97) vs. 66% (95% CI 0.40–0.86), p = 0.47, at 6 months and 68% (95% CI 0.43–0.87) vs. 72% (95% CI 0.46–0.90), p = 0.80, at 12 months in placebo and G-CSF groups, respectively. G-CSF treatment was safe, without any related serious adverse events. There was no difference in mortality between both arms, with five deaths (18.5%) in treatment vs. four (12.5%) in the placebo arm. Exploratory analysis demonstrated that the maximum rate of oxygen consumption during exercise (VO2 max) showed an improving trend in the G-CSF group.ConclusionG-CSF therapy was safe and well-tolerated in 12 months of follow-up. Although prevention of symptom progression could not be demonstrated in the present study, our results support further investigation of G-CSF therapy in Chagas cardiomyopathy patients.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT02154269].