Comparative Randomized Clinical Trials Research Articles

CAF to the Rescue! Potential and Challenges of Combination Antifungal Therapy for Reducing Morbidity and Mortality in Hospitalized Patients With Serious Fungal Infections.

The global burden of invasive fungal disease is substantial and escalating. Combination antifungal therapy (CAF) may improve patient outcomes by reducing development of resistance, improving drug penetration and rate of fungal clearance, and allowing for lower and less toxic antifungal drug doses; yet, increased cost, antagonism, drug-drug interactions, and toxicity are concerns. Clinical practice guidelines recommend antifungal monotherapy, rather than CAF, for most invasive fungal diseases due to a lack of comparative randomized clinical trials. An examination of the existing body of CAF research should frame new hypotheses and determine priorities for future CAF clinical trials. We performed a systematic review of CAF clinical studies for invasive candidiasis, cryptococcosis, invasive aspergillosis, and mucormycosis. Additionally, we summarized findings from animal models of CAF and assessed laboratory methods available to evaluate CAF efficacy. Future CAF trials should be prioritized according to animal models showing improved survival and observational clinical data supporting efficacy and safety.

A comparative randomised clinical trial of Amrutadi kwath and Vasadi kath in the management of Vatarakta (Gout)

Vatarakta specially occurs in Madhyavastha which is Parihanikala in which Dhatukshaya takes place. Khavaigunya (Rikta srotas) occurs in Asthi which is responsible for the production of Vatarakta. Vatarakta is a disease related with khavaigunya found in raktavaha strotas which include vitiated vata and rakta, so termed as vatarakta. Due to properties of sukshmatva and saratva of vayu, dravatva and saratva of rakta they spread all over the body. Symptoms of Vatarakta are shool, toda, daha, vaivarnya described by various acharya. Symptoms of Gouty arthritis are similar as of vatarakta Joint pain, Swelling, stiffness, disability and crepitations over small joint. Gouty arthritis is the most common form of arthritis, which occurs in middle age. Amrutadi Kwath and Vasadi Kwath have most of contents are snigdha, guru and mrudu. By virtue of these properties, this alleviates vata and pitta. Hence these are used in diseases which arise due to vitiation of vata and pitta. in vatarakta by its vatapittashamaka prabhav and snigddha, mrudu gunas by vatanulomana kriya. Amrutadi kwath is very effective in relieving the symptoms of vatarakta. Materials and Method: Total 80 patients of the age group 25-60 years presenting with signs and symptoms of vatarakta were selected randomly from OPD of the department of kayachiktsa. The 40 patients of trial group were treated with Amrutadi kwath and 40 patients of control group were subjected to vasadi kwath. Conclusion: Amrutadi Kwath showing significant results than Vasadi Kwath in symptoms of Vatarakta (Gout).

A comparative Clinical Trial of Laparoscopic Appendectomy versus Open Appendectomy in uncomplicated Cases

Background: Appendicitis is one of the most frequent causes of acute abdominal pain and usually leads to the surgery called appendectomy. Various advantages can be associated with laparoscopic appendectomy but possible disadvantages include longer operative time and complications. Objectives: The purpose of this research was to find out the differences between laparoscopic appendectomy (LA) and open appendectomy (OP) in patients with uncomplicated acute appendicitis focusing on operative time, length of hospital stay, postoperative pain, postoperative complication rates, and patient satisfaction. Methods: The present study was a comparative randomized clinical trial performed in Farooq Teaching Hospital and Hameed Latif Teaching Hospital from January 2023 to January 2024. Two hundred patients with uncomplicated appendicitis were randomly chosen and divided into the laparoscopic appendectomy(n=100) and the open appendectomy(n=100). Primary outcomes were operative time, length of hospital stay, postoperative pain as assessed by the Visual Analog Scale, and complications. Secondary measures were time to resume normal activities, and patients’ satisfaction, measured on a Likert scale. Descriptive statistics, Student’s t-test and chi-square test were used for analysis and p≤0.05 was considered significant. Results: Laparoscopic appendectomy took a relatively longer mean operative time (54. 9 ± 14. 2 min) in comparison with open appendectomy (31. 4 ± 11. 1 min) with p<0.001 but overall, the patients who underwent laparoscopic appendectomy had lesser hospital stay (1. 4 ± 0. 6 days) than those who underwent open appendectomy (2.7 ± 2.5 days, p<0.01). Patients were able to get back to their normal activities sooner (11. 5 ± 3. 1 days; 16. 1 ± 3. 3 days; t = -3. 80; p<0.01) and expressed higher level of satisfaction (4.7 ± 0.6 vs. 3.9 ± 0.7, p<0.01). Conclusion: Compared to open appendectomy, laparoscopic appendectomy has a longer operative time, but the advantages include less postoperative recovery time, less postoperative pain and higher postoperative patient satisfaction.

52833 A 1% selenium disulfide-based shampoo is as beneficial as 2% ketoconazole shampoo to manage moderate to severe scalp seborrheic dermatitis: a comparative randomized clinical trial

52833 A 1% selenium disulfide-based shampoo is as beneficial as 2% ketoconazole shampoo to manage moderate to severe scalp seborrheic dermatitis: a comparative randomized clinical trial

Effect of propolis mouthwash on the incidence of ventilator-associated pneumonia in intensive care unit patients: a comparative randomized triple-blind clinical trial

ObjectivesVentilator-associated pneumonia (VAP) increases the length of hospitalization and mortality rate. This study aimed to determine the effect of propolis mouthwash on the incidence of VAP in intensive care unit (ICU) patients.Materials and methodsTriple-blind, comparative randomized, controlled clinical trial was conducted over one year, with 110 ICU patients at Imam-Hossein and Bahar hospitals (Shahroud) and Kowsar Hospital (Semnan) in Iran. The intervention group used 15 cc of 0.06% propolis mouthwash solution twice daily at 8 AM and 4 PM for seven days. The control group used 15 cc of 0.2% chlorhexidine mouthwash at the same times and duration. Data were collected using a demographic questionnaire, APACHE II, Beck Oral Assessment Scale, and Modified Clinical Pulmonary Infection Score (MCPIS).ResultsThere was no significant difference in demographic information, disease severity, and oral health between the two groups before and after intervention (P > 0.05). The incidence of VAP in the intervention group compared to the control group was 10.9% vs. 30.9% on the third day (P = 0.0166, 95% CI: 0.53–0.83 and RR = 0.35), 23.6% vs. 43.6% on the fifth day (P = 0.0325 and 95% CI: 0.31–0.95 and RR = 0.54), and 25.5% vs. 47.3% on the seventh day (P = 0.0224, 95% CI: 0.32–0.92, and RR = 0.54). The Mann–Whitney indicated the incidence of VAP was significantly lower in the intervention group on the third, fifth, and seventh days.ConclusionPropolis mouthwash can be considered as an alternative to chlorhexidine mouthwash for ICU patients.Clinical relevancePropolis mouthwash serves as a simple, economical intervention to potentially reduce incidence of VAP.Trial registration(IRCT20110427006318N12, date 02.04.2019).

Clinical trial of tolerability, safety and immunogenicity of influenza inactivated split-vaccine Flu-M in children aged 6 to 17 years

Purpose. To evaluate the tolerability, safety and immunogenicity of influenza inactivated split flu vaccine Flu-M during single immunization of children aged 6 to 17 years.Materials and methods. A multicentre double-blind comparative randomised clinical trial of influenza inactivated split vaccine Flu-M for immunisation of children aged 6 to 17 years (the reference agent – Ultrix vaccine) was conducted. Children aged 12 to 17 years inclusive (300 children) were studied at stage I, and children aged 6 to 12 years (300 children) at stage II. Volunteers of each age category were randomised 1:1 into 2 groups comparable in sex and age, one was vaccinated with Flu-M vaccine and the other with Ultrix vaccine. The follow-up, including various laboratory and clinical tests, lasted for 28 days from the time of vaccination.Results. Both vaccines were well tolerated by children aged 12 to 17 years and by children aged 6 to 12 years. There were no severe or serious adverse events. By all criteria of immunogenicity evaluation, vaccine Flu-M was not inferior to the comparison vaccine Ultrix.Conclusion. Influenza inactivated split Flu-M vaccine produced by SPbNIIVS is approved for use for specific prophylaxis of influenza in children aged 6 to 17 years in the Russian Federation, the Republic of Belarus, Latin America and the Caribbean.The trial is registered at ClinicalTrials. gov (NCT 05317767).

Commentary: A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children.

Commentary: A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children.

Identifying and addressing unmet clinical needs on the use ofzanubrutinib in chronic lymphocytic leukemia: A consensus-based position paper from an ad hoc expert panel.

Zanubrutinib has been approved for treating patients with different lymphoproliferative disorders and now represents a significant breakthrough in treating relapsed/refractory and previously untreated patients with chronic lymphocytic leukemia (CLL). Because few systematic studies or comparative randomized clinical trials have been conducted, optimal use of zanubrutinib in approved indications may be challenging. This article presents the results of a group discussion among an ad hoc constituted panel of experts to identify and address unmet clinical needs (UCNs) in using zanubrutinib in patients with CLL. Key UCNs were selected according to the criterion of clinical relevance using the Delphi process. Panel members reviewed the results of first-line and upstream controlled trials in which the efficacy and toxicity profile of zanubrutinib and other BTK inhibitors were investigated in patients with CLL. Based on a critical discussion of data, the panel produced recommendations for using zanubrutinib and proposals for new studies to increase the evidence for the optimal treatment of patients with CLL. The recommendations given by the panel are intended for use not only by expert centers but, above all, by less experienced hematologists as well as general practitioners.

The role of fractional laser-assisted drug delivery in enhancing the efficacy of topical bimatoprost solution in the treatment of alopecia areata: An intra-patient comparative randomized clinical trial.

Transepidermal drug delivery is a novel therapeutic technique to boost efficacy of topical drugs. In this clinical trial we evaluate the efficacy of the combination of fractional carbon dioxide (FCO2) laser and bimatoprost solution compared to bimatoprost alone in the treatment of alopecia areata. This is a prospective intra-patient comparative randomized clinical trial on 20 patients with alopecia areata. In each participant two patches were chosen to randomly receive either topical 0.03% bimatoprost solution (twice a day for 12 weeks) alone or in combination with FCO2 laser (every 2 weeks for 12 weeks). Then response to treatment was evaluated by the measurement of the severity of alopecia tool score system (SALT) score, percentage of hair regrowth, physician assessment and patients' satisfaction. SALT score was reduced significantly during treatment sessions and after a 3-month follow-up in both treatment groups (p = 0.000). The mean percentage of improvement in SALT score in the combination therapy and monotherapy groups were 46.43 ± 4.35% and 21.16 ± 4.06% at the end of the study and 46.42 ± 5.75% and16.11 ± 3.10% at the end of the follow-up period, respectively (p = 0.000). A general linear model of two-way analysis demonstrated a significantly superior outcome in the combination therapy group compared to the monotherapy group during time (F1.6, 13.2 = 43.8. p = 0.000). Fractional ablative laser can be considered as an assistant method for enhancing of efficacy of topical drugs especially in refractory cases of patchy alopecia areata.

Grafts in Peyronie's surgery without the use of prostheses: a systematic review and meta-analysis.

Peyronie's disease (PD) is characterized by abnormal penile curvature, and various surgical methods have been developed using different graft materials. However, there is currently no universal agreement on which type of graft is the best. The objective of this review was to evaluate the available literature and identify the most effective graft material for penile curvature correction in PD. A literature search was conducted using electronic databases, including PubMed, Scopus, and the Cochrane Library. The patients, intervention, comparison, and outcome (PICO) approach was used to define the eligibility of studies. Two authors independently selected studies, evaluated them, and extracted data. Random-effect models using the DerSimonian-Laird method were used. Most studies were single-arm studies and had a high risk of bias. Buccal mucosa grafts (BMG) were found to result in the highest penile straightening rates and were associated with the least de novo erectile dysfunction. TachoSil grafts demonstrated a high success rate in straightening despite a higher mean preoperative curvature, while Tutoplast grafts had a higher incidence of postoperative erectile dysfunction. BMG had the highest percentage of postoperative penile straightening. Overall, the TachoSil graft showed the best performance when preoperative curvature is taken into account. Based on the available literature, BMG appear to be the most effective for penile curvature correction in PD, but this is offset by the requirement for low preoperative curvature. The TachoSil graft shows the best overall performance when preoperative curvature is considered. Comparative randomized clinical trials are still needed to determine graft superiority.

Efficacy of Adding Sitagliptin to Ongoing Metformin on Metabolic Profile, Triglyceride-Glucose Index, Vitamin D3, and Liver Tests in Patients Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease: A Double-Blind Randomized Clinical Trial

IntroductionDipeptidyl peptidase-4 inhibitors (DPP-4i) provide potent anti-diabetic effects in patients with type 2 diabetes mellitus (T2DM), but their role in the presence of nonalcoholic fatty liver disease (NAFLD) is not well-known. The aim of this clinical trial was to evaluate the effects of sitagliptin on the metabolic profile and liver tests in metformin-treated T2DM patients with NAFLD. Patients-MethodsThis was a prospective, 12-week, single-center, comparative randomized clinical trial (RCT) enrolling 66 adult T2DM patients with NAFLD (diagnosed by ultrasound). Patients were randomly assigned to either metformin (2000 mg/day, n=33) or sitagliptin + metformin (100 and 2000 mg/day, respectively, n=33), administered orally. Certain metabolic parameters, i.e., fasting blood sugar (FBS), hemoglobin A1c (Hb1A1c), triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL), vitamin D3 (vitD3), alkaline phosphatase (ALP), alanine aminotransferase (SGPT) and aspartate aminotransferase (SGOT) were measured at baseline and after 12 weeks. Triglyceride-glucose (TG-G) index was also calculated. ResultsAll biochemical variables decreased by a greater extent in the sitagliptin+metformin group compared with the metformin group with differences in FBS (p=0.030), TC (p=0.017), TG (p=0.008), SGPT (p=0.018) and vitD3 (p=0.001) reaching statistical significance. Furthermore, the mean reduction of the TG-G index was significantly greater in the sitagliptin+metformin vs. metformin group (0.67 vs. 0.21, respectively; p=0.017). ConclusionSitagliptin+metformin therapy led to significantly greater improvements in FBS, TC, TG, SGPT, vitD3 and TG-G compared with the metformin monotherapy group. Other biomarkers also decreased more in the sitagliptin+metformin vs. metformin group, but these differences did not reach statistical significance. The present findings should be interpreted with caution but there are indicating certain metabolic benefits after sitagliptin addition in metformin-treated T2DM patients with NAFLD. Further studies are required to elucidate these effects and provide strong evidence for safe conclusions.

Does routine partial lateral sphincterotomy with open hemorrhoidectomy improve postoperative pain?

ObjectiveIn this study we aimed to detect the difference regarding the postoperative pain and continence in patients with third and fourth degree hemorrhoidal disease who underwent either hemorrhoidectomy alone or combined hemorrhoidectomy with partial internal sphincterotomy for the treatment of hemorrhoidal disease.Patients and methodsThis prospective comparative randomized clinical trial was conducted at hospitals of Tanta University during the period from March 2021 to August 2022 on 100 patients with third or fourth degree hemorrhoids who were randomly assigned either to group A, patients who only underwent hemorrhoidal excision by the classical technique of Milligan–Morgan or group B, with added partial lateral sphincterotomy to the classic technique. All patients in both groups underwent anorectal manometry both preoperatively and postoperatively. Pain following surgery was analyzed by using visual analog scale system at 24 h, 48 h, and on 10th postoperative day, other complications including incontinence, infection, hematoma, bleeding, and anal stricture were evaluated at 24 h, 48 h, 10th postoperative day, 1 month, and after 3 months.ResultsTotal 100 patients were divided among both groups. The mean age of the patients was 37.7±11.3 and 36.3±11.3 years in group A and group B, respectively. Thirty-two males and 18 females were in group A in comparison to 33 males and 17 females in group B. During follow-up periods, patients in group B had less postoperative pain than those in group A with statistically significant difference. None of the patients developed fecal incontinence for solid or liquid stools in both groups, except for nine patients developed only mild degree of incontinence for flatus in the first week that improved gradually till completely resolved before the end of the 3 months follow up.ConclusionThe addition of partial internal sphincterotomy to the classical haemorrhoidectomy technique significantly improves postoperative pain without increasing overall related morbidity.

Эффективность регидратирующей терапии при вирусных гастроэнтеритах у детей

Aim: to compare the efficacy of reduced osmolarity oral rehydration solution (ORS) with zinc and infusion therapy with salt and sugar-salt solutions in children suffering from viral gastroenteritis (VGE) complicated by dehydration syndrome of I-II stage and II stage. Patients and Methods: a prospective open-ended comparative randomized clinical trial was conducted The children were divided into two groups: the main group (n=45) with therapy used reduced osmolarity ORS (carbohydrates 2.84 g, glucose 2.82 g, chlorides 0.453 g, zink 0.003 g, osmolarity: 245 mOsm/L, per 1 sachet), and the comparison group (n=34), receiving standard infusion therapy with salt-sugar solutions. The severity of acute gastroenteritis was assessed using a modified Vesikari score. Comprehensive clinical and laboratory examination of children was performed before and after treatment Results: the mean severity of the patients' condition on the modified Vesikari score was 13.26±0.7 points for VGE, which corresponds to the moderate severity. In 42 (93.3±4.5%) patients of the main group, the condition stabilization and reduction of pathological losses were achieved during the first 6 hours, and therefore oral rehydration was continued. In this case, the active use of ORS was conducted for 24–48 hours with an assessment of the trend in general and topical symptoms, as well as laboratory parameters of the fluid and electrolyte balance and renal excretion of nitrogenous compounds. 3 patients (6.66±3.7%) who required further parenteral fluid administration were excluded from the study due to the lack of proper oral rehydration effect associated with the vomiting and the impossibility of further therapeutic manipulations. During oral rehydration in the main group, the febrile reaction duration was comparable in the lasting with the comparison group. Normalization of general well-being in the form of the fatigue disappearance was noted in the compared groups at the same time, while the vomiting cessation was recorded in a significantly shorter time in the main group. Exicosis and diarrhea were managed to be stopped in the main and comparison groups at almost comparable time. Conclusion: rehydration with low-osmolar ORS helps to avoid possible complications of parenteral fluid administration and a traumatic situation for a child KEYWORDS: exicosis, dehydration syndrome, viral gastroenteritis, acute intestinal infection, oral rehydration, oral rehydration therapy, oral rehydration solution, zinc, low-osmolar oral rehydration solution, children. FOR CITATION: Bekhtereva M.K., Komarova A.M. Rehydration therapy efficacy of viral gastroenteritis in children. Russian Journal of Woman and Child Health. 2024;7(2):177–183 (in Russ.). DOI: 10.32364/2618-8430-2024-7-2-14.

Gingival displacement before impression making: A prospective, comparative randomized clinical trial

Gingival displacement is used in prosthodontics to obtain an accurate impression. However, randomized clinical trials to analyze the performance of different gingival displacement products are lacking. The purpose of this prospective, comparative randomized clinical trial was to evaluate the clinical effectiveness of 3 gingival displacement techniques: Racegel cordless, Racegel with a cord, and Racestyptine with a cord. A prospective, multicenter randomized, open label, 3-arm parallel group study was carried out in private dental practices. Patients with prepared teeth with healthy gingiva were recruited to make impressions before and after gingival displacement, which were digitized. Lateral and vertical gingival displacements were measured with computer-aided 3-dimensional analysis performed by a single operator who was blinded to the technique and the patient. For mean lateral gingival displacement, each gingival displacement method was compared with a required clinical value of 200µm with the Student t test. The comparison of means among the 3 groups was performed using an ANOVA. Periodontal indices were recorded immediately and 7 to 14days after gingival displacement. The percentages were compared with the chi-squared test or the Fisher exact test (α=.05 for all tests). Eighty-eight participants were enrolled. The mean lateral gingival displacement obtained by Racestyptine with a cord (253 ±59µm, P<.001) and by Racegel with a cord (247 ±61µm, P<.001) were significantly higher than 200µm. Lateral displacement observed with Racegel cordless was 207 ±57µm (P=.53). For vertical gingival displacement, no difference among the 3 techniques was found. The astringent effect of these products was confirmed by the absence of crevicular fluid or bleeding. No periodontal damage was observed immediately or 7-14days after displacement. The study showed that cord impregnated with Racestyptine and Racegel with or without a cord provided a sufficient sulcus opening before impression making in prosthodontics, consistent with the clinical requirements for lateral displacement.

Canal wall up versus canal wall down mastoidectomy techniques in the pediatric population with cholesteatoma: A systematic review and meta-analysis of comparative studies.

The optimal surgical management of cholesteatoma remains controversial. Within pediatric otolaryngology, one of the most vital points of contention is the selection of canal wall-up (CWU) versus canal wall-down (CWD) procedures. Pediatric cholesteatoma has high rates of recurrence (16%-54%). In adults, there is evidence that the selection of surgical techniques affects recurrence rates. This has not been shown in children. 1. To systematically review the literature on recurrent and residual cholesteatoma after CWU and CWD in children and perform a meta-analysis of the data. 2. To assess the rates of recurrent and residual cholesteatoma between CWU and CWD techniques in pediatric patients. 3. To assess hearing outcomes by evaluating postoperative differences in the air-bone gap (ABG) between CWU and CWD techniques. A systematic search of PubMed, Embase, Scopus, and Cochrane Collaboration was performed from inception to May 1st, 2020, to identify studies that compared CWU and CWD procedures for acquired cholesteatoma in children. Search records were screened in duplicate by four reviewers. Inclusion criteria consisted of comparative randomized clinical trials and observational studies assessing outcomes of CWU and CWD techniques in the pediatric population. Studies involving patients with congenital cholesteatoma were excluded. Four reviewers working independently and in duplicate systematically reviewed and extracted study data. Dichotomous variables were analyzed as risk ratios (RR), while continuous variables were compared using weighted mean differences (MD). The risk of bias was assessed using the CLARITY Scale. The outcomes were recurrence, residual disease, air-bone gap (ABG), and air conductive (AC) thresholds. After screening 1036 publications, 17 retrospective cohort studies were selected. 1333 children were included; the overall mean age was ten years (SD 7.9), and the overall mean follow-up time was 5.9 years (SD 6.6). CWU and CWD techniques were performed in 60% (796) and 40% (537) cases. We did not find differences in cholesteatoma recurrence (RR: 1.50, 95% CI 0.94; 2.40; n=544; I2 0%; Tau [2]: 0.00), or rates of residual cholesteatoma (RR 1.51, 95% CI 0.96; 2.38, n=506; I2: 0%; Tau [2]: 0.00) in patients who underwent CWU and CWD mastoidectomy. The mean air-bone gap was lower with CWU than CWD (mean difference: 7.60, 95% CI -10.65; -4.54; n=242; I2: 71%; Tau [2]: 5.98). and relevance: We show similar rates of recurrence and residual disease after either CWU or CWD tympanoplasty. Our results challenge the fundamental principle of CWD surgery as a standard technique, as there is no difference in rates of recurrence and residual disease in CWU and CWD. Moreover, audiometric results support CWU with improved hearing outcomes. PROSPERO identifier: CRD42020184029.

A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children.

Background: Atopic dermatitis (AD) aetiology is not exactly identified, but it is characterized by pruritic skin reactions with elevation in the levels of inflammatory markers. Despite the fact that Corticosteroids are the mainstay therapy in the management of AD, they have many local and systemic adverse effects. Objective: The aim of this study is to evaluate the efficacy and safety of topical tacrolimus ointment in comparison to topical hydrocortisone cream in the management of the AD of children diagnosed with AD. Patients and Methods: This study was conducted on 200 children with AD. They were simply randomized into two groups, the tacrolimus group treated with 0.03% topical tacrolimus ointment and the hydrocortisone group treated with 1% hydrocortisone cream twice daily during the 3weeks study period. Results: At the end of the study, both the tacrolimus and hydrocortisone groups showed a significant decline in the mean serum level of IL-10, IL-17, and IL-23 (p < 0.05) when compared to their baseline levels. However, the tacrolimus group showed a more significant decrease (p < 0.05) in the mean serum level of IL-10, IL-17, and IL-23 as compared to the hydrocortisone group [Mean differences = 1.600, 95% CI: 0.9858-2.214; 1.300, 95% CI: 1.086-1.514 and 4.200, 95% CI: 3.321-5.079]. Moreover, the median mEASI decreased similarly from 32 to 21 in the tacrolimus group and from 30 to 22 in the hydrocortisone group (p > 0.05) [Median difference = -2.000, 95% CI: -2.651 to -1.349; Median difference = 1.000, 95% CI: 0.3489-1.651]. Mild to moderate transient stinging and erythema were the main adverse effects that showed higher incidence in the tacrolimus group than in the hydrocortisone group (p < 0.05). In most cases, they resolved within 3-4days. Besides, tacrolimus ointment did not cause skin atrophy as compared to the hydrocortisone group (p < 0.05). Conclusion: Tacrolimus ointment is more beneficial than hydrocortisone cream in managing AD in children in terms of lowering the inflammatory markers, however, there is no difference on the dermatitis severity scale. Moreover, tacrolimus is safer with a better side effect profile compared to hydrocortisone. Trial Registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05324618).

Pulpectomy vs. Pulpotomy as Alternative Emergency Treatments for Symptomatic Irreversible Pulpitis-A Multicenter Comparative Randomised Clinical Trial on Patient Perceptions.

There needs to be more general agreement on the most effective treatment for the emergency patient with Symptomatic Irreversible Pulpitis (SIP). This equivalence randomised clinical study compared the clinical efficiency, as an urgent treatment, of pulpotomy (POT) and pulpectomy (PEC) in the permanent teeth with SIP. The primary outcome was pain management, and the secondary outcome was the patient's perception of duration, comfort, and satisfaction. 80 patients were blindly and randomly allocated into two equal parallel groups, the control group treated by PEC and the test group by POT. Data were collected through numerical rating scales (NRS) during the intervention and 6, 24, and 72 h post-op. Non-parametric tests were used to analyse the data. The Brunner-Longer models were adopted for longitudinal data and the analysis of variance (ANOVA)-type statistical was used. The mean preoperative pain levels for the whole sample scored 5.8 ± 2.8 and significantly decreased to 2.1 ± 2.4 at 6 h, 1.5 ± 2.1 at 24 h, and 1.3 ± 2 at 72 h, without any differences between the groups. No significant differences were found in the patient's perception of treatment discomfort or duration between the groups. Three days after the intervention, patient satisfaction was high, with 9.2 ± 1.7 and 9.1 ± 2 in the PEC and POT groups, respectively. Self-reported pain was the only variable penalising the patient's final satisfaction. The current randomised control trial (RCT) showed that both pulpectomy and pulpotomy effectively eliminate pain and achieve high levels of patient satisfaction. Furthermore, the patient's perceptions of the duration and discomfort of the two treatments were similar. Given that pulpotomy is a faster and more straightforward technique, it may be recommended as a viable and pragmatic option for treating emergency patients with symptomatic irreversible pulpitis.

Unmet Clinical Needs in the Management of Idiopathic Multicentric Castleman Disease: A Consensus-based Position Paper From an ad hoc Expert Panel.

Castleman disease describes a group of heterogeneous clinicopathological disorders now included in the tumor-like lesions with B-cell predominance of the World Health Organization classification. Managing idiopathic multicentric Castleman disease (iMCD) is challenging, because few systematic studies or comparative randomized clinical trials have been conducted. International, consensus evidence-based guidelines for iMCD were published in 2018, but gaps in the therapeutic options for difficult-to-treat patients, who do not respond to siltuximab and other conventional therapies, still exist. This article presents the results of group discussion among an ad hoc constituted Panel of Italian experts to identify and address unmet clinical needs (UCNs) in managing iMCD. Recommendations on the appropriateness of clinical decisions and proposals for new research concerning the identified UCNs were issued through formalized multiple-step procedures after a comprehensive analysis of the scientific literature. The following key UCNs were addressed: strengthening the diagnostic certainty in iMCD patients before planning first-line therapy; management of siltuximab therapy; choice and management of immune-modulating, or chemotherapy agents in patients resistant/intolerant to siltuximab therapy. While most of the conclusions reached by the Panel are consistent with the existing guidelines, some alternative therapeutic options were stressed, and the discussion contributed to bringing forth the issues that need further investigation. Hopefully, this comprehensive overview will improve the practice of iMCD and inform the design and implementation of new studies in the field.

Unmet clinical needs in the use of zanubrutinib in malignant lymphomas (Waldenström macroglobulinemia, marginal zone lymphoma and mantle cell lymphoma): A consensus-based position paper from an ad hoc expert panel.

Zanubrutinib has been approved for the treatment of patients with different lymphoproliferative disorders, and now represents a major breakthrough in the treatment of patients resistant or relapsing after the recommended therapies. Because few systematic studies or comparative randomized clinical trials have been conducted, optimal use of the drug in approved indications is challenging, and questions are emerging on its use in earlier stages of the disorders. This article presents the results of group discussion among an ad hoc constituted panel of experts aimed at identifying and addressing unmet clinical needs (UCNs) in the use of zanubrutinib in the lymphomas which have received the approval of use, specifically Waldenström macroglubulinemia, marginal zone lymphoma and mantle cell lymphoma. Key UCNs were selected according to the criterion of clinical relevance using the Delphi process. The panel produced recommendations and proposals for new studies for the management of the identified UCNs. These recommendations are intended for use not only by expert centers but above all by not experienced hematologists as well as general practitioners.

The estriol use in the perioperative period by patients with genital prolapse

Introduction. Postmenopausal women in a state of oestrogen deficiency often experience pelvic prolapse with underlying genitourinary menopausal syndrome, when the progression of atrophic processes in the vaginal mucosa comes to the forefront.Aim. To evaluate the results of the use of topical hormonal therapy in the perioperative period to improve the vaginal epithelial surface appearance in postmenopausal women who need surgical treatment of pelvic prolapse.Materials and methods. A comparative prospective randomized clinical trial included 60 postmenopausal patients aged 60 to 69 years with a postmenopausal period of 10 to 20 years, suffering from POP-Q stage II–IV pelvic prolapse (ICS, 1996). All patients were recommended surgical treatment using vaginal approach. The treatment group (Group 1) included 30 patients who received topical hormonal therapy with an estriol drug (Ovestin cream, 1 mg/g) within 1 month before reconstructive plastic surgery. The comparison group (Group 2) included 30 patients who did not receive hormonal treatment in the perioperative period.Results. No complications were observed in the treatment group after reconstructive plastic surgery in the early and late postoperative periods. In the comparison group, natural urination was not achieved in 9 of 30 (35.0%) women on Day 2 after surgery, in 4 of 30 (13.3%) patients on Day 3. Also in that group, 4 of 30 (13.3%) patients experienced infectious and inflammatory complications in the postoperative period, the mucous membrane healing in 5/30 (16.6%) patients took a long time, over 1 month.Conclusions. The use of topical hormonal therapy with an estriol drug in the perioperative period in patients who require surgical treatment of pelvic prolapse results in the relief of vulvovaginal atrophy symptoms and adequate regeneration of the vaginal mucosa, which helps reduce the likelihood of complications in both early and late postoperative periods.