Placebo-controlled Randomized Study Research Articles

Effects of fecal microbiota transplantation on clinical outcomes and fecal microbiota of foals with diarrhea.

Diarrhea in foals can be associated with disruption of the intestinal microbiota (dysbiosis). Effective management of intestinal dysbiosis in foals has not been demonstrated. Fecal microbiota transplantation (FMT) in foals with diarrhea influences the intestinal microbiota and improves clinical and clinicopathological outcomes. Twenty-five foals <6 months of age with diarrhea and systemic inflammatory response syndrome at 3 veterinary hospitals. A prospective randomized placebo-controlled cohort study. Foals in the FMT group (n = 19) or control group (n = 9) received FMT or electrolyte solution once daily for 3 days. Fecal samples were obtained on Day 0 (D0), D1, D2, D3, and D7. Within group and between group data analyses were performed for clinical, clinicopathological, and microbiota variables. Treatment had no effect on survival (FMT 79%; control 100%, P = .3) or resolution of diarrhea (FMT 68%; control 55%, P = .4). On D3, the white blood cell count of the FMT group was lower than the control group (D3 FMT group median 6.4 g/L [5-8.3 g/L]; D3 control group median 14.3 g/L [6.7-18.9 g/L] P = .04). Heart rate reduced over time in the FMT group (D0 median 80 bpm [60-150 bpm]; D2 median 70 bpm [52-110 bpm] [P = .005]; and D3 median 64, [54-102 bpm] [P < .001]). Phylum Verrucomicrobiota, genus Akkermansia, and family Prevotellaceae were enriched in the FMT group on D1 (linear discriminate analysis > 4). In foals with diarrhea, FMT appears safe and can be associated with some clinical and microbiota changes suggestive of beneficial effect.

Unlocking the psycho-social-dermal axis: A double blinded randomized placebo controlled study unveiling the influence of a novel topical formulation on skin quality, attractiveness, quality of life, and sexual satisfaction.

Improved skin appearance is closely linked to higher self-esteem, favorable first impressions, and enhanced quality of life, with skincare products often being formulated with biostimulatory and regenerative ingredients to both enhance skin health and provide psychological benefits. Certain components, such as phospholipids and botanicals, may not only improve skin quality, but also impact mood, romantic bonding, and sexual attraction. To assess whether a novel topical skin care product formulated with a proprietary combination of proteins, lipids, and botanical derivatives, can potentially result in a robust psycho-social-dermatological benefit via modulation epidermal oxytocin and pheromonal pathways. In this single-center prospective, randomized, controlled, double-blinded study, 40 female subjects were randomly assigned to use of either active novel skincare products, or placebos, for 4-8 weeks. Skin assessments, standardized photography, first impression ratings, and questionnaires on confidence and sexual satisfaction were conducted. Thirty-nine subjects completed the study and demonstrated a statistically significant improvement in skin quality following 4 and 8 weeks of use, with improvements of greater magnitude demonstrated with a longer duration of use. Product users projected a better first impression and appeared on average 3 years younger than their actual age, with 86% of subjects reporting increased confidence. Product users found random people of the opposite sex to be more attractive 88% of the time and reported improvement in sexual satisfaction in 90% of the categories. The use of this novel topical product culminated in statistically significant improvements in skin quality, confidence, sexual relationship satisfaction, perceived attractiveness, and youthfulness, highlighting its potential in anti-aging and mood enhancement.

P-082 Use of TetraSOD® in male infertility: double-blind randomized placebo-controlled study

Abstract Study question Can the use of TetraSOD® (microalgae with high content of the antioxidant enzyme superoxide dismutase) improve semen quality and reduce oxidative stress in sperm? Summary answer The use of TetraSOD® reduces the oxidative stress of sperm, increasing the total sperm count in oligozoospermia and reducing the double-stranded DNA sperm fragmentation. What is known already Male factor is present in approximately 50% of the infertile couples, a large number of them of unknown or idiopathic origin. It has been demonstrated that semen quality is deteriorating over time, perhaps as a result of exposure to several environmental factors related with lifestyle that could impact both directly and indirectly on the complex process of spermatogenesis. Some of these bad habits of lifestyle increase the levels of oxidative stress in semen, which is associated with lower sperm concentration and motility. In this scenario, the use of antioxidants can be useful to increase sperm quality. Study design, size, duration Double-blind randomized placebo-controlled clinical study to assess the effect of 250 mg of TetraSOD® (microalgae with high content of the primary antioxidant enzyme superoxide dismutase). Eighty patients with idiopathic infertility showing asthenozoospermia, oligozoospermia or oligoasthenozoospermia were recruited and randomized to receive 250 mg of TetraSOD® (TSOD group) or placebo (Placebo group) for 3 months. Participants/materials, setting, methods Men with asthenozoospermia, oligozoospemia or aligoastenozoospermia and idiopatic infertility were recruited after informed consent signature. Patients were randomized into two groups. TetraSOD® group received 250 mg of TetraSOD®during 3 months, and Placebo group received capsules without TetraSOD® during the same period of time. Seminogram, double-strand sperm DNA fragmentation (COMET assay) and sORP (static oxidation- reduction potential) were studied at baseline (V0) and after 3 months (V3). Main results and the role of chance TetraSOD® consumption for three months elicited a statistically significant increase (Wilcoxon matched-pairs signed rank test; p=0.02) in the average number of sperms per ejaculate (from 17.06 x 106 to 41.94 x 106) in participants displaying oligozoospermia (&amp;lt;39 x 106 sperms) at V0. In contrast, the lower variation in the measured values in the Placebo group was not statistically significant. Regarding sORP, a statistically significant decrease (Wilcoxon matched-pairs signed rank test; p=0.0233) was observed in participants who displayed a value at V0 between 1.34-10. After TetraSOD® consumption, the average changed from 2.96 to 1.91 mv/106 sperm/ml from V0 to V3. However, not statistically significant changes were detected in the Placebo group between sORP values at V0 and V3. Moreover, in relation to double-stranded DNA breaks, a statistically significant decrease (Wilcoxon matched-pairs signed rank test; p=0.01) in the average percentages (from 31.81% to 25.93%) was measured after consumption of TetraSOD® at V3 in participants displaying a compromised redox status (sORP&amp;gt;1.34-10) at V0. No significant changes were found in the Placebo group. Limitations, reasons for caution The study was performed only in one ethnic group, so in future studies other ethnicities should be included. Wider implications of the findings TetraSOD® may improve male fertility because increases the number of sperms per ejaculate in oligozoospermia and reduces double-stranded DNA fragmentation in sperm when individuals display an altered redox status in semen. Such results might be related to the indirect antioxidant effect of TetraSOD®, reducing oxidative stress in seminal fluid. Trial registration number Not applicable

(017) FLIBANSERIN IMPROVES LIBIDO AND SEXUAL SATISFACTION IN WOMEN WITH BREAST CANCER ON ENDOCRINE THERAPY

Abstract Introduction Decreased libido is a distressful symptom during and after cancer treatment. This is the first prospective longitudinal study that investigates the use of flibanserin to treat decreased libido in breast cancer patients on endocrine therapy. Objective This study evaluates the efficacy of flibanserin as measured by change in desire, sexual function, and distress from sexual dysfunction. These outcomes are measured using the following validated instruments: Female Sexual Function Index (FSFI) both desire and total scores, Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF) and patient distress via FSDS-R. Methods Forty-three women with stage 0-III ER+ breast cancer on endocrine therapy for at least 3 months who reported HSDD as defined by the DSM-IV and ISSWH consensus paper were enrolled on an IRB-approved prospective, longitudinal trial from both an academic center and an alliance community site. All patients took flibanserin 100mg nightly for 24 to 36 weeks. Patients were monitored closely for 52 weeks for adverse events, with medical exams and questionnaires at baseline, week 4, 8, 16, 24, 52 with optional week 36 appointments. Given the small sample size, descriptive, graphical, and nonparametric paired tests for pairwise comparisons of a measure were performed. Results Participants reported improved libido and sexual satisfaction as demonstrated by both the PROMIS-SF and FSFI data (see Table 1). 35/43 (83.3%) patients completed the FSFI and 25/43 (58.1%) completed the PROMIS-SF. The mean overall total FSFI score increased from 11 at baseline, to 17 at week 8 and 24 at week 36. The PROMIS data for interest in sexual activity improved from a baseline mean score of 43 to 51 at 8 weeks, to 54 at 24 weeks and 55 at 36 weeks. Similarly, the FSFI data in the domains of desire and arousal improved respectively from 1.90 and 1.56 at baseline to 3.03 and 3.05 at 8 weeks, 3.30 and 3.17 at week 16 and 3.53 and 4.01 at week 36. Satisfaction with sex life also improved from PROMIS baseline of 46 to 49 at week 8 and 55 at week 36. FSFI data for the domain of satisfaction indicate parallel trends with a baseline score of 2.36, increasing to 3.15 at week 8 and 4.45 at week 36. Furthermore, vaginal discomfort scores improved on both the PROMIS and FSFI. FSFI data on lubrication also showed improvement with a baseline mean score of 1.85 increasing to 2.84 by week 8, 3.24 at week 24 and 4.01 at week 36. However, the PROMIS suggests a decrease in lubrication from baseline to week 8. Patient distress also decreased throughout the study as measured on the FSDS-R and distress thermometer. There were no severe adverse events. The most common adverse events were nausea, somnolence and dizziness. Conclusions Flibanserin improves libido and overall sexual function as measured by the PROMIS-SF and FSFI in breast cancer patients on endocrine therapy. The exciting data from this pilot study is currently informing a larger randomized placebo-controlled study evaluating the efficacy of flibanserin in women with breast cancer. Disclosure Yes, this is sponsored by industry/sponsor: Sprout Pharmaceuticals Clarification: Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Ms. Medicine, NanOlogy LLC, Paxman Cooling Ltd, Procter and Gamble, Rejoy, Revision Skincare, Sermonix, Shook, Hardy and Bacon, Spectrum Pharmaceuticals, Sprout Pharmaceuticals, TerSera.

In the article “Double blind randomized placebocontrolled study of the efficacy and safety of proroxan in the complex therapy of generalized anxiety disorder”

In the article “Double blind randomized placebocontrolled study of the efficacy and safety of proroxan in the complex therapy of generalized anxiety disorder”

Antibiotics for Acute Sinusitis in Children: A Meta-Analysis.

Acute sinusitis is one of the leading causes of antibiotic prescriptions in children. No recent systematic reviews have examined the efficacy of antibiotics compared with placebo. We sought to determine if antibiotics are superior to placebo in the treatment of acute sinusitis in children. Medline and Embase were searched from their origin to July 2023. We considered randomized placebo-controlled studies focusing on the treatment of acute sinusitis. In all studies, symptoms were present for <4 weeks and subjects were <18 years of age. Two authors independently extracted the data. We pooled data primarily using fixed-effects models. Analysis of 6 included studies showed that antibiotic treatment reduced the rate of treatment failure by 41% (with a risk ratio of 0.59; 95% confidence interval 0.49-0.72) compared with placebo. There was substantial heterogeneity between the studies (I2 = 69.7%), which decreased substantially when the 1 study with a high risk of bias was removed (I2 = 26.9%). Children treated with antibiotics were 1.6 times more likely to have diarrhea than those who were not treated with antibiotics (risk ratio = 1.62, 95% confidence interval 1.04-2.51). A small number of studies were eligible for inclusion. Included studies differed in their methodology. In children with clinically diagnosed acute sinusitis, antibiotics significantly reduced the rate of treatment failure compared with placebo. However, given the favorable natural history of sinusitis, our results could also support close observation without immediate antibiotic treatment.

Transversus abdominis plane block as a component of anesthesia in kidney transplantation

Aim. To evaluate the safety and efficacy of the transversus abdominis plane block in kidney transplantation from deceased donor.Material and methods. The first stage included a retrospective comparative analysis of the results using the transversus abdominis plane block in renal transplantation. Group I (n=30) included patients who underwent transversus abdominis plane block after kidney transplantation; in comparative group II (n=58) the TAP-block wasn’t performed. We assessed the daily requirement for trimeperidine on the first day after kidney transplantation. The second stage was a prospective randomized placebo-controlled study. The patients were randomly divided into 2 groups with respect to whether the transversus abdominis plane block was provided with an active drug, or placebo was used; so the sodium chloride 0.9% was injected into the transversus abdominis plane in the intermuscular fascial plane between the internal oblique and transversus abdominis muscle in patients of Group III (n=31), and a local anesthetic was injected in patients of Group IV (n=34).) The daily requirements for trimeperidine, tramadol were assessed as well as the pain severity according to visual analogue scale at 1, 6, 12, 24 hours after surgery, the incidence of adverse events in the gastrointestinal tract; and several laboratory parameters (cortisol, interleukin-1, interleukin-6) related to pain syndrome were analyzed.Results. As a result of pseudorandomization, 17 cases were included in each of two retrospective stage, which were comparable in terms of patients' main characteristics (p&gt;0.05). The daily requirement for trimeperidine in the transversus abdominis plane block group (Group I) was lower than in the comparison group with a trend toward statistical significance (p=0.07). The median daily dose of trimeperidine in Group III (placebo control) was 59.5 mg (interquartile range: 51.5–72.0), which was higher than in Group IV (45.5 mg; interquartile range: 38.5–62.0) (p=0.039). The postoperative pain severety assessed by visual analogue scale was also statistically significantly higher in group III at the timepoint of 12 hours after surgery, making 4.0 points (interquartile range: 2.5–5.0) versus 1.5 points (interquartile range: 0.5–2.5) in group VI (p=0.015). There were no differences between the groups in pain severity at 1, 6, and 24 hours after surgery. The daily requirement for tramadol was also statistically significantly higher in Group III, amounting to 50 mg (interquartile range: 0–100) versus 0 (interquartile range: 0–55 mg) in the active drug Group IV (p=0.045).Conclusion. Our study showed that the use of the transversus abdominis plain block was safe and effective, yielding encouraging results, which demonstrated a clinically significant reduction in the need for opioid analgesics and in the incidence of adverse events in the postoperative period after transversus abdominis plane block which contributes to the early activation of patients. Therefore, further studies are needed to improve the package of multimodal perioperative analgesia after kidney transplantation.

Intraperitoneal local anesthetic instillation as a method to attenuate pneumoperitoneum induced hemodynamic response during laparoscopic surgeries: A randomized placebo controlled study

Laparoscopy is associated with significant hemodynamic changes due to pneumoperitoneum creation. We sought to study the effectiveness of intraperitoneal local anesthetic instillation in attenuating pneumoperitoneum-mediated hemodynamic response in patients undergoing laparoscopic cholecystectomy. This randomized study was conducted after approval from the institutional ethics committee, and 100 patients were randomly assigned to either group R (40 mL of 0.2% Ropivacaine intraperitoneally) or group N (40 mL of 0.9% normal saline intraperitoneally). Data analysis was performed using SPSS version 23. Independent Samples T test was used to compare hemodynamic variables between groups at regular intervals. Statistical significance was set less than 0.05.: Heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial blood pressure were significantly lower in Group R than in Group N at 15,30, 45,60,75, and 90 min (P&amp;#60;0.05).: Intra peritoneal instillation of 0.2% Ropivacaine in laparoscopic cholecystectomy attenuates intra operative hemodynamic changes associated with pneumoperitoneum.

Arginine in sickle cell vaso-occlusive crisis: A randomised placebo control trial

Sickle cell disease is one of the most common hemoglobinopathies in India. A vaso-occlusive crisis is one of the most common indications for hospitalization, it accounts for 70% of hospitalization. To compare efficacy of Arginine in vaso-occlusive episode(VOE) management in terms of mean fall in pain score at discharge between intervention (Arginine) &amp; placebo group among sickled children with skeletal vaso-occlusive crisis between 2-14 years of age. This randomized placebo control study was carried out after getting clearance from the institutional ethical &amp; research committee, from November 2019 to October 2021 in the Indoor of Pediatrics Department, Veer Surendra Sai Institute of Medical Science (VIMSAR), Burla, Sambalpur. There is significant fall in pain score in case group as compared with control group as evidenced by p value being less than 0.001, indicating that l-arginine has significant role in reducing sickle cell vaso-occlusive episode. Mean Length of stay (LOS) in hospital in case group was 2.16, while in control group was 2.69. p value being calculated showed the value to be less than 0.001, which shows importance of l-arginine in reducing in mean length of stay in hospitalization. L-arginine plays a vital role in treating vaso-occlusive episodes. It helps to reduce the pain gradually as evidenced by noting down pain score at the time of admission &amp; every 24 hours of therapy till discharge. It also helps to reduce the mean duration of hospitalization in vaso-occlusive episode.

(029) Safety and Efficacy of Botulinum Neurotoxin in the Treatment of Erectile Dysfunction Refractory to Phosphodiesterase Inhibitors: Results of a Randomized Controlled Trial

Abstract Introduction There has been recent interest in the use of botulinum neurotoxin (BoNT) in the field of Andrology, whereby it has been investigated in the treatment of penile retraction and premature ejaculation. Objective To evaluate the safety and efficacy of intracavernosal BoNT-A injection in the treatment of patients with erectile dysfunction (ED) refractory to oral phosphodiesterase inhibitors (PDE5Is). Methods A double-blind randomized placebo-controlled prospective comparative study conducted at one center and involved 70 patients with ED refractory to PDE5Is. At baseline, the following data were collected: erection hardness score (EHS), peak systolic velocity (PSV), end diastolic velocity (EDV), sexual health inventory for men (SHIM), and the sexual encounter profile 2&amp;3 (SEP-2&amp;3) questionnaires. Treatment group (n = 35) received a single ICI of 100 units of BoNT-A in 2 ml of saline and control group (n = 35) received a single ICI of 2 ml of saline. EHS, PSV, and EDV were assessed at 2 weeks post treatment. SHIM, SEP-2, SEP-3, and global assessment questionnaire (GAQ-Q1&amp;Q2) were completed at 2-, 6-, and 12-weeks post treatment. Results Two weeks post treatment, the treatment group showed a statistically significant improvement in the mean EHS, PSV, EDV, and GAQ-Q1 positive responders (p &amp;lt; 0.001) compared to the control group. At 6- and 12-weeks post treatment, the treatment group showed a statistically significant improvement in the SHIM scores, SEP-2, and GAQ-Q1&amp;Q2 positive responders compared to the control group. At 6 weeks, where there was a 5-point improvement in the mean SHIM score of the treatment group (10±5.9 from 5.4±1.7 at baseline) versus no improvement in the placebo group, 18 patients in the treatment group (53%) were able to have an erection hard enough for vaginal penetration versus only one patient in the control group. Conclusions BoNT-A is safe and effective as a potential treatment for ED refractory to PDE5I therapy. Disclosure No.

Current Trends, Challenges for Research, and Therapeutic Perspectives in Nutritional Psychiatry

"Nutritional interventions in the field of psychiatry have been explored more intensively in the last two decades, but definitive conclusions based on the retrieved data in the literature about the efficacy of this therapeutic approach are difficult to formulate. This observation has multiple explanations, e.g., these therapeutic interventions are very heterogenous, cohort studies usually enroll different psychiatric populations or healthy subjects with minor psychiatric symptoms, nutritional supplements or special diets are commonly recommended as add-ons to the pharmacological interventions (thus making it difficult to differentiate the impact of each therapy on the outcomes), placebo-controlled randomized studies are still very few, etc. Therefore, a narrative review focused on the main challenges reported during the research in the field of nutritional psychiatry (NP) may be useful for clinicians interested in strategies to augment the efficacy of pharmacological treatments or to find new solutions with low risk of adverse events in patients with organic comorbidities or multiple concomitant medications. Data about the efficacy and tolerability of nutritional interventions explored for psychiatric disorders were searched in four electronic databases (PubMed, Cochrane, Clarivate/Web of Science, and EMBASE). Omega-3 polyunsaturated fatty acids supplementation, healthy diet interventions, folate and vitamin B12, S-adenosyl-L-methionine, N-acetyl cysteine, vitamin B1 and B6, vitamin D, minerals, psychobiotics, inositol, and herbal products were the main interventions identified, and their demonstrated efficacy was quite heterogenous, while their tolerability and safety were good. Therefore, NP is a domain of research that may benefit from more good-quality and longer-duration trials, in order to verify the effectiveness of such augmentation strategies to the already validated treatments."

Functional brain responses to emotional faces after three to five weeks of intake of escitalopram in healthy individuals: a double-blind, placebo-controlled randomised study

Short-term intake of selective serotonin reuptake inhibitors (SSRIs) modulates threat-related amygdala responses in healthy individuals. However, how SSRI intake over a clinically relevant time period modulates threat-related amygdala responses is less clear. In a semi-randomised, double-blind, placebo-controlled study of 64 healthy individuals (SSRI n = 32, placebo n = 32), we examined the effect of 3–5 weeks of SSRI escitalopram (20 mg daily) on brain response to angry, fearful and neutral faces using BOLD fMRI. Data was analysed using a whole-brain region-wise approach extracting standardised effects (i.e., Cohen’s D). The study was conducted at the Copenhagen University Hospital. A priori, we hypothesised that SSRI would attenuate amygdala responses to angry and fearful faces but not to neutral ones. Whether SSRI modulates correlations between amygdala responses to emotional faces and negative mood states was also explored. Compared to placebo, 3–5 weeks of SSRI intake did not significantly affect the amygdala response to angry, fearful, or neutral faces (|Cohen’s D|< 0.2, PFWER = 1). Whole-brain, region-wise analyses revealed significant differences in frontal (|Cohen’s D|< 0.6, PFWER < .01) and occipital regions (|Cohen’s D|< 0.5, PFWER < .01). SSRI did not modulate correlations between amygdala responses to emotional faces and negative mood states. Our findings indicate that a 3–5 week SSRI intake impacts cortical responses to emotional stimuli, an effect possibly involved in SSRI’s therapeutic efficacy.Trial registration Clinical Trials NCT04239339.

Prognostic factors of patients (pts) with salvage-line metastatic colorectal cancer (mCRC).

115 Background: Randomized clinical trials provide the best evidence for the effects of a new treatment. However, the use of a placebo control arm may present practical and ethical concerns for enrolled patients and treating providers. The CRC ARCAD global database includes a total of 1,673 individual patient data (IPD) treated with placebo plus best supportive care in a salvage-line setting for refractory mCRC. By using placebo IPD, we have proposed to construct a synthetic control arm for clinical trials (Yoshino T. et al., Nature Medicine 2023). Methods: From 40,889 IPD from 59 studies in ARCAD mCRC database, 723 placebo pts were selected from 4 placebo-controlled randomized studies in a salvage-line setting (CORRECT, RECOURSE, CONCUR and TERRA). We analyzed the impact of baseline patient characteristics and various prognostic factors on outcome in the placebo control. Results: The adjusted hazard ratios (HRs) (95% confidence interval [CI]) were 0.52 (0.40-0.67) for the number of metastatic sites (1 vs 2+), 0.71 (0.59-0.84) for ECOG performance status (PS) (0 vs 1), 0.54 (0.45-0.66) for liver metastases (No vs Yes), 0.54 (0.40-0.71) for peritoneal metastases (No vs Yes), and 0.51 (0.38-0.70) for Royal Marsden Hospital (RMH) Score (consisting of albumin level, number of metastatic sites, and LDH level) (0-1 vs 2-3). Conclusions: Number of metastatic sites, ECOG PS, liver metastasis, peritoneal metastasis and RMH Score were significant prognostic factors in patients with mCRC receiving placebo in a salvage-line setting. Further prognostic factors should be investigated to increase the accuracy of the proposed synthetic control arm. [Table: see text]

Double blind randomized placebo-controlled study of the efficacy and safety of proroxan in the complex therapy of generalized anxiety disorder

Introduction. The clinical picture of generalized anxiety disorder is characterized by diffuse anxiety, muscle tension and multiple symptoms of hyperactivity of the sympathetic part of the autonomic nervous system. As an alpha-adrenoblocker, proroxan can reduce the hyperactivity of the autonomic nervous system, thereby reducing the severity of anxiety and its somatic symptoms.Aim. To evaluate the efficacy of proroxan in the correction of autonomic disorders in patients with generalized anxiety disorder compared to placebo.Materials and methods. 100 people participated in the study: 50 – in the study group received the SSRI escitalopram, 50 – in the control group received SSRI + placebo. The diagnosis of generalized anxiety disorder was made on the basis of ICD-10 criteria. Psychometric assessment using the Montgomery-Asberg scale was performed (only at the screening visit). Weekly psychometric evaluation was performed using the Hamilton anxiety scale, the SCL-90-R scale to assess somatic manifestations of anxiety, and general clinical impression scales (CGI-S disease severity and CGI-I general improvement).Results. In the course of the study, statistically significant decrease in the mean value of CGI-S scale was observed in both groups, however, more pronounced in the proroxan group (p &gt; 0.05); in the CGI-I scale, more pronounced improvement was observed in the first week of treatment in the proroxan group (p &gt; 0.05). The HAM-A scale also showed a more significant reduction in anxiety in the proroxan group than in the placebo group (p &gt; 0.05). The SCL-90-R SOM scale showed a decrease in the mean value in both groups, more pronounced in the proroxan group, which confirms the effect of the drug on autonomic symptoms of anxiety (p &gt; 0.05).Conclusions. The obtained results confirm the superiority of combination therapy with escitalopram and proroxan in the treatment of generalized anxiety disorder compared to monotherapy. The advantages of proroxan were the absence of sedative effect and, in general, good tolerability, absence of withdrawal syndrome and control of vegetative manifestations of anxiety.

The effect of zoledronic acid on hip geometry in renal transplant recipients: a double-blind placebo-controlled randomized study

BackgroundIn renal transplant patients, bisphosphonates may prevent bone loss, but little is known about their effects on bone microarchitecture and geometrical hip parameters, as the key factors of bone stability. This study aimed to analyze the effect of zoledronic acid on the mentioned parameters in kidney transplant patients.MethodsIn this double-blind, randomized trial, 33 patients were followed for six months after administering either 4mg of zoledronic acid or a placebo. Bone mineral density (BMD) measurement of the spine, hip, radius, and whole body was obtained, and trabecular bone score (TBS) was evaluated using the software. Geometric assessment at the proximal femur was performed by the HSA program.ResultsEighteen patients in the intervention group and 15 in the control group completed the study. The mean percentages of the changes in the BMD at the lumbar spine and whole body were significantly different between the placebo and intervention groups (-0.23% vs. 4.91% and -2.03% vs. 1.23%) (P < 0.05). Zoledronic acid appeared to enhance the subperiosteal diameter, endocortical diameter, and cross-sectional moment of inertia (CSMI) at the narrow neck in comparison with placebo (P < 0.05); however, no difference in TBS was observed between both groups (P > 0.05).ConclusionsWe concluded that a single administration of zoledronic acid might ameliorate bone loss at the lumbar spine and the whole body and maintain the subperiosteal diameter, endocortical diameter, and CSMI as parameters of bone strength at the narrow neck of the proximal femur after six months in renal-transplant recipients.Trial registrationThis study was registered in IRCT (ID: IRCT20181202041821N1) on 04–05-2019.

Reappraising 21years of the WHI study: Putting the findings in context for clinical practice.

Menopausal hormone treatment (MHT) is recommended for the management of menopause symptoms. The Women's Health Initiative (WHI) placebo-controlled randomised study examined the effects of continuous combined or estrogen-only MHT on the risk of non-communicable diseases (NCDs) in post-menopausal women. The study was terminated prematurely after an interim analysis showed an increased risk of breast cancer diagnosis, which led to a rapid decrease in MHT use worldwide. Subsequently, limitations of the study design and its interpretation in the context of other clinical studies has contributed to a more nuanced appreciation of the risk-benefit profile of differing MHT regimens regarding risk associated with the class of progestogen prescribed, its pattern of prescription, duration of use and timing of initiation related to menopause onset. This review provides a contextual interpretation of the WHI placebo-controlled study and evaluates the impact of bioidentical MHT, with a focus on combined therapies containing micronised progesterone, on the risk of chronic NCDs in post-menopausal women.

Effect of flibanserin on libido in women with breast cancer on adjuvant endocrine therapy.

12015 Background: Breast cancer and its treatment can cause decreased libido. This study evaluates the use of Flibanserin in women with breast cancer on endocrine therapy who are experiencing decreased libido. It is the first study evaluating Flibanserin for medically induced decreased libido. Methods: 37 women (mean age of 49) with stage 0-III ER+ breast cancer on endocrine therapy for at least three months were enrolled on a longitudinal IRB-approved trial from both an academic center and an alliance community site. All patients met criteria for the diagnosis of HSDD as defined by the DSM-IV and ISSWSH consensus paper. Patients took Flibanserin 100mg at bedtime for 24 weeks and were followed for 52 weeks. Patients were monitored closely with medical exams and questionnaires at baseline, weeks 4, 8, 16, 24 and 52. Feasibility and efficacy of Flibanserin was measured by patient reported validated instruments such as Female Sexual Function Index (FSFI), Pittsburg Sleep Quality Index (PSQI), PROMIS, and EQ5D. Results: A statistically significant improvement in the sexual domains of desire, arousal, lubrication, orgasm, satisfaction, and pain were seen as measured by the FSFI while on Flibanserin, which declined after discontinuing the medication. At baseline, patients had an average libido of 1.7, which increased to 2.8 at 24 weeks and declined to 2.5 after discontinuing treatment. Sexual confidence and satisfaction at baseline were an average of 1.2 and 1.6 respectively and increased to an average of 2.5 and 2.6 after treatment. Ability to become lubricated was 1.3 at baseline and increased to 4.4 at 24 weeks. Ability to maintain lubrication and ease of lubrication both averaged 1.6 at baseline and increased to 3.4 at week 24. Ease and frequency of climax scored an average 1.4 at baseline, then increased to 2.6 and 2.9 respectively at week 24. Patients reported less pain and distress with sexual intercourse throughout the study and an increased number of sexually satisfying events. At baseline, the average score for overall state of health was 78/100. At 24 weeks, the average score increased to 93 and declined to 82 at week 52 (after medication was discontinued). Patients slept an average of 6.7 hours per night at baseline, which increased to 7.7 hours on Flibanserin and decreased to 5.5 hours after discontinuing the medication. Conclusions: Our study found statistically significant improvement in the sexual domains of desire, arousal, lubrication, orgasm, satisfaction, and pain as measured by the FSFI from baseline to week 24 while on Flibanserin. It also showed improved overall health-related quality of life and sleep. Flibanserin is an effective treatment option for women with breast cancer. A larger randomized placebo-controlled study is still needed to further evaluate Flibanserin in women with breast cancer and medically induced decreased libido. Clinical trial information: NCT03707340 .

The effect of lumbopelvic manipulation on electromyography parameters of gluteus medius and vastus medialis in patients with patellofemoral pain syndrome: A double-blind, placebo-controlled trial

BackgroundPatellofemoral Pain Syndrome is the most common cause of anterior knee pain, especially in active young people. This study aimed to evaluate the effect of lumbopelvic manipulation on electromyography parameters of gluteus medius and vastus medialis in patients with patellofemoral pain syndrome. MethodsIn this double-blind placebo-controlled randomized clinical trial study, 26 patients with a diagnosis of patellofemoral pain syndrome were randomly divided into two groups. The first group received Lumbopelvic manipulation and the second group was a control group that received placebo manipulation. Electromyography activity of vastus medialis and gluteus medius muscles were evaluated as primary outcomes during the single-leg squat; pain intensity during rest and functional tasks (step up, step down, single leg squat) were assessed by numerical pain rating scale. Functional status was evaluated by step-down test and the score of the Kujala patellofemoral questionnaire, as secondary outcomes. All evaluations were performed before and after the intervention, except pain intensity at rest and the Kujala patellofemoral questionnaire that were assessed before the intervention and one week after. ResultIn both groups, no significant difference was observed before and after the intervention in terms of average amplitude and the onset of gluteus medius and vastus medialis. However, in the lumbopelvic manipulation group, pain intensity during rest and functional tests significantly decreased compared to the control group. Functional status significantly improved in the lumbopelvic manipulation group, with no significant difference between group comparisons. ConclusionLumbopelvic manipulation caused a reduction in pain intensity and improvement of functional status in the rehabilitation of patients with patellofemoral Pain Syndrome. However, it seems that this method could not change the EMG activity of muscles in these patients. Implications for practice•The results of present study can help physiotherapists to understand the possible underlying pathomechanics of patellofemoral pain syndrome and more effective treatment of these group of patients.

Revised protocol for secondary prevention of congenital cytomegalovirus infection with valaciclovir following infection in early pregnancy.

A previous randomized placebo-controlled study found valaciclovir to be effective in reducing the rate of vertical cytomegalovirus transmission from mother to fetus. The better results in women infected in the first trimester compared to the periconception period were attributed to the timing of treatment. The aim of the present study was to evaluate valaciclovir efficacy in this setting using a revised protocol. All pregnant women treated with valaciclovir in 2020-2022 who met the same criteria as in the original study were identified retrospectively from the database of the same medical center. Treatment, however, was initiated earlier: up to 9 weeks or 8 weeks from the presumed time of infection in women infected in the periconception period or the first trimester, respectively. The primary endpoint was rate of vertical cytomegalovirus transmission. Results were compared with the placebo arm in the previous study. Among 178 women who completed valaciclovir treatment, amniocentesis was positive for cytomegalovirus in 14 women (7.9%), significantly (p<0.001) lower compared with 14 of 47 (30%) in the placebo arm in the previous study. The proportion of positive amniocentesis in the valaciclovir was significantly lower than the placebo arm both among women infected in the first trimester (14/119 vs 11/23; OR=0.15; 95% CI 0.05-0.45, p <0.001), as well as among those infected in the periconception period (0/59 vs 3/24, OR=0; 95% CI 0-0.97, p=0.02). This study provides further evidence of the efficacy of valaciclovir in preventing vertical transmission of cytomegalovirus after primary maternal infection. Efficacy is improved with earlier treatment.

Efficacy of Silodosin versus Sildosin plus Tadalafil as medical expulsive therapy for lower ureteric stones: A prospective randomized placebo controlled study

Efficacy of Silodosin versus Sildosin plus Tadalafil as medical expulsive therapy for lower ureteric stones: A prospective randomized placebo controlled study