Randomized Clinical Trial Study Research Articles

The effects of atomoxetine and trazodone combination on obstructive sleep apnea and sleep microstructure: A double-blind randomized clinical trial study

Study objectiveswe aimed to compare the effects of atomoxetine and trazodone (A-T) in combination with placebo in patients with obstructive sleep apnea (OSA). MethodsThis randomized, placebo-controlled, double-blind, crossover trial study was conducted in adults with OSA referred to a Sleep Clinic. Participants with eligibility criteria were recruited. Patients were studied on two separate nights with one-week intervals, once treated with trazodone (50 mg) and atomoxetine (80 mg) combination and then with a placebo and the following polysomnography tests. ResultsA total of 18 patients with OSA completed the study protocol, 9(50%) were male, the mean age was 47.5 years (SD = 9.8) and the mean Body mass index of participants was 28.4 kg/m2 (SD = 3.4). Compared with the placebo, the A-T combination resulted in significant differences in AHI (28.3(A-T) vs. 42.7 (placebo), p = 0.025), duration of the REM stage (1.3%TST (A-T) vs. 13.1%TST (placebo), p = 0.001), and the number of REM cycles (0.8 (A-T) vs. 4.7 (placebo), p = 0.001), number of apneas (38.3 (A-T) vs. 79.3 (placebo), p = 0.011), number of obstructive apneas (37.2 (A-T) vs. 75.2 (placebo), p = 0.011), oxygen desaturation index (29.5 (A-T) vs. 42.3 (placebo), p = 0.022) and number of respiratory arousals (43.2 (A-T) vs. 68.5 (placebo), p = 0.048). This decrement effect did not change among those with a low-arousal phenotype of OSA. ConclusionsThe A-T combination significantly improved respiratory events’ indices compared with placebo in patients with OSA. This combination is recommended to be assessed in a large trial. It could be an alternative for those who do not adhere to the standard available treatments for OSA.

Success rates of endotracheal intubation using the standard method versus the modified-ramped position.

The sniffing position used in intubation has disadvantages, including suboptimal glottic view, respiratory problems, increased risk of aspiration, and pain. In this regard, we have proposed new conditions to facilitate intubation and tube placement in patients with a Mallampati score higher than 2, by introducing a new position called the modified rapid airway management positioner (RAMP) position. The authors compared various parameters to improve intubation conditions between these two positions. This intervention is a randomized clinical trial study, with a random sampling method that divides the patients into two groups: a control group placed in the standard position (S) and an intervention group placed in the modified (M) RAMP position. An anesthesiologist performed intubation. In group (S), patients were placed in the supine position as usual, and a pillow with a height of 10cm was placed under their heads. In group (M), the patients were placed in the supine position on a modified RAMP with a triangular shape, 15cm in height, and 80cm in length, at a 30° angle. The pillow had lengths of 20 and 80cm. In the present study, 112 patients were investigated, consisting of 58 women (51.8%) and 54 men (48.2%). The intubation time in the intervention group using the modified RAMP roll technique was significantly shorter (51.25s) compared to the control group using the standard method (88.39s) (P=0.019). The results of the study showed that the modified RAMP roll improved the general conditions of intubation and led to a better view of the glottis in direct laryngoscopy. This is a very important aspect of intubation, and with a better view of the pharynx and glottis, the intubation procedure can be performed with higher quality, reducing the number of intubation attempts and the duration of the procedure.

Evidence-Supported Interventions for Reducing Secondary Stroke Risk in Sub-Saharan Africa: A Systematic Review.

The study set out to perform a systematic literature review of evidence-based interventions that target the reduction of secondary stroke risk in Africa. The review analyzed longitudinal intervention studies conducted in Sub-Saharan Africa, focusing on adult participants who had suffered a prior stroke. It encompassed publications and peer-reviewed papers sourced from reputable databases, including PubMed, Ovid, Cochrane, and Web of Science. Three randomized clinical trial (RCT) studies were included with sample sizes ranging from 16 to 400 participants, mean age ranged between 50 and 66 years, with 64.5% male participants. All studies applied multidisciplinary team interventions of enhanced patient follow-up involving care givers, nurse educators, physicians, and social workers. Interventions ranged from comprehensive patient education, tracking of medication adherence and enforcing healthy lifestyle behaviors (regular exercise, regular BP checks, and dietary changes). We found a decrease in Systolic Blood Pressure over time in 2 of 3 treatment groups, an improvement in medical adherence in all treatment groups, and a decrease in cholesterol levels in 1 treatment group. Evidence-based interventions involving multidisciplinary teams and comprehensive patient education were found to demonstrate promising results in reducing secondary stroke risk in Africa, leading to significant improvements in medical adherence and reductions in systolic blood pressure in the majority of treatment groups. However, more research is required to confirm the influence of these interventions on cholesterol levels and to establish their lasting advantages in preventing strokes among African communities.

Comparison between Intra-Articular Corticosteroid Injection with Physiotherapy and Corticosteroid Injection Alone in Management of Early Stage Frozen Shoulders: A Randomized Clinical Trial

Introduction: Frozen shoulder (FS) is the most prevalent cause of shoulder pain and impairment, affecting 2-4% of all adults. As an appropriate strategy of treatment for FS, supportive physiotherapy treatment (PT) and exercises within the limits of pain has been recommended. Objective: To compare between intra-articular corticosteroid injection with physiotherapy and corticosteroid injection alone in the management of early-stage frozen shoulder. Methods: This prospective randomized clinical trial study was done among 23 patients with symptoms of early-stage (stage I or II) FS in the Department of Orthopedics, Monno Medical College Hospital from July to December 2022. Two groups were formed out of all the patients. While the other group (non-PT) did not receive any additional physiotherapy treatment, one group did. A follow-up was planned for weeks 6, 12, and 26. Results: Patients who had symptoms for ≥6 months was significantly higher in PT group (81.8%) in comparison to non-PT group (p<0.05). Patients who took physiotherapy treatment was significantly higher in PT group (72.7%) in comparison to non-PT group (p<0.05). The median total SPADI scores in the PT group at baseline, which were 82 (IQR: 35-86) and in the non-PT group, which were 80 (IQR: 65-87), showed the significant pain and limitations of frozen shoulder (FS) in its early stages. Both therapy groups significantly improved at the primary endpoint of 6 weeks for SPADI scores (p<0.05). At 6 weeks compared to baseline, passive ROM increased significantly (p<0.05). Each of the three ROM orientations showed significant changes in favor of the PT group after 12 weeks (p<0.05). At 6 weeks after baseline, both pain scores and Rand-36 physical component scale scores significantly increased (p<0.05). Conclusion: In the first 12 weeks of the early stage of frozen shoulder, physiotherapy in addition to corticosteroid injection improves range of motion (ROM) and functional mobility limitations compared ............

The Effect of Cognitive Behavioral Group Therapy on the Improvement of Postmenopausal Women’s Body Image: A Randomized Clinical Trial

Background: The physiological changes in postmenopausal women, especially age-related physical changes, may lead to negative experiences in body image among these women. Objectives: This study aimed to determine the effectiveness of cognitive behavioral group therapy on the negative body image of postmenopausal women. Methods: This parallel randomized clinical trial study was conducted on 22 eligible postmenopausal women attending a health care center in Ahvaz, Iran, in 2018. They were randomly selected and assigned to intervention and control groups (n = 11 per group). The intervention group attended eight 90-minute sessions of cognitive behavioral therapy (CBT) based on the Cash 8-step model. All participants completed the body image concern inventory (BICI) and Multidimensional Body-Self Relations Questionnaire (MBSRQ) before, immediately after, and 1 month after the intervention. The chi-square test, independent t-test, and repeated measures test were used to investigate the trend of changes in BICI and MBSRQ and their domains over time in both groups. P values less than 0.05 were considered statistically significant for all tests. Results: Before the intervention, there were no statistically significant differences in demographic characteristics (such as age, age of menopause, and body mass index (BMI)) between the 2 groups; also, there were no statistically significant differences in the mean scores of MBSRQ and BICI between the 2 groups (P < 0.05). After the intervention, a significant increase was observed in the mean scores of MBSRQ and its 3 out of 6 domains (appearance evaluation (AE), appearance orientation (AO), and body areas satisfaction (BAS); P < 0.05), while a significant decrease was observed in the mean scores of BICI in the intervention group compared with the control group (P < 0.05). Conclusions: Cognitive behavioral group therapy based on the Cash 8-step model in postmenopausal women can promote satisfaction with their body image.

The effectiveness of walking exercise on the bowel preparation before colonoscopy: a single blind randomized clinical trial study

Background and AimBowel preparation is a crucial factor affecting the diagnostic accuracy of colonoscopy, and few randomized control trials evaluated enhancement in bowel preparation. In this study, we aimed to evaluate the effectiveness of walking exercises on bowel preparation before a colonoscopy procedure.MethodsThe present study is a single-blind randomized controlled trial involving 262 patients scheduled for colonoscopy procedures. These patients were randomly assigned to two groups: an intervention group (n = 131) and a control group (n = 131). In the intervention group, participants followed a predetermined plan that included the consumption of specific liquids and foods, bisacodyl pills, polyethylene glycol powder, and a regimen of walking exercises in preparation for their colonoscopy. Conversely, individuals in the control group followed the same regimen but were not instructed to engage in walking exercises. On the day of the colonoscopy, both groups were assessed for their level of physical activity using a foot counter. Additionally, an experienced gastroenterologist evaluated and compared the bowel preparation between the two groups using the Boston Bowel Preparation Scale (BBPS).ResultsThe number of footsteps recorded in the two groups exhibited a significant difference (P < 0.001). Although there was no statistically significant difference between the intervention and control groups in terms of mean BBPS scores (6.26 ± 1.9 vs. 6.29 ± 1.9, P = 0.416), individuals who took more than 6900 steps had significantly higher BBPS scores compared to those with fewer than 6900 footsteps (6.62 ± 1.8 vs. 5.92 ± 1.9, P = 0.003).In the univariate analysis, BBPS was found to be significantly associated with individuals under the age of 50 (OR: 2.45, 95% CI: 1.30–4.61, P = 0.006) and smoking status (OR: 0.41, 95% CI: 0.17–0.94, P = 0.043). In the multivariate analysis, the relationship between BBPS and age below 50 and smoking remained significant (OR: 2.50, 95% CI: 1.30–4.70, P = 0.005, and OR: 0.38, 95% CI: 0.16–0.93, P = 0.034, respectively).ConclusionA higher number of footsteps taken especially more than 6900 can significantly enhance bowel preparation; however, walking exercise as an intervention before colonoscopy is not significantly associated with BBPS. Also, older people and smokers seem to have fewer benefits from walking exercises for bowel preparation.Trial registrationISRCTN32724024 (Registration date:22/08/2018).

Diagnosis and treatment of “chronic Lyme”: primum non nocere

BackgroundApproximately 10% of patients experience prolonged symptoms after Lyme disease. PTLDS (post treatment Lyme disease syndrome) is a controversial topic. It has been described as a source of overdiagnosis and off-label treatment. This review aims to describe the diagnostic errors and adverse events associated with the diagnosis and treatment of PTLDS.Methodssystematic review of the literature in the Medline and Cochrane Library databases, according to PRISMA criteria, including randomized clinical trials (RCT), observational studies, and case reports addressing diagnostic errors and adverse events published between January 2010 and November 2020 in English or French. Selection used a quadruple reading process on the basis of the titles and abstracts of the different articles, followed by a full reading.Results17 studies were included: 1 RCT, 6 observational studies and 10 case reports. In the 6 observational studies, overdiagnosis rates were very high, ranging from 80 to 100%. The new diagnoses were often psychiatric, rheumatological and neurological. Disorders with somatic symptoms were often cited. Diagnostic delays were identified for cancers and frontoparietal dementia. In the RCT and observational studies, prolonged anti-infective treatments were also responsible for adverse events, with emergency room visits and/or hospitalization. The most common adverse events were diarrhea, sometimes with Clostridium difficile colitis, electrolyte abnormalities, sepsis, bacterial and fungal infections, and anaphylactic reactions.ConclusionThis review highlights the risks of prolonged anti-infective treatments that have not been proven to be beneficial in PTLDS. It emphasizes the ethical imperative of the “primum non nocere” principle, which underscores the importance of not causing harm to patients. Physicians should exercise caution in diagnosing PTLDS and consider the potential risks associated with off-label treatments.

An Indian Drug, Ocimum Sanctum - A Clinical Trial Study

A Prospective Experimental, randomised clinical trial was conducted at RHMC, Rajkot for a period of 6 months with a 3 – month intervention and follow up period, aiming to ascertain the Effectiveness of OCIMUM SANCTUM through a clinical trial. In this study, after Screening of patients, it is observed that the most cases were presented with Respiratory symptoms, GI symptoms, GUT symptoms and Reproductive symptoms. 30 cases completed the study in which marked improvement were seen in 50% cases, moderate improvement in 30% cases and mild improvement or no improvement is observed in 20% cases. Ocimum Sanctum offered highly significant relief to the patients suffering from Respiratory complaints markedly, followed by the GIT symptoms, GUT symptoms and Reproductive symptoms with the use of 30 CH potency. Ocimum sanctum is safe with no adverse effects. In future, studies can be done for clinical verification of Ocimum Sanctum as it is a small and lesser-known drug and there is a limitation of time duration. Keywords: Ocimum Sanctum, Homoeopathy, Randomized clinical trial study.

Comparative Study between the Effect of Single Anastomosis Gastric Bypass versus Roux-en-Y Gastric Bypass in Morbidly Obese Patient as Regard Remission of Type-2 DM

Abstract Background Accumulating evidence obviously supports the superiority of weight loss surgery over non-surgical treatments for management of morbidly obese patients in terms of outcomes as sustained weight loss, improved quality of life and prevention, reduction, or resolution of comorbidities (e.g., Type 2 Diabetes Mellitus, dyslipidemia), as well as reduced overall mortality. Objective To compare Type 2 DM remission as well as the metabolic effects of 2 types of bariatric surgery; Single Anastomosis gastric Bypass and Roux-en-Y Gastric bypass, in the first year postoperative follow up in relation to DiaRem Scoring system. Patients and Methods This is a prospective randomized clinical trial study conducted in AinShams University Hospitals bariatric surgery unit over 40 patients with minimal follow-up of 12 months. 2 groups of patients: Group A: composed of 20 patients that undergoing OAGB as a metabolic surgery for control of Type 2 DM. Group B: composed of 20 patients that undergoing Reux-en-Y gastric bypass as a metabolic surgery for control of Type 2 DM. Patients were randomly distributed among both groups using simple randomization odds and evens where odd patients were included in group A and even patients were included in group B. Results We find that Roux-en-Y operation is more potent as regard remission of DM than MGB/OAGB (80% versus 65%) and that remission of DM depends on diabetes itself (duration, HBA1C, C-PEPTIDE) and these are the main determinants of remission. And DiaRem score is good predictor of DM remission in low scoring categories however in high scoring categories it is poor in prediction of DM remission Conclusion No statistical difference between both groups as regard remission of DM however numerically it is obvious that Roux-en-Y is more potent metabolic surgery in order to be statistically significant the study needs to be repeated over larger sample size. The main determinant noticed during the study influencing remission is the duration of DM and preoperative C-peptide level-in addition to HBA1C level. We must put into our consideration the post operative complications of MGB/OAGB as regard biliary reflux and failure which are more less in Roux-enY operation but in order to be evaluated longer duration of follow up is needed. We recommend Roux-en-Y as a metabolic surgery for patients with early onset DM type II with BMI ranging from 30-40. The study needs to be repeated over larger sample size and longer duration to determine the long term effects of metabolic surgery.

Ultrasound Guided Fascia Iliaca Block versus Femoral Nerve Block for Post Operative Analgesia for Patient Undergoing Total Knee Arthroplasty

Abstract Background Total knee arthroplasty (TKA) is commonly performed in patients with end-stage osteoarthritis or rheumatic arthritis of the knee to relieve joint pain, increase mobility, and improve quality of life. Multimodal techniques featuring peripheral nerve blocks have demonstrated a significant advantage in perioperative pain relief for TKA patients. Peripheral nerve blocks have gained more attention because of the discovery of new and more trustworthy anesthesia medications and developments in technology and anesthesia. Peripheral nerve blocks can also be used for anesthesia of the operation area and are commonly used for postoperative analgesia being with general anesthesia. Aim of the Study To compare the effect of Fascia iliaca versus femoral nerve block on postoperative anaelgesia in patients undergoing TKA. Patients and Methods This is a prospective randomized clinical trial study was conducted in Ain Shams University Hospitals within a period of 6 months. Seventy adult patients scheduled for total hip arthroplasty (THA), under spinal anesthesia were included in this study and randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes: Group I (FICB group) received ultrasound guided Fascia iliaca compartment block (FICB) and Group II (FNB group) received ultrasound guided femoral nerve block. Results There was a statistically significant mean in FNB group compared to FIB group according to VAS score after 6 hrs postoperative and shows significant higher mean in FNB group after 12 hrs and 24 hrs postoperative. Also, a statistically significant increase mean/hrs in FIB group compared to FNB group was found according to first time to ask analgesia and also shows statistically significant higher mean in FNB group compared to FIB group according to total pethidine given (mg). At PACU arrival there is no difference between two groups as two groups were recovering from anesthesia then fascia illiaca block group showed the best response as regard as pain control post operatively for 12 hours postoperative then there is no statistical difference between two groups. There was statistically significant difference between groups as regard as visual analog score. As regard to total dose of morphine used in each group, facia illiaca block scientifically used less amount of morphine than control group (P &amp;lt; 0.001). Conclusion The fascia iliaca block and femoral nerve block provide the same analgesic effect during early post operative period; however after 6 hrs, fascia iliaca block provides a more efficient pain control and less morphine consumption.

Analgesic Sparing Effect of Dexamethasone with Levobupivacaine in Quadratus Lumborum Block in Patients Undergoing Unilateral Inguinal Hernia Repair

Abstract Background The QLB is an effective analgesic technique for various abdominal wall incisinos. The QLB covers T7 to L2 dermatomes. Levobupivacaine is a long-acting LA agent, commonly used for peripheral nerve block due to its better safety profile than that of bupivacaine. Dexamethasone as an adjuvant to LA has been shown to prolong the duration of pain-free period, less requirement for rescue opioids consumption, more patient satisfaction and lesser incidence of nausea and vomiting. Objective To assess the analgesic sparing effect of adding dexamethasone to levobupivacaine in quadratus lumborum block in patients undergoing unilateral inguinal hernia repair under general anesthesia. Patients and Methods After approval of the anesthesiology department and scientific and ethical committees, this prospective double blind randomized clinical trial study was conducted in Ain Shams University Hospitals. Sixty patients scheduled for elective ingunial surgeries under general anesthesia were included in this study. Results Our study did not have any complications associated with the use of dexamethasone with levobupivacaine in QLB. Type 1 QLB failed to provide postoperative analgesia in surgeries involving dissection in the retroperitoneal area as there were high chances of damaging the thoracolumbar fascia. Conclusion The addition of dexamethasone to levobupivacaine in QLB in unilateral inguinal hernia repair surgery provides a prolonged duration of postoperative analgesia, with reduced analgesic requirements, a better quality of analgesia in terms of NRS compared to levobupivacaine alone group.

Ketofol Infusion versus Isoflurane as Maintenance of Anesthesia on Hemodynamics in Radical Cystectomy Operation

Abstract Background radical cystectomy is a major operation where bleeding from sacral plexus during dissection of the bladder may occurs leading to hemodynamic instability and organ ischemia due to hypo perfusion. So using anesthetic drugs that provide hemodynamic stability will decrease intraoperative and post-operative morbidity and ICU and hospital stay. Objectives The Aim of this study is to compare the effect of anesthetic agent ketofol infusion versus isoflurane inhalation on hemodynamics in maintenance of anesthesia in radical cystectomy operation as a primary outcome and recovery time as a secondary outcome. Methods and material This prospective randomized clinical trial study was conducted in Ain Shams University hospital after approval of the anesthesia department and the local ethics and research committee over 6 months and after obtaining a written informed consent. Sixty patients underwent radical cystectomy were included in the study their ages range between 50 and 70 years old and classified as ASA I and II, III. The patients were randomly divided using computer generated randomization into two groups 30 patients in each (n = 30), Group I received isoflurane inhalation while group K received Ketofol infusion. Results this study demonstrated that maintenance of anesthesia by ketofol infusion provides more hemodynamic stability with maintaining of blood pressure and heart rate rather than isoflurane inhalation. Conclusions We conclude that maintenance of anesthesia with ketofol infusion provides more hemodynamic stability and least intraoperative and postoperative morbidity than isoflurane inhalation in patients undergoing radical cystectomy.

Evaluation of the effect of oral Ketamine compared to placebo on pain reduction in patients with renal colic: a double-blind randomized clinical trial study

Introduction: Renal colic caused by urolithiasis is one of the common causes of severe pain and referral to the emergency room. Using a multimodal method in controlling this type of pain by available anesthetics such as ketamine can help relieve pain, increase satisfaction and reduce hospitalization. Method: This study was conducted as a double-blind clinical trial. 44 patients with renal colic with ASA class 1 were divided into two intervention and control groups. Pethidine (1mg/kg) was administered to both groups. In the intervention group, oral ketamine (0.5 mg/kg) dissolved in 5% dextrose was prescribed, and in the control group, 5% dextrose serum (0.1 ml/kg) was used. Pain intensity was measured by numerical method (NRS) before the treatment and half, one, two and three hours after the intervention. Findings: The median age of the intervention group was 35.2 and the control group was 38.9 (p=0.092). The average amount of pethidine consumed in the intervention group was 94 mg and in the control group was 89 mg, and there was no significant difference between the two groups (p=0.095). In the intervention group, 27.3% and in the control group, 72.7% needed additional pethidine (p=0.000). In hours one, two and three after treatment, the intensity of pain in the intervention group was lower than in the control group, and only in the third hour this difference was statistically significant (p = 0.03). Conclusion: The use of oral ketamine can reduce restlessness without causing side effects and along with pethidine can help relieve the pain of renal colic in the emergency department

Parenteral Ready-to-Use Fixed-Dose Combinations Including NSAIDs with Paracetamol or Metamizole for Multimodal Analgesia-Approved Products and Challenges.

The combination of non-steroidal anti-inflammatory drugs (NSAIDs) with non-opioid analgesics is common in clinical practice for the treatment of acute painful conditions like post-operative and post-traumatic pain. Despite the satisfactory results achieved by oral analgesics, parenteral analgesia remains a key tool in the treatment of painful conditions when the enteral routes of administration are inconvenient. Parenteral ready-to-use fixed-dose combinations of non-opioid analgesics combinations, including NSAIDs and paracetamol or metamizole, could play a central role in the treatment of painful conditions by combining the advantages of multimodal and parenteral analgesia in a single formulation. Surprisingly, only in 2020, a parenteral ready-to-use fixed-dose combination of ibuprofen/paracetamol was launched to the market. This review aims to investigate the current availability of combinations of NSAIDs with paracetamol or metamizole in both European and American markets, and how the combination of such drugs could play a central role in a multimodal analgesia strategy. Also, we explored how the parenteral formulations of NSAIDs, paracetamol, and metamizole could serve as starting elements for the development of new parenteral ready-to-use fixed-dose combinations. We concluded that, despite the well-recognized utility of combining NSAIDs with paracetamol or metamizole, several randomized clinical trial studies demonstrate no clear advantages concerning their efficacy and safety. Future clinical trials specifically designed to assess the efficacy and safety of pre-formulated fixed-dose combinations are required to generate solid evidence about their clinical advantages.

The Impact of Loving-Kindness Meditation on Compassion Fatigue of Nurses Working in the Neonatal Intensive Care Unit: A Randomized Clinical Trial Study.

Compassion fatigue is a common complication in nurses, which can lead to burnout, job dissatisfaction, and a decline in the quality of patient care. This study aimed to investigate the impact of loving-kindness meditation on compassion fatigue of nurses working in the neonatal intensive care unit (NICU). This cluster-blinded randomized clinical trial study was conducted on 66 NICU nurses in 2 educational hospitals selected. The intervention group received a 1-month online program for daily training and practice of loving-kindness meditation. The control group received miscellaneous files on mental health during the COVID-19 pandemic period. The Nursing Compassion Fatigue Inventory (NCFI) was filled out by the 2 groups, before and after the intervention. The results showed that the mean scores of the NCFI in the intervention group decreased significantly compared with before the intervention (P = .002). In comparison with the control group, there was a significant difference between the mean scores of the 2 groups after the intervention (P = .034). Among nurses working in NICU, loving-kindness meditation significantly reduces compassion fatigue after 1 month. These findings support the use of this intervention for nurses.

Prevention of Post-Partum Hemorrhage: Comparison of Oxytocin and Misoprostol. A Two center study in the Bamenda and Nkwen Health Districts

Background: Postpartum hemorrhage is one of the most common obstetrical complications affecting up to 18% of deliveries. Globally, it is responsible for 35 – 55% of peripartum maternal deaths. In Cameroon, the maternal mortality rate is at 406 maternal death per 100,000 live births, with PPH being the leading cause accounting for about 25%. This study aimed to compare the efficacy and safety of misoprostol versus oxytocin in the prevention of postpartum hemorrhage in the Bamenda Health District and Nkwen Health District. Methods: This was a hospital-based randomized clinical trial study in the Bamenda Regional Hospital and Nkwen District Hospital. The study was conducted from March 1st to May 31st 2021 including pregnant women who delivered at the maternity at these two hospitals. All their pregnancy was singleton gestation at term and haven given their informed consent. Women with known history of cardiac, renal, hepatic diseases or any coagulopathy, Cesarean delivery were excluded. We randomized 308 participants in a 1:1 ratio to receive 800 μg of oral misoprostol or 10IU of oxytocin intramuscularly during the active management of third stage of labor (AMSTL). The Hemoglobin (Hb) concentration and hematocrit (HCT) of the participants were measured before and 24hrs after delivery. Our primary outcome of interest was (Post-Partum Hemorrhage) PPH, defined as Hb change ≥ 1g/dl within 24hrs of delivery. Secondary outcomes included; mean Hb change, Hb change ≥2g/dl (severe PPH). Dichotomous outcomes between study groups were compared by estimating crude relative risks (RRs) with 95% confidence intervals. Logistic regression (the chi-square test) was done to determine the factors associated with the occurrence of postpartum hemorrhage, with a level of significance at 5%. Results: After 24hrs, Postpartum hemorrhage (PPH) occurred in 41 (26.6%) and 47 (30.5%) participants in the misoprostol and oxytocin groups respectively (RR= 0.87, 95% C.I= 0.61 - 1.24, p=0.449). Severe postpartum hemorrhage occurred in 3 (1.9%) and 5 (3.2%) participants in the misoprostol and oxytocin groups respectively (RR= 0.6, 95% C.I=0.15 - 2.47, p=0.723). Past history of PPH (aOR=10.1 (3.5 – 28.6), p&lt;0.0001), augmentation of labor (aOR=3.4 (1.6 – 7.1), p=0.0011), fetal birth weight ≥3.5Kg (aOR=2.5 (1.3 – 4.8), p=0.0074) and retained products (aOR= 8.4 (4.2 – 16.7), p&lt;0.0001) were risk factors of PPH. Participants in the misoprostol group more commonly experienced shivering (RR 3.2, 95% CI 2.0 - 5.1, p&lt;0.0001) and nausea/vomiting (RR 35.5, 95% CI 8.9 – 142.2, p&lt;0.0001). Conclusion: Oral misoprostol at the dose of 800μg is as effective as 10 IU IM Oxytocin in the prevention of PPH and is a potent alternative to oxytocin. Most common risk factors of PPH are past history of PPH, augmentation of labor, fetal weight ≥ 3.5kg and retained products. Side effects were mostly associated with 800μg of oral Misoprostol.

Comparison of Immediate Effect of High-power Pain Threshold Ultrasound and Deep Transverse Friction Massage on Active Myofascial Trigger Points

Introduction: The study was conducted to compare the immediate effect of high-power pain threshold ultrasound (HPPTUS) and deep transverse friction massage (DTFM) as a traditional technique on the treatment of upper trapezius active myofascial trigger points in male patients with mechanical neck pain.&#x0D; Materials and Methods: In this parallel single-blind randomized clinical trial study, 60 men with mechanical neck pain (mean age: 30.57±6.19 years) who met the inclusion and exclusion criteria were randomly assigned to HPPTUS and DTFM as the control group. A visual analog scale (VAS), pain pressure threshold (PPT), and range of motion (ROM) of cervical lateral flexion (CLF) were assessed before and after treatment.&#x0D; Results: Analysis of pre- and post-treatment findings showed that the VAS (P&lt;0.01), PPT (P&lt;0.01), and ROM of CLF (P&lt;0.01) improved significantly in both groups while ROM of CLF increased significantly more in the HPPTUS group. An indirect correlation was found between the pre-treatment ROM of CLF and ROM of CLF improvement in both groups. A significant indirect correlation was observed between pre-treatment VAS and ROM of CLF improvement in the HPPTUS group. In the DTFM group a significant indirect correlation was found between pre-treatment ROM of CLF and VAS improvement.&#x0D; Conclusion: The results showed that HPPTUS can be used as an effective treatment for active trigger points (TP). It seems that this method is more effective than deep transverse friction massage.&#x0D;

The effect of lemon inhalation aromatherapy on pain, nausea, as well as vomiting and neurovascular assessment in patients for lower extremity fracture surgery: a randomized trial

BackgroundComplementary and integrative medicine may be effective for postoperative outcomes. This study aimed to determine the effect of lemon inhalation aromatherapy on pain, nausea, and vomiting and neurovascular assessment in patients for lower extremity fracture surgery.MethodsThis is a randomized clinical trial study. Ninety patients who had undergone lower extremity fracture surgery were randomly assigned to the intervention (lemon aromatherapy) and control groups. Lemon aromatherapy was started in the morning of the surgery and extended at two-hour intervals until the end of the surgery, in the recovery room, and 16 h after surgery. Numerical pain and nausea and vomiting scales, the Rhodes Index of Nausea, Vomiting, and Retching, and the WACHS Neurovascular Observation Chart were used to assess the outcomes before and after the intervention (in the recovery room and 4, 8, 12, and 16 h post-surgery). The data were analyzed using the Wilcoxon test, ANCOVA, and Repeated Measure ANCOVA.ResultsA significant difference was observed between the groups in terms of the intensity of pain (P < 0.001) and nausea and vomiting (P = 0.001) during the study period. Moreover, a significant difference was found between groups as to the frequency and severity of nausea, vomiting, and retching. The amount and duration of postoperative vomiting and nausea were significantly lower in the intervention group compared to the control group. In addition, lemon inhalation aromatherapy decreased the frequency of anti-emetic drug administration in the recovery room (P = 0.04) and 16 h post-surgery (P = 0.03).ConclusionsThis study indicated that aromatherapy reduced pain intensity, postoperative nausea, vomiting, and retching, as well as the incidence of anti-emetic drug administration. Therefore, using lemon inhalation aromatherapy to relieve pain and reduce nausea and vomiting is suggested for lower extremity fracture patients who have undergone surgery.Trial registrationThis study was registered in the Iranian Registry of Clinical Trail (Number = 57,331, IRCT20130616013690N10, approved 24/07/2021) (https://www.irct.ir/trial/57331).

Verbal Working Memory-Balance program training alters the left fusiform gyrus resting-state functional connectivity: A randomized clinical trial study on children with dyslexia.

Sufficient activation of the left fusiform gyrus is important in reading ability acquisition due to its role in reading and naming, working memory (WM), and balance tasks. Recently, a newly-designed training program, Verbal Working Memory-Balance (VWM-B), has been evaluated on children with dyslexia, and its positive effects were shown on reading ability, WM capacity, and postural control. In the present study, we aimed to estimate the functional connectivity alterations of the left fusiform gyrus following training by the VWM-B. Before and after 15 sessions of training, the fMRI and other tools data were collected on a sample of children with dyslexia, who were allocated into two control and experiment groups. Data analyses showed the increased functional connectivity of the left fusiform gyrus between the left anterior temporal fusiform cortex, left and right Crus II regions of the cerebellum, and the left middle frontal gyrus. Moreover, VWM-B training significantly improved the reading and naming ability, WM capacity, and postural control of participants in the experiment group in comparison to the control. The current study findings emphasize the critical role of the left fusiform gyrus in reading ability. Moreover, it provides evidence to support the existence of cerebellar deficits in dyslexia.

Comparison of diversity across real-world evidence, randomized clinical trial, and Surveillance, Epidemiology, and End Results (SEER) data in patients with metastatic breast cancer.

e18670 Background: Compared with patients in typical care settings, participants in randomized clinical trials (RCTs) tend to be younger and less diverse. We compared representation of age, race, and ethnicity at initiation of first-line (1L) therapy for metastatic breast cancer across real-world evidence (RWE), RCT, and Surveillance, Epidemiology, and End Results (SEER) registry data. Methods: RWE and SEER inclusion criteria were based on corresponding RCTs. We compared age, race, and ethnicity at initiation of 1L therapy among female patients with metastatic breast cancer across 2 RWE chart review studies (completed between 2019-2021), 4 RCTs with similar eligibility (reported between 2014–2021), and the latest SEER registry data (2017–2019) using t-tests and 2-sided chi-square tests. Results: We collected demographics of 57,479 patients (RWE: n = 860, 1.5%; RCT: n = 2,707, 4.7%; SEER: n = 53,912, 93.8%). Mean age at 1L therapy initiation was significantly higher in RWE than RCT studies (61.8 vs 56.0 years) and representation of Black patients was significantly higher in RWE than RCT studies (25.3% vs 2.9%), both P&lt; .001. Mean age at metastatic diagnosis in SEER was 59.0 years; age at 1L initiation was not reported. SEER included 13.4% Non-Hispanic Black patients. Hispanic representation was 11.2% in RWE, not reported in RCT, and 15.9% in SEER studies (Table). Conclusions: Decisions about treatment choices among clinicians and payers are primarily driven by RCT results, yet they may not be representative of real-world populations. We found that RCTs had lower representation of older and Black patients than both SEER and RWE studies. Limitations included varying study periods, lack of Hispanic ethnicity reporting in RCTs, differential SEER participation by US region, and potential patient overlap. Well-conducted RWE studies may fill gaps left by RCTs for improving representation and generalizability to patients with metastatic breast cancer. [Table: see text]