Randomized Clinical Trial Study Research Articles

The Effect of Sumac Fruit on Serum Lipids and Body Mass Index in Hemodialysis Patients.

Sumac fruit is an antioxidant and reduces serum triglyceride (TG) and cholesterol (CHOL) levels. Therefore, this study aimed to investigate the effect of sumac fruit on serum lipids and body mass index (BMI) of hemodialysis (HD) patients. This triple-blind randomized clinical trial study was conducted for 12 weeks on HD patients. Participants were randomly divided into three groups of 2-gram sumac (N = 40), 3-gram sumac (N = 40), and placebo (N = 40) by nonprobability consecutive sampling and stratified block randomization method based on inclusion criteria. Serum lipids and BMI were measured at the beginning of the study and also at the end of the sixth and the twelfth weeks. The physical activity and 24-hour dietary recall questionnaires were used to collect data. No significant difference was found between the level of nutrient and micronutrient intake (P > 0.05), physical activity (P=0.159), and BMI (P=0.718) of patients in the three groups before and after the intervention. However, the difference in serum low-density lipoprotein (LDL) levels in each studied group was significant over time (P < 0.001). The difference was not statistically significant between the groups before the intervention, 6 and 12 weeks after the intervention (group effect), and between the study groups over time (time-group interaction). No statistically significant difference was observed between the mean levels of TG (P=0.875), CHOL level (P=0.969), LDL level (P=0.998), high-density lipoprotein (HDL) level (P=0.136), and BMI (P=0.608) in the groups over time. Consumption of sumac fruit significantly changed the LDL level over time. Although BMI and serum lipids changed in HD patients, these changes were not significant. Future studies are needed to determine the effective dose of sumac and any dose increase should take toxicity into account and consider a larger sample size and longer intervention and follow-up times.

Impact of Peroperative Intravenous Lidocaine on Postoperative Analgesia in Laparoscopic Cholecystectomy

The present study was undertaken to evaluate the outcome of peroperative intravenous lidocaine in reducing the intensity of postoperative pain after laparoscopic cholecystectomy.This prospective randomized clinical trial study was conducted in the Department of Anaesthesiology, Sir Salimullah Medical College Mitford Hospital (SSMC MH), Dhaka between April 2014 to September 2014. A total of 80 patients of chronic cholecystitis or cholelithiasis undergoing laparoscopic cholecystectomy in SSMC MH, Dhaka were consecutively included in the study and were randomly assigned to two study groups. Patients in the study group received I/V lidocaine administration @ 3 mg/kg/h and those in the control group received normal saline (0.9% saline) in the same volume by a different observer. When compared the changes in haemodynamic variables from baseline to endpoint of the study shows that there was no significant difference between the groups in terms of heart rate, systolic, diastolic and mean blood pressures except a sudden rise of the parameters at 5 minutes after induction. However, the systolic blood pressure of study group experienced a slight reduction from 30 minutes onwards to the end of the observation and differed significantly from the corresponding SBPs of the control group. The mean BP of both the groups also showed similar trend like systolic BPs.The SpO2 in both study and control groups was maintained at 99 to 100% throughout the study. The study concluded that peroperative infusion of nontoxic dose of lidocaine decreases the intensity of postoperative pain and reduces the postoperative analgesics(inj. Pethidine) requirement without causing any significant adverse effects. Sir Salimullah Med Coll J 2022; 30: 148-154

The effect of diluted ropivacaine in distending fluid on cramping pain after hysteroscopic surgeries: a randomized clinical trial study.

The effect of ropivacaine on postoperative hysteroscopy has not yet been evaluated; this study investigated the effect of diluted ropivacaine in distending media during hysteroscopy on postoperative cramping pain. This double-blind randomized clinical trial was conducted on 60 women who underwent hysteroscopy at a tertiary hospital. Normal saline was used as the distending fluid in both groups. The intervention group received 10 mL of 2% ropivacaine in only one bottle of 1,000 mL normal saline as a distending fluid, while the control group received 10 mL of normal saline in 1,000 mL normal saline during hysteroscopy. Patients' pain scores were evaluated before hysteroscopy and at 2, 6, 12, 24, and 48 hours after hysteroscopy. Based on the results, the pain measured by visual analog scale (VAS) score was significant at 6 and 12 hours after the intervention was significantly lower than that in the ropivacaine group (3.03±1.57 vs. 4±1.49, P=0.02 at 6 hours and 1.28±1.36 vs. 2.4±1.43, P=0.003 at 12 hours). There were no significant differences in the VAS scores at 2, 24, and 48 hours after the intervention between the two groups. Ropivacaine in the distending fluid during hysteroscopy is associated with a significant reduction in pain within a few hours after hysteroscopy with no remarkable adverse effects.

Therapeutic effect of laparoscopic salpingotomy vs. salpingectomy on patients with ectopic pregnancy: A systematic review and meta-analysis.

Background and aimLaparoscopic treatment of ectopic pregnancy mainly includes laparoscopic salpingotomy and salpingectomy. We aimed to assess the therapeutic effect of laparoscopic salpingotomy and salpingectomy on patients with tubal pregnancy.MethodsFrom January 2000 through June 2022, the Cochrane Library, Medline, PubMed, Web of Science, EMBASE, and the Chinese Biomedicine Database were searched for studies that compared the therapeutic effect of laparoscopic salpingotomy vs. salpingectomy in the treatment of tubal pregnancy.ResultsTwenty-four randomized clinical trials (RCTs) studies were incorporated into this analysis. No statistical differences were found between the two groups in terms of operation duration and postoperative hospitalize length, but the volume of intraoperative blood loss in patients with laparoscopic salpingotomy was less than that in salpingectomy. Importantly, the natural intrauterine pregnancy rate after laparoscopic salpingotomy was significantly higher than those who underwent salpingectomy. In addition, laparoscopic salpingotomy can better protect the ovarian reserve function and endocrine function and provide favorable conditions for the second pregnancy.ConclusionPatients with ectopic tubal pregnancy should give priority to laparoscopic salpingotomy for embryo extraction.

Intra-articular remifentanil on postoperative pain in knee arthroscopic surgery; a double blind randomized clinical trial

BackgroundWe aimed to assess the efficacy of intra-articular remifentanil in relieving postoperative pain after knee arthroscopy. MethodsWe conducted a double-blind randomized clinical trial study on 60 patients. Patients were divided into two equal groups. The control group received 25 ml of intra-articular normal saline, and the intervention group received 200 μg of remifentanil dissolved in 25 ml of saline. We evaluated at rest postoperative pain at 1, 3, 6, 12, 18, and 24 h after the surgery using the Visual Analog Scale (VAS). Patients with VAS scores of 4 or more received meperidine (pethidine). The first time meperidine was requested and the total amount of meperidine consumed was recorded. ResultsOut of 60 patients, 49 were male (81.6%), and the mean age of participants was 32.71 (7.02) years. An hour after the surgery, the control group showed a mean VAS score of 8.66 (1.26), and decreased to 2.53 (1.67) at the end of 24 h. The intervention group started with a mean VAS score of 2.23 (1.81) and ended at 0.10 (0.305). All patients in the control group and 11 (36.7%) patients in the intervention group asked for analgesics during follow-up. The mean total meperidine dose in the control and intervention groups was 108.33 (23.97) mg and 13.33 (19.40) mg, respectively (P < 0.001; 95% confidence interval of the difference 83.72 to 106.27). ConclusionsIntra-articular remifentanil may decrease postoperative pain and analgesic requirements in patients undergoing knee arthroscopy.

The effect of continuous care model on sleep quality in postmenopausal women: a randomized clinical trial study.

Introduction and ObjectiveSleep disorder leads to several mental, physical, and behavioral complications. Through continuous care model, it is possible to achieve an efficient recognition of the problems of these patients and allow them to participate in solving their health issues. The effects of continuous care model on sleep quality in postmenopausal women were examined.Material and MethodsTotally, 110 postmenopausal women visiting health center in Kermanshah, Iran took part in this clinical trial. The participants were selected between May 2017 and September 2017. The participants were allocated to control and experimental groups randomly each with 55 members. The normal cares were provided to the control group, while the experimental groups took part in group consultation sessions (once every week, four session each 60-90min). Quality of sleep was examined based on Pittsburg sleep quality index before the intervention, immediately after the intervention, and a month flowing the completion of the intervention. For data analyzing, Friedman’s test, Mann-Whitney test, and chi-square test were used in SPSS.ResultsA significant difference was found in the mean scores of the quality of sleep in the experimental group in three measurements occasions in the study (p=0.001). Despite lack of any significant difference before the intervention between the two groups, there was a significant decrease in the sleep quality score in the experimental group one month after the completion of the intervention compared to the control group (p<0.05).ConclusionThe continuous care model improved the sleep quality in the postmenopausal women.

Effect of therapeutic versus prophylactic anticoagulation therapy on clinical outcomes in COVID-19 patients: a systematic review with an updated meta-analysis

BackgroundPrevious studies demonstrate a reduced risk of thrombosis and mortality with anticoagulant treatment in patients with COVID-19 than in those without anticoagulation treatment. However, an open question regarding the efficacy and safety of therapeutic anticoagulation (T-AC) versus a lower dose, prophylaxis anticoagulation (P-AC) in COVID-19 patients is still controversial.MethodsWe systematically reviewed currently available randomized clinical trials (RCTs) and observational studies (OBs) from January 8, 2019, to January 8, 2022, and compared prophylactic and therapeutic anticoagulant treatment in COVID-19 patients. The primary outcomes were risk of mortality, major bleeding, and the secondary outcomes included venous and arterial thromboembolism. Subgroup analysis was also performed between critically ill and non-critically ill patients with COVID-19 and between patients with higher and lower levels of D-dimer. Sensitivity analysis was performed to decrease the bias and the impact of population heterogeneity.ResultsWe identified 11 RCTs and 17 OBs fulfilling our inclusion criteria. In the RCTs analyses, there was no statistically significant difference in the relative risk of mortality between COVID-19 patients with T-AC treatment and those treated with P-AC (RR 0.95, 95% CI, 0.78–1.15, P = 0.60). Similar results were also found in the OBs analyses (RR 1.21, 95% CI, 0.98–1.49, P = 0.08). The pooling meta-analysis using a random-effects model combined with effect sizes showed that in the RCTs and OBs analyses, patients with COVID-19 who received T-AC treatment had a significantly higher relative risk of the major bleeding event than those with P-AC treatment in COVID-19 patients (RCTs: RR 1.76, 95% CI, 1.19–2.62, P = 0.005; OBs: RR 2.39, 95% CI, 1.56–3.68, P < 0.0001). Compared with P-AC treatment in COVID-19 patients, patients with T-AC treatment significantly reduced the incidence of venous thromboembolism (RR 0.51, 95% CI, 0.39–0.67, P<0.00001), but it is not associated with arterial thrombosis events (RR 0.97, 95% CI, 0.66–1.42, P = 0.87). The subgroup analysis of OBs shows that the mortality risk significantly reduces in critically ill COVID-19 patients treated with T-AC compared with those with P-AC treatment (RR 0.58, 95% CI, 0.39–0.86, P = 0.007), while the mortality risk significantly increases in non-critically ill COVID-19 patients treated with T-AC (RR 1.56, 95% CI, 1.34–1.80, P < 0.00001). In addition, T-AC treatment does not reduce the risk of mortality in COVID-19 patients with high d-dimer levels in RCTs. Finally, the overall sensitivity analysis after excluding two RCTs studies remains consistent with the previous results.ConclusionsIn our integrated analysis of included RCTs and OBs, there is no significant difference between the mortality of T-AC and P-AC treatment in unselected patients with COVID-19. T-AC treatment in COVID-19 patients significantly reduced the incidence of venous thromboembolism but showed a higher risk of bleeding than those with P-AC treatment. In addition, P-AC treatment was superior to T-AC treatment in non-critically ill COVID-19 patients, the evidence supporting the necessity for T-AC treatment in critically ill COVID-19 patients came only from OBs.Trial registrationProtocol registration: The protocol was registered at PROSPERO (CRD42021293294).Graphical abstract

The effect of endotracheal administration of N-acetyl cysteine and heparin on the level of secretion and partial thromboplastin time in acute respiratory distress syndrome patients under mechanical ventilation: A randomized clinical trial study

Background and aims: Acute respiratory distress syndrome (ARDS) treatment is supportive, and there is no currently approved treatment for it. This study, therefore, aimed to investigate the effect of endotracheal administration of N-acetyl cysteine (NAC) and heparin on the level of secretion and partial thromboplastin time (PTT) in ARDS patients under mechanical ventilation. Methods: In this clinical trial study, 70 patients aged over 18 years (30 women and 40 men) admitted to the intensive care unit were randomly selected following the allocation rule and then divided into two groups (intervention and control). In addition to the routine and available treatments in the ward given to the patients in both groups, the control group also received 10 mL of normal saline every six hours through the endotracheal route, while the intervention group received 500 units of heparin plus 200 mg of NAC dissolved in 10 mL of normal saline every six hours through the same administration route. Results: The mean and standard deviation levels of PTT in the control and intervention groups were 30.3743 ± 7.78008 and 32.2286 ± 8.31047, respectively, with no significant difference (P&gt;0.05); the volume of secretion on days 1-3 was not significantly different between the two groups, but the difference was statistically significant from day 4 onwards (P&lt;0.05). Conclusion: Taking the combination of NAC and heparin through the endotracheal route was effective in reducing pulmonary secretion, and may have been considered a considerable positive step in providing patients suffering from acute respiratory failure and under mechanical ventilation with supportive care. However, it is recommended that further clinical studies be conducted before arriving at any definitive conclusion.

Levofloxacin versus ceftriaxone and azithromycin for treating community-acquired pneumonia: a randomized clinical trial study.

We compared two common antibiotic regimens for the treatment of mild to moderate CAP: levofloxacin versus β-lactam and macrolide combination; in terms of their efficacy and side effects. Patients with mild to moderate CAP were randomized into two groups. Group I received a combination of 1 gram ceftriaxone daily and 500 mg azithromycin daily for 5-7 days. Group II received levofloxacin 750 mg daily for five days. The signs and symptoms, hospitalization length, and the side effects were investigated. There were 77 and 74 patients in groups I and II. The vital signs of group II were significantly better on the 3rd day of admission, except for the temperature (P=0.09). The O2 saturation of group II was markedly improved on the 5th day of admission (P=0.0061). In terms of clinical symptoms and hospitalization length, group II was considerably better. However, the rate of side effects in both groups was similar (P=0.885). Hospitalized patients with mild to moderate CAP might take more advantage of fluoroquinolone administration. It could improve the patients' signs and symptoms and reduce hospitalization length, compared with the combination of macrolide and cephalosporin, with the same rate of side effects.

The effect of remifentanil on hemodynamic response to laryngeal mask airway insertion in induction of anesthesia with propofol fentanyl or propofol ketamine in cataract surgery

Background. Induction of general anesthesia may cause hemodynamic instability. Remifentanil is often prescribed to suppress the hemodynamic response to anesthesia. The aim of this study was to investigate the effect of remifentanil on hemodynamic response to induction of anesthesia with propofol fentanyl or propofol ketamine and laryngeal mask airway (LMA) insertion. Methods. This double-blind randomized clinical trial study was performed on 44 candidates for cataract surgery in Feyz Hospital, Isfahan, Iran from March to June 2020. Patients were randomly assigned into two groups using random allocation software. The first group received 1 mcg/kg fentanyl and the second group received 0.5 mg/kg ketamine. Also, both groups received 1 mg/kg propofol and 0.5 mcg/kg remifentanil intravenously. Hemodynamic parameters were measured and recorded at study times, and the results were analyzed statistically. Results. The mean age (P=0.199), weight (P=0.050), height (P=0.9), and frequency distribution of gender (0.763) and American Society of Anesthesiologists (ASA) score (0.069) were not significantly different between the two groups. Systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) in fentanyl group were significantly lower than the ketamine group immediately before LMA insertion, as well as 1, 3, and 5 minutes after LMA insertion (P &lt;0.050). In addition, the mean heart rate (HR) in the fentanyl group decreased significantly at different time (P&lt;0.001), but no significant difference was observed in ketamine group (P=0.056). In addition, the mean HR did not differ significantly between the two groups in any of the follow-up times (P&gt;0.050). Conclusion. Intravenous administration of remifentanil in induction of anesthesia with propofol-ketamine and propofol-fentanyl reduced changes in hemodynamic responses to LMA insertion. This hemodynamic stability was increased by adding remifentanil to the propofol-ketamine combination. Practical Implications. Remifentanil is associated with weakening of hemodynamic responses to LMA insertion in induction of anesthesia with propofol and ketamine or propofol and fentanyl; this effect can be associated with safety in cardiac patients.

Effect of Telenursing on Caregiver Burden of Care and Incidence of some Complications in Patients with Acute Stroke Discharged from Neurological Wards: A Randomized Control Trial

Background: Brain stroke is the main cause of death and disability worldwide. This disease can cause major complications in patients and place a great burden of care on caregivers. Therefore, this study was conducted to determine the effect of telenursing on the burden of care in caregivers and the rate of complications in patients with acute brain stroke discharged from neurological wards. Methods: This two-arm parallel-group single-blind randomized clinical trial study was carried out on 72 patients with acute brain stroke discharged from neurological wards in Qom, Iran, in 2019. The patients and their caregivers were divided to control and intervention groups using random block allocation. In addition to the usual training of the ward, the intervention group received training and counseling based on their needs through phone calls for 4 weeks. However, the control group received only the usual ward training. Immediately after discharge from the hospital and 1 month later, the average care load in caregivers and urinary problems, bedsores, and the number of falls in patients were measured. A demographic questionnaire, Caregiver Burden Inventory, Braden Scale, Morse Scale, and a urinary problem checklist were used for data collection. The data were analyzed using the chi-square test, Mann-Whitney U test, independent t-test, and paired t-test by SPSS software (version 24). Results: After the intervention, the mean scores of the caregiver’s burden of care in the control and counseling groups were 35.22 ± 17.215 and 8.00 ± 7.556, respectively (P &lt; 0.001). In addition, the counseling group experienced remarkably fewer urinary problems (P &lt; 0.001) and falling (P = 0.011). Conclusions: This study showed that telenursing reduced the burden of care in caregivers and decreased urinary tract infections and the number of falls in patients with acute stroke. Therefore, nurses and healthcare providers can use this program to improve the lifestyle of patients with acute brain stroke and their caregivers.

Analgesic Characteristics of Bupivacaine Alone and in Combination with Dexmedetomidine or Meperidine in Spinal Anesthesia during Cesarean Section: A Double-Blind Randomized Clinical Trial Study.

Background Comparing bupivacaine's adjuvants in spinal anesthesia, we assessed the specific blocking characteristics and adverse effects of bupivacaine alone and in combination with dexmedetomidine or meperidine in spinal anesthesia during cesarean section. Methods In this double-blind randomized clinical trial study, ninety pregnant women were divided into groups to receive 10 mg bupivacaine (group B), 10 mg bupivacaine with 5 μg dexmedetomidine (group BD), or 10 mg bupivacaine with 10 mg meperidine (group BM) intrathecal. Patients were assessed for the quality of analgesia during operations. Durations of sensory and motor blocks and anesthesia-related complications were analyzed using SPSS 21, and p values <0.05 were considered statistically significant. Results The onset of sensory and motor blocks was essentially the same in all treated groups. Block regression time was significantly prolonged in the BD group compared to the B and BM groups (p < 0.001). The duration of analgesia was significantly longer in the BD and BM groups than in the B group (p < 0.001). The level of sedation in the BD group was higher than in the B group. Shivering occurred in 40% of patients in the B group, which was significantly more than that of the BD (16.6%) and BM (33.3%) groups. Itching happened in 33.3% of women in the BM group which was statistically more than that of the B (3.33%) and BD (0) groups. The incidence of adverse effects was the same in all groups. Conclusion The combination of bupivacaine with dexmedetomidine significantly prolonged sensory and motor regression time and duration of analgesia.

Co-treatment of gonadotropin and letrozole in infertile women with endometriosis: A doubleblind randomized clinical trial

BackgroundThe common causes of infertility in women with endometriosis are folliculogenesis alternation, steroidogenesis and fertilization impairment, oocyte and embryo quality reduction, and implantation defect.ObjectiveTo compare in vitro fertilization (IVF) cycle success rates of women with endometriosis who were treated with letrozole + gonadotropin (LA) vs. placebo + gonadotropin (PA).Materials and MethodsThis double-blind, randomized clinical trial study was conducted with 94 infertile women with endometriosis (47 in the LA group and 47 in the PA group) who were candidates for IVF, from April-June 2021. For all participants, the long agonist protocol was applied. In both groups, gonadotropin-releasing hormone agonist was prescribed in the mid-luteal stage and from the third day of the cycle, and gonadotropin was started and its doses were regulated based on the patient's age, serum anti-Mullerian hormone and follicle-stimulating hormone. From the third day of the menstrual cycle, 5 mg of letrozole daily for 5 days was prescribed for the LA group, while the placebo was prescribed for the PA group on the identical days and duration. After embryo transfer, biochemical and clinical pregnancy were measured in the 2 groups.ResultsThe gonadotropin dosage (p 0.01) and estradiol level (p = 0.02) on the human chorionic gonadotropin administration day were significantly lower in the LA group compared with in the PA group. Fetus transfer was done for 32 women. No significant differences were detected between the study groups regarding biochemical or clinical pregnancy (p = 0.72 for both).ConclusionLetrozole as a co-treatment drug in the IVF cycle of women with endometriosis can significantly reduce the gonadotropin dosage and estradiol level with the same pregnancy rates.

Effect of Polycitra-K and Bicitra in the Treatment of Pediatric Nephrolithiasis: A Double-Blind Randomized Trial.

Background: Urolithiasis is a common, sever, painful, and costly disease with a high probability of relapse. This study was performed to compare the effect of Polycitra-K containing potassium citrate and Bicitra containing sodium citrate in the treatment of kidney stones in children who referred to Hazrat Masoumeh hospital in Qom. Methods: This double-blind randomized clinical trial study was carried out on 176 patients aged between 5 and 18 years old with kidney stones, hypocitraturia, and negative urine who referred to Hazrat Masoumeh hospital in Qom (Iran). Patients were divided into 2 groups of treatment (a dose of 1 mL/kg or 1-1.5 mg/ kg Polycitra-K) and control (Bicitra in the same dose). The results of kidney ureter bladder X ray (KUB ) was followed and the 2 groups were compared. The chi-square test or the Fisher exact test was used to analyze qualitative values in the treated groups. Results: Regarding bladder stones, there was a significant difference between the 2 treatment groups (p = 0.025), in which16 patients (18.2%) in the Polycitrat-K group and 29 patients (33%) in the Bicitra group had bladder stones. With respect to stone passage, 58 patients (65.9%) in the Polycitra-K group and 36 patients (40.9%) in the Bicitra group were recorded. Conclusion: Oral Polycitrat-K is an effective preferential supplement against kidney stones in children due to urine alkalization, but the results of our study showed that both Polycitrat-K and Bicitra drugs have similar effects as therapeutic agents. Registration code in the Iranian Registry of Clinical Trials: IRCT20190619043945N1

Effect of Low-Level Laser Therapy on Trismus, Facial Swelling, and Pain Following Surgical Extraction of Impacted Lower Third Molars

Background: Light amplification by the stimulated emission of radiation (laser) is currently used as a therapy method for decreasing inflammation followed by oral surgeries. Therefore, the present study aimed at evaluating the effect of using diode low-power laser irradiation (photobiomodulation) on the amount of pain, swelling, and trismus due to latent mandibular third molar surgery (surgical removal of latent mandibular third molars). Methods: In this double-blind randomized clinical trial study, 16 individuals with latent mandibular third molars with an identical condition were selected. The teeth were randomly assigned to two groups of laser irradiated intervention group and a non-irradiated control group. A 940 nm diode laser with an output power of 200 mW and an energy density of 12 J/cm2 was applied for 60 seconds at a distance of 1 cm three intraoral points and an extraoral point. The distance between incisal edges of upper and lower central teeth, the horizontal distance between corners of lips and auricle (LE), the vertical distance between the outer canthus of the eye and the mandibular angle (EA), and pain visual analogue scale were measured before surgery and two and seven days after surgery. Results: There was no statistically significant difference between the two groups regarding EA and LE before intervention and on days 2 and 7 after intervention (P&gt;0.05). However, the pain score was significantly higher before intervention (3.31±0.7 vs. 2.38±0.8, P=0.001) and on day 2 after intervention (6.5±1.32 vs. 4.5±0.97, P&lt;0.001) in the control group. On day 7, a higher maximum jaw opening (MJO) was observed in the intervention group (40.68±5.76 vs. 36.81±4.35, P=0.04). Conclusions: Adjunctive diode laser photobiomodulation after third molar surgery was associated with a significant reduction in pain and trismus.

Changing trends in clinical research literature on PubMed database from 1991 to 2020

BackgroundClinical research publications have become the dominant source and basis of clinical evidence-based decision-making. Exploring the type and quantity of clinical research publications in the PubMed database is useful for clarifying the changing trends of clinical research development in recent years. Therefore, a longitudinal analysis of the type and quantity of clinical research publications in the PubMed database over three decades was conducted.MethodsThe PubMed database was searched to retrieve clinical research according to the type and year of publication from January 1, 1991 to December 31, 2020. The research types were classified as primary and secondary literature.ResultsA total of 1,078,404 primary literatures were retrieved and the constituent proportions were ranked from high to low as case report/series (27.54%), randomized clinical trials (RCTs) (23.62%), cohort studies (21.05%), cross-sectional studies (17.49%), case control studies (9.15%), non-RCTs (1.01%), and pragmatic clinical trials (PCTs) (0.15%). Correspondingly, 1,302,173 secondary literatures were retrieved and ranked as narrative review (70.88%), systematic review (15.02%), systematic review and meta-analyses (13.89%), traditional meta-analyses (4.48%), expert consensus (2.31%), guidelines (1.49%), scoping reviews (0.68%), net meta-analyses (0.40%), and umbrella reviews (0.04%). The average annual growth rate for the primary literature was 10.28%, and ranked from high to low as PCTs (83.68%), cohort studies (17.74%), cross-sectional studies (17.61%), non-RCTs (12.11%), case control studies (8.86%), RCTs (7.68%), case report/series (7.51%); while that for the secondary literature was 10.57%, and ranked from high to low as net meta-analyses (48.97%), umbrella reviews (47.09%), scoping reviews (41.92%), systematic reviews and meta-analyses (33.44%), systematic reviews (33.05%), traditional meta-analyses (12.49%), expert consensuses (9.22%), narrative review (8.72%), and guidelines (2.82%). ConclusionBoth the composition and number of clinical studies changed significantly from 1991 to 2020. Based on the trend, the case report/series, case control study, and narrative review are on the decline, while cohort study, cross-sectional study, systematic reviews, and systematic review and meta-analysis literature have increased. To improve the quality of clinical evidence, we recommend RCT and cohort study give priority to access to allocated research resources in future.

The effect of a planned lactation education program on the mother’s breastfeeding practice and weight gain in low birth weight infants: a randomized clinical trial study

BackgroundLow birth weight (LBW) infants are more prone to possible growth disorders, and their mothers need more specific education sessions regarding breastfeeding practice. This study aimed to investigate the effect of a planned lactation education program on the mother’s breastfeeding practice and weight gain in LBW infants.MethodsA randomized clinical trial study was conducted on 80 mother-LBW infant dyads admitted to a gynecology and obstetrics hospital. The participants were selected randomly and divided into an experimental group and a control group, each with 40 mothers. Information on LBW infants’ weight and the mothers’ breastfeeding practice was collected using a questionnaire at birth. Then, a planned lactation education program was implemented in the experimental group in two sessions in the hospital and three 20-minute sessions in comprehensive health centers. Finally, the weight of 14–15 day-old and two-month-old LBW infants and the mothers’ breastfeeding practice for 14–15 day-old LBW infants in the two groups were recollected and analyzed using SPSS software version 16.ResultsComparing the LBW infants’ weights and mothers’ breastfeeding practice revealed no statistically significant difference between the two groups pre-intervention. However, significant differences were observed between the two groups post-intervention in terms of weight gain in the LBW infants over 14–15 days and two months of age (F = 4720.6, p < 0.001) and the mothers’ breastfeeding practice for 14-15-day-old infants (p < 0.001).ConclusionsGiven the positive impact of lactation education on the mother’s breastfeeding practice and LBW infants’ weight, planned lactation education courses should be applied for LBW infants’ mothers.Trial registrationThis study was retrospectively registered in the Clinical Trial Registration Center of Iran, with the code: IRCT20120215009014N421 on 14/04/2022.

Assessment of Cortisol Hormonal Level and Relation With Age in Infertile Women With ICSI Outcome

In human-assisted reproduction both partners need to be evaluated during counseling because causes of infertility are due to male factors and female factors. some body hormones play important role in fertile women and cortisol one of these hormones which is essential for normal ovulation, cortisol usually increases during the follicular phase of the menstrual cycle, play a role in the early stages of follicular development by their interaction with aromatase activity and granulose cell functions. To investigate the correlation of cortisol hormonal level in serum and in follicular fluid that relationship with age in women under Intracytoplasmic sperm injection outcome. Its randomized prospective clinical trial study performance conducting in the Higher Institute for Infertility Diagnosis and Assisted Reproductive Technologies / AlNahrain University, Baghdad-Iraq, during the period from November2021to June 2022. a total of Sixty-three Infertile Iraqi women, who planned to inter intrasytoplasmic sperm injection program. The blood sample and follicular fluid sample obtained from all infertile women inter intracytoplasmic sperm injection program to measure cortisol hormonal level at specific days of this study. There was increase in cortisol level in women aged between (30-40) years, So there was significant finding between cortisol level and this age group and there was increase in cortisol level in women aged &lt; 30 years at the same day and no significant difference in cortisol level in women age more than 40. Significant differences in cortisol level appear in group of women age between (30-40) years, also the same result appears in group of women age more than &gt; 40 years and no significant differences in cortisol level in women aged &lt; 30. No significant differences in cortisol level in all age women group (30-40) years, &lt;30 years ,and the women age &gt; 40 years

EFFICACY OF 4% ARTICAINE BUCCAL INFILTRATION VERSUS INFERIOR ALVEOLAR NERVE BLOCK FOR MANDIBULAR MOLARS WITH SYMPTOMATIC IRREVERSIBLE PULPITIS: A SYSTEMATIC REVIEW AND META-ANALYSIS.

To compare the anesthetic efficacy of buccal infiltration (BI) using 4% articaine vs 4% articaine or 2% lidocaine inferior alveolar nerve block (IANB) for mandibular molars with symptomatic irreversible pulpitis. PubMed, Cochrane, Web of Science, Scopus, and ClinicalTrials.gov were searched using MESH terms and specific keywords. Included articles were Randomized Clinical Trials (RCTs), which compared 4% articaine BI vs conventional IANB in terms of the efficacy of pulpal anesthesia and success rate. The quality assessment of included studies was done according to the Cochrane risk of bias assessment tool. Studies were quantitatively assessed using fixed or random effect models. Out of 756 articles, 5 RCT studies were included with a total number of 500 patients: 231 in 4% articaine BI group, 150 in 2% lidocaine IANB group, and 119 in 4% articaine IANB group. Our meta-analysis results showed that patients anesthetized with 4% articaine BI had a similar success rate compared to 2% lidocaine IANB [pooled RD: 0.14 (95% CI, -0.01 to 0.29); P = .08]. Similarly, there was non-significant difference when compared to 4% articaine IANB [RD:-0.01 (95% CI, -0.13 to 0.11; P = .86)]. Patients anesthetized with 4% articaine BI presented comparable pain scores compared to IANB (4% articaine or 2% lidocaine) [pooled MD: -0.14 (95% CI, -0.38 to 0.11); P = .27]. Regarding quality assessment, 3 studies were considered to have a low risk of bias, one study has an unclear risk of bias, and one study has a high risk of bias. 4% articaine BI showed comparable results in terms of pain relief and success rate in comparison with 2% lidocaine IANB or 4% articaine IANB. However, due to the limited number and small sample size of included studies, these findings should be considered carefully, and further studies are required to confirm our findings.

The effects of botulinum toxin A injection on the lateral pterygoid muscle in patients with a painful temporomandibular joint click: a randomized clinical trial study

BackgroundTemporomandibular disorder (TMD) is the main cause of non-dental pain in orofacial area. The most common symptoms of TMD are joint pain, joint sound and limitation of jaw function. Botulinum toxin (BTX) injection is considered a potential treatment for TMD due to its pain-relieving properties and its ability to reduce muscle activity. Most of the studies are case series and further investigations are required to prove the efficacy of this treatment modality. Thus, in this study, we aimed to investigate the effect of BTX-A injection on the lateral pterygoid (LP) muscle and to evaluate its efficacy regarding TMD.Materials and methodsThirty-eight patients (19 women and 19 men; mean age of 26.53 years) with painful unilateral temporomandibular joint click and LP muscle tenderness were enrolled in this study. They were divided into two groups; one received an extraoral BTX-A injection in the LP muscle, and the other received a placebo injection. Pain severity, jaw movements, click severity, and Helkimo index were recorded at the first visit, as well as one week, one month, and three months after the intervention. Data were analyzed using repeated-measures analysis of variance and t-tests.ResultsThe results showed that click severity was not significantly different between the BTX-A and placebo groups (P = 0.07). Pain and Helkimo index decreased significantly in the BTX group (P = 0.00 and P = 0.006, respectively); however, there was no significant difference between the two groups (P = 0.22 and P = 1, respectively). There was a significant difference in lateral movements between the groups (P = 0.00) but not in protrusive movement (P = 0.095).ConclusionsIt can be concluded that although some studies have stated that BTX injection can make the click sound disappear, in this study, we did not find a significant difference between the two groups. Furthermore, our results showed that click and pain severity decreased, but the difference was not statistically significant. Therefore, further studies with a higher dosage of BTX and more participants are recommended.Trial registration The local Ethics Committee of Shiraz University of Medical Sciences approved this research (IR.SUMS.REC. 01/10/2018 and IRCT20130521013406N3).