scholarly journals Comparison of Efficacy and Side Effects of Azithromycin and Co-Amoxiclav in the Treatment of Acute Sinusitis in Adults: A Randomized Clinical Trial

2016 ◽  
Vol 8 (11) ◽  
pp. 178
Author(s):  
Soroush Amani ◽  
Ali Mohammadi-Najafabadi ◽  
Ali Ahmadi
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Repeated Measures ◽  
Acute Sinusitis ◽  
Chi Square ◽  
Significant Difference ◽  
Group 2 ◽  
Double Blinded ◽  
Minor Criteria

<p><strong>BACKGROUND:</strong> Regarding high prevalence of common cold and sinusitis in Chaharmahal and Bakhtiari Province and the lack of studies on patients referring hospitals in this province, this study was conducted to determine and compare the efficacy and side effects of azithromycin and co-amoxiclav.<strong></strong></p><p><strong>METHODS:</strong> This study was a double-blinded randomized clinical trial. The study population of this clinical trial was consisted of 90 patients with acute sinusitis aged 12-65 years. At least two major criteria or one major criterion and two minor criteria with duration of at least 7 days and at most 28 days, were some of the sinusitis diagnostic criteria for inclusion of the patients into the study. The patients were examined for symptoms prior to and twice after the treatment. The treatment was administration with <strong>500 mg</strong> azithromycin tablet per day for three days in group 1 (G1) and <strong>625 mg</strong> co-amoxiclav tablet every <strong>8 h</strong> for 10 days in group 2 (G2). The data were analyzed by repeated measures analysis of variance, independent t-test, and chi-square in Stata software and P &lt; 0.05 was considered significant.<strong></strong></p><p><strong>RESULTS: </strong>Mean±Standard deviation age of all patients was 32.14±9.91 years. Out of 90 participants in the study, 50 (55.56%) were male and the rest were female. The patients’ symptoms were quantitatively similar in the two groups (22.3±2 and 22.2±1.9 in G1 and G2, respectively) prior to the intervention. The score at second examination decreased to 3.7±2.1 in G1 and to 9.4±2.7 in G2, significantly different from that prior to intervention and between the two groups (P&lt;0.001). Although the score decreased in the two groups at third examination, it was not significant in the two groups (P=0.652). The cure rate in azithromycin group was derived 87.5% and 88%, and in co-amoxiclav group 32.4% and 83.3% at the days 5 and 10 of treatment, respectively. The most prevalent side effects in the two groups were diarrhea and nausea. The prevalence of diarrhea was obtained 21% and 33% in G1 and G2, respectively. </p><strong>CONCLUSION: </strong>No significant difference in side effects was seen between the two groups. Although the cure was faster in the patients treated with azithromycin than those treated with co-amoxiclav, co-amoxiclav is still considered as adequately working against acute sinusitis bacterial pathogens. In view of this efficacy, co-amoxiclav seems to lead to no drug resistance and could be used to treat the patient

scholarly journals Comparing the efficacy and safety of Dexmedetomidine/Ketamine with Propofol/Fentanyl for sedation in colonoscopy patients: A double-blinded randomized clinical trial

2021 ◽  
Vol 20 ◽  
Author(s):  
Reza Aminnejad ◽  
Ahmad Hormati ◽  
Hamed Shafiee ◽  
Faezeh Alemi ◽  
Maryam Hormati ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Score ◽  
Randomized Clinical Trial ◽  
Repeated Measures ◽  
Vital Signs ◽  
P Value ◽  
Chi Square ◽  
Ramsay Sedation Scale ◽  
Repeated Measures Analysis ◽  
Double Blinded

Background: In this double-blinded randomized clinical trial, we aimed to compare the safety and efficacy of a combination of dexmedetomidine and ketamine [DK] with propofol and fentanyl [PF] for sedation in colonoscopy patients. Methods: In this study, 64 patients who underwent colonoscopy were randomized into two groups: 1) A, which received PF, and 2) B, which received DK for sedation. Among 64 patients, 31 patients were included in PF, and 33 patients were included in the DK group. Both groups were similar in terms of demographics. Patients’ sedation score (based on Ramsay sedation scale) and vital signs were recorded at 2, 5, 10, and 15 minutes. Complications including apnea, hypotension, hypoxia, nausea, and vomiting, along with gastroenterologist satisfaction and patients’ pain score (based on Wong-Baker faces pain assessment scale), were recorded by a checklist. Data were analyzed by SPSS v.18 software, using chi-square, independent t-tests, and repeated measures analysis with p<0.05 as the criterion for significant differences. Results: The mean score of sedation was 4.82±0.49 in the DK group and 5.22±0.45 in the PF group [p value=0.001]. Serious complications, including hypotension [p value=0.005] and apnea [p value=0.10] were significantly higher in the PF group. Satisfaction of gastroenterologist [p value= 0.400] and patients’ pain score [p value = 0.900] were similar among groups. Conclusion: Combination of DK provides sufficient sedation with fewer complications in comparison with PF in colonoscopy patients.

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

scholarly journals Coadministration of ibuprofen/caffeine on bleaching-induced tooth sensitivity: A randomized clinical trial

2021 ◽  
Vol 32 (3) ◽  
pp. 105-115
Author(s):  
Karine Letícia da Silva ◽  
Elisama Sutil ◽  
Diego Hortkoff ◽  
Renata Maria Oleniki Terra ◽  
Márcia Rezende ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Repeated Measures ◽  
Rating Scale ◽  
Absolute Risk ◽  
Tooth Sensitivity ◽  
Dental Bleaching ◽  
Significance Level ◽  
Significant Difference ◽  
The Absolute

Abstract This clinical trial evaluated the effect of the coadministration of ibuprofen/caffeine on bleaching-induced tooth sensitivity (TS). A triple-blind, parallel-design, randomized clinical trial was conducted on 84 patients who received ibuprofen/caffeine or placebo capsules. The drugs were administered for 48 hours, starting 1 hour before the in-office bleaching. Two bleaching sessions were performed with 35% hydrogen peroxide gel with 1-week interval. TS was recorded up to 48 hours after dental bleaching with a 0-10 visual analogic scale (VAS) and a 5-point numeric rating scale (NRS). The color was evaluated with VITA Classical and VITA Bleachedguide scales (ΔSGU) and VITA Easyshade spectrophotometer (ΔE*ab and ΔE00). The absolute risk of TS in both groups was evaluated using Fischer's exact test. Comparisons of the TS intensity (NRS and VAS data) were performed by using the Mann-Whitney test and a two-way repeated measures ANOVA, respectively. The color alteration between the groups was compared with the Student's t test. The significance level was 5%. There was no statistically significant difference between the groups for the absolute risk of TS (p = 1.00) or for the intensity of TS (p > 0.05). A bleaching of approximately 7 shade guide units was observed on the Vita Classical and Vita Bleachedguide scales, with no statistical difference between the groups. It was concluded that coadministration of ibuprofen and caffeine did not reduce the absolute risk or intensity of TS and did not interfere with the efficacy of dental bleaching.

scholarly journals A comparative study on the effect of calcitriol and cinacalcet on hyperparathyroidism in hemodialysis patients; a double-blinded randomized clinical trial

2021 ◽  
Vol 11 (1) ◽  
pp. e12-e12
Author(s):  
Saeed Mardani ◽  
Faranak Sadat Filsouf
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Hemodialysis Patients ◽  
Significant Difference ◽  
Before And After ◽  
Calcium Phosphorus ◽  
Stage Renal Disease ◽  
Double Blinded ◽  
End Stage ◽  
Calcium And Phosphate Metabolism

Introduction:Chronic kidney disease (CKD) has lots of complication like calcium and phosphate metabolism disorders, hyperparathyroidism, vitamin D deficiency and metabolic acidosis. Objectives: The aim of this study was to determine and compare the effect of calcitriol and cinacalcet on hyperparathyroidism in hemodialysis patients due to end-stage renal disease (ESRD). Patients and Methods: This study was a double-blinded randomized clinical trial, which was conducted on 60 hemodialysis patients in 2017-2018. The patients were randomly assigned to two groups of 30 patients, which one group was treated with cinacalcet and the other group was treated with calcitriol. During this study, phosphorus, calcium and iPTH were measured. Results: The results showed that in the group treated with cinacalcet, the amount of calcium [t(22)=0.294, P>0.05] and the amount of phosphorus [t(22)=1.87, P>0.05] did not change significantly while iPTH values before and after the study had statistically significant difference [t(22)=4.37, P<0.05]. In group treated with calcitriol, the calcium, phosphorus and iPTH values did not change significantly (P>0.05). Calcium changes in the cinacalcet group compared to the calcitriol group [t (47) =-1.14, P>0.05] and also, the amount of phosphorus changes [t (47) =-1.022, P>0.05] was not statistically significant. The iPTH changes were not statistically significant between the two groups however iPTH in the calcitriol group was higher than the cinacalcet group [t (47) =-1.13, P>0.05]. Conclusion: In contrast to calcitriol, cinacalcet significantly reduced iPTH and did not significantly change calcium and phosphorus levels. Trial Registration: The trial was registered by Iranian Registry of Clinical Trials (IRCT) (identifier: IRCT20190702044076N1; https://en.irct.ir/trial/40547, Ethical code# IR.SKUMS.REC.1397.026).

scholarly journals Efficacy of Lignocaine in Gel and Spray form during Buccal Infiltration Anesthesia in Children: A Randomized Clinical Trial

2014 ◽  
Vol 15 (6) ◽  
pp. 750-754 ◽  
Author(s):  
Anshul Sharma ◽  
BS Suprabha
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Permanent Teeth ◽  
Chi Square ◽  
Topical Anesthetic ◽  
Significant Difference ◽  
Spray Form ◽  
Buccal Infiltration ◽  
Infiltration Anesthesia

ABSTRACT Aim To compare the efficacy of 15% lignocaine spray and 8% lignocaine gel as a topical anesthetic, in reducing pain, during buccal infiltration in children. Materials and methods Forty-two patients aged between 7 and 12 years requiring restorative procedures/extraction/pulp therapy of primary/ permanent teeth in the maxillary arch, under buccal infiltration anesthesia were selected for the study. The participants were randomly allocated into 2 groups of 21 each. In group A, 8% lignocaine gel and in group B, 15% lignocaine spray was applied prior to buccal infiltration. Pain was assessed using Wong-Baker faces pain rating scale (WBFPRS) and faces legs activity cry and consolability (FLACC) painscale. Results Pearson's chi-square test revealed that there was no significant difference in the FLACC scores of the two groups (p = 0.54). Independent t-test demonstrated that there was no significant difference in Wong-Bakers faces pain score between the two agents (p = 0.07). Conclusion There is no significant difference in the efficacy of 15% lignocaine spray and 8% lignocaine gel as a topical anesthetic in controlling pain during buccal infiltration anesthesia, in children. How to cite this article Sharma A, Suprabha BS, Shenoy R, Rao A. Efficacy of Lignocaine in Gel and Spray form during Buccal Infiltration Anesthesia in Children: A Randomized Clinical Trial. J Contemp Dent Pract 2014;15(6):750-754.

Comparing the Effects of Epley Maneuver and Cinnarizine on Benign Positional Paroxysmal Vertigo: A Randomized Clinical Trial

2019 ◽  
Vol 8 ◽  
pp. 866
Author(s):  
Masoumeh Saeedi ◽  
Mohammad Hossein Khosravi ◽  
Mohammad Ehsan Bayatpoor
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Analogue Scale ◽  
Treatment Method ◽  
Significant Difference ◽  
Epley Maneuver ◽  
Benign Positional Paroxysmal Vertigo ◽  
The Mean ◽  
Repositioning Maneuver

Background: The fastest and safest treatment method of BPPV is repositioning maneuvers. In Iran, these methods are not widely used, and many physicians use medical therapy, despite their side effects, for management of BPPV. Materials and Methods: In this randomized clinical trial patients with BPPV were randomly allocated to Epley repositioning maneuver or Cinnarizine (25mg every 8 hours) for two weeks. The patients were evaluated for symptoms using visual analogue scale (VAS) scoring system before the intervention, first and second weeks after intervention. In the second and third visitd, the results of the hallpike test were recorded for both groups. Results: 43 patients with a mean age of 46.88±11.08 years in two Epley and Cinnarizine group underwent analysis. The mean VAS score for improvement of symptoms after the intervention was 1.66±1.06 in Epley and 1.50±0.91 in Cinnarizine group (P=0.57). Conclusion: we found that there is no significant difference between Epley maneuver and Cinnarizine for treatment and controlling symptoms of BPPV. [GMJ.2019;Inpress:e866]

scholarly journals The degree of color change, rebound effect and sensitivity of bleached teeth associated with at-home and power bleaching techniques: A randomized clinical trial

2013 ◽  
Vol 07 (04) ◽  
pp. 405-411 ◽  
Author(s):  
Fatemeh Velayati Moghadam ◽  
Sara Majidinia ◽  
Joseph Chasteen ◽  
Marjaneh Ghavamnasiri
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Color Change ◽  
Rebound Effect ◽  
Color Difference ◽  
Chi Square ◽  
Tooth Color ◽  
Anterior Teeth ◽  
Significant Difference ◽  
At Home

ABSTRACT Aim: The purpose of the present randomized clinical trial was to evaluate the color change, rebound effect and sensitivity of at-home bleaching with 15% carbamide peroxide and power bleaching using 38% hydrogen peroxide. Materials and Methods: For bleaching techniques, 20 subjects were randomized in a split mouth design (at-home and power bleaching): In maxillary and mandibular anterior teeth (n = 20). Color was recorded before bleaching, immediately after bleaching, at 2 weeks, 1, 3 and 6 month intervals. Tooth sensitivity was recorded using the visual analog scale. The Mann-Whitney test was used to compare both groups regarding bleaching effectiveness (∆E 1 ), rebound effect (∆E 2 ) and color difference between the rebounded tooth color and unbleached teeth (∆E 3) while the Wilcoxon compared ∆E within each group. Distribution of sensitivity was evaluated using the Chi-square test (α =0.05). Results: There was no significant difference between groups regarding ∆E 1 and ∆E 3 (P > 0.05). Even though, ∆E 2 showed no significant difference between groups after bleaching as well as at 2 week, 1 month and 3 month follow-up periods (P > 0.05). Although, significant difference was found in ∆E 2 (P < 0.05 Mann-Whitney) between two methods after 6 months and a high degree of rebound effect was obtained with power bleaching. Within each group, there was no significant difference between ∆E 1 and ∆E 3 (P < 0.05 Wilcoxon). The distribution of sensitivity was identical with both techniques (P > 0.05).Conclusion: Bleaching techniques resulted in identical tooth whitening and post-operative sensitivity using both techniques, but faster color regression was found with power bleaching even though color regression to the baseline of the teeth in both groups was the same after 6 months.

scholarly journals Efficacy of midazolam administration to control blood pressure in patients diagnosed with ‘Hypertensive crisis’: a Randomized Clinical Trial

2020 ◽  
Author(s):  
Mohammad Reza Khorsand ◽  
Mostafa Enayatrad ◽  
Seyed Meysam Yekesadat ◽  
Maryam Khodayar ◽  
Amir Noyani
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Systolic Blood Pressure ◽  
Diastolic Blood Pressure ◽  
Hypertensive Crisis ◽  
Repeated Measure ◽  
Chi Square ◽  
Significant Difference ◽  
Before And After ◽  
Double Blinded

Abstract Introduction: Hypertensive crisis defines as a sudden rise in blood pressure that can adversely affect the vital organs. As such, it is recommended to take midazolam to lower the blood pressure in patients of hypertensive crisis. This study aims to investigate the midazolam efficacy as an emergency care to control the blood pressure in patients diagnosed with hypertensive crisis. Methods The current paper represents a double-blinded clinical trial study that examines the patients of the hypertensive crisis who referred to Imam Hossein Hospital of Shahroud, 2018. Patients with systolic/diastolic blood pressure greater than 180/110 mm Hg and with healthy vital organs were selected randomly and divided into three groups of 43 participants. All patients’ blood pressure in both arms, and after a period of 10 minutes in the left arm, was checked and was checked again after administering the medication for 4 times of 15 minutes till 1 hour complete. IBM SPSS Amos 23 was implemented. One-way ANOVA, Chi-Square and Repeated measure tests were performed to carry out statistical analysis. The level of significance of 0.05 was considered. Results in the group of midazolam, it was observed a reduction of 20.6% (P = 0.024), 17.4% (P = 0.001), and 19.1% (P = 0.009) for the systolic blood pressure, diastolic blood pressure, and blood pressure average, respectively. In such case, it was also indicated to be a significant difference of the reduction before and after the treatment. The group of captopril showed a decrease of 19.9% (P = 0.001), 13.5% (P = 0.008), and 16.7% (P = 0.001) for the systolic blood pressure, diastolic blood pressure, and blood pressure average, respectively. It was also observed to be a significant difference in reducing the blood pressure before and after the treatment. The group of midazolam and captopril showed the greatest reduction of blood pressure before, in the middle, and after carrying out the treatment methods. As such, systolic blood pressure, diastolic blood pressure, and the blood pressure average changed to the reduction of 23.5% (P = 0.047), 17.4% (P = 0.021), and 20.5% (P = 0.031), respectively. No significant difference was observed among these three groups (P = 0.239).

scholarly journals Synbiotics and Treatment of Asthma: A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial

2019 ◽  
Vol 8 ◽  
pp. 1350
Author(s):  
Maryam Hassanzad ◽  
Keyvan Maleki Mostashari ◽  
Hosseinali Ghaffaripour ◽  
Habib Emami ◽  
Samane Rahimi limouei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Positive Effects ◽  
Outpatient Visits ◽  
Significant Difference ◽  
Asthma In Children ◽  
Double Blinded ◽  
Experimental Group

Background: We examined the efficiency and safety of a specific synbiotic compound, brand name Kidilact®, in the treatment of asthma in children 12 years of age or younger. Materials and Methods: This double-blinded, randomized, placebo-controlled clinical trial was conducted in Tehran, Iran, from May 22, 2016, to May 21, 2017. One hundred children, 12 years of age or younger, who suffered from mild to moderate asthma were recruited in this study. The subjects were randomly divided into two groups; the experimental group received a sachet of Kidilact®, and the control group received a sachet of placebo once a day for six months. Both groups were compared in terms of the frequency of asthma attacks that were severe enough to require administration of fast-acting medications, the number of outpatient visits for asthma-related problems, and the frequency of hospitalization due to exacerbated symptoms of asthma. Results: There were fewer complaints of drug-induced side effects, e.g., vomiting, headache, stomachache, and diarrhea, exacerbated cough, and constipation in the experimental group than in the control group. Overall, a significantly greater number of participants in the experimental group were satisfied with the therapeutic intervention than those in the control group, as verified by the participants and their parents/guardians self-report. There was no significant difference between both groups in the frequency of asthma attacks and hospitalization due to exacerbated symptoms of asthma. The only significant difference between both groups was the count of outpatient visits. While the control group made 55 outpatient visits to the hospital, participants in the experimental group visited the hospital only 19 times (P=0.001). Conclusion: Results of our study indicates that synbiotic compound Kidilact® generally alleviates the symptoms of asthma in children of 12 years of age or younger, resulting in less frequent outpatient visits to the hospital due to asthma-related problems while rarely causing any side effects. Due to ease of use, the rarity of side effects, and their indirect positive effects on quality of life of asthmatic patients, we recommend that synbiotics be incorporated in regular treatment and management of children with asthma. [GMJ.2019;8:e1350]

scholarly journals Effect of Foot Reflexology on Postoperative Pain in Patients Undergoing Tibia Plating Surgery: A Randomized Clinical Trial

2020 ◽  
Vol 10 (3) ◽  
pp. 258-269
Author(s):  
Fatemeh Imani ◽  
◽  
Ebrahim Nasiri ◽  
Houshang Akbari ◽  
Mohammad Reza Safdari ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Randomized Clinical Trial ◽  
Repeated Measures ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
Chi Square ◽  
Chi Square Test ◽  
And Control

Objective: One of the major problems of patients after orthopedic surgeries is acute pain. The present study aims to evaluate the effect of foot reflexology massage on postoperative pain in patients undergoing plating surgery for tibia fracture. Methods: This study is a randomized clinical trial conducted on 96 patients who were candidates for tibia plating surgery referred to Imam Ali Hospital in Bojnourd, Iran, randomly divided into intervention and control groups. Foot reflexology massage in the intervention group was performed on patients’ healthy feet for 10 minutes, one hour before surgery. In the control group, the foot sole was touched for one minute without any pressure. Pain intensity was measured using the standard Visual Analog Scale before and immediately after the intervention and 2, 4, 6, 12 and 24 hours after surgery. Data were analyzed using chi-square test, t-test, repeated measures ANOVA, Mann-Whitney U and Friedman tests. Results: The baseline pain scores in the intervention and control groups were reported 8.1±0.9 and 8.4±0.9, respectively. After the intervention, the pain score in these groups was reduced to 6.9±1.1 and 8.1±1.0, respectively (P<0.001). At other times, up to 24 hours after surgery, the pain reduction was higher in the intervention group (P<0.05). Conclusion: Foot reflexology massage reduces postoperative pain of patients undergoing tibia plating surgery. Therefore, this method can be used to reduce pain and anxiety in orthopedic surgery patients.

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