Comparison of the effectiveness of ondansetron versus metoclopramide in hyperemesis gravidarum: a randomized clinical trial

2021 ◽  
Author(s):  
Fatemeh Moradiha ◽  
Sahar Farahmandrad ◽  
Hamideh Gholami
Keyword(s):  
Clinical Trial ◽  
Hospital Stay ◽  
Pregnant Women ◽  
Randomized Clinical Trial ◽  
Hyperemesis Gravidarum ◽  
Length Of Hospital Stay ◽  
Economic Effects ◽  
Nausea And Vomiting ◽  
Repeated Measure ◽  
Significant Difference

Objective: Nausea and vomiting are the most common complications and the first cause of hospitalization of pregnant women in the first trimester of pregnancy. Given the maternal and fetal complications as well as the negative psychosocial and economic effects of nausea and vomiting, the present study aimed to compare the antiemetic effects of ondansetron and metoclopramide. Methods: The present double-blind randomized clinical trial study was conducted on 153 pregnant women with a complaint of nausea and vomiting during pregnancy referred to the obstetrics and gynecology ward. Patients were randomly divided into two metoclopramide and ondansetron groups. The outcomes of interest were nausea and vomiting, the number of used doses of the drug, and the length of hospital stay. The Pregnancy-Unique Quantification of Emesis (PUQE) questionnaire was used to assess the severity of nausea and vomiting. Results: The mean age was significantly higher in the metoclopramide group (28.44±6.45 vs. 25.43±5.42 years, P=0.004). On day 3, the PUQE score was significantly higher in the ondansetron group (6.60±1.10 vs. 6.56±0.88, P<0.001). The decrease in the severity of nausea and vomiting was significantly higher in the ondansetron group (5.29±1.35 vs. 4.90±1.17, P=0.05) in the second day compared to the first day. In the repeated measure analysis, significant differences were found between the two treatment groups (F=7.01, P=0.009). There was no significant difference between the two groups in terms of the length of hospital stay (P>0.05). Conclusion: In this study, ondansetron revealed more efficacy than metoclopramide on the nausea and vomiting of pregnancy (NVP) management. Ondansetron may, therefore, be considered as a safe and effective alternative for metoclopramide in the treatment of NVP.

scholarly journals Efficacy and safety of novel herbal tablets in COVID-19 patients in hospital stay days, ICU admission and mortality rate thereof: An open-label, single-blind randomized clinical trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Mojtaba Varshochi ◽  
Mohammad Shahi ◽  
Maryam Rahimzadeh ◽  
Hasan Amini ◽  
Ramin Mohammadzadeh
Keyword(s):  
Clinical Trial ◽  
Hospital Stay ◽  
Randomized Clinical Trial ◽  
Standard Treatment ◽  
Length Of Hospital Stay ◽  
Crocus Sativus ◽  
Open Label ◽  
Icu Admission ◽  
Herbal Compound ◽  
Single Blind

Background: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the super-spreading virus, has claimed hundreds of thousands of lives worldwide. Objectives: This study aimed to evaluate the effectiveness of the novel suggested herbal compound, formulated as compressed tablets, in reducing the length of hospital stay (LoS), intensive care unit (ICU) admission, and mortality in confirmed COVID-19 cases. Methods: Following an open-label, single-blind randomized clinical trial design, a total of 200 patients aged 18-65 admitted to Imam Reza hospital in Tabriz, northwest of Iran, were randomized to intervention and control groups in a 1:1 ratio, i.e., 100 subjects in each group. The former received standard treatment along with the compressed herbal tablets, and the latter only received the standard treatment. Adverse reactions incidence within 180 days after the beginning of the intervention was set as the primary safety endpoint. The most important and active ingredients of the tablets were Terminalia chebula, Glycyrrhiza glabra, Anacyclus pyrethrum, Senna alexandrina, Ferrula asafoetida, Pistacia lentiscus, Zizyphus jujuba, Crocus sativus, Echinacea angustifolia, and Hyssopus officinalis. This trial is registered at the Iranian Registry of Clinical Trials (code: IRCT20200522047545N1). Results: Those in the intervention arm had significantly lower rates of LoS (7.38 vs. 9.45, P = 0.030), ICU admission (6 out of 100 vs. 32 out of 100, P = 0.000), and mortality (1 vs. 19 out of 100, P = 0.000). Conclusions: Our observations suggest that adequate improvement is provided by the prepared herbal compound along with substantial savings in hospitalization hoteling costs. While further multi-center studies with a larger sample size are needed to extend our knowledge regarding the effect of this new option, these novel clinical data may well provide a new alternative for the management of COVID-19 disease.

The Effect of Acupressure on the Severity of Nausea, Vomiting, and Retching in Pregnant Women: A Randomized Controlled Trial

2020 ◽  
Vol 27 (4) ◽  
pp. 252-259 ◽  
Author(s):  
Fatemeh Tara ◽  
Hamidreza Bahrami-Taghanaki ◽  
Masoud Amini Ghalandarabad ◽  
Ziba Zand-Kargar ◽  
Hamideh Azizi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Linear Regression Analysis ◽  
Nausea And Vomiting ◽  
Singleton Pregnancy ◽  
Chi Square ◽  
Significant Difference ◽  
Before And After ◽  
Beta Coefficient

Introduction: Nausea and vomiting are common problems during pregnancy. Previous studies have shown that stimulation at Neiguan (PC6) acupoint can be effective in controlling pregnancy-induced nausea and vomiting. However, more evidence is required for approving this method on controlling pregnancy-induced nausea and vomiting. The aim of this study was to determine the efficacy of PC6 acupoint pressure stimulation on the severity of nausea, vomiting, and retching in pregnant women. Method: This randomized, multi-center clinical trial was conducted on pregnant women referring to Health Centers and Ommolbanin Hospital in Mashhad, Iran, during December 2016 to September 2017. Women with first singleton pregnancy and below 12 weeks were included. Patients were randomly allocated into three groups of (1) PC6 pressure (4 times a day, for 10 min), (2) sham acupressure, and (3) medication with vitamin B6 and metoclopramide. Assessment of severity of nausea, vomiting, and retching was done based on the Rhodes Index on the first and fifth day (before and after the intervention). Pearson chi-square test, one-way ANOVA, Kruskal-Wallis, and Wilcoxon tests were used for statistical analysis using SPSS version 18. This clinical trial was registered at the Iranian Registry of Clinical Trials (IRCT) with the code IRCT201512187265N6. Results: Ninety patients with a mean age of 26.40 ± 4.73 years were studied in 3 groups of 30. There was no significant difference between the 3 groups in terms of the severity outcomes before the intervention, while, after the intervention, the three groups were significantly different on the fifth day in terms of vomiting frequency, distress from retching, distress from vomiting, duration of nausea, distress from nausea, amount of vomiting, frequency of nausea, and frequency of retching (p < 0.001 for each outcome). According to the linear regression analysis, the correlation between occupation with vomiting frequency (beta coefficient = 0.252) and nausea severity (beta coefficient = –0.213) was statistically significant. Conclusion: It seems that PC6 acupoint pressure can reduce the severity of nausea, vomiting, and retching in pregnant women.

Efficacy of tele-rehabilitation compared with office-based physical therapy in patients with knee osteoarthritis: A randomized clinical trial

2017 ◽  
Vol 24 (8) ◽  
pp. 560-565 ◽  
Author(s):  
Kamran Azma ◽  
Zahra RezaSoltani ◽  
Farid Rezaeimoghaddam ◽  
Afsaneh Dadarkhah ◽  
Sarasadat Mohsenolhosseini
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Knee Osteoarthritis ◽  
Randomized Clinical Trial ◽  
Age Groups ◽  
Repeated Measure ◽  
Osteoarthritis Of The Knee ◽  
Post Intervention ◽  
Significant Difference ◽  
The Mean

Introduction Knee osteoarthritis is a major cause of disability among the middle to senior age groups. Despite being effective, office-based physical therapy (OBPT) needs professional human resources and is both costly and time-consuming. We aimed to compare the efficacy of tele-rehabilitation (tele-rehab) compared with OBPT in patients with knee osteoarthritis. Methods In this randomized clinical trial, patients with symptomatic osteoarthritis of the knee were assigned to participate in either a 6-week home-based tele-rehab or an OBPT program between 2015 and 2016. Our primary outcome was the mean change from the baseline until 1 and 6 month's post-intervention in scores of the Knee injury and Osteoarthritis Outcome Score (KOOS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). We used analysis of variance for the repeated measure statistical test. Results A total of 54 patients entered the final analysis, with 27 in each group. The mean age of the patients was 58.2 ± 7.41 years and 60.2% were female. In the tele-rehab and OBPT group, KOOS scores increased from baseline to 6 months post-intervention (50.6 to 83.1 and 49.8 to 81.8) respectively. There was no significant difference between tele-rehab and OBPT groups in any of the studied scales. Discussion The tele-rehab program is as effective as OBPT in improving the function of patients with knee osteoarthritis. Considering the much lower time and cost consumed by tele-rehab, it is the recommended program for the older population living in remote sites.

Comparative Effectiveness of Ventral vs Dorsal Surgery for Cervical Spondylotic Myelopathy

Neurosurgery ◽  
2011 ◽  
Vol 68 (3) ◽  
pp. 622-631 ◽  
Author(s):  
Zoher Ghogawala ◽  
Brook Martin ◽  
Edward C. Benzel ◽  
James Dziura ◽  
Subu N. Magge ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pilot Study ◽  
Hospital Stay ◽  
Randomized Clinical Trial ◽  
Cervical Spondylotic Myelopathy ◽  
Short Form ◽  
Hospital Costs ◽  
Length Of Hospital Stay ◽  
Hospital Charges ◽  
Fusion Surgery

Abstract BACKGROUND: Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction. OBJECTIVE: To determine the feasibility of a randomized clinical trial comparing the clinical effectiveness and costs of ventral vs dorsal decompression with fusion surgery for treating CSM. METHODS: A nonrandomized, prospective, clinical pilot trial was conducted. Patients ages 40 to 85 years with degenerative CSM were enrolled at 7 sites over 2 years (2007–2009). Outcome assessments were obtained preoperatively and at 3 months, 6 months, and 1 year postoperatively. A hospital-based economic analysis used costs derived from hospital charges and Medicare cost-to-charge ratios. RESULTS: The pilot study enrolled 50 patients. Twenty-eight were treated with ventral fusion surgery and 22 with dorsal fusion surgery. The average age was 61.6 years. Baseline demographics and health-related quality of life (HR-QOL) scores were comparable between groups; however, dorsal surgery patients had significantly more severe myelopathy (P &lt; .01). Comprehensive 1-year follow-up was obtained in 46 of 50 patients (92%). Greater HR-QOL improvement (Short-Form 36 Physical Component Summary) was observed after ventral surgery (P = .05). The complication rate (16.6% overall) was comparable between groups. Significant improvement in the modified Japanese Orthopedic Association scale score was observed in both groups (P &lt; .01). Dorsal fusion surgery had significantly greater mean hospital costs ($29 465 vs $19 245; P &lt; .01) and longer average length of hospital stay (4.0 vs 2.6 days; P &lt; .01) compared with ventral fusion surgery. CONCLUSION: Surgery for treating CSM was followed by significant improvement in disease-specific symptoms and in HR-QOL. Greater improvement in HR-QOL was observed after ventral surgery. Dorsal fusion surgery was associated with longer length of hospital stay and higher hospital costs. The pilot study demonstrated feasibility for a larger randomized clinical trial.

scholarly journals The Effect of Psycho-Education Intervention Based on Relaxation Methods and Guided Imagery on Nausea and Vomiting of Pregnant Women

2019 ◽  
Author(s):  
Mansou Shakiba ◽  
Homeyra Parsi ◽  
Zahra Pahlavani Shikhi ◽  
Ali Navidian
Keyword(s):  
Pregnant Women ◽  
Hyperemesis Gravidarum ◽  
Statistical Tests ◽  
Intervention Group ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Relaxation Methods ◽  
Average Value ◽  
Significant Difference ◽  
Quasi Experimental

Objective: The present study aims at evaluating the effects of psycho-education based on relaxation methods on Hyperemesis Gravidarum (HG). Materials and methods: This is a quasi-experimental study, with pretest and posttest design, which was carried out on 100 pregnant women with complaints of nausea and vomiting who had referred to general health centers to receive pregnancy care. In accordance with the specified content, women in the intervention group received 3 sessions of psycho-education based on relaxation methods for a week. Four weeks after the end of education and before the 16th week of pregnancy, data were gathered from both the intervention and control groups using the Pregnancy-Unique Quantification of Vomiting and Nausea (PUQEN) scale. Data were analyzed with the aid of statistical tests. Results: There was no significant difference between the average values of HG in the intervention group and the control group prior to the intervention. However, after receiving psycho-education, the average value of nausea and vomiting in pregnant women of the intervention group (5.11 ± 1.60) was significantly lower than that in the control group (6.00 ± 1.66) (p = 0.035). Conclusion: The psycho-education based on relaxation methods of this study had a positive and significant effect on reducing the intensity of HG. It is helpful to integrate the educational content of this intervention in the caring programs of pregnant women with nausea and vomiting.

scholarly journals Effects that passive cycling exercise have on muscle strength, duration of mechanical ventilation, and length of hospital stay in critically ill patients: a randomized clinical trial

2017 ◽  
Vol 43 (2) ◽  
pp. 134-139 ◽  
Author(s):  
Aline dos Santos Machado ◽  
Ruy Camargo Pires-Neto ◽  
Maurício Tatsch Ximenes Carvalho ◽  
Janice Cristina Soares ◽  
Dannuey Machado Cardoso ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Physical Therapy ◽  
Muscle Strength ◽  
Hospital Stay ◽  
Randomized Clinical Trial ◽  
Critically Ill Patients ◽  
Length Of Hospital Stay ◽  
Cycling Exercise ◽  
Peripheral Muscle

ABSTRACT Objective: To evaluate the effects that passive cycling exercise, in combination with conventional physical therapy, have on peripheral muscle strength, duration of mechanical ventilation, and length of hospital stay in critically ill patients admitted to the ICU of a tertiary care university hospital. Methods: This was a randomized clinical trial involving 38 patients (≥ 18 years of age) on mechanical ventilation who were randomly divided into two groups: control (n = 16), receiving conventional physical therapy; and intervention (n = 22), receiving conventional physical therapy and engaging in passive cycling exercise five days per week. The mean age of the patients was 46.42 ± 16.25 years, and 23 were male. The outcomes studied were peripheral muscle strength, as measured by the Medical Research Council scale, duration of mechanical ventilation, and length of hospital stay. Results: There was a significant increase in peripheral muscle strength (baseline vs. final) in both groups (control: 40.81 ± 7.68 vs. 45.00 ± 6.89; and intervention: 38.73 ± 11.11 vs. 47.18 ± 8.75; p < 0.001 for both). However, the range of increase in strength was higher in the intervention group than in the control group (8.45 ± 5.20 vs. 4.18 ± 2.63; p = 0.005). There were no significant differences between the groups in terms of duration of mechanical ventilation or length of hospital stay. Conclusions: The results suggest that the performance of continuous passive mobilization on a cyclical basis helps to recover peripheral muscle strength in ICU patients. (ClinicalTrials.gov Identifier: NCT01769846 [http://www.clinicaltrials.gov/])

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