scholarly journals Efficacy of pregabalin versus nortriptyline in the treatment of chronic low backache with radiculopathy: an open label observational study

2019 ◽  
Vol 8 (8) ◽  
pp. 1749
Author(s):  
Annapurna V. T. ◽  
Nivedita Maity ◽  
Ravikumar T. V.
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Analogue Scale ◽  
Radicular Pain ◽  
Efficacy And Safety ◽  
Open Label ◽  
Treatment Groups ◽  
Significant Difference ◽  
Reduction Of Pain ◽  
Vas Scores

Background: The efficacy and safety of Pregabalin and Nortriptyline have been proved individually in low backache with radicular pain. However, there are limited number of studies comparing the efficacy of Pregabalin and Nortriptyline in Chronic Low Backache (CLBA) with radicular pain. Hence the present study was designed to determine the efficacy as well as tolerability of Pregabalin in comparison with that of Nortriptyline for reduction of pain in CLBA. The present study was an open label prospective observational study.Methods: Patients with CLBA, 15-60 years of age without specific cause and significant neurological deficit were included in the study. Severity of pain was assessed by Visual Analogue Scale (VAS). Patients were followed up at 2 and 4 weeks and their VAS scores and side effects were noted.Results: Both Pregabalin and Nortriptyline were effective in reducing pain, from baseline to 2 weeks and up to 4 weeks of treatment in chronic low backache with radicular pain, but there was no statistically significant difference between the two treatment groups. The incidences of side effects were less in the Nortriptyline treatment group as compared to Pregabalin.Conclusions: From the results of the present study it can be concluded that both Pregabalin and Nortriptyline were equally effective in the treatment of chronic low backache with radicular pain, but the incidence of adverse effects were more with Pregabalin as compared to Nortriptyline.

Clinical Observations on Postoperative Vomiting Treated by Auricular Acupuncture

2003 ◽  
Vol 31 (03) ◽  
pp. 475-480 ◽  
Author(s):  
Yongsuk Kim ◽  
Chang-Whan Kim ◽  
Keon-Sik Kim
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Acupuncture Treatment ◽  
Postoperative Nausea And Vomiting ◽  
Auricular Acupuncture ◽  
Postoperative Vomiting ◽  
Treatment Groups ◽  
Female Patients ◽  
Clinical Observations ◽  
Significant Difference

We studied the effect of auricular acupuncture on postoperative nausea and vomiting (PONV). One hundred female patients undergoing transabdominal hysterectomy were entered into the study. The patients were divided into two groups (auricular acupuncture treatment group and non-treatment group) in order to test the effectiveness of auricular acupuncture. There was no significant difference in age, weight, height or duration of anesthesia among the two groups of patients. There was a significant difference between the control and auricular acupuncture treatment groups in the incidence of vomiting 12 hours after surgery (68% and 30%, respectively, p < 0.01). No noteworthy side effects from treatment were observed. Auricular acupuncture is effective in reducing vomiting following transabdominal hysterectomy in female patients.

scholarly journals Comparison of Oral Zinc Sulfate with Systemic Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis

2011 ◽  
Vol 2011 ◽  
pp. 1-4 ◽  
Author(s):  
Mohamad Javad Yazdanpanah ◽  
Mahnaz Banihashemi ◽  
Fakhrozaman Pezeshkpoor ◽  
Mohammad Khajedaluee ◽  
Sororozaman Famili ◽  
...  
Keyword(s):  
Side Effects ◽  
Cutaneous Leishmaniasis ◽  
Side Effect ◽  
Zinc Sulfate ◽  
Cure Rate ◽  
Meglumine Antimoniate ◽  
Treatment Groups ◽  
Significant Difference

The purpose of this study was to investigate comparison between oral zinc sulfate and meglumine antimoniate in the treatment of cutaneous leishmaniasis (CL). So 100 patients with CL were included and randomly divided into two groups. The first group was treated with oral zinc sulfate (10 mg/kg/day during 45 days period), and the second group was treated with systemic meglumine antimoniate (20 mg/kg/day intramuscularly for 20 days). Acceptable cure after completing 45 days of followup occurred in 30.2% of lesions in first group, while this was 35.5% for the second group. There is not any significant difference between the two treatment groups (P=0.42). Serious side effects resulting in treatment discounting occurred in only meglumine antimoniate group. Although cure rate of systemic meglumine antimoniate group was better the treatment with zinc sulfate is much easier, cheaper, more convenient in consumption, safer, and nearly close cure percentage to systemic meglumine antimoniate injections without serious side effect.

scholarly journals Clinical efficacy on glycemic control and safety of mesenchymal stem cells in patients with diabetes mellitus: Systematic review and meta-analysis of RCT data

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0247662
Author(s):  
Jingjing He ◽  
Desheng Kong ◽  
Zhifen Yang ◽  
Ruiyun Guo ◽  
Asiamah Ernest Amponsah ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Treatment Group ◽  
Random Effects ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Control Group ◽  
Efficacy And Safety ◽  
Significant Difference

Background Diabetes mellitus as a chronic metabolic disease is threatening human health seriously. Although numerous clinical trials have been registered for the treatment of diabetes with stem cells, no articles have been published to summarize the efficacy and safety of mesenchymal stem cells (MSCs) in randomized controlled trials (RCTs). Methods and findings The aim of this study was to systematically review the evidence from RCTs and, where possible, conduct meta-analyses to provide a reliable numerical summary and the most comprehensive assessment of therapeutic efficacy and safety with MSCs in diabetes. PubMed, Web of Science, Ovid, the Cochrane Library and CNKI were searched. The retrieval time was from establishment of these databases to January 4, 2020. Seven RCTs were eligible for analysis, including 413 participants. Meta-analysis results showed that there were no significant differences in the reduction of fasting plasma glucose (FPG) compared to the baseline [mean difference (MD) = -1.05, 95% confidence interval (CI) (-2.26,0.16), P<0.01, I2 = 94%] and the control group [MD = -0.62, 95%CI (-1.46,0.23), P<0.01, I2 = 87%]. The MSCs treatment group showed a significant decrease in hemoglobin (Hb) A1c [random-effects, MD = -1.32, 95%CI (-2.06, -0.57), P<0.01, I2 = 90%] after treatment. Additionally, HbA1c reduced more significantly in MSC treatment group than in control group [random-effects, MD = -0.87, 95%CI (-1.53, -0.22), P<0.01, I2 = 82%] at the end of follow-up. However, as for fasting C-peptide levels, the estimated pooled MD showed that there was no significant increase [MD = -0.07, 95%CI (-0.30, 0.16), P<0.01, I2 = 94%] in MSCs treatment group compared with that in control group. Notably, there was no significant difference in the incidence of adverse events between MSCs treatment group and control group [relative risk (RR) = 0.98, 95%CI (0.72, 1.32), P = 0.02, I2 = 70%]. The most commonly observed adverse reaction in the MSC treatment group was hypoglycemia (29.95%). Conclusions This meta-analysis revealed MSCs therapy may be an effective and safe intervention in subjects with diabetes. However, due to the limited studies, a number of high-quality as well as large-scale RCTs should be performed to confirm these conclusions.

scholarly journals MLTI-14. A SYSTEMATIC REVIEW OF TREATMENT PARADIGMS FOR PATIENTS WITH BREAST CANCER AND ONE OR MORE BRAIN METASTASES

2019 ◽  
Vol 1 (Supplement_1) ◽  
pp. i17-i17
Author(s):  
Yosef Ellenbogen ◽  
Karanbir Brar ◽  
Nebras Warsi ◽  
Jetan Badhiwala ◽  
Alireza Mansouri
Keyword(s):  
Breast Cancer ◽  
Systematic Review ◽  
Adverse Events ◽  
Brain Metastases ◽  
Treatment Options ◽  
Inclusion Criteria ◽  
Open Label ◽  
Treatment Groups ◽  
Molecular Features ◽  
Significant Difference

Abstract BACKGROUND: Upwards of 50% of patients with advanced breast cancer are diagnosed with brain metastases (BM). Treatment options for these patients have been rapidly evolving due to increased understanding of the tumor pathophysiology and its genetic underpinnings. This systematic review of randomized controlled trials (RCTs) aims to clarify the evidence guiding the treatment of brain metastases from breast cancer. METHODS: MEDLINE, EMBASE, Cochrane Controlled Register of Trials, ClincialTrials.gov, and Web of Science were searched from inception to October 2018 for RCTs comparing treatments for breast cancer BM. We screened studies, extracted data, and assessed risk of bias independently and in duplicate. Outcomes assessed were overall survival (OS), progression-free survival (PFS), and adverse events (Grade 3+). RESULTS: Among 3188 abstracts, only 3 RCTs (N=412; mean sample size per group N=54.7) meeting inclusion criteria were identified. The studies were phase II or III open-label parallel superiority trials. Inclusion criteria among these trials consisted of age &gt;18 with radiologic evidence of &gt;1 BM. Exclusion criteria consisted of poor-performance functional status (ECOG &gt;2 or KPS &lt; 70). The treatment groups included whole-brain radiation therapy (WBRT) vs WBRT + Temozolomide, WBRT vs WBRT + Efaproxiral, and Afatinib vs Vinorelbine vs investigators’ choice (86% of these patients received WBRT or SRS prior to study enrolment). While two trials found no significant difference in OS, one trial found significant improvement in OS with Efaproxiral in addition to WBRT compared to WBRT alone (HR 0.52; 95%CI 0.332–0.816). No significant differences were found with PFS or rate of adverse events amongst treatment groups. CONCLUSION: Considering the high prevalence of breast cancer BM and our improved understanding of genomic/molecular features of these tumors, a greater number of RCTs dedicated at this disease are needed.

scholarly journals Anti-Inflammatory Effect of Musa acuminata Stem

2020 ◽  
Vol 14 (02) ◽  
pp. 294-298
Author(s):  
Maharani Laillyza Apriasari ◽  
Selviana Rizky Pramitha ◽  
Dewi Puspitasari ◽  
Diah Savitri Ernawati
Keyword(s):  
Treatment Group ◽  
Musa Acuminata ◽  
Control Group ◽  
Control Group Design ◽  
Treatment Groups ◽  
Tnf Α ◽  
Significant Difference ◽  
Anti Inflammatory ◽  
Mucosal Wound ◽  
Inflammatory Effect

Abstract Objective This study was designed to assess the anti-inflammatory effect of Musa acuminata through the expression of tumor necrosis factor-α (TNF-α) and nuclear factor kappa β (NF-κB) after 3 days of application of Musa acuminata stem extract (MASE) gel on oral mucosal wound. Materials and Methods An experimental study with post-test only control group design was conducted. Twenty male Rattus norvegicus (Wistar) were injured on their left buccal mucosa and treated three times a day with MASE gel of varying concentrations: 0% (as control), MASE 25%, MASE 37.5%, and MASE 50%. On day 3, a biopsy was performed on each mucosal wound for later immunohistochemical analysis for the expressions of TNF-α and NF-κB. Results The highest expression of TNF-α was observed in the control group (13.20 ± 1.79), while the lowest was in the treatment group using 50% MASE (6.40 ± 1.14). Meanwhile the comparison between treatment groups did not highlight any significant difference (p > 0.05). The highest expression of NF-κB was observed in the control group (13.20 ± 1.30), whereas the lowest was in the treatment group using MASE 50% (6.40 ± 1.14). NF-κB was significantly lower in the treatment group using MASE 50% when compared with other treatment groups (p < 0.05). Conclusion Application of MASE on mucosal wound reduces the expression of TNF-α and NF-κB at all concentrations. The anti-inflammatory effect of MASE 50% was the strongest one.

scholarly journals A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Timothy Devos ◽  
Tatjana Geukens ◽  
Alexander Schauwvlieghe ◽  
Kevin K. Ariën ◽  
Cyril Barbezange ◽  
...  
Keyword(s):  
Treatment Group ◽  
Phase Ii ◽  
Clinical Efficacy ◽  
Active Treatment ◽  
Standard Of Care ◽  
Active Treatment Group ◽  
Proof Of Concept ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Phase

Abstract Background The COVID-19 pandemic has imposed an enormous burden on health care systems around the world. In the past, the administration of convalescent plasma of patients having recovered from SARS and severe influenza to patients actively having the disease showed promising effects on mortality and appeared safe. Whether or not this also holds true for the novel SARS-CoV-2 virus is currently unknown. Methods DAWn-Plasma is a multicentre nation-wide, randomized, open-label, phase II proof-of-concept clinical trial, evaluating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19 in Belgium. Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72 h before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chest-CT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis. Patients are randomized in a 2:1 ratio to either standard of care and convalescent plasma (active treatment group) or standard of care only. The active treatment group receives 2 units of 200 to 250 mL of convalescent plasma within 12 h after randomization, with a second administration of 2 units 24 to 36 h after ending the first administration. The trial aims to include 483 patients and will recruit from 25 centres across Belgium. The primary endpoint is the proportion of patients that require mechanical ventilation or have died at day 15. The main secondary endpoints are clinical status on day 15 and day 30 after randomization, as defined by the WHO Progression 10-point ordinal scale, and safety of the administration of convalescent plasma. Discussion This trial will either provide support or discourage the use of convalescent plasma as an early intervention for the treatment of hospitalized patients with COVID-19 infection. Trial registration ClinicalTrials.govNCT04429854. Registered on 12 June 2020 - Retrospectively registered.

Double-Blind Comparison of Maternal Analgesia and Neonatal Neurobehaviour following Intravenous Butorphanol and Meperidine

1979 ◽  
Vol 7 (3) ◽  
pp. 224-230 ◽  
Author(s):  
Robert Hodgkinson ◽  
Robert W Huff ◽  
Robert H Hayashi ◽  
Farkhanda J Husain
Keyword(s):  
Side Effects ◽  
Severe Pain ◽  
Randomized Study ◽  
Analgesic Efficacy ◽  
Foetal Heart Rate ◽  
Efficacy And Safety ◽  
Cervical Dilation ◽  
Double Blind ◽  
Significant Difference ◽  
Blind Comparison

Butorphanol (1 mg and 2 mg) and meperidine (40 mg and 80 mg), given intravenously, were evaluated for analgesic efficacy and safety in a double-blind randomized study employing 200 consenting pre-partum patients in moderate to severe pain during the late first stage of labour. Both drugs provided adequate relief of pain to the mothers. There was no significant difference in the rate of cervical dilation, the foetal heart rate, the Apgar score, pain relief or neonatal neurobehavioural scores between those receiving butorphanol and those receiving meperidine. Twenty-two mothers who received butorphanol and eleven who received meperidine nursed their infants with no adverse effects observed. Side-effects were generally infrequent in this study; however, more side-effects were reported by the patients and observed by the investigator in the meperidine-treated cases (13%) than in the cases treated with butorphanol (2%).

scholarly journals Efficacy and safety of prophylactic use of ketamine for prevention of postanesthetic shivering: a systematic review and meta analysis

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Yang Zhou ◽  
Abdul Mannan ◽  
Yuan Han ◽  
He Liu ◽  
Hui-Lian Guan ◽  
...  
Keyword(s):  
Side Effects ◽  
Incidence Rate ◽  
Meta Analysis ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Central Register ◽  
Postanesthetic Shivering ◽  
Significant Difference ◽  
The Difference ◽  
Prophylactic Use

Abstract Background Postanesthetic shivering is a common complication of anesthesia, which accounts for much discomfort in postoperative patients and may increase postoperative complications in high-risk patients. Due to the lack of high-quality evidence, it is difficult to draw a conclusion about optimal anti-shivering medication. The main purpose of this meta-analysis was to analyze and evaluate the efficacy and safety of prophylactic use of ketamine for preventing postanesthetic shivering. Methods We searched the following databases: Medline, Embase, and the Cochrane Central Register of Controlled Trails for randomized controlled trials. The primary outcome observed was the difference of the incidence rate of postanesthetic shivering between ketamine group and placebo group. The secondary outcomes were the sedation score and incidence of the side effects caused by ketamine and any other drugs utilized in the studies. Results In this meta-analysis, we analyzed a total of 16 trials including 1485 patients. Ketamine reduced the incidence rate of postanesthetic shivering compared to a placebo (odds ratio [OR]: 0.13, 95% confidence interval [CI]: 0.06 to 0.26, P<0.01). Regarding side effects, there was no evident variability of the incidence of nausea and vomiting. Usage of ketamine was associated with a lower rate of hypotension and bradycardia when compared to a placebo. Hallucinations were more frequently observed in patients who received higher doses of ketamine. No significant difference was found in the incidence of postanesthetic shivering with ketamine versus other pharmacological interventions. Conclusions Ketamine can prevent postanesthetic shivering without severe side effects. However, ketamine shows no advantage over other anti-shivering drugs.

scholarly journals A comparison between spironolactone and spironolactone plus finasteride in the treatment of hirsutism

2004 ◽  
pp. 351-354 ◽  
Author(s):  
F Kelestimur ◽  
H Everest ◽  
K Unluhizarci ◽  
F Bayram ◽  
Y Sahin
Keyword(s):  
Side Effects ◽  
Free Testosterone ◽  
Serum Levels ◽  
Blood Chemistry ◽  
Treated Group ◽  
Sex Hormone Binding Globulin ◽  
Efficacy And Safety ◽  
Dehydroepiandrosterone Sulphate ◽  
Treatment Groups ◽  
The Mean

OBJECTIVE: To compare the clinical efficacy and safety of the combination of spironolactone (100 mg/day) plus finasteride (5 mg/day) and spironolactone (100 mg/day) alone in the treatment of hirsutism. PATIENTS AND MEASUREMENTS: Sixty-five hirsute women were randomly assigned to one of these two treatment groups. Hirsutism score was measured according to the modified Ferriman-Gallwey scoring system. Baseline and post-treatment assessments were carried out in each subject by an investigator blinded to the therapy. Both groups had similar demographic properties at baseline. The serum levels of total and free testosterone, dehydroepiandrosterone sulphate and sex hormone-binding globulin were measured at the beginning and after 1 year of therapy. Blood chemistry and side-effects were evaluated during the study. Hirsutism scores were decreased significantly in both groups at the end of the year. RESULTS: The mean percentage change in hirsutism scores from baseline in the spironolactone plus finasteride-treated group (51.3%) was significantly (P<0.005) higher than in the group treated with spironolactone alone (36.6%). Patients from both treatment groups experienced similar side-effects. CONCLUSIONS: We have concluded that a combination of spironolactone plus finasteride is a safe and effective therapy in the treatment of hirsutism.

Efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor in the primary and secondary prevention of chemotherapy-induced neutropenia in patients with lymphoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e20061-e20061
Author(s):  
Meifeng Tu ◽  
Jun Zhu ◽  
Yuqin Song
Keyword(s):  
Secondary Prevention ◽  
Primary Group ◽  
Granulocyte Colony Stimulating Factor ◽  
Efficacy And Safety ◽  
Colony Stimulating Factor ◽  
Primary And Secondary Prevention ◽  
Open Label ◽  
Significant Difference ◽  
Chemotherapy Induced Neutropenia ◽  
Stimulating Factor

e20061 Background: To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF, brand name: Jinyouli) in the primary and secondary prevention of chemotherapy-induced neutropenia in patients with lymphoma. Methods: This single-center, one-arm and open-label clinical study enrolled 119 patients with lymphoma in Peking University Cancer Hospital & Institute from May 2016 to December 2018. Patients ≥45 kg received a single dose of PEG-rhG-CSF for 6mg, < 45kg for 3mg, subcutaneous injection once in 24-48 h after chemotherapy. Results: 119 lymphoma patients, including 60 primary and 59 secondary prevention patients, underwent a total of 427 cycles of chemotherapy. The overall incidence of febrile neutropenia (FN) was 6.32% (27/427), with rates of 5.39% and 7.17% in the primary and secondary prevention groups, respectively. There was no significant difference between two groups ( P> 0.05).The incidence of FN was significantly lower in the second cycle than in the first cycle in both the primary and secondary prevention groups ( In the primary group: cycle 1 vs. cycle 2: 15.00% vs. 2.22%, respectively, P= 0.027; In the secondary group: cycle 1 vs. cycle 2: 16.95% vs. 5.08%, respectively, P= 0.040). The overall incidence of grade Ⅳ neutropenia was 13.58% (58/427), with rates of 8.82% and 17.94% in the primary and secondary prevention groups, respectively. There was a significant difference between two groups ( P= 0.006). The incidence of grade Ⅳ neutropenia was significantly lower in the second cycle than in the first cycle (In the primary group: cycle 1 vs. cycle 2: 25.00% vs. 4.44%, respectively, P= 0.005; In the secondary group: cycle 1 vs. cycle 2: 47.46% vs. 11.86%, respectively, P< 0.001). The main treatment-related adverse event was bone pain, with an incidence of 2.52% (3/119). Conclusions: PEG-rhG-CSF can effectively reduce the incidence of FN and neutropenia with good safety in patients with lymphoma after chemotherapy. Primary prevention can significantly reduce the risk of grade IV neutropenia in all chemotherapy cycles compared with the secondary prevention. Clinical trial information: NCT02905916 .

Sign in / Sign up

Export Citation Format

Share Document