scholarly journals The addition of omeprazole to ondansetron for treating chemotherapy-induced nausea and vomiting in pediatric cancer patients

2018 ◽  
Vol 1 (1) ◽  
pp. 42
Author(s):  
Perjuangan Dapot Hamonangan Simbolon ◽  
Selvi Nafianti ◽  
Pertin Sianturi ◽  
Bidasari Lubis ◽  
Aznan Lelo
Keyword(s):  
Placebo Group ◽  
Cancer Patients ◽  
Pediatric Cancer ◽  
Controlled Trial ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Chi Square ◽  
Double Blind ◽  
Significant Difference ◽  
Pediatric Cancer Patients

Background Chemotherapy-induced nausea and vomiting are some of the most disturbing side effects in pediatric cancer patients. The standard recommendation is the use of 5-hydroxytryptamine 3 receptor antagonist, such as ondansetron, to treat these symptoms. Despite this treatment, more than 50% of patients still experience nausea and vomiting.Objective To evaluate the effect of the addition of omeprazole to ondansetron in the treatment of chemotherapy-induced nausea and vomiting.Methods A double-blind, randomized, controlled trial was conducted at Haji Adam Malik Hospital, Medan, North Sumatera, from March to May 2016. Subjects were children aged 1 to 18 years, diagnosed with cancer, and who received intravenous chemotherapy. Patients were randomized to receive either a single dose of ondansetron (0.5 mg/kg) plus placebo or ondansetron (0.5 mg/kg) plus omeprazole (0.5 mg/kg). The severity of nausea and vomiting were measured using the Rhodes index of nausea, vomiting, and retching during the 24 hours after initiation of emetogenic chemotherapy. The primary outcome of efficacy was the proportion of patients who achieved complete response (lack of nausea/vomiting). Statistical analysis was performed by Chi-square and Fischer’s exact tests.Results Seventy eligible pediatric patients were randomized into two groups: 32 subjects in the ondansetron + placebo group and 38 others in the ondansetron + omeprazole group. The therapy failed in 50% (16/32) of the ondansetron + placebo group and 18.4% (7/38) of the ondansetron + omeprazole group. There was a significant difference in the clinical response between groups (P=0.01).Conclusion The addition of omeprazole to ondansetron for the treatment of chemotherapy-induced nausea and vomiting is more effective than administration of ondansetron alone.

scholarly journals The addition of omeprazole to ondansetron for treating chemotherapy-induced nausea and vomiting in pediatric cancer patients

2018 ◽  
Vol 58 (1) ◽  
pp. 42
Author(s):  
Perjuangan Dapot Hamonangan Simbolon ◽  
Selvi Nafianti ◽  
Pertin Sianturi ◽  
Bidasari Lubis ◽  
Aznan Lelo
Keyword(s):  
Placebo Group ◽  
Cancer Patients ◽  
Pediatric Cancer ◽  
Controlled Trial ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Chi Square ◽  
Double Blind ◽  
Significant Difference ◽  
Pediatric Cancer Patients

Background Chemotherapy-induced nausea and vomiting are some of the most disturbing side effects in pediatric cancer patients. The standard recommendation is the use of 5-hydroxytryptamine 3 receptor antagonist, such as ondansetron, to treat these symptoms. Despite this treatment, more than 50% of patients still experience nausea and vomiting.Objective To evaluate the effect of the addition of omeprazole to ondansetron in the treatment of chemotherapy-induced nausea and vomiting.Methods A double-blind, randomized, controlled trial was conducted at Haji Adam Malik Hospital, Medan, North Sumatera, from March to May 2016. Subjects were children aged 1 to 18 years, diagnosed with cancer, and who received intravenous chemotherapy. Patients were randomized to receive either a single dose of ondansetron (0.5 mg/kg) plus placebo or ondansetron (0.5 mg/kg) plus omeprazole (0.5 mg/kg). The severity of nausea and vomiting were measured using the Rhodes index of nausea, vomiting, and retching during the 24 hours after initiation of emetogenic chemotherapy. The primary outcome of efficacy was the proportion of patients who achieved complete response (lack of nausea/vomiting). Statistical analysis was performed by Chi-square and Fischer’s exact tests.Results Seventy eligible pediatric patients were randomized into two groups: 32 subjects in the ondansetron + placebo group and 38 others in the ondansetron + omeprazole group. The therapy failed in 50% (16/32) of the ondansetron + placebo group and 18.4% (7/38) of the ondansetron + omeprazole group. There was a significant difference in the clinical response between groups (P=0.01).Conclusion The addition of omeprazole to ondansetron for the treatment of chemotherapy-induced nausea and vomiting is more effective than administration of ondansetron alone.

scholarly journals Perbandingan Aromaterapi Pepermin dengan Ondansetron Intravena sebagai Terapi Rescue Mual Muntah Pascaoperasi Mastektomi

2019 ◽  
Vol 7 (1) ◽  
pp. 25-32
Author(s):  
Arna Fransisca ◽  
Iwan Fuadi ◽  
Dewi Yulianti Bisri
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Chi Square ◽  
Double Blind ◽  
Consecutive Sampling ◽  
Randomized Controlled ◽  
Significant Difference

Mual muntah pascaoperasi merupakan salah satu komplikasi anestesi dan operasi yang menjadi perhatian khusus karena memengaruhi kualitas pelayanan kesehatan, memperpanjang lama perawatan, dan meningkatkan angka morbiditas perioperatif. Pascaoperasi payudara berkaitan dengan angka kejadian mual muntah pascaoperasi yang tinggi. Beberapa konsensus penatalaksanaan mual muntah pascaoperasi merekomendasikan pemberian terapi nonfarmakologi dengan aromaterapi sebagai terapi rescue untuk mengatasi mual muntah pascaoperasi. Tujuan penelitian ini adalah membandingkan aromaterapi pepermin dengan ondansetron sebagai terapi rescue dalam menurunkan kejadian mual muntah pascaoperasi mastektomi. Penelitian ini merupakan penelitian eksperimental yang dilakukan secara prospektif dengan desain penelitian double blind randomized controlled trial dan consecutive sampling terhadap 32 subjek penelitian yang menjalani operasi mastektomi elektif dan memenuhi kriteria inklusi di RSUP Dr. Hasan Sadikin Bandung pada bulan Juli–September 2018. Pada penelitian ini, data ordinal diuji dengan Uji Mann Whitney dan untuk data kategorik diuji dengan uji chi-square. Hasil penelitian ini didapatkan penurunan kejadian mual muntah pascaoperasi yang signifikan pada kelompok pepermin dibanding dengan kelompok ondansetron dengan perbedaan yang bermakna (p<0,05) pada penilaian menit kedua dan menit kelima setelah perlakuan. Simpulan, aromaterapi pepermin efektif menurunkan kejadian mual muntah pascaoperasi mastektomi dan dapat digunakan sebagai alternatif terapi atau terapi tambahan untuk penatalaksanaan mual muntah pascaoperasi.Comparison of Peppermint Aromatherapy with Ondansetron Intravenous as a Rescue for Postoperative Nausea Vomiting after Mastectomy SurgeryPostoperative nausea and vomiting are among anesthesia and surgery  complications that receive special considerations as it affects the quality of healthcare services, prolongs care, and increases perioperative morbidities. The incidence of postoperative nausea and vomiting is high in patients that have undergone breast surgery. The consensus for postoperative nausea and vomiting management recommends non-pharmacological treatments, one of which is through the use of aromatherapy as a rescue to resolve postoperative nausea and vomiting. This study aimed to compare the effects of peppermint aromatherapy and ondansetron as a rescue in reducing the incidence of postoperative nausea and vomiting after elective mastectomies. This was a prospective experimental double blind randomized controlled trial study with consecutive sampling on 32 research subjects underwent elective mastectomies and met the inclusion criteria in Dr. Hasan Sadikin General Hospital in July–September 2018. The ordinal data were tested using the Mann Whitney statistics test and the categorical data using the chi square test. The results show a significant decrease in nausea and vomiting incidence in the peppermint group compared to the ondansetron group with significant difference (p<0.05) in two minutes and five minutes after treatment. In conclusion, peppermint aromatherapy is effective in reducing the incidence of postoperative nausea and vomiting after mastectomies and can be used as an alternative or additional treatment in managing postoperative nausea and vomiting.

The effect of foot reflexology on chemotherapy-induced nausea and vomiting in digestive or lung cancer patients: a randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Audrey Murat-Ringot ◽  
Pierre Jean Souquet ◽  
Fabien Subtil ◽  
Florent Boutitie ◽  
Marie Preau ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Controlled Trial ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Digestive Cancer ◽  
Complementary Medicines ◽  
Antiemetic Drugs ◽  
Platinum Based Chemotherapy ◽  
Significant Difference ◽  
Delayed Nausea

BACKGROUND Cancer is a chronic disease with an incident worldwide had been 24.5 million and 9.6 million deaths in 2017. Lung and colorectal cancer are the most common cancer for both sexes and according to national and international recommendations platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting may persist. Moreover, cancer patient are increasingly interested in alternative and complementary medicines and express the desire that non-pharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology decreases significantly the severity of chemotherapy-induced nausea and vomiting in breast cancer patients. OBJECTIVE The primary objective of the present study was to assess the benefits of foot reflexology as a complement to conventional treatments on severity of acute chemotherapy-induced nausea and vomiting in digestive or lung cancer patients. The secondary objectives assessed were the frequency and severity of delayed chemotherapy-induced nausea and vomiting, quality of life, anxiety, and self-esteem. METHODS The present study was conducted between April 2018 and April 2020 in French University Hospital. This is an open-label randomized controlled trial. Participants are randomized into two groups: 40 to interventional group (conventional care with foot reflexology) and 40 to control group (conventional care without foot reflexology). Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient. Eligible participants are patients with a lung or digestive cancer with indication for platinum-based chemotherapy. RESULTS The severity of acute nausea and vomiting was assessed with a visual analogue scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for control group (20.6%, P = 0.01). Across all cycle, the foot reflexology group showed a trend towards less frequent delayed nausea (P=0.28), a significantly less frequent consumption of antiemetic drugs (P=0.04), and no significant difference for vomiting (P=0.99); there was a trend towards a perception of stronger severity for delayed nausea in the control group (P=0.39). According to quality of life and anxiety, there was no significant difference between the interventional group and the control group (P=0.32 and P=0.53 respectively). CONCLUSIONS In conclusion, the present study results indicated that foot reflexology decreased significantly the severity of acute nausea and consumption of antiemetic drugs in lung and digestive cancer patients. No side effects from foot reflexology have been noted. In order to better respond to a desire of patients for non-pharmacological treatments and CAMs to be used in hospitals to improve their care, the results of this study showed that foot reflexology seems to be a promising complement to conventional antiemetic drugs. To assess the performance of this intervention in routine practice, a larger study with several health care centers would be relevant with a cluster RCT. CLINICALTRIAL The present study registered with clinicaltrials.gov: NCT03508180 (28/06/2018) INTERNATIONAL REGISTERED REPORT RR2-10.2196/17232

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

scholarly journals Randomised Double-Blind Trial of Combination Antibiotic Therapy in Rheumatoid Arthritis

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Angela Smith ◽  
Caroline Doré ◽  
Peter Charles ◽  
Alena Vallance ◽  
Tara Potier ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Placebo Group ◽  
Active Treatment ◽  
Active Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Good Evidence ◽  
Double Blind ◽  
Acr20 Response ◽  
Significant Difference

Objective. A combination of intravenous clindamycin and oral tetracycline has been used for many years as a treatment for active rheumatoid arthritis (RA), despite the absence of good evidence for its efficacy. A single-blind pilot study of this therapy suggested that a double-blind placebo-controlled trial was warranted.Methods. Patients with active RA were randomised in a 2 : 1 ratio to receive active treatment or placebo for 25 weeks. The active treatment consisted of intravenous clindamycin in a reducing regime, and oral tetracycline twice daily three times a week. 50 patients were to be recruited. The primary outcome measure was the proportion of patients achieving an ACR20 response.Results. An interim statistical analysis was performed after 20 patients had completed the study. Two patients in the active group achieved an ACR20 response, with none in the placebo group (NS). There was a better ESR20 response in the placebo group (P=.02). There were no other significant differences between the groups. The results indicated that it was unlikely that a significant difference in ACR20 response would emerge if the remaining 30 patients were recruited. The trial was therefore halted.Conclusion. This antibiotic regime is unlikely to be a valuable therapy for active rheumatoid arthritis.

scholarly journals Randomized controlled trial of erdosteine for acute cough in children with colds

2011 ◽  
Vol 51 (2) ◽  
pp. 111
Author(s):  
Yenny Yenny ◽  
Roni Naning ◽  
Amalia Setyati
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Improvement ◽  
Common Cold ◽  
Controlled Trial ◽  
Research Subjects ◽  
Acute Cough ◽  
Chi Square ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference

Background T h e prevalence of the common cold in children is high, v.ith 30% of cases exhibiting an acute cough, the most common complaint by parents. Erdosteine, a recently developed cough medicine, is available for children. Erdosteine has been reported to increase mucodliary clearance, act as an antioxidant and prevent bacterial adhesion.Objective To assess the clinical improvement in acute cough in children \\lith a common cold taking erdosteine vs. a placebo.Methods We conducted a double􀀾blind, randomized, controlled trial at the Public Health Center of Gedongtengen, Yogyakarta with 140 children selected by a consecutive sampling method. Research subjects were randomized by computer program into two treatment groups, those receiving erdosteine therapy and those receiving a placebo. Both groups were monitored for 6 days. A scoring system was used to assess the improvement of acute cough symptoms and analyzed by Chi-square test.Results No significant differences in basic characteristics, cough severity, or environment were found among the 140 children with common cold in the two groups. After 6 days of treatment, no significant difference in clinical improvement of acute cough was found between the erdosteine (65 subjects improved out of 70) and placebo groups (62/70),92.5% and 88.6%, respectively (P=0.382).Conclusion Erdosteine was not more effective than the placebo for treatment of acute cough in children with common cold.

scholarly journals Granisetron versus Granisetron-Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Pediatric Strabismus Surgery: A Randomized Double-Blind Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Renu Sinha ◽  
Dilip Shende ◽  
Souvik Maitra ◽  
Neeraj Kumar ◽  
Bikash Ranjan Ray ◽  
...  
Keyword(s):  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Strabismus Surgery ◽  
Nausea And Vomiting ◽  
Fisher Exact Test ◽  
Double Blind ◽  
Exact Test ◽  
Oculocardiac Reflex ◽  
Significant Difference

Aim.Efficacy of granisetron and combination of granisetron and dexamethasone was evaluated for prevention of postoperative nausea and vomiting (PONV) in children undergoing elective strabismus surgery.Methods.A total of 136 children (1–15 years) were included. Children received either granisetron (40 mcg/kg) [group G] or combination of granisetron (40 mcg/kg) and dexamethasone (150 mcg/kg) [group GD]. Intraoperative fentanyl requirement and incidence and severity of oculocardiac reflex were assessed. PONV severity was assessed for first 24 hours and if score was >2, it was treated with metoclopramide. Postoperative analgesia was administered with intravenous fentanyl and ibuprofen.Results.The demographic profile, muscles operated, and fentanyl requirement were comparable. Complete response to PONV in first 24 hours was observed in 75% (51/68) of children in group G and 76.9% (50/65) of children in group GD, which was comparable statistically (p=0.96, Fisher exact test; OR 1.11, 95% CI 0.50, 2.46). Incidence of PONV between 0 and 24 hours was comparable. One child in group G required rescue antiemetic in first 24 hours and none of the children had severe PONV in group GD. There was no significant difference in incidence or severity of oculocardiac reflex.Conclusion.Dexamethasone did not increase efficacy of granisetron for prevention of PONV in elective pediatric strabismus surgery. Registration number of clinical trial wasCTRI/2009/091/001000.

Apixaban Reduces Hospitalization In Patients With Venous Thromboembolism: An Analysis Of The AMPLIFY-EXT Trial

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3638-3638 ◽  
Author(s):  
Xianchen Liu ◽  
John Thompson ◽  
Hemant Phatak ◽  
Jack Mardekian ◽  
Anthony R. Porcari ◽  
...  
Keyword(s):  
Placebo Group ◽  
Venous Thromboembolism ◽  
Controlled Trial ◽  
Anticoagulation Therapy ◽  
Cox Proportional Hazards ◽  
Employment Equity ◽  
Double Blind ◽  
Significant Difference ◽  
Equity Ownership

Abstract Introduction Venous thromboembolism (VTE) is associated with a considerable risk for morbidity and recurrence and related hospitalizations. In the Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy-Extended Treatment (AMPLIFY-EXT) trial, a double-blind placebo-controlled trial with 12 months of treatment, two doses of apixaban (2.5 mg and 5 mg, twice daily) versus placebo significantly reduced symptomatic recurrent VTE or all-cause death without increasing the rate of major bleeding among 2,482 VTE patients who had completed 6-12 months of anticoagulation therapy. In this study, the effects of apixaban therapy versus placebo on medical hospitalization during AMPLIFY-EXT trial were evaluated. Methods A total of 2,477 patients who received study drugs were included in the analysis. All-cause hospitalizations during the trial were captured by dedicated case report forms. Outcomes of interest were; rate of hospitalizations and time from randomization to the first hospitalization. Patients were censored at either death, loss to follow-up, or end of study, whichever came first. Effects of treatment with apixaban versus placebo on the rates of hospitalization were assessed using Cox proportional hazards regression models. Results During a mean follow-up of 12.3 months, 138 patients were hospitalized at least once, 62 (7.5%/year) in the placebo group (n=826), 42 (4.8%/year) in the apixaban 2.5 mg group (n=840), and 34 (4.0%/year) in the apixaban 5 mg group (n=811). Compared with placebo, apixaban 2.5 mg [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.44–0.96; p=0.030] and 5 mg (HR 0.54, 95%CI 0.36–0.83, p=0.004) were both associated with significant reduction in hospitalization. There was no significant difference in hospitalizations between the 2 doses of apixaban (5 mg vs. 2.5 mg: HR 0.84, 95%CI 0.53–1.32, p=0 .445). The mean time to first hospitalization was 153.7 days in the placebo group, 196.9 days in the apixaban 2.5 mg group, and 202.4 days in the apixaban 5 mg group (Figure). Conclusions Extended anticoagulation with apixaban at either a dose of 5 mg or 2.5 mg significantly reduced the risk of hospitalization, possibly due to the reduction in VTE recurrence. Disclosures: Liu: Pfizer: Employment, Equity Ownership. Thompson:Pfizer: Employment, Equity Ownership. Phatak:BMS: Employment, Equity Ownership. Mardekian:Pfizer: Employment, Equity Ownership. Porcari:Pfizer: Employment, Equity Ownership. Johnson:Pfizer: Employment, Equity Ownership.

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