Ramosetron for the Prevention of Cisplatin-Induced Acute Emesis: A Prospective Randomized Comparison with Granisetron

2002 ◽  
Vol 30 (3) ◽  
pp. 220-229 ◽  
Author(s):  
YK Kang ◽  
YH Park ◽  
BY Ryoo ◽  
YJ Bang ◽  
KS Cho ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Patient Compliance ◽  
Adult Patients ◽  
Nausea And Vomiting ◽  
Blind Study ◽  
Acute Emesis ◽  
Significant Difference ◽  
Equivalent Efficacy ◽  
To Receive ◽  
Single Blind

Control of nausea and vomiting is very important in determining patient compliance with cisplatin chemotherapy. A multicentre, randomized, single-blind study was conducted to compare the tolerability and efficacy of ramosetron with those of granisetron over 24 h following cisplatin administration to cancer patients. In eight study centres, a total of 194 adult patients were randomly assigned to receive either intravenous ramosetron 0.3 mg or intravenous granisetron 3.0 mg. The anti-emetic effect of ramosetron determined from the no-vomiting rate lasted longer, but there was no significant difference in the number of acute vomiting episodes or the severity of nausea between the two groups. In the tolerability evaluation, there were no statistically significant differences between the two groups, except for a higher incidence of dull headache in the granisetron group. Ramosetron and granisetron appear to have equivalent efficacy and tolerability profiles, but the effects of ramosetron on the prevention of acute vomiting in patients undergoing cisplatin chemotherapy were longer lasting.

scholarly journals The Effects of a Preoperative Steroid/Anesthetic Injection on Post-Tonsillectomy Pain

2003 ◽  
Vol 82 (4) ◽  
pp. 305-308 ◽  
Author(s):  
Timothy M. Cupero ◽  
Sam Y. Kim ◽  
Andrew B. Silva
Keyword(s):  
Statistical Analysis ◽  
Postoperative Pain ◽  
Active Treatment ◽  
Generalized Estimating Equations ◽  
Blind Study ◽  
Significant Difference ◽  
The Right ◽  
And Control ◽  
To Receive ◽  
Single Blind

We conducted a placebo-controlled, single-blind study to determine the efficacy of a local preoperative injection of a steroid/anesthetic combination in preventing post-tonsillectomy pain. We randomized 21 adults to receive either triamcinolone/bupivacaine on the left side and saline on the right or vice versa. Injections were administered in the area of the tonsillar pillars following intubation and prior to tonsillectomy. Based on the “generalized estimating equations” model of statistical analysis, we found no significant difference in the degree of postoperative pain between the active-treatment and control sides.

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

Study of a New Analgesic Compound in the Treatment of Tension Headache*

1976 ◽  
Vol 4 (1) ◽  
pp. 74-78 ◽  
Author(s):  
J Borges ◽  
C Zavaleta
Keyword(s):  
Side Effects ◽  
Pharmacological Activity ◽  
Clinical Success ◽  
Tension Headache ◽  
Symptomatic Treatment ◽  
Blind Study ◽  
Effective Combination ◽  
Significant Difference ◽  
Starting Dose ◽  
Single Blind

The effect of a new analgesic compound ( propoxyphene, acetaminophen, caffeine, hydroxyzine) was investigated in a single-blind study comparing it with plain acetaminophen administered to forty patients with tension headache. For the study, patients were assigned to one of two groups of twenty each. Starting dose for each group was one to two tablets followed by one tablet every four to six hours. The results show that 90% clinical success was obtained with the analgesic compound, while a 45% success was obtained with plain acetaminophen. This is a statistically significant difference. Side-effects observed with analgesic compound were primarily drowsiness and dizziness of mild intensity; acetaminophen caused gastro-intestinal alterations ( nausea, vomiting) and dizziness of greater severity. Therapy was withdrawn in 20% of patients taking acetaminophen because of side-effects. The dosage of analgesic compound required to control each episode of tension headache way smaller than that of acetaminophen. These results can be explained by a possible potentiation of pharmacological activity of the compound's components. It can be concluded that the analgesic compound is a new and effective combination for the symptomatic treatment of tension headache.

scholarly journals Effect of ginger tea on chemotherapy-induced nausea and vomiting among cancer patients in selected hospitals, Bhubaneswar, Odisha

2020 ◽  
Vol 11 (1) ◽  
pp. 1165-1171
Author(s):  
Sasmita Das ◽  
Mary Preety Banra ◽  
Neethu Maria Joseph
Keyword(s):  
Cancer Patients ◽  
Research Design ◽  
Demographic Data ◽  
Large Population ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Food Component ◽  
Significant Difference ◽  
Chi Square Analysis ◽  
And Control

A quasi-experimental research study (posttest only research design) was conducted to evaluate the effect of ginger tea on chemotherapy-induced nausea and vomiting among cancer patients in selected hospitals of Bhubaneswar and to find out the association of level of chemotherapy-induced nausea and vomiting with selected socio-demographic variables. For this study, a quantitative experimental approach and post-test only research design was adopted. 100 patients were selected by convenience sampling technique and categorized into experimental (n=50) and control group (n=50) for this study. Self- structured socio-demographic proforma and self- structured record analysis proforma was used to collect socio-demographic data and modified nausea and vomiting scale was used to measure the level of chemotherapy-induced nausea and vomiting among cancer patients. The data was analyzed by using SPSS version 20.0 (Statistical Package for the Social Science). The post-testt level of chemotherapy-induced nausea and vomiting among experimental and control groups was compared by unpaired‘t’ test and the result showed (p=<0.0001) significant difference between both groups. The chi-square analysis shows a statistically significance association between chemotherapy-induced nausea and vomiting and the emetogenic potential of the drug in both groups and in control group age was also significance associated. The ANOVA test revealed the statistically significance of the posttest level of chemotherapy-induced nausea and vomiting within groups of the emetogenic potential of a drug. The present study concluded that the food component, like ginger tea, is an effective home remedy for the reduction of chemotherapy-induced nausea and vomiting among cancer patients. Further study can be conducted with a large population, different dose and compositions of ginger and with different adjuvant therapy to manage nausea and vomiting among cancer patients.

High-dose intravenous metoclopramide versus combination high-dose metoclopramide and intravenous dexamethasone in preventing cisplatin-induced nausea and emesis: a single-blind crossover comparison of antiemetic efficacy.

1985 ◽  
Vol 3 (2) ◽  
pp. 245-251 ◽  
Author(s):  
S B Strum ◽  
J E McDermed ◽  
D F Liponi
Keyword(s):  
Patient Preference ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Chemotherapy Response ◽  
Antiemetic Efficacy ◽  
Study Results ◽  
Nausea And Emesis ◽  
To Receive ◽  
Single Blind ◽  
Crossover Comparison

We tested the safety and antiemetic effectiveness of intravenous (IV) dexamethasone (DXM) as an adjunct to high-dose IV metoclopramide (MCP) to prevent nausea and vomiting induced by high-dose cisplatin chemotherapy. Response was determined by using objective and subjective criteria. Thirty patients were randomly assigned to receive MCP alone at a dose of 2 mg/kg IV for three doses or the same dose of MCP plus 20 mg of DXM IV for three doses. Twenty evaluable patients received a second course of cisplatin and were crossed over to the opposite arm. Study results did not show a statistically significant advantage of combination MCP plus DXM over MCP alone using strict objective criteria for antiemetic response. However, patients subjectively preferred MCP plus DXM over MCP alone by nearly a 6:1 ratio, regardless of the randomization sequence. Although the addition of DXM does not appear to objectively improve emetic protection with high-dose MCP, we recommend MCP plus DXM to prevent nausea and vomiting induced by high-dose cisplatin chemotherapy when the use of steroids is not contraindicated, in view of patient preference for the combination.

Antihypertensive Effect of Oxprenolol and Chlorthalidone in Fixed Combination, Given Once Daily

1979 ◽  
Vol 7 (6) ◽  
pp. 519-523 ◽  
Author(s):  
R Buoninconti ◽  
M Motolese ◽  
M Rubegni
Keyword(s):  
Clinical Response ◽  
Patient Compliance ◽  
Moderate Hypertension ◽  
Antihypertensive Effect ◽  
Fixed Combination ◽  
Once Daily ◽  
Patient Study ◽  
Treatment Regimes ◽  
Significant Difference ◽  
Single Blind

In a multicentre, single-blind, within-patient study, the effectiveness and tolerability of the fixed combination oxprenolol 80 mg + chlorthalidone 10 mg per tablet given once daily, compared to the well established b.i.d. schedule, has been investigated in forty out-patients with mild to moderate hypertension. After a two-weeks placebo wash-out, twenty patients were given 1 tablet b.i.d. of the fixed combination for 4 weeks and thereafter 2 tablets once-daily for a further 4 weeks; the remaining twenty patients were given the fixed combination in the reverse order. There was no significant difference in clinical response between the two treatment regimes, which were equally effective and well tolerated. However, patient compliance might be considerably improved with the once-daily dosage schedule of the fixed combination.

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.

Short-course olanzapine to prevent delayed emesis following carboplatin/paclitaxel for gynecologic cancer: a randomised study

2019 ◽  
Vol 105 (3) ◽  
pp. 253-258 ◽  
Author(s):  
Luigi Celio ◽  
Gabriella Saibene ◽  
Stefano Lepori ◽  
Fabrizio Festinese ◽  
Monica Niger ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Small Sample Size ◽  
Gynecologic Cancer ◽  
Small Sample ◽  
Delayed Emesis ◽  
Randomised Study ◽  
Patient’S Satisfaction ◽  
Acute Emesis ◽  
Short Course ◽  
Significant Difference

Purpose: To explore efficacy of short-course olanzapine with or without low-dose dexamethasone for prevention of delayed emesis in gynecologic cancer patients receiving carboplatin/paclitaxel. Methods: This was a prospective study in 81 chemo-naive patients receiving 0.25 mg intravenous palonosetron, 16 mg dexamethasone, and 10 mg oral olanzapine before chemotherapy. On days 2 and 3, patients randomly received 10 mg olanzapine (arm A; n=27), 10 mg olanzapine plus 4 mg dexamethasone (arm B; n=27), or 8 mg dexamethasone (reference arm C; n=27). The primary endpoint was total control (TC; no vomiting, no rescue antiemetics, and no nausea) on days 2–5, using a diary. Secondary endpoints included proportion of patients with no emesis impact on daily life using the Functional Living Index–Emesis (FLIE) questionnaire, and patient’s satisfaction with antiemetic coverage. Results: Fifty-two percent of patients in arm A ( P=0.406), 59% in arm B ( P=0.779), and 67% in arm C had a delayed TC. Secondary analyses showed no significant difference across arms in any efficacy endpoint. FLIE scores as well as mean satisfaction scores were similar across arms. Conclusions: In this exploratory study with a small sample size, we did not find any clue about better control of delayed emesis with either olanzapine regimen in gynecologic cancer patients treated with carboplatin/paclitaxel and receiving the same prophylaxis for acute emesis.

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