A randomized trial of tropisetron in the prophylaxis of nausea and vomiting induced by chemotherapy

Thirty patients receiving cisplation or non-cisplatin (containing cyclophosphamide and adriamycin) chemotherapy were enrolled in a randomized, crossover study comparing the efficacy of single dose of Navoban (tropisetron, 5 mg) and Kytril (granisetron, 3 mg). The effective control of acute vomiting induced by cisplatin was achieved in 95.2% (20/21) of patients receiving Navoban and 90.5% (19/21) in those receiving Kytril. Complele control rate was 71.4% (15/21) in Navoban arm, and 81.0% (17/21) in Kytril arm. Total control of delayed vomiting (day 2-5) was 71.4%-90.4% in Navoban arm, while it was 66.7%-4% in Kytril arm. The effective control of vomiting induced by non-cisplatin drugs was achieved in 9/9 in both arms. It is concluded that both agents are effective in the control of vomiting induced by chemotherapy. They have identical adverse effects and are well tolerated by the patients.     

Interaction of Hsp70 chaperones with substrates

The purpose of this study was to examine the effectiveness of progressive muscle relaxation (PMR) in reducing the nausea, vomiting, and anxiety induced by chemotherapy in Japanese patients. Subjects comprised 60 cancer chemotherapy patients who were hospitalized in a cancer center. These subjects were randomly assigned to either the experimental or control group. In addition to routine nursing care, subjects in the experimental received PMR training, while those in the control received contact with the investigator. Results from this study verified the effectiveness of PMR in reducing total scores used to measure nausea, vomiting, and retching; subscale scores of nausea; and subjective feelings of anxiety. The efficacy of PMR to reduce subscale scores of vomiting was not verified, partly due to an extremely low incidence of vomiting.     

Antiemetic efficacy of granisetron in pediatric cancer treatment--(2). Comparison of granisetron and granisetron plus methylprednisolone as antiemetic prophylaxis

A crossover clinical trial was carried out to compare the effectiveness and safety of granisetron alone (40 micrograms/kg) with that from a combination of granisetron plus methylprednisolone (MPL, 10 mg/kg) for control of emesis and vomiting induced by anticancer drugs in children with cancer. Complete control of emesis and vomiting were achieved in 95% (19/20 cases) of patients receiving the combination compared to 85% (17/20 cases) of patients receiving granisetron alone. There were no clinical toxicities or side effects in either treatment group. These data indicated that the combination of granisetron plus MPL was superior for control of emesis and vomiting in children receiving cytostatic anticancer drugs.     

Modern aspects of antiemetic therapy

We summarized the current knowledge about chemotherapy and radiotherapy-induced nausea and vomiting. Nausea and vomiting are among the most frequent side effects in the treatment of malignancies, and they are very unpleasant for the patient. We reviewed basic aetiological and physiological mechanisms (except that of delayed emesis, which is not enough explored), particularly the role of serotonin in acute chemotherapy and radiotherapy-induced nausea and vomiting. An oncologist cannot make many changes in the treatment of malignancies and patient-related prognostic factors, but he (she) can make changes in the treatment of nausea and vomiting in order to improve the quality of life of patients with malignancies. We also listed some of the most widely used antiemetic drugs with their most important pharmacological properties. Important progress in the control of nausea and vomiting was obtained by the use of selective antagonists of 5-HT3-receptors such as ondansetron, granisetron, tropisetron and dolasetron. Usually ondasetron and granisetron were used. Their clinical activity is similar but better results were obtained with the combination of 5-HT3-antagonists and corticosteroids (complete response was approximately 90%) than by their individual use (complete response was approximately 50%). The problem of delayed emesis has not yet been solved, and best results were obtained with the combination of metoclopramide and corticosteroids. For the control of nausea and vomiting caused by radiotherapy, orally given ondansetron is effective.     

Early neuropsychological impairment in HIV-seropositive intravenous drug users: evidence from the Italian Multicentre Neuropsychological HIV Study

The purpose of this study was to document the emetogenic potential of intrathecal chemotherapy (IC) in children and to evaluate the efficacy of ondansetron in reducing nausea and vomiting with this chemotherapy treatment. Patients less than 18 years of age with acute lymphoblastic leukemia were eligible to participate in a survey project measuring the emetogenic potential of various chemotherapy treatments. Patients surveyed for 1 or more IC treatments were included in this report. The IC consisted of methotrexate, hydrocortisone and cytarabine, dosed according to patient age. A nausea/vomiting survey instrument was completed by each patient and/or parent following IC treatment. The instrument rated nausea, vomiting and daily activity interference (DAI) on a 4-point scale of 0 = none, 1 = mild, 2 = moderate and 3 = severe, and collected data on the number of vomiting and/or retching episodes in addition to the child's appetite following the chemotherapy treatment. When ondansetron was employed, it was administered in an i.v. infusion at a dose of 0.15 mg/kg before and after chemotherapy or as an oral dose of 4 mg or 8 mg before chemotherapy. Courses of IC without antiemetics were analyzed to determine the emetogenic potential of IC. For patients receiving IC both with and without ondansetron, courses were compared with each patient used as their own control to determine the influence of ondansetron upon survey responses. Statistical analysis consisted of nonparametric Friedman 2-way ANOVA for ordinal variables and a paired t-test for continuous variables. The binomial test was employed to analyze for differences between ondansetron and no antiemetic in the number of patients with complete control of both nausea and vomiting or vomiting alone. A total of 63 children with a mean age of 7.6 +/- 4.2 years were each studied on one or more occasions. Thirty-seven children were surveyed for 87 IC treatments without antiemetics (group I), and 17 children from this group were surveyed for 48 IC courses with i.v. ondansetron (group IA). An additional 18 children were subsequently surveyed for 39 IC courses with i.v. ondansetron (group II). Fifteen patients (7 of whom were members of group I) were surveyed following 33 IC courses with oral ondansetron (group III). The survey scores for group I patients were: nausea severity 1.3 +/- 1.1, vomiting severity 1.2 +/- 1.1, DAI 1.2 +/- 1.0 and mean number of emetic episodes 4.7 +/- 8.4. The mean appetite score was 1.5 +/- 1.1. For patients in group IA, nausea severity (0.8 +/- 0.9), vomiting severity (0.5 +/- 0.8), DAI (0.7 +/- 0.8), and the number of emetic episodes (1.4 +/- 2.8) were all significantly lower than with prior IC treatments without ondansetron. For complete protection, children receiving i.v. ondansetron had greater complete protection rates from both nausea and vomiting or vomiting alone than did patients receiving no antiemetic. Survey responses were also lower for patients receiving oral ondansetron, but insufficient control data did not allow for statistical analysis. IC results in mild to moderate nausea and vomiting in children. The emetogenic potential of IC is significantly reduced by i.v. ondansetron.     

Comparing the effectiveness of behavioral treatment for chemotherapy-induced nausea and vomiting when administered by oncologists, oncology nurses, and clinical psychologists.

72 cancer patients with anticipatory nausea and vomiting (ANV) were randomly assigned to no-treatment control or to systematic desensitization (SD) from 5 behaviorally trained clinical psychologists, 6 clinical oncologists, or 10 oncology nurses. The treatment was effective in reducing ANV and posttreatment nausea and vomiting compared to control patients, with no significant differences in effectiveness found between clinical psychologists and oncology staff. Although medical personnel should not engage patients in psychotherapy or other interventions that cannot be completed successfully, they can treat patients effectively with SD. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Evaluation of nutritional status by immunologic assessment in bulimia nervosa: influence of body mass index and vomiting episodes

The nutritional status of 21 patients suffering from bulimia nervosa was evaluated by anthropometric and immunologic indexes in comparison with a control group (n = 15). In addition, the influence of body mass index (BMI; in kg/m2) values and vomiting episodes on the nutritional status of bulimic patients was assessed. Anthropometry showed no signs of malnutrition in either group, except for those patients with low weights (BMI < 19). Bulimic patients had lower lymphocyte counts than did control subjects, except for those without vomiting (NVBN). All T lymphocyte subsets tested as well as CD57 cells were lower (22% and 55%, respectively) in bulimic patients than in control subjects, but the CD19 cell subset remained unmodified. The low-weight bulimic group (LWBN) had lower CD4 cell counts than did the normal-weight (BMI > 19) bulimic group. The NVBN group had lymphocyte subpopulations similar to those in the control group, except for CD57, which was lower. The bulimic patients with vomiting had the lowest cell subset values. These results suggest a depleted nutritional status in all bulimic patients studied, even those with normal weights. The LWBN group had the most depleted nutritional status and the NVBN group was least affected at a subclinical level. CD57 can be considered a good marker of nutritional status in this syndrome because it was the only subpopulation altered in all groups.     

Evaluation of the results of cleft lip and palate surgical treatment: preliminary report

We have analysed randomized controlled studies which reported the incidence of postoperative nausea and vomiting (PONV) after propofol anaesthesia compared with other anaesthetics (control). Cumulative data of early (0-6 h) and late (0-48 h) PONV were recorded as occurrence or non-occurrence of nausea or vomiting. Combined odds ratio and number-needed-to-treat were calculated for propofol as an induction or maintenance regimen, early or late outcomes, and different emetic events. This was performed for all control event rates and within a range of 20-60% control event rates. We analysed 84 studies involving 6069 patients. The effect of propofol on PONV was dependent mainly on the method of administration, time of measurement and range of control event rates. When all studies were included the number-needed-to-treat to prevent PONV with propofol was more than 9 when used for induction of anaesthesia and at best 6 when used for maintenance. Within the 20-60% control event rate range, best results were achieved with propofol maintenance to prevent early PONV: the number-needed-to-treat to prevent early nausea was 4.7 (95% confidence interval 3.8-6.3), vomiting 4.9 (4-6.1) and any emetic event 4.9 (3.7-7.1). Within the 20-60% control event rate, of five patients treated with propofol for maintenance of anaesthesia, one will not vomit or be nauseated in the immediate postoperative period who would otherwise have vomited or been nauseated. This may be clinically relevant. In all other situations the difference between propofol and control may have reached statistical significance but was of doubtful clinical relevance. Treatment efficacy should be established within a defined range of control event rates for meaningful estimates of efficacy and for comparisons.     

Conditioned side effects induced by cancer chemotherapy: Prevention through behavioral treatment.

Cancer patients receiving chemotherapy often experience nausea and vomiting that develop as a result of classical conditioning. In order to determine whether this nausea and vomiting could be delayed or prevented, 24 cancer patients were randomized either to a group that received progressive muscle relaxation training (PMRT) plus guided imagery (GI), or to a no-treatment control group. Relaxation training sessions were held before the initiation of chemotherapy and during the first three chemotherapy treatments. Results indicated that patients receiving PMRT and GI had significantly less nausea and vomiting and significantly lower blood pressures, pulse rates, and dysphoria, especially anxiety, than did control patients. Nurse observations corroborated patient reports. These data suggest that early training in PMRT and GI can reduce and perhaps prevent the development of conditioned nausea and vomiting, and can alleviate high anxiety levels in cancer patients who receive emetogenic chemotherapy. (16 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Management of nausea and vomiting in children

When children experience nausea and vomiting (N/V) as side effects of anesthesia or chemotherapy, a major role for nurses is to promote comfort. In addition to the discomfort of N/V in children, other detrimental effects include dehydration, weight loss, fluid and electrolyte imbalance, and emotional distress. This article describes the physiological pathways through which the vomiting center is stimulated to cause nausea and vomiting and identifies appropriate interventions for blocking these pathways using both pharmacological and nonpharmacological means. Medications used to control nausea and vomiting, including phenothiazines, substituted benzamide, corticosteroids, benzodiazepines, antihistamines, and serotonin antagonists, are discussed. Nonpharmacological interventions that are described include reducing anxiety, music therapy, hypnosis, progressive muscle relaxation, dietary modifications, and acupressure.     

JC virus detection in the cerebrospinal fluid of AIDS patients with progressive multifocal leucoencephalopathy and monitoring of the antiviral treatment by a PCR method

Data from two published and one new meta-analysis were reviewed to compare the antiemetic efficacy of three different anaesthetic regimens: (i) propofol anaesthesia compared with another anaesthetic (control); (ii) anaesthesia without nitrous oxide compared with the same anaesthetic with nitrous oxide (control); (iii) propofol anaesthesia without nitrous oxide (TIVA) compared with another anaesthetic with nitrous oxide (control). Efficacy (prevention of postoperative nausea and vomiting compared with control) was estimated using odds ratio and number-needed-to-treat methods, and compared within a range of 20-60% control event rates for early efficacy (0-6 h) and 40-80% for late efficacy (0-48 h). Propofol anaesthesia or omitting nitrous oxide had similar effects on vomiting, both early and late. Propofol (but not omitting nitrous oxide) decreased the incidence of nausea. TIVA studies were documented poorly; appropriate comparison with other interventions were not possible. Efficacy of treatments should be compared within a setting-specific range of control event rates. There is insufficient evidence that TIVA with propofol is an anaesthetic technique with a low emetogenic potency.     

Epidural buprenorphine and epidural droperidol for post-operative nausea or vomiting

For 120 young patients who had undergone reconstruction of anterior cruciate ligament of the knee, we investigated the effect of epidural administration of buprenorphine on the incidence of nausea or vomiting, and the anti-emetic effect of epidural administration of droperidol. In the group who had received bolus injection of buprenorphine 0.1 mg, nausea or vomiting occurred early most often, and the injection was not useful to prolong analgesic effect. In the another group who had received continuous epidural infusion of buprenorphine 0.3 mg, nausea or vomiting occurred late. Bolus injection of droperidol 2.5 mg was not useful to prevent nausea or vomiting caused by continuous epidural infusion of buprenorphine. While, continuous infusion of droperidol 5 mg was effective in decreasing nausea or vomiting caused by continuous epidural infusion of buprenorphine. In conclusion, continuous epidural administration of droperidol is useful to prevent nausea or vomiting.     

Cognitive-behavioral and response-prevention treatments for bulimia nervosa.

This study was designed to assess the additive effects of major components of cognitive-behavioral treatment for bulimia nervosa. Seventy-seven female patients with bulimia nervosa were allocated at random to one of four conditions: wait-list control, self-monitoring of caloric intake and purging behaviors, cognitive-behavioral treatment, and cognitive-behavioral treatment combined with response prevention of vomiting. In the treatment conditions, participants were seen individually for fourteen 1-hr sessions over a 4-month period. All the treatment groups showed significant improvement, whereas the wait-list control group did not. Cognitive-behavioral treatment was, however, the most successful in reducing purging and in promoting positive psychological changes. Fifty-six percent of participants in this condition ceased binge eating and purging by the end of treatment, and the frequency of purging declined by 77.2% during the same period. Of the three treatment conditions, only cognitive-behavioral treatment was superior to the wait-list control. At the 6-month follow-up, 59% of the cognitive-behavioral group were abstinent, and purging had declined by 80%. Cognitive-behavioral treatment was significantly superior to the other treatment groups at this time. Thus, the addition of response prevention of vomiting did not enhance the efficacy of cognitive-behavioral treatment, and the evidence suggests that it may have had a deleterious effect. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Results of a genome-wide genetic screen for panic disorder

There is some controversy over whether or not a discrete site that integrates vomiting activities in somatic and autonomic nerves is present in the medulla oblongata. On the basis of our previous studies, we hypothesized that the temporal patterns of muscle contractions in vomiting are generated by a central pattern generator in the retrofacial area of the rostral medulla. To investigate this hypothesis further, the effects of electrical and chemical lesions of the medullary area were observed in decerebrate paralyzed dogs. Efferent activities of the phrenic and abdominal muscle nerves were recorded to recognize fictive vomiting. The right half of the medulla oblongata was transversely severed about 3 mm rostral to the obex. Fictive vomiting responses to vagal stimulation still appeared after hemisection in all 11 dogs. In addition, stimulation of the contralateral reticular area dorsomedial to the retrofacial nucleus produced fictive vomiting even after hemisection. An electrical lesion or injection of kainic acid (0.5-1.0 microl) was applied at the point where reticular stimulation induced fictive vomiting. After this destruction, no activities that corresponded to fictive vomiting could be induced by stimulation of vagal afferents or the reticular site. Salivation was decreased by hemisection, and decreased further, but was not completely abolished, with destruction of the reticular area. Kainic acid is known to selectively destroy neural cell bodies. Therefore, we concluded that neuronal somata in the reticular formation dorsomedial to the retrofacial nucleus play an essential role in the central patterning of vomiting activities in peripheral motor nerves.     

Tuberculosis control in the face of the HIV epidemic

A retrospective survey of postoperative nausea and vomiting (PONV) in the recovery room over a five year period was conducted, followed by a prospective study of 200 adult patients to estimate the incidence and predisposing factors to nausea and vomiting during the first 24 hours after anaesthesia and surgery in Nigerians. In the retrospective study only records of 61 patients (0.79%) out of the 7714 post anaesthetic recovery room charts reviewed revealed documentation of vomiting. These were 20 males (32.8%) and 41 females (67.2%). In the prospective study, the incidence of post operative nausea and vomiting within twenty four hours of surgery was 41.6% and 19.6%, respectively. But only two out of 39 patients (one per cent) vomited within the first three hours in postoperative period. The frequency of vomiting varied from one to 15 times and women had significantly more emetic symptoms than men (p < 0.05). Preoperative administration of pethidine and morphine was associated with postoperative nausea and vomiting. It is suggested that Nigerian women should be considered for prophylactic anti-emetic therapy, especially when narcotic analgesic are to be employed in their anaesthetic management.     

Problem dieting behaviors among young adolescents

OBJECTIVE: To examine dieting, eating and exercise behaviors, use of diet pills, and vomiting or use of laxatives to lose weight among younger adolescents. DESIGN: Analysis of data from a modified version of the Youth Risk Behavior Survey administered to middle school students in North Carolina in 1995. SETTING: Fifty-three randomly selected middle schools in North Carolina. SUBJECTS: Two thousand three hundred thirty-one students in the sixth, seventh, and eighth grades. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Responses to questions regarding weight control practices, including vomiting or laxative use, dieting, exercise, or diet pill use. RESULTS: Of the students surveyed, 110 (9.7%) of the girls and 46 (4.0%) of the boys reported vomiting or using laxatives to lose weight. Among the girls, vomiting or laxative use was associated with feeling overweight, other weight loss practices, older age, being a poor student, smoking, eating more salads or vegetables, and eating more candy or other sweets (P< or =.01). A logistic regression model consisting of diet pill use, dieting to lose weight, lower academic achievement, and currently trying to lose weight correctly classified 92% of female students who had or had not vomited or used laxatives. Among boys, vomiting or laxative use was associated with feeling overweight, other weight loss practices, minority racial status, smoking, frequency of eating hamburgers or other high-fat meats, and frequency of eating french fries or potato chips (P< or =.01). A model consisting of diet pill use, minority race, dieting to lose weight, smoking, feeling overweight, and number of servings of hamburgers, hot dogs, or barbecue correctly classified 97% of the boys who had or had not vomited or used laxatives. CONCLUSION: Younger adolescents trying to lose weight engage in a variety of problem dieting and weight loss behaviors that can compromise health and may be associated with eating disorders.     

Pharyngocutaneous fistula following total laryngectomy and post-operative vomiting

The significance of post-operative vomiting as a risk factor in the development of a pharyngocutaneous fistula was examined. The case records of 50 consecutive patients undergoing laryngectomies (39 men, 11 women, average age 64 years) were examined, 17 also underwent a simultaneous radical neck dissection. A fistula developed in eight patients (16%) and the median time to its diagnosis was 11 days (range 3-15 days). Several potential risk factors were examined including age, gender, previous radiotherapy, TNM stage, differentiation of tumour, simultaneous radical neck dissection and also the occurrence of vomiting post-operatively. In this series of patients only vomiting in the early post-operative period appeared to be related to the development of a fistula (regression summary: R2 = 0.6, t-value 5.6, P < 0.0001). An episode of vomiting was recorded in eight patients and of these six (75%) subsequently developed a fistula. The median time of post-operative vomiting was 7.5 days (range 1-10 days) and the diagnosis of a fistula occurred at a mean of 1.2 +/- 0.4 days after the episode of vomiting. In a study of this nature it is not possible to conclude that a causal relationship exists between vomiting and fistula development. However, if this is the case a potential means of decreasing the incidence of fistulae following laryngectomy may be available.     

Assistive technology in Tennessee

OBJECTIVES: To compare two activated charcoal preparations (Carbomix and Actidose-Aqua) in terms of amount ingested and incidence of vomiting after ingestion. METHODS: Single blinded prospective randomised controlled trial. RESULTS: The mean amount of charcoal ingested was Carbomix 26.5 g, Actidose-Aqua 19.5 g. The mean difference was 7 g (95% confidence interval (CI) 1.5 to 12.4 g). The incidence of vomiting was for the Carbomix 6% and the Actidose-Aqua 8%. The mean difference in vomiting was 2% (95% CI -0.8 to 4.8) CONCLUSIONS: Carbomix administration results in an increased amount of activated charcoal ingested after oral administration. Rates of vomiting after activated charcoal administration were low when compared with previously reported rates.     

Observation of relationship between gastric filling and vomiting during chemotherapy

The purpose of studying the relationship between degree of gastric filling and vomiting during chemotherapy is to reduce the occurrence of vomiting. 42 patients were selected to give intravenous chemotherapy at 3-4 h after a small simple breakfast. The result showed that there was a relationship between the degree of gastric filling and vomiting during chemotherapy.     

Use of oral and intravenous ondansetron in patients treated with cisplatin

Ondansetron, a selective 5-HT3 antagonist, has been shown to be effective in preventing chemotherapy-induced nausea and vomiting. From July and August 1991, 25 patients were accrued in a phase II study to assess the efficacy of ondansetron in patients receiving cisplatin-containing chemotherapy. Patients received intravenous cisplatin 100 mg/m2, given either as a 24-hour infusion on day 1 or in divided doses as eight-hour infusions daily on days 1 to 3. Each patient received 24 mg of ondansetron per day for six days. Intravenous dexamethasone 24 mg was given daily on the days of cisplatin infusion. The emetic episodes and degree of nausea were evaluated daily. "Good" control of emesis (0-2 episodes of vomiting) and nausea (mild or no nausea) ranged from 64-100% and 88-100% respectively. Failure in emesis control occurred most frequently on days 3 and 4. Ondansetron was generally well tolerated with only minimal side-effects. One patient developed unexplained encephalopathy which resolved completely. Our results suggest that ondansetron is an effective anti-emetic agent with minimal toxicities. Randomised studies comparing ondansetron against "standard" anti-emetics should be conducted.