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Granisetron vs dolasetron for acute chemotherapy-induced nausea and vomiting (CINV) in high and moderately high emetogenic chemotherapy: an open-label pilot study.

OBJECTIVE: Comparative studies examining the use of oral serotonin type 3 (5-HT(3)) receptor antagonists for the management of acute chemotherapy-induced nausea and vomiting (CINV) are limited. Therefore, we performed an experiential open-label pilot study at Stony Brook Hospital to allow clinicians to make informed formulary decisions at our institution and to stimulate further study. Specifically, the objective of this study was to compare the effectiveness of oral granisetron versus oral dolasetron for prophylaxis of acute CINV. RESEARCH DESIGN AND METHODS: The study was conducted during the period of 1 February 2001 to 31 March 2001. Patients (n = 26) with lymphoma or malignancies of the lungs, larynx, or uterus undergoing moderately high and highly emetogenic chemotherapy were studied. Patients admitted during February (n = 13) were administered a single oral dose of 100 mg of dolasetron; those admitted in March (n = 13) received a single oral dose of 2mg of granisetron. All patients were administered intravenous dexamethasone 20 mg before the initiation of chemotherapy. MAIN OUTCOME MEASURES: Patients were monitored for at least 24 h by clinicians. The data recorded for each patient included age, sex, the number of episodes of nausea and emesis, the intensity of nausea (when applicable), and the number of doses of rescue antiemetic medication administered (when applicable). RESULTS: Overall, granisetron provided significantly greater control of acute CINV than dolasetron. More patients treated with granisetron experienced total control of nausea and vomiting (69.2 vs 23.1%, p < 0.05). Fewer granisetron-treated patients experienced emesis (7.7 vs 53.8%, p < 0.05) and nausea (30.8 vs 76.9%, p < 0.05). Of those patients who experienced nausea, intensity was significantly less with granisetron than with dolasetron (p < 0.05). Consequently, a significantly greater proportion of patients treated with dolasetron required a rescue antiemetic and significantly more doses of rescue antiemetics (both p < 0.01). CONCLUSIONS: These data suggest that oral granisetron may demonstrate improved CINV outcomes compared with oral dolasetron in patients undergoing moderately high and highly emetogenic chemotherapy.

Antiemetics↗

Impact of nausea and vomiting on quality of life in cancer patients during chemotherapy.

It is commonly claimed that the nausea and vomiting accompanying cytotoxic chemotherapy have a negative impact on health-related quality of life. While this may seem self-evident, until a few years ago there was little empirical data demonstrating that the failure to control postchemotherapy emesis affects aspects of quality of life. In spite of their limitations, several observational studies showed that nausea and vomiting associated with chemotherapy induced a decrease in health-related quality of life with respect to patients without nausea and vomiting. This has also been demonstrated after the adjustment for health-related quality of life before chemotherapy that is an important prognostic factor of chemotherapy-induced nausea and vomiting. Furthermore, one study suggests that the optimal time of assessment of quality of life to evaluate the impact of chemotherapy-induced nausea and vomiting is day 4 if a 3-day recall period is used or day 8 when the recall period is 7 days. In double-blind studies the efficacy, tolerability and impact on quality of life of the 5-HT3 receptor antagonists was superior with respect to metoclopramide, alizapride and prochlorperazine. Similar results have been achieved with the combination of ondansetron with dexamethasone, the standard treatment for the prevention of acute emesis induced by moderately emetogenic chemotherapy, with respect to the metoclopramide plus dexamethasone combination. Instead, in another double-blind study, in patients submitted to moderately emetogenic chemotherapy, a 5-HT3 antagonist did not seem to significantly increase complete protection from delayed emesis and the patients' quality of life with respect to dexamethasone alone. In conclusion, the evaluation of quality of life in randomized trials comparing different antiemetic drugs for the prevention of chemotherapy-induced nausea and vomiting can add important information useful for the choice of the optimal antiemetic treatment.

Antiemetics↗

Clinical characteristics associated with the development of anticipatory nausea and vomiting in cancer patients undergoing chemotherapy treatment.

Approximately one in four patients experiences nausea and/or vomiting in anticipation of a chemotherapy treatment by the time of their fourth treatment cycle. Anticipatory nausea and vomiting is a prevalent problem of clinical significance in the total management of chemotherapy side effects. While refractory to standard antiemetic treatment, anticipatory nausea and vomiting has been successfully treated with behavioral approaches such as systemic desensitization. The present study was designed to identify the characteristics of patients at high risk for developing anticipatory side effects. Early identification of cancer patients prone to developing anticipatory side effects could lead to preventive measures. One hundred seventy-six consecutive ambulatory patients with histologically confirmed cancer who were being treated at three geographically separate hospitals of the University of Rochester Cancer Center were studied at the time of their fourth chemotherapy treatment. Patients found to experience anticipatory nausea and vomiting were significantly more likely (P less than .001) to have four or more of the following characteristics than patients who did not report anticipatory side effects: (1) less than 50 years of age; (2) the experience of nausea and/or vomiting after their last chemotherapy treatment; (3) a description of nausea after the last treatment as "moderate, severe, or intolerable"; (4) a description of vomiting after the last treatment as "moderate, severe, or intolerable"; (5) the reporting of the side effect "warm or hot all over" after their last treatment; (6) a susceptibility to motion sickness; (7) the experience of "sweating after their last treatment"; (8) and the experience of "generalized weakness after their last chemotherapy treatment." Results support a view that anticipatory side effects are conditioned and point to practical interventions for their clinical control.

Antineoplastic Agents↗

Prevention of adjustment disorders and anticipatory nausea secondary to adjuvant chemotherapy: a double-blind, placebo-controlled study assessing the usefulness of alprazolam.

PURPOSE AND METHODS: Although a high prevalence of adjustment disorders and anticipatory nausea secondary to adjuvant chemotherapy (CT) has been reported, little has been done to develop strategies to prevent these problems. A double-blind, placebo-controlled study was therefore designed to assess the usefulness of adding low-dose alprazolam (0.5 mg to 2 mg per day) to a psychologic support program including progressive relaxation training designed to prevent the aforementioned conditions. Fifty-seven women undergoing adjuvant CT for stage II primary breast cancer agreed to participate in the assessment, which was conducted at four time points: before starting CT, 6 weeks after CT, before the fourth CT, and after the fourth CT. The Hospital Anxiety and Depression Scale (HADS), Montgomery and Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Scale (HAS), Revised Symptom Checklist (SCL-90-R), Morrow Assessment of Nausea and Emesis (MANE), and World Health Organization (WHO) grading of acute and subacute toxicities were used to compare the alprazolam (AA) and placebo (PA) arms of the study. RESULTS: At the second evaluation, the results showed a higher rate of anticipatory nausea (18% v 0%) in the PA compared with the AA arm (P = .038). These differences were no more significant at each of the further assessments. Significant differences were found for the intake of hypnotics at each assessment visit, with the rate of hypnotic users being significantly higher in the PA (19%) compared with the AA (0%) arm at the fourth assessment (P < .05). Anxiety and depression scores of self- and observer-report were similar in the two arms. A significant relationship was found between the development of anticipatory nausea and the self-report of anxiety and depression score measured by HADS at baseline. The average HADS total score at baseline was 15.33 (SD = 6.56) for patients who developed anticipatory nausea and 11.23 (SD = 6.67) for other patients. CONCLUSION: The adjunct of alprazolam to a psychologic support program delays the occurrence of anticipatory nausea and controls sleeping problems secondary to adjunct CT. Although studies are needed to improve the efficacy reported here, physicians may already consider the use of alprazolam for cancer patients undergoing CT.

Adjustment Disorders↗

Transdermal scopolamine for the reduction of postoperative nausea in outpatient ear surgery: a double-blind, randomized study.

We evaluated the effect of transdermal scopolamine on the incidence of postoperative nausea and vertigo after outpatient ear surgery (exploratory tympanotomy, mastoidectomy, or endolymphatic sac and oval and round window surgery) in a double-blind, placebo-controlled study. A transdermal patch containing either scopolamine (n = 19) or placebo (n = 20) was placed behind the nonsurgical ear 2 h before surgery. Anesthesia was induced with thiopental (4-6 mg/kg intravenously [i.v.]), sufentanil (0.5 microgram/kg i.v.), and vecuronium (0.1 mg/kg i.v.) and maintained with isoflurane (0.2%-2%) and nitrous oxide (70%) in oxygen. Patients were observed postoperatively in the recovery room and after discharge for 72 h. There was no significant difference between groups with respect to time in recovery room, time to discharge, incidence of in-house nausea, vomiting, amount of antiemetics required, or postoperative visual analog scale (VAS) scores while in the hospital. After discharge, there were lower VAS nausea scores (by repeat measures analysis, P < 0.05) and a lower reported incidence of nausea (31% vs 62%; P < 0.05) and vertigo (6.2% vs 25%; P < 0.05) in the active patch group versus the placebo group. There was a higher incidence of dry mouth in the active patch group (44% vs 25%). Seven patients did not complete the study due to failure to keep the patch in place or failure to return the diary from home; and one patient from the placebo patch group was admitted for uncontrolled nausea and vomiting. The authors concluded that transdermal scopolamine is effective in reducing, but not eliminating, postoperative nausea and vertigo after discharge in outpatient ear surgery.

Administration, Cutaneous↗

Does neostigmine administration produce a clinically important increase in postoperative nausea and vomiting?

Neostigmine is used to antagonize neuromuscular blocker-induced residual neuromuscular paralysis. Despite the findings of a previous meta-analysis, the effect of neostigmine on postoperative nausea and vomiting remains unresolved. We reevaluated the effect of neostigmine on postoperative nausea and vomiting while considering the different anticholinergics as potentially confounding factors. We performed a systematic literature search using MEDLINE, Embase, Cochrane library, reference listings, and hand searching with no language restriction through December 2004 and identified 10 clinical, randomized, controlled trials evaluating neostigmine's effect on postoperative nausea and vomiting. Data on nausea or vomiting from 933 patients were extracted for the early (0-6 h), delayed (6-24 h), and overall (0-24 h) postoperative periods and analyzed with RevMan 4.2 (Cochrane Collaboration, Oxford, UK) and multiple logistic regression analysis. The combination of neostigmine with either atropine or glycopyrrolate did not significantly increase the incidence of overall (0-24 h) vomiting (relative risk, 0.91; 95% confidence interval, 0.70-1.18; P = 0.48) or nausea (relative risk, 1.24; 95% confidence interval, 0.98-1.59; P = 0.08). Multiple logistic regression analysis indicated that there was not a significant increase in the risk of vomiting with large compared with small doses of neostigmine. Contrasting a previous analysis, we conclude that there is insufficient evidence to conclude that neostigmine increases the risk of postoperative nausea and vomiting.

Humans↗

The twenty-degree reverse-Trendelenburg position decreases the incidence and severity of postoperative nausea and vomiting after thyroid surgery.

BACKGROUND: In this randomized, single-blind, controlled study, we evaluated whether the 20 degrees reverse-Trendelenburg position had an effect on postoperative nausea and vomiting in patients undergoing thyroid surgery. METHODS: Patients (n = 224) were given a standardized propofol anesthetic. Intraoperatively, patients were randomly assigned into two groups according to the tilt of the table maintained during surgery: patients were positioned with the neck extended and the table tilted with 20 degrees reverse-Trendelenburg or with the neck extended and the table positioned at a horizontal tilt. All episodes of postoperative nausea, vomiting, nausea severity score, frequency of vomiting, and the use of antiemetics were recorded during the first 24 h after anesthesia. We divided this time period into 0-3 h and 3-24 h. RESULTS: During the 0-3 h postoperative period, all observed episodes were comparable between groups. However, during the 3-24 h and the overall postoperative period, the incidence of nausea and/or vomiting, the nausea severity score, and frequency of vomiting were significantly less in the 20 degrees reverse-Trendelenburg position. CONCLUSION: The 20 degrees reverse-Trendelenburg position effectively ameliorates postoperative nausea and/or vomiting.

Adult↗

The psychophysiology of nausea.

Nausea is an unpleasant sensation usually referred to the stomach and sometimes followed by vomiting. Little is known about the subjective aspects of nausea because like pain and fatigue, it is a private sensation. We conceive of nausea as a complex control mechanism that signals us when not to eat. Our research in the areas of motion sickness and chemotherapy has led us to propose that we each have a dynamic threshold for nausea, which depends on the interaction of inherent factors and more changeable psychological factors, and that this threshold effects the individual's cognitive appraisal of both the nauseogenic stimulus and his/her bodily change in response to the nauseogenic stimulus. Inherent factors that are described are age, gender and race; psychological factors that are included are anxiety, expectation, anticipation and adaptation. The physiological responses that have been found to accompany nausea include an increase in sympathetic nervous system activity, a decrease in parasympathetic activity, an increase of abnormal dysrhythmic gastric activity, and an increase in plasma vasopressin. It is concluded that beneficial selective reduction of nausea will depend on a greater knowledge of the interaction of the psychological and physiological variables.

Humans↗

Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents.

STUDY OBJECTIVE: To develop and validate an instrument to assess nausea intensity in children aged 4-18 years. DESIGN: Prospective, descriptive study. SETTING: Tertiary-quaternary, university-affiliated pediatric hospital. PATIENTS: Four pediatric inpatient groups (177 patients): group 1 (107), those receiving cancer chemotherapy; group 2 (24), those receiving cancer chemotherapy before hematopoietic stem cell transplantation; group 3 (23), those with cancer who were not receiving cancer chemotherapy; and group 4 (23), those without cancer. INTERVENTION: We developed a scale with a standard script for administration, the Pediatric Nausea Assessment Tool (PeNAT). Revisions were made after face validity testing with clinicians and parents, and pilot testing with 15 inpatients undergoing chemotherapy. MEASUREMENTS AND MAIN RESULTS: The PeNAT scores were obtained 4-24 hours after chemotherapy in groups 1 and 2. Dietary intake scores and number of emetic episodes were recorded for the 4 hours before PeNAT administration for all patients in group 2 and 36 patients in group 1. Parents of a subset of patients made an independent assessment of their child's nausea and pain intensities immediately before PeNAT administration. Reliability was evaluated in groups 1 and 2 by correlating the first and second (obtained 1 hr after the first) PeNAT scores. Construct validity was evaluated by comparing PeNAT scores in groups 1-4. Criterion-related validity was evaluated by correlating PeNAT scores with emetic episodes and dietary intake. Convergent and discriminant validity were evaluated by correlating PeNAT scores with parental assessments of nausea and pain. Significant differences in PeNAT scores were noted among the study groups (p=0.035). Moderate correlation was noted between the first and second PeNAT scores (Spearman rho = 0.649). The PeNAT scores correlated modestly with emetic episodes (Spearman rho = 0.322) but not with dietary intake (Spearman rho = -0.217). Children's PeNAT scores correlated moderately with their parents' assessment of nausea (Spearman rho = 0.442), whereas little correlation was seen between children's PeNAT scores and parents' assessment of pain (Spearman rho = 0.167). CONCLUSION: The PeNAT is a new instrument that can be used by children to assess nausea intensity.

Adolescent↗

Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control.

Nausea and vomiting are two of the most feared side effects of cancer chemotherapy and radiotherapy. Chemotherapy-induced nausea and vomiting can be broadly categorized as acute (occurring within 24 hours of therapy), delayed (persisting for 6-7 days after therapy), or anticipatory (occurring prior to chemotherapy administration). Breakthrough and refractory nausea and vomiting describe the symptoms of uncontrolled emesis. Evidence suggests that good control of nausea and vomiting during the acute period correlates with the control of delayed emesis. Conversely, protection failure during the first 24 hours has a high predictive value for delayed emesis in the same cycle. The 5-HT(3)-receptor antagonists, regarded as the 'gold standard' in antiemetic therapy, are the first-line treatment for moderately and highly emetogenic chemotherapy and radiotherapy regimens in adults and children. Evidence suggests that the 5-HT(3)-receptor antagonists administered in combination with corticosteroids afford the best protection from symptoms of acute emesis and, by extrapolation, the most effective prevention of delayed emesis. Antiemetic therapeutic guidelines stress that the goal of therapy is to prevent cytostatic-induced nausea and vomiting. Therefore, the prophylactic use of the most effective antiemetic regimen-taking into consideration the emetogenicity of the chemotherapy and individual patient characteristics-must be adhered to in order to prevent acute, delayed, and anticipatory nausea and vomiting.

Antiemetics↗

Ondansetron. An update of its therapeutic use in chemotherapy-induced and postoperative nausea and vomiting.

Ondansetron is a selective 5-HT3 receptor antagonist which has previously been reported in the Journal to be a promising new agent for use as prophylaxis against nausea and vomiting caused by chemotherapy and radiotherapy. Since the publication of this original review, further studies have been published that show ondansetron to be an effective antiemetic agent in patients receiving chemotherapy and radiotherapy. Several studies have shown ondansetron to be a more effective antiemetic agent than high-dose metoclopramide in patients with emesis induced by high- and low-dose cisplatin treatment, and noncisplatin chemotherapy-induced emesis. The drug as mono-therapy does not appear to offer any advantage over alternative therapies against delayed high-dose cisplatin-induced nausea and vomiting; however, extremely limited data suggest that ondansetron plus dexamethasone may be useful in this indication. Trials have shown combination therapy with ondansetron and dexamethasone to be significantly more effective than both ondansetron monotherapy and a standard antiemetic regimen comprising metoclopramide, dexamethasone and diphenhydramine against acute high-dose cisplatin-induced emesis. Results from a number of small scale trials suggest that ondansetron may be an effective treatment for chemotherapy-induced emesis refractory to conventional antiemetic therapy. Ondansetron also appears to be more effective against refractory emesis induced by noncisplatin chemotherapy than that induced by cisplatin chemotherapy. Several trials have shown ondansetron to be more effective than placebo as prophylaxis against postoperative nausea and vomiting; a further trial has shown single-dose ondansetron to be significantly more effective than single-dose droperidol or metoclopramide in this indication. In addition, several trials have shown ondansetron to be more effective than placebo as treatment for nausea and vomiting that has commenced postoperatively. The overall incidence of adverse events in ondansetron recipients during chemotherapy-induced emesis studies was 36%. Headache and constipation are the most common adverse events during ondansetron therapy. Thus, recent data affirms the efficacy of ondansetron in the treatment of acute chemotherapy-induced nausea and vomiting and shows it to be especially efficacious when combined with dexamethasone. It appears that the drug will also have a substantial role in the prophylaxis and treatment of postoperative nausea and vomiting.

Antineoplastic Agents↗

Granisetron. An update of its therapeutic use in nausea and vomiting induced by antineoplastic therapy.

Granisetron is a selective serotonin3 (5-hydroxytryptamine3, 5-HT3) receptor antagonist which has significant antiemetic activity against chemotherapy-induced nausea and vomiting. A single prophylactic intravenous dose is sufficient to control acute nausea and vomiting in approximately 60 to 70% of patients. In comparative studies, the acute antiemetic efficacy of granisetron is equivalent or superior to that of traditional antiemetic regimens even in patients receiving highly emetogenic cisplatin-containing chemotherapy. However, limited data have suggested that granisetron therapy offers no advantages over traditional antiemetics in terms of the control of delayed emesis. Recently, a number of large randomised studies have directly compared the efficacy and tolerability of granisetron, ondansetron and tropisetron and reported no significant differences between the 3 drugs in controlling acute nausea and vomiting, although 1 study reported a modest statistical advantage for granisetron over ondansetron but not tropisetron in the complete control of vomiting. In crossover studies, significantly more patients preferred granisetron to either ondansetron or tropisetron. The efficacy of granisetron appears to be maintained with repeated doses over several cycles of chemotherapy, although the influence of various prognostic factors affecting antiemetic response has not been adequately analysed. Concomitant administration of dexamethasone significantly improves the acute antiemetic efficacy of granisetron, increasing response rates by approximately 15%. Granisetron is an effective antiemetic in children undergoing highly emetogenic chemotherapy, and effectively controls radiotherapy-induced and postoperative nausea and vomiting. Trials using an oral formulation are scarce at present, but preliminary results suggest a similar efficacy and tolerability profile to that of the intravenous formulation. Granisetron has been well tolerated in clinical trials. The most frequently reported adverse event has been headache (14%). Extrapyramidal effects, which can limit the use of traditional antiemetics such as metoclopramide, have not been reported with granisetron. Thus, recent data confirm that granisetron is an effective and well tolerated agent for the prophylactic treatment of chemotherapy-induced acute nausea and vomiting, with efficacy equivalent or superior to that of other currently available agents. It has a promising role to play in paediatric oncology, and is an effective agent in controlling radiotherapy-induced acute emesis. Granisetron offers comparable or superior efficacy in controlling acute nausea and vomiting with a much simpler dosage regimen than that of traditional antiemetic regimens.

Adult↗

Gastric arrhythmia and nausea of motion sickness induced in healthy Japanese subjects viewing an optokinetic rotating drum.

The purpose of this study was to investigate whether nausea or gastric dysrhythmia, including tachygastria, which was determined by electrogastrography (EGG), were observed during optokinetic motion sickness in healthy Japanese volunteers. Twelve volunteers (9 men and 3 women) participated in the study. The subjects were asked to sit in a chair with their heads positioned in the center of a drum whose inside had been painted with black and white stripes. After a 15 min resting period, the drum was rotated at a speed of 60 degree/sec for 15 min. The EGG was continuously recorded for a total of 45 min (15 min resting period, 15 min rotation period, and 15 min recovery period). The severity of nausea was evaluated with a visual analogue scale (VAS) before, immediately after, and 15 min after the cessation of drum rotation. Other motion sickness symptoms were evaluated by scores of subjective symptoms of motion sickness (SSMS). Of 12 subjects who completed the study, 10 complained of nausea immediately after cessation of drum rotation. The VAS score for nausea immediately after the drum rotation period and 15 min after cessation of the rotation was significantly higher than during the resting period. The EGG during the drum rotation period showed a decrease in normogastria, which was accompanied with an increase in tachygastria. We conclude that gastric tachyarrhythmia and nausea may be induced by viewing an optokinetic rotating drum in healthy Japanese subjects who may have a hypersusceptibility to vection-induced motion sickness. The gastric dysrhythmia obtained with EGG could be a useful observation to support the appearance of nausea induced by optokinetic motion sickness.

Adult↗

[Usefulness of ramosetron hydrochloride on nausea and vomiting in CMF or CEF therapy for breast cancer].

The inhibitory effect of ramosetron hydrochloride (Ram), a 5-HT3 receptor antagonist, on nausea and vomiting occurring in CMF or CEF therapy as a pre- or postoperative adjuvant chemotherapy or chemotherapy for recurrent cancer was evaluated in 34 patients with breast cancer. On days 1 and 8, the patients received Ram (0.3 mg) concomitantly with these agents intravenously and were observed for nausea and vomiting to evaluate the inhibitory effect. Food intake was observed at the same time. On day 1, there was moderate to severe nausea in one patient and vomiting in two patients, while results for 32 of 34 patients (94.1%) were classified as "excellent". On day 8, no moderate or severe nausea was seen, but vomiting occurred in one patient; the results of 33 patients (97.1%) were classified as "excellent". Even when considering only 12 patients who had experienced nausea or vomiting on chemotherapy, 11 showed an "excellent" response on day 1. Moreover, no patient received any additional dose of an anti-emetic drug within 24 hours of Ram administration. Food intake decreased to less than 50% of the baseline in three patients on day 1 and four patients on day 8. Administration of Ram to breast cancer patients on CMF or CEF therapy is thus concluded to be useful in the inhibition of nausea and vomiting.

Adult↗

[Clinical usefulness of ondansetron hydrochloride for nausea and vomiting during repeated courses of chemotherapy for malignant lymphoma--impact of prognosis announcement on anti-emetic effect and evaluation of patient perception of chemotherapy-associated adverse events].

We evaluated the efficacy and safety of ondansetron hydrochloride (OND) on nausea and vomiting during repeated courses of CHOP or ACOMP-B therapy in patients with malignant lymphoma. The impact of the prognosis announcement on the anti-emetic effect and chemotherapy-associated adverse events was also investigated. Forty-two subjects with malignant lymphoma who underwent CHOP or ACOMP-B therapy including cyclophosphamide 600 mg/m2 and adriamycin 40 mg/m2 were investigated for a maximum of 6 courses. For acute nausea and vomiting, ondansetron was injected intravenously before the start of chemotherapy on the first day of each course of chemotherapy. For delayed emesis, ondansetron was administered orally for 4 days from the following day. The efficacy on acute nausea and vomiting was found to be 95.0% (1st course), 95.0% (2nd course), 90.9% (3rd course), 88.2% (4th course), 92.3% (5th course) and 91.7% (6th course), respectively. A high efficacy of > or = 85% was also obtained for delayed nausea and vomiting on each day. Though the adverse event of elevated GPT value developed in one subject. It was mild and resolved. No difference in efficacy was seen with or without announcement of prognosis to patients. Following the investigation on antiemetic effect, patient perception of chemotherapy-induced adverse events was evaluated. The most common event was hair loss, followed by taste abnormality and numbness and hyposthesia of the tips of the fingers. The incidence of nausea and vomiting was the 4th and 5th most common, which are less frequent than in the report of Coates in 1983. In conclusion, ondansetron is considered clinically useful with stable anti-emetic effect on both acute and delayed nausea and vomiting over repeated courses of chemotherapy, without any significant safety problem.

Aged↗

Acustimulation wristbands for the relief of chemotherapy-induced nausea.

CONTEXT: Substantial evidence suggests that acupuncture-point stimulation may be effective in controlling side effects of chemotherapy. OBJECTIVE: To examine the efficacy of an acustimulation wristband for the relief of chemotherapy-induced nausea. DESIGN: Randomized clinical trial using a 3-level crossover design. SETTING: Three outpatient oncology clinics in the northeastern United States. PARTICIPANTS: Twenty-five women and 2 men who experienced moderate or more severe nausea following their first chemotherapy treatment. INTERVENTION: We compared active acustimulation of the Pericardium 6 (PC-6) point on the ventral surface of the wrist with sham acustimulation (a corresponding point on the posterior surface of the wrist). A control group received no acustimulation. OUTCOME MEASURES: Severity of nausea and quantity of antiemetic medication used. RESULTS: No statistically significant differences in average severity of nausea were observed between the 3 interventions. However, the data showed a difference close to statistical significance in the severity of delayed nausea reported during active acustimulation compared to no acustimulation (P <.06). In addition, patients took fewer antinausea pills during the active-acustimulation cycle of this experiment compared to the no-acustimulation phase (P < .05). CONCLUSION: Findings on the efficacy of an acustimulation band for the control of chemotherapy-induced nausea are positive but not conclusive. These findings provide ample justification for further study of acustimulation in clinical oncology.

Acupuncture Therapy↗

Ondansetron in the treatment of postoperative nausea and vomiting in ambulatory outpatients: a dose-comparative, stratified, multicentre study.

The safety and efficacy of ondansetron were evaluated in the treatment of postoperative nausea and vomiting. Five hundred patients who experienced nausea or vomiting in the Post-Anaesthesia Care Unit within the first 2 h of recovery were randomized to receive either 1, 4, or 8 mg of ondansetron, or placebo. All patients had undergone ambulatory surgery with general endotracheal anaesthesia. Episodes of emesis, nausea scores, adverse events, vital signs, and laboratory values were assessed before and during the 24 h after study drug administration. Patients were evaluated for the first 2 h in the Post-Anaesthesia Care Unit then followed up for the next 22 h. Complete response was defined as no emetic episodes, no nausea or no rescue anti-emetic medication. For the 0-24 h study period, complete response occurred in only 15% of the placebo group compared to 41%, 47%, and 47% in the 1, 4, and 8 mg ondansetron groups, respectively. Mean nausea scores (scale of 0-10) during the initial observation period (0-2 h) were significantly lower for all doses of ondansetron [2.2 (1 mg), 1.7 (4 mg), and 2.1 (8 mg)] compared to placebo (3.0). The optimal dose of ondansetron for the treatment of postoperative nausea and vomiting was found to be 4 mg. All doses of ondansetron were well tolerated. No clinically significant increases in laboratory parameters or alterations in haemodynamic stability occurred in the ondansetron groups compared to placebo.

Adolescent↗

Influence of promethazine on symptom-therapy scores for nausea during patient-controlled analgesia with morphine.

We assessed whether adding promethazine to the syringe containing morphine for patient-controlled analgesia (PCA) decreases nausea after gynecologic surgery. Patients were assigned randomly to receive PCA (morphine 1.5 mg, 6-min lockout interval) with or without promethazine (0.625 mg/PCA dose, providing an average of 17.6 mg/24 h). Assessments included a visual analogue scale (VAS) for nausea (0 = none, 10 = worst possible) at scheduled times, rescue therapy requirements, and a maximum symptom-therapy score that provided an aggregate assessment of nausea intensity, duration, and response to rescue therapy (0 = no nausea; 1 = mild; 2 = moderate, requiring droperidol; 3 = severe or persistent, requiring droperidol; 4 = requiring droperidol+transdermal scopolamine; 5 = unrelieved). Nausea scores on the visual analogue scale at 2, 6, 8, and 24 h and use of rescue droperidol identified no significant differences between the groups. However, symptom-therapy scores differed significantly, with median values of 0 and 2, respectively, for the promethazine-treated and control groups. We conclude that simultaneous titration of morphine and promethazine decreases nausea associated with PCA therapy; the difference may best be appreciated with use of the combined symptom-therapy score.

Adult↗