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[Clinical study on the inhibitory effect of a 5-HT3 antagonist, granisetron, for nausea and vomiting induced by chemotherapy (CHOP, VEPA, high-dose ETP) for non-Hodgkin's lymphoma].

The antiemetic effect of granisetron on nausea and vomiting induced by cancer chemotherapy (CHOP, VEPA, VEPA-B, massive dose of ETP) was studied in fifty patients with non-Hodgkin's lymphoma. There was almost no difference in the inhibitory effect by regimen, with the rates of perfect inhibition of nausea and vomiting standing at 55.6% to 60%. Nausea and vomiting was perfectly controlled in 60% of 35 patients receiving CHOP therapy. As a part of this study, a comparison was made of perfect inhibitory effect on nausea and vomiting by potency of chemotherapy under the potency scale of 750 mg/m2 of CPA as 1, revealing no significant difference in the rates of complete inhibition as 71.4% for a drug potency of less than 0.8 vs 52.4% for 0.8 or above (p = 0.26). However, it was clear that the higher the dose of chemotherapy, the lower the rate of complete inhibition. The results confirmed the high efficacy and safety of granisetron in the treatment of nausea and vomiting induced by cancer chemotherapy.

Adult↗

A study evaluating the efficacy and tolerability of tropisetron in combination with dexamethasone in the prevention of delayed platinum-induced nausea and emesis.

BACKGROUND: Chemotherapy-induced emesis is one of the most disturbing side effects of cancer therapy. Control of acute emesis has improved substantially during recent years, but control of delayed emesis and nausea remains a challenging problem. The role of 5-HT3 receptor antagonists in the treatment of delayed emesis is disputed. METHODS: Tropisetron, a highly specific 5-HT3 receptor antagonist, was compared (as an adjunct to dexamethasone) with placebo in a randomized, double blind, multicenter trial for the prevention of delayed emesis during platinum-containing chemotherapy. Three hundred chemotherapy-naive women with gynecologic malignancies were included. The cisplatin dose was in the range of 50-100 mg/m2. RESULTS: Acute emesis was prevented completely in 87% of patients and acute nausea in 77% of patients in the complete series. During the complete delayed period (Days 2-6), total control of emesis was achieved in 77% of the dexamethasone and tropisetron-treated patients and in 72% of the patients receiving dexamethasone and placebo (P = 0.2473). During the same period nausea was controlled completely in 42% of the dexamethasone and tropisetron group and in 41% of the dexamethasone and placebo group. On Day 3, complete protection from nausea was achieved in 65% of patients receiving tropisetron and in 51% of patients receiving placebo (P = 0.0304). Constipation occurred more frequently in the tropisetron group. CONCLUSIONS: Tropisetron added to dexamethasone improved control of delayed nausea on Day 3 compared with placebo. No significant differences were recorded regarding control of delayed emesis.

Adult↗

[Effect of ondansetron hydrochloride injection and tablet against nausea and vomiting in lung cancer patients receiving carboplatin].

We investigated the efficacy of combination of ondansetron hydrochloride injection and tablet against nausea and vomiting in 22 lung cancer patients (total number of chemotherapy courses: 23) receiving chemotherapy of single-dose carboplatin (CBDCA) at a dose of 302.2 +/- 31.9 mg/m2. For suppressing emesis, the patients were given 4 mg of ondansetron injection on the day of CBDCA injection (Day 1), and 4 mg/day of ondansetron tablet for Days 2 to 5. The following results were obtained 5 days after the administration of carboplatin. 1) Control of nausea graded 'Good' or better counted for 95% or higher of all cases for each day of the chemotherapy. A complete nausea suppression rate was seen in 91.3%, 81.0%, 71.4%, 63.6% and 71.4% from Day 1 to Day 5, respectively. 2) Control of vomiting graded 'Major' control or better was achieved in 95% or more of all cases, for each day. The complete vomiting suppression rate observed from Day 1 to Day 5 was 91.3%, 78.3%, 65.2%, 69.6% and 91.3%, respectively. 3) Inhibitory effect on nausea and vomiting for each day of Days 1 to 5 graded as 'Effective' or better was shown in 90% or higher of all cases; based on overall judgement for Days 1 to 5, all cases were graded as 'Effective' or better. 4) The proportion of cases which was evaluated as 'Can eat most of the meal' was 88.0%, 73.9%, 50.7%, 50.7% and 65.2% from Days 1 to 5, respectively, against 95.7% prior to the start of chemotherapy. 5) No adverse drug reaction or abnormal clinical laboratory values were seen along with ondansetron. 6) In conclusion, combined treatment with ondansetron injection and tablet was considered clinically useful in control of nausea and vomiting during administration of carboplatin, and may also be useful for out-patient chemotherapy.

Adult↗

[Influence of postoperative pain therapy on nausea and vomiting].

PROBLEM: Postoperative nausea and vomiting remains an important problem. Many risk factors have been identified; however, the importance of postoperative analgesic technique and patient expectation remain poorly defined. METHODS: We prospectively collected data on postoperative nausea and vomiting (PONV) in four groups of randomly selected patients (n=50 per group) who received either simple analgesics, nurse-administered intravenous morphine (NAA), patient-controlled analgesia (PCA) with morphine or epidural analgesia with bupivacaine and fentanyl. Patients were questioned regarding any past history of PONV or motion sickness, their preoperative expectation of suffering PONV and satisfaction with their antiemetic therapy. RESULTS: The incidence of nausea was higher in both morphine groups P<0.05), women (P<0.05), those less than the median age of their group (P<0.05) and those with a past history of PONV (P<0.05) or motion sickness (P<0.05). Most patients did not expect to experience PONV (19.3%). The incidence of nausea was higher in those expecting to experience PONV than in those not expecting to suffer PONV (P<0.01). Of those who received postoperative antiemetic treatment, 23.6% were dissatisfied or very dissatisfied with their therapy. Few patients received a prophylactic antiemetic drug (15%). CONCLUSIONS: Study results show that patient expectation is a potent predictor of postoperative nausea, a risk factor hitherto ignored in the anaesthetic literature, and that, in the provision of analgesia following major surgery, epidural analgesia is associated with less PONV than intravenous morphine.

English Abstract↗

Effect of acupuncture on nausea of pregnancy: a randomized, controlled trial.

OBJECTIVE: To compare acupuncture with sham (placebo) acupuncture for treatment of nausea of pregnancy. METHODS: In a subject- and observer-masked, randomized, controlled trial in the maternity unit at Exeter Hospital, we gave 55 women between 6 and 10 weeks' gestation genuine, traditional-style acupuncture or sham treatment with a cocktail stick on three or four occasions over 3 weeks. The main outcome measure was nausea score, as determined by subject report on a visual analogue scale in a daily diary. Anxiety and depression also were assessed. RESULTS: Nausea scores decreased from a median of 85.5 (interquartile range 71.25-89.75) to 47.5 (interquartile range 29.25-69.5) in the acupuncture group and from 87.0 (interquartile range 73.0-90.0) to 48.0 (interquartile range 14.0-80.0) in the sham treatment group. There was strong evidence of a time effect (P <.001) but no evidence of a group effect (P =.9) or a group-time interaction (P =.8). Similarly, there was evidence of time effects in scores for anxiety and depression but no group differences. The study had a power of 95% to detect significant differences in nausea scores. CONCLUSION: Acupuncture was as effective in treating nausea of pregnancy as a sham procedure.

Acupuncture Therapy↗

How can we best prevent or treat postoperative nausea and vomiting?

In pursuit of preventing or rapidly rescuing patients from postoperative nausea and vomiting, new clinical studies provide revised postoperative nausea and vomiting risk prediction tools, risk stratification formulae, comparative trials to identify the most appropriate cost-effective anti-emetics, and several trials recommending the addition of steroids in anti-emetic prophylactic multimodal approaches. Common variables that identify high-risk postoperative nausea and vomiting patients include female sex, a history of postoperative nausea and vomiting or motion sickness, young age, volatile anesthetic agents, nitrous oxide, and the administration of opioids. The most successful approach to the prevention of postoperative nausea and vomiting is multimodal, with combination anti-emetics, dexamethasone, aggressive hydration, the avoidance of opioids, and aggressive pain control.

Journal Article↗

Tactile massage and severe nausea and vomiting during pregnancy--women's experiences.

Nausea and vomiting during pregnancy is a condition with an obscure aetiology. The treatment is symptomatic but there is a lack of alternative treatments. Tactile massage is known to give relaxation and increased well-being in connection with different illnesses, but has never been studied on women with severe nausea and vomiting during pregnancy (SNVP). The aim of this study was to describe hospitalized women's experiences of SNVP and of tactile massage. A phenomenological method was used. Ten hospitalized women with SNVP were included. Each woman was given tactile massage on three separate occasions. After the final massage an open interview was used covering both the experience of severe nausea and vomiting, and of tactile massage. The findings revealed an essential meaning summarizing the experience: to obtain a relieving moment of rest and access to the whole body when nausea rules life. When nausea is experienced as controlling a woman's life, tactile massage is experienced as promoting relaxation and gives her an opportunity to regain access to her body. The findings suggest that tactile massage is a good alternative and complement to traditional treatment of SNVP.

Activities of Daily Living↗

Treating pregnancy-related nausea and vomiting with ginger.

OBJECTIVE: To review literature assessing the safety and efficacy of the use of ginger to treat nausea and vomiting in pregnancy. DATA SOURCES: Iowa Drug Information Service (1966-September 2004), International Pharmaceutical Abstracts (1971-September 2004), MEDLINE (1966-September 2004), and EMBASE (1966-September 2004) were searched. Key terms included ginger, nausea, vomiting, emesis, and pregnancy. DATA SYNTHESIS: Studies evaluating the safety and efficacy of ginger in the management of nausea and vomiting in pregnancy were reviewed. Various doses and forms of ginger were used to treat women during their first and second trimesters of pregnancy. Ginger has been shown to improve the symptoms of nausea and vomiting compared with placebo in pregnant women. CONCLUSIONS: While data are insufficient to recommend ginger universally and there are concerns with product quality due to limited regulation of dietary supplements, ginger appears to be a fairly low-risk and effective treatment for nausea and vomiting associated with pregnancy. In low doses, this may be appropriate for patients not responding to traditional first-line therapies.

Clinical Trials as Topic↗

Understanding anticipatory nausea.

PURPOSE/OBJECTIVES: To address the concept of anticipatory nausea within the theoretical framework of classical conditioning. DATA SOURCES: Published articles, book chapters. DATA SYNTHESIS: Although classical conditioning explains much in the development of anticipatory nausea, other factors also are at work. Preventing this phenomenon is necessary because it is difficult to treat and control once it develops. CONCLUSIONS: Nurses are in a position to identify patients at highest risk for developing anticipatory nausea and implement interventional strategies to prevent/minimize it. IMPLICATIONS FOR NURSING PRACTICE: Many aspects of anticipatory nausea have not yet been researched well. Nurses must study how anticipatory nausea develops and interventions that can be used to reduce its prevalence.

Age Distribution↗

Efficacy of ondansetron and prochlorperazine for the prevention of postoperative nausea and vomiting after total hip replacement or total knee replacement procedures: a randomized, double-blind, comparative trial.

BACKGROUND: Limited data are available on the efficacy of ondansetron hydrochloride compared with prochlorperazine maleate for the treatment of postoperative nausea and vomiting (PONV). OBJECTIVE: To evaluate the comparative efficacy of ondansetron and prochlorperazine for the prophylaxis of PONV in patients undergoing total hip replacement or total knee replacement procedures. METHODS: A randomized, double-blind, comparative trial was conducted at a tertiary care, university hospital. Seventy-eight patients undergoing elective total hip or total knee replacement procedures received a single dose of ondansetron hydrochloride (n = 37), 4 mg intravenously, or prochlorperazine maleate (n = 41), 10 mg intramuscularly, at the end of the surgical procedure. Rescue therapy was administered every 4 hours as needed during the initial 48 hours. Primary outcome measures were the incidences and severity of PONV. Secondary outcome measures included the number of rescue antiemetic doses required, number of physical therapy cancellations because of PONV, length of hospital stay, and cost of antiemetic agents administered. RESULTS: The incidence of nausea was significantly greater in the ondansetron group compared with the prochlorperazine group (81% vs 56%; odds ratio, 3.4; 95% confidence interval, 1.2-9.4) as was the severity of nausea (P = .04). Multivariate analysis identified administration of ondansetron, history of PONV, obesity, and female sex as risk factors for a nausea event. The incidence of vomiting tended to be greater in the ondansetron group (49% vs 32%; odds ratio, 2.0; 95% confidence interval, 0.8-5.0). The need for rescue antiemetic therapy was also greater in the ondansetron group (46% vs 27%; odds ratio, 2.3; 95% confidence interval, 0.9-6.0). The mean antiemetic drug cost per patient was significantly greater for the ondansetron group ($47.56 vs $2.47; P<.001). However, the proportion of patients who were unable to participate in physical therapy because of PONV and the median length of hospital stay were similar in both groups. CONCLUSION: Prochlorperazine is associated with superior efficacy and significant cost savings compared with ondansetron for the prevention of PONV in patients undergoing total hip and total knee replacement procedures.

Adult↗

Nonpharmacologic factors in the development of posttreatment nausea with adjuvant chemotherapy for breast cancer.

A prospective, longitudinal design was used to determine the role of nonpharmacologic factors in the development of posttreatment nausea (PTN). Forty-five women with no previous chemotherapy experience who were receiving a single regimen of adjuvant chemotherapy for breast cancer were interviewed before and after their first six infusions. Seventy-one percent of patients developed PTN. The PTN was related to the following: patients' physical status at the onset of treatment; heightened anxiety during infusions; susceptibility to nausea and vomiting after eating certain foods; and expectations of developing chemotherapy-related nausea. Anxiety during infusions, susceptibility to nausea and vomiting, and expectations of side effects also accounted for differences in the frequency, intensity, and severity of PTN. These findings offer strong support for the view that nonpharmacologic factors contribute to individual differences in gastrointestinal responses to chemotherapy.

Adult↗

Comparison of intermittent ondansetron versus continuous infusion metoclopramide used with standard combination antiemetics in control of acute nausea induced by cisplatin chemotherapy.

BACKGROUND: Ondansetron is a serotonin antagonist that recently has been introduced as a preventive agent for chemotherapy-induced nausea and vomiting. The current study was performed to determine the degree of antiemetic control of ondansetron in combination with dexamethasone and lorazepam, and to compare this combination to the previously very effective regimen of lorazepam, dexamethasone, diphenhydramine, and continuous-infusion metoclopramide. METHODS: Eighty chemotherapy-naive patients with newly diagnosed neoplasms undergoing cisplatin combination chemotherapy were randomized to receive one of two combination antiemetic regimens: lorazepam, dexamethasone, intermittent intravenous ondansetron; or lorazepam, dexamethasone, continuous-infusion metoclopramide, and diphenhydramine. RESULTS: There was major control (0-1 episodes) of acute nausea-vomiting in all of the patients receiving the ondansetron combination antiemetic regimen, which was significantly better (P < 0.05) than the major control of the acute nausea-vomiting of the patients receiving the metoclopramide combination antiemetic regimen. The ondansetron-treated patients experienced only a mild headache as their only toxicity and had significantly (P 0.0026) less diarrhea, akathisia, and acute dystonic reactions than the patients receiving the metoclopramide regimen. Delayed nausea was controlled with prophylactic prochlorperazine. CONCLUSIONS: The ondansetron regimen was more effective and less toxic, but its cost was 20 times more than the metoclopramide regimen.

Adult↗

Granisetron is equivalent to ondansetron for prophylaxis of chemotherapy-induced nausea and vomiting: results of a meta-analysis of randomized controlled trials.

BACKGROUND: The introduction of serotonin antagonists as antiemetics for prophylaxis of chemotherapy-induced nausea and vomiting represented a major step toward better patient tolerance and adherence to this type of treatment. Several published trials compared different serotonin antagonists without demonstrating clear superiority of any one of them. Because most of these trials compared ondansetron with granisetron, the authors conducted a meta-analysis to determine if the current data available show any therapeutic difference between them. METHODS: MEDLINE and CANCERLIT databases were searched from 1990 to May 1999, and pertinent article references also were surveyed, without restriction to English language. The authors included all randomized controlled trials (RCTs) that had more than 25 patients per arm and compared ondansetron to granisetron for prophylaxis of acute (A) (< 24 hours) and delayed (D) (> 24 hours) nausea (N) and vomiting (V) induced by highly (H) or moderately (M) emetogenic chemotherapy. Only the first chemotherapy cycle was considered for studies that involved a crossover design. RESULTS: Fourteen studies with 6467 evaluable patients among the 21 studies retrieved were selected for this meta-analysis. In none of the eight scenarios studied (AHV, AHN, AMV, AMN, DHV, DHN, DMV, and DMN) could the authors detect any significant differences in the antiemetic efficacy of any of these medications. CONCLUSIONS: The authors conclude that both granisetron and ondansetron have similar antiemetic efficacy for prophylaxis of chemotherapy-induced nausea and vomiting. Because the number of comparative studies that addressed the delayed nausea and vomiting scenarios is low, further RCTs are still needed to confirm these results.

Antiemetics↗

Aprepitant for the control of chemotherapy induced nausea and vomiting in adolescents.

Nausea and vomiting are common side effects of chemotherapy in adult and pediatric patients. Even with standard antiemetic therapy, a significant number of patients continue to experience acute and delayed symptoms. When used in combination with standard antiemetic therapy, a new class of antiemetics, the neurokinin-1 (NK-1) receptor antagonists, have been shown to improve both acute and delayed nausea and vomiting in adults. In this report, we describe the NK-1 receptor antagonist aprepitant in two adolescent patients receiving highly emetogenic chemotherapy who had experienced refractory nausea and vomiting with previous chemotherapy courses. The addition of aprepitant to the antiemetic regimen in the patients resulted in significant subjective improvement in nausea and vomiting as well as quality of life. These results in our adolescent patients are promising, but there is a need for well-designed studies to determine the efficacy, dosing, and safety of aprepitant in children of all ages.

Adolescent↗

Food cravings and aversions during pregnancy: relationships with nausea and vomiting.

Food cravings and food aversions are common during pregnancy. A mechanism that may explain these changes in food preference is taste aversion learning. Accordingly, this study examined the temporal association between the first occurrences of nausea, vomiting, food cravings and food aversions during pregnancy. Ninety-nine women completed a questionnaire that asked about the occurrence, timing of first onset, duration, strength and targets of these symptoms. Nausea and vomiting were reported by 80% and 56% of the women, food cravings and aversions by 61% and 54% respectively. Although more women experienced both food cravings and aversions than either symptom alone, cravings and aversions were statistically unrelated. There was a significant positive correlation between week of onset of nausea and of aversions. In 60% of women reporting both nausea and food aversions, the first occurrence of each happened in the same week of pregnancy. No such association was found for cravings. These retrospective accounts provide good support for taste aversion learning as a mechanism for the development of some but not all food aversions during pregnancy. Prospective data are needed to confirm these temporal relationships and to assist understanding of the emergence of food cravings.

Adult↗

Idiopathic gastroparesis in patients with unexplained nausea and vomiting.

Nausea and vomiting are symptoms sometimes associated with motor dysfunction. We compared a group of young patients suffering from chronic nausea and/or vomiting and normal upper gastrointestinal x-ray series with a control group. The members of both groups underwent isotopic examinations of their stomachs. The aim of the study was to find a simple method of checking the stomach and proving a motor dysfunction in a group of patients with chronic, inexplicable nausea and vomiting. Patients and controls fasted for at least 6 hr were given 0.5 mCI of [99mTc] diethylene triaminopentaacetic acid orally in 150 cc milk with 50 g cornflakes. A time-activity curve was obtained and radioactivity over the stomach was recorded exponentially. The parameter of the T1/2 emptying time was used. In normal controls T1/2 emptying time ranged from 18 to 26 min. Twenty-five symptomatic patients were examined, three of whom achieved normal values, but 22 patients showed pathologic results ranging from 36 to 184 min. In patients with chronic nausea and/or vomiting an isotopic examination of the stomach may provide a simple and rapid diagnostic method of evaluation.

Adult↗

A double-blind, multicentre comparison of intravenous dolasetron mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy.

The potent serotonin receptor (5-HT3) antagonists are new highly selective agents for the prevention and control of chemotherapy-induced nausea and vomiting that have been shown to be comparable to or more effective than traditional metoclopramide regimens. This study was designed to compare the antiemetic efficacy of dolasetron and metoclopramide in chemotherapy-naive and non-naive cancer patients receiving high-dose cisplatin-containing chemotherapy. This multicentre, double-blind, randomized trial compared the efficacy and safety of single i.v. doses of dolasetron mesilate salt (1.2 or 1.8 mg/kg) and metoclopramide (7 mg/kg) in 226 patients for the prevention of acute emesis and nausea associated with the administration of high-dose (> or = 80 mg/m2) cisplatin. Efficacy and safety were evaluated for 24 h. Complete responses were achieved by 57%, 48%, and 35% of patients given dolasetron mesilate 1.8 mg/kg (P = 0.0009 vs metoclopramide), dolasetron mesilate 1.2 mg/kg (P = 0.0058 vs metoclopramide), and metoclopramide, respectively. Overall, dolasetron was significantly more effective than metoclopramide for time to first emetic episode, nausea, patient satisfaction, and investigator global assessment of efficacy. Males, chemotherapy-naive patients, and alcoholics had higher response rates. Dolasetron was well tolerated, with mild-to-moderate headache most commonly reported. Twelve percent of patients receiving metoclopramide reported extrapyramidal symptoms compared with 0% of patients receiving dolasetron. In conclusion, dolasetron mesilate was effective for the prevention of CINV with high-dose cisplatin. Single i.v. doses of dolasetron mesilate were more effective than 7 mg/kg metoclopramide in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, 1.8 mg/kg dolasetron mesilate consistently produced the highest response rates and appears to be the most effective dose for further clinical development.

Acute Disease↗

Anticipatory nausea in cancer patients receiving chemotherapy: classical conditioning etiology and therapeutical implications.

The delivery of cytotoxic drugs in cancer treatment is often accompanied by posttreatment side effects (e.g., nausea). Moreover, there is evidence that cancer patients are at risk to develop these side effects in anticipation of chemotherapy (i.e., anticipatory nausea [AN]). AN can be explained as the result of a classical conditioning process with the cytotoxic drug as the unconditioned stimulus (US). Stimuli paired with the US (e.g., smells, tastes) can become conditioned stimuli (CSs) eliciting AN as the conditioned response (CR). The present study was conducted to test whether AN shows characteristics of a CR. Fifty-five ambulatory cancer patients were asked to record nine kinds of physical symptoms (e.g., nausea, vomiting, sweating) on time-scheduled symptom lists: after an infusion (indicating posttreatment symptoms) and prior to their next infusion (indicating anticipatory symptoms). Each measurement period covered a maximum of 48 hours. AN was reported by ten patients (18.08%). Data revealed (a) a statistically significant association between posttreatment nausea and vomiting, respectively, and AN; (b) the occurrence of AN increased with drug emetogenity (i.e., US-intensity); and (c) the duration of AN increased with temporal proximity to the infusion. The results support the conditioning model. Thus, it is proposed to prevent AN by classical conditioning techniques (e.g., overshadowing).

Antineoplastic Combined Chemotherapy Protocols↗