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Objectives: Methotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy., Design: Double-blind, randomised, controlled trial of methotrimeprazine versus haloperidol., Setting: 11 palliative care sites in Australia., Participants: Participants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours., Interventions: Based on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours., Main Outcome Measures: A ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change., Results: Response to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In the per protocol analysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Complete per protocol response rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm., Conclusion: This study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea., Trial Registration Number: ACTRN 12615000177550., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: This is an updated version of the original Cochrane Review published in Issue 4, 2013, on Levomepromazine for nausea and vomiting in palliative care.Nausea and vomiting are common, distressing symptoms for patients receiving palliative care. There are several drugs which can be used to treat these symptoms, known as antiemetics. Levomepromazine is an antipsychotic drug is commonly used as an antiemetic to alleviate nausea and vomiting in palliative care settings., Objectives: To evaluate the efficacy of, and adverse events associated with, levomepromazine for the treatment of nausea and vomiting in palliative care patients., Search Methods: For this update we searched electronic databases, including those of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE, up to February 2015. We searched clinical trial registers on 7 October 2015 for ongoing trials., Selection Criteria: Randomised controlled trials of levomepromazine for the treatment of nausea or vomiting, or both, in adults receiving palliative care. We excluded studies in which symptoms were thought to be due to pregnancy or surgery., Data Collection and Analysis: We assessed the potential relevance of studies based on titles and abstracts. We obtained copies of any study reports that appeared to meet the inclusion criteria for further assessment. At least two review authors read each paper to determine suitability for inclusion and discussed discrepancies in order to achieve a consensus., Main Results: In the original review, we identified 421 abstracts using the search strategy. We considered eight studies for inclusion but ultimately excluded them all from the review. We updated the search in February 2015 and identified 35 abstracts, but again none met the inclusion criteria. We identified two trials from clinical trial registers, one of which is ongoing and one of which was closed due to poor recruitment., Authors' Conclusions: As in the initial review, we identified no published randomised controlled trials examining the use of levomepromazine for the management of nausea and vomiting in adults receiving palliative care, and our conclusion (that further studies of levomepromazine and other antiemetic agents are needed to provide better evidence for their use in this setting) remains unchanged. We did, however, identify one ongoing study that we hope will contribute to the evidence base for this intervention in future updates of this review.

Background: Nausea and vomiting are common, distressing symptoms for patients receiving palliative care. There are several agents which can be used to treat these symptoms. Levomepromazine is an antipsychotic drug which is commonly used to alleviate nausea and vomiting in palliative care settings., Objectives: To evaluate the efficacy of and adverse events (both minor and serious) associated with the use of levomepromazine for the treatment of nausea and vomiting in palliative care patients., Search Methods: We searched the electronic databases including CENTRAL, MEDLINE, and EMBASE using relevant search terms and synonyms in March 2013., Selection Criteria: Randomised controlled trials of levomepromazine for the treatment of nausea or vomiting, or both, for adults receiving palliative care. Studies where symptoms were thought to be due to pregnancy or surgery were excluded., Data Collection and Analysis: The potential relevance of studies was assessed based on titles and abstracts. Any study reports which appeared to meet the inclusion criteria were obtained for further assessment. All three authors read these papers to determine their suitability for inclusion and discussed discrepancies to achieve a consensus., Main Results: The search strategy identified 421 abstracts from which eight studies were considered but all were excluded from the review., Authors' Conclusions: No randomised controlled trials were identified examining the use of levomepromazine for nausea and vomiting in palliative care. Further studies of levomepromazine and other antiemetic agents are needed to provide better evidence for their use in this setting.

Introduction: Nausea and vomiting are distressing symptoms affecting between 20% and 70% of patients with advanced cancer. Methotrimeprazine is a phenothiazine antipsychotic used in palliative care for the management of terminal agitation and nausea/vomiting but there is only anecdotal evidence to support its use in palliative care., Aim: To establish whether nausea/vomiting in palliative care patients is improved by the administration of low-dose methotrimeprazine., Methods: Patients with advanced malignancy were entered at different treatment levels according to symptom severity. The dose was altered according to response (minimum dose 6.25 mg daily po, maximum 25 mg by 24-h subcutaneous infusion). Symptoms and side effects were recorded daily from 0 (baseline) to day 5 using a four-point scale. Any improvement in nausea/vomiting score was taken as a response., Results: Sixty-five patients were entered. The cause of nausea and vomiting was multifactorial in the majority of patients, 35/65 (54%). As expected in a study of patients with poor performance status, the attrition rate was high. Of 53 patients evaluable for response at day 2, 33 (62%) showed some improvement in nausea or vomiting. At day 5, improvement was seen in 20/34 (58%). There was no significant change in "side effects" from baseline with time., Conclusion: These results suggest that methotrimeprazine has antiemetic activity.

Levomepromazine (previously known as methotrimeprazine), despite virtually no high quality scientific data to support its use, has become a very popular antiemetic for use in patients with advanced cancer. This article considers the reasons for this.