Long-Term Safety and Clinical Effectiveness of Controlled-Release Metoclopramide in Cancer-Associated Dyspepsia Syndrome: A Multicentre Evaluation

Abstract

Patients with cancer frequently report gastrointestinal symptoms such as anorexia, early satiety, nausea, vomiting, and bloating. A reduction of the severity of some of these symptoms would benefit the patient by enhancing quality of life and improving their treatment. Forty-eight patients (25 female and 23 male; mean age 63 ±11 years) with a minimum two-week history of cancer-associated gastrointestinal symptoms were assigned to a single, open-label treatment group and received controlled-release metoclopramide 20 mg–80 mg q12h for a maximum period of 12 weeks (mean 46 ±35 days). There was a 40%-60% decrease in the severity of nausea over the first two weeks of treatment, and an approximate 50% reduction in severity of vomiting over the first four weeks of treatment. Appetite and bloating also improved, although smaller and less consistent changes were observed. Patient ratings of overall clinical effectiveness with respect to relief from symptoms and tolerability of side effects indicated that controlled-release metoclopramide was highly and moderately effective in 36% and 30% of the patients, respectively. Controlled-release metoclopramide is a useful treatment for the management of gastrointestinal symptoms associated with the cancer-associated dyspepsia syndrome including nausea, vomiting, loss of appetite, and bloating.

An open study of methotrimeprazine in the management of nausea and vomiting in patients with advanced cancer

“…There was a statistically significant improvement in nausea in three studies and of vomiting in two series, but the studies vary in quality and methodology, and the numbers of patients included is small. Subsequently, a further uncontrolled study of controlled-release metoclopramide has been published suggesting benefit in the control of cancerassociated dyspepsia syndrome [18]. A recent systematic review of the efficacy of antiemetics in the treatment of nausea in patients with far-advanced cancer confirms the lack of evidence to support existing consensus-based guidelines for the management of N/V and points to the need for more well-designed studies [19].…”

Systematic review of the efficacy of antiemetics in the treatment of nausea in patients with far-advanced cancer

“…Whereas the uncontrolled studies had high response rates (75-93%) to standard regimens, the RCT had much lower responses rates (23-36% for nausea, 18-52% for vomiting). Similar response rates were achieved whether drug selection was empirical [18,19,21,27] or based on the patient's clinical picture [8,9,16,20].…”

“…The initial Medline and EmBase searches for nausea and vomiting in advanced cancer produced a list of more than 1100 citations, of which only 22 (1.9%) had titles that appeared relevant to the topic of the review. Limiting the search to meta-analyses revealed seven citations, only one of which appeared relevant [16], the others all relating to chemotherapy-induced emesis. A systematic review of haloperidol, published as a letter and not coded electronically as a systematic review, was found subsequently when searching for uncontrolled studies [17].…”

“…One RCT on nausea that met the inclusion criteria was excluded after retrieval when it was found to contain duplicate data published in another included study [22]. The electronically identified "meta-analysis" turned out to be an uncontrolled study [16]. Ultimately, 21 studies were included in the review: 2 systematic reviews, 7 RCT and 12 uncontrolled studies.…”

“…Seven uncontrolled studies were also located electronically that met the review criteria [8,9,16,23,24,25,26]. Hand searching revealed one randomized trial [27] and two uncontrolled studies [28,29] that had been missed by the electronic search.…”