Article

A meta-analysis of prevention of postoperative nausea and vomiting: randomised controlled trials by Fujii et al. compared with other authors

Consultant Anaesthetist, Torbay Hospital, South Devon NHS Foundation Trust, Torquay, UK.
Anaesthesia (Impact Factor: 3.85). 06/2012; 67(10):1076-90. DOI: 10.1111/j.1365-2044.2012.07232.x
Source: PubMed

ABSTRACT The population sampling in randomised controlled trials by Fujii et al. have been shown to exhibit unusual distributions. This systematic review analysed the effectiveness of prophylactic antiemetics in trials by Fujii et al. compared with other authors. Granisetron was more effective in trials by Fujii et al., relative risk ratios (RRR (95% CI)): nausea 0.53 (0.42-0.67), p = 0.00021; vomiting 0.60 (0.50-0.73), p = 0.00094. Ramosetron was also more effective in studies by Fujii et al.: vomiting 0.60 (0.39-0.91), p = 0.02; nausea or vomiting 0.71 (0.56-0.91); p = 0.006. In comparison with granisetron, droperidol was less effective in trials by Fujii et al. than others: nausea 2.41 (1.72-3.36), p = 2.5 × 10(-7) ; vomiting 1.73 (1.26-2.38), p = 6.4 × 10(-4) . Postoperative nausea and vomiting was less likely to trigger rescue antiemesis after granisetron and metoclopramide in studies by Fujii et al., 0.40 (0.27-0.60), p = 9.7 × 10(-6) . Triggered rates of rescue were not different in studies by others for droperidol, granisetron and metoclopramide, but were less common after granisetron than droperidol and metoclopramide in studies by Fujii et al., 0.50 (0.38-0.66), p = 1.7 × 10(-6) and 0.47 (0.34-0.64), p = 2.6 × 10(-6) , respectively. There was no synergism between antiemetics in trials by other authors. In contrast, in studies by Fujii et al., postoperative nausea and vomiting was more likely if granisetron was administered alone: nausea 4.20 (1.94-9.08), p = 2.6 × 10(-4) ; vomiting 4.50 (2.55-7.97), p = 2.3 × 10(-7) ; nausea or vomiting 5.00 (2.84-8.81), p = 2.5 × 10(-8) . Similarly, droperidol was less effective in studies by Fujii et al. if administered alone: vomiting 2.76 (1.25-6.11), p = 0.01; nausea or vomiting 2.96 (1.46-6.00), p = 2.7 × 10(-3) . The conclusion is that if, as recommended, data with unusual distributions are removed from meta-analysis and articles by Fujii et al. excluded, then the antiemetic effects of granisetron and ramosetron are greatly reduced; further, there is no evidence of synergism between antiemetics and indeed, some evidence of antagonism between antiemetic agents.

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    ABSTRACT: BACKGROUND:Ramosetron has been shown to have a very strong effect for preventing postoperative nausea and vomiting (PONV) in previous meta-analyses. However, these previous meta-analyses included a number of studies by Fujii et al. which have now been proven to have been fabricated. In the present meta-analysis, we reevaluated the effectiveness of ramosetron in preventing PONV after excluding Fujii et al.'s randomized controlled trials.METHODS:We searched MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and Web of Science. All double-blind randomized controlled trials that tested the efficacy of ramosetron compared with a placebo or other drugs as a control in the prophylaxis of PONV were considered to be eligible. The first postoperative 24 hours were divided into early (0-6 hours) and late (6-24 hours) time periods, and we collected these data separately.RESULTS:A total of 1372 patients were included in the final analysis. Compared with a placebo, ramosetron reduced the incidence of early postoperative nausea (PON) (relative risk [RR] [95% confidence interval] 0.59 [0.47-0.73]: number needed to treat [NNT] [95% confidence interval] 6.0 [4.3-9.7]), late PON (RR 0.65 [0.49-0.85]: NNT 7.2 [4.6-16.6]), early postoperative vomiting (POV) (RR 0.48 [0.31-0.74]: NNT 14.8 [8.3-70.4]), and late POV (RR 0.50 [0.35-0.73]: NNT 12.3 [7.1-47.6]). Compared with ondansetron, ramosetron reduces early POV (RR 0.50 [0.28-0.90]: NNT 24.1 [10.7-98.0]) and late POV (RR 0.53 [0.34-0.81]: NNT 27.2 [12.0-102.0]) but not PON.CONCLUSIONS:Ramosetron has a significant effect for preventing PONV compared with a placebo, but less than that reported in previous analyses. Ramosetron also has statistically significant differences in preventing early and late POV compared with ondansetron, but the clinical significance may be questioned because the NNTs are large.
    Anesthesia and analgesia 06/2013; 117(2). DOI:10.1213/ANE.0b013e31829847a1 · 3.42 Impact Factor

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