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. 2021 Nov 16;2021(11):CD012775. doi: 10.1002/14651858.CD012775.pub2

Jantunen 1992.

Study characteristics
Methods Randomised, prospective, cross‐over study with 2 arms
  • comparison of ondansetron + dexamethasone vs tropisetron + dexamethasone


Enrolment period: n.r.
  • 47 patients entered


Masking: open‐label
Baseline patient characteristics: reported
Follow‐up: yes
Participants Inclusion criteria
  • outpatients and inpatients designated to receive 2 similar courses of non‐cisplatin‐containing chemotherapy separated by at least 14 days


Exclusion criteria
  • brain metastases

  • signs of bowel obstruction

  • experienced vomiting within 12 h before start of the study


Median age, years: 58.3 in males, 49.5 in females
Gender: male (14) + female (33)
Tumour/cancer type: solid tumour (breast, lung, melanoma, other)
Chemotherapy regimen: non‐cisplatin‐containing chemotherapy (CNF, CMF, CEF, VAC, carboplatin‐containing, DTIC‐containing, epirubicin‐containing, MTX‐5‐FU, MMM)
Country: n.r.
Interventions Cross‐over study
Experimental: arm A: ondansetron
8 mg ondansetron + 10 mg dexamethasone (loading dose of ondansetron was followed by 8 mg ondansetron given orally twice at 8‐h intervals)
Experimental: arm B: tropisetron
5 mg tropisetron + 10 mg dexamethasone
Outcomes control of vomiting during first 24 h was scored as
  • total: no vomiting

  • partial: 1 to 4 vomits

  • failure: more than 4 vomits

Notes
  • no information regarding sponsor and clinical trial registration reported

  • study authors did not provide disclosure of potential conflicts of interest

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: randomised trial but method of randomisation not reported
Allocation concealment (selection bias) Unclear risk Comment: allocation concealment not reported
Blinding of participants and personnel (performance bias)
Blinding of participants High risk Comment: open‐label
Blinding of participants and personnel (performance bias)
Blinding of personnel High risk Comment: open‐label
Blinding of outcome assessment (detection bias)
Subjective outcomes (Patient reported outcomes) High risk Comment: patients and personnel were not blinded towards the intervention and therefore might influence subjective outcomes analysis
Incomplete outcome data (attrition bias)
Subjective outcomes (Patient reported outcomes) Low risk Quote: "thirty‐nine patients were evaluable for cross‐over analysis"
Selective reporting (reporting bias) Low risk Comment: all outcome measures were reported in the results section
Other bias Low risk Comment: no information to suggest other sources of bias