Eguchi 2015.
Study characteristics | ||
Methods | Prospective, randomised, double‐blind, placebo‐controlled trial Multicentre study with 22 institutions Country: Japan Study duration: 8 days |
|
Participants |
Number of participants: 34 (18 intervention/16 control) adult cancer patients (35 allocated) Inclusion criteria: age > 18 yrs; histological diagnosis of advanced cancer; expected life expectancy of > 4 months; no future plans for chemotherapy, radiotherapy, or surgical treatment; CRF refractory to other treatments; ability to take oral medications, inpatient treatment; ALT ≤ 300 U/mL; AST ≤ 300 U/mL; creatinine ≤ 3.0 mg/dL; bilirubin ≤ 3.0 mg/dL Exclusion criteria: severe heart disease; diabetes mellitus; active gastrointestinal ulcers, viral hepatitis, infectious disease, or tuberculosis; radiotherapy or chemotherapy in the previous 4 weeks; surgery for their cancer in the prior 2 weeks; history of corticosteroid allergy; corticosteroids use in the last 2 weeks; inadequate understanding of their condition |
|
Interventions | Participants were randomly assigned to 2 groups in 1:1 ratio Intervention group: methylprednisolone 16 mg twice daily, orally for 7 days Control group: placebo twice daily for 7 days |
|
Outcomes |
Primary outcome Change in VAS score for fatigue from day 0 to 8 Secondary outcomes Change in VAS score for appetite from day 0 to 8. Change in QoL on QoL–ACD score on days 0, 3, and 8 Laboratory examinations were taken on days 0 and 8 Adverse events were recorded daily and the level of severity was recorded on a 5‐point Likert‐type scale |
|
Notes | The study was underpowered, so was unable to prove the efficacy of methylprednisolone in improving CRF. The was evidence of a difference in the secondary endpoints. The study was partially funded by the Epidemiological and Clinical Research Information Network; no reference made to potential COIs |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "dynamic randomization method" |
Allocation concealment (selection bias) | Low risk | Central randomisation at data centre |
Blinding of participants and personnel (performance bias) Participant‐reported fatigue relief | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) Participant‐reported fatigue relief | Unclear risk | No clear statement of how assessors were blinded |
Incomplete outcome data (attrition bias) Participant‐reported fatigue relief | Low risk | < 10% of participants did not complete the study |
Selective reporting (reporting bias) | Low risk | None detected |