Jowkar 2011.
Methods | Randomised controlled, parallel‐group design This study was conducted at a single dermatology centre in Iran |
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Participants | 44 "healthy patients with hand eczema that did not use topical medication in 2 weeks ago or systemic medication in 1 month ago were enrolled" (participants aged 12 to 60 years with hand eczema) No dropouts Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • 4% topical cream of Fumaria parviflora L. alcoholic extract for 4 weeks twice daily, 10 grams on hand surface skin in probably 22 participants, although this is not clearly described in the article Control intervention • Placebo twice daily in probably 22 participants for 4 weeks Participants were followed up until 2 weeks after the end of treatment Duration 6 weeks (4 weeks active treatment, 2 weeks follow‐up) |
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Outcomes |
Primary outcome of the trial
Other outcomes of the trial
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Notes | The number of participants in each group is not described, and the ratio intervention vs placebo is unclear Because the data are presented in a graphical manner, they are difficult to reproduce. The secondary outcome ‐ reduction in severity investigator‐rated ‐ was included but did not provide reproducible data Study authors were contacted on 28 February 2014 and replied the same day Declarations of interest: none declared Funding: the study was supported by Shiraz University of Medical Science Sample size rationale: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomization was conducted based on block randomization design" Comment: randomisation block design suggests the use of a randomisation code list; however study authors denied the existence of a randomisation list in personal communication |
Allocation concealment (selection bias) | Low risk | No details about allocation concealment in the article; however personal communication clarified that treatment allocation was done by a third person |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind (patient‐physician) placebo‐controlled study" Comment: no additional information is provided in the article. Personal communication clarified that placebo and actual treatment were the same in appearance, and the secretary (third party, not involved in actual treatment) dispensed the study drugs |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "both dermatologist and patients were blind to study groups. Data were recorded by an assessor" Comment: physicians were blinded and unaware of treatment allocation, which was done by a third person |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "a total of 44 patients completed the study" Comment: one patient was excluded from the study due to side effects; however more than 80% completed the study |
Selective reporting (reporting bias) | Low risk | No discrepancy between the registered trial (IRCT 1388103030741N1) and the original article with regard to outcomes |
Other bias | Unclear risk | Baseline characteristics depicted in graphs; not stated whether there was a significant difference between groups Diagnostic certainty: yes The study was completed |