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. 2019 Apr 26;2019(4):CD004055. doi: 10.1002/14651858.CD004055.pub2

Jowkar 2011.

Methods Randomised controlled, parallel‐group design
This study was conducted at a single dermatology centre in Iran
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
  • Healthy participants with hand eczema


Exclusion criteria of the trial
  • Use of topical medication in the 2 weeks before the study

  • Systemic treatments 1 month before the study

  • Pregnancy

  • Lactation

  • Hypersensitivity to study drugs


Study population
  • Gender: 30 female, 14 male

  • Age: mean 33.3 years, range 13 to 58 years

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)
Outcomes Primary outcome of the trial
  • Investigator‐rated reduction in severity of hand eczema at week 0 and week 6 (2 weeks after termination of therapy) by means of the Eczema Area and Severity Index (EASI), which is validated for atopic dermatitis and scores erythema, papules, excoriation, and lichenification on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe and multiplies this by an area score


Other outcomes of the trial
  • Adverse events

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
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