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

Sharma 2006.

Methods Parallel‐group, randomised controlled trial
This study was carried out in a secondary care setting at a single centre in India
Participants 21 participants with proven nickel allergy by patch testing
No dropouts
Inclusion criteria of the trial
  • Chronic recurring vesicular hand eczema

  • Solely allergic to nickel as proven by patch testing


Exclusion criteria of the trial
  • Usage of prosthesis

  • Pregnancy

  • Lactation

  • History of alcoholism

  • Abnormal biochemistry (glucose and liver function tests) or blood counts


Study population
  • Gender: 15 female, 6 male

  • Age: mean 34.1 years, range 18 to 50 years

Interventions Intervention
• Low‐nickel diet and disulphiram 125 mg daily in the first 2 weeks and 250 mg daily in weeks 3 and 4 in 11 participants
Control intervention
• Normal diet and placebo tablet (lactose) for 4 weeks in 10 participants
Participants were followed up for 2 to 12 weeks after end of treatment
Duration
Up to 16 weeks (4 weeks of active treatment, 2 to 12 weeks of follow‐up)
Outcomes Primary outcome of the trial
  • Investigator‐rated (?) severity of hand eczema (total severity scores for the parameters itching, vesicles, crusting, scaling, and fissuring) at baseline, week 2, and week 4


Other outcomes
  • Adverse events

Notes Two weeks after the start of a low‐nickel diet in the experimental group, disulphiram was started for a duration of 4 weeks. Participants in the control group were treated only with a placebo tablet during those 4 weeks. In addition, the low‐nickel diet was continued during follow‐up (i.e. 12 weeks after disulphiram was stopped)
The secondary outcome ‐ reduction in severity, investigator‐rated ‐ was included, but the article did not provide reproducible data
Study authors were contacted for additional information with regards to the risk of bias table
Declarations of interest: none declared
Funding: no funding
Sample size rationale: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "all the 21 patients were randomly divided in 2 groups"
Comment: no further details in the article. Personal communication with study authors clarified that they had used a lottery system
Allocation concealment (selection bias) Low risk No details about how allocation was concealed from participants and clinicians. Personal communication clarified that this was done by a third person
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "it was a comparative study and participants were not aware if they belonged to study group or control group (single blind trial)"
Comment: participant blinding attempted with the use of placebo tablets (lactose tablets), although participants in the control group were allowed to continue with their normal diet, while the intervention group remained on the low‐nickel diet. Site personnel probably were not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "it was a comparative study and participants were not aware if they belonged to study group or control group (single blind trial)"
Comment: observers were not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk None of the participants dropped out, and all participants were included in the analyses (21 of 21 = 100%)
Selective reporting (reporting bias) Unclear risk No trial registration found. In the Methods section, no clear description is given of the outcome parameters; in the Results section, outcomes are listed that are not described in the Materials section
Other bias Unclear risk Baseline comparisons: no baseline comparisons
Diagnostic certainty: yes
The study was completed