Veien 1995.

Methods	Parallel‐group, randomised controlled trial This study was conducted at 4 dermatological departments and clinics in Denmark
Participants	47 participants (11 male and 36 female) with hand eczema of at least 6 months' duration. All had or previously had atopic dermatitis. All without positive reaction to standard patch test series Dropouts: 9 Inclusion criteria of the trial Eczema of the hands and/or fingers for at least 6 months A minimum score of 5 according to the adopted scoring system At least 18 years of age Current or past atopic dermatitis according to criteria of Hanifin and Rajka Exclusion criteria of the trial Type IV allergy Study population Gender: 36 female, 11 male Age: not stated
Interventions	Intervention • Oral ranitidine 300 mg twice daily (21/23 participants) for 16 weeks Control intervention • Placebo tablets (17/24 participants) for 16 weeks Both groups received betamethasone cream/ointment and emollient Duration 16 weeks
Outcomes	Primary outcomes of the trial Not defined Other outcomes Observer‐rated severity scoring based on scoring (0 = absent, 1 = mild, 2 = moderate, 3 = severe) for erythema, vesicles, scaling, pruritus, and fissures, and 1 to 3 score for area involved Participant‐rated treatment result: 0 = unchanged/aggravated, 1 = slight improvement, 2 = marked improvement, 3 = clear at baseline and at weeks 4, 8, 12, and 16 Observer‐rated treatment result: 0 = unchanged/aggravated, 1 = slight improvement, 2 = marked improvement, 3 = clear at baseline and at weeks 4, 8, 12, and 16 Participant‐ and physician‐rated (combined?) overall result: successful (marked alleviation or clear) or failed (unchanged/aggravated) Scores of separate items for outcome 1 Adverse events
Notes	Published as brief communication. Analysis according to intention‐to‐treat principle, but no details given The secondary outcome ‐ reduction in severity, investigator‐rated ‐ was included, although because standard deviations were missing, we were unable to reproduce the data Study authors were contacted by email but were unable to answer all of our questions because the study was conducted such a long time ago Declarations of interest: not stated Funding: the study drugs were provided by Glaxo Denmark A/S, and Glaxo provided an employee to assist with the study. The emollients were provided by Rhône‐Poulene, and statistical analyses were performed by Biomedica, Copenhagen, Denmark Sample size rationale: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "the patients were randomly selected" Comment: no further details given in the article; personal communication with study authors clarified that a computer‐generated code was used
Allocation concealment (selection bias)	Low risk	No details in the article about how allocation was concealed from participants and clinicians. Personal communication with study authors clarified the following: "The allocation was concealed from patients and investigators by numbers on identical boxes of tablets containing either ranitidine or placebo". Because randomisation was done by a third party, boxes were identical, and investigators received the randomisation code only in a sealed envelope, this was considered an adequate method to prevent selection bias
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "the patients were randomly selected to receive oral ranitidine, 300 mg twice daily, or placebo tablets of identical appearance" Comment: double‐blind design. Because randomisation was done by a third party and staff received identical looking boxes for ranitidine and placebo, it was not possible for participants and staff to know the treatment arm
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "the code was broken when all the patients had completed the study and all results were recorded" Comment: randomisation was carried out by a third party; therefore observers could not have known the treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "statistical evaluations were based on the intention‐to‐treat principle" Comment: intention‐to‐treat analysis
Selective reporting (reporting bias)	High risk	No trial registration found. The Results section is very concise. In the Results section, it is unclear whether the outcome was based on participants' or investigators' scores or on a combination of these, and only total scores or significance levels are given
Other bias	Low risk	Baseline comparisons: the 2 groups were comparable with regard to age, duration of dermatitis, eczema at other sites, and presence of other atopic symptoms Diagnostic certainty: yes The study was completed