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. 2020 May 5;2020(5):CD011941. doi: 10.1002/14651858.CD011941.pub2

Brockow 2007b.

Study characteristics
Methods Two‐group parallel, phase III pragmatic randomised controlled trial

  • Setting: multi‐centre study (five centres) with outpatients living in the respective spa town or within a radius of 50 km from the spa centres located in Germany

  • Duration of enrolment: August 2001 to April 2005

  • Follow‐up time: 3 to 6 months
Participants Inclusion criteria of the trial

  • Patients with psoriasis without substantial changes during the last month

  • Psoriasis Area and Severity Index (PASI) of > 10 and/or an involvement of > 15% of the total body surface area


Exclusion criteria of the trial

  • Persons with erythrodermic, pustular or isolated palmoplantar psoriasis

  • Patients younger than 18 years

  • Pregnant or breast‐feeding women

  • Persons with malignant hypertension, coronary heart disease, heart failure, arrhythmia, or a history of malignancies

  • Patients currently on photosensitising agents or on medications negatively affecting psoriasis

  • Patients who were not legally competent

  • Patients who received phototherapy 4 weeks prior to study entry


Characteristics (intervention versus control): balanced except gender

  • Age: mean age in years (SD): 49.8 (13.8) versus 50.0 (12.7), number assessed: 78 versus 77

  • Gender (M/F, %): 58 (74%) / 20 (26%) versus 44 (57%) / 33 (43%), number assessed: 78 versus 77, significantly more females with control

  • Skin type (N, %): I: 4 (5%) versus 1 (1%); II: 12 (15%) versus 10 (13%); III: 51 (65%) versus 52 (68%); IV: 10 (13%) versus 14 (18%); V: 1 (1%) versus 0 (0%)

  • Severity: median (interquartile range) PASI score (0 to 72): 17 (12 to 24) versus 18 (12 to 23), number assessed: 77 versus 75

  • Pprevious treatment:

    • any experience of former phototherapy: 87% (68 of 81) versus 87% (67 of 83);

    • previous systematic antipsoriatic agents: 23% (18 of 78) versus 27% (21 of 78);

    • history of inpatient care because of psoriasis: 56% (39 of 70) versus 49% (32 of 66).

  • Duration of condition: not reported
Interventions Intervention (n = 81)

  • Low concentrated saline spa water baths followed by artificial ultraviolet B (UVB). Patients took a 20‐minute whole body saline spa water bath with a temperature of 37°C prior to UVB irradiation. Patients were allowed to dab off but not to wipe their skin after bathing. Within 10 minutes after bathing, patients were irradiated with UVB.

  • Low concentrated saline spa water baths : sodium chloride concentrations varied between 4.5% and 12% depending on the local source. Concentration: 45 g/L to 120 g/L NaCl present in spring water.

  • Artificial UVB : either broadband UVB (280 nm to 320 nm) or selective UVB phototherapy (300 nm to 320 nm) were used as irradiation sources. Narrowband UVB (311 nm) was also admitted, but no spa centre provided it. Minimal erythema dose (MED) was assessed before the start of treatment to determine the starting dose. Starting dose was 50% of MED (visit 1). From visit 2 to 10 UVB dose was increased by 25% of MED, afterwards by 10% of MED. If an erythema occurred, UVB dose was adjusted depending on the severity of erythemal response. 18 Patients were treated three times a week until remission or for a maximum of 6 weeks (18 sessions). Remission was defined as a reduction of PASI below a score of 5. Mean starting dose was 0.044 J/cm2. Average dose per visit was 0.27 J/cm2. Cumulative dose was 4.74 J/cm2.


Control intervention (n = 83)

  • Artificial UVB alone : mean starting dose was 0.044 J/cm2. Average dose per visit was 0.25 J/cm2. Cumulative dose was 4.30 J/cm2. Other conditions equal those reported for the intervention.


The interventions were applied once a day, three days a week, for up to six weeks, and reaching a maximum number of 18 applications. Duration of UV irradiation was not reported.
Outcomes Primary outcomes of the trial

  1. PASI‐50: Reduction of ≥ 50% of the Psoriasis Area and Severity Index (PASI) or the involved body surface area. PASI was assessed at baseline, after 2 weeks, after 4 weeks, at the end of the intervention period (maximum: 6 weeks).


Secondary outcomes of the trial

  1. PASI‐75: reduction of ≥75% of the Psoriasis Area and Severity Index (PASI) or the involved body surface area. PASI was assessed at baseline, after 2 weeks, after 4 weeks, and at the end of the intervention period (maximum: 6 weeks). In the conclusion of the abstract, the authors used the phrase "at the end of a 6‐week treatment course". In the protocol adherence of the results, the authors used the phrase "Average treatment period was 6.6 weeks (SD 1.2)." Therefore, we assume that the expression 'end of treatment' can is consistent with the time point of six weeks after start of treatment.

  2. S‐PASI: self‐administered PASI by the patients. S‐PASI was assessed at baseline, after 2 weeks, after 4 weeks, at the end of the intervention period (maximum: 6 weeks), after 3 months, and after 6 months.
Notes Funding not reported
Conflicts of interest: issue not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (page 1028): "Study participants were externally randomized [...] via a central telephone hotline. One computer‐generated randomization list with blocks of 12 masked to the site investigators was prepared for each of the participating spa centres by the responsible biometrician of the study."
Comment: the authors clearly described an adequate random sequence generation, which was judged as low risk of bias.
Allocation concealment (selection bias) Low risk Quote (page 1028): "Allocation concealment was broken shortly before the first intervention was administered by the responsible phototherapists at the spa centres."
Comment: the authors clearly described an adequate concealment of the allocation, which was judged as low risk of bias.
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote (page 1029): "Blinding of the participants was not possible due to the nature of the interventions."
Comment: the authors reported that they did not blind investigators and patients and we judged a high risk of performance bias.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote (page 1029; page 1030): "Blinding of PASI raters was intended. The study center did not inform the trial sites (dermatological clinics) about treatment allocation. Only the phototherapists at the spa centers knew the treatment allocation. Both patients and phototherapists were instructed not to inform the PASI raters or other staff at the trial sites about treatment allo‐ cation. Success of observer blinding was evaluated at the end of the intervention period. A questionnaire asked the PASI raters to state whether they knew treatment allocation or not. [...] At the end of the intervention period PASI raters stated that they knew the treatment allocation in 50% of cases (65/129)."
Comment: we judged an unclear risk as blinding was tried but was not achieved.
Incomplete outcome data (attrition bias)
All outcomes High risk 2 of 81 patients of the intervention group withdrew early and did not attend follow‐up visits. 19 of 83 patients of the control group withdrew early and did not attend follow‐up visits.
Comment: we think that the proportion of dropouts is high and may affect the outcome. Thus, we judged a high risk of attrition bias.
Selective reporting (reporting bias) Unclear risk Comment: we did not identify a selective reporting issue and judged an unclear risk of bias.
Other bias Unclear risk Comment: we did not identify other bias such as design‐specific risks of bias, baseline imbalance, blocked randomisation in unblinded trials, and differential diagnostic activity.