Tierney 2009.
| Methods | This was a within‐participant RCT in which 1 side of an anatomical site received the intervention, and the other side received a control topical therapy. 4 laser treatments were given at monthly intervals, followed by a 2‐month observation period | |
| Participants | The trial recruited 22 HS participants with moderate to severe disease, as defined by a Hurley grade of II or III. 34 bilaterally affected anatomical sites (axilla/groin/inframammary) were randomised | |
| Interventions | Left and right sides of the same anatomical site received either:
Laser treatment settings:
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| Outcomes |
Primary outcomes
Tierney 2009 reported results 3 months after the first laser treatment, and Mahmoud 2010 (a secondary publication) reported results after a further 2‐month observation period Secondary outcomes
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| Notes | Upon discussion with the study authors, we were told that during the first month of the trial, participants received the topical therapy only. At the end of the first month, they received their first laser treatment, and this continued monthly for the next 3 months, administering a total of 4 treatments. Following this, there was a 2‐month observation period with no laser treatment The authors indicated that there was no support from commercial sponsors. The study was funded in part by an American Society for Dermatologic Surgery Cutting Edge Research Grant and the Shahani Fund. The authors acknowledged support from the Hidradenitis Suppurativa Foundation |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A coin toss was used |
| Allocation concealment (selection bias) | Low risk | A coin toss was used |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were unblinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Detection bias was low risk for investigator‐reported outcomes – "blinded nontreating physician investigators performed scoring evaluations" ‐ but high risk for participant‐reported outcomes |
| Incomplete outcome data (attrition bias) All outcomes | High risk | There was no intention‐to‐treat analysis, and 5 participants (23% of total), including 8 anatomical sites (24% of total), dropped out and their results were not included |
| Selective reporting (reporting bias) | Unclear risk | The study was registered prospectively on ClinicalTrials.gov, NCT00494351. The primary outcome was stated to be Hidradenitis Severity Score, but both the original Sartorius 2003 score and a version modified by the authors were measured. The timing of primary end points was not stated |
| Other bias | High risk | 3 episodes of cellulitis at non‐treatment sites required antibiotic therapy, which may have affected the results |
BD: twice daily. BMI: body mass index. CRP: C‐reactive protein. DLQI: Dermatology Life Quality Index. EOW: every other week. ESR: erythrocyte sedimentation rate. GC: gentamicin‐collagen. HS: hidradenitis suppurativa. HS‐LASI: HS Lesion, Area and Severity Index. HS‐PGA: Hidradenitis Suppurativa Physician's Global Assessment. HSSI: Hidradenitis Suppurativa Severity Index. IPL: intermittent pulsed light. ITT: intention‐to‐treat. LOCF: last observation carried forward. Nd:YAG: neodymium‐doped yttrium aluminium garnet. PC: primary closure PDT: photodynamic therapy. PGA: Physician Global Assessment. RCT: randomised controlled trial. S. aureus: Staphylococcus aureus. S/c: subcutaneous. TWPI: Total Work Productivity Impairment. VAS: visual analogue scale.