APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
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DOI: 10.3310/hta14370 <strong>Health</strong> <strong>Technology</strong> <strong>Assessment</strong> 2010; Vol. 14: No. 37<br />
Study details Population details Treatment details Results Interpretation<br />
Authors’ conclusions<br />
One treatment with<br />
PDT using topical<br />
5-ALA appears to be<br />
as effective and well<br />
tolerated as 3 wk of<br />
twice-daily topical 5-FU,<br />
a cheap and widely<br />
available alternative<br />
Appraisal This<br />
study appeared to be<br />
too small to detect<br />
significant treatment<br />
effects. The methods<br />
and results were not<br />
clearly reported and<br />
measures to reduce<br />
bias (e.g. randomisation,<br />
blinding and allocation<br />
concealment) were<br />
not reported at all<br />
so the reliability of<br />
the conclusions is<br />
questionable<br />
Morbidity The mean lesional area before treatment for<br />
PDT was 1322 mm2 and 6 mth after treatment was 291 mm2 (a reduction of 73%, 95% CI 61% to 84%). For 5-FU, mean<br />
lesional area was 1390 mm2 before treatment and 297mm2 after (a reduction of 70%, 95% CI 61% to 80%). There was no<br />
statistically significant difference in reduction of lesional area<br />
between PDT and 5-FU at 6 mth (p = 0.72). No patients were<br />
completely cleared of AKs with either treatment<br />
QoL and return to normal activity Not assessed<br />
AEs All patients experienced mild to moderate pain at PDT<br />
sites. In wk 1, PDT sites were significantly more painful than<br />
5-FU sites, but this difference was absent in wk 2 and reversed<br />
in wk 4. There was no significant difference between treatments<br />
overall over the 4-wk period. Daily symptom diaries were<br />
completed by 11 patients. In wk 1, PDT sites were significantly<br />
more erythematous than 5-FU sites but this difference was<br />
absent in wk 2 and reversed in wk 3 and 4. There was no<br />
significant difference between treatments overall over the<br />
4-wk period. There was no blistering, ulceration, scarring or<br />
photosensitivity reaction after either treatment method. One<br />
patient experienced contact sensitivity to 5-FU<br />
Trial treatments ALA–PDT<br />
vs 5-FU (within-participant<br />
comparison)<br />
Intervention ALA–PDT:<br />
Thick surface scale was<br />
removed if present then 20%<br />
5-ALA was applied topically<br />
and covered in a lightimpermeable<br />
dressing for 4 hr.<br />
PDT was administered with<br />
a halogen lamp (580–740 nm,<br />
150 J/cm2 , mean fluence rate<br />
80 mW/cm2 )<br />
Comparator 5-FU cream<br />
(5%) was applied topically<br />
twice a day to one hand for<br />
3 wk by thorough massage<br />
Treatment intention<br />
Curative<br />
Type(s) of lesion and<br />
histology AK<br />
Main eligibility criteria It<br />
appeared that patients with a<br />
long history of AKs affecting<br />
the forearms and hands were<br />
eligible for inclusion<br />
Patient characteristics<br />
% Male: 47<br />
Age range: 53–79 yr<br />
Concomitant treatment<br />
Not stated<br />
Authors Kurwa et al.<br />
(1999) 47<br />
Data source Full<br />
published paper<br />
Country UK<br />
Language English<br />
Study design RCT<br />
No. of participants<br />
Total: 17<br />
Intervention: 17<br />
Comparator: 17<br />
No. of recruiting<br />
centres Not stated<br />
Follow-up period<br />
and frequency 1 wk,<br />
4 wk and 6 mth<br />
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