A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of a Chinese herbal product (P07P) for the treatment of canine atopic dermatitis
Tm. Nagle et al., A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of a Chinese herbal product (P07P) for the treatment of canine atopic dermatitis, VET DERMATO, 12(5), 2001, pp. 265-274
A randomized, double-blind, placebo-controlled trial of P07P, a product der
ived from a traditional Chinese herbal remedy, was undertaken in 50 dogs wi
th atopic dermatitis. Owners recorded a daily itch score for 4-14 days befo
re treatment and during treatment. Packets of powder containing P07P or pla
cebo were added to the food once daily for 8 weeks. Dogs were assessed for
erythema, surface damage, overall coat condition and seborrhoea by the same
investigator, as well as for pruritus and general demeanour, at 0 (visit 2
), 28 (visit 3) and 56 (visit 4) days of treatment or at withdrawal. Invest
igator and owner assessments of response were recorded after 28 and 56 days
of treatment or at withdrawal. The predefined primary outcome measure was
the owners' assessment of response at the end of treatment. Nine of the 24
dogs (37.5%) in the P07P group but only 3 of the 23 dogs (13%) in the place
bo group were considered to have improved, but this difference was not stat
istically significant (P = 0.09). There was a significantly higher withdraw
al rate due to worsening of condition in the placebo group (P = 0.04). Mean
daily itch score in the second 28-day period of the study was significantl
y higher than baseline in the placebo group (P = 0.01) but not in the P07P
group (P = 0.30). Pruritus scores showed a significant deterioration from b
aseline at the final visit in the placebo group (P = 0.01) but not in the P
07P group (P = 1.00). There was a significant difference between the groups
in change from baseline in erythema score at visit 3 (P = 0.05). There wer
e no significant differences (P > 0.05) in surface damage, seborrhoea, over
all coat condition and general demeanour scores within or between the group
s throughout the study. The product was well tolerated with no severe or se
rious adverse events recorded. P07P may be beneficial as a novel nonsteroid
al therapy for the management of dogs with atopic dermatitis.