Reviewer's report
Title:Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting
from chronic anal fissure: a phase 3, randomized, double-blind,
placebo-controlled study
Version: 2Date:4 December 2012
Reviewer: H Karanlik
Reviewer's report:
In placebo controlled studies, using term of "phase 3" is discussible. The term of
"phase 3" should remove from headline and manuscript.
were tubes of NTG weighed in the study. If not, how was compliance with the
treatment or placebo assessed?
What pain were the patients asked to record on the VAS scale? worst pain,
avarage pain, in a day or in a defecation?
Expansion of the findings in previous similar studies may help the reader place
this trial in the context of previous work.
how you can explain frequency of headache in placebo group (70% in placebo vs
47.6 in NTG group). The discussion around headaches and dose of NTG would
benefit from clarification.
Did patients use any carrier to apply NTG and was it the same as the control?
The tubes for both ointments can be identical. This is blinded study. In this way,
authors should clarify tubes were not identical for patients and doctors?
What did you use as placebo?
Aside from the above comments the authors are to be congratulated on an
interesting and well performed study.
Reviewer's report
Title:Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting
from chronic anal fissure: a phase 3, randomized, double-blind,
placebo-controlled study
Version: 2Date:4 December 2012
Reviewer: H Karanlik
Reviewer's report:
In placebo controlled studies, using term of "phase 3" is discussible. The term of
"phase 3" should remove from headline and manuscript.
were tubes of NTG weighed in the study. If not, how was compliance with the
treatment or placebo assessed?
What pain were the patients asked to record on the VAS scale? worst pain,
avarage pain, in a day or in a defecation?
Expansion of the findings in previous similar studies may help the reader place
this trial in the context of previous work.
how you can explain frequency of headache in placebo group (70% in placebo vs
47.6 in NTG group). The discussion around headaches and dose of NTG would
benefit from clarification.
Did patients use any carrier to apply NTG and was it the same as the control?
The tubes for both ointments can be identical. This is blinded study. In this way,
authors should clarify tubes were not identical for patients and doctors?
What did you use as placebo?
Aside from the above comments the authors are to be congratulated on an
interesting and well performed study.
Please review this paper.
user
Reviewer's report
Title:Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting
from chronic anal fissure: a phase 3, randomized, double-blind,
placebo-controlled study
Version: 2Date:4 December 2012
Reviewer: H Karanlik
Reviewer's report:
In placebo controlled studies, using term of "phase 3" is discussible. The term of
"phase 3" should remove from headline and manuscript.
were tubes of NTG weighed in the study. If not, how was compliance with the
treatment or placebo assessed?
What pain were the patients asked to record on the VAS scale? worst pain,
avarage pain, in a day or in a defecation?
Expansion of the findings in previous similar studies may help the reader place
this trial in the context of previous work.
how you can explain frequency of headache in placebo group (70% in placebo vs
47.6 in NTG group). The discussion around headaches and dose of NTG would
benefit from clarification.
Did patients use any carrier to apply NTG and was it the same as the control?
The tubes for both ointments can be identical. This is blinded study. In this way,
authors should clarify tubes were not identical for patients and doctors?
What did you use as placebo?
Aside from the above comments the authors are to be congratulated on an
interesting and well performed study.
assistant