4
• Apr–Jun 2014 • Vol LIII • No 4
Clinical Studies
Efficacy of Pilex Tablets and
Ointment in the Treatment of
Piles and Fissures
A clinical trial was undertaken to study
the efficacy
of Pilex
tablets and
ointment
in the
treatment
of piles, with or
without anal fissures.
The study included 108 patients with symptoms of piles, of
which 8 patients did not complete the course of treatment. All
patients were treated for 6 weeks. For the first 2 weeks, patients
were given 2 tablets of Pilex orally, thrice daily and Pilex ointment
applied locally twice daily (at bed time and in the morning after
defecation). For the next 4 weeks, the dosage of the tablets was
reduced to 1 tablet thrice daily and the application of ointment
was continued as earlier.
Gross reduction in the severity of symptoms was noticed within
1 week of treatment in 70% of first degree piles, 45% of second
degree piles, 75% of third degree piles, and in almost all the
cases of fissure-in-ano. The size of the pile mass started regressing
within 1 to 2 weeks of treatment. In this study, the efficacy
of Pilex tablets and ointment has been very good (Table 1). A
feeling of subjective improvement within a week of initiation
of treatment is observed in almost all the patients. Thus, it can
be concluded that Pilex tablets and ointment are efficient in the
treatment of piles and fissures.
Table 1.
Results of Pilex Therapy in 108 Cases
Grade of Piles
No. of
Cases
Response to Treatment
Very Good % Good % Fair % Poor %
First Degree
60
9
15 30 50 17 28 4 7
Second
Degree
27
2
7 11 41 11 41 3 11
Third Degree 6
–
– – – 4 67 2 33
Fissure-in-ano 15
–
– 15 100 – – – –
Source
:
Reddy SS, et al.
Probe
. 1984;XXIII(4):213–217.
Safety and Efficacy of Diarex
Syrup in ChildrenWith
Diarrhea
This study evaluated the safety and efficacy of Diarex
syrup in children suffering from diarrhea. Seventy-five
children aged 3 to 10 years, presenting with symptoms
of diarrhea were included in this study and randomized
into 2 groups—Diarex group (n = 40) and placebo
group (n = 35).
In the Diarex group, Diarex syrup was administered at a dosage
of 7.5 mL to children aged 3 to 5 years and 15 mL to children
aged 6 to 10 years, thrice daily for 7 days. Children in the placebo
group received similar looking placebo at the same dosage for
7 days. All children were followed up on day 3 and day 7 for
evaluation of symptoms.
Statistically significant effect was observed with Diarex syrup as
compared to placebo treatment in the parameters like frequency
and nature of stools (Table 2). Reduction in values was observed
for abnormal contents and odor in the stool. There were no
adverse effects observed during the study.
Thus, it can be concluded that Diarex syrup is effective and safe in
relieving the symptoms of diarrhea in children.
Table 2.
Evaluation of Bowel Characteristics
Parameters
Visits
Diarex Syrup Placebo Significance
Frequency
of Stools
At screening 7.64 ± 1.61 7.53 ± 1.36
NS
Day 3
3.59 ± 1.33 4.24 ± 1.37
P
< .0275
Day 7
1.82 ± 0.91 2.21 ± 0.93
P
< .045
Nature of
the Stools
At screening 2.97 ± 0.16 2.97 ± 0.17
NS
Day 3
2.49 ± 0.51 2.63 ± 0.49
NS
Day 7
2.15 ± 0.37 2.14 ± 0.36
NS
NS, not significant.
Statistical test: Mann Whitney test
Source
:
Moharana PK. Data on file.
