Clinical Safety and Efficacy of Pilex Tablets and Ointment ... - medIND

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Clinical Safety and Efficacy of Pilex Tablets and
Ointment in the Management of Hemorrhoids
dIbyendu gautam*, manasI basu banerJee**, shIb shankar roy Chowdhury † , JaydeV PramanIk ‡
AbSTRACT
Hemorrhoids are an abnormal swelling of the blood vessels in the anal canal; treatment is indicated only when they become
symptomatic. Conservative treatment typically consists of increasing dietary fiber, oral fluids to maintain hydration, nonsteroidal
anti-inflammatory drugs (NSAIDs), sitz baths and rest. Surgery is indicated when conservative treatment fails;
but, the results are often unsatisfactory and recurrence may occur. However, in the general management of hemorrhoids,
colorectal surgeons agree that severe painful thrombosed hemorrhoids should be excised. The main ingredients of Pilex tablet
are Terminalia chebula, Cassia fistula, Emblica officinalis, which improve appetite, correct hepatic function and have mild laxative
properties thereby facilitating bowel evacuation and reducing local trauma to the hemorrhoidal vessels. The main ingredients
of Pilex ointment are Mimosa pudica, Vitex negundo, Eclipta alba and Solanum nigrum. These herbs possess styptic and antiinflammatory
properties and help in regeneration of the vascular endothelium. Pilex tablets orally and ointment locally have
been very favorably reported for the amelioration and treatment of piles in various clinical trials and also established by a
large number of clinicians and surgeons. This review summarizes the effects of the polyherbal formulations Pilex tablets and
ointment in patients of hemorrhoids.
keywords: Pilex tablets, Pilex ointment, hemorrhoids
Hemorrhoids, or piles, as they are commonly
known as, have plagued humankind since
ancient times. On the day of the decisive battle
at Waterloo, Napoleon Bonaparte was in pain because
of a severe case of thrombosed hemorrhoids, which
impaired his battlefield conduct. 1
Hemorrhoids are an abnormal swelling in the blood
vessels in the anal canal. The most common symptom
is bright red blood in stool. Other symptoms range
from itchiness, pain, swelling, protrusion, bleeding,
constipation and difficulty evacuating, to large fungating
masses or prolapsed piles. 2 These symptoms occur
due to a vicious circle of events. Vascular, submucosal
cushions protrude through a tight anal canal, become
further congested by the sphincter and hypertrophy so
that they then protrude more easily. Management of
hemorrhoids is directed at breaking this circle.
There are two types of hemorrhoids, external and
internal, according to their position with respect to the
dentate line. 3 The internal hemorrhoids develop within
*Professor, Dept. of Surgery
**Associate Professor, Dept. of Pharmacology
† Associate Professor, Dept. of Surgery
Medical College and Hospital, Kolkata
‡ Ayurvedic Consultant
Kawagachhi Gramin Health and Research Centre, Parganas, West Bengal
address for correspondence
Prof. Dibyendu Gautam, Dept. of Surgery
Medical College and Hospital, Kolkata, West Bangal
E-mail: drdivyendu@gmail.com
the anus beneath the lining. An internal hemorrhoid
can cause severe pain if it is completely prolapsed. 4
The external hemorrhoids develop near the anus and
are covered by very sensitive skin. If a blood clot
(thrombosis) develops in an external hemorrhoid,
it becomes a painful, hard lump and may bleed if it
ruptures. 5 Internal hemorrhoids are classically divided
into four categories (I-IV) based on the degree of
prolapse. Recently, it has been suggested that it is
more appropriate to classify them on the basis of
presence or absence of bleeding or prolapse. 6
The prevalence of symptomatic hemorrhoids ranges
from 4.4% in the general population to 36.4% in general
practice. 7 The pathophysiology is not completely
understood other than that structural and vascular
changes are involved. 8 A detailed history is important.
Besides the routine physical examination (visual
inspection of the anal region, digital examination,
anoscopy), patients 50 years, patients of any age with bleeding
and anemia, those with persistent bleeding despite
medical therapy, select patients with significant family
history of colorectal malignancy and those with other
symptoms such as abdominal pain and bloating and
diarrhea. 9 Treatment is only indicated if they become
symptomatic. But, colorectal surgeons agree that all
painful thrombosed hemorrhoids should be excised.
Conservative treatment typically consists of increasing
Indian Journal of Clinical Practice, Vol. 22, No. 9, February 2012
443

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dietary fiber, oral fluids to maintain hydration,
analgesics, sitz baths and rest. 3 Increased fiber intake
improves outcomes. 10 There is scant evidence to
support use of topical agents and suppositories for
treatment. 3 Steroid-containing agents should not be
used for >14 days as they may cause thinning of the
skin. 3 Hemorrhoidectomy is indicated for large third-
and fourth-degree hemorrhoids, mixed hemorrhoids
with a prominent external component and incarcerated
internal hemorrhoids requiring urgent intervention.
Hemorrhoids that fail to respond to medical
management may be treated with rubber band ligation,
sclerosis and thermotherapy. Rubber band ligation has
been demonstrated to be the most effective method
to treat symptomatic internal hemorrhoids that have
failed conservative management. 11-14 Complications of
this procedure include vasovagal response, anal pain,
bleeding from early dislodgment and pelvic sepsis. 15
This review summarizes six clinical studies wherein Pilex
tablets and ointment were evaluated in hemorrhoids.
PILEx TAbLET AND ITS PHARMACOLOGY
Pilex tablets contains various herbs: Their pharmacological
actions are as described below.
Pharmacological Actions of Principal Herbs
Balsamodendron mukul (Syn. Commiphora
mukul): The guggulusterone fraction showed antiinflammatory
activity, comparable to approximately
one-fifth that of hydrocortisone and equal
to phenylbutazone and ibuprofen. 16
Shilajeet (Purified): It has been used as antiinflammatory
agent. Results of its use in diabetes,
fever, anemia, anorexia, spasmodic pain, obesity,
abdominal disorders and skin diseases have been
documented. It also has cardiotonic activity. 17,18
Melia azadirachta (Syn. Azadirachta indica): The
leaves and bark have antimicrobial, antifungal,
anthelmintic, insecticidal, antiviral, antipyretic and
anti-inflammatory activities. It has been used in
inflammatory gum diseases, boils, sores, measles,
small pox and other cutaneous infections. 19,20
Berberis aristata: The extract has bitter, cholagogue,
antidiarrheal, stomachic, laxative, antipyretic and
antiseptic activities. It also has anti-inflammatory,
hypotensive and antiamebic activities. 21 The
laxative activity is useful in hemorrhoids. 22
Emblica officinalis: It has antiviral, antibacterial
and antiallergic activities and is rich in phenols.
The aqueous extract has antibacterial activity
444 Indian Journal of Clinical Practice, Vol. 22, No. 9, February 2012
against Staphylococcus aureus. 23 It is useful in viral
hepatitis, premature atherosclerosis, anemia, acne,
fistula, etc. 24
Terminalia chebula: It has antibacterial, antifungal
activity against many dermatophytes and enhances
immunity. It also has antispasmodic and potent
wound healing activities. It is widely prescribed
in constipation, ulcer, gastroenteritis, cough,
hemorrhoids and other skin diseases. 25
Terminalia belerica: It has hepatoprotective action. 26
Being one of the ingredients of Triphala, T. belerica
also has gastroprotective and laxative properties. 27
Cassia fistula: It is used in conditions of
hematemesis, pruritus, leukoderma, diabetes
and other common dermatological infestations,
inflammatory disorders and constipation. 28
C. fistula pod infusion has been safely utilized as a
laxative and as a substitute for the official Senna. 29
Bauhinia variegata: It has laxative, antibacterial,
blood purifying, antioxidant, antitumor and
hepatoprotective properties. 30,31
Mesua ferrea: It has potent broad-spectrum
antimicrobial actions. 32 Its astringent and styptic
actions are useful in bleeding piles. 33
Pilex Ointment and its Pharmacology
Pilex ointment is a herbomineral formulation. The
synergistic actions of constituent herbs reduce
varicosities of venous plexus in hemorrhoids.
Mimosa pudica: It’s astringent and styptic actions
are useful in bleeding piles. 34
Eclipta alba: It has anti-inflammatory and analgesic
activities. 35
Vitex negundo: It’s potent broad-spectrum
antimicrobial action prevents secondary microbial
infection. 36 V. negundo also has potent and directly
dose-dependent analgesic, strong antihistamine
activity (which helps to control associated itching),
membrane stabilizing and antioxidant activities. 37,38
Anti-inflammatory activity due to triterpenoids and
antihistamine activity have been demonstrated. 39
Calendula officinalis: It has anti-inflammatory and
analgesic activities and accelerates wound healing
by epithelial regeneration. 40 C. officinalis improves
network of basal membrane collagenous substance,
which re-normalizes the capillary membranes
resistance. It subsequently induces reduction in
the hemorrhoidal mass of the dilated veins of
hemorrhoidal plexus. 40 It also has potent free
radical scavenging activities. 41

Cinnamomum camphora: It has analgesic activity
and relieves pain by reducing sensitivity of the
brain or nervous system to pain. 42 It accelerates
wound healing by epithelial regeneration and
has potent broad-spectrum antimicrobial actions 43
including free radical scavenging activities. 44
Tankana: Its potent broad-spectrum antimicrobial
actions prevent secondary microbial infections. 45
Yashada Bhasma: It has potent anti-inflammatory
and analgesic actions and accelerates wound
healing by epithelial regeneration. 46
Clinical Studies of Pilex Tablet and Ointment
Pilex has been put to stringent safety and tolerability
evaluation. Six clinical studies are summarized below.
Study 1: Indigenous drug therapy for hemorrhoids 47
Material and methods: The study included 100
patients with first- and second-degree uncomplicated
hemorrhoids. Fifty patients were given a placebo;
the remaining 50 patients were given Pilex therapy.
Bleeding was the most common symptom in all the
patients, followed by pain during/after defecation (92%)
and mucus discharge (72%). A detailed history including
digital examination and proctoscopy was done to
exclude other causes of bleeding per rectum. Initially,
Pilex tablets were given in a dose of two tablets thricedaily
for 1 week, followed by two tablets twice-daily
for 4 weeks. A maintenance dose of one tablet twicedaily
was given till symptomatic relief was obtained.
Pilex ointment was used in all as a supplement.
Results
Pilex Group: Fifty percent showed remarkable
improvement in the form of complete cessation
of bleeding, pain and discharge. Proctoscopy in
these patients revealed significant shrinkage of
the pile masses and improvement in hemoglobin.
Good response in the form of marked regression
of bleeding, pain and discharge was seen in 26%
of cases. The shrinkage of pile mass was to a lesser
extent in these patients. Poor response, either
subjectively or objectively, was seen in 24%.
Placebo Group: In first-degree hemorrhoids,
improvement was seen only in 20%. Ten percent
showed some improvement in symptoms with
some shrinkage of pile masses and reduction in
discharge. Remaining 70% had a poor subjective
or objective response in the follow-up period of
six months. Several of them later switched over
to some other form of therapy like injection and
surgery as they were unwilling to continue.
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Conclusion: Treatment with Pilex was highly satisfactory;
it was unsatisfactory in the placebo group.
Study 2: Pilex versus Daflon in hemorrhoids 48
Material and methods: Thirty patients with Grades I,
II and III of internal and external hemorrhoids were
included in the trial. Patients with evidence of rectal
prolapse, malignancy and systemic debilitating illness
were excluded from the trial. All the patients were
subjected to history taking and physical examination
including digital examination and proctoscopy. Patients
were divided into two groups of 15 each. Group A
patients received Pilex tablets, two tablets thrice-daily
after meals for 1 week, followed by two tablets twicedaily
for 5 weeks. All the patients were advised to apply
Pilex ointment twice-daily before and after evacuation
of the bowel. Group B patients received Daflon tablets
one tablet thrice-daily for 6 weeks. All the patients
were examined at weekly intervals of six weeks for
subjective evaluation, which was graded with scores:
1 - Mild relief, 2 - Moderate relief and 3 - Complete
relief. Objective evaluation was done at the beginning
and at six weeks at end of study.
Results
Group A: Patients treated with Pilex tablet and ointment.
Grade I: Pilex tablet and ointment was found
very effective in controlling bleeding. About
90% of patients reported complete recovery; on
proctoscopy after four weeks of treatment, the
mucosa was normal. Bleeding was checked within
2-3 weeks of treatment. Shrinkage in piles gradually
occurred over 3-4 weeks in 80%.
Grade II: Moderate reduction in size and
inflammation on hemorrhoidal mass; bleeding was
controlled in over 90% of cases.
Grade III: Mild reduction in size and inflammation
of hemorrhoid mass. But, bleeding stopped within
four weeks of treatment.
Group B: Patients treated with Daflon
Grade I: More than 90% of patients responded in
terms of bleeding per rectum. There was a mild
decrease in size and inflammation of pile mass.
Grade II: Bleeding was controlled in >90% of cases.
Minimal to mild reduction in size and inflammation
of mass was reported after 4-6 weeks of treatment.
Grade III: Effective in controlling bleeding; minimal
change in size and inflammation was reported.
Conclusion: Daflon tablets and Pilex tablet and
ointment are equally effective in controlling bleeding,
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irrespective of the grade of hemorrhoids. Bleeding was
checked in both the groups over a period of 2-3 weeks.
Pilex tablet and ointment are better than Daflon tablet
in reducing inflammation and size of hemorrhoidal
mass in Grades I and II. Pilex tablet and ointment
induced complete remission in most cases with Grade I
hemorrhoids. They also had better efficacy in reducing
pain than Daflon, in terms of early recovery.
Study 3: Role of Pilex tablets and ointment in the
treatment of piles and fissures 49
Material and methods: One hundred eight cases of
piles, with/without anal fissures, were treated with
a combination of Pilex tablets and Pilex ointment for
six weeks; for the first two weeks with 2 tablets of
Pilex thrice-daily orally and Pilex ointment applied
locally twice-daily (at bedtime and in the morning
after defecation). For the next four weeks, the dose of
the tablets was reduced to one tablet thrice-daily and
the application of ointment was continued as earlier.
Patients with other associated conditions like fistula-inano
and anorectal growths were excluded. Every week,
the patients were assessed regarding subjective feeling,
symptomatic improvement, proctoscopic assessment
of the size of the pile mass and complications, if any.
Bleeding at the time of defecation was the predominant
symptom, followed by pain and heaviness in the
anorectal region (n = 81).
Results: Eighty-two cases of piles of all degrees and 26
cases of fissure-in-ano were treated with Pilex tablets
and ointment. Almost all patients reported subjective
improvement within a week of starting treatment.
An objective improvement was found in all cases of
fissures and in most cases of piles.
Conclusion: In early cases of piles and fissure-in-ano,
Pilex tablets and ointment constitute a good alternative
to surgery. Even in late cases, when surgery is
contraindicated, or is to be postponed, this conservative
regimen can provide adequate remission for a relatively
longer period.
Study 4: Pilex therapy in the treatment of
hemorrhoids 50
Material and methods: Fifty patients were studied.
Each patient irrespective of degree of hemorrhoids was
treated with Pilex tablets (2 tablets thrice-daily) and
Pilex ointment (applied twice-daily) simultaneously for
eight weeks.
Results: Thirty cases of first-degree of piles showed
very good response to Pilex therapy; 24 cases (80%)
446 Indian Journal of Clinical Practice, Vol. 22, No. 9, February 2012
were completely relieved from bleeding; four cases
(13.3%) showed improvement and only two cases (6.7%)
reported no improvement. Mucous discharge and
perineal pain was completely relieved in 60% and 80%
cases, respectively. Three cases (10%) showed complete
disappearance of piles and reduction in pile mass was
observed in 21 cases (70%). There was no change at all
in six cases (20%). Symptomatic relief was noted from
2nd week after the start of therapy and was dramatic at
the end of eight weeks.
In second-degree hemorrhoids, response to Pilex
therapy was also good. Bleeding completely stopped
in 10 cases (66.6%), improved in three cases (20%) and
continued in two cases (13.4%). Six (40%) out of total
15 cases showed complete relief of prolapse of the pile
mass. Sixty percent showed reduction in the size of
piles and one case (6.6%) had complete reduction of
pile mass. Discharge and perineal pain were also
relieved in 57.1% and 60% of cases, respectively.
Symptomatic relief was observed from 3rd week after
the start of therapy and was remarkable at the end of
eight weeks.
In five cases of third-degree hemorrhoids, response
to Pilex therapy was satisfactory and a notable
change was found in the relief of symptoms. One
case showed complete relief from prolapse; three cases
showed improvement and only one case reported
no improvement. Forty percent of patients showed
complete relief from bleeding probably due to relief of
congestion, reduction in prolapse and size of pile mass.
One patient had recurrence, who presented after six
months; but was relieved after a further 30-day therapy
with Pilex tablets and Pilex ointment.
Conclusion: Most cases showed complete relief from
bleeding probably due to relief of congestion, reduction
in prolapse and size of pile mass with Pilex therapy.
Study 5: Clinical trial of Pilex tablets and ointment in
the treatment of hemorrhoids 51
Material and methods: Fifty patients with bleeding per
rectum who had piles, mainly first- and second-degree
and a few third-degree were recruited. Patients were
grouped into the following three: First-degree (congested
blood vessels, but no prolapse), second-degree
(prolapsed on straining but, regressed spontaneously)
and third-degree (continuously prolapsed). All patients
were subjected to Pilex therapy with both tablets and
ointment from the day of attendance for six weeks in
the following schedule:
Dose: Pilex tablet; two tablets thrice-daily for 1 week or
till symptomatic relief (usually 2-3 weeks) followed by

one tablet thrice-daily for the rest of the course. Pilex
ointment applied per rectum at least thrice a day.
Follow-up: Every week for six weeks; fortnightly for
three months and then monthly for rest of the trial
period (upto 1 year) or as deemed necessary.
All 10 females and 20 males had constipation and used
some laxatives in the form of drugs or diet. These
patients were prescribed easily digestible high residue
diet and antianemic supportive therapy. If there was
no response after a full course of six weeks, a gap of
two weeks was allowed and then Pilex course was
repeated. A total of 4-5 such courses were tried before
declaring trial cases as failed. Failed trial cases were
subjected to other forms of treatment, mainly surgical.
Results
Out of 42 Group ‘A’ cases classified (Good), 33
were first-degree piles and nine were early seconddegree
piles, all of them were symptom-free after
Pilex therapy during the follow-up period.
Group ‘B’ cases with (Fair) response consisted of
two first-degree and three second-degree piles.
During follow-up, they had mild recurrence of
symptoms usually at 4-6 weeks after the first course
and required another course of Pilex therapy.
During the rest of the follow-up period they were
symptomless.
All Group ‘C’ cases classified as (Poor) were thirddegree
piles with long history and were subjected
to operative treatment; Pilex therapy gave them
temporary relief from symptoms.
Forty-two cases had disappearance of all symptoms
and no relapse. Fair results i.e., symptoms persisted
slightly and required further course of Pilex, were
noticed in five cases. Failed trial cases, 3 in number,
required surgical intervention. There were no toxic
or side reactions in any case.
Conclusion: Eighty-four percent of first-degree and
early second-degree piles remained symptom-free in
the 1-year follow-up period. This study had 50 cases.
An extensive study with prolonged follow-up is required
for definite assessment of Pilex therapy in piles.
Study 6: Clinical trial of Pilex combination therapy in
the treatment of hemorrhoids 52
Material and methods: This study included 60 cases
of internal piles. All patients had bleeding (100%); 34
cases had constipation (55.6%), 26 had discomfort or
pain (43.3%), 16 had itching (26.6%) and only 12 had
discharge (20%) as a presenting symptom. Twenty-
five cases had already received some form of medical
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treatment; of these, five cases had received injections
for piles. Pilex tablets were given in the dose of two
tablet t.i.d. for 4 weeks followed by one t.i.d. for
2 months along with local application of Pilex ointment
b.i.d.
Results: At the end of 6-8 weeks, bleeding completely
stopped in 51 cases (85%) and diminished in the
remaining nine cases (15%); constipation was
completely checked in 22 (64.7%), diminished in 10
(29.4%) and remained the same in 2; pain or discomfort
was relieved in 15 (57.6%), diminished in nine (34.6%)
and remained the same in 2; itching was relieved in 10
(62.5%), decreased in five and remained the same in
1; discharge was relieved in eight (66.6%), diminished
in 3 and remained the same in one. Proctoscopic
examination also showed control of congestion and
reduction in pile masses.
Conclusion: Combination treatment with Pilex tablets
and ointment gives excellent results in all cases of firstdegree
piles (100%) and in 15 cases of second-degree
piles (75%). Three cases of second-degree piles, three
cases of third-degree showed good response and three
cases of third-degree showed fair response. Only three
cases of third-degree piles showed poor response. No
local or general side-effects or toxicity were observed
with Pilex combination therapy in our study.
SUMMARY AND CONCLUSION OF THE REVIEW
Hemorrhoids are a common anorectal disorder
worldwide. Avoidance of constipation is key in treating
hemorrhoids. Most patients can be effectively treated
with fiber supplementation and local ointments. Surgery
is indicated in patients with acute complications or
those in whom conservative treatment has failed. Pilex
tablet and ointment, a polyherbal formulation, has been
extensively studied and has been found to be safe and
effective in patients suffering from hemorrhoids.
Pilex tablet has beneficial effects due to the synergistic
activity of its potent constituent herbs. The antiinflammatory
action reduces swelling of hemorrhoidal
tissue and expedites healing; its styptic action controls
bleeding. It also has antimicrobial, antifungal,
anthelmintic, insecticidal, antiviral, antipyretic, laxative,
antipruritic, blood purifying and antioxidant activity.
Pilex ointment has useful astringent and styptic
actions; the anti-inflammatory, analgesic, membrane
stabilizing activities and strong antihistamine activity
help to control associated itching, accelerate wound
healing. It improves the network of basal membrane
collagenous substance, which leads to re-normalization
of the capillary membranes resistance and reduction in
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hemorrhoidal mass of the dilated veins of hemorrhoidal
plexus. Results of the clinical studies reviewed show
rapid and effective relief in symptoms like shrinkage
of hemorrhoidal mass, control of bleeding per rectum,
relief from itching, reduction of pain and discomfort
during defecation, relief from constipation, control
of secondary infection and recurrence and clinical
improvement in local condition. Pilex combination
therapy is safe and effective in the management of
uncomplicated early hemorrhoids as was shown in the
substantial sample size of the patients reviewed.
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