[The Antiseptic (1976): 10, 541]
Pilex therapy in Piles - a Preliminary Report
D.R. Mukherjee, D.R., M.B.,B.S. (Cal.), M.S. (Cal.), Clinical Tutor
and
Poddar, H. M.B.,B.S. (Cal.), M.S. (Cal.), Reader,
Department of Surgery, N.R.S. Medical College, Calcutta, India.
INTRODUCTION
Piles are varicose veins occurring in the ano-rectal region involving the plexus formed by the
superior, middle and inferior haemorrhoidal veins. Piles can be external (covered by skin), internal
(covered by mucous membrane), interno-external (when both types are associated). They may be a
natural consequence of the erect posture in man or due to the absence of valves in the portal venous
system or occlusion of the veins of the rectal mucosa (Howley, 1973); while others suggest
infection or increased intra-abdominal pressure (Barkitt, 1972). They may be a safety-valve
mechanism to a hypertensive subject. Pecten-bands (Lord, 1972) or Corpus cavernosum recti
(Stelzner et al., 1962) is also blamed as an aetiology of this condition.
Treatment of piles depends on the degree and symptomatology. Conservative treatment with diet
and drugs is of preventive and to a lesser degree of curative value. Local application of various
ointments, sclerosal injection therapy, rubber band legation and cryosurgery can be used with
advantage. In some cases, haemorroidectomy and Lord’s massive four finger dilatation of anal
canal and lower rectum may be of high curative value.
Many indigenous drugs have been used in India for many decades in the treatment of piles.
This short paper is meant to be a preliminary assessment of the results of the treatment of first
degree (without prolapse), and second degree piles (prolapse on straining at stool but return
spontaneously) with Pilex tablets and ointment for a short period to have a basis for a wider trial in
this part of the country in future.
MATERIAL AND METHODS
Patients with bleeding per rectum were selected from the surgical out-patients department under the
Senior Surgeon (H.P.) in N.R.S. Medical College, Calcutta. Only diagnosed first and second degree
piles were treated and followed up for a short period of four weeks from 1st December, 1975.
A detailed history including the age, sex, occupation, diet, family history, bowel habits, duration of
bleeding, pain in perineum, itching, discharge together with other local and general symptoms was
recorded. In every case, general systemic examination, proctoscopic and digital per rectal
examination were performed. In all cases, number, size, situation, colour and degree of piles were
noted with diagrams. Routine stool, urine and blood examination (specially Hb%, B.T. and C.T.)
were done in all cases.
There were 12 males and 3 females. None of the females had any symptoms associated with
pregnancy or childbirth. All 3 female cases were multiparous.
All 15 cases were non-vegetarians and all were Bengalee Hindus. The bleeding had no definite
relation with occupation as amongst males - 4 were sedentary clerks, 4 were cultivators, 2 were
manual labourers and 2 were students. All females were housewives.
All had suffered from intestinal amoebiasis at least once in their life time.
All females and 4 males were constipated. All constipated patients were used to some laxatives in
the form of drugs or diets (Bael, Isopgul, etc.).
Table I: Age-sex incidence of the study cases
Age group in years
No. of patients
Males
Females
10 to 20
2
2
–
21 to 30
5
4
1
31 to 40
6
4
2
41 to 50
2
2
–
11 out of 15 patients were between 21 and 40 years age.
1.
2.
3.
4.
5.
6.
Table II: Symptomatic analysis
Symptoms
No. of patients
Bleeding per rectum
15
Occasional blood and
mucous in stool
15
Bleeding without pain
10
Bleeding with pain
5
Constipation
7
Perianal itching
6
Table III: Extent of bleeding in relation to the degree of piles
Amount of bleeding
First degree
Second degree
Profuse
1
2
Moderate
2
2
Slight
7
1
Routine blood studies were done in all cases. Anaemia was present in all cases; BT and CT were
within normal limits in all cases.
Table IV: Haemoglobin level of the study series
Haemoglobin per cent
No. of patients
Below 8 g%
3
Between 8 g% and 9 g%
4
Between 9 g% and 10 g%
8
Hb percentages were found proportionate to the amount of bleeding and 2 patients over 40 were
found to be hypertensive. Below 8g% Hb levels were found in profuse bleeding cases.
TREATMENT OF THE CASES
These patients were given easily digestible high-residue diet and anti-anaemic treatment. Patients
were put on specific treatment with Pilex tablets and ointment from the day of attendance.
Each tablet of Pilex contains:
Balsamodendron mukul
Melia azadirachta seeds
Shilajeet (Purified)
Exts. Phyllanthus emblica
Terminalia chebula
Terminalia belerica
Berberis aristata
Arisaema wallichianum
Cassia fistula
Bauhinia variegata
0.13 g
7 mg
16 mg
16 mg
16 mg
16 mg
32 mg
3 mg
16 mg
16 mg
Pilex is specially processed in the fresh juices and decoctions of the following plants: Commelina
salicifolia, Mimosa pudica, Acorus calamus, Blumea lacera, Amorphophallus campanulatus and
Caesalpinia bonducella.
Patients were prescribed Pilex tablets, 2 tablets thrice daily for one week and then maintained on 1
tablet thrice daily for the whole trial period. They were followed up weekly for the total 4 weeks
follow-up period.
Along with Pilex tablets, Pilex ointment was also advised for per rectal application at least three
times daily. This regimen was easily accepted by all of our patients in preference to local injection
treatment or operative interference.
The composition of Pilex ointment is as follows:
Exts. Mimosa pudica
5%
Vitex negundo
3%
Calendula officinalis
2%
Exts. Eclipta alba
3%
Aesculus hippocastanum
2%
Camphor
1.225%
Base q.s. ad.
100%
Prepared in Melia azadirachta, Ailanthus excelsa, Blumea balsmifera, Eclipta alba, Allium
ascalonicum, Acorus calamus, Solanum nigrum etc.
RESULTS OF THERAPY
The results of Pilex therapy was assessed mainly by weekly follow-up of these cases by recording
the bleeding, pain, itching, proctoscopic findings and serial haemoglobin percentage recordings.
From the Table it is evident that most of the patients showed both subjective and objective
improvements in three weeks. Definite improvement in haemoglobin percentage was observed in 4
weeks of treatment with Pilex therapy and haematinics.
Table V: Results of the treatment in the study series as assessed by proctoscopic findings, bleeding and
pain during weekly follow-up
1 wk.
2 wks.
3 wks.
4 wks.
Proctoscopic findings
1. Decreased congestion
1
7
12
12
2. Reduction in size
–
–
5
10
3. Completely disappeared
–
–
–
–
4. No changes
14
8
3
2
Bleeding
Persisting
Profuse
2
1
–
–
Moderate
4
2
1
–
Slight
9
11
12
11
No bleeding
–
1
2
4
Haemoglobin
Below 8 g%
3
2
2
1
Between 8 - 9 g%
4
4
3
3
Between 9 - 10 g%
8
9
10
10
Above 10 g%
Nil
Nil
Nil
1
Pain
Persisting as before
10
8
6
1
Persisting with less intensity
2
3
4
4
No pain
3
4
5
10
SUMMARY
1. Fifteen patients with piles received therapy with Pilex tablets and ointment with haematinic
supportive measures.
2. At the end of 4 weeks bleeding completely stopped in 26.7 per cent and lessened in 73.3 per
cent of the cases.
3. Pain was initially present in 85.8 per cent of the cases. At the end of the trial, it was persisting
only in 6.6 per cent of cases; while in 79.2 per cent of the cases pain was relieved.
Symptomatic improvement was observed mostly from the second week in first and second degree
piles. In 79.2 per cent of the cases decreased congestion was noted by 4 weeks. Size of the mass
was reduced in 66 per cent of cases during that time.
The number of cases treated was small and the duration of treatment short, but subjective
improvement was found in the majority of cases with Pilex treatment. In our opinion, a further
extensive trial in all types of piles may be worth-while for evaluation of these drugs in therapy of
piles.
ACKNOWLEDGEMENT
We are thankful to the Principal-cum-Superintendent, N.R.S. Medical College, Calcutta for
allowing us to conduct the clinical study in this hospital.
REFERENCES
1. Bailey and Love, Short Practice of Surgery.
2. Goligher, J.C., Surgery of the Anus, Rectum and Colon.
3. Hawley, P.R., Recent Advances in Surgery. Ed. Selyn Taylor, 1973.