NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810

ORIGINAL ARTICLE

CALCIUM DOBESILATE IN SYMPTOMATIC TREATMENT

OF HEMORRHOIDAL DISEASE: AN INTERVENTIONAL
STUDY
Hiteshkumar D Patel1, Amul N Bhedi1, Asutosh P Chauhan2, Rachit M Joshi3
1Assistant
Professor, Department of Surgery, Govt. Medical College, Baroda; 2Assistant Professor, Department of
Biochemistry, Govt. Medical College, Baroda; 3Assistant Professor, Department of Physiology, GMERS,
Gandhinagar

Correspondence: Hiteshkumar D Patel, Email: [email protected]

ABSTRACT
Introduction: Hemorrhoidaldisease is one of the commonest ailments that affects mankind and is currently
believed to be caused by distal displacement and structural distortion of anal cushions, which are physiologic
structuresA randomized, double blind, controlled study was conducted to investigate the efficacy of oral and local
calcium dobesilate therapy in treating acute attacks of internal hemorrhoids.
Methods: fiftynine (59)adult patients with first or second-degree internal hemorrhoids were treated with calcium
dobesilate for six weeks, while 56 patients received only a high fiber diet to serve as control. Both symptoms and
anoscopic inflammation were scored on a scale from 0 to 2 before and six weeks after treatment.
Results: Asuccess rateof 83.05% percent with cessation of bleeding plus lack of severe anitis anoscopically at 6
weeks were achieved with calcium dobesilate. Thepretreatmentsymptoms score of 2 were fell significantly to
0.39±0.16 and the pretreatment anitis score of 1.73±0.12 fell to 0.59±0.17 at 6 weeks (p=0.0002 for both
comparisons). The symptoms and anoscopic inflammation score obtained with calcium dobesilate therapy were also
significantly better than those with diet only. (P=0.0016 and p=0.0014,respectively).
Conclusions: oral as well as local calcium dobesilate treatment supplemented with diet and bowel habits discipline
provides an effective, fast, and safe symptomatic relief from acute symptoms of Hemorrhoidal disease. This
symptomatic relief is associated with significant improvement in anoscopically observed inflammation.

Keywords: Calcium dobesilate, hemorrhoidal disease

INTRODUCTION methods can be performed in opd basis without

anesthesia, and more than 90 percent of symptoms can
Hemorrhoidaldisease is one of the commonest ailments
be successfully controlled by such nonexcisional
that affects mankind and is currently believed to be
techniques with fewer complications and pain,
caused by distal displacement and structural distortion
compared with hemorrhodectomy.7, 13More
of anal cushions, which are physiologic structures.1,
2Anatomicstudies have revealed that the anchoring and
conservative policy is based on the current data that
hemorrhoids are normal anatomic structure and age
supporting sub epithelial tissue deteriorates with aging,
related structural changes occur in every person,
and the descended loose lining becomes more sensitive
whereassymptoms develop in some people.3, 4. Calcium
to trauma from stool, occasionally resulting in venous
dobesilate (calcium 2,5 dihydroxybenzenesulfonate) is a
distention, inflammation, erosion, bleeding, and/or
drug with previously demonstrated efficacy in the
thrombosis.3,4 the finding of proctoscopicanitis which
treatment of diabetic retinopathy and chronic venous
correlates with enlarged lamina propria,capillaries with
insufficiency.8, 9,12
inflammation, is associated with occurrence of
hemorrhoidal bleeding and/or pain.4,5,11. These beneficial effects of the drug are related to its
ability to decrease capillary permeability, platelet
The treatment can be grouped into conservative (diet
aggregation and blood viscosity and to increase
and vascular tonification), nonexcision (sclerotherapy,
lymphatic transport. Because these properties would
cryotherapy, manual anal dilatation, diathermy and
reasonably be expected to contribute to the acute
electro coagulation) and surgical methods (ligation and
inflammatory attacks of hemorrhoidaldisease,
hemorrhoidectomy). 1,2,7extent of mucosal fixation by
thisrandomized, double blind study was conducted to
injection sclerotherapy,infrared photocoagulation,or
investigate the efficacy of calcium dobesilate in treating
band ligation almost never reaches to that of surgical
acute attacks of hemorrhoidal disease, based on
hemorrhodectomy, most of these alternative fixation
objective healing and subjective/symptomatic criteria.6
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MATHODS relief and/or persistentrectal bleeding.Anoscopy

examination performed on every weekly and score as
Total of 115 adult patients with first and second-degree
follows:0=pink, healthymucosa without any sign of
hemorrhoids diagnosed by clinical symptoms and
inflammation, 1=mild anitis (inactive grade 2
anoscopy examination are included in this study.
hemorrhoid without overt inflammatory signs or
Inclusion Criteria: in all patients, intermittent 2=easily bleeding hemorrhoids with signs of
symptoms attributable to hemorrhoids had existed for inflammation. For patients with more than one
longer than six months and rectal bleeding was currently hemorrhoid the worst lesion was considered for
present. Hemorrhoids that bleed but do not prolapse outcome. If bleeding persist for more than two weeks
outside the anal canal (bulge into the lumen of the after starting of either therapy and/or anitis score 2 was
proctoscope) are labeled as first degree hemorrhoidsand noted at 2 weeks this regarded as treatment failure. If
that prolapse on defecation but reduce spontaneously or mild anitis with cessation of bleeding was noted at 2
can be reduced digitally and remain reduced labeled as weeks then calcium dobesilate was continue for two
second degree hemorrhoids. more weeks and patients were advised to come
immediately if they developsymptoms. Any recurrent
Exclusion Criteria: 1.patients with 3 or 4 hemorrhoids bleeding was evaluated by anoscopy and colonoscopy
in whomprolapse needed manual reduction or was not examination and consider as recurrent of hemorrhoids
reducible disease if no other source of bleeding found.
2.concurrent fistula or chronic anal fissure,
inflammatory bowel disease, diabetes, coagulation RESULTS AND DATA ANALYSIS
disorders, abnormal sexual habits, previous anorectal
surgery or previous treatment of hemorrhoid disease Calcium dobesilate therapy was carried out in 59 cases
with any method other than diet modification and/or and diet therapy in 56 cases.35 patients in diet control
topical agents. Rectosigmoidoscopyand barium enema group were male and median age was 44 years (range,
(if indicated) was included in workup to rule out 22-64). In calcium dobesilate group 39 patients were
colorectal cause of symptoms. male and median age of 46(range 26-68). All of the
patients had current rectal bleeding. Duration of rectal
Ethical approval was obtained from the university bleeding varied from 1 month to 3 years. The anitis
ethical committee. Written informed consent was taken scores of group A and group B at entry were also
from all patients.
comparable (1.70±0.14 and 1.73±0.12 respectively,
After initial anoscopy examination at entry day the p=0.66).
patients were randomlyallotted by envelope method to
enter study or control group. Table 1 showing presenting symptoms:
Group A (control group n=56): diet manipulation and Symptoms Patients (%)
lifestyle advice. Bleeding per rectum 115 (100)
Anal pain 38 (33)
Group B (calcium dobesilate n=59) after initial
Anal discomfort 29 (25)
anoscopy examination, calcium dobesilate capsule (500
Anal pruritus 46 (40))
mg) was given in the dosage of two capsule twice a day
Tenesmus 22 (19)
for one week and one capsule for once a day for 5
Constipation/irregular bowel habits 86 (75)
weeks and calcium dobesilate ointment (0.5%w/w) was
applied twice a day before and after defecation. The
therapy was given for six weeks and each case examined Group A: After 6 weeks of diet therapy, symptoms
after every week to see the improvement or otherwise score in group A (1.34±0.19;p=0.023) was
of various symptoms associated with hemorrhoids. The noted.16patients were symptoms free and 8 patients
patients also received dietary and lifestyle advice, as did were declared partial relief.32 (57.14%) of the 56
patients in the control group. patients still had rectal bleeding and anitis score after 6
weeks reached at 1.34±0.22 vs. 1.70±0.14 at entry
Diet manipulation: a high fiber diet was advised to all p=0.0439.the results are shown in table 2.
patients in both groups and educated about importance
of fiber (fruits, vegetables etc.) in healthy nutrition. Group B: after 6 weeks of calcium dobesilate therapy,
Heavy consumption of spices was also not cessation of rectal bleeding plus lack of severe anitis
allowed.Encouragement was given to correct unhealthy occur in 48 patients indicating success rate of 81.35%
defecation habits such as ignoring the need to pass p=0.0051 compared with 44% rate of control group.
stools, irregular meals, straining and lack of exercise. Time of significant relief from symptoms averaged 6.5
days range (2- 12 days) post treatment anitis score
Patient follow up and evaluation of healing: the (0.59±0.17) was significantly better than the
patients were reexamined on every weekly. If
symptomatic relief was achieved the day of relief from pretreatment anitis score (1.73±0.12,p=0.0003) as well
symptoms was recorded. Score as follows:0=significant as posttreatment score of the control
relief or lack of any symptoms, 1=partial relied of group1.34±0.22;p=0.0013). There was no toxic or
symptoms –minorcomplaints with no bleeding or 2=no untoward reaction to the capsule and ointment during
study period.
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Table 2: symptomatic and anoscopic score and success rate of group A (diet) and group B (study)
Group Symptoms score Anitis score Success rate
Before treatment after treatment Before treatment after treatment
A-diet (n=56) 2 1.34±0.19 1.70±0.14 1.34±0.22 42.85%
B-study (n=59) 2 0.51±0.11 1.73±0.12 0.59±0.17 84.75%

Table 3: Symptoms and Anitis score of Group A However we cannot evaluate long term result in form of
(control) and group B (study) recurrence because of short term follow up period.
Scores Group A Group B CONCLUSION
(n=56) (%) (n=59) (%)
Symptoms score before treatment Calcium dobesilate treatment supplemented with high
0 - fiber diet is highly effective in symptomatic acute
1 - attacks of 1 and 2 degree internal hemorrhoids. This
2 56(100) 59(100) improvement is superior to that obtained in control diet
Symptoms score after treatment group without any noticeable side effects.
0 16(28.57) 40(67.79) Howeverfurther data required for long-term course of
1 8(14.28) 10(16.94) patients with this drug.
2 32(57.14) 9(15.25)
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