Date of Award
2014
Document Type
Dissertation
Degree Name
Master of Medicine (MMed)
Department
General Surgery (East Africa)
Abstract
Background: The medical management of chronic anal fissure varies among clinicians because no single treatment has yet approached an overall healing rate similar to lateral sphincterotomy. However, chemical sphincterotomy has the advantage of not carrying the presumed high risk of faecal incontinence.
Glyceryl Trinitrate is commonly used in our practice with varied response.
This study set out to evaluate the effectiveness of a locally compounded preparation of 0.2% topical Nifedipine in the treatment of chronic anal fissure and to compare the investigational product to 0.2% Glyceryl Trinitrate in overall healing rate and relieving pain.
Design: Single centre, parallel, double-blind randomized controlled trial.
Setting: The surgical outpatient department at Aga Khan University Hospital (Nairobi).
Participants: Patients with chronic anal fissure were recruited from the surgical outpatient department.
Intervention: A computer generated randomization sequence was used to allocate treatment.
Patients were randomly allocated to receive Glyceryl Trinitrate or Nifedipine, both applied 12 hourly topically to the perianal region for a period of eight weeks.
Main Outcome measure: The primary outcome measure was overall healing rate of chronic anal fissure after eight weeks of treatment. Secondary outcome measures were cumulative healing rate, time to resolution of pain and occurrence of headache.
Results: There was no significant difference recorded between the test and control drugs with regard to age, gender, duration of symptoms, fissure position or entry VAS pain score. Seventy five patients (Glyceryl Trinitrate n=38; Nifedipine n=37) were randomized. The mean age was 36.3 years (SD 11.9) with a mean duration of symptoms of 37.4 weeks (SD 36). Males comprised 48.6 percent of the patients. Seven patients were excluded from analysis because of loss to follow up or missing data, leaving 68 (n=33; n=35) patients for intention to treat analysis.
Healing rate was higher (p=0.001) with Nifedipine (94.3 percent) as compared with Glyceryl Trinitrate (60.6 percent). The mean time to healing was shorter (p
Conclusion: Topical application of 0.2% Nifedipine was more effective than Glyceryl Trinitrate in the management of chronic anal fissure and hence should be considered as first line treatment for chemical sphincterotomy in the treatment of chronic anal fissure in view of higher overall healing rate, availability and better side effect profile.
Recommended Citation
Siboe, M. W. (2014). A double-blind randomized controlled trial comparing effectiveness of 0.2% topical nifedipine versus 0.2% topical glyceryl trinitrate in the treatment of chronic anal fissure (Unpublished master's dissertation). Aga Khan University, East Africa.