Diltiazem Ointment Research Articles

Doppler‐guided haemorrhoidal artery ligation: long‐term outcome and patient satisfaction

Conventional Milligan-Morgan haemorrhoidectomy is associated with significant pain and potentially hazardous complications. Doppler-Guided Haemorrhoidal Artery Ligation (DGHAL) may offer a lower risk, pain-free alternative. We present our early and long-term outcome experience with DGHAL, combined with patient views and satisfaction with the procedure. One hundred and thirteen DGHALs were performed over a 13 month period by two surgeons in a single centre. Patients graded the severity of postoperative pain on visual-analogue scales. Clinical follow-up was at 6 weeks (n = 103), with long-term follow-up (n = 90) by postal questionnaire at median of 30 months. Seven out of one hundred and three (6%) patients reported postoperative discomfort requiring analgesia. Ninety-three out of one hundred and three (90%) patients reported complete relief or significant improvement in their symptoms at 6 weeks, dropping to 77/90 (86%) at 30 months. Anal fissures developed in 2/103 (2%) patients, both treated with Diltiazem ointment. Further surgery was required in 8/90 (9%) patients. Eighty-two out of ninety (91%) patients said they would undergo DGHAL again. DGHAL is a relatively painless, safe, and effective procedure for symptomatic stage I-III haemorrhoids, for which we have demonstrated long-term durability and acceptability. Its role lies between office based procedures and more invasive operative interventions.

Efficacy and safety of topical diltiazem 2% in anal fissure

ObjectivesTo evaluate the effectiveness and safety of 2% diltiazem ointment in the treatment of anal fissure. To analyse the relationship between healing and diagnosis, and duration of the treatment, and the number of applications. MethodsA prospective observational study of all patients diagnosed with anal fissure that began treatment with topical diltiazem between January and June in 2007. Diltiazem ointment was prepared in the Pharmacy Service. Effectiveness and safety were assessed by a telephone survey conducted with each patient after 8 weeks of treatment, adding it to the patient's clinical records. The variables that were analysed were healing, adverse effects, diagnosis, duration of treatment, and number of applications, among others. Follow-up was carried out for up to 1 year until complete healing of the fissure. The data analysis was carried out by descriptive statistics, crosstabs, and x2. ResultsA total of 70 patients were included in the study and anal fissure healed in 48.6% of them. Healing occurred in 54.5% of patients with anal fissure and in 33.3% of patients with anal fissure and haemorrhoids. Some adverse effects occurred in 30% of patients. Therapy was abandoned due to adverse reactions for 5.7%. The fissure was cured for 60% of patients who underwent treatment for a month or more. More than twice-daily applications did not lead to improved healing. There were no significant statistical differences in these results. ConclusionsDespite not having found statistical differences between the analysed variables, treatment of anal fissures with 2% diltiazem ointment has avoided surgery in nearly 50% of patients, with few adverse effects.

Comparison of internal sphincterotomy with topical diltiazem for post-hemorrhoidectomy pain relief

To assess the efficacy of internal sphincterotomy compared with application of topical 2% Diltiazem ointment after hemorrhoidectomy for pain relief. Prospective randomized study. In an 18-month period, 108 subjects with uncomplicated Grade 3/ 4 hemorrhoids were enrolled in the study and were randomized into two equal groups: Subjects in Group A underwent internal sphincterotomy at time of primary surgery while those in Group B received 1 g of 2% Diltiazem ointment locally, thrice daily for seven days. Postoperative pain perception was measured using visual analog score (VAS) and on the basis of number of analgesic tablets (Tab tramadol 50 mg) required in each group. Time to discharge, time to return to work and incidence of complications measured and compared. Statistical techniques applied were Student T test, Chi-square and Fisher's Exact Test. There were 102 analyzable subjects (Group A: 50 and Group B: 52). The mean VAS score was significantly less in the internal sphincterotomy group from the fourth postoperative day onwards compared to topical Diltiazem (2.23 vs. 3.72; P =0.031). Similarly, the mean requirement of analgesic tablets [10.54 vs. 15.40; P =0.01] was much lower in Group A. There was no significant difference in terms of time to discharge and time to return to work between the two groups. The incidence of complications was more with the internal sphincterotomy group (11.5% vs. 3 %; P =0.488). In patients undergoing hemorrhoidectomy, addition of surgical internal sphincterotomy results in lesser pain in the postoperative period as compared to those receiving topical application of Diltiazem.

Comparison of Topical Glyceryl Trinitrate with Diltiazem Ointment for the Treatment of Chronic Anal Fissure: a Randomized Clinical Trial

Background: The aim of this study was to compare the effect of topical glycerol trinitrate ointment (GTN) with topical diltiazem hydrochloride ointment (DTZ) in the treatment of chronic anal fissure.Method: Prospectively, 102 patients were treated randomly with either GTN ointment (0.2%) or DTZ ointment (2%) a couple of times daily for 12 weeks.Results: Forty-five patients (88.2%) in group DTZ and 36 patients (70.6%) in group GTZ had a reduction of symptoms. The decrease in the symptoms for group DTZ was significantly more than for group GTN (P = 0.02). Mean time for symptom reduction was 2.44 ± 0.30 in group DTZ and 2.50 ± 0.28 weeks in group GTN with no significant differences between the two groups (P > 0.05). Complete relief of symptoms was observed in 72.5% and 54.9% patients in groups DTZ and GTN, respectively. The frequency of complete relief of symptoms between the two groups was not significant (P > 0.05). Complete remission of anal fissure occurred in 66.7% patients in group DTZ and 54.9% patients in group GTN, which shows no significant difference. Mean time taken for fissure healing in the GTN group was dramatically less than in the DTZ group (P = 0.001). Finally, 33.3% of patients in the DTZ group and 45.1% of patients in the GTN group underwent operation. The need for operation was not significantly different between the two groups (P > 0.05). Conclusion: Both DTZ and GTN are equally effective and can be the preferred first-line treatment of chronic anal fissure. However, GTN is associated with a higher rate of headache, and should be replaced by DTZ.

A pilot comparative study of fissurectomy/diltiazem and fissurectomy/botulinum toxin in the treatment of chronic anal fissure

Treatment of chronic anal fissure (CAF) by fissurectomy with botulinum toxin A (BTA) injection results in a healing rate of greater than 90%. BTA injection, however, can cause incontinence and perianal sepsis. The decrease in sphincter pressure following topical treatment with 2% diltiazem cream (DTC) is comparable to that following BTA injection but with potentially fewer complications and at less cost. We report the shortterm results of a pilot study comparing fissurectomy with BTA and fissurectomy followed by DTC for the treatment of CAF. The recorded outcomes of CAF following treatment with the two methods were analysed retrospectively. Patients underwent either fissurectomy followed by injection of 40 U BTA into the internal sphincter (group A) or fissurectomy followed by the perianal application of DTC twice daily for 8 weeks (group B). Symptom resolution and treatment side effects at the initial follow-up were compared. Demographics, fissure characteristics and the number of multiparous women between the two groups were comparable. At a median follow-up of 12 weeks (range 8-20 weeks), the two groups had similar rates of complete symptom resolution (group A, 25/28, 89.3%; group B, 19/23, 82.6%; p=0.7739), with minor side effects. In this small pilot study fissurectomy combined with chemical sphincterotomy resulted in high short-term fissure healing rates. The study also suggested that fissurectomy followed by 8 weeks of topical DTC may be as good as fissurectomy with BTA injection in the treatment of CAF. A prospective study, adequately powered to determine the significance of differences is needed.

A Comparison of the Effects of Diltiazem and Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: A Randomized Clinical Trial

Anal fissure is a common problem affecting all age groups with an equal incidence in both sexes. Traditional surgical treatments, like manual anal dilatation or a sphincterotomy, effectively heal most fissures within a few weeks but such procedures may result in anal incontinence. In recent years, various medical therapies have been used for the treatment of chronic anal fissure without fear of incontinence. Ninety patients with a symptomatic anal fissure were randomly divided into three groups. Group I was treated with 2% diltiazem ointment, Group II was treated with 0.2% glyceryl trinitrate (GTN) ointment, and Group III was kept as the control group. The improvement in the signs and symptoms, the time taken for healing, and side effects were recorded in each group. The patients were followed up monthly and then every 3 months for any recurrence of fissure. Comparative evaluations of the three groups regarding an improvement in symptoms, progress in healing, appearance of side effects, and recurrence were made using the Tukey HSD test. Diltiazem ointment was found to be superior regarding pain relief, fewer side effects, and late recurrence as compared with GTN ointment. Diltiazem ointment (2%) and GTN ointment (0.2%) are both effective treatment modalities for chronic anal fissure, with diltiazem giving better patient outcome.

The long-term results of diltiazem treatment for anal fissure

The effects of diltiazem treatment on symptoms of chronic anal fissures and their long-term outcome were investigated. One hundred and twelve patients were supplied with 6-week course of 2% diltiazem cream for twice-daily topical application. The medical notes and extended follow-up by telephone for 112 patients were recorded and statistically analysed. The success rate and satisfaction of topical diltiazem were each over two thirds. Nearly 80% of patients reported no adverse effects, and it seems that those complaints attributed to diltiazem rarely led to reduced compliance. After diltiazem therapy for fissure, 59% of patients required further treatment (medical and/or surgical) over the average 2-year period of follow-up. The reported adverse effects of topical diltiazem treatment in patients with anal fissures were more common than previously thought, although compliance was rarely affected. During consultation regarding the advantages and disadvantages of surgical vs. chemical sphincterotomy, patients should be aware that the majority of patients receiving diltiazem as the primary treatment for anal fissure subsequently require further treatment.

Tratamientos terapéutica de la fisura anal crónica

Current treatment of chronic anal fissure continues to be based on conventional conservative measures in a high percentage of cases. What is known as chemical sphincterotomy aims to achieve a temporary decrease of anal pressures that allows fissures to heal. There are various alternatives such as nitroglycerine or diltiazem ointment and botulinum toxin injections. However, because of collateral effects and recurrences in the medium term, the definitive role of these treatments remains to be elucidated. Nevertheless, chemical sphincterotomy should be the first option in patients with a high risk of incontinence. "Open" or "closed" lateral internal sphincterotomy performed in the ambulatory setting with local anesthesia can currently be considered the ideal treatment of chronic anal fissure refractory to conservative measures so long as the patient is informed about the risk of minor incontinence. This procedure provides rapid and permanent recovery in more than 95% of patients. There is evidence demonstrating that the incontinence rate is related to the extent of the lateral internal sphincterotomy and consequently the extent of this procedure should be reduced to the length of the fissure.

A Randomized, Prospective, Double-Blind, Placebo-Controlled Trial of the Effect of a Calcium Channel Blocker Ointment on Pain After Hemorrhoidectomy

Spasm of the internal sphincter plays a role in hemorrhoidal disease and may be a source of anal pain after hemorrhoid surgery. We have evaluated the effects of topical diltiazem, a calcium channel blocker, in reducing pain after hemorrhoidectomy. After hemorrhoidectomy, 18 patients were randomly assigned to receive 2 percent diltiazem ointment (n = 9) or a placebo ointment (n = 9). Ointments were applied to the perianal region three times daily for seven days. Patients were prescribed hydrocodone bitartrate (Vicodin) to take as needed. The type and number of prescribed or nonprescribed medications taken during the postoperative period were recorded. Patients maintained a log to measure postoperative pain daily and perceived benefit of the ointment, using a Visual Analog Scale ranging from 0 to 10. Any postoperative morbidity noted during the follow-up period was recorded. Patients using the diltiazem ointment had significantly less pain and greater benefit than those in the placebo group throughout the first postoperative week. Postoperative pain scores in the placebo group averaged 8.8 +/- 1.2 early and diminished to 5.2 +/- 1.7 at the end of one week, compared to the diltiazem group of 5.2 +/- 2.4 early and 2.3 +/- 1.2 at the end of one week (P < 0.001, both time periods). Perceived benefit in the placebo group averaged 2.7 +/- 1.2 vs. 5.6 +/- 1.4 in the diltiazem group (P < 0.001). Total and daily narcotic use was higher in the placebo group, but this was not statistically significant (P = 0.13). No differences in the frequency of use of nonsteroidal anti-inflammatory drugs and acetaminophen were seen between the two groups, and there were no differences in morbidity between the two groups. Perianal application of 2 percent diltiazem ointment after hemorrhoidectomy significantly reduces postoperative pain and is perceived as beneficial, with no increase in associated morbidity. Patients using a placebo ointment tend to take more prescription narcotics for pain relief postoperatively, with a similar usage of nonsteroidal anti-inflammatory drugs and acetaminophen, although differences were not significant.

The role of topical diltiazem in the treatment of chronic anal fissures that have failed glyceryl trinitrate therapy.

The treatment of anal fissures has evolved over the last 5 years with the development of topical treatments aimed at reducing sphincter hypertonia. This is thought to improve anal mucosal blood flow and promote healing of the fissure. This study reports the use of topical diltiazem in patients with chronic anal fissures that have failed previous treatment with topical 0.2% glyceryl trinitrate (GTN). Forty-seven patients with chronic anal fissure who had previously failed at least one course of topical GTN were recruited prospectively from a single centre. Patients were instructed to apply 2 cm (approximately 0.7 g) of 2% diltiazem cream to the anal verge twice daily for eight weeks. Symptoms of pain, bleeding and itching were recorded on a linear analogue score prior to starting the cream and then repeated at 2 weekly intervals. Patients were asked to report side-effects throughout the study period. Healing of the fissure was assessed after 8 weeks of treatment. Forty-six patients completed treatment; of these, 22 had healed fissures (48%). Ten of the 24 patients with persistent fissures were symptomatically improved and wished no further treatment. Of the 14 patients who remained symptomatic, one was given a repeat course of 0.2% glyceryl trinitrate with subsequent healing of the fissure, 10 were recruited into an ongoing study involving injections of botulinum toxin into the internal anal sphincter and three were referred for surgery. This study shows that topical 2% diltiazem is an effective and safe treatment for chronic anal fissure in patients who have failed topical 0.2% GTN. The need for sphincterotomy can be avoided in up to 70% of cases.

Topical diltiazem ointment in the treatment of chronic anal fissure.

Chronic anal fissure has traditionally been treated surgically. Initial enthusiasm for chemical sphincterotomy has waned because of poor outcomes with glyceryl trinitrate ointment. In this study the use of topical 2 per cent diltiazem ointment has been investigated as an alternative method of chemical sphincterotomy. A prospective assessment of 71 consecutive patients with a chronic anal fissure treated with 2 per cent topical diltiazem ointment for a median duration of 9 (range 2--16) weeks was performed. Fifty-one patients (75 per cent) experienced healing of the fissure after 2--3 months of treatment with topical diltiazem. Seventeen patients who did not heal were treated for a further 8 weeks with topical diltiazem. Eight of these patients subsequently healed with diltiazem. Fifty-nine of 67 patients who completed follow-up therefore healed on diltiazem ointment. Four patients experienced perianal dermatitis and one patient experienced headaches. No other side-effects were recorded. After a median of 32 (range 14--67) weeks' follow-up following completion of treatment, 27 of 41 patients available remain symptom free. Six of seven patients with recurrent fissure were treated successfully by repeat chemical sphincterotomy. Topical 2 per cent diltiazem ointment used as an agent for chemical sphincterotomy for chronic anal fissure offers significant healing rates but does not have a significant side-effect profile, which may aid compliance to treatment. Early recurrences are common but usually amenable to further chemical sphincterotomy.