Nitroglycerin Group Research Articles

Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study

To determine the efficacy and safety of 'healer' cream as monotherapy in the treatment of acute and chronic anal fissure. A prospective, randomized, single blinded, comparative trial. Sixty patients suffering from anal fissure were included in the study. Patients were randomly divided into three groups: group A: treated with 'healer' local cream application 3 times daily; group B: treated with nitroglycerine 0.25% local cream 3 times daily; group C: treated with a lidocaine 2% cream applied locally 3 times daily. All the followings were followed up and compared between groups. (1) Visual pain analogue score after defecation; (2) severity of straining and discomfort during defecation; (3) frequency of ulcer healed at 30 days; (4) any side effects or complications. The pain scoring after defecation was significantly reduced in the three treatment groups. The group treated with 'healer' isosorbide-di-nitrate showed the greatest reduction of the visual pain analogue score median from 9 before treatment to 3 & 1 after 10 and 20 days respectively, while the median visual pain analogue score in group B treated with nitroglycerine cream was 9 reduced to 4 & 2 after 10 and 20 days respectively, and the median visual pain analogue score in lidocaine group only dropped from 9 to 6 and 4, respectively. The reduction of both pain scoring and defecation scoring with 'healer' was statistically significantly greater than the other two treatments by Kruskal-Wallis test, P<0.001. The number of patients experiencing complete relief and passing stools easily after 10 days was significantly higher in 'healer' group, by Pearson Chi square = 22.94, P<0.001. After 30 days, the fissures were healed in 18 (90%) of 20 patients in the 'healer' group and in 12 (60%) of 20 in the nitroglycerin group, while only 6 (30%) of patients treated with lidocaine cream had their fissures healed by the 30 days treatment. Chi square = 15 (P = 0.001). 'Healer' is a promising effective and safe line of treatment in acute and chronic anal fissure. The characteristic pharmacokinetics of isosorbide-di-nitrate leads to a better effect than nitroglycerin in healing (more prolonged action). Also the less fast absorption than nitroglycerin leading to a smoother dose concentration curve, may be the cause that headache is less frequent and less severe in 'healer' treatment versus nitroglycerin.

Blood loss and endocrine responses in hypotensive anaesthesia with sodium nitroprusside and nitroglycerin for mandibular osteotomy

The purpose of this study was to determine the differences in endocrine responses, blood loss and arterial blood gas profiles between patients subjected to hypotensive anaesthesia or normotensive anaesthesia and those between patients given sodium nitroprusside (SNP) or nitroglycerin (NTG) as the hypotensive agent. 36 patients, who were scheduled to undergo mandibular osteotomy, were recruited for the study. Their hormonal responses, metabolic responses, arterial blood gas profiles and blood loss were determined during hypotensive anaesthesia induced by either SNP or NTG and normotensive anaesthesia induced by sevoflurane (SEV). Blood loss was smaller and the duration of surgery was shorter in the SNP and NTG groups than in the SEV group. The plasma levels of adrenocorticotrophic hormone, cortisol, vasopressin, norepinephrine and dopamine increased during surgery in all 3 groups. There were no significant differences in the hormone levels, among the 3 groups, or between the SNP and NTG groups.

Five-year prospective comparison study of topical glyceryl trinitrate treatment of chronic lateral epicondylosis at the elbow

BackgroundTopical glyceryl trinitrate (GTN) treatment has previously demonstrated short-term efficacy in the treatment of lateral epicondylosis. No long-term follow-up has been performed.HypothesisBenefits from topical GTN persist 5 years after the...

The Effect of Glyceryl Trinitrate Ointment on Posthemorrhoidectomy Pain and Wound Healing

Spasm of the internal sphincter may be a source of anal pain and delayed healing after hemorrhoidectomy. This study assessed whether glyceryl trinitrate (GTN) ointment reduces pain and promotes wound healing after hemorrhoidectomy. A prospective, randomized, double-blind, placebo-controlled trial was conducted comparing effects of an ointment containing GTN (0.2 percent) vs. a placebo ointment. The study preparations were self-applied by the patient to the surgical site twice per day for two weeks after the hemorrhoidectomy. Pain was assessed with a visual analog scale, and 24-hour analgesic use was recorded on postoperative days 1, 3, and 7. Complete healing was defined as complete epithelialization and evaluated at the end of the third postoperative week. Sixty-nine patients were randomly assigned to receive topical 0.2 percent GTN group or placebo. Data from 30 patients in each group were available for analyses. Patients in the GTN group experienced significantly less postoperative pain than those with placebo on days 1, 3, and 7 (P < 0.05). Use of prescribed analgesics (metamizole and acetaminophen) was significantly greater for the placebo group on days 1 and 3. Wound healing at the end of the third postoperative week was significantly greater with GTN compared with placebo (76.7 percent vs. 46.7 percent, P = 0.02). Compared with placebo, perianal application of 0.2 percent GTN ointment significantly decreases postoperative pain after hemorrhoidectomy and reduces analgesic requirements in the immediate postoperative period. GTN ointment also achieves more rapid healing of wounds.

Topical anal fissure treatment: placebo-controlled study of mononitrate and trinitrate therapies

The present study aims to evaluate and compare the efficacy of two nitrate gels, containing isosorbide-5-mononitrate (ISMN) or glyceryl trinitrate (GTN), in the therapy of chronic anal fissure. The patients were randomly assigned to three groups: 0.1% ISMN gel (21 patients), 0.1% GTN gel (21 patients) and a placebo group (ten patients). The ethic committee of our hospital approved the protocol and informed consent was obtained from all participants. All patients underwent clinical examination, visual inspection of the fissure and anal manometry prior to and after therapy. The chronic anal fissure was completely healed in 71% of the patients treated with ISMN, 67% with GTN and in 30% from the placebo group. One patient in the ISMN group reported mild headache. Three patients in the GTN group had anal burning. Both topical nitrate treatments (ISMN and GTN) were effective for chronic anal fissures. The reduction of the anal pressure was slightly higher after ISMN treatment (28%) than the treatment with GTN (23%). However, the statistical difference was not significant (p>0.05).

Transdermal Nitroglycerin as an Adjuvant to Patient‐Controlled Morphine Analgesia after Total Knee Arthroplasty

Nitroglycerin (NTG) has been shown to be a useful adjunct for pain treatment without increasing adverse side effects. The effects of NTG on postoperative morphine consumption after knee replacement were evaluated. After undergoing total knee replacement, patients receiving patient-controlled morphine analgesia were randomly assigned to receive either an NTG or a placebo patch. The blinded investigator assessed each patient using a visual analogue scale at rest and while moving, as well as the patient's morphine requirements, sedation score, sleep quality, nausea and vomiting, vital signs and postoperative bleeding. Two of the patients in the NTG group suffered postoperative myocardial infarctions after removal of the patch. Because of these two serious adverse effects, the study was stopped prematurely. In the subset of patients studied, NTG conferred no advantage over placebo in pain control (visual analogue scale at rest or during movement) and in satisfaction scores. The use of NTG patches conferred no advantage over the use of placebo in patients receiving patient-controlled morphine analgesia after total knee replacement. Two myocardial infarcts occurred in this group. Therefore, the safety of postoperative NTG patch use for pain control must be questioned.

Abstract 4469: Reversal of No-Reflow/Slow-Flow during Percutaneous Coronary Intervention in Patients with Acute Myocardial Infarction–A Prospective Randomized Study Comparing Intracoronary Infusion of Diltiazem, Verapamil and Nitroglycerin

No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a poor clinical outcome. The present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage. In a consecutive series of 236 direct PCI for AMI, no-reflow/slow-flow phenomenon [TIMI flow grade (TFG) &lt;3] was observed in 30 patients (12.7%). All lesions in the infarction-related-coronary (IRC) were treated by stents. The 30 patients were randomised to one of three groups: intracoronary infusion of diltiazem (n=10), verapamil (n=10) and nitroglycerin (n=10). All the drugs were given via an infusion catheter distal to the angioplasty site. Pre-PCI, post-PCI and after drugs were given, IRC flow was assessed using TFG and TIMI frame count (TFC) by blinded angiographic readers. LVEF through echocardiography and NT-proBNP levels were measured at days 1 and 30 post-PCI. Patient, procedural characteristics and the baseline IRC flow post-PCI in the three groups were similar. The average intracoronary infusion drug dose was diltiazem 0.8mg, verapamil 0.4mg and nitroglycerin 0.4mg. All the three drugs could improve the IRC flow measured by TFG and TFC significantly (p&lt;0.05). Compared with nitroglycerin, diltiazem and verapamil could improve the IRC flow more significantly (p&lt;0.05). The improvements in TFG and TFC did not differ significantly between the diltiazem and verapamil groups (p&gt;0.05). Five patients in the verapamil group developed transient heart block, not seen with diltiazem (p&lt;0.01). During 30 days follow-up, the LVEF improved insignificantly in the three groups. The NT-proBNP levels in the diltiazem and verapamil groups were lower than nitroglycerin group (p&lt;0.05). There is no significant difference in the NT-proBNP levels between the diltiazem and verapamil groups. The intracoronary infusion of diltiazem or verapamil can reverse no-reflow/slow flow phenomenon more effectively than infusion of nitroglycerin during direct PCI for AMI. The efficacy of diltiazem and verapamil is similar but diltiazem seems safer.

The ECLIPSE Trials: Comparative Studies of Clevidipine to Nitroglycerin, Sodium Nitroprusside, and Nicardipine for Acute Hypertension Treatment in Cardiac Surgery Patients

Acute hypertension during cardiac surgery can be difficult to manage and may adversely affect patient outcomes. Clevidipine is a novel, rapidly acting dihydropyridine L-type calcium channel blocker with an ultrashort half-life that decreases arterial blood pressure (BP). The Evaluation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events trial (ECLIPSE) was performed to compare the safety and efficacy of clevidipine (CLV) with nitroglycerin (NTG), sodium nitroprusside (SNP), and nicardipine (NIC) in the treatment of perioperative acute hypertension in patients undergoing cardiac surgery. We analyzed data from three prospective, randomized, open-label, parallel comparison studies of CLV to NTG or SNP perioperatively, or NIC postoperatively in patients undergoing cardiac surgery at 61 medical centers. Of the 1964 patients enrolled, 1512 met postrandomization inclusion criteria of requiring acute treatment of hypertension based on clinical criteria. The patients were randomized 1:1 for each of the three parallel comparator treatment groups. The primary outcome was the incidence of death, myocardial infarction, stroke or renal dysfunction at 30 days. Adequacy and precision of BP control was evaluated and is reported as a secondary outcome. There was no difference in the incidence of myocardial infarction, stroke or renal dysfunction for CLV-treated patients compared with the other treatment groups. There was no difference in mortality rates between the CLV, NTG or NIC groups. Mortality was significantly higher, though, for SNP-treated patients compared with CLV-treated patients (P=0.04). CLV was more effective compared with NTG (P=0.0006) or SNP (P=0.003) in maintaining BP within the prespecified BP range. CLV was equivalent to NIC in keeping patients within a prespecified BP range; however, when BP range was narrowed, CLV was associated with fewer BP excursions beyond these BP limits compared with NIC. CLV is a safe and effective treatment for acute hypertension in patients undergoing cardiac surgery.

Nitroglycerin- and Nicardipine-Induced Hypotension Does Not Affect Cerebral Oxygen Saturation and Postoperative Cognitive Function in Patients Undergoing Orthognathic Surgery

The aim of this study was to investigate the influence of nitroglycerin- and nicardipine-induced hypotension on regional cerebral oxygen saturation (rSO(2)) and postoperative cognitive function in patients undergoing orthognathic surgery. Sixty adult patients scheduled for orthognathic surgery were randomly assigned to either the nitroglycerin group (group 1) or nicardipine group (group 2). After induction of anesthesia, hypotension was induced with continuous infusion of nitroglycerin or nicardipine. Mean arterial pressure (MAP), heart rate (HR), and rSO(2) were measured at the following time points: before induction of anesthesia, immediately before commencing induced hypotension, at 30 and 60 minutes after induced hypotension, and immediately before the end of surgery. Cerebral desaturation was defined as a reduction of rSO(2) less than 75% of baseline for > or = 15 seconds. The Mini Mental State Examination (MMSE) was conducted before surgery and then repeated after 1 week. Baseline rSO(2) values were similar in the 2 groups. There were no significant differences in rSO(2) values between the 2 groups. Cerebral desaturation was not observed in any of the patients. Both nitroglycerin and nicardipine reduced MAP and increased HR during induced hypotension as compared with the baseline values (P < .05). No differences in MAP and HR during baseline and induced hypotension were observed between the 2 groups. Decreased MMSE scores were not observed in any of the patients. Cerebral oxygen saturation and postoperative cognitive function were not impaired during nitroglycerin- and nicardipine-induced hypotension in patients undergoing orthognathic surgery.

Intravenous nitroglycerin for prevention of pancreatitis after therapeutic endoscopic retrograde cholangiography: a randomized, double-blind, placebo-controlled multicenter trial

Several studies have suggested that nitroglycerin promotes pancreatic drainage and thereby helps to prevent pancreatitis occurring after endoscopic retrograde cholangiography (ERC). We performed a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy of intravenous nitroglycerin for preventing acute pancreatitis in moderate- to high-risk patients undergoing ERC. The patients underwent therapeutic ERC for gallstone removal, bile duct stenosis, or sphincter of Oddi dysfunction (SOD). They were randomly allocated to receive an intravenous nitroglycerin bolus of 0.1 mg, then 35 microg/kg per minute intravenously (maximum dose 9 mg) for 6 h, or an identical placebo regimen. Serum amylase and lipase levels were determined before and 24 h after ERC. The study was terminated after the interim analysis. The intention-to-treat population consisted of 208 patients enrolled in 20 centers, of whom 105 received nitroglycerin and 103 placebo therapy. Post-ERC pancreatitis (mild/moderate/severe) occurred in 25 patients, comprising 10 (3/5/2) in the nitroglycerin arm and 15 (5/6/4) in the placebo arm (OR 0.62, 95 % CI 0.26 - 1.45; P = 0.26). Pancreatitis-related hospital stays were similar in the two groups (median 4 days, range 2 - 13 days in the nitroglycerin group; median 5 days, range 2 - 20 days in the placebo group). The incidence of pancreatitis in patients with SOD did not differ between the groups (4/11 in the nitroglycerin arm, and 4/15 in the placebo arm). Adverse events were more frequent in the nitroglycerin group and led to cessation of drug infusion in 10 patients in the nitroglycerin arm and in 2 patients in the placebo arm ( P = 0.019). In this study, nitroglycerin offered a limited and clinically nonsignificant benefit for the prevention of post-ERC pancreatitis. Its use did not improve the technical success rate of ERC.

Delayed anti-arrhythmic effect of nitroglycerin in anesthetized rats: Involvement of CGRP, PKC and mK ATP channels

Delayed anti-infarct and anti-stunning effects of nitroglycerin (NTG) have well been established in some animal models. The main goals of this study in anesthetized rats were to determine whether NTG has a delayed anti-arrhythmic effect and if so, whether calcitonin gene-related peptide (CGRP), protein kinase C (PKC) and mitochondrial K ATP channels (mK ATP) are involved in triggering this response. For this purpose, on day 0, male Wistar rats received NTG (120 μg/kg, iv) with or without pre-administration of PKC inhibitor chelerythrine (CHE), capsaicin (CAP) to deplete CGRP from sensory nerves or mK ATP channel blocker 5-hydroxydecaonic acid (5HD). On day 1, their hearts were subjected to 30 min ischemia and 120 min reperfusion. In rats pretreated with NTG, the incidence of ventricular tachycardia and ventricular fibrillation and the mortality rate significantly reduced (from 100%, 61% and 18.1% in the control group to 45.4%, 10% and 0% in the NTG group, respectively). Infarct size also reduced from 58 ± 4.7% in the control group to 31 ± 3.7% in the NTG group. These effects were abolished by CHE, CAP and 5HD, which none of them alone had any effect on infarct size or the incidence of myocardial arrhythmias. These results show that a low dose of NTG has a delayed anti-arrhythmic effect and this effect may share a common mechanism with anti-infarct effects of this drug, involving CGRP release and PKC and mK ATP activation.

Safety and Efficacy of New Glyceryl Trinitrate Suppository Formula: First Double Blind Placebo-Controlled Clinical Trial

This study was designed to assess the safety and efficacy of 0.2 percent glyceryl trinitrate suppository form in the healing of chronic anal fissure. Thirty-four patients with symptomatic chronic anal fissures were assigned to 0.2 percent glyceryl trinitrate suppository (n = 21) or placebo (n = 13) in a double blind design. Patient's symptom scores were registered at first visit. A validated daily chart was given to assess their symptoms on a daily basis. Both groups received psyllium from the beginning of the study. They were assessed at two-week intervals for six weeks. Then, they started a washout period of one month and after that were crossed over for another six weeks. Chi-squared, t-tests, and analysis of variance were used for statistical analysis. Complete healing at six weeks was achieved in 12 of 21 patients (57 percent) in the glyceryl trinitrate group and 5 of 13 patients (38 percent) in the placebo (P < 0.05). The overall healing rates at the end of study were 15 of 21 (71 percent) vs. 11 of 13 (84 percent) in the glyceryl trinitrate and placebo groups, respectively (P > 0.05). Application of 0.2 percent glyceryl trinitrate suppository form represents a new, promising, and effective treatment for chronic anal fissure.

CHRONIC ANAL FISSURE

. Topical application of glyceryl trinitrate (GTN) ointment heals anal fissures, providing an alternative to the traditional first linetreatment of surgical sphincterotomy. Setting: Tathlith General Hospital Saudi Arabia. Period: January 2001 – April 2003. Objective: Todetermine the effectiveness and safety of topical 0.5% glyceryl trinitrate (GTN) in the management of chronic anal fissure. Patients &amp; methods:Individual Patients were randomized to receive 0.5%GTN paste or placebo three times per day for six weeks in addition to oral senna and/orlactulose. Patients took laxatives alone for further 6 weeks. Patients were followed every week for six weeks and then fortnightly for anothersix weeks to assess pain scores and were given advice. Results: Fifty patients were recruited in this study and 44 patients completed the trial(23 in the GTN group and 21 in the placebo group), patients who could not complete the study were excluded. At 6 weeks, 74% of patients hadno pain in the GTN group as compared to the 29% in the placebo group. In 26% of cases treatment was unsuccessful. At three month followup there was no early recurrence. The prevalence of headaches was 65% in GTN group ( reported by 15 patients) and 24% in placebo group(reported by 5 patients). Mean pain scores were lower in the GTN group as compared to the placebo group. Conclusions: The use of 0.5%GTN induces healing of chronic anal fissures and may by used as a first line of treatment in patients with chronic anal fissure. Successfultreatment may come at the expense of a high incidence of headaches.

Three-year Followup Study of Topical Glyceryl Trinitrate Treatment of Chronic Noninsertional Achilles Tendinopathy

Topical glyceryl trinitrate treatment has demonstrated short-term efficacy in chronic noninsertional Achilles tendinopathy. No long-term followup is reported. We aimed to assess if the demonstrated efficacy of this treatment persisted 3 years after discontinuation of therapy. A follow-up study of 52 patients (68 tendons) treated with 6 months of glyceryl trinitrate therapy or placebo was performed 3 years after cessation of therapy. Assessment included pain scores, return to previous activity, the Victorian Institute of Sport Achilles tendon scale (VISA-A), asymptomatic patient outcomes, clinical assessment of tendon tenderness, and functional hop test. Patients treated with topical glyceryl trinitrate had significantly less Achilles tendon tenderness (p = 0.03), and improved VISA-A scores (p = 0.04) than those in the placebo group; 88% (28 of 32 tendons) of patients were completely asymptomatic at 3 years (VISA-A score of 100) compared to 67% (24 of 36 tendons) of patients treated with rehabilitation alone (p = 0.03 with Chi square analysis). Other outcome measures showed nonsignificant trends towards improvement in the glyceryl trinitrate group (pain scores p = 0.07, functional hop test p = 0.07, and return to sport p = 0.16). The mean estimated effect size for all outcome measures was 0.21. Topical glyceryl trinitrate treatment has demonstrated efficacy in treating chronic noninsertional Achilles tendinopathy, and the treatment benefits continue at 3 years. Significant differences in asymptomatic patient outcomes for the glyceryl trinitrate group continue at 3 years, and this is confirmed by the effect size estimate. This suggests that the mechanism of action of topical glyceryl trinitrate on chronic tendinopathies is more than an analgesic effect.

Preventive effects of nitroglycerine on glucocorticoid-induced osteoporosis in growing rats

The preventive effects of nitroglycerine (NG) on glucocorticoid-induced osteoporosis in growing rats were studied. Three-month-old female Wistar rats were randomly divided into control group (CON), dexamethasone group (DXM), DXM plus a low dose NG group (NG-L), DXM plus a middle dose NG group (NG-M) and DXM plus a high dose NG group (NG-H), 8 rats in each group. The rat model of osteoporosis was developed by intramuscular injection of dexamethasone twice a week. NG 0.2, 0.4 and 1.0 mg/kg was administered by oral gavages to the treatment groups every day for 12 weeks. Rats in CON group and DXM group were treated with normal saline of the same amount. After the treatment, the bone mineral density (BMD) and bone metabolism-associated biochemical markers were determined. Compared with CON group, BMD of lumbar spine and femur in DXM group was decreased significantly (P<0.05 and P<0.01 respectively), blood BGP levels and NO levels reduced (both P<0.01), and TRAP level increased (P<0.05). As compared with DXM group, BMD, serum BGP and NO were increased, and TRAP decreased in NG-L group and NG-M group, but had no significant difference in comparison to CON group. All the markers other than serum NO and TRAP levels had no significant difference between NG-H group and DXM group. It was concluded that low or middle doses of NG could prevent glucocorticoid-induced bone loss in growing rats, but high dose of NG could not. Supplement with NO donor could be considered as a preventive treatment for glucocorticoid-induced osteoporosis in a developing skeleton.

Randomized comparison of intravenous terbutaline vs nitroglycerin for acute intrapartum fetal resuscitation

The purpose of this study was to compare terbutaline and nitroglycerin for acute intrapartum fetal resuscitation. Women between 32-, 42 weeks' gestation were assigned randomly to 250 microg of terbutaline or 400 microg nitroglycerin intravenously for nonreassuring fetal heart rate tracings in labor. The rate of successful acute intrapartum fetal resuscitation and the maternal hemodynamic changes were compared. Assuming a 50% failure rate in the terbutaline arm, we calculated that a total of 110 patients would be required to detect a 50% reduction in failure in the nitroglycerin group (50% to 25%), with an alpha value of .05, a beta value of .20, and a power of 80%. One hundred ten women had nonreassuring fetal heart rate tracings in labor; 57 women received terbutaline, and 53 women received nitroglycerin. Successful acute resuscitation rates were similar (terbutaline 71.9% and nitroglycerin 64.2%; P = .38). Terbutaline resulted in lower median contraction frequency per 10 minutes (2.9 [25-75 percentile, 1.7- 3.3] vs 4 [25-75 percentile, 2.5- 5]; P < .002) and reduced tachysystole (1.8% vs 18.9%; P = .003). Maternal mean arterial pressures decreased with nitroglycerin (81-76 mm Hg; P = .02), but not terbutaline (82-81 mm Hg; P = .73). Although terbutaline provided more effective tocolysis with less impact on maternal blood pressure, no difference was noted between nitroglycerin and terbutaline in successful acute intrapartum fetal resuscitation.

Botulinum toxin vs glyceryltrinitrate for the medical management of chronic anal fissure: a meta‐analysis

The objective of this review was to analyse systematically the prospective randomized controlled trials on the effectiveness of botulinum toxin (BTX) and glyceryltrinitrate (GTN) for the pharmacological management of chronic anal fissure (CAF). A systematic review of the literature was undertaken. Prospective randomized controlled trials on the effectiveness of BTX and GTN for the management of CAF were selected according to specific criteria and analysed to generate summative data. Six studies encompassing 355 patients with CAF were retrieved from electronic databases. Only three randomized controlled trials on 180 patients qualified for the meta-analysis according to inclusion criteria. There were 90 patients in BTX and 90 in the GTN group. BTX and GTN were equally effective in healing/improving the CAF. There was no statistically significant difference between the two pharmacotherapies [RR 1.29 (0.98-1.70) 95% CI, z = -1.83, P = 1.93, Fig. 1]. However, there was statistically significant heterogeneity among the trials (Q = 4.03, df = 1, P = 0.042). On fixed effect model, GTN was associated with higher incidence of total side effects [fixed effect model RR 0.14 (0.05-0.40) 95% CI, z = -3.71, P = 0.0002] and headache [RR 0.07 (0.02-0.20) 95% CI, z = -5.05, P = 0.0007] among patients of CAF. Botulinum toxin is as effective as GTN for the management of CAF but it is associated with a lower complication rate. BTX can be recommended as a first-line therapy for chemical sphincterotomy in patients of CAF. However, a major and multi-centre randomized controlled trial is required to support this treatment approach in order to establish stronger evidence.

The efficacy of diltiazem and glyceryltrinitrate for the medical management of chronic anal fissure: a meta-analysis

The objective of this review is to systematically analyze the prospective randomized controlled trials on the effectiveness of diltiazem (DTZ) and glyceryltrinitrate (GTN) for the pharmacological management of chronic anal fissure (CAF). A systematic review of the literature was undertaken. Prospective randomized controlled trials on the effectiveness of DTZ for the management of CAF were selected according to specific criteria and analyzed to generate summative data. Five studies encompassing 263 patients with CAF were retrieved from the electronic databases. Only two randomized controlled trials on 103 patients qualified for the meta-analysis. There were 53 patients in the DTZ group and 50 patients in the GTN group. Both DTZ and GTN were equally effective for the treatment of CAF (random-effect model risk ratio [RR] 0.29 [90.06-1.33] 95% confidence interval [CI], z=0.62, p=0.536). However, there was significant heterogeneity between the trials. GTN was associated with higher side effects rate (fixed-effect model RR 0.45 [0.28-0.73] 95% CI, z= -3.22, p=0.001) and higher headache rate (fixed-effect model RR 0.33 [0.17-0.64] 95% CI, z= -3.27, p=0.001) as compared to DTZ. There was no statistically significant recurrence rate of CAF between two pharmacotherapies (fixed-effect model RR 0.66 [0.18-2.41] 95% CI, z= -0.62, p=0.535). Both DTZ and GTN are equally effective and can be used for the management of CAF. However, GTN is associated with a higher rate of side effects (headache/anal irritation), and it should be replaced by DTZ. The recurrence rate of CAF after the use of both pharmacotherapies is equal.

CHRONIC ANAL FISSURES

Objective: The objective of this study was to compare the topical GTN andlateral internal sphincterotomy for the treatment of chronic anal fissure. Setting: This was a prospective randomizedcohort study conducted at Isra University Hospital, Hyderabad between September 2004 and August 2005. Materialand Methods: Fifty patients fulfilling the selection criteria were randomly divided into two equal groups. One group wastreated with topical glyceryl trinitrate (GTN) ointment and other group was treated with lateral internal sphincterotomy.Patients were followed up in outpatients department after regular intervals for about one year. The data was collectedand two groups were compared with special reference to pain relief, fissure healing and recurrence rate. Results: Painrelief was observed in 96% of the patients in GTN group as compared to 92% of the patients in sphincterotomy groupafter 6 weeks. Complete healing of fissure was observed in 92% of the patients in GTN group as compared to 88% ofthe patients in sphincterotomy group after 6 weeks. Recurrence was observed in 16% of the patients in GTN group ascompared to 4% of the patients in sphincterotomy group after one year. Conclusion: GTN and lateral internalsphincterotomy are comparable in terms of pain relief and fissure healing after 6 weeks. Topical GTN is suggested tobe the initial treatment whereas lateral internal sphincterotomy is suggested to be reserved for the patients notresponding to topical GTN or having recurrence after completion of treatment with GTN.

Comparison of topical glyceryl trinitrate with lignocaine ointment for treatment of anal fissure: A randomised controlled trial

Introduction Topical glyceryl trinitrate (GTN) has gained popularity as a treatment for anal fissure in the West. In our country, lignocaine is still the current treatment for the entity. This study was done to compare the effect of GTN with lignocaine in terms of healing rate and recurrence in South Asian population. Methods A prospective, double blinded, randomised controlled trial was conducted on 50 patients (both treatment arms included) of all ages and either gender with a clinical diagnosis of anal fissure. Group A was given 0.2% GTN ointment and Group B was given lignocaine ointment. Both subjective and objective signs of healing were assessed and adverse effects of the treatment were sought. Results Symptomatic relief was earlier with GTN as compared with lignocaine. Pain relief was steady and sustained in those treated with GTN but returned to pre-treatment status within 5 weeks in patients with lignocaine. After 8 weeks of treatment, 80% of patients in Group A showed clinical signs of healing compared to 32% in Group B ( p = 0.001). Headache was the main side effect of GTN. At 6-month follow-up, recurrence was seen in 3/8 patients in Group B compared to 8/20 in the GTN Group ( p = 1). Conclusion Topical GTN has earlier and a higher rate of clinical healing of anal fissure with acceptable side effects. The recurrence rate is high and comparable to lignocaine ointment. It is a safe and an effective treatment of anal fissure in a South Asian population.