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MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol.
El Charif, MH, Doughan, S, Kredly, R, Kassas, S, Azab, R, Sbaity, E
BMC complementary medicine and therapies. 2021;(1):75
Abstract
BACKGROUND Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures. METHODS This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient's global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments. DISCUSSION The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04153032 . Clinical Trial Registration Date: 06-NOVEMBER-2019.
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Topical diltiazem for pain after closed hemorrhoidectomy.
Rodríguez-Wong, U, Ocharán-Hernández, ME, Toscano-Garibay, J
Revista de gastroenterologia de Mexico. 2016;(2):74-9
Abstract
BACKGROUND Anal sphincter spasm contributes to the appearance of postoperative pain following hemorrhoidectomy. AIM: To determine the efficacy of topical diltiazem in the control of post-hemorrhoidectomy pain. MATERIAL AND METHODS A randomized, prospective, experimental, double-blind study was conducted on 2 groups of patients in the postoperative period of closed hemorrhoidectomy. Each group consisted of 17 patients. Group A received topical diltiazem in the anal region 3 times a day and group B received a placebo. Ketorolac was administered to both groups as rescue therapy. RESULTS In group A, the mean score on the visual analog scale was 2.97±1.18cm at 24h, 1.51±1.18cm at 48h, and 0.84±0.92cm at 72h. In group B, it was 6.82±1.9cm at 24h, 5.3±1.66cm at 48h, and 4.32±2.13cm at 72h (P<.001, 95% CI). The mean number of analgesic doses in group A was 2.41±0.87 at 24h, 1.11±0.85 at 48h, and 0.94±0.96 at 72h. In group B, it was 3.82±0.52 at 24h, 3.64±0.70 at 48h, and 2.88±1.26 at 72h (P<.001, 95% CI). CONCLUSIONS In this study, topical administration of diltiazem resulted in a statistically significant reduction of postoperative pain in patients that underwent closed hemorrhoidectomy.
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Comparison of topical isosorbide mononitrate, topical diltiazem, and their combination in the treatment of chronic anal fissure.
Bulus, H, Varol, N, Tas, A, Coskun, A
Asian journal of surgery. 2013;(4):165-9
Abstract
BACKGROUND/OBJECTIVE Chronic anal fissure is a painful condition that is associated with an increase in internal anal sphincter pressure. The main aim of this study is to evaluate the efficacy and adverse effects of topical isosorbide 5 mononitrate and topical diltiazem, when administered either as single agents or in combination, in the treatment of anal fissure. METHODS Patients with chronic anal fissure were enrolled in the study. They were randomized into three groups: Group A (0.2% isosorbide 5 mononitrate users), Group B (2% diltiazem users), and Group C (2%diltiazem + 0.2% isosorbide 5 mononitrate users). Pain was evaluated using a visual analog scale (VAS). Level of strain during defecation was graded on a 4-point scale. RESULTS A total of 55 patients were enrolled in the study. The average ages of patients in Groups A, B, and C were 37.94 ± 16.19, 42.83 ± 13.21, 40 ± 13.58 years, respectively. After treatment, pain completely abated in 55.6% of patients in Group A, 27.8% (n = 5) in Group B, and 42.1% (n = 8) in Group C. The decreases in average VAS values prior to and after treatment in Groups A, B, and C were statistically significant (p values 0.0001, 0.001, and 0.0001, respectively). Average strain scores prior to and after treatment were 2.11/0.72 for Group A, 2.17/0.94 for Group B, and 1.95/0.47 for Group C. Strain during defecation prior to and after treatment in Groups A, B, and C was statistically significant (p values 0.001, 0.001, and 0.003, respectively). CONCLUSION Topical diltiazem and a combination of nitrate and diltiazem can be used in the treatment of anal fissure. However, the agents are not significantly superior each other.
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Evaluation of the efficacy of a combination of diltiazem and periprostatic nerve block in pain control during transrectal ultrasonography-guided biopsy of the prostate.
Jindal, T, Mandal, SN, Biswas, G, Karmakar, D
Annals of the Royal College of Surgeons of England. 2013;(5):361-4
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INTRODUCTION The choice of analgesia during prostate biopsy remains controversial. The pain has dual origin: from the insertion of the probe as well as the biopsy itself. Periprostatic nerve block (PPNB) is currently the gold standard modality for decreasing pain of prostate biopsy but it does not alleviate the pain of probe insertion. A randomised controlled trial was performed to test the efficacy and safety of the combination of topical application of diltiazem gel and PPNB for pain control during transrectal ultrasonography guided prostate biopsy. METHODS A total of 73 patients who were to undergo their first prostate biopsy were randomised to receive either 2ml of 2% topical diltiazem gel or a placebo 15 minutes before the biopsy. All the patients then had a PPNB using 1% lignocaine. A ten- point visual analogue scale was used to record the pain immediately after the insertion of the probe and during the biopsy. Any adverse effects were also recorded. RESULTS There was no significant difference in the mean age and prostate volumes between the groups. There was a significantly lower mean pain score due to probe insertion in those patients who received topical diltiazem than in the placebo group (p<0.0001). There was no significant difference between the pain scores during the biopsy itself between the two groups. CONCLUSIONS Topical diltiazem significantly reduces the pain of probe insertion during prostate biopsy and can be used effectively as an adjuvant to PPNB.
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Diltiazem inhibits human intestinal cytochrome P450 3A (CYP3A) activity in vivo without altering the expression of intestinal mRNA or protein.
Pinto, AG, Horlander, J, Chalasani, N, Hamman, M, Asghar, A, Kolwankar, D, Hall, SD
British journal of clinical pharmacology. 2005;(4):440-6
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AIMS: To determine the effect of diltiazem on intestinal CYP3A activity and protein and mRNA expression in vivo in healthy subjects. METHODS Intestinal biopsies were obtained from ten healthy controls and from ten healthy subjects after receiving diltiazem 120 mg bid for 7 days. Intestinal CYP3A activity, CYP3A4 protein and mRNA concentrations were quantified in both groups. Intestinal CYP3A activity was determined by incubation of small bowel homogenate with midazolam (25 microM) and NADPH for 5 min and the rate of formation of 1'-hydroxymidazolam was quantified. RESULTS All subjects in the treatment group had detectable diltiazem concentration in the serum. While there was no significant difference in CYP3A4 protein and mRNA expression between the control and treatment groups, the formation of 1'-hydroxymidazolam (446 pmol min(-1) mg(-1) 6 (control) vs. 170 (CI 112, 228) pmol min(-1) mg(-1) 95% confidence interval (CI 269, 623) (diltiazem group)) was significantly reduced (P < 0.05). CONCLUSION Diltiazem decreased small bowel CYP3A activity by 62% as a result of irreversible inhibition with no corresponding change in intestinal CYP3A4 mRNA or protein concentrations.
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Efficacy of calcium channel blockers as maintenance therapy for asthma.
Ann Twiss, M, Harman, E, Chesrown, S, Hendeles, L
British journal of clinical pharmacology. 2002;(3):243-9
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AIMS: Previous bronchoprovocation studies indicate that nifedipine attenuates airway responsiveness to several stimuli whereas diltiazem has no effect. The aim of this study was to determine whether such studies predict the efficacy of calcium channel blockers as maintenance therapy for persistent asthma. METHODS Twenty-one otherwise healthy adults with persistent asthma, mean age 25 years, completed treatment with maximum tolerated doses of placebo (P), nifedipine (N), and diltiazem (D) in a double-blind, randomized, three-treatment, three-period, crossover manner, each for 4 weeks. Frequency and severity of asthmatic symptoms were recorded twice daily, as well as peak expiratory flow and frequency of 'prn' use of inhaled terbutaline. Blood pressure, heart rate, P-R interval of the ECG and spirometry were measured biweekly. At the end of each treatment, airway responsiveness to exercise was measured. RESULTS The mean (s.e. mean)% of days with wheeze was 69plus minus7% during P, 75plus minus6% during N and 72plus minus6% during D (P=0.7). FEV1 was 79plus minus2% of predicted during P, 81plus minus2% during N and 79plus minus2% during D (P=0.6). The decrease in FEV1 after exercise was 32plus minus4% during P, 32plus minus5% during N and 27plus minus4% during D (P=0.5). Heart rate was elevated during N (P=0.0002) whereas P-R interval was prolonged during D (P=0.0001). CONCLUSIONS Maintenance therapy with calcium channel blockers, at doses that produce cardiovascular effects, do not suppress the signs and symptoms of persistent asthma. Previous bronchoprovocation studies did not predict these results.
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Silent ischemic interval on exercise test is a predictor of response to drug therapy: a randomized crossover trial of metoprolol versus diltiazem in stable angina.
Dwivedi, SK, Saran, RK, Mittal, S, Gupta, R, Narain, VS, Puri, VK
Clinical cardiology. 2001;(1):45-9
Abstract
BACKGROUND AND HYPOTHESIS There is no method available to predict the relative antianginal efficacy of beta blockers and calcium-channel antagonists. The present study was undertaken to assess the role of silent ischemic interval (SII) on exercise treadmill test (ETT) as a predictor of response to therapy with metoprolol and diltiazem in patients with stable angina. METHODS Thirty-four patients with stable angina were divided into two groups depending upon the presence or absence of an SII gap of at least 1 min between onset of ST depression and appearance of angina on ETT. Metoprolol (50-100 mg twice daily) and diltiazem (60-120 mg three times daily) were randomly assigned for 6 weeks to patients in each group, and then patients were crossed over for further 6 weeks after a washout period of 2 weeks. Antianginal efficacy was assessed by clinical and exercise parameters. RESULTS In patients with SII, the clinical responder rate was better with metoprolol than with diltiazem (90 vs. 60%, respectively), and on ETT, metoprolol produced significant improvement in the total exercise time (p< 0.01), time to 1 mm ST depression (p <0.01), time to angina (p <0.01), and a significant decrease in peak rate-pressure product (p<0.001), whereas diltiazem had no significant effect on exercise parameters. However, in patients without SII, metoprolol and diltiazem had a similar clinical responder rate (57%), and both produced a significant increase in total exercise time (p < 0.01), time to 1 mm ST depression (p < 0.01), and time to angina (p < 0.01). In addition, metoprolol had a significant effect on peak rate-pressure product (p < 0.001). CONCLUSION Silent ischemic interval on ETT can be a predictor of response to antianginal therapy in stable angina, as patients with SII respond better to metoprolol and those without SII respond equally to both metoprolol and diltiazem.
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Effects of diltiazem prophylaxis on the incidence and clinical outcome of atrial arrhythmias after thoracic surgery.
Amar, D, Roistacher, N, Rusch, VW, Leung, DH, Ginsburg, I, Zhang, H, Bains, MS, Downey, RJ, Korst, RJ, Ginsberg, RJ
The Journal of thoracic and cardiovascular surgery. 2000;(4):790-8
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OBJECTIVES We sought to determine whether early prophylaxis with an L -type calcium channel blocker reduces the incidence and morbidity associated with atrial fibrillation/flutter and supraventricular tachyarrhythmia after major thoracic operations. METHODS In this randomized, double-blind, placebo-controlled study, 330 patients were given either intravenous diltiazem (n = 167) or placebo (n = 163) immediately after lobectomy (> or =60 years) or pneumonectomy (> or =18 years) and orally thereafter for 14 days. The primary end point with respect to efficacy was a sustained (> or =15 minutes) or clinically significant atrial arrhythmia during treatment. RESULTS Postoperative atrial arrhythmias (atrial fibrillation/flutter = 60; supraventricular tachyarrhythmias = 5) occurred in 25 (15%) of the 167 patients in the diltiazem group and 40 (25%) of the 163 patients in the placebo group (P = .03). When compared with placebo, diltiazem nearly halved the incidence of clinically significant arrhythmias (17/167 [10%] vs. 31/163 [19%], P = .02). The 2 groups did not differ in the incidence of other major postoperative complications or overall duration or costs of hospitalization. No serious adverse effects caused by diltiazem were seen. CONCLUSIONS After major thoracic operations, prophylactic diltiazem reduced the incidence of clinically significant atrial arrhythmias in patients considered at high risk for this complication.