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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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2.
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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3.
Magnesium sulfate or diltiazem as adjuvants to total intravenous anesthesia to reduce blood loss in functional endoscopic sinus surgery.
Aravindan, A, Subramanium, R, Chhabra, A, Datta, PK, Rewari, V, Sharma, SC, Kumar, R
Journal of clinical anesthesia. 2016;:179-85
Abstract
STUDY OBJECTIVE This study was designed to know whether addition of magnesium sulfate (MgSO4) or diltiazem to total intravenous anesthesia (TIVA) (propofol) aided reduction in blood loss during functional endoscopic sinus surgery (FESS). The secondary outcomes measured were surgeon's assessment of the surgical field and hemodynamics. DESIGN Randomized, double-blinded, placebo-controlled trial. SETTING Operating room. PATIENTS Forty-five American Society of Anesthesiologists I and II adult patients (18-60years) undergoing FESS. INTERVENTIONS All groups received propofol-fentanyl TIVA. Patients were randomly allocated to 1 of the 3 groups (MgSO4 group, n=15; diltiazem group, n=15; saline group, n=15). MEASUREMENTS Intraoperative bleeding was quantified, and quality of surgical field was graded. Hemodynamic parameters were recorded. MAIN RESULTS Addition of both MgSO4 and diltiazem significantly reduced blood loss (240 and 350mL) in comparison to control group (415mL) (P=.003). The surgical field was significantly better in the MgSO4 group compared with the diltiazem (P=.028) and saline groups (P=.0001). CONCLUSION It was concluded that the addition of both MgSO4 and diltiazem to TIVA propofol results in significant reduction in blood loss and significant improvement in the quality of surgical field during FESS without causing any adverse effects on the hemodynamics or on the recovery from anesthesia. The surgical field in the MgSO4 group was significantly better than that in the diltiazem group (P=.04).
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Diltiazem vs. Metoprolol in the Management of Atrial Fibrillation or Flutter with Rapid Ventricular Rate in the Emergency Department.
Fromm, C, Suau, SJ, Cohen, V, Likourezos, A, Jellinek-Cohen, S, Rose, J, Marshall, J
The Journal of emergency medicine. 2015;(2):175-82
Abstract
BACKGROUND Diltiazem (calcium channel blocker) and metoprolol (beta-blocker) are both commonly used to treat atrial fibrillation/flutter (AFF) in the emergency department (ED). However, there is considerable regional variability in emergency physician practice patterns and debate among physicians as to which agent is more effective. To date, only one small prospective, randomized trial has compared the effectiveness of diltiazem and metoprolol for rate control of AFF in the ED and concluded no difference in effectiveness between the two agents. OBJECTIVE Our aim was to compare the effectiveness of diltiazem with metoprolol for rate control of AFF in the ED. METHODS A convenience sample of adult patients presenting with rapid atrial fibrillation or flutter was randomly assigned to receive either diltiazem or metoprolol. The study team monitored each subject's systolic and diastolic blood pressures and heart rates for 30 min. RESULTS In the first 5 min, 50.0% of the diltiazem group and 10.7% of the metoprolol group reached the target heart rate (HR) of <100 beats per minute (bpm) (p < 0.005). By 30 min, 95.8% of the diltiazem group and 46.4% of the metoprolol group reached the target HR < 100 bpm (p < 0.0001). Mean decrease in HR for the diltiazem group was more rapid and substantial than that of the metoprolol group. From a safety perspective, there was no difference between the groups with respect to hypotension (systolic blood pressure < 90 mm Hg) and bradycardia (HR < 60 bpm). CONCLUSIONS Diltiazem was more effective in achieving rate control in ED patients with AFF and did so with no increased incidence of adverse effects.
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Pharmacokinetic interactions between the orexin receptor antagonist almorexant and the CYP3A4 inhibitors ketoconazole and diltiazem.
Dingemanse, J, Cruz, HG, Gehin, M, Hoever, P
Journal of pharmaceutical sciences. 2014;(5):1548-56
Abstract
Almorexant, a tetrahydroisoquinoline orexin receptor antagonist and first representative of a new class of compounds for the treatment of insomnia, is a substrate of the cytochrome P450 3A4 isoenzyme (CYP3A4). Two randomized two-way crossover studies were performed in healthy subjects investigating the pharmacokinetic interaction between almorexant and the CYP3A4 inhibitors ketoconazole and diltiazem. When administered as a single dose of 100 mg almorexant during steady state of ketoconazole (400 mg once daily for 14 days) or diltiazem treatment (300 mg once daily for 11 days), the exposure to almorexant was 10.5- and 3.5-fold, respectively, greater when compared with almorexant alone. Exposure to the phenol metabolites M3 and M8 increased in the presence of the CYP3A4 inhibitors, whereas that to M6 (dealkylated metabolite) decreased. Concomitant ketoconazole decreased formation of the dehydrogenated metabolite M5 and diltiazem increased concentrations of this metabolite. Higher almorexant exposure was associated with an increased incidence of typical almorexant-related adverse events such as fatigue (both studies) and somnolence (ketoconazole study only). The present results indicate that dose adaptation must be considered when almorexant would be coadministered with inhibitors of CYP3A4.