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Apollo Pronk - One of the best experts on this subject based on the ideXlab platform.
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topical Diltiazem cream versus botulinum toxin a for the treatment of chronic anal fissure a double blind randomized clinical trial
Annals of Surgery, 2012Co-Authors: Morsal Samim, Bas Twigt, Lennart Stoker, Apollo PronkAbstract:Objective: A double-blind randomized clinical trial to compare topical Diltiazem with botulinum toxin A (BTA) in the treatment of chronic anal fissure. Background: Chronic anal fissures remain a challenging condition. Topical Diltiazem and BTA are promising agents in the treatment of anal fissure. As to date Diltiazem and BTA were never compared in a solid randomized trial, which is the purpose of this study. Methods: One hundred thirty-four patients were randomized to receive either Diltiazem cream and placebo injection or BTA injection and placebo cream. The primary end point was fissure healing after 3 months. Results: After 3 months healing of the fissure was noted in 32 of 74 (43%) patients in the Diltiazem group and 26 of 60 (43%) patients in the BTA group. Reduction >50% in mean pain score was noted in 58 of 74 (78%) patients in the Diltiazem group and 49 of 60 (82%) patients in the BTA group. Perianal itching was the only side effect reported and was noted in 15% of patients in the Diltiazem group, and this difference was statistically significant (P = 0.012). Conclusions: BTA yields higher healing rates in the short term, though after 3 months Diltiazem and BTA resulted in equal healing rates. Also no significant difference in pain reduction was observed for both treatments. This study shows no significant advantage of one treatment compared to the other. This randomized clinical trial is registered by the Dutch Trial Register as NTR1012. efficacious and results in fissure healing in more than 90% of the patients. It is important to note however, that up to 9% of the patients experience incontinence as a consequence of this procedure. 7 Topical glyceryl trinitrate (GTN) and isosorbide dinitrate (ISDN), both nitric oxide (NO) donors, result in a considerably lower healing rate of approximately 65%. GTN and ISDN treatment have also been reported to result in headaches as a side effect, causing many patients to discontinue treatment. 5-8 In the past few years, 2 new promising products, Topical Diltiazem and BTA, were evaluated in prospective randomized trials. Both BTA and Diltiazem cause relaxation of muscle tone; whereas BTA blocks the release of acetylcholine from pr1esynaptic nerve ends, Diltiazem is a calcium channel blocker. 9-11 Topical Diltiazem and BTA were found to be equal or superior to NO donors in the treatment of anal fissures considering time to healing. 10-11 In addition, regarding side effects, and in particular headaches, both BTA and Diltiazem were shown to be better treatment options when compared to NO donors. 12 Here we present the results of a randomized trial comparing the effects of Diltiazem cream and BTA in the treatment of anal fissures. To the best of our knowledge this is the first double-blind randomized trial between Diltiazem cream and BTA in the treatment of chronic anal fissures.
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topical Diltiazem cream versus botulinum toxin a for the treatment of chronic anal fissure a double blind randomized clinical trial
Annals of Surgery, 2012Co-Authors: Morsal Samim, Bas Twigt, Lennart Stoker, Apollo PronkAbstract:OBJECTIVE: A double-blind randomized clinical trial to compare topical Diltiazem with botulinum toxin A (BTA) in the treatment of chronic anal fissure. BACKGROUND: Chronic anal fissures remain a challenging condition. Topical Diltiazem and BTA are promising agents in the treatment of anal fissure. As to date Diltiazem and BTA were never compared in a solid randomized trial, which is the purpose of this study. METHODS: One hundred thirty-four patients were randomized to receive either Diltiazem cream and placebo injection or BTA injection and placebo cream. The primary end point was fissure healing after 3 months. RESULTS: After 3 months healing of the fissure was noted in 32 of 74 (43%) patients in the Diltiazem group and 26 of 60 (43%) patients in the BTA group. Reduction >50% in mean pain score was noted in 58 of 74 (78%) patients in the Diltiazem group and 49 of 60 (82%) patients in the BTA group. Perianal itching was the only side effect reported and was noted in 15% of patients in the Diltiazem group, and this difference was statistically significant (P = 0.012). CONCLUSIONS: BTA yields higher healing rates in the short term, though after 3 months Diltiazem and BTA resulted in equal healing rates. Also no significant difference in pain reduction was observed for both treatments. This study shows no significant advantage of one treatment compared to the other. This randomized clinical trial is registered by the Dutch Trial Register as NTR1012.
John H. Scholefield - One of the best experts on this subject based on the ideXlab platform.
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Diltiazem heals glyceryl trinitrate resistant chronic anal fissures a prospective study
Diseases of The Colon & Rectum, 2002Co-Authors: M Jonas, W J Speake, John H. ScholefieldAbstract:PURPOSE: Both topical Diltiazem, a calcium channel blocker, and glyceryl trinitrate, a nitric oxide donor, lower anal pressure and heal two-thirds of chronic anal fissures. This study evaluated the efficacy of Diltiazem for fissures that failed to heal with glyceryl trinitrate. METHODS: Consecutive patients with persistent chronic fissures despite treatment with 0.2 percent glyceryl trinitrate ointment underwent anal manometry before and for 1 hour after application of 700 mg of 2 percent Diltiazem gel to the distal anal canal. Patients applied Diltiazem twice daily for eight weeks or until the fissure had healed. At fortnightly review, fissure healing was assessed, and side effects were noted. Patients scored symptoms of pain, bleeding, and irritation using linear visual analog scales at the initial and follow-up visits. RESULTS: In 39 patients (13 males; median age, 42 (range, 20– 80) years), topical 2 percent Diltiazem gel lowered anal resting pressure by 20 percent from a median of 93 to 74 cm H2O (P < 0.0001, Wilcoxon), and fissures healed in 19 (49 percent) within 8 weeks. Before Diltiazem, 27 patients (69 percent) had used a complete course of glyceryl trinitrate (0.5 g twice daily for 8 weeks), and 12 (44 percent) of these healed with Diltiazem. The remaining 12 patients had discontinued glyceryl trinitrate prematurely or used less because of headaches; 7 (58 percent) of these healed with Diltiazem, and 5 (42 percent) did not. Side effects occurred in four patients (10 percent): three reported perianal itching but continued with treatment, and one developed headaches, drowsiness, and mood swings six weeks into treatment and stopped Diltiazem at that time. CONCLUSION: Topical 2 percent Diltiazem is effective treatment for glyceryl trinitrate–resistant chronic anal fissures. Side effects, mainly perianal itching, may occur in 10 percent of patients but are generally tolerated.
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Diltiazem heals glyceryl trinitrate resistant chronic anal fissures a prospective study
Diseases of The Colon & Rectum, 2002Co-Authors: M Jonas, W J Speake, John H. ScholefieldAbstract:PURPOSE: Both topical Diltiazem, a calcium channel blocker, and glyceryl trinitrate, a nitric oxide donor, lower anal pressure and heal two-thirds of chronic anal fissures. This study evaluated the efficacy of Diltiazem for fissures that failed to heal with glyceryl trinitrate. METHODS: Consecutive patients with persistent chronic fissures despite treatment with 0.2 percent glyceryl trinitrate ointment underwent anal manometry before and for 1 hour after application of 700 mg of 2 percent Diltiazem gel to the distal anal canal. Patients applied Diltiazem twice daily for eight weeks or until the fissure had healed. At fortnightly review, fissure healing was assessed, and side effects were noted. Patients scored symptoms of pain, bleeding, and irritation using linear visual analog scales at the initial and follow-up visits. RESULTS: In 39 patients (13 males; median age, 42 (range, 20– 80) years), topical 2 percent Diltiazem gel lowered anal resting pressure by 20 percent from a median of 93 to 74 cm H2O (P < 0.0001, Wilcoxon), and fissures healed in 19 (49 percent) within 8 weeks. Before Diltiazem, 27 patients (69 percent) had used a complete course of glyceryl trinitrate (0.5 g twice daily for 8 weeks), and 12 (44 percent) of these healed with Diltiazem. The remaining 12 patients had discontinued glyceryl trinitrate prematurely or used less because of headaches; 7 (58 percent) of these healed with Diltiazem, and 5 (42 percent) did not. Side effects occurred in four patients (10 percent): three reported perianal itching but continued with treatment, and one developed headaches, drowsiness, and mood swings six weeks into treatment and stopped Diltiazem at that time. CONCLUSION: Topical 2 percent Diltiazem is effective treatment for glyceryl trinitrate–resistant chronic anal fissures. Side effects, mainly perianal itching, may occur in 10 percent of patients but are generally tolerated.
Morsal Samim - One of the best experts on this subject based on the ideXlab platform.
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topical Diltiazem cream versus botulinum toxin a for the treatment of chronic anal fissure a double blind randomized clinical trial
Annals of Surgery, 2012Co-Authors: Morsal Samim, Bas Twigt, Lennart Stoker, Apollo PronkAbstract:Objective: A double-blind randomized clinical trial to compare topical Diltiazem with botulinum toxin A (BTA) in the treatment of chronic anal fissure. Background: Chronic anal fissures remain a challenging condition. Topical Diltiazem and BTA are promising agents in the treatment of anal fissure. As to date Diltiazem and BTA were never compared in a solid randomized trial, which is the purpose of this study. Methods: One hundred thirty-four patients were randomized to receive either Diltiazem cream and placebo injection or BTA injection and placebo cream. The primary end point was fissure healing after 3 months. Results: After 3 months healing of the fissure was noted in 32 of 74 (43%) patients in the Diltiazem group and 26 of 60 (43%) patients in the BTA group. Reduction >50% in mean pain score was noted in 58 of 74 (78%) patients in the Diltiazem group and 49 of 60 (82%) patients in the BTA group. Perianal itching was the only side effect reported and was noted in 15% of patients in the Diltiazem group, and this difference was statistically significant (P = 0.012). Conclusions: BTA yields higher healing rates in the short term, though after 3 months Diltiazem and BTA resulted in equal healing rates. Also no significant difference in pain reduction was observed for both treatments. This study shows no significant advantage of one treatment compared to the other. This randomized clinical trial is registered by the Dutch Trial Register as NTR1012. efficacious and results in fissure healing in more than 90% of the patients. It is important to note however, that up to 9% of the patients experience incontinence as a consequence of this procedure. 7 Topical glyceryl trinitrate (GTN) and isosorbide dinitrate (ISDN), both nitric oxide (NO) donors, result in a considerably lower healing rate of approximately 65%. GTN and ISDN treatment have also been reported to result in headaches as a side effect, causing many patients to discontinue treatment. 5-8 In the past few years, 2 new promising products, Topical Diltiazem and BTA, were evaluated in prospective randomized trials. Both BTA and Diltiazem cause relaxation of muscle tone; whereas BTA blocks the release of acetylcholine from pr1esynaptic nerve ends, Diltiazem is a calcium channel blocker. 9-11 Topical Diltiazem and BTA were found to be equal or superior to NO donors in the treatment of anal fissures considering time to healing. 10-11 In addition, regarding side effects, and in particular headaches, both BTA and Diltiazem were shown to be better treatment options when compared to NO donors. 12 Here we present the results of a randomized trial comparing the effects of Diltiazem cream and BTA in the treatment of anal fissures. To the best of our knowledge this is the first double-blind randomized trial between Diltiazem cream and BTA in the treatment of chronic anal fissures.
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topical Diltiazem cream versus botulinum toxin a for the treatment of chronic anal fissure a double blind randomized clinical trial
Annals of Surgery, 2012Co-Authors: Morsal Samim, Bas Twigt, Lennart Stoker, Apollo PronkAbstract:OBJECTIVE: A double-blind randomized clinical trial to compare topical Diltiazem with botulinum toxin A (BTA) in the treatment of chronic anal fissure. BACKGROUND: Chronic anal fissures remain a challenging condition. Topical Diltiazem and BTA are promising agents in the treatment of anal fissure. As to date Diltiazem and BTA were never compared in a solid randomized trial, which is the purpose of this study. METHODS: One hundred thirty-four patients were randomized to receive either Diltiazem cream and placebo injection or BTA injection and placebo cream. The primary end point was fissure healing after 3 months. RESULTS: After 3 months healing of the fissure was noted in 32 of 74 (43%) patients in the Diltiazem group and 26 of 60 (43%) patients in the BTA group. Reduction >50% in mean pain score was noted in 58 of 74 (78%) patients in the Diltiazem group and 49 of 60 (82%) patients in the BTA group. Perianal itching was the only side effect reported and was noted in 15% of patients in the Diltiazem group, and this difference was statistically significant (P = 0.012). CONCLUSIONS: BTA yields higher healing rates in the short term, though after 3 months Diltiazem and BTA resulted in equal healing rates. Also no significant difference in pain reduction was observed for both treatments. This study shows no significant advantage of one treatment compared to the other. This randomized clinical trial is registered by the Dutch Trial Register as NTR1012.
M Jonas - One of the best experts on this subject based on the ideXlab platform.
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Diltiazem heals glyceryl trinitrate resistant chronic anal fissures a prospective study
Diseases of The Colon & Rectum, 2002Co-Authors: M Jonas, W J Speake, John H. ScholefieldAbstract:PURPOSE: Both topical Diltiazem, a calcium channel blocker, and glyceryl trinitrate, a nitric oxide donor, lower anal pressure and heal two-thirds of chronic anal fissures. This study evaluated the efficacy of Diltiazem for fissures that failed to heal with glyceryl trinitrate. METHODS: Consecutive patients with persistent chronic fissures despite treatment with 0.2 percent glyceryl trinitrate ointment underwent anal manometry before and for 1 hour after application of 700 mg of 2 percent Diltiazem gel to the distal anal canal. Patients applied Diltiazem twice daily for eight weeks or until the fissure had healed. At fortnightly review, fissure healing was assessed, and side effects were noted. Patients scored symptoms of pain, bleeding, and irritation using linear visual analog scales at the initial and follow-up visits. RESULTS: In 39 patients (13 males; median age, 42 (range, 20– 80) years), topical 2 percent Diltiazem gel lowered anal resting pressure by 20 percent from a median of 93 to 74 cm H2O (P < 0.0001, Wilcoxon), and fissures healed in 19 (49 percent) within 8 weeks. Before Diltiazem, 27 patients (69 percent) had used a complete course of glyceryl trinitrate (0.5 g twice daily for 8 weeks), and 12 (44 percent) of these healed with Diltiazem. The remaining 12 patients had discontinued glyceryl trinitrate prematurely or used less because of headaches; 7 (58 percent) of these healed with Diltiazem, and 5 (42 percent) did not. Side effects occurred in four patients (10 percent): three reported perianal itching but continued with treatment, and one developed headaches, drowsiness, and mood swings six weeks into treatment and stopped Diltiazem at that time. CONCLUSION: Topical 2 percent Diltiazem is effective treatment for glyceryl trinitrate–resistant chronic anal fissures. Side effects, mainly perianal itching, may occur in 10 percent of patients but are generally tolerated.
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Diltiazem heals glyceryl trinitrate resistant chronic anal fissures a prospective study
Diseases of The Colon & Rectum, 2002Co-Authors: M Jonas, W J Speake, John H. ScholefieldAbstract:PURPOSE: Both topical Diltiazem, a calcium channel blocker, and glyceryl trinitrate, a nitric oxide donor, lower anal pressure and heal two-thirds of chronic anal fissures. This study evaluated the efficacy of Diltiazem for fissures that failed to heal with glyceryl trinitrate. METHODS: Consecutive patients with persistent chronic fissures despite treatment with 0.2 percent glyceryl trinitrate ointment underwent anal manometry before and for 1 hour after application of 700 mg of 2 percent Diltiazem gel to the distal anal canal. Patients applied Diltiazem twice daily for eight weeks or until the fissure had healed. At fortnightly review, fissure healing was assessed, and side effects were noted. Patients scored symptoms of pain, bleeding, and irritation using linear visual analog scales at the initial and follow-up visits. RESULTS: In 39 patients (13 males; median age, 42 (range, 20– 80) years), topical 2 percent Diltiazem gel lowered anal resting pressure by 20 percent from a median of 93 to 74 cm H2O (P < 0.0001, Wilcoxon), and fissures healed in 19 (49 percent) within 8 weeks. Before Diltiazem, 27 patients (69 percent) had used a complete course of glyceryl trinitrate (0.5 g twice daily for 8 weeks), and 12 (44 percent) of these healed with Diltiazem. The remaining 12 patients had discontinued glyceryl trinitrate prematurely or used less because of headaches; 7 (58 percent) of these healed with Diltiazem, and 5 (42 percent) did not. Side effects occurred in four patients (10 percent): three reported perianal itching but continued with treatment, and one developed headaches, drowsiness, and mood swings six weeks into treatment and stopped Diltiazem at that time. CONCLUSION: Topical 2 percent Diltiazem is effective treatment for glyceryl trinitrate–resistant chronic anal fissures. Side effects, mainly perianal itching, may occur in 10 percent of patients but are generally tolerated.
Hana Kocour Kroupova - One of the best experts on this subject based on the ideXlab platform.
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investigation of Diltiazem metabolism in fish using a hybrid quadrupole orbital trap mass spectrometer
Rapid Communications in Mass Spectrometry, 2016Co-Authors: Olga Koba, Christoph Steinbach, Katerina Grabicova, Hana Kocour Kroupova, Tomas Randak, Roman GrabicAbstract:RATIONALE Diltiazem, a calcium channel blocker drug, is widespread in the environment because of its incomplete elimination during water treatment. It can cause negative effects on aquatic organisms; thus, a rapid and sensitive liquid chromatography/mass spectrometry (LC/MS) method to detect its presence was developed. Our approach is based on accurate mass measurements using a hybrid quadrupole-orbital trap mass spectrometer that was used to measure Diltiazem and its metabolites in fish tissue. METHODS Blood plasma, muscle, liver, and kidney tissues of rainbow trout (Oncorhynchus mykiss), exposed for 42 days to 30 μg L(-1) Diltiazem, were used for the method development. No metabolite standards were required to identify the Diltiazem biotransformation products in the fish tissue. RESULTS Overall, 17 phase I Diltiazem metabolites (including isomeric forms) were detected and tentatively identified using the MassFrontier spectral interpretation software. A semi-quantitative approach was used for organ-dependent comparison of the metabolite concentrations. CONCLUSIONS These data increase our understanding about Diltiazem and its metabolites in aquatic organisms, such as fish. These encompass desmethylation, desacetylation and hydroxylation as well as their combinations. This study represents the first report of the complex Diltiazem phase I metabolic pathways in fish.
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Bioconcentration, metabolism and half-life time of the human therapeutic drug Diltiazem in rainbow trout Oncorhynchus mykiss.
Chemosphere, 2015Co-Authors: Christoph Steinbach, Roman Grabic, Ganna Fedorova, Olga Koba, Oksana Golovko, Katerina Grabicova, Hana Kocour KroupovaAbstract:Diltiazem is a human therapeutic drug and a member of the group of calcium channel blockers having widespread use in the treatment of angina pectoris and hypertension. The objective of the present study was to assess the bioconcentration, metabolism, and half-life time of Diltiazem in rainbow trout Oncorhynchus mykiss. Juvenile trout were exposed for 21 and 42 days to three nominal concentrations of Diltiazem: 0.03 µg L(-1) (environmentally relevant concentration), 3 µg L(-1), and 30 µg L(-1) (sub-lethal concentrations). The bioconcentration factor (BCF) of Diltiazem was relatively low (0.5-194) in analysed tissues, following the order kidney > liver > muscle > blood plasma. The half-life of Diltiazem in liver, kidney, and muscle was 1.5 h, 6.2 h, and 49 h, respectively. The rate of metabolism for Diltiazem in liver, kidney, muscle, and blood plasma was estimated to be 85 ± 9%, 64 ± 14%, 46 ± 6%, and 41 ± 8%, respectively. Eight Diltiazem metabolites were detected. The presence of desmethyl Diltiazem (M1), desacetyl Diltiazem (M2), and desacetyl desmethyl Diltiazem (M3) suggests that rainbow trout metabolize Diltiazem mainly via desmethylation and desacetylation, similar to mammals. In addition, Diltiazem undergoes hydroxylation in fish. At environmentally relevant concentrations, Diltiazem and its metabolites were identified in liver and kidney, indicating the potential for uptake and metabolism in non-target organisms in the aquatic environment.