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  • 1
    Electronic Resource
    Electronic Resource
    Effect of an enteric-release formulation of naloxone on intestinal transit in volunteers taking codeine (2001)
    Oxford UK : Blackwell Science Ltd
    Alimentary pharmacology & therapeutics 15 (2001), S. 0 
    Details
    ISSN: 1365-2036
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Constipation is a common side-effect of opioid therapy; in addition to their analgesic effect, opioids reduce intestinal secretion and motility with an increase in whole-gut transit time. Naloxone, a specific opioid antagonist, reverses these effects but may also cause symptoms of opioid withdrawal in patients on long-term therapy.〈section xml:id="abs1-2"〉〈title type="main"〉Aim:To use an enteric-release formulation, designed to produce a topical effect in the gut, with minimum systemic effects.〈section xml:id="abs1-3"〉〈title type="main"〉Methods:Naloxone 10 mg b.d. and codeine 30 mg b.d. were used with identical placebo capsules in four sets of studies; 12 male volunteers were given the drugs alone and in combination, with a control study involving double placebo, during each of four study periods. Whole-gut transit time was calculated and compared for each treatment period.〈section xml:id="abs1-4"〉〈title type="main"〉Results:Naloxone, both alone and with codeine, significantly shortened the mean whole-gut transit time compared with the control period, respectively, from 53.1 to 42.1 h (P=0.005) and to 40.7 h (P=0.024). Urgency to defecate was reported by two volunteers on naloxone alone and by three on combination therapy.〈section xml:id="abs1-5"〉〈title type="main"〉Conclusions:The results show that the naloxone formulation counteracts the effect of codeine on intestinal transit, suggesting that it may have useful clinical applications.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2036.2001.00970.x
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  • 2
    Electronic Resource
    Electronic Resource
    Nitric oxide mediates a therapeutic effect of nicotine in ulcerative colitis (2000)
    Oxford UK : Blackwell Science Ltd
    Alimentary pharmacology & therapeutics 14 (2000), S. 0 
    Details
    ISSN: 1365-2036
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Ulcerative colitis is a condition of nonsmokers in which nicotine is of therapeutic benefit.〈section xml:id="abs1-2"〉〈title type="main"〉Aims:To examine the in vitro effect of nicotine on colonic smooth muscle activity and the role of nitric oxide (NO) as a mediator.〈section xml:id="abs1-3"〉〈title type="main"〉Methods:Nicotine, 1–10 μM, was administered to strips of circular muscle from the distal sigmoid colon of 9 patients with active ulcerative colitis and 18 with colorectal cancer. The effect of electrical field stimulation (EFS) was examined before nicotine was added. Finally L-NAME, a NO synthetase inhibitor, was added before nicotine was administered again.〈section xml:id="abs1-4"〉〈title type="main"〉Results:Muscle strips developed similar spontaneous resting tone. In response to EFS, ulcerative colitis tissue developed lower tensions than the controls. Nicotine significantly reduced the resting tone and peak tension after EFS, with a greater effect in controls. With L-NAME, peak tensions were increased more in ulcerative colitis than controls, and nicotine produced a much smaller reduction.〈section xml:id="abs1-5"〉〈title type="main"〉Conclusions:Nicotine reduces circular muscle activity, predominantly through the release of nitric oxide—this appears to be ‘up-regulated’ in active ulcerative colitis. These findings may explain some of the therapeutic benefit from nicotine (and smoking) in ulcerative colitis and may account for the colonic motor dysfunction in active disease.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2036.2000.00847.x
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  • 3
    Electronic Resource
    Electronic Resource
    Enteric-release glyceryl trinitrate in active Crohn’s disease: a randomized, double-blind, placebo-controlled trial (2001)
    Oxford UK : Blackwell Science Ltd
    Alimentary pharmacology & therapeutics 15 (2001), S. 0 
    Details
    ISSN: 1365-2036
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Mucosal ischaemia may contribute to the pathogenesis of Crohn’s disease. Microvascular abnormalities have been found in colonic resection specimens, and mucosal levels of constitutive nitric oxide synthase are reduced.〈section xml:id="abs1-2"〉〈title type="main"〉Aim:To assess the efficacy of a novel, enteric-release formulation of the nitric oxide donor, glyceryl trinitrate, aimed at increasing the mucosal circulation and relaxing smooth muscle in the affected bowel.〈section xml:id="abs1-3"〉〈title type="main"〉Methods:The trial was randomized, double-blind and placebo-controlled. Baseline disease activity was assessed by a structured symptom diary, with blood tests and a quality of life assessment. Patients with a Crohn’s disease activity index of ≥ 150 and 〈 450 were randomized to receive 12 weeks of either glyceryl trinitrate (initially 6 mg twice daily, increasing to 9 mg twice daily after 6 weeks) or an identical placebo. Assessments were repeated at 6 and 12 weeks.〈section xml:id="abs1-4"〉〈title type="main"〉Results:Seventy patients (22 male) entered the study; 34 were given glyceryl trinitrate and 36 placebo. At 12 weeks, there were no differences between the treatment groups in terms of Crohn’s disease activity index, pain, stool frequency, inflammatory markers or quality of life scores.〈section xml:id="abs1-5"〉〈title type="main"〉Conclusions:Enteric-release glyceryl trinitrate did not benefit patients with mild to moderately active Crohn’s disease. Whilst ischaemia may contribute to the pathogenesis of Crohn’s disease, our results fail to provide supportive evidence for this hypothesis.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2036.2001.01120.x
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  • 4
    Electronic Resource
    Electronic Resource
    Nicotine enemas for treatment of ulcerative colitis: a study of the pharmacokinetics and adverse events associated with three doses of nicotine (2004)
    Oxford, UK : Blackwell Science Ltd
    Alimentary pharmacology & therapeutics 20 (2004), S. 0 
    Details
    ISSN: 1365-2036
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Background : Transdermal nicotine is of value in active ulcerative colitis but causes adverse events because of systemic absorption. Nicotine enemas may give rise to fewer adverse events.Aim : To assess the pharmacokinetics of nicotine enemas in three doses.Methods : Thirteen volunteers, all non-smokers but three ex-smokers, were given enemas on separate occasions containing 3, 6 and 9 mg of nicotine, in ascending dose order. Adverse events were recorded and blood samples taken over 8 h for measurement of serum nicotine and cotinine.Results : Enemas were retained by most subjects. Eleven of 14 adverse events were ‘early’– 30–105 min after the enema, corresponding to maximum plasma nicotine concentrations; three events were later, 4–8 h after the enema and unrelated to the tmax. ‘Early’ adverse events occurred in eight subjects – six with 9 mg. The three highest plasma nicotine concentrations were with 9 mg and associated with headache, nausea and sweating. Only one had adverse events with 3 mg and withdrew from the study. Nicotine Cmax with 6 and 9 mg doses were respectively two and three times the value with 3 mg. Peak nicotine concentrations occurred 44–50 min after the enema.Conclusion : The 6 mg dose of nicotine probably represents the dose to use in clinical practice – for the highest therapeutic dose with a low risk of adverse events.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1365-2036.2004.02199.x
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  • 5
    Electronic Resource
    Electronic Resource
    Naloxone treatment for irritable bowel syndrome — a randomized controlled trial with an oral formulation (2002)
    Oxford, UK : Blackwell Science Ltd
    Alimentary pharmacology & therapeutics 16 (2002), S. 0 
    Details
    ISSN: 1365-2036
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Background : Opioids change gut motility and secretion, causing delayed intestinal transit and constipation. Endorphins play a role in the constipation troubling some patients with irritable bowel syndrome; hence naloxone, an opioid antagonist, may have a therapeutic role.Aim : To assess the efficacy and safety of an oral formulation of naloxone in irritable bowel syndrome patients with constipation.Methods : A randomized, double-blind, placebo-controlled trial was performed. Patients fulfilling the Rome II criteria for irritable bowel syndrome (constipation-predominant and alternating types) were randomized to receive 8 weeks of treatment with naloxone capsules, 10 mg twice daily, or identical placebo.Results : Twenty-eight patients entered the study, which was completed by 25. ‘Adequate symptomatic relief’ was recorded in six of 14 on naloxone and three of 11 on placebo. Whilst the differences were not significant, improvements in severity gradings and mean symptom scores for pain, bloating, straining and urgency to defecate were greater with naloxone than placebo for all parameters. In addition, quality of life assessments improved to a greater extent in patients taking naloxone.Conclusions : Preliminary results suggest that naloxone is well tolerated and beneficial in patients with irritable bowel syndrome and constipation. A larger clinical trial is needed to provide sufficient statistical power to assess efficacy.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2036.2002.01320.x
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  • 6
    Electronic Resource
    Electronic Resource
    Nicotine enemas for active ulcerative colitis—a pilot study (1997)
    Oxford, UK : Blackwell Science Ltd
    Alimentary pharmacology & therapeutics 11 (1997), S. 0 
    Details
    ISSN: 1365-2036
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Since transdermal nicotine is of value in the treatment of active ulcerative colitis but is often associated with side-effects, an alternative in the form of topical therapy with nicotine enemas has been developed.〈section xml:id="abs1-2"〉〈title type="main"〉MethodsIn an open study, 22 patients with active colitis, all non-smokers, were asked to take a 100 mL enema containing 6 mg of nicotine every night for 4 weeks. Pre-trial treatment using mesalazine (n=16), oral prednisolone (8), cyclosporin (1) and azathioprine (1) was kept constant for the month prior to assessment and during the study period. Symptoms, with stool frequency, were recorded on a diary card and an endoscopy was performed with rectal biopsy at the beginning of the study and after 4 weeks.〈section xml:id="abs1-3"〉〈title type="main"〉ResultsSeventeen of the 22 patients completed 1 month of treatment. Mean duration of relapse was 29 weeks, range 3–94. Sixteen of 17 improved their St Mark's score. Urgency and stool frequency improved in 12 patients, sigmoidoscopic and histological scores in 10. Three patients had a full remission of symptoms with normal sigmoidoscopy. Six of 10 with a partial response continued with the enemas for a second month and five showed further improvement with full remission in two. The enema appeared effective when added to conventional treatment and produced few side-effects.〈section xml:id="abs1-4"〉〈title type="main"〉ConclusionTopical nicotine therapy for ulcerative colitis may have a place in future management, but controlled studies are needed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2036.1997.00220.x
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