Computerized planimetry in the objective assessment of the antispasmodic effect of Zamifenacin in double contrast barium enemas.
A prospective, randomized, double-blind study was undertaken to evaluate Zamifenacin 30 mg (Pfizer Ltd), a novel, orally-administered, gut-specific muscarinic receptor antagonist, as an adjuvant to the double contrast barium enema examination (DCBE). Zamifenacin was compared with placebo in terms of side-effects and colonic tone. Analysis of colonic tone was carried out by two independent observers, using a subjective grading system and also by an objective method using computerized planimetry. Interobserver variability was also assessed. Zamifenacin is safe and well tolerated but at the prescribed dose is an ineffective antispasmodic for DCBE. Subjective assessment of colonic tone was shown to be of limited value whilst the objective analysis using computerized planimetry was reliable and highly reproducible.
Hughes
T
T
Imaging Laboratory, Royal Victoria Infirmary, Newcastle upon Tyne, UK.
Wright
A R
AR
Owen
J P
JP
Keir
M J
MJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D001466:Barium Sulfate; D003106:Colon / Q000000981:diagnostic imaging / Q000187:drug effects*; D003108:Colonic Diseases / Q000517:prevention & control; D004149:Dioxoles / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004733:Enema; D006801:Humans; D007091:Image Processing, Computer-Assisted; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000494:pharmacology*; D015588:Observer Variation; D010880:Piperidines / Q000009:adverse effects / Q000494:pharmacology*; D011446:Prospective Studies; D011859:Radiography; D013035:Spasm / Q000517:prevention & control
D004149:Dioxoles; D018727:Muscarinic Antagonists; D010880:Piperidines; D001466:Barium Sulfate; C097932:zamifenacin