Judgment rendered February 13, 2014. Application for rehearing may be filedwithin the delay allowed by art. 2166,La. C.C.P. CONTRACTORS, INC. AND LUBA CASUALTY INSURANCE COMPANYOffice of Workers’ Compensation, District 1-WPatrick Fox Robinson, Workers’ Compensation JudgeBefore STEWART, DREW and GARRETT, JJ. DREW, J.: In this long-running dispute which has included a 2003 trial and thre
Buccosante.frA Pilot Study on the Clinical Effectsof Forans Nutri-Gard® for relief ofGastric Ulcers in Horses R. van den Hoven, S. Wlaschitz, S.Leinker, C.Uray. Clinical Department of Small Animals and Horses, Clinic of InternalMedicine and Infectious Diseases, Veterinary University of Vienna, Veterinärplatz 1, A-1210 Vienna, Austria.
Since 3 meter endoscopes have become routinely available for
coating of the ulcer by a polysulfated sugar such as sucralfate.
equine diagnostic purposes, equine gastrology has come to its This substance possibly also induces the mucosal production of full potential. Among many other clinical investigators, it was the protective prostraglandin E2 (PGE2), which is also the main especially Murray and his co-operators who gave equine goal of the third therapeutic approach according to gastrology an upsurge. It is now commonly known that gastric Merritt (2003). Feeding corn oil also may increase mucosal ulcers are recognised problems in thoroughbred and standard PGE2 synthesis (Merritt, 2003). A combination of sucralfate and bred race horses. The prevalence in horses stabled at race H2-antagonisten is also given to horses. If this is a rational tracks or at training yards is estimated between 66 and 90% combination remains questionable, since in man sucralfate is (Hammond et al. 1986, Murray 1994). Even in leisure horses the only used to treat ulcers in the pars glandularis and in the prevalence is about 37% (Murray et al. 1989). Most lesions in the duodenum and not for oesophageal ulcers. Orsini (2000) living horse can be found endoscopically in the epithelium of the believes that this fact may be the explanation for the apparent pars cutanea, especially near the margo plicatus. In horses kept lack of efficacy of sucralfate in horses, since most equine ulcers at pasture the condition is rather uncommon (Murray 1994). It is are not located in the pars glandularis.
presumed that the squamous epithelial lining of the parscutanea of the horse stomach has a limited resistance to peptic The bioavailability of H2-antagonists for the horse is less than injury similar to the oesophageal mucosa of man in man (Orsini 2000), which complicates treatment. However (Orlando 1991). When horses are not eating, the equine gastric proton pump inhibitors appear to pose more potential (Papoch mucosa becomes exposed periodically to highly acidic 1993, Sangiah et al, 1989).Treatment of race and sport horses conditions (Murray and Schusser 1993). This condition may with drugs like omeprazole, ranitidine and cimetidine may occur in stabled horses that are fed oats or pellets 2 or 3 times cause problems in doping control. Recently FEI allowed daily in combination with limited amounts of roughage. Horses competition horses to be treated with omeprazole and at pasture continuously fill their stomachs with food, thereby ranitidine, but other racing and equestrian organisations still continuously buffering the gastric acid production and gastric prohibit the presence of any foreign substance in the body of the ulcers will develop less likely. The term “Equine Gastric Ulcer horse and its excreta. Apart from doping rules and side effects, Syndrome” (EGUS) has been adopted in reference to a number the other drawback of these pharmacological substances is of specifically unique problems that can manifest as mucosal erosion and ulceration within either the oesophagus, stomachor upper duodenum, or some combination thereof (Orsini, Alternatives to buffer intragastric pH or protect the ulcers may 2000). In the majority of cases only the stomach is affected.
be pectin-lecitin based product (Pronutin®). Venner et al. (1999) Gastric ulceration in mature horses may be suspected from described favourable effects on ulcer healing by this product.
subjective clinical signs such as mild to severe colic, poor Another plant based product is Nutri-Gard®. It contains a appetite, poor body condition, dullness and attitude changes, concentrated level of potato cell wall fibre. The product has a poor performance and other behavioural changes (Murray et al.
very high water binding capacity with 90% absorbed in less than 1989, Orsini 2000). As could be expected from the vague clinical one minute. Furthermore it contains lecithin, inulin, galactose, symptoms, Murray et al (1989) reported that the correlation between clinical signs and severity of ulceration appearsquite variable.
The purpose of this study was to investigate the protective andhealing effect on EGUS of Nutri-Gard® in competition horses.
The therapeutic strategies for ulcer healing include 3 basic The study was an explorative clinical study using routine clinical approaches. The first approach is to keep the intragastric pH>4, endoscopy techniques for evaluation of treatment and did not which can be achieved with HCl buffering compounds such as Al/Mg hydroxide, or alternatively with histamine –2-antagonists(H2-antagonsits) such as cimetidine or ranitidine (Furr andMurray 1989). Both drugs must be given 3 times daily. There isstill doubt on the efficacy of H2-antagonsits on ulcer healing(Nieto et al. 2001). A more efficient drug, the proton pumpinhibitor omeprazole, only needs to be given once daily(MacAllister et al, 1999) and was highly effective in a large fieldtrial (Johnson et al, 2001). The second approach may be the Materials and Methods
Clinical cases and treatment
Thirteen patients with clinical and/or endoscopical symptoms of
Lesions were scored immediately by the endoscopist according gastric ulcer disease, comprising racing animals and saddle to the practitioner’s simplified scoring system (Andrews et al, horses, were used. The distribution of age, gender and use are 1997; Orsini, 2000) on a scale from 0 to 3 (0 -intact mucosa, can have mild reddening and/or mild hyperkeratosis; 1 - smallsingle or multiple ulcers; 2 -big solitary or multiple ulcers; 3 – extended, confluent ulcers with regions with deep ulceration).
All observations were recorded and photographs were taken After initial analysis, an alternative scorings system was used tosemi-quantify lesion number and severity of blinded randomised endoscopic photographs of the abnormal gastric areas of the cases. Two experienced endoscopists who were in ignorance of the case information, scored the randomly ordered picturesaccording to the system (Table II) of MacAllister et al. (1997).
Table II: No./Severity score according to MacAllister et al. (1997) At the start of the treatment, the clinical histories of the animals were taken in order to find out if animals had been medically treated within the last 4 weeks. Horses that had been treatedless than 4 weeks before presentation with cimetidine, Deeper structures involved (depth Grade 1) ranitidine or omeprazole were not included in the trial.
The horses were stabled in the facilities of the clinic of internalmedicine for about 18 hours. After endoscopy and initiation of therapy, animal were sent home and received their regular feed which comprised pasture hay and commercial horse pellets, oats or muesli. Pasture hay was of moderate quality. Nutri-Gard® was mixed with the pellets and or oats. No other medication or feed supplement was given to the horses duringthe conduct of the trial. The management of the majority of the The data were analysed with Friedman test using SPSS 11.5 for horses could be supervised by personnel of the clinic of internal Windows. Kendall correlation was used for comparison of medicine, since most of the horses were housed on yards that were frequently visited for other reasons too. After 14 days andafter 28 days animals returned to the clinic for their second andthird gastroscopic examination.
The study was set up as a longitudinal self controlled study.
Gastric ulcer scores before and after Nutri-Gard® treatment
were compared case by case over a one month observation
period. The trial was executed from December 2003 till
After over night fasting, the animals underwent gastroscopy
under standing conditions in stocks. If deemed necessary, a
sedative mixture of detomidine (Domosedan®) and butorphanol
(Butomidor®) was administered intravenously.
Thirteen horses entered the study. All horses underwent a first
The EGUS Scores obtained by the unblinded observers and and a second gastroscopic examination. Two horses that were the Severity (SC) and the Number Scores (NS) obtained by already healed on Day 14 were allowed to omit the final blinded endoscopist were moderately correlated (EGUS with examination on 28 Days. One horse that had not shown NS: r2 = 0.66 - 0.81, EGUS with SC: r2 = 0.65 - 0.81). The median improvement by the 14-day examination did not report for its scores and their 95%-confidence intervals are given in Table IV.
28-day examination appointment. This horse was considered asa treatment failure.
The total numbers of ulcers had decreased by treatment as wasshowed by the1.5 unit decrease in score, but this reduction in NS A treatment effect was already seen after 14 days of was not statistically significant (p=0.128). The ulcers had supplementing the feed with Nutri-Gard® in 38% (5 out of 13) of decreased in severity in the opinion of unblinded endoscopists.
the cases. At 28 days after start of treatment the success rate The SC had improved by 1.5 units, but this difference was also had increased to 69% (8 out of 13). The body weight changes are statistically not significant (p=0,203).
The trial was set up as a self-controlled study. This design type is
Table III. Mean, minimum, maximum and standard deviation suitable for initial investigations of new treatments of body weight and ulcer score before (day 0), after 14 days (Louis et al, 1986). We performed this study to get an impression of treatment (day 14) and at 28 days of treatment (day 28).
whether its worth to further study the effects of the product. The first ulcer scoring system that was used by the endoscopists during the examination of the horses was the practitioner’s simplified scoring system (Andrews et al, 1997; Orsini 2000), alsoknown as EGUS score. Andrews et al (1997) used this scoring system to evaluate the effects of omeprazole treatment in a dose confirmation trial. Using the EGUS score, we could show that Nutri-Gard® improved or healed gastric ulcers in 69% of thetreated horses. Although 39% of the horses already showed improvement after 14 days, most of the cases needed 28 days to show a clear treatment effect. Andrews et al (1999) reported thatspontaneous improvement or healing of ulcers was found in 32%of their cases, while treatment with 4 mg/kg omeprazole daily for A quantification of the effect using the EGUS score was 1 month resulted in improvement or healing of 92% of the cases.
performed and the results are given in Table IV. The average pre-treatment score in that study was 2.2, which isslightly less than the mean EGUS score of 2.4 in our study. Taking Table IV. Median and 95%-confidence intervals for each a spontaneous healing percentage of 32%, the observed healing of 69% in our study analysed by Chi2-test on proportional data wassignificantly different (p=0.05). Since the clinical success rate after Nutri-Gard® treatment was significantly greater than that what could have occurred after spontaneous improvement or healing,we concluded that Nutri-Gard® treatment has a beneficial activity on the healing of gastric ulcer syndrome in the horse. Compared to the omeprazole healing rate, Nutri-Gard® under our testing conditions appeared less potent. The healing based onimprovement of scores in our study could not be proven by statistically significant differences.
In an explorative trial, Venner et al (1999) reported ulcer healingafter a 14 day treatment period with a pectin-lecitin based An example of the endoscopic appearance of a healed case is product. In contrast to this, Murray and Grady (2002) could not find a preventive effect of this pectin-lectin complex on gastricmucosal lesions in a feed deprivation model in ponies, although in2 of 8 ponies showed some protective effect could be seen.
The conclusion of our study was that we could show that
Forans Nutri-Gard® was better than spontaneous healing and
that clinical ulcer scores improved after a one-month treatment
period, however this trend was not statistically significant. These
initial findings support further studies with the product in larger
groups of horses using more advanced study designs.
The mean body weight first increased and later decreased, Acknowledgement
however the changes were not significant (p=0.097). The EGUS The authors would like to thank Mr. David Foran, Foran Equine score had improved by 1 scoring unit after one month, this Products Ltd, a division of Forans Chemicals Ltd., Dublin 10, difference was not statistically significant (p=0.095).
Ireland, for material and financial support.
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Articles Using Optimal Methods Published in Other Journals Arozullah, A.M., Lee, S.D., Khan, T., Kurup, S., Ryan, J., Bonner, M., Soltysik, R.C., & Bandarenko, N., Pandey, D.K., Buffie, C.G., Literacy and Social Support in Predicting the Preventability of Hospital Admission. Journal Sarode, R., Raife, T.J., Kiss, J.E., Raisch, D.W., of General Internal Medicine , 21 , 140-145. D