Acupuncture: clinical trials in the horse.

A discussion of the merits of acupuncture therapy and a review of experiments that support the neurogenic mediation of acupuncture are presented. Case reports are included as examples of the therapeutic value of acupuncture in treatment of intestinal and musculoskeletal disorders in the horse. Statistical importance cannot be credited to the clinical experiences reported here because of the small number of cases. Hopefully, the clinical success reported will encourage continued investigation of the clinical efficacy and adjunctive value of acupuncture in the veterinary profession.     

Designing and running clinical trials on farms.

This article covers the key concepts in design and implementation of clinical trials for valid, interpretable data. Well done field trials should include a clearly defined research question and assessment of a clinically relevant outcome, an appropriate sample size for the question and study design, an appropriate trial design that includes random assignment of animals to treatment and control group, blinded assessment of clinical outcome, and appropriate statistical analysis.     

Amoxycillin: clinical trials in dogs and cats

Amoxycillin, a new broad spectrum semi-synthetic penicillin was subjected to preliminary clinical testing in 351 cases in dogs and 264 in cats in veterinary practices. Two formulations were used: capsules by mouth and an aqueous suspension by injection. Those taking part were asked to use amoxycillin in the treatment of all conditions that they considered required an antibiotic and to report their results in terms of success or failure according to criteria laid down. Samples were taken whenever practicable for bacteriology. Dose ranges were 4 to 11 mg per kg for the oral capsules twice daily in dogs and most cats and 11 mg per kg once daily in some cat cases over five days and 2 to 7 mg per kg for the injectable suspension once daily in both species for three to five days. Results for the full range of conditions are given in tabulated form. Overall percentage of success according to the criteria laid down was 80.1%.     

Postoperative pain control in cats: clinical trials with medetomidine and butorphanol

OBJECTIVE: To evaluate the analgesic effects of medetomidine (MED) and butorphanol (BTO) in cats after ovariohysterectomy. STUDY DESIGN: A placebo-controlled, blinded monocenter clinical study. ANIMALS: Healthy adult female client-owned cats. METHODS: Sixty-four cats weighing 3.15 +/- 0.6 kg, presented to the University of Helsinki's Small Animal Teaching Hospital for routine elective ovariohysterectomy, received MED at 15 microg/kg (n = 18), BTO at 0.1 mg/kg (n = 23), or saline (PL) (n = 23) intramuscularly immediately after ovariohysterectomy. Level of pain perception, degree of restlessness, and extent of sedation were scored subjectively before and at 30, 60, 90, and 120 minutes after test-drug administration. RESULTS: BTO provided the best pain relief, followed by MED. Saline provided the least pain relief. Both MED and BTO effectively and identically prevented postoperative restlessness. MED and BTO produced an identical degree of sedation that was better than the PL. CONCLUSIONS: Both MED (at 15 microg/kg) and BTO (at 0.1 mg/kg) prevent postoperative pain in cats after ovariohysterectomy. Clinical Relevance-MED and BTO are useful for preventing postoperative pain in cats.     

Control of selection bias in parallel-group controlled clinical trials in dogs and cats: 97 trials (2000-2005)

OBJECTIVE: To determine how selection bias (allocation bias) was controlled in published clinical trials. DESIGN: Retrospective study. SAMPLE POPULATION: 97 parallel-group controlled clinical trials published from January 2000 through December 2005 in 12 peer-reviewed journals. PROCEDURES: Journals were hand searched to identify eligible reports. Details concerning allocation of animals to study groups, baseline characteristics of the groups, and the number of animals allocated to each group were recorded. RESULTS: Randomization was the stated method of allocating animals to groups in 87% of the reports, yet in only 11% of reports were both randomization of the group allocation process and concealment of the allocation sequence described. Studies reported as randomized were more likely to report baseline characteristics of the study groups for comparison than studies that did not report randomization (88% vs 54%). Studies in which baseline group characteristics were reported had more subjects allocated to each study group (median, 16) than those that did not (median, 11). CONCLUSIONS AND CLINICAL RELEVANCE: Randomization was reported as the method of allocating study animals to groups in most publications, indicating that the potential power of randomization in controlling selection bias is appreciated by clinical investigators seeking to determine the efficacy of an intervention. However, in most reports, little corroborating information was included to support the claim. The absence of this information makes it difficult for practitioners to critically review the impact of bias on study results and make informed decisions regarding patients.     

Sources and handling of losses to follow-up in parallel-group randomized clinical trials in dogs and cats: 63 trials (2000-2005)

OBJECTIVE: To determine the sources and handlingof losses to follow-up (LTF) in parallel-group randomized clinical trials (RCTs). SAMPLE POPULATION: 63 parallel-group RCTs of > 24 hours' duration published from January 2000 through December 2005. PROCEDURES: Journals were hand searched for eligible reports. Details concerning the presence, cause, and amount of LTF; statistical handlingof data missingbecause of LTF; type of analyses performed; number of animals randomly allocated and analyzed; and the acknowledgement of the potential impact of LTF were recorded. RESULTS In 81% (51/63) of trials, LTF were reported. In 80% (41/51) of those studies, losses in the analysis were ignored, and in only 18% (9/51) was the potential impact of LTF on study results acknowledged. Of the 47 studies in which sources of LTF were reported, 72% had loss of subjects because of investigator withdrawals, 30% because of deaths, and 26% because of owner withdrawals. Median loss of subjects for those studies was 12% because of investigator withdrawal (range, 2% to 52%), 8% because of death (1% to 28%), and 4% because of owner withdrawal (2% to 33%). CONCLUSIONS AND CLINICAL RELEVANCE: Most RCTs had LTF, most of which were attributable to investigators removing randomly allocated animals from the study. In most studies, data from animal LTF were ignored and, therefore, only a subgroup of randomly allocated subjects was included in the data analysis. Most reports did not address the potential for a postrandomization selection bias associated with ignoring LTF and did not acknowledge the potential impact of the missingdata on their results.     

Oxibendazole: critical anthelmintic trials in equids.

The efficacy of oxibendazole against gastrointestinal parasites of horses was evaluated by the critical test method. Naturally infected ponies of various ages were given single oral doses of 5, 10, or 15 mg-kg of bodyweight. The drug was highly effective against adult large strongylids (Strongylus vulgaris, S edentatus, S equins), adult small strongylids (especially species of the genera Cylicostephanus, Cylicocyclus, Cyaathostomum, and Triodontophorus), and adult and larval stages of the large pinworm, Oxyuris equi. There was no apparent dose-related differences in efficacy. Oxibendazole was less effective against fourth-stage small strongylid larvae than it was against adults. The drug was inactive against stomach bots (Gasterophilus spp), tapeworms (Anoplocephala magna and A perfoliata), lungworms (Dictyocaulus arnfieldi), abdominal worms )Setaria equina), and mature or immature nematodes in locations other than the lumen of the gastrointestinal tract.     

The role of the public sector in the development and implementation of animal health policies.

Although it is widely accepted that both the public and private sectors have a role to play in improving animal health, the debate centers on the balance between the two. The comparative advantages of each sector depend on: (i) whether the targeted disease can affect humans; (ii) its degree of contagiousness; (iii) whether it is endemic or exotic; and (iv) the economic costs associated with the disease. The rationale for public intervention is weaker for non-contagious than for contagious diseases; governments, though, can play a support role in several areas: e.g. generation and dissemination of information on health management, fostering participation of producers' organization in the eradication of endemic diseases, or helping private research institutions and funders to overcome the hurdles posed by widespread uncertainty and high costs associated with basic research. Control and eradication of contagious diseases in characterized by strong externalities; bio-security measures implemented by any producer affect his/her neighbors. A major factor affecting the design of appropriate health policies for contagious diseases is whether the disease is endemic or exotic in a particular population. The externality exists for endemic diseases--but for exotic diseases there is only the possibility of an externality (which materializes solely in the case of an outbreak). For exotic diseases, therefore, the perception of the risk of an outbreak is a major determinant of producers' behavior and of public prevention policies. The perception by producers and policy makers of the probability of occurrence of an outbreak of an exotic disease depends on the time elapsed since the last outbreak in the country or in neighboring countries. In general, perception of the risk of an outbreak will be lower than the true risk for most exotic diseases that have been absent for many years--but might be higher than the true risk if an outbreak was recently reported in the region. Taxes and private insurance have been proposed to internalize the externality; however, these policies cannot solve the health externality. Alternative programs (such as joint public-private eradication campaigns) are proposed as a means to minimize the externality.     

Cancer antigen 15/3: possible diagnostic use in veterinary clinical oncology. Preliminary study

The cancer antigen 15/3 is a mucin that is associated with the cell membrane, encoded by the MUC1 gene, and recognized by the monoclonal-clone DF3 antibody. The latter antigen was discovered to be specific for both the identification of human mammary neoplasia and during patient follow-up evaluations. The aim of this study is to report and compare the results of the application of direct chemiluminescence in canine blood sera and the kit utilized in human medicine for the determination of Ca 15/3 to verify the diagnostic efficiency of the kit in cases presenting mammary tumors. Specifically, CA 15/3 has proven to be measurable in all samples assayed to distinguish clinically healthy subjects from those with mammary neoplasia.

     

Critical tests and clinical trials on oxibendazole in horses with special reference to removal of Parascaris equorum.

The efficacy of oxibendazole given at dose level of 10 mg/kg of body weight was determined by 10 critical tests in foals and by 2 clinical trials in 20 foals (16 treated, 4 nontreated), with special interest in the drug activity against Parascaris equorum. The drug was uniformly efficacious (100%) against P equorum in the 10 critical-test foals, each having between 22 and 236 ascarids. Posttreatment reductions of ascarid egg counts in fecal samples were also 100% in suckling foals treated with oxibendazole given as a drench. Ascarid eggs did not reappear in fecal samples until the 8th week after foals were treated. A paste formulation of oxibendazole at 10 mg/kg also eliminated ascarid eggs from feces of 12 suckling foals. Strongyle EPG were markedly reduced by oxibendazole in the 10 critical-test foals and in 16 treated sucklings in the clinical trials. Egg and larval count data on foals in both the critical tests and the clinical trials also indicated oxibendazole was active against Strongyloides westeri. Untoward effects of treatment with oxibendazole were not observed.     

Evaluation of stratification factors and score-scales in clinical trials of treatment of clinical mastitis in dairy cows

There is often a need to reduce sample size in clinical trials due to practical limitations and ethical considerations. Better comparability between treatment groups by use of stratification in the design, and use of continuous outcome variables in the evaluation of treatment results, are two methods that can be used in order to achieve this. In this paper the choice of stratification factors in trials of clinical mastitis in dairy cows is investigated, and two score-scales for evaluation of clinical mastitis are introduced. The outcome in 57 dairy cows suffering from clinical mastitis and included in a clinical trial comparing homeopathic treatment, placebo and a standard antibiotic treatment is investigated. The strata of various stratification factors are compared across treatments to determine which other factors influence outcome. The two score scales, measuring acute and chronic mastitis symptoms, respectively, are evaluated on their ability to differentiate between patients classified from clinical criteria as responders or non-responders to treatment. Differences were found between the strata of the factors severity of mastitis, lactation number, previous mastitis this lactation and bacteriological findings. These factors influence outcome of treatment and appear relevant as stratification factors in mastitis trials. Both score scales differentiated between responders and non-responders to treatment and were found useful for evaluation of mastitis and mastitis treatment.