Impact of a Novel Homeopathic Complex Medicine on the Management of Multiple Antibiotic-Resistant Bovine Mastitis: An Open-Label, Non-Randomized, Placebo-Controlled Trial.

BACKGROUND: Bovine mastitis is characterized by an inflammatory process in the mammary gland and represents one of the main diseases affecting a dairy herd. Management of mastitis is most commonly via antibiotics, but the rising incidence of multiple antibiotic resistance (MAR) means that additional options are needed. Homeopathic products can be administered in dairy farming for a range of clinical reasons and may be preferential due to the absence of residues. OBJECTIVES: The aim of this study was to assess the potential of a novel homeopathic complex medicine in managing bovine mastitis. METHODS: Twenty-four lactating Holstein cows with mastitis were divided into two groups: the homeopathic complex group received a homeopathic complex daily for 60 days at a dose of 20 g/d; the placebo group received the calcium carbonate vehicle without homeopathic medicines at the same dose and repetition. The main outcome measure was somatic cell count (SCC; cells/mL), with additional outcome measures including milk production (kg/d), milk constituents (percentage of protein, fat, lactose and total milk solids), and serum levels of cortisol, glucose, ammonia and lactic acid. All outcomes were measured at the beginning of the study and after 30 and 60 days. Milk samples were also collected from all animals at the beginning of the study, confirming a high (>0.2) MAR index for isolated bacterial cultures. RESULTS: Assessment of SCC showed a statistically significant difference favoring the homeopathic complex versus placebo group at day 60. A reduction in serum cortisol levels and an increase in fat, lactose and total milk solids in animals treated with the homeopathic complex at day 60 were also seen. Other outcome measures did not show statistically significant inter-group differences. CONCLUSION: The results of this non-randomized, open-label, placebo-controlled trial suggest the potential for a novel homeopathic complex medicine in management of multiple antibiotic-resistant bovine mastitis, thus offering dairy farmers an additional option to antibiotics and making dairy products safer for consumer health and milk production more sustainable.

Mastitis prevention and control practices and mastitis treatment strategies associated with the consumption of (critically important) antimicrobials on dairy herds in Flanders, Belgium.

The main objectives of this study were to evaluate to what extent variations in herd-level antimicrobial consumption (AMC) can be explained by differences in management practices that are consistently effective in the prevention of (sub)clinical mastitis, on the one hand, and by differences in mastitis treatment strategies, on the other hand. Antimicrobial consumption data were obtained during 2012 and 2013 by "garbage can audits" and expressed as antimicrobial treatment incidences (ATI) for all compounds combined (total ATI) and for the critically important antimicrobials for human health separately. Data on mastitis prevention and control practices were obtained via face-to-face interviews performed during herd visits in March 2013. Some management practices and treatment strategies related to udder health were associated with the total AMC. However, the results demonstrated that implementing effective udder health management practices does not necessarily imply a low AMC and vice versa. Herds participating in a veterinary herd health management program and herds selectively drying off cows used fewer antimicrobials compared with herds not participating in such a program or applying blanket dry-cow therapy. Moreover, herds treating (some) (sub)clinical mastitis cases with intramammary homeopathic substances consumed fewer antimicrobials than herds not applying such homeopathic treatments. Besides these factors, no other direct association was found between effective udder health management practices on the one hand and AMC on the other hand. Also, the use of critically important antimicrobials was only associated with the way in which subclinical mastitis cases were treated. The latter indicates that the AMC of critically important antimicrobials is potentially driven by factors other than those included in this study such as those related to the "mindset" of the veterinarians and their farmers. Future research should therefore aim to unravel the reasoning of vets and their farmers behind the use of those critically important antimicrobials for the treatment of mastitis and other diseases.

Early udder inflammation in dairy cows treated by a homeopathic medicine (Dolisovet): a prospective observational pilot study.

BACKGROUND: Mammary inflammation in dairy cows is a widespread problem in dairy farming resulting in significant economic and welfare concerns. Dolisovet (Belladonna 1dH, Calendula MT, Echinacea 1dH, Dulcamara 1cH) a homeopathic medicine, licensed in France and indicated for the restoration of mammary function in cows is presented as a 10 g tube of ointment for intramammary use. METHOD: A prospective, uncontrolled, observational pilot study involving the collection and analysis of data from 31 udder quarters identified as being inflamed by an automated milking system (AMS) was conducted to evaluate the effect of Dolisovet on selected parameters of mammary inflammation. Inflamed quarters were identified when milk quality started to deteriorate, via an alert generated by the AMS, on the basis of electrical conductivity (EC). Milk yield and EC were retrieved five to seven days prior to the AMS alert, on the day of and for the following seven days. Dolisovet was administered twice daily for two consecutive days, commencing on the day of the AMS alert. RESULTS: A significant reduction in EC was observed 4-7 days following the first treatment. An increase in milk yield was also observed following the first treatment. CONCLUSION: Dolisovet may have a beneficial therapeutic effect in the early stages of udder inflammation and for restoring udder health and function. This medicine may be an effective first line treatment for sub-clinical bovine mastitis, reducing the need for antibiotics. Randomised, controlled studies should be undertaken to further investigate this possibility.

Development of unconventional treatments for mastitis in dairy cattle.

Background: The increase in the intensity of livestock industries, by improving the technology of animal product manufacturing, largely depends on the correct organization of herd reproduction and the intensity of using the biological capabilities of the animal organism. Various diseases, including such common diseases as mastitis, complicate the successful reproduction and growth of enterprise productivity. The widespread use of antibiotic-containing drugs for the treatment of mastitis creates a number of inevitable consequences for the body. The relevance of the study is due to the fact that the residual content of antibiotics in the collected milk after the course of treatment poses a serious danger to human health and reduces the quality of dairy products obtained from such milk. Aim: The authors set the task of developing a new, antibiotic-free method of treating bovine mastitis. This paper is devoted to the problem of improving methods of treating the subclinical mastitis in dairy cattle by alternative methods during the interlactation period. Methods: The leading method for the study of this problem is an experimental method that allows to develop and test a veterinary homeopathic substance for the treatment of subclinical mastitis in cows during the interlactation period. Results: This paper presents materials on the typification of microflora in the milk of cows with subclinical mastitis and the effectiveness of a veterinary homeopathic substance developed by the authors. The use of the veterinary homeopathic substance provided a high therapeutic effect, and did not cause side effects and complications in cows. Conclusion: The resulting veterinary substance was tested and introduced into the "Izhevskiy" natural complex of Akmola region as a new alternative method of treating subclinical mastitis in cows. Based on this substance, a drug for the treatment of mastitis will be developed and proposed for production.

Efficacy of homeopathic and antibiotic treatment strategies in cases of mild and moderate bovine clinical mastitis.

The objective of this clinical control trial was to examine the effectiveness of the classical homeopathic treatment strategy in cases of mild and moderate bovine clinical mastitis in comparison with antibiotic and placebo treatments. Owing to characteristics of the selected herds, only cases of clinical mastitis caused by environmental pathogens and clinical cases with negative bacteriological result in the pre-treatment milk sample were included in the trial. A total of 136 lactating dairy cows with 147 affected quarters from four herds in Germany were randomly allocated to three treatment groups. The cows were examined on days 0, 1, 2 and on days 7, 14, 28 and 56 post initial infection to assess clinical signs. Simultaneously, with the exception of days 1 and 2, quarter milk samples for laboratory examinations (bacteriology, somatic cell count) were collected to assess bacteriological and cytological cure rates. On days 28 and 56, treatment strategies did not differ significantly with respect to the clinical outcomes and the total cure rate in cases of bacteriological negative mastitis (n=56). In cases of pathogen-positive mastitis (n=91), the cure rate after 4 and 8 weeks was similar between the two treatment strategies, homeopathy and antibiotic treatment, but the difference between the homeopathic and the placebo treatment at day 56 was significant (P<0·05). The results indicate a therapeutic effect of homeopathic treatment in cases of mild and moderate clinical mastitis. However, independent of treatment strategy and bacteriological status, the total cure rate was on a low level, revealing limitations in the effectiveness of both antibiotic and homeopathic treatment strategies.

Comparative effectiveness of individualised homeopathy and antibiotics in the treatment of bovine clinical mastitis: randomised controlled trial.

Based on the widespread use of homeopathy in dairy farm practice when treating mastitis, a blind randomised controlled trial (RCT) was conducted to assess the effectiveness of homeopathic treatment of clinical mastitis on four dairy farms. The study considered specific guidelines for RCTs as well as the basic principles of individualised homeopathy and involved 180 lactating dairy cows. Evaluation of cure rates was based on clinical investigation of the udder and on laboratory analysis of milk samples. In culture-positive cases, the antibiotic treatment provided suboptimal bacteriological cures (60-81 per cent) but was more effective than individualised homeopathy (33-43 per cent) whose effects appeared little different to those of placebos (45-47 per cent) (P≤0.05). On the cytological cure level, all three treatment methods were similarly ineffective: antibiotic being 2-21 per cent, individualised homeopathy 0-8 per cent and placebo 3-13 per cent (P≤0.05; P=0.13). Antibiotics, individualised homeopathy and placebo had similar effects on bacteriological and cytological cure in cases of culture-negative milk samples (P>0.4) and Escherichia coli infections (P=1.0). The study results implied that the effectiveness of individualised homeopathy does not go beyond a placebo effect and successful treatment is highly dependent on the specific mastitis pathogen. Thus, antimicrobial or alternative remedies used should be based on the bacterial culture of the milk sample. TRIAL REGISTRATION NUMBER: NTP-ID: 00008011-1-9, Pre-results.

Controlled clinical trial of the effect of a homoeopathic nosode on the somatic cell counts in the milk of clinically normal dairy cows.

Cows in a 250-cow Holstein-Friesian herd were allocated at random to be treated with either a homoeopathic nosode or a negative control, both treatments being applied by means of an aerosol spray to the vulval mucous membranes. A total of six treatments were given over a period of three days and milk samples were taken for the determination of somatic cell counts (SCC) on days -3, 3, 7, 9, 14, 21 and 28. Individuals applying the treatments or carrying out the SCC determination were unaware of which animals were receiving which treatment. Owing to the wide natural variations in SCC, the trial had only a 71 per cent possibility of detecting a 30 per cent difference in SCC between the two groups. There were no significant differences between the SCC of the two groups on any sample day, but there were significant variations between the SCC on different days (P=0.003) in both groups.

Lack of efficacy of homeopathic therapy against post-calving clinical mastitis in dairy herds in the Waikato region of New Zealand.

AIM: To compare clinical and bacteriological cure rates of clinical mastitis following treatment with either antimicrobials or homeopathic preparations. METHODS: Seven spring-calving herds from the Waikato region of New Zealand were used to source cases of clinical mastitis (n = 263 glands) during the first 90 days following calving. Duplicate milk samples were collected for bacteriology from each clinically infected gland at diagnosis and 25 (SD 5.3) days after initial treatment. Affected glands were treated with either an antimicrobial formulation or a homeopathic remedy. Generalised linear models with binomial error distribution and logit link were used to analyse the proportion of cows that were clinical treatment cures and the proportion of glands that were classified as bacteriological cures, based on initial and post-treatment milk samples. RESULTS: Mean cumulative incidence of clinical mastitis was 7% (range 2-13% across herds) of cows. Streptococcus uberis was the most common pathogen isolated from culture-positive samples from affected glands (140/209; 67%). The clinical cure rate was higher for cows treated with antimicrobials (107/113; 95%) than for cows treated with homeopathic remedies (72/114; 63%) (p < 0.001) based on the observance of clinical signs following initial treatment. Across all pathogen types bacteriological cure rate at gland level was higher for those cows treated with antimicrobials (75/102; 74%) than for those treated with a homeopathic preparation (39/107; 36%) (p < 0.001). CONCLUSIONS AND CLINICAL RELEVANCE: Using herds located in the Waikato region of New Zealand, homeopathic remedies had significantly lower clinical and bacteriological cure rates compared with antimicrobials when used to treat post-calving clinical mastitis where S. uberis was the most common pathogen. The proportion of cows that needed retreatment was significantly higher for the homeopathic treated cows. This, combined with lower bacteriological cure rates, has implications for duration of infection, individual cow somatic cell count, costs associated with treatment and animal welfare.

Inferring relationships between clinical mastitis, productivity and fertility: a recursive model application including genetics, farm associated herd management, and cow-specific antibiotic treatments.

A dataset of test-day records, fertility traits, and one health trait including 1275 Brown Swiss cows kept in 46 small-scale organic farms was used to infer relationships among these traits based on recursive Gaussian-threshold models. Test-day records included milk yield (MY), protein percentage (PROT-%), fat percentage (FAT-%), somatic cell score (SCS), the ratio of FAT-% to PROT-% (FPR), lactose percentage (LAC-%), and milk urea nitrogen (MUN). Female fertility traits were defined as the interval from calving to first insemination (CTFS) and success of a first insemination (SFI), and the health trait was clinical mastitis (CM). First, a tri-trait model was used which postulated the recursive effect of a test-day observation in the early period of lactation on liability to CM (LCM), and further the recursive effect of LCM on the following test-day observation. For CM and female fertility traits, a bi-trait recursive Gaussian-threshold model was employed to estimate the effects from CM to CTFS and from CM on SFI. The recursive effects from CTFS and SFI onto CM were not relevant, because CM was recorded prior to the measurements for CTFS and SFI. Results show that the posterior heritability for LCM was 0.05, and for all other traits, heritability estimates were in reasonable ranges, each with a small posterior SD. Lowest heritability estimates were obtained for female reproduction traits, i.e. h(2)=0.02 for SFI, and h(2)≈0 for CTFS. Posterior estimates of genetic correlations between LCM and production traits (MY and MUN), and between LCM and somatic cell score (SCS), were large and positive (0.56-0.68). Results confirm the genetic antagonism between MY and LCM, and the suitability of SCS as an indicator trait for CM. Structural equation coefficients describe the impact of one trait on a second trait on the phenotypic pathway. Higher values for FAT-% and FPR were associated with a higher LCM. The rate of change in FAT-% and in FPR in the ongoing lactation with respect to the previous LCM was close to zero. Estimated recursive effects between SCS and CM were positive, implying strong phenotypic impacts between both traits. Structural equation coefficients explained a detrimental impact of CM on female fertility traits CTFS and SFI. The cow-specific CM treatment had no significant impact on performance traits in the ongoing lactation. For most treatments, beta-lactam-antibiotics were used, but test-day SCS and production traits after the beta-lactam-treatment were comparable to those after other antibiotic as well as homeopathic treatments.

Considerações sobre o tratamento das mastites / Considerations on the treatment of mastitis

A mastite é considerada o maior problema dos animais destinados à produção de leite. Altera a sua composição e aumenta a contagem de células somáticas (CCS). Os micro-organismos envolvidos na doença podem ser origem infecciosa, como Staphylococcus aureus, ou ambiental, tal como Escherichia coli. A cultura bacteriana é uma ferramenta de diagnóstico e auxilia na detecção do patógeno causador da mastite. No entanto, fatores como fagocitose podem desencadear um resultado negativo. Quando estabelecido um programa de controle de mastite, o diagnóstico precoce e o início do tratamento adequado dos casos clínicos são fundamentais para se atingir os objetivos e seu sucesso, está relacionado com o patógeno envolvido. A indicação do tratamento de longa duração, ou terapia estendida, tem melhorado a resposta ao tratamento em casos de mastite por S. aureus, no entanto, com 30-50% de cura. Do ponto de vista do manejo dos animais, devido a alta contagiosidade deste patógeno, sua persistência no rebanho e custo em função ao tratamento, muitas vezes, o descarte do animal tem sido priorizado a fim de controlar os casos de mastite em propriedades. As medidas de controle são muito importantes para contribuir com a redução de casos de mastite por este patógeno. A indicação do tratamento intramamário associada com sistêmico tem poder efetivo em casos de mastite por E. coli, cujos casos agudos apresentam-se com sepse e toxemia. São abordados ainda aspectos de tratamentos alternativos das mastites, utilizados principalmente no processo orgânico de produção leiteira.(AU)

Mastites are considered a major problem on animals for milk production. Changes the milk composition and increases the somatic cell count (SCC). The microorganism involved in the disease may be infectious origin such as Staphylococcus aureus or environmental such as Escherichia coli. Bacterial culture is a diagnostic tool and aids in the detection of pathogenic causing masitis. However factor such as phagocytosis may result a negative result. When established a mastitis control program early diagnose and the initiation of appropriate treatment of clinical cases are fundamental for achieving the goals and success is related to the pathogen involved. The indication of treatment of long duration, or extended therapy has improved the response to the treatment in cases of matitis by S. aureus, however with 30-50% of cure. From the view point of handling of animals, given the high infectiousness of this pathogen, its persistence in the herd and cost-effective as a function of response to treatment often has prioritized the animal's discard in order to control the mastitis cases in properties. Control measures are very important to contribute the reduction of cases of mastitis symptoms by this pathogen. The indication of intramammary treatment associated with systemic has power effective in cases of mastitis by ­E. coli, whose acute cases present with sepsis and toxemia. Also address aspects of alternative treatments of mastitis, mainly used in the organic process of milk production.(AU)

Comparative efficacy of homeopathic and allopathic systems of medicine in the management of clinical mastitis of Indian dairy cows.

Mastitis is the major problem of dairy animals despite a number of preventive and therapeutic approaches. Treatment is costly and out of reach of farmers of developing countries like India. The treatment cost of bovine mastitis with conventional treatment has been calculated. Good results have been claimed with homeopathic treatment however, treatment costs are not available. This article reports the treatment economics of homeopathic drugs conventional drugs for the management of bovine mastitis. Ninety-six mastitic quarters (non-fibrosed 67 and fibrosed 29) were treated with a homeopathic combination medicine. Another 96 quarters with acute mastitis (non-fibrosed) treated with different antibiotics were included in the study. The animals were selected from dairy farm of the Indian Veterinary Research Institute and from private dairy farms. The overall effectiveness of homeopathic combination medicine in the treatment of acute non-fibrosed mastitis was 86.6% with a mean recovery period of 7.7 days (range 3-28), and total cost of therapy as Indian Rupees 21.4 (0.39 Euros, US$ 0.47). The corresponding cure rate for the antibiotic group was 59.2% with a mean recovery period of 4.5 days (range 2-15) and an average treatment cost of Rs.149.20 (2.69 Euros, US$ 3.28). We conclude that the combination of Phytolacca, Calcarea fluorica., Silica, Belladonna, Bryonia, Arnica, Conium and Ipecacuanha (Healwell VT-6) was effective and economical in the management of mastitis in lactating dairy cows.

[The administration of homeopathic drugs for the treatment of acute mastitis in cattle]. / Untersuchungen über den Einsatz homöopathischer Arzneimittel zur Behandlung akuter Mastitiden beim Rind.

The general principles of homeopathic therapy are described together with a number of homeopathic drugs used for the treatment of acute bovine mastitis. Fifty cows with acute mastitis were used in the study. The initial treatment comprised aconitum D 4, phytolacca D 1 and bryonia D 4. In subsequent treatments phytolacca D 1, bryonia D 4 and lachesis D 8 either singly or in combination were used; mercurius solubilis D 4 was also used. Encouraging results, especially in the treatment of cases of E.coli mastitis, were achieved.

Comparison of homeopathy, placebo and antibiotic treatment of clinical mastitis in dairy cows - methodological issues and results from a randomized-clinical trial.

Based on the widespread use of homeopathy in treatment of animal disease and the poor documentation of its possible effects and consequences, a clinical trial was carried out in order to evaluate the efficacy of homeopathy in treatment of clinical mastitis in dairy cows and a design for clinical studies on homeopathic treatment, taking into account the guidelines for randomized-clinical trials (RCT) as well as the basic principles of homeopathy. A three-armed, stratified, semi-crossover design comparing homeopathy, placebo and a standardized antibiotic treatment was used. Fifty-seven dairy cows were included. Evaluation was made by two score scales, with score I measuring acute symptoms and score II measuring chronic symptoms, and by recording the frequencies of responders to treatment based on four different responder definitions. Significant reductions in mastitis signs were observed in all treatment groups. Homeopathic treatment was not statistically different from either placebo or antibiotic treatment at day 7 (P = 0.56, P = 0.09) or at day 28 (P = 0.07, P = 0.35). The antibiotic treatment was significantly better than placebo measured by the reduction in score I (P < 0.01). Two-thirds of the cases both in the homeopathy and placebo groups responded clinically within 7 days. The outcome measured by frequencies of responders at day 28 was poor in all treatment groups. Evidence of efficacy of homeopathic treatment beyond placebo was not found in this study, but the design can be useful in subsequent larger trials on individualized homeopathic treatment.

Evaluation of a homeopathic complex in the clinical management of udder diseases of riverine buffaloes.

We report an uncontrolled observational study of the treatment of udder diseases of buffalo, using a homeopathic complex medicine. Mastitis is an economically important disease of buffaloes. In India economic losses due to mastitis are estimated at 526 million US dollars annually. Conventional veterinary treatment relies on costly antibiotics; cure rate is only 60% in field conditions with a problem of milk residues. The present investigation was undertaken to evaluate the effectiveness of a homeopathic complex in the management of clinical udder health problems of riverine buffaloes. Cases of subclinical mastitis were excluded from the study. A total of 102 mastitic quarters (fibrosed--40, nonfibrosed--62) and five cases each of blood in milk and udder oedema in lactating buffaloes were treated with a homeopathic complex consisting of Phytolacca 200c, Calcarea fluorica 200c, Silicea 30c, Belladona 30c, Bryonia 30c, Arnica 30c, Conium 30c and Ipecacuanha 30c. The diagnosis of udder diseases and recovery criterion was based on physical examination of udder and milk and CMT/WST score. Bacteriological analysis and somatic cell count were not performed. Treatment was 80 and 96.72% effective in cases of fibrotic mastitis and nonfibrosed mastitis respectively. Recovery period was 21-42 days (fibrosed) and 4-15 days (nonfibrosed). Udder oedema and blood in milk responded favourably in 2-5 days. Cost of treatment was 0.07 US dollars per day. The homeopathic complex medicine may be effective and economical in the management of udder health problems of buffaloes. Definitive conclusions are premature due to the limited number of observations and lack of control group.

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.