PandemieGrippaleV1, Istex, Corpus, bibRecord, 001872

Prevention of Influenza Episodes With Colostrum Compared With Vaccination in Healthy and High-Risk Cardiovascular Subjects

Identifieur interne : 001872 ( Istex/Corpus ); précédent : 001871; suivant : 001873

Prevention of Influenza Episodes With Colostrum Compared With Vaccination in Healthy and High-Risk Cardiovascular Subjects

Auteurs : Maria Rosaria Cesarone ; Gianni Belcaro ; Andrea Di Renzo ; Mark Dugall ; Marisa Cacchio ; Irma Ruffini ; Luciano Pellegrini ; Gilberto Del Boccio ; Filiberto Fano ; Andrea Ledda ; Angelica Bottari ; Andrea Ricci ; Stefano Stuard ; Giulia Vinciguerra

Source :

Clinical and Applied Thrombosis/Hemostasis [ 1076-0296 ] ; 2007-04.

RBID : ISTEX:D0190EAE2E87E3BD0D916EBBFFFB9D09B3BC45BF

English descriptors

Teeft :
- Antiviral drugs, Bovine, Bovine colostrum, Bovine milk, Cardiovascular, Cardiovascular patients, Cardiovascular subjects, Chronic diarrhea, Colostrum, Colostrum group, Colostrum groups, Colostrum subjects, Colostrum vaccination group, Control group, Control groups, Coronary patients, Dropout, Event subjects, Gianni belcaro, Health food supplement, Healthy individuals, Healthy subjects, Higher risk, Hospital admission, Hospital admissions, Human colostrum, Immune response, Immunoglobulin, Influenza, Influenza vaccination, Larger study, Nonmedical causes, Oral colostrum, Prophylaxis, Prophylaxis groups, Pulmonary hypertension, Relative costs, Rheumatoid arthritis, Side effects, Total number, Vaccination, Vaccination group, Vaccination subjects, Vaccine.

Abstract

The efficacy of a 2-month treatment with oral colostrum in the prevention of flu episodes compared with antiinfluenza vaccination was evaluated. Groups included healthy subjects without prophylaxis and those receiving both vaccination and colostrum. After 3 months of follow-up, the number of days with flu was 3 times higher in the non-colostrum subjects. The colostrum group had 13 episodes versus 14 in the colostrum + vaccination group, 41 in the group without prophylaxis, and 57 in nontreated subjects. Part 2 of the study had a similar protocol with 65 very high-risk cardiovascular subjects, all of whom had prophylaxis. The incidence of complications and hospital admission was higher in the group that received only a vaccination compared with the colostrum groups. Colostrum, both in healthy subjects and high-risk cardiovascular patients, is at least 3 times more effective than vaccination to prevent flu and is very cost-effective.

Url:

https://api.istex.fr/ark:/67375/M70-6JBKRTFX-T/fulltext.pdf

DOI: 10.1177/1076029606295957

Links to Exploration step

ISTEX:D0190EAE2E87E3BD0D916EBBFFFB9D09B3BC45BF

Le document en format XML

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<author wicri:is="90%"><name sortKey="Bottari, Angelica" sort="Bottari, Angelica" uniqKey="Bottari A" first="Angelica" last="Bottari">Angelica Bottari</name>
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<author wicri:is="90%"><name sortKey="Vinciguerra, Giulia" sort="Vinciguerra, Giulia" uniqKey="Vinciguerra G" first="Giulia" last="Vinciguerra">Giulia Vinciguerra</name>
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<author wicri:is="90%"><name sortKey="Cacchio, Marisa" sort="Cacchio, Marisa" uniqKey="Cacchio M" first="Marisa" last="Cacchio">Marisa Cacchio</name>
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<author wicri:is="90%"><name sortKey="Pellegrini, Luciano" sort="Pellegrini, Luciano" uniqKey="Pellegrini L" first="Luciano" last="Pellegrini">Luciano Pellegrini</name>
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<author wicri:is="90%"><name sortKey="Stuard, Stefano" sort="Stuard, Stefano" uniqKey="Stuard S" first="Stefano" last="Stuard">Stefano Stuard</name>
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<series><title level="j">Clinical and Applied Thrombosis/Hemostasis</title>
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<profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Antiviral drugs</term>
<term>Bovine</term>
<term>Bovine colostrum</term>
<term>Bovine milk</term>
<term>Cardiovascular</term>
<term>Cardiovascular patients</term>
<term>Cardiovascular subjects</term>
<term>Chronic diarrhea</term>
<term>Colostrum</term>
<term>Colostrum group</term>
<term>Colostrum groups</term>
<term>Colostrum subjects</term>
<term>Colostrum vaccination group</term>
<term>Control group</term>
<term>Control groups</term>
<term>Coronary patients</term>
<term>Dropout</term>
<term>Event subjects</term>
<term>Gianni belcaro</term>
<term>Health food supplement</term>
<term>Healthy individuals</term>
<term>Healthy subjects</term>
<term>Higher risk</term>
<term>Hospital admission</term>
<term>Hospital admissions</term>
<term>Human colostrum</term>
<term>Immune response</term>
<term>Immunoglobulin</term>
<term>Influenza</term>
<term>Influenza vaccination</term>
<term>Larger study</term>
<term>Nonmedical causes</term>
<term>Oral colostrum</term>
<term>Prophylaxis</term>
<term>Prophylaxis groups</term>
<term>Pulmonary hypertension</term>
<term>Relative costs</term>
<term>Rheumatoid arthritis</term>
<term>Side effects</term>
<term>Total number</term>
<term>Vaccination</term>
<term>Vaccination group</term>
<term>Vaccination subjects</term>
<term>Vaccine</term>
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<front><div type="abstract" xml:lang="en">The efficacy of a 2-month treatment with oral colostrum in the prevention of flu episodes compared with antiinfluenza vaccination was evaluated. Groups included healthy subjects without prophylaxis and those receiving both vaccination and colostrum. After 3 months of follow-up, the number of days with flu was 3 times higher in the non-colostrum subjects. The colostrum group had 13 episodes versus 14 in the colostrum + vaccination group, 41 in the group without prophylaxis, and 57 in nontreated subjects. Part 2 of the study had a similar protocol with 65 very high-risk cardiovascular subjects, all of whom had prophylaxis. The incidence of complications and hospital admission was higher in the group that received only a vaccination compared with the colostrum groups. Colostrum, both in healthy subjects and high-risk cardiovascular patients, is at least 3 times more effective than vaccination to prevent flu and is very cost-effective.</div>
</front>
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<author><json:item><name>Maria Rosaria Cesarone MD</name>
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<json:item><name>Gianni Belcaro MD, PhD</name>
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<json:item><name>Andrea Di Renzo BA</name>
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<json:item><name>Mark Dugall PhD</name>
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<json:item><name>Marisa Cacchio MD</name>
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<json:item><name>Irma Ruffini MD</name>
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<json:item><name>Luciano Pellegrini MD</name>
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<json:item><name>Gilberto Del Boccio MD</name>
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</affiliations>
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<json:item><name>Filiberto Fano BA</name>
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<json:item><name>Andrea Ledda MD</name>
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</affiliations>
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<json:item><name>Angelica Bottari MD</name>
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</affiliations>
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<json:item><name>Andrea Ricci MD</name>
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</affiliations>
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<json:item><name>Stefano Stuard MD</name>
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<abstract xml:lang="en"><p>The efficacy of a 2-month treatment with oral colostrum in the prevention of flu episodes compared with antiinfluenza vaccination was evaluated. Groups included healthy subjects without prophylaxis and those receiving both vaccination and colostrum. After 3 months of follow-up, the number of days with flu was 3 times higher in the non-colostrum subjects. The colostrum group had 13 episodes versus 14 in the colostrum + vaccination group, 41 in the group without prophylaxis, and 57 in nontreated subjects. Part 2 of the study had a similar protocol with 65 very high-risk cardiovascular subjects, all of whom had prophylaxis. The incidence of complications and hospital admission was higher in the group that received only a vaccination compared with the colostrum groups. Colostrum, both in healthy subjects and high-risk cardiovascular patients, is at least 3 times more effective than vaccination to prevent flu and is very cost-effective.</p>
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         <contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Cesarone</surname>
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<aff>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</aff>
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<given-names>Marisa</given-names>
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<aff>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</aff>
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<aff>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</aff>
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<aff>From San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</aff>
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         <contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Bottari</surname>
<given-names>Angelica</given-names>
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<aff>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</aff>
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         <contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Ricci</surname>
<given-names>Andrea</given-names>
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<aff>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</aff>
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         <contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Stuard</surname>
<given-names>Stefano</given-names>
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<degrees>MD</degrees>
<aff>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</aff>
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         <contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Vinciguerra</surname>
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<aff>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</aff>
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<abstract><p>The efficacy of a 2-month treatment with oral colostrum in the prevention of flu episodes compared with antiinfluenza vaccination was evaluated. Groups included healthy subjects without prophylaxis and those receiving both vaccination and colostrum. After 3 months of follow-up, the number of days with flu was 3 times higher in the non-colostrum subjects. The colostrum group had 13 episodes versus 14 in the colostrum + vaccination group, 41 in the group without prophylaxis, and 57 in nontreated subjects. Part 2 of the study had a similar protocol with 65 very high-risk cardiovascular subjects, all of whom had prophylaxis. The incidence of complications and hospital admission was higher in the group that received only a vaccination compared with the colostrum groups. Colostrum, both in healthy subjects and high-risk cardiovascular patients, is at least 3 times more effective than vaccination to prevent flu and is very cost-effective.</p>
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<meta-value>130 Prevention of Influenza Episodes With Colostrum Compared With Vaccination in Healthy and High-Risk Cardiovascular SubjectsThe Epidemiologic Study in San Valentino SAGE Publications, Inc.200710.1177/1076029606295957 Maria RosariaCesarone MD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy GianniBelcaro MD, PhD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy, cardres@abol.it AndreaDi Renzo BA San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy MarkDugall PhD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy MarisaCacchio MD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy IrmaRuffini MD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy LucianoPellegrini MD From San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy GilbertoDel Boccio MD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy FilibertoFano BA San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy AndreaLedda MD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy AngelicaBottari MD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy AndreaRicci MD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy StefanoStuard MD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy GiuliaVinciguerra PhD San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy The efficacy of a 2-month treatment with oral colostrum in the prevention of flu episodes compared with antiinfluenza vaccination was evaluated. Groups included healthy subjects without prophylaxis and those receiving both vaccination and colostrum. After 3 months of follow-up, the number of days with flu was 3 times higher in the non-colostrum subjects. The colostrum group had 13 episodes versus 14 in the colostrum + vaccination group, 41 in the group without prophylaxis, and 57 in nontreated subjects. Part 2 of the study had a similar protocol with 65 very high-risk cardiovascular subjects, all of whom had prophylaxis. The incidence of complications and hospital admission was higher in the group that received only a vaccination compared with the colostrum groups. Colostrum, both in healthy subjects and high-risk cardiovascular patients, is at least 3 times more effective than vaccination to prevent flu and is very cost-effective. influenza prevention colostrum vaccination Influenza (flu) causes many deaths and a large amount of costs worldwide. Vaccines standardized to contain hemoagglutinin protein of different viruses and antiviral drugs are available for its pro- phylaxis or treatment. These products are aimed mainly at the prevention of serious consequences, including hospitalization and death, that affect par- ticularly the weaker members of the population such as children, individuals aged 65 years and older, and patients debilitated with chronic disease. Even though the recommendations for prevention Address correspondence to: Gianni Belcaro, MD, PhD, San Valentino Vascular Screening Project, C.so Umberto I, 18 San Valentino, 65120 Pescara, Italy; e-mail: cardres@abol.it. Clinical and Applied Thrombosis/Hemostasis Vol. 13, No. 2, April 2007 130-136 DOI: 10.1177/1076029606295957 © 2007 Sage Publications of influenza are well defined,1,2 a significant num- ber of influenza-associated hospitalization occur among the elderly3 and in children.3,4 The occurrence of new “drift”5 or a new emerging virus6 may reduce the cost-effective per- formance of vaccines and antiviral drugs, however, and the impact of vaccination benefit sometimes is considered to be overestimated.7,8 New prevention tools should be available that may improve the defense against the virus that causes flu. One of these could be colostrum. Colostrum is produced by the mammary gland within 48 to 73 hours after the birth of offspring. This period is so significant to ensure a correct immuno- logic status that without colostrum, many newborn mammals do not survive. Human colostrum is an important source of proteins, fats, carbohydrates, and vitamins and minerals, and includes several bio- logically active molecules essential for immunity, 131 such as immunoglobulins (Ig) and growth factors. For several reasons, however, human colostrum is not easily available, storable, or usable as a supple- ment. Bovine colostrum is the most common source as food supplement. Despite the lack of a defined composition profile and fluctuation of Ig titer, all types of bovine colostrum contain neutralizing Ig against pathogens.9 Factors present both in bovine and human colostrum, even though not identical are compara- ble, and most elements are present in higher quan- tities and concentrations in bovine colostrum. In general, the specific antibodies found in colostrum include those for Escherichia coli, Salmonella spp, Streptococcus spp, Helicobacter pylori, Candida spp, rotavirus, and other common pathogens.10 Some clinical studies have already shown that colostrum includes factors that are able to reduce chronic diarrhea in immunodeficient subjects,11,12 diarrhea caused by rotavirus in children,13 and improve symptoms of upper respiratory tract infections in adults.14 The aim of this study was the evaluation of the use of oral colostrum in preventing flu episodes linked to winter compared with anti-flu vaccination, and also the consideration of a com- parable group subjects using no prophylaxis. The colostrum used was derived from nonimmunized animals and characterized by a standardized composition, and results obtained in this study cannot necessarily be produced by all types of colostrum. Also, a high-risk group with cardio- vascular problems was included because an episode of flu in these subjects can easily become severe and severely increase morbidity and even mortality. METHODS AND MATERIALS Study Design Subjects analyzed in this study were evaluated within the framework of the epidemiologic screen- ing project (PAP/PEA) in San Valentino, Vasto, and Spoltore (Abruzzo, Italy), which repeats—with differ- ent characteristics, being based on high-resolution ultrasound imaging of the arterial wall—the frame- work of the Framingham Study. The PAP/PEA study, in its 12th year of activity, includes constant contact with the subjects in the local populations that are being evaluated, which is ideal for this type of mon- itoring study. The study was performed as a clinical registry trial. Patients Inclusion Criteria In Part 1 of the study, 144 healthy individuals of both sexes (age range, 30 to 80 years) were included and divided in 4 groups. Two similar groups were formed by subjects who underwent flu vaccination within 2 weeks before the inclusion: one group of 44 subjects took colostrum, and the other group of 39 did not take any type of immunostimulant or antiviral drug. A third compa- rable group of 38 subjects received only colostrum, without a flu vaccination. The prophylaxis groups were compared with a fourth group of 23 subjects who did not use any prophylaxis. Exclusion Criteria Excluded were subjects with severe clinical dis- ease, chronic diseases, an infection not controlled by treatment, and those with diabetes. Patients who had hospital admissions or surgery within 4 months before inclusion, for any reason, were also excluded. Treatment Subjects in the colostrum groups used oral tablets (one daily, at 8:00 AM, for 8 weeks). The com- position of the colostrum, in chewable tablets (ARD Colostrum, Corcon srl, Milan, Italy) containing 400 mg of defatted bovine freeze-dried colostrum with its characteristics, is reported in Table 1. The use of other drugs, and particularly antiinfective drugs and antibiotics, were avoided. Vaccination had been performed within 2 weeks before inclusion into the follow-up period. The type of vaccine administered was the standard anti-flu vaccine supplied by the Italian National Health Service. Evaluation of the outcome was made consider- ing as targets: a. the presence and frequency of flu episodes within the 2 months of prophylaxis; b. the presence and frequency of flu episodes in the third month (without prophylaxis); c. the total number of days of malaise and/or lost working days; d. the relative costs due to the loss of work- ing days; e. the need for treatments and hospital admissions; and f. the number of event-free subjects. 132 After the admission visit, all subjects were reeval- uated by phone or personal contact every 2 weeks with a questionnaire. Part 2 of the study included very high-risk sub- jects, including end-stage coronary patients and patients with pulmonary hypertension or severe cardiovascular problems. The protocol was com- parable to the one described in healthy individuals (part 1). However, because of the higher risk, all groups had prophylaxis (there was no control group without prophylaxis). Statistical Analysis Results were evaluated according to the analysis of variance (flu episodes and days of malaise), and a comparison (Mann-Whitney) non- parametric test was performed at the end of the study. An intention-to-treat analysis (ITTA) was performed considering the difference between the numbers of negative events (flu episodes plus the number of dropouts) in the different groups. RESULTS Part 1 All groups were comparable (Table 2) for age and sex distribution. Dropouts were determined by nonmedical causes, including failure to come to the control evaluation, failure to follow prescrip- tions or minor errors, and breaking of the prophy- laxis protocol. Episodes and Days of Flu or Malaise In the colostrum group (Table 3), the average number of flu episodes in 2 months was 0.335 (range, 0 to 3) and was significantly lower than the average in the vaccination group and in controls. In the colostrum group there was 25% of days of disease considering the total in the nonprophylaxis group (P < .05). The days of disease in the colostrum group were 30% of those recorded in the vaccination group (P < .05). The difference is clinically relevant and significant, even considering 133 Vax = vaccination; Col = colostrum; F/M = female/male. a. Initially 144 subjects were included, 137 completed the 3-month follow-up, and 7 dropouts were determined by nonmedical causes. b. The mean ages and SD are shown in parenthesis. TABLE 3. Evaluation of Parameters Modified by Prophylaxis in the Four Groupsa a. Data are shown as mean values and ranges, corresponding to days of malaise. b. Vaccination plus treatment plus lost days. c. Intention-to-treat analysis (ITTA): the total number of event subjects (patients having at least one flu episode) is added to dropouts (total). This number is divided by the included subjects, and dropouts are therefore considered as events. Events in the vaccination and control groups were 1.44 times higher than in the colostrum group. The difference is statistically significant (P < .05). the total of 3 months of observation (P < .05) including 1 month without colostrum. The total number of days of disease was 3 times larger in untreated controls and in subjects who had been treated with vaccination. The group treated with vaccination and colostrum had results strictly comparable with the results observed in the group receiving only colostrum. The relative costs were significantly lower in the 2 colostrum groups (P < .05) than in the others groups and were comparable in the 2 colostrum groups. The total number of episodes (days of malaise) in the colostrum group was 13 versus 14 in the colostrum + vaccination group: 41 in the group without prophylaxis and 57 in the vaccination group, which is significantly higher (P < .05) than in the 2 colostrum groups. The higher number of episodes may suggest that vaccination itself may induce a number of days with malaise in some individuals. The difference in the incidence of events asso- ciated with flu, plus the dropouts in each group, between colostrum subjects and controls was 4.2 (178/41.4); the incidence of events in nontreated controls was therefore 4.2 times higher (P < .05). The difference in incidence in events between colostrum subjects and vaccination subjects was 3.9 (163.8/41.4); therefore, the incidence in events in vaccination subjects was 3.9 times higher than the incidence in the colostrum subjects (P < .05). Intention-to-Treat Analysis The total number of event subjects (patients having at least 1 flu episode) is added to dropouts (total). This number is divided by the included sub- jects. The dropouts are therefore considered as events. Events in the vaccination and control groups were 1.44 times higher than in the colostrum group. The difference is statistically significant (P < .05). 134 TABLE 4. Details of High-Risk Study Subjects (Part 2)a ITTA = intention-to-treat analysis. a. Part 2 of study included very high-risk subjects (end-stage coronary patients, patients with pulmonary hypertension or severe car- diovascular problems). The protocol was comparable to the one described in healthy individuals (part 1). However due to the higher risk all groups had prophylaxis (there was no control group without prophylaxis). b. Data in parenthesis are the mean ages ± SD. c. P < .05. Part 2 The second part of the study (Table 4) included very-high-risk subjects (end-stage coronary patients, patients with pulmonary hypertension or severe car- diovascular problems). Of a group of 65, 60 completed the study: 21 were treated with colostrum, 20 with vaccination in association with colostrum, and 19 with vaccination only. The prophylaxis groups were clini- cally comparable for age and sex distribution. Events As summarized in Table 4, only 3 of 20 patients completing the study in the colostrum group had flu associated with an important bronchopulmonary complication. In the vaccination + colostrum group, 3 of the 20 patients completing the study also had cardiopulmonary problems. Finally, in the vaccina- tion group, 6 of 19 patients completing the study had severe flu with cardiopulmonary complications that resulted in 1 death. Hospital admissions in these groups are also summarized in Table 4. The incidence of complications and hospital admission (ITTA) was significantly higher (P < .05) in the group using only vaccination. Costs Costs evaluated during the study, mainly owing to the lost working days, were parallel to the occurrence of events. In the colostrum group, costs were very close to 30% of those observed in the noncolostrum groups. If we consider hospital admissions (not observed in the colostrum group, in part 1 of the study), partic- ularly bronchopulmonary complications that followed the flu episodes in elderly patients, the difference in costs becomes even higher considering that some of these episodes lasted well beyond the 3 months of observation. No hospital admission was recorded in the colostrum group and this observation, which should be verified by larger studies, is of particular interest. Tolerability No significant problems with tolerability or side effects were observed during the study. Compliance was very good (>88%), as only 12% of the tablets were not used or not correctly used. This finding is very useful considering that it is a prophylaxis and not a disease, which usually attains a higher level of compliance. DISCUSSION Vaccinations have generally produced a strik- ing improvement in public health, reducing mor- tality and morbidity through an improvement in specific immunity, by increasing awareness, and very often, just by a generic stimulation of immu- nity. However, variation in virulence, antigenic characteristics, and in protein content of several viruses, reflecting their adaptation to changing sit- uations, make the results of flu vaccination quite unpredictable. Several objections to the routine use of vacci- nation have been raised. Many subjects seem to have a limited benefit from vaccination, which is active in developing immunity, particularly in young subjects because their immune response is very effective. In elderly subjects, the immune response seems to be very limited, and therefore, vaccination in these subjects seems to have a minor effect and benefit.15 There is also the problem of 135 the type of virus used for prevention, which may be different from the one that actually causes disease in specific areas, populations, and times.6,16,17 The use of vaccination in subjects with severe immuno- logic and inflammatory disorders18 can be also questioned because most vaccines may not be safe, including those individuals with rheumatoid arthri- tis; concerns have also been raised about flu vacci- nation in pregnancy.19 The efficacy of flu vaccination and its cost- effectiveness is probably questionable because of the possible presence of unknown and known side effects.20,21 A relation between the incidence of intussusception associated with the first dose of vaccine in infants was recently shown.22 It is theo- retically possible that long-term effects may result from elements present in the vaccination material that are presently unknown, such as unknown viral fractions. Even though flu vaccination has the lowest incidence of side effects compared with other types of vaccination,20 complications may occur at a variable distance in time from the vac- cination; therefore, it is difficult to define and evaluate them carefully. The use of colostrum, on the contrary, is prac- tically free of side effects. Furthermore, the dosage used in this study is very low, corresponding to 400 mg of colostrum. Chronic diarrhea in HIV infection,11,12 diar- rhea caused by rotavirus infection in children,13 and upper respiratory infection in adults,14 have been treated successfully with a high con- centration of purified immunoglobulins from colostrum, which is necessary once an infection has already taken place. For prophylaxis, how- ever, a lower concentration of a multicomponent large-spectrum product such as colostrum can be sufficient. A very low concentration of insulin-like growth factor I,23 lactoferrin, and lactoperoxidase24 can be sufficient to determine protection as a nonspecific defense, and similarly, complement factors25 and oligosaccharides 26,27 can increase the body's capa- bility to produce passive immunity. A low concen- tration of colostrum has been found to increase the oxidative burst of leukocytes,28 and also low concentrations of transforming growth factor-β1, such as that present in colostrum, were able to reduce the gastric damage induced by indomethacin.29,30 Colostrums containing different quantities of immunoglobulins were found similarly active in the reduction of endotoxin burden in rats and the infil- tration of bacteria in mesenteric lymph nodes.31 Cytokines such as interleukin-1β (IL-1β), IL-6, tumor necrosis factor-α, and interferon-γ, which are pres- ent in colostrum,32 may stimulate production of neutralizing antibodies against hemagglutinin and neuramidase of the virus surface. All these observa- tions indicate that colostrum activity belongs to a combination of protective factors that may allow an antiviral prophylaxis. In many instances, flu starts from the intes- tinal tract, and protection in situ may be one of the advantages given by colostrum. Local activity in the gut may be the most important factor. However, rotavirus antibody were shown to survive during the passage through the gut, which may also determine systemic immunity.33 Very-high-risk subjects, including end-stage coronary patients, patients with pulmonary hypertension, and those and severe cardiovascular problems, usually have a very severe prognosis in case of flu, which almost always is associated with severe bronchopulmonary complications that often lead to hospital admission. The prevention in these patients is very important, but the effects of vaccination in these individuals seem to be of very low efficacy owing to the very reduced immune response.7 We conclude from our obser- vations that colostrum appears to offer a more effective protection. A larger study is now in progress. It could indicate that in severely ill subjects with poten- tially fatal risks from cardiovascular complications, colostrum may offer an important increase in resist- ance, whereas vaccination, considering both age and the relative decrease in immunologic resistance and activity of these subjects, may be really ineffective or only marginally useful. The efficacy of colostrum in these subjects may be even more important because they may have more complex and severe cardiores- piratory complications. A larger study could provide new data on the efficacy of colostrum as a preven- tive measure to limit the diffusion and effects of flu in high-risk cardiovascular patients. CONCLUSION The present study suggests a safe and cost- effective method—which still needs more evalua- tion in specific groups, particularly high-risk cardiovascular patients—that may be considered at least an important clinical alternative to vacci- nation. There is evidence that in some situations in which vaccination is contraindicated, the use of colostrum may be not only more effective but the only practical solution. 136 REFERENCES Couch RB Prevention and treatment of influenza. New Engl J Med. 2000;347:1778-1787. Hemingway CO, Poehling KA Change in recommendation affects influenza vaccination among children 6 to 59 months of age. Pediatrics. 2004;114:948-952. Thompson WW, Shay DK, Weintraub E., et al. Influenza-associated hospitalizations in the United States. JAMA. 2004; 15;292:1333-1340. Neuzil KM, Mellen BG, Wright PF, Mitchel EF, Griffin MR The effect of influenza on hospitalization, outpatient visits, and courses of antibiotics in children. 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<mods version="3.6"><titleInfo lang="en"><title>Prevention of Influenza Episodes With Colostrum Compared With Vaccination in Healthy and High-Risk Cardiovascular Subjects</title>
<subTitle>The Epidemiologic Study in San Valentino</subTitle>
</titleInfo>
<titleInfo type="alternative" lang="en" contentType="CDATA"><title>Prevention of Influenza Episodes With Colostrum Compared With Vaccination in Healthy and High-Risk Cardiovascular Subjects</title>
<subTitle>The Epidemiologic Study in San Valentino</subTitle>
</titleInfo>
<name type="personal"><namePart type="given">Maria Rosaria</namePart>
<namePart type="family">Cesarone</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Gianni</namePart>
<namePart type="family">Belcaro</namePart>
<namePart type="termsOfAddress">MD, PhD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy,</affiliation>
<affiliation>E-mail: cardres@abol.it</affiliation>
</name>
<name type="personal"><namePart type="given">Andrea</namePart>
<namePart type="family">Di Renzo</namePart>
<namePart type="termsOfAddress">BA</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Mark</namePart>
<namePart type="family">Dugall</namePart>
<namePart type="termsOfAddress">PhD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Marisa</namePart>
<namePart type="family">Cacchio</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Irma</namePart>
<namePart type="family">Ruffini</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Luciano</namePart>
<namePart type="family">Pellegrini</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>From San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Gilberto</namePart>
<namePart type="family">Del Boccio</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Filiberto</namePart>
<namePart type="family">Fano</namePart>
<namePart type="termsOfAddress">BA</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Andrea</namePart>
<namePart type="family">Ledda</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Angelica</namePart>
<namePart type="family">Bottari</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Andrea</namePart>
<namePart type="family">Ricci</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Stefano</namePart>
<namePart type="family">Stuard</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<name type="personal"><namePart type="given">Giulia</namePart>
<namePart type="family">Vinciguerra</namePart>
<namePart type="termsOfAddress">PhD</namePart>
<affiliation>San Valentino-Spoltore Vascular Screening Project, Department of Biomedical Sciences, G D'annunzio University, Chieti, Pescara, Italy</affiliation>
</name>
<typeOfResource>text</typeOfResource>
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<place><placeTerm type="text">Sage CA: Los Angeles, CA</placeTerm>
</place>
<dateIssued encoding="w3cdtf">2007-04</dateIssued>
<copyrightDate encoding="w3cdtf">2007</copyrightDate>
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<language><languageTerm type="code" authority="iso639-2b">eng</languageTerm>
<languageTerm type="code" authority="rfc3066">en</languageTerm>
</language>
<abstract lang="en">The efficacy of a 2-month treatment with oral colostrum in the prevention of flu episodes compared with antiinfluenza vaccination was evaluated. Groups included healthy subjects without prophylaxis and those receiving both vaccination and colostrum. After 3 months of follow-up, the number of days with flu was 3 times higher in the non-colostrum subjects. The colostrum group had 13 episodes versus 14 in the colostrum + vaccination group, 41 in the group without prophylaxis, and 57 in nontreated subjects. Part 2 of the study had a similar protocol with 65 very high-risk cardiovascular subjects, all of whom had prophylaxis. The incidence of complications and hospital admission was higher in the group that received only a vaccination compared with the colostrum groups. Colostrum, both in healthy subjects and high-risk cardiovascular patients, is at least 3 times more effective than vaccination to prevent flu and is very cost-effective.</abstract>
<subject><genre>keywords</genre>
<topic>influenza prevention</topic>
<topic>colostrum</topic>
<topic>vaccination</topic>
</subject>
<relatedItem type="host"><titleInfo><title>Clinical and Applied Thrombosis/Hemostasis</title>
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<identifier type="ISSN">1076-0296</identifier>
<identifier type="eISSN">1938-2723</identifier>
<identifier type="PublisherID">CAT</identifier>
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<part><date>2007</date>
<detail type="volume"><caption>vol.</caption>
<number>13</number>
</detail>
<detail type="issue"><caption>no.</caption>
<number>2</number>
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<extent unit="pages"><start>130</start>
<end>136</end>
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Prevention of Influenza Episodes With Colostrum Compared With Vaccination in Healthy and High-Risk Cardiovascular Subjects

Prevention of Influenza Episodes With Colostrum Compared With Vaccination in Healthy and High-Risk Cardiovascular Subjects

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