Professional Documents
Culture Documents
Influcid
Influcid
Sources: CDC: Common Colds, Update: February 27, 2015; WHO Fact sheet No 211, Revised March 2014; Fendrick A. Monot AS, Nightengale B et al. The economic burden of noni-nfluenza-related viral respiratory
tract infection in the US. Arch Intern Med. 2003;163:487-494
Uzroci prehlade i gripa..Virusi
• …su mali zarazni organizmi(20 - 300 nm).
„Imagine a pinhead!“
Generalno
• najčešće virusne infekcije utiču na gornji respiratorni trakt – one su
izazvane mnoštvom različitih virusa ( npr. Virus influenza, Rhinovirus i
Adenovirus)
Statistika
• Odrasle uhvati prehlada 2-4 puta godišnje
• Deca pate od preglade 6-12 puta godišnje.
Symptoms
Upper Respiratory Tract Infections (URTI)
Dijagnoza …
…najčešće zasnovano na simptomima!
Prehlada Grip
Spor početak bolesti Iznenadan, akutni početak simptoma
Blaga slabost (umor i nedostatak energije) Intenzivna slabost
Niska do umerene temperature (uglavnom oko 39 Visoka temperatura (preko 39 ºC), obično traje nekoliko dana
ºC)
Povremeno blage do umerene glavobolje Jake glavobolje
Blag do umeren bol u mišićima Jak bol u mišićima
Suv kašalj Kašalj sa bolovima u grudima i poteškoće u disanju
Upaljeno grlo Upaljeno grlo
Zapušen nos Zapušen nos
Crvene oči sa osećajem peckanja i povećana osetljivost na
svetlost
Upper Respiratory Tract Infections (URTI)
Prehlada / Grip (karakteristike)
Prehlada Grip
Slow onset of the disease Very sudden, acute onset of symptoms
Mild general malaise (tiredness and loss of energy) Intense malaise
Low to moderate fever (usually below 39 º Celsius) High fever (above 39 º Celsius), usually lasting for several days
Occasionally mild to moderate headache Heavy headache
Mild to moderate pain in limbs and muscles Intense pain in limbs and muscles
Dry cough Cough with chest pain and difficulty in breathing
Sore throat Sore throat
Runny or congested nose Runny or congested nose
Pink eye with burning sensation and light sensitivity
Upper Respiratory Tract Infections (URTI)
Najčešća terapija
© Pöllö
• antivirusni lekovi
© Politikaner
• amantadine and rimantadine
• oseltamivir and zanamivir
• godišnja vakcinacija
• imunomodulatorni lekovi
• simptomatska terapija
(e.g. antipiretici, antihistaminici, mucolitici, odmor, dosta tečnosti,
izbegavanje fizičkog napora“)
Upper Respiratory Tract Infections (URTI)
Profilaksa
• mere higijene,npr.Čišćenje ruku temeljno i redovno
• dijeta:zdrava,uravnotežna, bogata vitaminima i mineralima
• vežba: umeren i redovan trening
• Dodatni vrući i hladni tuševi, manje stresa, odmaranje
© Fotolia
Najbolja zaštita je jak imuni sistem!
Influcid® - na prvi pogled
Influcid® -
Influcid® kapi
Influcid tablete
250.0 mg
Drops - preparation formula
Active ingredients:
(per 100 g solution)
Aconitum D3 dil. 10.0 g
Bryonia D2 dil. 10.0 g
Eupatorium perfoliatum D1 dil. 10.0 g
Gelsemium D3 dil. 10.0 g
Ipecacuanha D3 dil. 10.0 g
Phosphorus D5 dil. 10.0 g
Excipients:
Ethanol 96 % (v/v) 2.2 g
Purified water 37.8 g
100.0 g
Key benefits of Influcid®
• Aconitum
• Bryonia
• Eupatorium perfoliatum
• Gelsemium
• Ipecacuanha
• Phosphorus
Influcid® - active ingredients
Activne supstance Terapijsko delovanje / karakteristike
Aconitum D3 - akutne,iznenadne bolesti
- simptomi nastaju nakon izlaganja suvom,hladnom vremenu i jakim
vetrovima
- visoka temperatura praćena nemirnošcu i velikom žeđi
Eupatorium perfoliatum D1 - violent aching in bones / limbs throughout the whole body and great
soreness of muscles
- useful in residual bone pain after a cold
d g a
an in form
in
Aconitum
Photos: © H. Zell
Aconitum
Botaničko ime:
Aconitum napellus (monkshood)
Početni materijal:
sveža biljka, prikupljena na početku
cvetanja
© H. Zell
Aconitum
Terapeutsko delovanje:
• simptomi se pojavljuju nakon izlaganja suvom,
hladnom vremenu i jakom vetru.
© H. Zell
© Magnus Manske
Bryonia Bryonia dioica
Botanical name:
Bryonia dioica (red bryony) and
Bryonia alba (white bryony) Photos: © H. Zell
Starting material:
fresh root harvested before flowering
Bryonia alba
Bryonia
Therapeutic action:
• symptoms develop slowly but forcibly
© H. Zell
© SB Johnny
Eupatorium perfoliatum
Botanical name:
Eupatorium perfoliatum (boneset)
Starting material:
fresh aerial parts collected at the start
of flowering
© H. Zell
Eupatorium perfoliatum
Therapeutic action:
• all conditions with distressing, violent aching
bones and great soreness of muscles
© H. Zell
Gelsemium
Botanical name:
Gelsemium sempervirens (yellow jasmine)
Starting material:
fresh underground parts
© H. Zell
Gelsemium
Therapeutic action:
• great bodily and mental prostration:
muscular weakness, tiredness, heaviness and soreness
mental prostration: apathic, dull, dizzy, drowsy, tired
• excessive trembling
© H. Zell
Botanical name:
Cephalis ipecacuanha (Ipecac root)
Therapeutic action:
• persistent nausea and vomiting
© BXXD / CC-by-sa
Phosphorus
Mineral:
Phosphorus (white phosphorus), P
Starting material:
white phosphorus © BXXD / CC-by-sa
Phosphorus
Therapeutic action:
• irritated, inflamed mucous membranes with
a burning sensation and blood-streaked
discharges
• Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
• Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
• Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
• Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
• Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
• Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
• Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
• Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
Studies on Influcid®
• Thinesse-Mallwitz M. et al. A homeopathic combination preparation in the treatment of feverish URTIs. (2015)
• Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
• Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
• Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
• Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
• Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
• Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
• Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
• Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
INFI ̶ INflucid® u lečenju infekcija gornjeg respiratornog trakta
* M. Thinesse-Mallwitz, V. Maydannik, T. Keller, P. Klement. A homeopathic combination preparation in the treatment of feverish upper respiratory tract infections:
An international, randomized, controlled trial. Forsch Komplementmed Vol. 22, Issue 3, June 2015.
Glavni kriterijumi uključivanja
• Starost od 1 do 65 godine
▪ umor
▪ slabost
▪ bol u telu
▪ za decu: razdražljiv/smanjena aktivnost
M. Thinesse-Mallwitz (2015)
Glavni kriterijum isključenja:
• Pozitivni brzi test za grupu A ß-hemolytic streptococci (GABHS)
• URTI complications, lower respiratory tract disease, other acute or chronic ENT disease,
obstructive anatomic lesions in the nasopharynx
• Hypersensitivity / present contraindications to any of the ingredients and/or excipients
of Influcid® or the defined symptomatic medication
• Tretman sa
• antibioticima, glukokortikosteroidima, imunomodulatorima, antihistaminicima
tokom prethodne 4 nedelje or at enrolment & during the trial
• Antivirusni lekovi
• any other cold medication for relief of URTI
during the past 7 days prior & during the trial
ENT = Ear-Nose-Throat
M. Thinesse-Mallwitz (2015)
Definition of symptomatic on-demand medication
M. Thinesse-Mallwitz (2015)
Treatment with Influcid® tablets
M. Thinesse-Mallwitz (2015)
Visit schedule
Baseline 1.Follow-up 2. Follow-up 1.Follow-up 2- Follow-up Termination
Visit Call Call Visit Visit Visit
Day 1 Day 2 Day 3 Day 41 Day 81 Day 152
M. Thinesse-Mallwitz (2015)
Wisconsin Upper Respiratory Symptom Survey (WURSS-21) *
M. Thinesse-Mallwitz (2015)
Main secondary outcome criteria:
• Effectiveness assessment based on:
• Course of disease
[WURSS-21 symptom score, WURSS-21 quality of life score, WURSS-21 total score]
• Time to symptoms alleviation
[WURSS-21, item 1]
• Change in the ability to perform normal daily activities
• Use of symptomatic medication
• Outcome of treatment
[IMOS – Integrative Medicine Outcome Scale]
• Satisfaction with treatment
[IMPSS – Integrative Medicine Patient Satisfaction Scale]
M. Thinesse-Mallwitz (2015)
533 patients
screened
517 patients
intention-to-treat population
261 patients
256 patients
symptomatic treatment
symptomatic treatment only
+ Influcid®
M. Thinesse-Mallwitz (2015)
Patient characteristics (1/2):
+ values are means unless otherwise mentioned; * percentages were rounded to the nearest integer IFC = Influcid® plus on-demand symptomatic treatment
ST = on-demand symptomatic treatment
M. Thinesse-Mallwitz (2015)
Patient characteristics (2/2):
+ values are means unless otherwise mentioned; * percentages were rounded to the nearest integer; IFC = Influcid® plus on-demand symptomatic treatment
$ assessed in children below 12 years og age only; SD – standard deviation; ST = on-demand symptomatic treatment
2. Kriterijum reakcije
Odsustvo ili vrlo blagi simptomi 2-Test: p=0.0012
17.0 % 7.5 %
WURSS-21 stavka 1: „Koliko se bolesno osećate danas?“ (44 od 259 pacijenata) (19 od 252 pacijenta)
95% CI: 3.44-15.46%
= „0“ (nisam bolestan) ili „1“ (vrlo malo) 2puta za redom)
p < 0.0001
on Day 5 – Day 9
----- vertical solid lines: Confidence intervals’ ranges; ◊ diamonds: Differences point estimates
- - - horizontal dashed line: Zero reference line indicating “no difference”
M. Thinesse-Mallwitz (2015)
Course of disease: WURSS-21
`Symptom` Sum Score
M. Thinesse-Mallwitz (2015)
Course of disease: WURSS-21
`Quality of Life` Sum Score
M. Thinesse-Mallwitz (2015)
Course of disease: WURSS-21
`Total` Sum Score
All in all, the Influcid® group (IFC) showed a significant faster alleviation of
URTI-associated complaints* compared to the standard therapy group (ST).
(* WURSS-21 Symptom Sum Score and WURSS-21 Quality of Life Sum Score)
M. Thinesse-Mallwitz (2015)
“Absence or very mild degree of URTI-symptoms” (WURSS-21, item 1) *
comparing both treatment groups
chart displaying cumulated percentages of patients with symptoms alleviation (WURSS-21, item 1) by study day * “Absence or very mild degree of
including polynomial fit curves [length of green line: difference [days] between polynomial fit curves at 50% level]
– intention-to- treat (ITT) analysis (n=451)
URTI-symptoms” was defined as
WURSS-21 item 1 “How sick do you
feel today?” graded as 0 (“not sick”)
ST group
Patients who were additionally treated with Influcid® showed symptom alleviation
(i.e. absence or very mild symptoms) about 1-2 days earlier
compared to patients in the ST group.
M. Thinesse-Mallwitz (2015)
Change in the ability to perform normal daily activities
chart displaying cumulated number (%) of patients resuming normal daily activities during the study period – intention-to- treat (ITT) analysis (n=405)
p < 0.0001
1st Follow-up Visit
M. Thinesse-Mallwitz (2015)
Cumulated dosages of symptomatic medication
bar charts displaying cumulated dosages (Day1 – Day 14) of symptomatic medication – intention-to- treat (ITT) analysis (n=511)
p < 0.0001
M. Thinesse-Mallwitz (2015)
Outcome of treatment (IMOS) – measured at the termination visit
bar charts displaying absolute frequencies of patients by IMOS-scale categories at termination visit (n=502) by study group – intention-to- treat (ITT) analysis
p = 0.0003 p = 0.006
p < 0.0001
ST group (control)
very satisfied: 34.1% of 256 patients
Satisfaction with treatment was much higher in the Influcid® group (IFC).
The percentage of patients being ”dissatisfied“ with treatment was low and comparable
between the ST group and the IFC group (1.6% ST and 1.2% IFC respectively).
M. Thinesse-Mallwitz (2015)
Tolerability of treatment – measured at the termination visit
bar chart displaying absolute frequencies for tolerability of treatment assessments at termination visit by study group – intention-to- treat (ITT) analysis
M. Thinesse-Mallwitz (2015)
Adverse events (AEs)
85 AEs occurred in 64 patients
All AEs were non-serious!
(64/523; 12.2 % of all patients)
M. Thinesse-Mallwitz (2015)
Summary of Results
M. Thinesse-Mallwitz (2015)
Conclusions
M. Thinesse-Mallwitz (2015)
Studies on Influcid®
• Thinesse-Mallwitz M. et al. A homeopathic combination preparation in the treatment of feverish URTIs. (2015)
• Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
• Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
• Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
• Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
• Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
• Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
• Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
• Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
INFI – subgroup analysis (children aged 1 to <12 years)*
Methods:
The methods of the INFI-subgroup analysis are the same as in the complete
INFI-study.
is
ATA alys
D an s
p ar
W u ye )
R. Van Haselen (2016)
NE ubgro <12 2016
s n d
F I – ildre ishe
IN ch publ
(
RESULTS
is
ATA alys
D an s
p ar
W u ye )
R. Van Haselen (2016)
NE ubgro <12 2016
s n d
F I – ildre ishe
IN ch publ
(
523 patients (1 - 65 years)
Study population randomized into the complete INFI-study
INFI subgroup
analysis
264 patients (<12 years) UA: 163 patients
randomized DE: 101 patients
Stratification by age
261 patients (<12 years) - 59 children <3 years
intention-to-treat population - 99 children 3 to <6 years
- 103 children 6 to <12 years
Starting with two days after inclusion into the study, significantly higher proportions
of children treated with Influcid® were free of fever.
is
ATA alys
(p-value ranging between 0.0249 and <0.0001; 2-test ) D an s
p ar
W u ye )
R. Van Haselen (2016)
NE ubgro <12 2016
s n d
F I – ildre ishe
IN ch publ
(
“Absence or very mild degree of URTI-symptoms” (WURSS-21, item 1) *
comparing both treatment groups
* “Absence or very mild degree of
chart displaying cumulated percentages of children with symptoms alleviation (WURSS-21, item 1) by study day URTI-symptoms” was defined as
including polynomial fit curves [length of green line: difference [days] between polynomial fit curves at 50% level]
– intention-to- treat (ITT) analysis (n=231) WURSS-21 item 1 “How sick do you
feel today?” graded as 0 (“not sick”)
or 1 (“very mildly”) for both assessments
IFC group Day 6
----- vertical solid lines: Confidence intervals’ ranges; ◊ diamonds: Differences point estimates
- - - horizontal dashed line: Zero reference line indicating “no difference”
Hodges Lehmann
IFC ST MWU-test
Additional complaints estimates
(n=130) (n=131) p-value
[Shift days (CL)]
is
ATA alys
D an s
p ar
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R. Van Haselen (2016)
NE ubgro <12 2016
s n d
F I – ildre ishe
IN ch publ
(
Change in the ability to perform normal daily activities
chart displaying cumulated number (%) of children resuming normal daily activities during the study period – intention-to- treat (ITT) analysis (n=261)
40
is
ATA alys
D an s
p ar
W u ye )
R. Van Haselen (2016)
NE ubgro <12 2016
s n d
F I – ildre ishe
IN ch publ
(
Severity of disease
(severity of symptoms / health-related quality of life (QoL))
table displaying AUCs for WURSS “Symptom sum score”, “QoL sum score” and “Total sum score” (n=254) – intention-to- treat (ITT) analysis
IFC ST
n (%) n (%)
Total patients
129 (100.0%) 131 (100.0%)
with valid diary data
MWU-test
Patients with SM use 117 (90.7% ) 129 (98.5% ) p=0.0055
IFC = Influcid® plus on-demand symptomatic treatment; ST = on-demand symptomatic treatment
p=0.0723 IFC ST
1000
400
p<0.0001
(MWU-test)
200
0
Paracetamol [mg] Ambroxol [mg] Oxymetazoline
[μg]
table displaying duration of symptomatic medication use based on diary records (n=260) – intention-to- treat (ITT) analysis
p=0.0021 p=0.0018
(2-test) (2-test)
Satisfaction with treatment was much higher in the Influcid® group (IFC).
The percentage of children being ”dissatisfied“ with treatment was low and comparable
between the ST group and the IFC group (2.4% ST vs. 1.6% IFC).
is
ATA alys
D an s
p ar
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R. Van Haselen (2016)
NE ubgro <12 2016
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(
Tolerability of treatment – assessed at the termination visit
bar charts displaying absolute frequencies for tolerability of treatment assessed at the termination visit by study group – intention-to- treat (ITT) analysis
2 AEs in 2 children (2/131; 1.5%) were 4 AEs in 3 children (3/133; 2,3%) were
classified as adverse drug reactions (ADRs) classified as adverse drug reactions (ADRs)
1 ADR in 1 child (0.8%) 1 ADR in 1 child (0.8%) 2 ADRs in 1 child (0.8%) 2 ADRs in 2 children (1.6%)
was possibly related was unlikely related were possibly related were unlikely related
to Influcid® treatment: to Influcid® treatment: to symptomatic treatment: to symptomatic treatment:
is
• Vomiting • Bronchitis • Diarrhoea • Diarrhoea
ATA alys
• Rash • Otitis media D an s
p ar
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R. Van Haselen (2016)
NE ubgro <12 2016
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Summary of results
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R. Van Haselen (2016)
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Conclusion
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D an s
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R. Van Haselen (2016)
NE ubgro <12 2016
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Studies on Influcid®
• Thinesse-Mallwitz M. et al. A homeopathic combination preparation in the treatment of feverish URTIs. (2015)
• Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
• Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
• Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
• Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
• Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
• Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
• Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
• Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
Upper respiratory infections and feverish colds – effectiveness and
safety of Nisylen® tablets (syn. Eupatorium complex®, Nisyleen®,
Influcid®, Alpha CF®). *
* Heger, M., Blochin, B., Tschutschalin, A., Netjaschenko, V., Majdaschik, V. NI001. Nisylen® 001 – International outcome study (1997): Upper respiratory infections and
feverish colds – effectiveness and safety of Nisylen® tablets (syn. Eupatorium complex®, Nisyleen®, Influcid®, Alpha CF®). Deutsche Homöopathie-Union, Karlsruhe; 1997 [unpublished]
Patients:
600 patients (333 adults, 267 children ≤ 12 years)
Patient criteria:
• Adults and children of all ages and of both sexes
• Feverish flu-like diseases such as:
• Influenza
• Infections of the upper respiratory tract, e.g. pharyngitis, rhinopharyngitis,
laryngitis or laryngotracheitis
Heger (1997)
Treatment:
a) Children (< 12 years):
• initial dose: 1 tablets every 2 hours (max. 8 tablets a day)
• maintenance dose: 1 tablet 3 times a day
Heger (1997)
Control examinations:
• After 3, 5 and 9 days of treatment
• Symptoms were assessed by the physician at each visit
• Success of treatment and safety were rated by both, physician and patient
Heger (1997)
Primary outcome criterion:
• Change of total sum score of symptoms
=> the scoring system based on fever (rated on a 3-point scale)
and 7 leading symptoms (rated on a 5-point scale):
• Coryza
• Cough
• Headache
• Hoarseness
• Malaise (general tiredness and loss of energy)
• Pain in the limbs
• Sore throat
Heger (1997)
Secondary outcome criterion:
• Safety of Influcid®:
• tolerability
• adverse events
• adverse drug reactions
Heger (1997)
RESULTS
Heger (1997)
Patient characteristics:
• gender: male 45 %, female 55 %
• almost half of the patients (44.5%) were children up to 12 years
• mean age: 24 ± 19 years (range: 1 - 78 years)
• diagnoses:
• 56 % flu-like infections
• 44 % upper respiratory tract infections
• patients with intake of concomitant medication: 3 % (18/600 patients)
Heger (1997)
Change of total sum score of symptoms:
p < 0.0001
Heger (1997)
Flowchart: adverse events
600 patients
included into the study
13 patients
with a reported adverse event
(14 AE)
2 patients
with a reported Influcid®-related
adverse event
11 patients
with a reported adverse event
with no relationship to the intake of Influcid ®
587 patients
without an adverse event
Heger (1997)
Safety (i.e. appearance of adverse drug reactions):
99.7 %
(598/600) Patients without an Influcid®-related adverse event
0.3 %
(2/600) Patients with a probable Influcid®-related adverse event
Heger (1997)
Tolerability:
Influcid® was well tolerated – both physicians and patients are almost congruent
in their personal rating.
Heger (1997)
Conclusions:
Heger (1997)
Studies on Influcid®
• Thinesse-Mallwitz M. et al. A homeopathic combination preparation in the treatment of feverish URTIs. (2015)
• Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
• Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
• Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
• Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
• Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
• Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
• Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
• Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
[Clinical-pathogenetic mechanisms of the action of the drug
Influcid® in acute respiratory viral infections in children.] *
* Sitnikov, I.G., Moryakova, N.V. [Clinical-pathogenetic mechanisms of the action of the drug Influcid in acute respiratory viral infections in children.]
Infektsionnye Bolezni 2010; 8 (1): 44-47. Russian.
Patients: 86 patients (aged 3 - 6 years)
Sitnikov (2010)
Outcome criteria:
• Clinical assessment
• Duration of clinical symptoms in study group versus reference group
• Decrease in the severity of all clinical symptoms
• Lab investigations
• Analysis of the dynamics of biochemical parameters
(Influence of Influcid® on catecholamines and biogenic amines as
inflammation mediators.)
Sitnikov (2010)
RESULTS
Sitnikov (2010)
Patient characteristics:
• Diagnoses (n=86):
• 25.6 % influenza
• 42.0 % adenovirus infections identical frequencies
in both groups
• 32.4 % parainfluenza virus infections
• Severity of symptoms:
no significant
• Study group (n=50): 36 moderate (72 %), 14 severe (28 %) difference
• Reference group (n=36): 26 moderate (72.2 %), 10 severe (27.8 %) between groups
Sitnikov (2010)
Duration of clinical symptoms:
The study group also showed a smoother course of disease compared to the reference group
– while in the reference group 3 children developed bronchitis, none of the children in the study group did so.
Sitnikov (2010)
Decrease in the severity of all clinical symptoms:
Sitnikov (2010)
Analysis of the dynamics of biochemical parameters:
during treatment
Parameter before treatment Study group Reference group Normal
(healthy children)
(n = 50) (n = 36)
Adrenaline [mmol/l] 22.4 ± 2.2 ** 7.22 ± 0.9 4.09 ± 0.4 * 5.74 ± 0.7
Noradrenaline [mmol/l] 17.3 ± 3.4 * 8.21 ± 1.3 10.43 ± 2.3 * 7.64 ± 1.1
Serotonin [µmol/l] 0.86 ± 0.11 ** 0.55 ± 0.12 0.62 ± 0.08 * 0.51 ± 0.09
Histamine [µmol/l] 0.98 ± 0.09 ** 0.64 ± 0.11 0.79 ± 0.09 * 0.62 ± 0.12
Differences significant compared to physiological normal values at *p < 0.05 and **p < 0.01
• In the acute phase of illness, elevated biochemical blood parameters were detected in all children.
• During treatment, a decrease of the elevated parameters was seen in both groups, whereas a reduction
to normal values was only detected in the study group.
Sitnikov (2010)
Conclusions:
Influcid® demonstrated a high effectiveness with a significant (p < 0.05)
reduction in the duration of clinical symptoms.
Sitnikov (2010)
Studies on Influcid®
• Thinesse-Mallwitz M. et al. A homeopathic combination preparation in the treatment of feverish URTIs. (2015)
• Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
• Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
• Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
• Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
• Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
• Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
• Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
• Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
[Feverish colds: successful treatment with a homeopathic complex
medicine.] *
* Flaskamp, G., Galuska, S. [Feverish colds: successful treatment with a homeopathic complex medicine.] Der Kassenarzt 1992; (49): 42-50. German.
Patients:
94 patients (5 - 92 years)
Patient criteria:
• Adults and children of all ages and both sexes
• Feverish flu-like diseases
Flaskamp (1992)
Treatment:
• Pharmaceutical form: Influcid® drops
• Dosage: depending on the experience / recommendation of the physician
Flaskamp (1992)
Outcome criteria:
• Duration of symptoms / treatment
• Effectiveness
• Safety
Flaskamp (1992)
RESULTS
Flaskamp (1992)
Patient characteristics:
• Patients: 40.4 % male (n=38), 58.5 % female (n=55), unknown (n=1)
• Mean patient age: 37 ± 18 years
• Mean duration of symptoms before start of treatment: 4 ± 8 days
• Treatment: 90.4 % Influcid® only
9.6 % Influcid® plus concomitant medication (antitussive
agents, expectorants, nasal preparations)
Flaskamp (1992)
Dosage of Influcid®:
a) small doses frequently and regularly n=39
• initial dose: 10 drops / h (max. 12 times a day)
• maintenance dose: 10-20 drops, 3-4 times a day
b) less frequently
• fixed scheme: 20-30 drops, 3-4 times a day or n=28
5-15 drops, 3-8 times a day n=16
Flaskamp (1992)
Duration of symptoms / treatment:
p = 0.02
Starting treatment with Influcid® with the first symptoms and in the appropriate dose
reduces duration of symptoms / treatment by half.
Flaskamp (1992)
Effectiveness:
• Effectiveness rated by the physician at the end of treatment:
[rated on a 6-point scale: from very good to little effective]
In > 90 % of patients the effectiveness was rated „very good“ or „good“ by their physicians.
Flaskamp (1992)
Safety:
None of the 94 patients experienced any adverse drug reaction.
Flaskamp (1992)
Conclusions:
Effective
> 50 % of patients were free of symptoms within one week.
In > 90 % of patients the effectiveness / success of treatment was rated
„very good“ or „good“ by their physicians.
Success by frequency
Initially frequent intake is essential for successful treatment.
Flaskamp (1992)
Studies on Influcid®
• Thinesse-Mallwitz M. et al. A homeopathic combination preparation in the treatment of feverish URTIs. (2015)
• Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
• Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
• Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
• Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
• Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
• Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
• Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
• Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
In-vitro and in-vivo experiments on Influcid® *, **
* Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections (ARVI)]. Pharmaceutical bulletin 2003; No.33 (312). Russian.
** Garashchenko, T.I., Garashchenko, M.V., Mezentseva, M.V. [ Clinical and immunological rationale of administration homeopathic medicines for prevention and treatment of Influenza
and acute respiratory viral infections (ARVI).] Russian Medical Journal 2005; 13 (21): 1432-1437. Russian.
Methods:
a) in-vitro:
Influcid® drops (in different concentrations) were added to MDCK* cell cultures 24 h before
(„preventive“) and 24 h after („treatment“) inoculation with influenza virus A/Aichi 1/68 (H3N2);
3 days later viral titre was assessed by hemagglutination reaction
b) in-vivo:
Influcid® drops (in different concentrations) were injected intraperitoneally at dose of 0.1 ml /
outbred white mouse;
titres of interferon [U/ml] were assessed in blood samples taken 24 h and 48 h after
administration of Influcid®
* MDCK = Madin-Darby Canine Kidney
Study medicine Viral titre [lg HA U/ml] depending on concentration of study medicine
Influcid® N 1 (0.75 mg/ml) N 2 (0.075 mg/ml)
„preventive“
24 h before inoculation 0.2 ± 0.1 5.5 ± 0.6
• Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
• Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
• Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
• Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
• Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
• Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
• Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
• Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
[Activity of the preparation „Influcid” with respect to flu viruses
in model systems.] *
* Eropkin, M.Y., Prigoreva, V.A., Gudkova, T.M., Konovapova, N.I., Pobova, T.G., Baibus, D.M. et.al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.]
Medline-Express 2007; 194 (6): 3-6 Russian.
Methods (in-vitro):
Pharmaceutical form used: Influcid® drops
Infecting a day-old culture of MDCK* cells with flu viruses (30-min contact)
72 h incubation in CO2-incubator
Eropkin (2007)
Methods (in-vivo):
Pharmaceutical form used: Influcid® drops
Infecting 4-week-old, common mice with two intranasal doses (LD50 and 0.1 LD50) of the flu virus strain A/Puerto Rico/8/34 (H1N1).
control group (n=10): experimental group (n=10): control group (n=10): experimental group (n=10):
no treatment 50 µl Influcid® (diluted 25-fold by no treatment 50 µl Influcid® (diluted 25-fold by
physiological solution) physiological solution)
administered perorally administered perorally
once a day once a day
(~ corresponds to the daily dose (~ corresponds to the daily dose
in intensive treatment, in intensive treatment,
taking into account taking into account
the ratio of average weight of the ratio of average weight of
man and mouse) man and mouse)
Eropkin (2007)
Outcome criteria:
• Decrease of viral titre of different strains of flu viruses (in-vitro)
• Survival of flu virus-infected mice as an indicator for protective
effect of Influcid® (in-vivo)
Eropkin (2007)
RESULTS
Eropkin (2007)
Anti-viral activity of Influcid® (in-vitro):
Eropkin (2007)
Protective Effect of Influcid® (in-vivo):
Fig. 1. Fig. 2.
Eropkin (2007)
Studies on Influcid®
• Thinesse-Mallwitz M. et al. A homeopathic combination preparation in the treatment of feverish URTIs. (2015)
• Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
• Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
• Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
• Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
• Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
• Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
• Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
• Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
[Effect of Influcid in-vitro against the pandemic strain 2009
A (H1N1) „swine“ („Mexican“) flu.] *
* Eropkin, M.Y., Konovalova, N.I., Grigoreva, V.A., Baibus, D.M., Gudkova, T.M. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) „swine“ („Mexican“) flu.]
Tradizionnaja medizina 2009; 18 (3): 8-12. Russian.
Methods:
MDCK-cell culture plates were infected with a dilution of original virus-
containing allantoic liquid (“swine flu” A/California/07/09 (H1N1)).
Influcid® drops (in two different concentrations*) were added to the cell culture:
a) 1 h before infection with the virus (“prophylactic” plan) and
b) 1 h after infection with the virus (“treatment” plan)
Eropkin (2009)
Outcome criteria:
• Decrease of virus titre in the experiment compared to control (∆lgTID 50)
(=> interpreted as the anti-viral effect of Influcid®)
• Cell regeneration / viability of cells in culture (microtetrazol-test, MTT)
(=> interpreted as the degree of cellular resistance to viruses)
Eropkin (2009)
RESULTS
Eropkin (2009)
Anti-viral effect of Influcid® (in-vitro):
* pandemic virus A (H1N1), virus of „swine“ or „Mexican“ flu, causing a flu pandemic developing since April 2009
Eropkin (2009)
Cell regeneration / viability of cells in culture (MTT):
“prophylactic” “treatment”
plan plan
Fig. 1. Fig. 2.
Eropkin (2009)
Conclusions:
Eropkin (2009)
Studies on Influcid®
• Thinesse-Mallwitz M. et al. A homeopathic combination preparation in the treatment of feverish URTIs. (2015)
• Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
• Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
• Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
• Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
• Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
• Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
• Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
• Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
[The 2009 influenza epidemic in Russia: its origin, the
antigenic and biological properties of the virus and its sensitivity to
anti-viral agents.] *
* Eropkin, M.Y., Gudkova T.M., Danilenko, D.M., Konovalova, V.A., Grigor´eva, T.S., Smirnova, A.V. et. al. [The 2009 influenza epidemic in Russia: its origin, the antigenic
and biological properties of the virus and its sensitivity to anti-viral agents.] RMJ 2010; 18 (3): 1-6. Russian
Methods:
The same as mentioned in the previous study (Eropkin 2009).
Outcome criterion:
• Decrease of virus titre in the experiment compared to control (∆lgTID50)
(=> interpreted as the anti-viral effect of Influcid®)
Eropkin (2010)
RESULTS
Eropkin (2010)
Anti-viral effect of Influcid® (in-vitro):
Note:
An anti-viral effect is considered good,
if ∆lgID50 ≥ 2.0.
Virus type
Influcid® Pandemic influenza Pandemic influenza
concentration in Herpes type I Herpes type II Adenovirus type III virus virus
culture medium [%] HSV/SPb/248/88 HSV2/reference/2000 Ad3/reference/4120 A/California/07/09 A/St. Petersburg/05-09
(H1N1)v (H1N1)v
Influcid® showed a significant inhibition of virus replication for various types of viruses
(e.g. influenza viruses, herpes I and II and adenovirus type III).
Eropkin (2010)
Conclusions:
Eropkin (2010)
How to use Influcid®
(Posology)
How to take: general recommendations (1/2)
• Success by frequency
Achieve optimum effectiveness by taking Influcid® frequently and
regularly and in the appropriate dose.
How to take: general recommendations (2/2)
• An interval of approximately 30 minutes should be kept between
the intake of Influcid® and eating or drinking.
• Influcid® drops should be kept a little bit in the mouth before swallowing.
Treatment Prevention
Note:
every 1 - 2 hours
3 times a day
until improvement occurs
1 tablet ~ 10 drops
3 times a day
until recovery
Initial dose:
1 tablet every 2 hours max. 8 times a day
until improvement occurs 1 tablet
Children* 1 - 11 years
3 times a day
Subsequent dose:
1 tablet 3 times a day
Initial dose:
1 tablet (or 10 drops*) every hour
Children 12 years max. 12 times a day until improvement 1 - 2 tablets (or 10 - 20 drops*)
and adults occurs 3 times a day
Subsequent dose:
1 - 2 tablets (or 10 - 20 drops*) 3 times a day
* Influcid® should not be used in children under 1 year of age, since its use is not sufficiently documented in this age group.
** Influcid® drops contain 46 vol % alcohol, thus patients who suffer from alcoholism or high risk groups (patients with liver disease or epilepsy) should consider the alcohol content before taking them.
The same applies to children < 12 years.
1) Thinesse-Mallwitz (2015); 2) Van Haselen (2016); 3) Heger (1997); 4) Sitnikov (2010); 5) Flaskamp (1992); 6) Yershov (2003); 7) Garashchenko (2005); 8) Eropkin (2007); 9) Eropkin (2009); 10) Eropkin (2010);
Gentle
1) Thinesse-Mallwitz (2015); 2) Van Haselen (2016); 3) Heger (1997); 4) Sitnikov (2010); 5) Flaskamp (1992);
Balanced
1) Eropkin (2009); 2) Yershov (2003); 3) Garashchenko (2005); 4) Eropkin (2007); 5) Eropkin (2010);
References
1) Thinesse-Mallwitz M. et al. A homeopathic combination preparation in the treatment of feverish URTIs. (2015)
2) Van Haselen R et al. The effectiveness and safety of a homeopathic medicinal product in paediatric URTI […]
(2016)
4) Sitnikov, I.G. et al. [Clinical-pathogenetic mechanisms of the action of the drug Influcid […]. (2010)
5) Flaskamp, G. et al. [Feverish colds: successful treatment with a homeopathic complex medicine.]. (1992)
6) Yershov, F. [Proper pharmacotherapy of influenza and acute respiratory viral infections […]. (2003)
7) Garashchenko, T.I., et al. [Clinical and immunological rationale of administration homeopathic […]. (2005)
8) Eropkin, M.Y., et al. [Activity of the preparation „Influcid“ with respect to flu viruses in model systems.] (2007)
9) Eropkin, M.Y., et al. [Effect of Influcid in-vitro against the pandemic strain 2009 A (H1N1) […] (2009)
10) Eropkin, M.Y., et al. [The 2009 influenza epidemic in Russia […] (2010)
Overview of studies on Influcid®
* study group: on-demand standard symptomatic treatment (Paracetamol, Ambroxol, Oxymetazoline) + Influcid ®; control group: on-demand standard symptomatic treatment only
** study group: basic symptomatic treatment (e.g. antipyretics, mucolytics) + Influcid ®; control group: basic symptomatic treatment only
Contents
• Acute Upper Respiratory Tract Infections (URTI)
• Influcid® - at one Glance
• Influcid® - Ingredients and their Action
• Influcid® - Scientific Data
• How to use Influcid® (Posology)
• Influcid® - most important Facts
• Frequently Asked Questions (FAQ)
Frequently Asked
Questions (FAQ)
Does Influcid® attack viruses? How does it work?