Pruzon Satın Al Pruzon Müşteri Hizmetleri

Kalamin Calamine USA

Ateş Karıncasının Mitigator iğnesi ve ısırma tedavisiyle olan tedavisi- Randomize Kontrol Çalışması

Amaç-  ticari olarak mevcut olan bir ürünün ateş karıncası ısırmasından sonra ağrıyı azaltmak için Mitigator iğnesi ve ısırma tedavisiyle etkinliğini değerlendirmek.

Yöntem-Yirmi dört gönüllü hususlar her iki ateş karınca sokmalarına maruz bırakıldı. Hususlar 1 kolda Mitigator macunu ve diğer kolda kalamin losyonuna maruz kaldılar.  Konular 100 mm vizüel analog skalasında 60 saniye, 20 dakika ve 3 gün maruz kaldıktan sonra bir ağrı kaydedildi. A 2-tailed eşleştirilmiş t testi Mitigatorla tedavi edilen kolla kalamin losyonuyla tedavi edilen kol arasındaki farkı karşılaştırmak için kullanılandı.

Sebepler – 60cı saniyede Mitigator grubunun ortalama görsel analog ağrı skoru 23.9 ve kalamin grubu 24.5 tu. 20ci dakikada Mitigator grubunun puan ortalama skoru 7.6mm idi. 3cü günde, Mitigator grubunun puan ortalamaları ve 2,4 mm ve kalamin grubu için 2,9 mm idi. 60cı saniyede, 20ci dakikada ve ya 3cü günde ortalama analog skorunda hiç bir önemli bir değişiklik olmadı.

Sonuçlar-  ateş karıncasının ağrısının azaltılmasında kalamin ve Mitigator arasında hiç bir önemli bir değişiklik olmadı

 

Giriş

Ateş karıncaları orta-güney ve güneydoğu Birleşik Devletleri boyunca dağıtılmıştır. Ateş karıncasının yılda 1 milyondan çok kişini ısırdığı tahmin ediliyor ve bu ısırmalarla alakalı onbinlerce insan alerji ve infeksiyonlu komplikasyonlarla ilgili tedavi aramaktadır. Isırmaların şiddeti hafif, yerel püstül formasyonundan anafilaksin nadir durumlarına kadar değişebilir. Lokal enflamatuar yanıtı tipikdir ve ve geçici zayıflatmaya neden olabilir. Çok olduğu zaman alerjik ve ya infeksiyoz komplikasyonlar hayati ciddi durumlar yarata bilir.

Yöntemler

Bu çalışma rastgele bir çalışma olmuştur, ateş karıncasının tedavisi için tek denemelik kalamin losyonu vs Mitigator Walgreeens dükkânından alınmıştır. Topikal olarak uygulandığında Mitigator güvenli ve toksinsiz olarak kabul ediliyor. İçeriği su, ceviz kabukları, balmumu NF, pentaerythrityl tetracappryate, izopropil palmitat, ceterearyl alkol, polisorbat 60, sodyum bikarbonat, papain, denatüre alkol, sodyum hidroksit, metilparaben, propilparaben, emülsifiye edici ve fenoksietanol. Bu yazı zamanında Mitigatorun onsı yaklaşık $6 değerinde, kalamin losyonunun ise 6 onsı $2.79 değerindedir. Kurumsal gözden geçirme kurulu onayı çalışmaya başlamadan önce elde edilmiş ve yazılı bilgilendirilmiş onam tüm deneklerden alınmıştır. Gönüllü hususlar halk içinde yayınlanmış teşhir bültenleri kullanılarak alındı. Çalışmaya ilgi gösteren kişiler bir günlük görüşmede hep beraber bir araya geldiler. Denemenin amacını ve tasarımını duyduktan sonra katılmak için istekli olanlara bir sağlık tarama anketi verildi. Tüm kadınlardan denekler katılımı önce idrarda gebelik testi istendi. Aşağıdaki ölçütlere uygun bulunanlar kabul edildiler ve kayıt oldular 18-50 yaş arası ateş karıncası ısırmadan önce, ciddi bir tıbbi durumu olmayanlar, böcek ısırmalarına daha önce alerjisi olmayanlar, astım ve ya diğer reaktif havayolu hastalıkları olmayanlar ve cevize karşı alerjisi olmayanlar. Ayrıca, katılmak isteyenler 3 gün sonra bir takip oturumuna katılacaklarını sağlamak zorundaydılar. Hamile olanlar veya düzenli oral kortikosteroid, anti-inflamatuar ajan, veya antihistaminik kullananlar konu dışı bırakıldı. Yirmi dört kayıtlı hususlar (7 [% 28] kadın ve 17 [% 68] erkek) 10 canlı traş olmuş kol üstünde küçük bir kapda ateş karıncaları ısırmalarına maruz bırakıldı. Isırma 10 saniyelik oldu. Standart bir prosedur olarak karıncaları ısırdıktan sonra kaldırıldı. 1 dakikada tüm hususlara vücut bölgesi göstermek için ‘L’ (sol) ve ‘R’ (sağ) etiketli kart verildi. Kartlar uzunluğu 100 mm olan “en çok acı” ve “en az acı” etiketli görsel analog skalası içeriyordu. Hususlardan her kartta tedavi öncesi ağrı düzeyini gösteren görsel analog skalası çizmeleri istendi. Isırmalardan 90 saniye sonra Mitigator pastası kol üstünün zehirlenme bölgelerinin farklı yerlerine ve kalamin losyonunun 0,5 onsu alternatif kola uygulandı. Bu sürede hususların gözleri kapatıldı. Tedavi randomu tura ile belirlendi. Macun veya losyon kuvvetlice 2-3 dakika etkilenen bölgeye sürüldü, 10 dakika o şekilde kaldı ve daha sonra Mitigator için paket talimatlarına göre durulandı. 20 dakikada hususlardan tekrar ağrıyı derecelendirilmeleri istendi. Hususlar daha sonra görevden alındı ve bir sonraki 72 saat içinde ısırmaları istedikleri gibi tedavi etmelerine izin verildi. 72ci saatte hususlar takip için çalışma araştırmacılarının yanına döndüler ve kartların üçüncü setini tamamladılar. Yanıtlar kayd edildi ve statiksel analizler örnek için hazırlandı. Eşleştirilmiş t-testi ve Wilcoxon

 

Sonuçlar

Mitigator 8 kişide sol kolda ve 16 kişide sağ kolda yerleştirildi ve her bir kişide diğer kola kalamin losyonu uygulandı. Tedaviye hiçbir sistematik tepki olmadı. 60cı saniyede ya da 3cü günde gruplar arasında hiçbir fark görülmedi. Sadece 3 kişi ev tedavisine kayıt oldular 1ci gün ve 2 takip 2 kişi oral difenhidramin ve aspirin aldı

Netice

Mitigator ve kalamin losyonu tedavisi arasında ani veya gecikmeli ağrı gösterilebilir fark yoktu. Bu zehirlenmeler potansiyel hastalık kaynağı olarak kalıyor ve tedavisi için daha fazla araştırma gerekmektedir.

 

Wilderness and Environmental Medicine, 17, 21 25 (2006)

ORIGINAL RESEARCH

Treatment of Imported Fire Ant Stings With Mitigator

Sting and Bite Treatment—A Randomized Control Study

David C. Hile, MD; Troy P. Coon, MD; Carl G. Skinner, MD; Lisa M. Hile, MD; Phillip Levy, MD;

Manish M. Patel, MD; Michael A. Miller, MD

From Darnall Army Community Hospital, Fort Hood, TX (Drs Hile, Coon, Skinner, Levy, Hile, and Miller); Wayne State University–Detroit

Receiving Hospital, Detroit, MI (Dr Levy); and Emory University, Atlanta, GA (Dr Patel).

Objective.—To evaluate the efficacy of the commercially available product Mitigator Sting and

Bite Treatment in reducing the pain after imported fire ant stings.

Methods.—Twenty-four volunteer subjects were exposed to imported fire ant stings on both forearms.

The subjects received Mitigator paste on 1 arm and calamine lotion on the opposite arm, in a

blinded manner, from 90 seconds to 10 minutes after exposure. Subjects recorded pain on a 100-mm

visual analog scale 60 seconds, 20 minutes, and 3 days after exposure. A 2-tailed paired t test was

used to compare the difference in reduction of pain over time between the Mitigator-treated arms and

the calamine-treated arms.

Results.—At 60 seconds, the mean visual analog scale pain score was 23.9 mm for the Mitigator

group and 24.5 mm for the calamine group. At 20 minutes, the mean score was 7.6 mm (_ _ 16.3)

for the Mitigator group and 12.7 mm (_ _ 11.8) for the calamine group. At 3 days, the mean score

was 2.4 mm (_ _ 21.5) for the Mitigator group and 2.9 mm (_ _ 21.6) for the calamine group.

There was no significant difference between groups for change in visual analog scale pain score at

60 seconds, 20 minutes (P _ .256), or 3 days (P _ .64).

Conclusions.—There was no significant difference in pain relief between calamine and Mitigator

for imported fire ant stings.

Key words: imported fire ant, Hymenoptera, calamine lotion, insect bites and stings, therapeutic techniques

and equipment, pain management, analgesia, Mitigator

Introduction

Imported fire ants (IFAs) are widely distributed across

the south-central and southeastern United States, having

been introduced from their native habitat in sub-Amazonian

South America many decades ago. By far, the

most common and widely distributed species is Solenopsis

invicta, the red IFA. In recent years, red IFAs

have also been discovered in New Mexico, in California,

and on many Caribbean islands, as well as in Australia

and New Zealand.1

This abstract was presented at the annual conference of the Society

for Academic Emergency Medicine, May 22 to 25, 2005, in New York,

NY.

There was no funding in the production of the above manuscript.

Mitigator product was provided courtesy of Mr Pat Kennedy of

www.mitigator.net. We are not aware of any conflicts of interest.

Corresponding author: David Hile, MD, 2014 Lakefront Dr, Harker

Heights, TX 76548 (e-mail: hile_16@yahoo.com).

It is estimated that IFAs sting more than 1 million

people in the United States annually, and tens of thousands

of people will seek medical treatment for allergic

and infectious complications related to these stings.2 The

severity of the stings can range from mild, local pustule

formation to rare cases of anaphylaxis in predisposed

individuals.3,4 Development of a local inflammatory response

is typical and may result in temporary debilitation.

In the wilderness, allergic or infectious complications

may create a potentially life-threatening situation.

Efforts to diminish the duration and severity of symptoms

once a person has been stung have not yielded

positive results.5–7 Mitigator Sting and Bite Treatment

(American Natural Technology Sciences, Rogers, AR) is

a recently developed paste that targets the local inflammatory

reaction associated with IFA stings. Mitigator is

hypothesized to work by rendering the IFA venom ineffective,

possibly by protein denaturation. Although anecdotal

evidence of successful IFA treatment with Mit22

Hile et al

Sting technique.

igator exists, no randomized trials have been conducted.

This study was therefore designed to investigate the clinical

benefit of Mitigator through comparison with a common

standard therapy.

Methods

This study was designed as a randomized, single-blind

comparison trial of IFA sting treatment with Mitigator

vs calamine lotion purchased from a Walgreens store.

Mitigator is considered safe and nontoxic when applied

topically. The main ingredients are water, walnut shells,

emulsifying wax NF, pentaerythrityl tetracappryate, isopropyl

palmitate, ceterearyl alcohol, polysorbate 60, sodium

bicarbonate, papain, alcohol denatured, sodium hydroxide,

methylparaben, propylparaben, and phenoxyethanol.

At the time of this writing, Mitigator costs approximately

$6 for 1 ounce of scrub in comparison with

$2.79 for 6 ounces of calamine lotion. Institutional review

board approval was obtained before study initiation,

and written informed consent was obtained from

all subjects.

Volunteer subjects were recruited by using publicly

displayed bulletins. Individuals who expressed interest

in the study were gathered at a single-day event. After

hearing an explanation of the intent and design of the

trial, those who were willing to participate were given a

health-screening questionnaire. All female subjects were

required to take a urine pregnancy test before participation.

Subjects who met the following inclusion criteria

were consented and enrolled: age 18 to 50 years with

prior exposure to IFA stings, absence of a serious medical

condition, absence of previous IFA stings or allergic

reactions to insect bites or stings, absence of asthma or

other reactive airway diseases, and absence of a known

allergy to walnuts. In addition, those willing to participate

had to ensure ability to attend a follow-up session

3 days later. Subjects who were pregnant or were regularly

using oral corticosteroids, anti-inflammatory

agents, or antihistamines were excluded.

Twenty-four enrolled subjects (7 [28%] women and

17 [68%] men) were exposed to IFA stings on a small

shaved area of both forearms with a small cup containing

10 live IFAs (Figure). Sting exposure was for 10

seconds, based on a rough estimation of time for a typical

IFA encounter. After exposure, the subjects were

allowed to remove the ants, as would be standard procedure

for a reasonable person. At 1 minute, all subjects

were given cards labeled ‘L’ (left) and ‘R’ (right) to indicate

body site. The cards contained a visual analog

scale (VAS), 100 mm in length, with ends labeled ‘‘most

pain’’ and ‘‘least pain.’’ The subjects were asked to draw

a line through the VAS indicating pain level before treatment

on each card, with response for each arm considered

independently. At 90 seconds after the stings, treatment

with 0.5 ounces of Mitigator paste was applied to

a randomly selected envenomation site (left or right forearm),

and standard 0.5 ounces of calamine lotion was

applied to the alternative arm. Subjects were blinded to

treatment allocation. Treatment randomization (right or

left) was predetermined by a coin flip. The paste or lotion

was vigorously rubbed into the affected area for 2

to 3 minutes, left in place for 10 minutes, and then rinsed

off as per the package instructions for Mitigator. At 20

minutes poststing, subjects were asked to repeat the pain

rating on another pair of 100-mm VAS cards labeled

‘‘L’’ and ‘‘R’’ without seeing their initial responses. Subjects

were then dismissed and allowed to treat the stings

as desired for the next 72 hours. At 72 hours, the subjects

returned for direct follow-up with study investigators

and completed a third set of VAS cards.

Baseline VAS responses were recorded and statistical

analysis was performed for the self-pairing study sample.

A 2-tailed paired t test (parametric) and the Wilcoxon

signed rank test (nonparametric) were used to compare

differences in pain-score change from 60 seconds

to 20 minutes and from 60 seconds to 3 days for grouped

data of the Mitigator- and calamine-treated arms. By using

13 mm as the statistically significant difference in

change of pain over time between groups, with a power

of 80% and a 2-tailed alpha of 0.05, we determined that

a minimum of 21 subjects would be needed. We also

used a random-effects repeated-measures analysis of

variance and found similar results as with the paired t

test (results not reported).

Results

Mitigator was placed on the left arm in 8 subjects and

on the right arm in 16 subjects, with calamine lotion

Treatment of Imported Fire Ant Stings 23

Table 1. Perceived pain (in millimeters) by individual subjects on the visual analog scale

Subject

Mitigator

60 s 20 min 3 d

Calamine

60 s 20 min 3 d

1

2

3

4

5

6

7

8

9

10

11

12

22

57

67

17

2

3

19

32

33

7

11

51

4

11

42

3

0

0

7

1

15

2

0

32

0

2

9

0

8

0

0

0

10

2

0

14

10

32

58

15

5

3

23

9

24

4

5

64

4

11

17

13

4

0

6

6

21

21

12

14

0

0

9

4

28

0

0

0

4

2

0

3

13

14

15

16

17

18

19

20

21

22

23

24

17

26

7

2

27

16

22

27

49

48

8

4

1

0

0

2

24

9

0

19

5

6

0

0

0

0

6

0

0

1

2

4

0

0

14

0

74

27

19

1

32

17

23

8

49

52

30

4

25

0

7

3

10

6

9

0

57

35

25

0

1

0

0

0

0

0

0

1

3

4

11

0

Table 2. Mean perceived pain (in millimeters) by each subject

as recorded on the visual analog scale

Time

Mean pain

Calamine Mitigator

Difference

(95% CI) P value

60 s

20 min

3 d

24.5

12.8

2.92

23.9

7.63

2.42

0.583 (_6.22, 7.39)

5.13 (_1.94, 12.2)

0.500 (_1.88, 2.88)

.861

.147

.668

applied to the opposite respective arm in each individual.

There were no systemic reactions to IFA stings or adverse

reactions to treatment. Within-group baseline VAS

scores (Table 1) were generally similar, with the exception

of subject No. 13. There were no significant between-

group differences in mean VAS scores at baseline,

60 seconds, or 3 days (Table 2). Mean change in VAS

scores over time was statistically equivalent between

groups (Table 3). Only 3 of the subjects described the

use of any at-home therapy between day 1 and their

follow-up visit: 2 subjects used oral diphenhydramine

and 1 subject used oral aspirin and topical 1% hydrocortisone

cream on both arms. Subject No. 9 sought

medical care for her IFA stings, which had resulted in

bilateral arm hives when she went to work at a local

hospital 1 hour after her participation. She was treated

with diphenhydramine orally and a 5-day prescription

for prednisone. She had no complications at her 3-day

follow-up visit.

Discussion

Although fewer than 20% of those who seek medical

attention for IFA envenomation (1% of all who receive

IFA stings) will require an intervention such as treatment

of local infection or systemic reaction,8,9 identification

of effective treatment for IFA stings is important. Venom

from IFAs is composed of a mixture of allergens and

alkaloids, which shares some similarities to other Hymenoptera

species.3,10,11 The humoral responses invoked

by the envenomation include neurogenic inflammation

and cytokine cascade initiation as well as the generation

of humoral antibodies.11,12 Adverse local reactions may

occur as a result, and there have been several case reports

of IgE-mediated anaphylaxis.4,10 Immunotherapy

24 Hile et al

Table 3. Mitigator vs calamine lotion mean decrease in pain (in millimeters) from the visual analog scale

Time Mitigator Calamine Difference (95% CI) P value

60 s to 20 min

20 min to 3 d

60 s to 3 d

16.3

5.21

21.5

11.8

9.83

21.6

4.54 (_3.53, 12.6)

_4.625 (_11.4, 2.12)

_0.083 (_7.00, 6.83)

.256

.150

.640

has emerged as a potential therapy for people with severe

allergic reactions, but no advances have been made

regarding treatment of local pain and inflammation. Multiple

cellular processes are involved in the pain response,

and once initiated, pharmacotherapeutic intervention is

difficult. Although prophylactic treatment may effectively

block similar processes, as demonstrated in a recent

trial involving Chrysaora fuscescens and Chiropsalmus

quadrumanus (jellyfish) envenomations,13 this is not a

practical approach for IFA stings, as exposure is rarely

anticipated. Consequently, interventions directed at minimizing

pain are needed.

Available data on the treatment of IFA envenomations

are limited, and the manner of appropriate management

is uncertain. We believe this study is the first to address

the treatment of IFA stings through a randomized clinical

trial. We chose to investigate a commercially available

product (Mitigator) in an attempt to substantiate

subjective reports of its efficacy. However, we were unable

to demonstrate any statistical difference in relief of

pain when Mitigator was compared with a standardized

regimen with calamine treatment, and the situation remains

unresolved.

There may be multiple etiologies for the lack of statistically

significant differences in this study. Although

our study population was small, the number needed to

show a clinical difference on our VAS was sufficient. In

a study of this type, one would expect a curvilinear decrease

in pain, with the greatest difference in treatment

effect initially. Although there was a ‘‘trend’’ toward a

decrease in the Mitigator-treated arm at 20 minutes, the

difference was not significant. We acknowledge that subject

No. 13 in our study had a wide variability in pain

at onset between the calamine- and Mitigator-treated

arms. However, excluding this subject from the database

and recalculating the data still failed to demonstrate a

significant difference between the 2 treatments. Among

the multiple possible reasons for this is the inability of

the clinical setting to adequately reproduce the natural

environment. As those who have been stung will recall,

IFAs frequently ‘‘attack’’ in unison, and a person may

easily receive 10 to 20 stings before the ants can be

removed. Although approximately 10 ants were present

in each container in this study, many subjects experienced

just 2 or 3 stings. Furthermore, it is likely that the

ants expended their venom during the collection process

and therefore may have had less venom available during

the study than in the natural environment. This may have

led to decreased initial pain in the study population, thus

decreasing the apparent treatment effect. Because the

initial pain described by the subjects was low, demonstration

of therapeutic benefit from Mitigator, if it exists,

may require more volunteers than this study enrolled.

Future studies may benefit from attempts to increase initial

pain levels either by increasing the total number of

stings or by ‘‘resting’’ the IFAs for a number of days to

ensure that high levels of venom are present in the study

ants.

Conclusion

There was no demonstrable difference in immediate or

delayed pain relief between Mitigator and calamine lotion

therapy for IFA stings. These envenomations remain

a source of potential morbidity, and further investigation

into appropriate treatment is needed.

Acknowledgments

We thank the Brooke Army Medical Center Institutional

Review Board for reviewing and approving this study.

Mitigator Sting and Bite Treatment was provided upon

request for this study by Mr Pat Kennedy and American

Natural Technology Sciences, Rogers, AR; however, no

financial relationship exists between the investigators

and the manufacturer or distributors of Mitigator Sting

and Bite Treatment.

References

1. Morrison LW, Porter SD, Daniels E, Korzukhin MD. Potential

global range expansion of the invasive fire ant, Solenopsis

invicta. Biol Invasions. 2004;6:183–191.

2. Caldwell ST, Schuman SH, Simpson WM Jr. Fire ants: a

continuing community health threat in South Carolina. J

S C Med Assoc. 1999;95:231–235.

3. Freeman TM, Hylander R, Ortiz A, Martin ME. Imported

fire ant immunotherapy: effectiveness of whole body extracts.

J Allergy Clin Immunol. 1992;90:210–215.

Treatment of Imported Fire Ant Stings 25

4. Caplan EL, Ford JL, Young PF, Owenby DR. Fire ants

represent an important risk for anaphylaxis among residents

of an endemic region. J Allergy Clin Imunol. 2003;

111:1274–1277.

5. Ross EV, Badame AJ, Dale SE. Meat tenderizer in the

acute treatment of imported fire ant stings. J Am Acad

Dermatol. 1987;16:1189–1192.

6. Bruce S, Tschen EH, Smith EB. Topical aluminum sulfate

for fire ant stings. Int J Dermatol. 1984;23:211.

7. Parrino J, Kandawalla NM, Lockey RF. Treatment of local

skin response to imported fire ant sting. South Med J.

1981;74:1361–1364.

8. Yeager W. Frequency of fire ant stinging in Lowndes

County, Georgia. J Med Assoc Ga. 1978;67:101–102.

9. Adams CT, Lofgren CS. Incidence of stings or bites of the

red imported fire ant (Hymenoptera: Formicidae) and other

arthropods among patients at Ft. Stewart, Georgia, USA.

J Med Entomol. 1982;19:366–370.

10. Stafford CT. Hypersensitivity to fire and venom. Ann Allergy

Asthma Immunol. 1996;77:87–97.

11. Minton SA, Bechtel HB, Erickson TB. North American

arthropod envenomation and parasitism. In: Auerbach PS,

ed. Wilderness Medicine. 4th ed. St Louis, Mo: Mosby;

2001:863–887.

12. Freeman TM. Hymenoptera hypersensitivity in an imported

fire ant endemic area. Ann Allergy Asthma Immunol.

1997;78:369–372.

13. Kimball AB, Arambula KZ, Stauffer AR, et al. Efficacy

of a jellyfish sting inhibitor in preventing jellyfish stings

in normal volunteers. Wilderness Environ Med. 2004;15:

102–108.

Share

Speak Your Mind