Embedded Scribd iPaper - Requires Javascript and Flash Player

Israel Journal of Veterinary Medicine  Vol. 70 (3)  September 2015 Savariego, G. 26
Evaluation of the Safety of External Application of Herbal Oil
(“Gidan”) on Horses’ Limbs
Savariego, G., Tatz, J.A., Segev, G., Kelmer, G.
Koret School of Veterinary Medicine, Te Robert H. Smith Faculty of Agriculture, Food and Environment, Te Hebrew
University of Jerusalem, P.O.B. 12, Rehovot 76100, Israel.
*
Corresponding Author: Dr. Gal Kelmer, DVM., Koret School of Veterinary Medicine, Te Hebrew University of Jerusalem, Rehovot, Israel.
ABSTRACT
Tendons and ligaments injuries are highly common in the equine population and they tend to carry a high
recurrence rate and prolonged healing period. Te treatment and prevention of tendon injuries is complex
and the combination of complementary and alternative methods into current regimes may be benefcial.
However, the literature regarding the safety and efcacy of such treatments is scarce. “Gidan” is an herbal
liniment, designed according to traditional Chinese methods, for the relief of muscle and tendon related
pain. Tis study aimed to evaluate the safety of external application of “Gidan” on distal limbs of horses and
lay the foundation for future studies evaluating the efcacy of “Gidan” and similar materials. “Gidan” was
applied twice daily on two distal limbs of 10 horses for a 7 day period. Te two remaining limbs served as
controls and were treated with a carrier liniment without the “Gidan” herbal extracts. Two limbs of each
horse (“Gidan” and control) were bandaged. Allocation to treatments was random. Adverse skin reactions
were assessed, ranked and photographed during the trial period and at 5 days following last application.
Nearly half of the limbs tested exhibited mild adverse skin reactions, most of them delayed and were only
visible days after application was ceased. Analysis shows that bandaging was clearly the main risk factor for
developing such reactions. It was concluded that “Gidan” was not the cause of the dermatological reactions.
Te external topical use of “Gidan” herbal liniment on horses’ distal limbs appeared to be safe on non-
bandaged limbs. Te use of bandaging requires further evaluation.
Keywords: Gidan; Herbal; Safety; Chinese Medicine; Equine; Tendonitis.
INTRODUCTION
Lameness and other orthopedic problems were ranked in
a comprehensive survey conducted in the USA as the most
prevalent health issue afecting horses (1). Furthermore,
lameness was ranked by horse owners, riders and veterinar-
ians as the most concerning problem regarding the horse’s
health as it leads to a substantial loss of working days and
may even lead to euthanasia (1). Injuries attributed to
tendons and ligaments are perceived as being potentially
threatening to an equine athlete’s career as their initial
subtle clinical sign often tend to delay recognition at
which point they become severe and difcult to manage
successfully (2). Te anatomical architecture of tendons
and ligaments is designed to allow tendons to passively
transfer force generated by muscle to bony attachments
on the opposite side of a joint, or joints and in so doing
provide movement. Te biomechanically most signifcant
tendons and ligaments are located on the palmar/plantar
aspect of the equine distal limb. At that location they receive
signifcant weight-bearing loads and, are responsible for the
majority of the movements of the horse (3). Te unique
structural arrangement within tendons and ligaments al-
lows the horse to exercise at high speeds while minimizing
energy expenditure (3).
Israel Journal of Veterinary Medicine  Vol. 70 (3)  September 2015 27 Safety Study of Gidan Treatment
Te tendons, type 1 collagen fbers, have a crimp pattern
that contributes to its elasticity and enables storing energy in
an efective manner. Tese tendons are subjected to repeated
motion and degeneration over time and thus they are prone
to both acute and chronic injuries (4). Due to high collagen
content and low cell numbers, tendons and ligaments have a
slow metabolic rate of activity and it may take 8–12 months
to regain adequate tensile strength after signifcant damage
(5). Recurrence of tendon injury after return to full work
is rather frequent, depending on the severity of the injury,
rehabilitation program, tendon involved, forelimb versus
hind-limb and the therapies applied (5).
Te treatment and prevention of tendon and ligament
injuries is complex and usually requires a combination of
methods and disciplines in order to achieve the optimal
results. Currently used modalities include, among others,
conservative methods such as anti-infammatory medication,
ice and bandaging incorporated into a long resting period
(5). Recent and advanced methods aim to reduce healing
period and re-injury occurrence. One potentially useful
modality is the extracorporeal shockwave therapy, due to its
analgesic properties and it possible enhanced tendon healing
by stimulating vascular in-growth (6). Recently regenera-
tive medicine has been gaining increasing popularity; these
therapies include autogenous stem cell implantation, bone
marrow or adipose tissue derived and platelets rich plasma
(PRP) (7). All these regenerative modalities are aimed at
promoting cell proliferation, diferentiation and improving
the quality and the speed of healing. Tese methods seem
to carry an enormous potential but at this point lack solid
scientifc support (5).
Currently, the use of complementary and alternative
medicine is slowly establishing its status among other
therapeutic options as a valid and benefcial modality avail-
able for the equine practitioner (8). One major mode is the
use of herbs and herbal extracts from traditional Chinese
medicine (TCM) via topical application. Tis mode of ap-
plication has major advantages as it increases the assurance
that the herb interacts with the target tissue and reduces
concern of systemic efects. Topical application also allows
easy monitoring and observation regarding treatment efec-
tiveness and whether adverse reactions, e.g. allergy, irritation,
or progression of the disease, are on going (9). TCM prac-
titioners usually rely on the use of topical herbal pastes for
metabolic enhancements of tissue repairs. Tis route allows
the herbal essence to directly reach the underlying tissues
(10). Compared with oral route of administration avoiding
the initial hepatic screening and allows the medication to
exert its efect continuously as absorption advances (10).
Allergies are a potential adverse efect of virtually any
herbal or synthetic medication applied topically or systemi-
cally (11). Numerous human reports of allergic and other
dermatological reaction to herbal medicines are known to
occur, tending to be mild to moderate and transient in nature
(11). Tough herbal medication is generally perceived as safe,
especially when applied topically, a cutaneous adverse efect is
always a possibility and topical application of herbal remedies
is not without risk (11).
TCM is considered one of the most ancient healing arts
known to man, with documentation of practice of over 3000
years. Te Traditional Chinese Veterinary Medicine (TCVM)
has developed in close conjunction with the TCM. Tough
relatively new to western culture, the implementation of simi-
lar methods in animal medicine, has been known and well
documented for thousands of years (12). Te incorporation of
TCVM methods to the western veterinary medicine practice
is continuously growing due to increased interest both by
pet owners and practitioners, seeking complementary and
alternative treatment modalities and options (13).
According to the TCM, herbs used for medicinal pur-
poses hold a variety of characteristics, representing diferent
traits that are harnessed in order to apply proper medication.
Formulating herbal remedies requires proper integration of
those characteristics in order to achieve harmony and regain
balance (13).
“Gidan” liniment has been used by athletes, physical
therapist and orthopedists for the relief of muscle and ten-
don related pain post exercise for almost a decade, without
any known adverse efects (14). “Gidan” is composed of an
assembly of herbs extracts and essential oils based on their
therapeutic and medicinal virtues as attributed by TCM.
Te basis of the liniment is Olive oil (olea europaea, 68%)
solidifed with bee wax (18%) and it contains the following
extracts: MO YAO (Myrrh, commiphora myrrha), XIANG
RU) Olibanum, Boswellia carteri), HONG HUA (Safower,
Carthamus tinctorius) and SAN QI (Notoginseng, Panax
pseudoginseng) that according to TCM invigorates blood to
relieve pain, reduce swelling, and promotes tissue regenera-
tion (15). Te liniment also contains the following essential
oils (<0.5% each): Eucalyptus )Eucalyptus globules(, Lavender
Research Articles
Israel Journal of Veterinary Medicine  Vol. 70 (3)  September 2015 Savariego, G. 28
(Lavandula ofcinalis), Lemon (Citrus limonum), Rosmary
(Rosmarinus ofcinalis), Mint (Mentha piperita), Nutmeg
(Myristica fragrans) and Vitamin E (Tocopherol).
Te rising interest in combining herbal use with routine
veterinary medicine is in contrast to the lack of studies evalu-
ating the efcacy and safety. Tis study aims to evaluate the
safety of external application of “Gidan” on distal limbs of
horses. Ideally, this safety study will lay the foundation for
future studies evaluating the efcacy of “Gidan” and similar
materials.
MATERIALS AND METHODS
Horses
All of the horses in the study resided at “Shalva BaTeva”
ranch in Rishon LeZion, Israel. Te study group was com-
prised of 10 adult horses of various breeds, 9 males and 1
female. All of the horses were in good health, without any
visible skin lesions on or near the tested area. Te horses were
not treated with any other medication during the trial period.
Te mare was not pregnant. Te horses were kept in stalls
during the night and padlocked during the day and were
routinely fed and treated by the ranch personnel. Te horses
engaged in routine short daily riding activity.
Materials
“Gidan” liniment as described above was used as treatment
and 100% Olive oil (Olea europaea) solidifed with bees wax
liniment was used as control liniment.
Tested area
A 15 cm length palmar/plantar surface on each of the four
limbs was used, between the metacarpo/metatarso-phalangeal
joint (fetlock) and the tarsus/carpus ranging 180
0
covering
the palmar/plantar medial/lateral aspects of the digital fexor
tendons.
Administration
Two limbs of each horse were treated with “Gidan”. Te
ointment was applied on the skin and then massaged until
adequate absorption occurred which was about 30 seconds.
Afterwards one of the treated limbs was bandaged with a
commercial transport bandage (Non-woven polypropylene
transport bandage, Kibbutz Urim, Israel) and the other was
left uncovered. Te two remaining limbs served as controls
and were treated with the solidifed olive oil, and afterwards
one of the two limbs was also bandaged in the same manner
as the treated one. Te materials were administered twice
daily (q12h), manually, using new examination gloves for
each material for each horse.
Designation of groups
GB: Gidan treated and bandaged.
G: Gidan treated non-bandaged.
CB: Control bandaged.
C: Control non-bandaged.
Randomization
Te treatment of each limb (control versus “Gidan” and
bandage versus non-bandaged) was randomly assigned by
a simple draw and remained constant throughout the trial.
Trial period
Te trial was conducted for 7 days and thus each limb was
treated 14 times. A follow up examination (fnal evaluation)
of the limbs was conducted 5 days following the last lini-
ment administration. A veterinarian post-trial evaluation was
conducted 8 days following last liniment administration.
Reaction scale and rating
Troughout the trial period, and prior to administration of
the materials, the limbs were examined and rated on a 3 level
scoring scale:
0 – Normal limb without skin lesions.
1 – Mild reaction including mild manifestations of red-
ness, swelling, edema, alopecia, scaling, scufng and pruritis.
2 – Severe reaction such as dermatitis, bleeding, papules,
pustules and severe manifestations of redness, swelling,
edema, alopecia and scaling.
A similar examination and rating of the limbs was con-
ducted during the veterinary evaluation.
Documentation
Te limb reaction score (0-2) was documented in a chart and
a verbal description was added in the presence of any adverse
reaction. Te limbs were routinely photographed for visual
documentation and future reference. All procedures including
administration, bandaging, rating and documentation were
conducted by one person (GS).
Research Articles
Israel Journal of Veterinary Medicine  Vol. 70 (3)  September 2015 29 Safety Study of Gidan Treatment
Statistical analysis
Analysis was performed under the assumption that each leg
is independent and not infuenced by any manipulation ap-
plied to other legs of the same horse. Te Fisher exact test
was used to compare the proportion of skin lesions among
the 4 groups. Post hoc analysis was also performed using the
Fisher exact test to compare the proportion of skin reactions
between individual groups. Bonferroni correction for alfa was
applied in the post hoc analysis.
P < 0.05 was considered statistically signifcant, un-
less Bonferroni correction was applied. Analysis was
preformed using statistical software (SPSS 17.0 for
windows, Chicago IL, USA).
RESULTS
Complete data were available for eight horses. Two horses
were removed from the trial prior to its completion due to
relocation from the ranch (horse No. 4 on day 5 and horse
No. 8 on day 7). Tese two horses did not present any adverse
reaction on any limb prior to being removed and were not
available for later evaluation. Daily limb reaction data is
presented in Table 1. Of the eight remaining horses, three
limbs developed level 1 reaction during the 7 day application
period (day 6), all three limbs were bandaged and only one
of those was treated with “Gidan”.
Limb lesions
Te tested area of the left front limb of horse No. 10 (CB)
exhibited on day 6, three focal areas of alopecia and ero-
sions accompanied by a mild discharge. Te right hind limb
(GB) of that horse exhibited tenderness and mild discharge.
No lesions were observed on the two remaining limbs (G
and C). Material application was ceased and bandages were
removed. On day 7 crusting and scabbing of the tested area
was observed on both afected limbs. Te tested area of the
right forelimb (CB) of horse No. 9 also exhibited on day
6 tenderness and touch sensitivity, with no apparent skin
lesions.
Final evaluation adverse reactions
Upon fnal evaluation (5 days following last application) 15
of the 32 trial limbs (46.9%) had developed skin lesions. Tis
was due to additional 12 limbs that had developed lesions
similar to those previously presented by horses Nos. 9 and 10.
All the developed lesions were of mild nature (level 1) and
included crusting, alopecia, tenderness and mild discharge
(Figure 1). Fourteen of those limbs were bandaged (93.33%)
during the trial period and a total of 8 limbs (53.33%)
were treated with “Gidan”, with only one of the latter not
bandaged.
Tere was a statistically signifcant diference in the
proportion of skin reactions among the 4 treatment groups
(P = 0.011). A signifcantly higher rate of adverse reactions
was seen in group CB compared with group C (P = 0.001).
Similarly, there were signifcantly more adverse reactions in
the CB group compared to the G group (P = 0.001) and there
were signifcantly more adverse reactions in the GB group
compared to the C group (P = 0.001) (Table 2). In contrast,
no diference was found neither between the non-bandaged
control (C) and the non-bandaged treatment (G) groups
(P = 1.0) nor between the bandaged control (CB) and the
bandaged treatment (GB) groups (P = 1.0) (Table 3). Adverse
reaction occurred more frequently in the GB group compared
Table 1: Complete daily adverse reaction matrix for each horse according to treatment. G-Gidan, C-Control, GB-Gidan and Bandaged, CB-
Control and Bandaged. Number indicates level of reaction (0=no reaction, 1= mild reaction, 2= severe reaction). Horse no. 4 was removed from
the trial on day 5 and horse no. 8 on day 7
Horse G GB C CB G GB C CB G GB C CB G GB C CB G GB C CB G GB C CB G GB C CB G GB C CB
1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1
2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1
3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1
4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1
6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0
7 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1
8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 1 0 1
10 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 1 0 1 0 1 0 1
day 1 day 2 day 3 final evaluation day 7 day 6 day 5 day 4
Research Articles
Israel Journal of Veterinary Medicine  Vol. 70 (3)  September 2015 Savariego, G. 30
to the G group (P = 0.01), but this diference did not remain
statistically diferent when correction for Bonferroni multiple
comparisons was applied.
Post-trial veterinarian evaluation
Evaluation of the 32 limbs 8 days following the last applica-
tion showed that no additional lesions with the 15 reacting
limbs in advanced process of healing.
DISCUSSION
Te constant search for efective, inexpensive, minimally
invasive and safe treatment options motivates a growing
interest for incorporating traditional medicinal methods
into modern medicine practice (16). Literature evaluating
the efcacy and safety of such use is lacking. In this study,
we aimed to evaluate the safety of the external use of “Gidan”
herbal liniment on the distal limbs of horses. Te results show
that nearly half of the limbs tested exhibited mild adverse
skin reactions. Analysis of the afected limbs shows that
bandaging was clearly the main risk factor for developing
such reactions (P = 0.001) as only 1 of the reacting limbs
was un-bandaged. In addition, the signifcantly higher risk
in the bandaged limbs compared to the Gidan treated limbs
(P = 0.001) and the lack of signifcant diference between the
control and “Gidan” treated groups enabled us to conclude
the “Gidan” liniment was not the cause for the development
of the cutaneous adverse efects.
Te results of the current study are encouraging; since
they clearly support the safety of using the “Gidan” liniment
on horse’s limbs. Reliable information regarding the safety
of medications is essential for advancing medicine and this
study presents such data. It is hoped that this information
should be the basis for future studies to evaluate the efcacy
of “Gidan” in treating injured tendons.
Te adverse efects of the bandaging seems to be de-
layed, as reactions was visible mainly on day 12, which is 5
days after application and bandaging were terminated. One
potential explanation is that the oily-waxy consistency of
the tested liniments (“Gidan” and control) resulted in adhe-
sion of the bandages to the limbs causing micro-skin lesions
with every movement and with each bandage change. Te
lesions became visible later on, once the healing processes of
the cutaneous lesions progressed. In addition, bandaging of
Figure 1: Te fgure depicts post trial reactions of 5 diferent horses. A – Left forelimb of horse no. 10 (CB), B – Right forelimb of horse no.9
(CB), C – Right forelimb of horse no. 7 (CB), D – Left forelimb of horse no. 2 (GB), E – Right hind limb of horse no. 5 (GB).
Table 2: Comparison of each 2 treatments using Wilcoxon signed
ranks test. G – Gidan, C – Control, GB – Gidan and Bandaged,
CB – Control and Bandaged
G GB C CB C G CB GB
Total 8 8 8 8 8 8 8 8
Reacted
1
(12.5%)
7
(87.5%)
0
(0%)
7
(87.5%)
0
(0%)
1
(12.5%)
7
(87.5%)
7
(87.5%)
P. value 0.034
a
0.008
b
0.317 1.0
Table 3: Comparison of bandaged vs. non-bandaged limbs using
Wilcoxon signed ranks test. Each group containing both Gidan treated
and control limbs.
Bandaged Non-Bandaged
Total 16 16
Reacted 14 1
Rate 87.5% 6.25%
P. value 0.01
a
Research Articles
Israel Journal of Veterinary Medicine  Vol. 70 (3)  September 2015 31 Safety Study of Gidan Treatment
limbs combined with liniment application may cause skin
occlusion. Occlusion may predispose to the proliferation
of microorganisms, as it changes environmental conditions
of the skin, reduces evaporation and maintains a warm and
moist environment (17). Tus, an alternative theory is that
the material applied, when bandaged, allowed suitable (e.g.
anaerobic and moist) conditions for microorganism develop-
ment causing low grade local infection.
One potential limitation of this study is that absorption of
the liniment was not verifed prior to bandaging. Absorption
was only evaluated by visual and tactile sensations. Increasing
the time lag between application and bandaging may result
in safe bandaging of treated limbs.
One of the horses (No. 6) difered in the reaction pat-
terns as its two bandaged limbs did not exhibit any reaction
whereas the “Gidan” treated non-bandaged limb did. It is
possible that individual integument biophysical factors,
such as pH, temperature, lipid and mineral content led to
greater skin sensitivity to the “Gidan”. Nevertheless only
one of the two “Gidan” treated limbs of that horse showed
an adverse reaction, suggesting that the reaction was not
necessarily specifc to the liniment and may have been
facilitated by some intrinsic predisposing factors in that
particular limb.
Te results of this work clearly indicate that using the
liniment “Gidan” is safe, when applied for a week to the non-
bandaged distal limb of a horse. As tendon and ligaments
injuries may require prolonged healing period, the safety of
long-term use of the liniment may require further evaluation.
In conclusion, external topical use of “Gidan” herbal
liniment on horses’ distal limbs seems to be safe without the
application of bandageing. Te use of bandaging on treated
material may be safe after suitable absorption but in need of
further evaluation.
DISCLAIMER
All of the tested liniment as well as the control liniment were
manufactured and supplied by Nir Ziv from “Kol Hateva”
and the authors did not receive any form of payment for
performing or writing this study. Te results and conclusions
were not infuenced by the manufacturer.
REFERENCES
1. Kaneene, J.B., Whitney, A.R. and RoseAnn, M.: Te Michigan
equine monitoring system. II. Frequencies and impact of selected
health problems. Prev. Vet. Med. 29: 277-292, 1997.
2. Gillis, C.L.: Rehabilitation of tendon and ligament Injuries. In
proceedings. Annual convention of AAEP 43: 306-309, 1997.
3. Adams, O.R. and Stashak, T.S.: Lameness in Horses. 6
th
ed. Baxter,
G.M. Ed. Blackwell publishing, 2011.
4. Lin, T.W., Luis, C. and Louis, J.S.: Biomechanics of tendon injury
and repair. J. Biomech. 37: 865-877, 2004.
5. Moll, D.H.: Tendon Injuries in the Horse: Current Concepts of
Terapy & Rehabilitation. In proceedings. 81
st
Western Veterinary
Conference. 417-420, 2009.
6. McClure, S.R. and Merrit, D.K.: Extracorporeal shock-wave
therapy for Equine Musculoskeletal Disorders. Comp. Cont. Educ.
Prac. Vet. 25: 68-75, 2003.
7. Koch, T.G., Berg, L.C. and Betts, D.H.: Current and future re-
generative medicine – Principles, concepts, and therapeutic use of
stem cell therapy and tissue engineering in equine medicine. Can.
Vet. J. 50: 155-165, 2009.
8. Haussler, K.K.: Complementary therapies or the treatment of
musculoskeletal disorders. in: Robinson, N.E. Ed. Current Terapy
In Equine Medicine. 5
th
ed. Saunders. 567-572, 2003.
9. Yarnell, E. and Meserole, L.: Topical applications of botanical
medicine Aloe vera and other medicinal plants for healing. J. Al-
tern. Complement. Med. 2: 241-244, 1996.
10. Peng, L.H., Ko, C.H., Siu, S.W., Koon C.M., Yue, G.L., Cheng,
W.H., Lau, T.W., Han Q.B., Ng, K.M., Fung, K, P., Lau, C.B. and
Leung, P.C.: In vitro & in vivo assessment of a herbal formula
used topically for bone fracture treatment. J. Ethnopharmacol.
131: 282-289, 2010.
11. Ernst, E.: Adverse efects of herbal drugs in dermatology. Br. J.
Dermatol. 143: 923-929, 2000.
12. Xie, H. and Preast, V.: Traditional Chinese Veterinary Medicine.
1
st
ed. Jing Tang, 2002.
13. Xie, H. and Preast, V.: Xie’s Chinese Veterinary Herbology. 1
st
ed.
Blackwell publishing, 2010.
14. Personal communication: Ziv, Nir (nirziv88@gmail.com), product
manufacturer.
15. Wu, J.N.: An Illustrated Chinese Materia Medica. 1
st
ed. Oxford
Press, 2005.
16. Ernst, E.: Te role of complementary and alternative medicine.
BMJ. 321: 1133-1135, 2000.
17. Hutchinson, J.J. and McGuckin, M.: Occlusive dressing: a micro-
biologic and clinical review. Am. J. of Infect. Control. 18: 257-268,
1990.
Research Articles