KING KHALID NATIONAL GUARD HOSPITAL
PHARMACY AND THERAPEUTICS COMMITTEE
DRUG EVALUATION
Requestor:
GENERIC NAME OF THE DRUG: MEBO OINTMENT
Dr. Mansoor Ahmed Khan.
Clinical Pharmacist Adult Oncology / Hematology.
Manufacturer:
Julphar.
1.
Trade Name:
ß-sitosterol.
2.
AHFS Pharmacology- Therapeutic Class:
Tissue healing agent:
1. Skin Regeneration.
2. Analgesic Effects.
3. Prevention and Control of Infection ( Antibiotic ).
4. Anti-inflammatory Effects.
3.
Related Agents Already on Formulary:
Flamazine ( Silver Sulfadiazine )
4.
FDA Approved Indications:
1. First-degree burns, where the pain relief and the fast healing are remarkable, e.g.
sunburn.
2. Second degree burns, superficial and deep. If properly applied, no skin grafting is
needed and regeneration takes place from hair follicles and glands in the dermis
and subcutaneous tissue.
3. Third degree burns, to isolate the wound, reduce pain, and expedite nonsurgical
debridement of the necrotic tissue to prepare the wound for grafting.
5.
Registered in the Kingdom:
6.
Rationale for Formulary Addition:
x Yes
No
6.1
Physician’s (Requestor’s) perspective
6.2
Objective Literature Evaluation:
MEBO is of natural and herbal edible origin. It is composed of ß-sitosterol
0.25% as the main active ingredient. The base of the ointment is composed of
sesame oil and beeswax. In addition to that, MEBO includes in its formula 18
amino acids, 4 major fatty acids, vitamins, and polysaccharides.
Indications
1. First-degree burns, where the pain relief and the fast healing are
remarkable, e.g. sunburn.
2. Second degree burns, superficial and deep. If properly applied, no skin
grafting is needed and regeneration takes place from hair follicles and glands
in the dermis and subcutaneous tissue.
3. Third degree burns, to isolate the wound, reduce pain, and expedite
nonsurgical debridement of the necrotic tissue to prepare the wound for
grafting.
4. Donor site, to decrease pain, control infection, and expedite healing
(average of 7 days has been
reported).
5. Chronic wounds including bed ulcers, diabetic foot,and leg ulcers.
6. Post laser resurfacing, chemical peeling, anddermabrasion.
7. Surgical wounds including obstetrical wounds.
8. Wound of circumcision.
9. Mucous membrane wounds such as buccal ulcers.
10. Cracked heels and cracked nipples.
Dosage and Administration
1. Burns
a. First degree burns (Superficial burns)
MEBO should be applied as immediately as possible.
A thin layer (about 1mm thickness) should cover the burnt area. It is better to
keep the wound exposed, but if there is a need, a light dressing can be used.
Reapplication should be done 3-4 times daily if exposed or twice daily if
closed.
b. Second degree burns
First Phase – liquefying period
A thin layer should cover the burnt area and renewed 3- 4 times daily. Before
reapplication, the liquefied necrotic tissue and the residues of the old layer
should be wiped off gently. It is better to keep the wound exposed, but if there
is a need, a light dressing can be used and a relatively thicker layer (about
3mm thickness) should be applied and renewed twice daily.
Second Phase – repair period
MEBO should be applied as before, but less frequently (2 - 3 times daily).
Third Phase – rehabilitation period
MEBO should be applied as before, but only once daily.
c. Third degree burns
MEBO should be applied as mentioned before to liquefy the necrotic tissue.
A thin layer should cover the burnt site and renewed 3 to 4 times daily.
2. Donor Site
A thin layer should cover the donor site and renewed 3-4 times daily if
exposed or twice daily if closed.
3. Leg Ulcers
Sterile gauze should be impregnated with MEBO and should fill the cavity of
the ulcer, and renewed twice daily.
4. Surgical and Obstetrical Wounds
MEBO should cover the wound in a relatively thick layer (about 3mm) under a
sterile dressing and renewed twice daily.
5. Cracked Nipples
A thin layer should be applied to the nipple under a light pad, and renewed 34 times daily.
STUDY I : COMPARATIVE STUDY OF THE WOUND HEALING PROPERTIES OF
MOIST EXPOSED BURN OINTMENT (MEBO) AND SILVER SULPHADIAZINE
Burns expose the deeper tissues of the skin or body to invasive microbes. Topical
preparations for treating burn wounds, to be useful, should ideally have antibiotic power and
promote healing. Silver compounds have been the mainstay of topical burn treatment for
decades. However, most chemical substances retard wound healing. Several natural agents
such as honey and moist exposed burn ointment (MEBO) are believed to protect wounds
from infection and promote healing without causing any of the adverse effects of purified
chemicals. In this study, Jewo P.I. et al compared the wound healing properties of MEBO, a
herbal preparation of Chinese origin, with silver sulphadiazine (SSD), a long-standing
conventional burn dressing. Ten adult Sprague Dawley rats were divided into two groups.
They were housed in separate cages and received partial-thickness burn wounds on their
dorsal skin. They were then treated with MEBO and SSD. The wounds were inspected daily
until day 8, when all the animals were sacrificed, perfused with normal saline, and had their
wounds excised and prepared for histology. It was found that animals in both groups were
well preserved. No clinical infections occurred. Wound healing was at an advanced stage by
day 8 in all the animals. Clinical and histological examination showed that the two agents
gave the animals comparable protection and healing possibilities. It is concluded that MEBO
is a suitable and efficacious alternative to conventional silver-based topical therapies for
treating partial-thickness burn wounds.
STUDY II : EVALUATING THE ROLE OF ALTERNATIVE THERAPY IN BURN
WOUND MANAGEMENT: RANDOMIZED TRIAL COMPARING MOIST EXPOSED
BURN OINTMENT WITH CONVENTIONAL METHOD IN THE MANAGEMENT OF
PATIENTS WITH SECOND-DEGREE BURNS.
Ang ES et al
Moist exposed burn ointment (MEBO), from China, has been said to revolutionize burn
management. The study was conducted to compare MEBO with conventional management
(C) with respect to the rate of wound healing, antibacterial and analgesic effect, and hospital
costs. This is a prospective, randomized, controlled clinical trial conducted between 1 March
1997 and 24 October 1998. The trial was conducted in a specialized burn facility located in a
tertiary referral hospital in a developed and industrialized island-state in Southeast Asia. They
randomly assigned 115 consecutive patients between the ages of 12 and 80 who had partialthickness thermal burns covering less than 40% of body surface area (BSA) to receive either
MEBO or C. Fifty-seven patients were assigned to MEBO and 58 patients to C. The latter
group received twice-daily dressing changes; MEBO patients received MEBO every 4 hours.
Patients were hospitalized until 75% BSA had healed. BSA was determined by visual
inspection and charted on Lund and Browder charts regularly. Wound healing rate, bacterial
infection rate, pain score, and hospitalization costs were recorded. The median time to 75%
healing was 17.0 and 20.0 days with MEBO and C, respectively (HR = 0.67, 95% CI = 0.411.11, P =.11), suggesting similar efficacy between the 2 modalities. Bacterial infection rates
were similar between the 2 groups (HR = 1.10, 95% CI = 0.59-2.03, P =.76). MEBO imparted
a greater analgesic effect in the first 5 days of therapy and reduced hospital costs by 8%.
MEBO is as effective as conventional management but is not the panacea for all burn
wounds. The use of MEBO eases the management of face and neck burns and facilitates
early institution of occupational therapy in hand burns. It confers better pain relief such that
fewer opiates are used during the first 5 days after burn injury.
STUDY III : PAIN CONTROL IN A RANDOMIZED, CONTROLLED, CLINICAL TRIAL
COMPARING MOIST EXPOSED BURN OINTMENT AND CONVENTIONAL
METHODS IN PATIENTS WITH PARTIAL-THICKNESS BURNS.
Conventional management of partial-thickness burn wounds includes the use of paraffin
gauze dressing, frequently with topical silver-based antibacterial creams. Some creams form
an overlying slough that renders wound assessment difficult and are painful upon application.
An alternative to conventional management, moist exposed burn ointment (MEBO), has been
proposed as a topical agent that may accelerate wound healing and have antibacterial and
analgesic properties. One hundred fifteen patients with partial-thickness burns were randomly
assigned to conventional (n = 58) or MEBO treatment (n = 57). A verbal numerical rating
score of pain was made in the morning, after burn dressing, and some 8 hours later. Patient
pain profiles were summarized by locally weighted regression smoothing technique curves
and the difference between treatments estimated using multilevel regression techniques.
Mean verbal numerical rating scale pain levels (cm) in week 1 for all patients were highest at
3.2 for the after dressing assessment, lowest in the evening at 2.6, and intermediate in the
morning at 3.0. This pattern continued at similar levels in week 2 and then declined by a
mean of 0.5 in all groups in week 3. There was little evidence to suggest a difference in pain
levels by treatment group with the exception of the postdressing pain levels in the first week
when those receiving MEBO had a mean level of 0.7 cm (95% confidence interval, 0.2 to 1.1)
lower than those on conventional therapy. MEBO appeared to bring greater pain relief for the
postdressing assessment during the first week after burns. This initial relief, together with
comparable pain levels experienced on other occasions, indicates that MEBO could be an
alternative to conventional burns management.
STUDY IV : SCAR QUALITY AND PHYSIOLOGIC BARRIER FUNCTION
RESTORATION AFTER MOIST AND MOIST-EXPOSED DRESSINGS OF
PARTIAL- THICKNESS WOUNDS.
Atiyeh BS,
There is growing evidence of improved healing of full- and partial-thickness cutaneous
wounds in wet and moist environments. Retention of biologic fluids over the wound prevents
desiccation of denuded dermis or deeper tissues and allows faster and unimpeded migration
of keratinocytes over the wound surface. It allows also the naturally occurring cytokines and
growth factors to exert their beneficial effect on wound contracture and re-epithelialization.
Despite all of these documented benefits, applying the moist healing principles to large
surface areas, in particular to large burns, is hindered by the major technical handicap of
creating and maintaining a sealed moist environment over these areas. From January to
September 2001, healing of partial-thickness skin graft donor sites was studied in a
prospective comparative study of two types of moist dressings, Tegaderm (3M Health Care,
St. Paul, MN), a semipermeable membrane occlusive dressing, and moist exposed burn
ointment (MEBO) (Julphar; Gulf Pharmaceutical Industries, United Arab of Emirates), an
ointment that can provide a moist environment without the need of an overlying occlusive
dressing. Healing was assessed both clinically and with serial measurements of
transepidermal water loss (TEWL) and moisture. Following healing, scar quality was
evaluated by two members of the team separately using a visual analog scale. Results were
statistically analyzed. Faster healing was observed clinically with MEBO application.
Physiologic healing as determined by TEWL measurements occurred at an extremely
significant earlier stage for MEBO, and this was associated with better scar quality,
demonstrating a positive relationship between function and cosmetic appearance. Moreover,
the ointment is definitely easier to apply than the occlusive self-adhesive membrane, which
requires some degree of dexterity and expertise. MEBO application is an effective and valid
alternative to conventional occlusive dressings. Moreover, the observed improved anatomic
and physiologic healing indicates that MEBO may have a positive effect on healing more that
the mere fact of passive moisture retention.
STUDY V : THE ROLE OF ALTERNATIVE THERAPY IN THE MANAGEMENT OF
PARTIAL THICKNESS BURNS OF THE FACE--EXPERIENCE WITH THE USE OF
MOIST EXPOSED BURN OINTMENT (MEBO) COMPARED WITH SILVER
SULPHADIAZINE.
Ang ES.
Conventional management of partial thickness facial burn wounds includes the use of silver
sulphadiazine dressings. Silver sulphadiazine forms an overlying slough that makes wound
healing assessment difficult. Moist exposed burn ointment (MEBO) has been proposed as the
ideal burn wound dressing both for burns of the face and other sites. Proponents of MEBO
claim that it accelerates wound healing and results in scarless wound healing and at the
same time reduce bacterial colonisation and the need for analgesics. Ang ES et al present
their experience with MEBO in the management of partial thickness burns of the face. One
hundred and fifteen patients with partial thickness burns were randomly assigned to
conventional treatment or MEBO. Out of this, 112 were analysed. Thirty-nine patients
sustained facial burns; 17 received MEBO and 22 received silver sulphadiazine. Patients
were followed up daily until the burn wounds were reduced by 75% of original body surface
area (BSA). In patients with facial burns, MEBO was similar to silver sulphadiazine therapy
with respect to rate of wound healing. Minimal slough was present over the wounds in MEBOtreated wounds resulting in clearer assessment of healing progression. Advantages of MEBO
as compared to silver sulphadiazine in the management of partial thickness burns of the face
include convenient change of dressing and easier assessment of healing progression. This
suggests that MEBO is a useful alternative therapy for partial thickness burns of the face.
STUDY VI : BENEFIT- COST ANALYSIS OF MOIST EXPOSED BURN OINTMENT.
Atiyeh BS,
Burn injury is one of the most devastating injuries that may affect a patient. Even in
economically deprived areas, burn care is largely driven by relatively plentiful resources
equating quality of care with generous monitoring and clinical attention with little concern to
management cost. Burn care costs have been the subject of very few investigations and are
among the least studied by health services researchers. Nevertheless, it can be stated that
local care of burn wounds accounts for a large proportion of the cost per day for treating
patients. As economic times are changing and as market penetration of managed care
contracts and stiff competition in the health care industry gains momentum, ways to reduce
expenditures without adversely affecting the quality of care have become of primary
importance. Atiyeh BS et al report a randomized prospective comparative study analyzing
the benefit-cost value of moist exposed burn ointment (MEBO) application, an exposed
method for burn wound care without the need for a secondary covering dressing, as
compared to conventional closed methods.
STUDY VII : PHASE III BED SORE TREATED WITH MEBO IN COMBINATION
WITH MUSCULOCUTANEOUS FLAP TRANSPOSITION.
This study was done to observe the curative effect of MEBO in combination with local
musculocutaneous flap transposition in treating Phase III bed sore. MEBO was applied on the
wound 2 times a day. After one week, musculocutaneous flap transposition was performed
when the wound became fresh and when the granulation tissue appeared. All of the 8 cases
were healed with first intention. Six of them were followed up for 2 to 24 months. No
recurrence happened. For treating Phase III bed sore, applying MEBO for about one week
and then treating the bedsore with MEBO in combination with musculocutaneous flap
transposition could evidently shorten the course of the disease.
STUDY VIII : A Comparative Study of the Effects of Moist Burn Ointment, Silver
Sulfadiazine and Hot Dry Exposed Therapy on Controlling Pseudomonas Aeruginosa
Infection of Burn Bounds
This is a comparative study to value the effect of Moist Exposed Burn Ointment (MEBO),
silver sulfadiazine (SD-Ag) and hot dry exposed therapy on controlling burn wound infection
with Pseudomonas aeruginosa. One hundred and twenty Wistar rats were scalded on the
8
back to produce third degree injury and then contaminated with 4×10 Pseudomonas
aeruginosa. The animals were divided into 4 groups, 30 in each and were kept in separate
cages. The control group received no treatment, while the 3 test groups were treated with hot
dry exposed therapy, MEBO and 1 % SD-Ag respectively. On day 1, 3, 5, 7 and 9 after
treatment, animals were killed. Biopsy specimens and heart blood samples were collected for
determination of bacteria count of subeschar viable tissues, examination of pathological
section and heart blood culture. The results revealed that the animals in MEBO and SD-Ag
groups had fewer bacteria counts and lower positive rates of blood culture and pathological
examination than that of in the control group. The differences were significant. While, there
was no marked difference of the above determination index between the hot dry exposed
therapy group and the control group. It was suggested that MEBO and SD-Ag had the
efficacy of controlling burn wound invasive infection with Pseudomonas aeruginosa, while hot
dry exposed therapy had not. The results also revealed that there was a positive correlation
between bacteria count of subeschar viable tissues and the positive rate of pathological
examination. There was no significant difference between two methods with respect to the
diagnosis rates. The authors concluded that bacteria count of subeschar viable tissues was
still of value for the diagnosis of burn wound infection.
7.
Cost Impact and Comparisons with Others Formulary Agents
Available
Dosage
Form
ß-sitosterol
15 gm
Ointment
SR 27 / Tube
SR 108 / 4
Tubes
SR 648 / 24
Tubes
50 gm
Cream
SR 13.60 / Tube
SR 54.4 / 4
Tube
SR 326.4 / 24
Tubes
( MEBO Ointment )
Silver Sulphadiazine
( Flamazine )
Unit Cost (SR)
Cost/Treatment
(SR)
Estimated Yearly
Cost Impact (SR)
Drug
References:


Jewo P.I., et al , A Comparative study of the wound healing properties of moist exposed
burn ointment (MEBO) and silver sulphadiazine Annals of Burns and Fire Disasters
(ISSN 1592-9566) - Pending Publications .7 December 2007
Erik Sze-Wee Ang et al , Evaluating the Role of Alternative Therapy in Burn Wound
Management: Randomized Trial Comparing Moist Exposed Burn Ointment With
Conventional Methods in the Management of Patients With Second-degree Burns.
MedGenMed. 2001 Mar 6;3(2):3 Singapore,March 6, 2001

Ang E et al . Pain control in a randomized, controlled, clinical trial comparing moist
exposed burn ointment and conventional methods in patients with partial-thickness
burns. 2003 Sep-Oct;24(5):289-96.

Atiyeh BS et al . Scar quality and physiologic barrier function restoration after moist and
moist-exposed dressings of partial-thickness wounds. Dermatol Surg. 2003 Jan;29(1):1420.

Atiyeh BS et al .Benefit-cost analysis of moist exposed burn ointment. Burns. 2002
Nov;28(7):659-63.

Ang ES et al ,The role of alternative therapy in the management of partial thickness
burns of the face--experience with the use of moist exposed burn ointment (MEBO)
compared with silver sulphadiazine. Ann Acad Med Singapore. 2000 Jan;29(1):7-10.

Mu Xiaoxin . Phase III Bed Sore Treated with MEBO in Combination with
Musculocutaneous Flap Transposition , The Chinese Journal of Burns, Wounds and
Surface Ulcers 2000(4): 52-53

Ma En-qing , Chen Xiao-wu. A Comparative Study of the Effects of Moist Burn Ointment,
Silver Sulfadiazine and Hot Dry Exposed Therapy on Controlling Pseudomonas
Aeruginosa Infection of Burn Bounds, The Chinese Journal of Burns Wounds and
Surface Ulcers 1990, (3): 39-44
8.

Summary:

Burns expose the deeper tissues of the skin or body to invasive microbes. Topical
preparations for treating burn wounds, to be useful, should ideally have antibiotic power
and promote healing. Silver compounds have been the mainstay of topical burn treatment
for decades. However, most chemical substances retard wound healing. Several natural
agents such as honey and moist exposed burn ointment (MEBO) are believed to protect
wounds from infection and promote healing without causing any of the adverse effects of
purified chemicals.

MEBO is a suitable and efficacious alternative to conventional silver-based topical
therapies for treating partial-thickness burn wounds.

MEBO is as effective as conventional management but is not the panacea for all burn
wounds. The use of MEBO eases the management of face and neck burns and facilitates
early institution of occupational therapy in hand burns. It confers better pain relief such that
fewer opiates are used during the first 5 days after burn injury.

MEBO appeared to bring greater pain relief for the postdressing assessment during the
first week after burns. This initial relief, together with comparable pain levels experienced
on other occasions, indicates that MEBO could be an alternative to conventional burns
management.

MEBO application is an effective and valid alternative to conventional occlusive dressings.
Moreover, the observed improved anatomic and physiologic healing indicates that MEBO
may have a positive effect on healing more that the mere fact of passive moisture
retention.

Advantages of MEBO as compared to silver sulphadiazine in the management of partial
thickness burns of the face include convenient change of dressing and easier assessment
of healing progression. This suggests that MEBO is a useful alternative therapy for partial
thickness burns of the face.

In a randomized prospective comparative study analyzing the benefit-cost value of moist
exposed burn ointment (MEBO) application, an exposed method for burn wound care
without the need for a secondary covering dressing, as compared to conventional closed
methods.

For treating Phase III bed sore, applying MEBO for about one week and then treating the
bedsore with MEBO in combination with musculocutaneous flap transposition could
evidently shorten the course of the disease.

It was suggested that MEBO and SD-Ag had the efficacy of controlling burn wound
invasive infection with Pseudomonas aeruginosa, while hot dry exposed therapy had not.
The results also revealed that there was a positive correlation between bacteria count of
subeschar viable tissues and the positive rate of pathological examination. There was no
significant difference between two methods with respect to the diagnosis rates. The
authors concluded that bacteria count of subeschar viable tissues was still of value for the
diagnosis of burn wound infection.
9.
Recommendations:
9.1
10.
11.
12.
Formulary Status:
x
9.2
Restrictions:
9.3
Deletion from formulary:
Date Prepared:
Prepared by:
Reviewed by:
Approved
Not Approved
Roaa Matouq Khinkar , Clinical Pharmacy Candidates.
Dr. Obed Hayibor, Supervisor Clinical Pharmacy