A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture

Jaseng Hospital of Korean Medicine

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Essential Bee Venom (e-BV); Drug: Bee Venom (BV)

Study type: Interventional

Funder types: Other

Identifiers

NCT02364349

JS-CT-2015-01

Details and patient eligibility

About

This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).

Full description

This double-blinded randomized clinical trial investigates difference in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV). Twenty healthy volunteers aged 20-40 years were randomly allocated to the 2 groups and administered eBV and BV on left and right forearm, respectively, in accordance with group allocation. Physician, participant, and outcome assessor were blinded to group allocation. Local pain, swelling, itching, redness, wheals and adverse reactions were recorded by timepoint before and after treatment.

Enrollment: 20 patients

Sex: All

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals with no prior exposure to bee venom treatment
• Healthy individuals of both genders, 20 to 39 years old
• Individuals able to communicate their thoughts
• Voluntary participants who have provided written consent

Exclusion criteria

• Individuals on medications for chronic diseases (i.e. hypertension, hyperlipidemia)
• Individuals with past history of allergic dermatitis
• Individuals with past history of adverse events following bee stings
• Individuals with symptoms of common cold
• Individuals with fear of bee venom intervention or those who refuse to participate

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Bee Venom (BV) group

Active Comparator group

Description:

All subjects are injected with Bee Venom (BV, intervention), randomly assigned to the right or left forearm. Raw BV used dried BV prepared through collection from bee venom sacs and removal of impurities. The BV administration site on each subject was on the palmar side of the designated arm 5 cm below the middle of the elbow crease as it is convenient for observation and has high responsiveness. Pharmacopuncture sessions were also conducted in the morning for higher responsiveness.

Treatment:

Drug: Bee Venom (BV)

essential Bee Venom (eBV) group

Experimental group

Description:

All subjects are injected with essential Bee Venom (eBV, intervention), randomly assigned to the right or left forearm. eBV was prepared through the following methods: BV was collected from bee venom sacs and dried. LC/MS was used to analyze subdivisions of dried BV dissolved in purified water and passed through a sephadex G-25 column to collect histamine-free units. Collected units were filtered to eliminate allergenic substances including PLA2 of molecular weight 10 kDa or higher. The eBV administration site on each subject was on the palmar side of the designated arm 5 cm below the middle of the elbow crease as it is convenient for observation and has high responsiveness. Pharmacopuncture sessions were also conducted in the morning for higher responsiveness.

Treatment:

Drug: Essential Bee Venom (e-BV)