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

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

Detailed Description
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Bee Venom (BV)
* Drug: Essential Bee Venom (e-BV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bee Venom (BV) group<br>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. | Drug: Bee Venom (BV)<br>* Raw Bee Venom<br>* Other names: Bee Venom injection;|
| Experimental: essential Bee Venom (eBV) group<br>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. | Drug: Essential Bee Venom (e-BV)<br>* Bee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin<br>* Other names: Essential Bee Venom injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale(VAS) on Pain | Visual Analog Scale on Pain | 0.5 hours after intervention | 
| Wheal and erythema | traced on adhesive, transparent films and measured with 0.01mm calipher | 24 hours after intervention | 
| Visual Analog Scale(VAS) on Pain | Visual Analog Scale on Pain | 48 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale(VAS) on Pain | Visual Analog Scale on Pain, | 0, 2, 6, 24, 72, 96, 120, 144 hours after intervention | 
| Visual Analog Scale(VAS) for Wheal response | Wheal response | 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention | 
| Visual Analog Scale(VAS) for Skin irritation | Skin irritation | 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention | 
| Wheal and erythema | traced on adhesive, transparent films and measured with 0.01mm calipher | 0, 0.5, 6, 24, 72 hours after intervention | 
| Adverse events | General skin irritation, Heat flush, Nausea, Vomiting, Pain, Headache, Dizziness, Fatigue | 0, 6, 24, 72 hours after intervention |