Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research

China Medical University

Status: Completed

Conditions: Pain

Treatments: Drug: antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate); Drug: antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate); Device: acupuncture; Device: electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03805035

CMUH107-REC3-019

Details and patient eligibility

About

Acupuncture has been used in traditional Chinese medicine for around 3,000 years and is increasingly practiced worldwide. The effects of acupuncture in chronic pain have been investigated in many clinical trials. Histamine H1 receptor antagonists are commonly used for treating allergy. Recently, investigators found that histamine H1 receptor antagonists at relatively low doses facilitate EA analgesia in the acetic acid-induced abdominal writhing test. Investigators aim to further explore whether histamine H1 receptor antagonists also facilitate EA analgesia in humans.The aims of the proposed studies are to: Conduct a clinical trial to demonstrate that H1 receptor antagonists at relatively low doses facilitate EA analgesia in healthy volunteers. This study will recruit 40 healthy normal subjects (aged between 20 and 30 years) who will be randomly assigned to one of four groups: (1) Sham acupuncture (Shallow needling without electrical stimulation) at ST36 and GB34; (2) EA at ST36 and GB34; (3) EA at ST36 and GB34 plus low-dose chlorpheniramine (2 mg); (4) EA at ST36 and GB34 plus regular-dose chlorpheniramine (4 mg). The primary endpoint will be the pain threshold. It is expected that the completion of this proposed study will enhance our knowledge as to how acupuncture analgesia can be promoted by antihistamine drugs given at a low dose and help to define its application for clinical use.

Enrollment: 40 patients

Sex: All

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. . Age: 20 to 30 years of age.
2. . Agrees to undergo a comprehensive medical history and physical examination.
3. . No history of analgesic, sedative, dietary/appetite medication intake for more than 3 weeks prior to enrolment.

Exclusion criteria

1. . An ongoing medical condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being (e.g., hypertension, diabetes mellitus, or epilepsy).
2. . A compromised skin barrier (e.g., skin disease, allergy) that would interfere with the conduct of the EA procedure and assessments of the study.
3. . An implant such as a pacemaker, defibrillator, or electronic medical equipment.
4. . Pregnancy, or planning for pregnancy.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

sham EA group

Sham Comparator group

Description:

Minimal needling at ST36 and GB34 (n=10)

Treatment:

Device: acupuncture

true EA group

Experimental group

Description:

EA at ST36 and GB34 (n=10)

Treatment:

Device: electroacupuncture

EA+antihistamine(low dose) group

Active Comparator group

Description:

EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10)

Treatment:

Drug: antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)

Device: electroacupuncture

EA+antihistamine(high dose) group

Active Comparator group

Description:

EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10)

Treatment:

Device: electroacupuncture

Drug: antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)