Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research

NCT03805035 | Completed

• 1 other identifier: CMUH107-REC3-019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Electroacupuncture (EA); Antihistamine; Pain

Outcome Measures

Primary Outcomes (1)

• pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES)

  Transcutaneous electrical stimulation (TCES) is used as a method of inducing pain in the study. The procedure is to attach two electrode patches on the inside of the upper arm of the subject and then connect the electric stimulator. The current intensity will gradually increase from 0 mA, and each time increase 0.5amps until the subject feels pain in the visual analogy. Transcutaneous electrical stimulation (TCES) will be stopped at the visual analog scale of 5 (that means the moderate pain). The current intensity will be compared within and between each group.

  baseline and 10min after treatment

Study Arms (4)

sham EA group

SHAM COMPARATOR

Minimal needling at ST36 and GB34 (n=10)

Device: acupuncture

true EA group

EXPERIMENTAL

EA at ST36 and GB34 (n=10)

Device: electroacupuncture

EA+antihistamine(low dose) group

ACTIVE COMPARATOR

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

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

EA+antihistamine(high dose) group

ACTIVE COMPARATOR

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

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

Interventions

electroacupuncture DEVICE

Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)

EA+antihistamine(high dose) group; EA+antihistamine(low dose) group; true EA group

antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate) DRUG

Group 3 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)

Also known as: chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab)

EA+antihistamine(low dose) group

antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate) DRUG

Group 4 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)

Also known as: chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs)

EA+antihistamine(high dose) group

acupuncture DEVICE

Minimal needling at ST36 and GB34

Also known as: shallow needling

sham EA group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).
• A compromised skin barrier (e.g., skin disease, allergy) that would interfere with the conduct of the EA procedure and assessments of the study.
• An implant such as a pacemaker, defibrillator, or electronic medical equipment.
• Pregnancy, or planning for pregnancy.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

Related Publications (3)

• Traiffort E, Pollard H, Moreau J, Ruat M, Schwartz JC, Martinez-Mir MI, Palacios JM. Pharmacological characterization and autoradiographic localization of histamine H2 receptors in human brain identified with [125I]iodoaminopotentidine. J Neurochem. 1992 Jul;59(1):290-9. doi: 10.1111/j.1471-4159.1992.tb08903.x.

  PMID: 1351926 BACKGROUND

• Zhang WT, Jin Z, Luo F, Zhang L, Zeng YW, Han JS. Evidence from brain imaging with fMRI supporting functional specificity of acupoints in humans. Neurosci Lett. 2004 Jan 2;354(1):50-3. doi: 10.1016/j.neulet.2003.09.080.

  PMID: 14698480 BACKGROUND

• Lee YC, Tu CH, Chung HY, Luo ST, Chu YT, MacDonald IJ, Kotha P, Huang CC, Lane HY, Lin JG, Chen YH. Antihistamine promotes electroacupuncture analgesia in healthy human subjects: A pilot study. J Tradit Complement Med. 2022 Apr 21;12(5):511-517. doi: 10.1016/j.jtcme.2022.04.003. eCollection 2022 Sep.

  PMID: 36081814 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Electroacupuncture; Histamine Antagonists; Chlorpheniramine; dexchlorpheniramine; Tablets; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Pheniramine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Yi-Hung Chen, PhD

  Graduate Institute of Acupuncture Science, China Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 15, 2019
• Study Start: January 24, 2019
• Primary Completion: June 27, 2019
• Study Completion: June 30, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)