Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research

NCT ID: NCT03805035

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-24
• Study Completion Date: 2019-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

sham EA group

Minimal needling at ST36 and GB34 (n=10)

Group Type: SHAM_COMPARATOR

acupuncture

Intervention Type: DEVICE

Minimal needling at ST36 and GB34

true EA group

EA at ST36 and GB34 (n=10)

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: DEVICE

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

EA+antihistamine(low dose) group

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

Group Type: ACTIVE_COMPARATOR

electroacupuncture

Intervention Type: DEVICE

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

antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)

Intervention Type: 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)

EA+antihistamine(high dose) group

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

Group Type: ACTIVE_COMPARATOR

electroacupuncture

Intervention Type: DEVICE

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

antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)

Intervention Type: 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)

Interventions

electroacupuncture

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

Intervention Type: DEVICE

antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)

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)

Intervention Type: DRUG

antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)

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)

Intervention Type: DRUG

acupuncture

Minimal needling at ST36 and GB34

Intervention Type: DEVICE

Other Intervention Names

chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab); chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs); shallow needling

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Hung Chen, PhD

Role: STUDY_DIRECTOR

Graduate Institute of Acupuncture Science, China Medical University

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 1351926 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14698480 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36081814 (View on PubMed)

Other Identifiers

CMUH107-REC3-019

Identifier Type: -

Identifier Source: org_study_id