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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham EA group | Sham Comparator | Minimal needling at ST36 and GB34 (n=10) |
|
| true EA group | Experimental | EA at ST36 and GB34 (n=10) |
|
| EA+antihistamine(low dose) group | Active Comparator | EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10) |
|
| EA+antihistamine(high dose) group | Active Comparator | EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroacupuncture | Device | Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Hung Chen, PhD | Graduate Institute of Acupuncture Science, China Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | 404 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1351926 | Background | 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. | |
| 14698480 | Background |
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| 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) |
|
|
| 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) |
|
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| acupuncture | Device | Minimal needling at ST36 and GB34 |
|
|
| 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. |
| 36081814 | Derived | 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. |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| D006633 | Histamine Antagonists |
| D002744 | Chlorpheniramine |
| C018904 | dexchlorpheniramine |
| D013607 | Tablets |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D010632 | Pheniramine |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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