NCT03881319

The Efficacy of Different Doses of Acupuncture in Dysmenorrhea

Status unknown NA Last updated 19 March 2019

What this trial tests

NA trial testing Conventional gynecologic treatment in Premenstrual Syndrome in 105 participants. Status unknown.

Timeline

1 June 2018

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Taipei City Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	1 June 2018
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across Taiwan

Drugs / interventions tested

• Conventional gynecologic treatment — full drug profile →
• Low dose acupuncture
• High dose acupuncture

Conditions studied

• Premenstrual Syndrome — all drugs for Premenstrual Syndrome →
• Dysmenorrhea — all drugs for Dysmenorrhea →

Sponsor

Taipei City Hospital

Who can join

Adults 19 to 49, female only, with Premenstrual Syndrome or Dysmenorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Subjects in this study included premenstrual syndrome and dysmenorrhea.

Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus.

In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few.

Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Do different doses of acupuncture matter on autonomic nervous activity and symptom management in dysmenorrhea? A randomized controlled trial.
   Chien T, Huang Y, Kuo C, Cho Y, et al · · 2020 · DOI 10.21203/rs.3.rs-29051/v1