January 14, 2019

Help Fund Clinical Trial on Primary Dysmenorrhea

Do you have patients that experience Primary Dysmenorrhea (PDM)? Up to 90% of menstruating women in the United States experience PDM1 which is defined as pelvic pain directly before or during menstruation in the absence of a known pathology.1

Conventional treatment options for PDM include nonsteroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives (OCs).1

NSAIDs are generally safe when used in low doses for short time periods, but toxicity increases with increased dose and duration of the drug.2 In just a few days of use, gastrointestinal bleeding is observed in 41% of NSAID users3 and a number of adverse events have been shown to occur in clinical trials.3 Chronic use of NSAIDs results in: dyspepsia interfering with quality of life in 30% of users, gastrointestinal lesions in 35-60% of users, and gastric ulcerations in up to 25% of users.3 For PDM, NSAIDs are regularly prescribed to patients in dosages of 400 to 600 mg every four to six hours, or 800 mg every eight hours, beginning a few days before initiation of menses and continuing medication until the second or third day of menses.4

Oral contraceptive use is also associated with long-term risk. Long-term adverse events include an increased risk of cardiovascular disease, hypertension, stroke, venous thromboembolism, cervical cancer, and mild insulin resistance.5 Additionally, there is a lack of high-quality evidence to support the effectiveness of OCs for PDM.5

Pau d’ Arco (Tabebuia avellanedae) is a native Bignoniaceae tree located in Central and South America, the inner bark of which has been used medicinally for over 1,000 years.6 Tabebuia avellanedae has been shown to inhibit the expression of prostaglandin E2 and cyclooxygenase-27 in laboratory studies and has also been shown to be anti-inflammatory and to decrease pain responses in animal studies.6 Additionally, Tabebuia avellanedae has been shown to have antiulcerogenic properties, and to possibly be gastroprotective.8 Tabebuia avellanedae has not been associated with major adverse effects in human clinical trials.9

Ryan Bradley, ND, MPH and student Christine McClure are conducting a single arm, open label trial evaluating safety and tolerability of Pau d’ Arco as a natural alternative for PDM. This trial is Christine’s thesis as she completes her Naturopathic Doctor degree and Master of Science in Integrative Medicine Research degree at the National University of Natural Medicine.

Unfortunately, this trial will not exist without funding. A new method of raising research funding is being tried with an Indiegogo campaign, to raise the money needed to complete the trial above. This campaign is a student research project based on the social good of deceasing women’s pain. Additionally, this helps naturopathic medicine by increasing positive visibility of our profession and adding to our evidence base.

So please donate and share this campaign!


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