Menstrual Magic ® Clinical Study

Lloyd Trujillo, M.D.
FACOG
Fellow American College  of OB/GYN

DYSMENORRHEA,
HERBAL APPROACH TO MANAGEMENT

Dysmenorrhea, a common affliction of women, with its resultant painful menstrual cycles is notorious for creating cyclic monthly disability that is a leading cause for absenteeism from school and work. The two types of dysmenorrhea, primary and secondary dysmenorrhea are associated with peak levels of circulating prostaglandins, at the time of the menstrual cycle. Traditional pharmaceutical management for the treatment of this disorder has been to utilize COX-1/COX-2 inhibitors such as NSAIDS for the relief of painful cramps, albeit the use of these medications may have significant GI side effects that may limit their use.

The desire to seek out alternative management has led to increasing interest in herbal alternatives. Recently a traditional Eastern Mediterranean herbal remedy for primary dysmenorrhea has been evaluated as to its potential benefits in treating this malady.  Scientific analysis of this herbal alternative by the Dept. of Agriculture has recognized the three herbal constituents of Thyme, Sage, and Cumin as having biochemical composition with anti-prostaglandin benefits.

With the known anecdotal and historical treatment benefits associated with the use of this triad of herbal remedy in Eastern Mediterranean culture, efforts to extract the oils (Essential Oils, EO) from these herbs has proven to be successful.

In July of 2004 a study by Vedic Life Sciences(1), evaluated the effect of these EO’s and their potential for inhibition of uterine muscle contraction of the Wistar rat uterus, as well as simultaneous effects on prostaglandin level inhibition (specifically PGF2 alpha, and PGE2). Findings from this study revealed a dose dependent positive effect on prostaglandin inhibition. Also, Acute Oral Toxicity studies were performed on Sprague Dawley rats, resulting in no major adverse effects or mortality. Thus, with scientific evidence that prostaglandin inhibition was affected by the EO combination being studied, support of its potential clinical benefit could now be safely applied in a clinical evaluation.

In March of 2004 a clinical survey was underway whereby a group of women numbering 68 in total, were given samples of the EO in a gel cap form and were asked to complete a survey that encompassed questions regarding history of severity of menstrual cramps, and past personal treatment history. Of the 68 interviewed, 55 responded to the survey by completing a questionnaire after taking a sample of the EO, (2 gel caps). Questions regarding side effects and treatment efficacy were evaluated. Also, seventeen of the respondents were randomly selected, and underwent urinalysis testing to evaluate prostaglandin levels prior to taking the EO, and a follow up urinalysis 3 hours later after taking the EO to measure prostaglandin levels. Interestingly, the levels PGF2 alpha showed a fairly consistent decline after the first dose of the EO. However, the PGE2 levels did not show as consistent a decline if no change at all. Pharmacologically, the affect of PGF2 alpha on uterine muscle tone is well known to be a more potent modulator of smooth muscle contraction than PGE2. Further findings of the above clinical survey revealed the following information. One, that after a single dosing of 2 Gel caps of the EO, a significant number of patients felt relief of their cramps within the first hour. Second, the affect of the initial treatment was successful in fully relieving their pain for the remainder of their menses.

68 questionnaires with 55 respondents:

Results after taking 2 gel caps containing EO’s.

95% treatment efficacy with patients describing the following
56% > 24 hours relief
42% with no recurrent cramps after 3 days
23% had relief for 6 hours or less
5% no significant relief

Note: Patients initially describing average pain scale of  7.2(1=mild 10= severe). See graph 1

Onset of action after taking 2 gel caps containing EO”s.
93% relieved within 60 minutes
76% relieved within 30 minutes
47% relieved within 20 minutes
13% required 2 hours or longer.
(Included 3 patients with no change). See graph 2

Although these numbers are small in establishing the benefits that were seen with this survey, notable improvement in cramps relief was relatively consistent with those surveyed. A final survey related concern was the GI side effect of burping with the associated after taste of the herbal constituents. By adding mint this side effect was significantly diminished, otherwise no other significant side effects were noted.

As can be seen in the prostaglandin synthesis flow sheet. (See Image: Eicosanoid synthesis.png), the pathway to the formation of PGF2 alpha from PGE2, may well be an associated pathway along with the COX 1/COX 2 pathway blocked by the EO utilized in this herbal remedy for dysmenorrhea. This is implied by the negligible affect that the OE had on the PGE2 levels noted during the Rat study and the urine testing done in the clinical survey.

Obviously much more work will need to be done to fully understand the mechanism of action of this specific herbal remedy and its potential for benefiting those sufferers of cyclic menstrual pain. Even more so intriguing is the potential benefits that may be extracted from this information suggesting that COX1/COX2 inhibition by this herbal alternative could have significant medical use in the steroidal/  non-steroidal arena with its anti-inflammatory potential. Consideration for herbal intervention in treating arthritis, and asthma etc., is an alternative as suggested by these findings.
  
The outlook is promising in that research is showing that herbal alternatives have a significant scientific basis for alleviating common medical problems and have the added benefit of safety and efficacy.