RCT: Botanical blend Rhuleave-K controls hormones which impact menstrual cramp pain

Primary dysmenorrhea, aka menstrual cramping, is caused by natural chemicals called prostaglandins that are made in the lining of the uterus. The pain can be debilitating and accompanied by additional symptoms such as sweating, headache, nausea, vomiting and diarrhoea.

The burden of menstrual pain is the single most prevalent gynecological complaint that affects over half of women in their reproductive age. For many, the pain disrupts daily routines, leading to diminished work productivity, missed days at work or study, reduced sleep quality with knock-on effects on the overall quality of life.​

Non-steroidal anti-inflammatory medicines (NSAIDs) are a mainstay as they prevent prostaglandins’ production by inhibiting the enzyme cyclo-oxygenase (COX). However, NSAIDs may negatively impact the kidneys, liver, and circulatory system, raising the risk of thromboembolic problems. Herbal remedies could therefore be an effective solution. 

Ancient medicine utilised the powdered rhizome of Curcuma longa L​. (Zingiberaceae), also known as turmeric, to treat inflammation and wound healing while Boswellia serrata​ has demonstrated significant pharmacological efficacy in treating chronic inflammatory disorders. Sesame also has a known history of use in the ancient system of medicine related to menstrual irregularities. 

Using this ancient wisdom, Arjuna Natural developed its 'Rhuleave-K' botanical blend of turmeric and Boswellia extracts in a sesame oil base to help relieve pain.

Previous studies have found it an effective formulation for reducing musculoskeletal pain​. Therefore the present study was designed to investigate the effectiveness of the formulation for primary dysmenorrhea.

The study

The randomised, double-blinded, placebo-controlled study​, published in the 'Journal of Clinical Medicine', was conducted at the Smt. Meva Chaudhary Hospital in Jhansi, India, and involved 60 healthy women suffering from moderate to severe menstrual cramping.

In a one-day, single-dose study, the cohort of women was randomly split into two groups. One group was allocated 1000 mg Rhuleave-K in two soft gels, while the other received a placebo. The participants were administered their assigned treatments only when the menstrual pain reached a severity of 5 or greater on a 0–10 numerical rating scale (NRS).

After dosing, the participants were evaluated every 30 minutes for six hours to track changes in pain intensity and pain relief. The mean total pain relief of the treatment group was found to be 12.6 times better than the placebo group with a statistically significant difference at every 30-minute time point. Moreover, the overall difference in pain intensity following six hours of observation was 20 times better than the placebo group.  

“The excellent results we witnessed in the previous studies on musculoskeletal pain inspired us to see if we can extend Rhuleave-K’s benefits to other common forms of pain,” reports Benny Antony, PhD, Joint Managing Director for Arjuna Natural.

“Menstrual pain is a relentless burden for countless women globally. Many depend on over-the-counter NSAIDs to get pain relief. Yet more and more women are turning to natural therapies as they seek a comprehensive and enduring solution for menstrual pain relief. Rhuleave-K has the potential to offer an easy and rapid natural solution to this common issue, our company is dedicated to empowering women to take control of their well-being through natural solutions."

The report notes limitations of the study are the small sample size and the lack of a control group.

“Additional clinical trials are in the pipeline to further explore Rhuleave-K’s potential role in providing fast action menstrual pain relief and synergistic all-round support” concludes Antony.

Mechanism of action

It has been previously reported​ that curcumin was able to suppress the proliferation of endometrial cells by reducing estradiol level.

Bachmeier et al​. demonstrated estrogenic effects of putative phytoestrogens at physiological concentrations and showed estrogenic effects of curcumin. Estradiol is an important promoter of the growth of both eutopic and ectopic endometrium. The primary source of estradiol is the ovary, and estradiol has been recently found​ to be an effective regulator of endometriosis.

The effect of turmeric extracts on uterine contractions was investigated on strips isolated from mice uteri under the influence of estrogen. The results of the study​ indicated that these two herbal extracts may inhibit uterine contractions, which can be used as agents for the prevention of preterm labor. Their inhibition effects on contractions are caused by PGF2α, which could be useful for the treatment of dysmenorrhea.

Khayat et al., 2015​, reported that curcumin could modulate neurotransmitters and attenuate the physical symptoms of menstruation cycle by inhibiting COX-2 enzyme (prostaglandin E2 synthesis). 

Sesame (Sesamum indicum L.) oil in the test product contains the active compound sesamin. Sesamin, a sesame lignan, was recently reported​ to be converted by intestinal microflora to enterolactone, a compound with estrogenic activity. Enterolactone was the major metabolite of sesamin both in vivo and in vitro. 

Flaxseed lignans, isoflavones, and coumestans, have generally been categorized as the three major groups of phytoestrogens​. Enterolactone and enterodiol converted from flaxseed lignans by intestinal microflora are considered the agents responsible for estrogenic activity. It was reported recently that sesame lignans are also metabolised​ efficiently to enterolactone. Although it does not reduce serum oestrogen, sesame modulates hormone status​ to favour an environment that can antagonise oestrogen bioavailability and metabolism.

The authors of this study therefore suggest the unique composition of the test product relieves menstrual pain by selectively controlling the hormones that sense pain and controlling the contraction of the uterus to effectively shed the endometrium (lining) in a controlled manner, which contributes to preventing endometriosis that may develop at a later stage.

Source: Journal of Clinical Medicine

https://doi.org/10.3390/jcm12123968​

"Effect of Turmeric–Boswellia–Sesame Formulation in Menstrual Cramp Pain Associated with Primary Dysmenorrhea—A Double-Blind, Randomized, Placebo-Controlled Study"

Authors: Agarwal, D. and Chaudhary, P.