Supplementation with a high potency ginger extract may minimize the severity and intensity of menstrual pain and related symptoms, according to findings published in the Open Access Journal of Complementary and Alternative Medicine.
The trial included 50 healthy female subjects aged 18–35 years who had menstrual discomfort in the previous three consecutive months and who were diagnosed with primary dysmenorrhea, the clinical term for pre-menstrual syndrome (PMS). Subjects were instructed to record the severity of their menstrual cramps within the first three days of menstruation as baseline and in the first and second treatment follow-up cycles.
Conducted at Chennai Meenakshi Multispecialty Hospital in India, the study assigned participants to one of two groups, administering either 100 mg of Ginfort or placebo twice daily for 56 days. Ginfort, produced by Indian nutraceutical supplier Olene Life Sciences, is the newest offering in the DolCas Biotech portfolio.
Participants in the Ginfort group reported reduced frequency and severity of menstrual cramping from the first cycle, with an 84% reduction in spasms following two months of continuous dosing. Moreover, the women said they experienced relief from accompanying symptoms. Nausea, which affected roughly 80% of the women, was eliminated four weeks into the trial and remained absent throughout the 8-week investigation.
All subjects in the experimental group reported that they were completely satisfied with the treatment. In the placebo group, 46% of subjects were not satisfied and 54% were moderately satisfied.
“Taking ginger for PMS-type symptoms outside of its current short-term, peri-menstrual recommendations has merit,” said Shavon Jackson-Michel, an author on the study and director of medical and scientific affairs at DolCas Biotech. “We were suspecting that continuous use of Ginfort would improve the various study endpoints, for example, cramping, low back pain, nausea, and fatigue, but we were not sure. However, in deriving data that not only showed dramatic benefit at onset of use, but continual and cumulative benefit in the second cycle, we were pleasantly surprised.”
Dysmenorrhea is a substantial burden and more so than any other gynecological problem, affecting between 45-95% of women in their reproductive years, the researchers said. It is most associated with abdominal/uterine cramps, although other symptoms persist.
“Knowing the overlap between nausea and other GI symptoms and menstrual cramping, we thought to corroborate old data in the digestive space, with the potential for new data in our study of women with concomitant menstrual and digestive concerns,” Jackson-Michel said. “Physiologically, these two often occur together.”
The cause of primary dysmenorrhea is uncertain, but main features include uterine thickening and acute uterine contractions caused by excessive prostaglandin (PG) secretion, particularly PGE2 and PGF2 and leukotrienes, which play a role in acute and chronic inflammation. Family history, smoking, excessive bleeding, an irregular menstrual cycle, shorter or longer menstrual intervals, and stress are also common risk factors that can intensify symptoms.
According to the researchers, treating and managing dysmenorrhea not only improves women’s quality of life but also reduces the risk of female infertility and the development of chronic pain.
Some women, however, are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs), which are most used first-line pharmacological treatment for dysmenorrhea. Chronic use has also been associated with adverse effects including “gastrointestinal discomfort, central nervous system symptoms, nephrotoxic and hepatotoxic effects, hematologic abnormalities, bronchospasm, and edema,” the study noted.
Zingiber officinale (Ginger) is a medicinal plant with an extensive history of use in traditional medicine for the treatment of a variety of inflammatory conditions, including pain connected to dysmenorrhea.
The researchers on the study highlighted that the effectiveness of herbal extracts depends on the amount of active constituents present, which varies depending on the extraction and formulation techniques used.
“Lack of standardization and stability of ginger extracts are considered as primary reasons for varied results in past clinical trials with the extract,” they wrote. “Ginfort is a patented and stable high potency ginger extract.”
Ginfort is produced using Olene Life Sciences' Aqueosome or 'Trimolecular Complex' platform technology, which extends the benefit of a high dose paste extract of ginger to the powder format without significant loss or change to the quality or quantity of actives. DolCas Biotech explained that the technology increases the water solubility of Ginfort’s lipophilic polyphenols and produces a highlystable end product.
The researchers acknowledged study limitations including the absence of a “dose range evaluation of Ginfort, the inability to measure bleeding volume, the small sample size, and the fact that the study was conducted in a single center”. They recommended that future research compare the effects of Ginfort and standard NSAIDs on primary dysmenorrhea.
The study was funded and supported by Olene Life Sciences Private Limited, India.
Source: Open Access Journal of Complementary and Alternative Medicine
“High Potency Ginger Extract Reduces Menstrual Discomfort in Healthy Participants with Recurrent Dysmenorrhea Linked to Hypercontractility of the Uterus: a Randomized, Double-Blind, Placebo-Controlled Trial”
Authors: S. Nirvanashetty, et al