Topical Use of Plant Extract-Based Oil Blend in Relieving the Symptoms of Primary Dysmenorrhea: An Independent Clinical Study

Topical Use of Plant Extract-Based Oil Blend in Relieving the Symptoms of Primary Dysmenorrhea: An Independent Clinical Study

Amul S. Bahl
DOI: 10.4018/IJHSTM.2021010102
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Abstract

A high occurrence of primary dysmenorrhea denotes a considerable female health concern. The objective of this study has been to evaluate the efficacy of topical application of a synergistic blend of plant-extracts oil in relieving the symptoms of primary dysmenorrhea (menstrual pain, pain duration, and menstrual flow). The study design was randomized, double-blind, multi-phasic and was a placebo-controlled cross-over study. Participants were females, 18-20 years old with regular cycles and suffering from symptoms of primary dysmenorrhea. Sixty-four participants were randomly allocated to apply either the test oil or the placebo for first phase of the study. For the second phase, the interventions were switched. It was assessed that topical application of the oil significantly and efficiently reduced 1) menstrual pain within 30 minutes during the first three days of menstruation, 2) duration of menstrual pain during the first three days of menstruation, and 3) amount of menstrual flow as compared to the placebo.
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Introduction

Primary dysmenorrhea, commonly referred to as menstrual pain that occurs in lower abdomen area at the onset of menstruation, is one of the prevalent gynaecological disorders which affect more than 50% of women of reproductive age (Durian, 2004; Jamieson & Steege, 1996; Coco, 1999) and can severely restrict daily activities. It is differentiated from secondary dysmenorrhea referred to as painful menses resulting from identifiable gynaecological or pelvic pathology such as endometriosis (Durian, 2004).

The epidemiology of primary dysmenorrhea is difficult to ascertain because it is interpreted differently by each affected individual. Based on various reports, the occurrence of primary dysmenorrhea appears to vary between 25% to 90% among different countries and ethnicities with various severities (Chen et al., 2020; Conney et al., 2019; Okusanya et al., 2009; Durian, 2004; Banikarim et al., 2000; Coco, 1999). The prevalence rates of primary dysmenorrhea were reported as follows (Sut & Kahyaoglu-Sut, 2018): 89.1% in Iran (Habibi et al., 2015; Mirabi et al., 2014), 52.07% in Georgia (Gagua et al., 2012), 64% in Mexican university students (Ortiz, 2010), 87.8% in Turkish university students (Polat, 2009), 48.4% in Mexican high school students (Ortiz et al., 2009), 75% in secondary school students from urban and rural areas in Mansoura, Egypt (El-Gilany et al., 2005), 77% in Ethiopia (Gebeyehu et al., 2018), 69.4% in Malaysia (Lee et al., 2006), 60% in Canada (Burnett et al., 2005), and 80% in Australian high school girls (Hillen et al., 1999). The dysmenorrhea prevalence in women aged 18-45 years in the USA was reported as 90% (Jamieson & Steege, 1996). De Sanctis et al. (2015) reported that the prevalence of primary dysmenorrhea varied from 16% to 93%; the prevalence of perceived severe dysmenorrhea varied from 2% to 29% among girls. Studies in the Indian context have shown the occurrence range between 50% to 87.8% (Omidyar et al., 2016; Agarwal & Agarwal, 2010; Patel et al., 2006; Nair et al., 2007; Singh et al., 2008). Almost 70% of dysmenorrheic females experienced moderate to severe dysmenorrhea, whereas 5-20% of the participants reported severe pain that restricted daily activities (Omidyar et al., 2016).

The high occurrence of primary dysmenorrhea amid females denotes a considerable public health problem. One of the main effects resulting directly from the severity of the disorder is the absenteeism from a place of study or work. Longitudinal studies of young women determined that absenteeism rate lie between 34% to 50% (Andersh & Milson, 1982; Sundell et al., 1990). Based on these reports, it was estimated that absenteeism due to primary dysmenorrhea has accounted for an annual economic loss of 600 million work hours and 2 billion dollars in productivity (Dawood, 1984). A transverse study conducted in a South Indian city reported that approximately 50% of dysmenorrheic girls take absence from schools or colleges (Omidyar et al., 2016).

The first and second line of treatments, that are commonly recommended by a physician and employed in general by women, are Non-Steroidal Anti Inflammatory Drugs (NSAID) and oral contraceptive pills (OCP). However, both NSAID and OCP may result in some adverse outcomes. Around 10% of those who suffer from primary dysmenorrhea do not get relief with NSAID or OCP. Instead, some women develop or have contraindications to these medications (Lee & Kim, 2020; Urbina, Gutierrez, & Acre, 2019; Kaplan et al., 1994). Therefore, it seems necessary to find non-pharmacological, easy to use, effective and safer treatment for dysmenorrhea. Alternative treatments, which may range from acupuncture to laparoscopic surgery, have been referred to, but even though all such treatments have demonstrated some relief of dysmenorrhea symptoms, their efficacy has not been clinically established (Kaplan et al., 1994; Milson et al., 1994; Helms, 1987; Proctor & Murphy, 2001; Chen et al., 1996). A clinical study has shown the reduction in emotional, physical and behavioural symptoms in pre-menstrual syndrome with Valerian root extract tablets (Moghadam et al., 2016). A significant reduction in the pain and symptoms of dysmenorrhea was seen with ginger supplement (Vahdatpoor et al., 2019) whereas in another study (Shirooye et al., 2017) ginger usage in both oral and topical form was found effective to reduce pain. However, topical ginger oil usage with no complications was considered a better option than oral ginger supplement. A systematic review has studied the efficacy of a traditional herbal formula, that is Xuefu Zhuyu decoction, for primary dysmenorrhea treatment but found the results inconclusive due to small number of studies and a high bias risk (Leem et al., 2019).

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