Abstract

PMS is a condition that affects a woman's emotions, physical health, and behavior during specific days of her menstrual cycle. In the weeks preceding up to menstruation, most women of reproductive age experience physical discomfort or anguish. Normal symptoms are mild, but they might be severe enough to prevent people from going about their daily lives. Between a week and a few days before menstruation, some women suffer a variety of physical, behavioral, and psychological changes [1]. The most prevalent physical symptoms are bloating, painful breasts, and acne, whereas the most common mental symptoms are mood swings [2][3]. In order to cater this unmet need in the management of PMS and related symptoms, Power Gummies has developed their nutritional supplement ‘That Time of the Month Gummies’, these are tasty gummies with goodness of micronutrients and herbal extracts with scientific references of having potential to manage PMS and related symptoms. The main aim of the study was to evaluate clinical benefits of Power Gummies: That Time of The Month in women experiencing premenstrual syndrome.

Introduction & Background Information

Premenstrual syndrome has a vast range of possible signs and symptoms, however most women only encounter a few of them. Signs and symptoms of emotional and behavioral disorders, anxiety or tension, depressed state of mind, periods of weeping, Irritability or wrath, as well as mood swing, changes in appetite and food desires, having difficulty falling asleep (insomnia), withdrawal from social situations, concentration issues. For diagnosis, there must be a consistent pattern of emotional and physical symptoms that occur after ovulation and before menstruation and which interfere with daily living [2]. Bloating, painful breasts, and acne are the most common physical symptoms, whereas mood swings are the most common mental symptoms [2][3]. The prevalence of PMS in India has been found to range from 14.3 percent to 74.4 percent. Premenstrual dysphoric disorder (PMDD) is a much more severe form of premenstrual syndrome (PMS). It may affect women of childbearing age. It's a severe and chronic medical condition that needs attention and treatment. In India, the prevalence of PMDD has been found to range from 3.7 percent to 65.7 percent in subjects showing sign and symptoms related to PMS. The severity of PMS is directly proportional to age, parity, educational status, socioeconomic status [4]. Current available treatment for PMS includes antidepressants, nonsteroidal anti-inflammatory drugs (NSAIDs) and diuretics. Long-term use of such drugs can lead to complications associated with them and short-term use may produce transient benefit. The currently available dietary supplements which are in conventional dosage forms are found with poor consumer compliance and thus treatment adherence. This in turn can decrease the outcomes and improvement in premenstrual syndrome.

In order to cater this unmet need in the management of PMS and related symptoms, Aesthetic Nutrition Pvt. Ltd., has developed a nutritional supplement ‘That Time of the Month Gummies’, these tasty gummies with goodness of micronutrients and herbal extracts with scientific references of having potential to manage PMS and related symptoms.

The present study deals with the evaluation of the safety and efficacy of Power Gummies in women experiencing premenstrual syndrome.

Materials & Methods

Materials

Power Gummies contain vitamins like C and B6 and herbal extracts of chasteberry, milk thistle, citrus bioflavonoids, passion flower which helps in reducing premenstrual syndrome and perceived stress scale.

Methods

After getting approval from the ethics committee, the study was registered on CTRI website with registration number CTRI/2021/10/037425 [Registered on: 21/10/2021]. Patients were enrolled in the study only after registration of study on CTRI website.

The primary objectives of the study were to evaluate changes in symptoms like irritability, anxiety, angry outburst, confusion, social withdrawal, breast tenderness, abdominal pain, headache, gastric disturbances like bloating, constipation, body pain, hot flushes, night sweat, swelling of extremities etc. on VAS scale (0-10) from baseline to end of the study. The changes in premenstrual tension scale (PMTS) scale along with changes in quality of sleep questionnaire score were assessed as outcome of the study on baseline and end of study.

The secondary objectives of the study were to evaluate changes in perceived stress scale score, complete blood count, reduced GSH and serum iron levels along with changes in score of Menstrual Regulation Behaviour Questionnaire on baseline and end of the study.

Inclusion Criteria

Females of age group between 18 to 40 years (both inclusive) visiting the outpatient department of study site were considered for the study. Females with regular/ irregular menstrual cycle with a cycle length of 21-35 days were enrolled into the study. Females having any 3 signs and symptoms of premenstrual syndrome were considered for the study. The irritability, anxiety, breast tenderness, abdominal pain, headache, mood swings and hot flushes were assessed as clinical symptoms for selection of the subject in the study.

Exclusion Criteria

Subjects on hormonal replacement therapy were not considered for the study. Subjects with known systemic and metabolic diseases in investigator discretion not proving fit for trial were not enrolled in the study. Subjects with diagnosed cases of psychiatric disorder were not considered. Pregnant and lactating mothers were excluded from the study.

Study methodology

After the ethics committee’s approval, the clinical study was registered on the CTRI website. subjects of age between 18 to 40 years of age (Females only) attending outpatient/consultation department of study site(s) were screened for eligibility criteria. On screening visit, a written informed consent was obtained from subject confirming participation in the study. Subject’s demographic details were recorded. Subject underwent clinical examination, blood tests like complete blood count, reduced GSH and serum iron. Subject’s medical, surgical and treatment history was taken. Subject’s current medication if any was noted in the case record from (CRF). Vitals were recorded. The subject was considered for further evaluation as per the inclusion and exclusion criteria.

During screening visit and the entire study duration subjects were advised to refrain from antioxidant agents, vitamins, anti-inflammatory drugs, hormones, Nutraceutical, Ayurvedic, Siddha, Unani, herbal /homeopathic medicines for maintenance of health.

For the treatment group, at baseline visit, subject was provided with one container (for 2 menstrual cycles) each containing 40 PMS Gummies. Subject was advised to consume a given supplement in a dose of 2 Gummies a day- 3 days before the due date of menstrual cycle, 4 days during cycle and after 3 days of cycle. A total of 10 days.

Investigational product compliance was assessed by the investigator every week and on each and every follow up visit. If subject continuously miss dosing for >3 consecutive days or total missed dose > 6 during the one assessment duration (one menstrual cycle), she was treated as drop out of the study. Subject was allowed to come for follow between 5-7 days after the scheduled follow up visit (After each menstrual cycle for two consecutive cycles). Subject was advised to continue the diet and exercise regimen (which they are already following) during the entire study period. After completion of 2 months of study treatment, subjects were asked to stop investigational product and take advice of investigator for further treatment. Palatability with dosage compliance was assessed from baseline to end of the study. Subject was closely monitored for any adverse event starting from baseline visit till the end of the study visit.

Observation & Results

Study groups and allocation

Subjects were randomly divided into two groups Group 1 PMS Gummies (Treatment Group) and Group 2 Cognitive Behaviour Therapy (Control group). Total 101 subjects were enrolled in the study and a 1:1 allocation of subjects was followed.

Demographics and Baseline Characteristics A total of 91 subjects were analyzed in the study, 46 in PMS Gummies and 45 in the control group respectively. Total of 101 subjects were screened in the study. Nine subjects were not selected for the study and ten subjects (5 in each group) were dropped out from the study.

Changes in Emotional Symptom Score At baseline subjects in both groups showed similar patterns and scores of the emotional symptoms associated with PMS. There is significant reduction in emotional symptom scores in both groups. There was more reduction in symptoms and was faster in the PMS Gummies group than control. The changes observed in irritability, anxiety, angry outburst, confusion and social withdrawn were 36.40%, 36.31%, 37.06%, 37.85% and 37.01% reduction respectively after the 2nd menstrual cycle.

Changes in Physical Symptom Score At baseline subjects in both groups showed similar pattern and scores of the physical symptoms associated with PMS. There is significant reduction in physical symptom scores in both groups. There was more reduction in symptoms and was faster in PMS Gummies group than control. There was 36.30% reduction in breast tenderness, 36.15% reduction in abdominal pain, 36.57% reduction in headache, 37.92% reduction in bloating and 37.48%, 36.28%, 35.49%, 35.12%, 36.30% and 36.76% reduction in constipation, body pain, hot flushes, night sweat, swelling of extremities and acne, respectively when observed after 2nd menstrual cycle.

Changes in Perceived Stress Scale Score

At baseline both groups demonstrated similar PSS scores 3 days before and during the menstrual period which significantly reduced after treatment in both groups. At day 60, there was a 26.2% and 16.3% decrease in PSS score in PMS Gummies and control group respectively.

Changes in premenstrual tension scale (PMTS) score

At baseline both groups demonstrated a similar PMTS score 3 days before and during menstrual period which significantly reduced after treatment in both groups. At day 60, there was 51.9% and 30.7% decrease in PMTS score in PMS Gummies and control group respectively.

Changes in Sleep Quality Scale (SQS) Score

At baseline, there was a comparable sleep quality score between groups 3 days before and during menstrual period. The SQS score improved after treatment in both groups significantly. The percent improvement in PMS Gummies and control groups were 90% and 64.2% respectively.

Discussion

The results of this study showed that the administration of Power Gummies: That Time of The Month was safe and effective in reducing premenstrual syndrome, perceived stress and complaints related to difficulty in sleeping.

According to the findings of the study, treatment with PMS Gummies was more effective than Cognitive Behavioral Therapy (CBT) and counseling in reducing the overall severity of physical and emotional PMS symptoms, perceived stress, premenstrual tension in young women with PMS along with improvement in quality of sleep.

Results of the present study demonstrated that the severity of physical and emotional symptoms decreased after the intervention in both groups, but PMS Gummies decreased the severity of symptoms more than control.

It was observed that treatment with PMS Gummies led to the reduction of emotional, physical, stress and sleep related issues in PMS when assessed for two consecutive menstrual cycles. CBT was used along with counseling for control and PMS Gummies group. It has shown producing significant effectiveness either but PMS Gummies produce more effect magnitude wise compared to control.

PMG Gummies provide right blend of herbal extracts and micronutrients such as Vitamin C, Vitamin B6, Magnesium Sulphate, Passion Flower Extract, Citrus Bioflavonoids, Milk Thistle Extract and Chaste berry Extract. The micronutrients and other extracts are medically proven to help reduce PMS discomfort in women. Magnesium may play a role in the development of affective mood disorders, anxiety, sleeplessness, and mood swings are also alleviated [7]. Passionflower is marketed as a dietary supplement for anxiety and sleep issues, regulate body temperature, relax muscles, reduce pain, heart rhythm issues, menopausal symptoms and attention deficit hyperactivity disorder (ADHD) [8]. Citrus bioflavonoids can be found in citrus fruits such as tangerines, oranges and grapefruit. They are available in a variety of combinations or as single supplements. These have been utilized to regulate the body's blood flow and reduce swelling. Chaste berry extract is one of the most popular female reproductive health supplements. Milk thistle is used first and foremost for its protective and regenerative effect on the liver. Milk Thistle is a useful herb to help in all situations where liver detoxification is indicated. In relation to women’s health issues, it is especially helpful for all imbalances linked to excessive estrogen, including PMS, cystic breasts, fibroids, endometriosis, hormonal acne and infertility.

A clinical trial for longer duration is warranted to further know more about what difference PMS Gummies with herbal and micronutrient fortification can bring in the management of PMS.

There were around 50% subjects in both groups who were used to having rescue medication during menstrual cycle for PMS, those subjects were considered moderate. After two cycles of treatment, only 10% of the population (4 subjects) in the PMS Gummies group consumed rescue medication compared to 25 subjects in the control group needing analgesic, antipyretic or antacid as a rescue medication. It itself suggests that though the control group showed significant improvement in symptomatological profile in patients it had the role of rescue medication, whereas the large population of the PMS Gummies treated group did not require rescue medication, itself suggests effectiveness of PMS Gummies as an intervention. There were no adverse events recorded during the study period in both groups.

The strength of the study was the general representation of women in society as a study participant. There were university students, working and homemaker young women participating in this study. This provides a pulse of effectiveness of PMS Gummies in PMS management for young women with wide educational, socio economic diversity as representation of society.

An intervention like PMS Gummies having nutritional corrections along with herbal extract fortification could be an effective tool in management of PMS and related symptoms. The present study confirms safety and effectiveness of PMS Gummies in management of PMS.

Conclusion

The need of reducing the severe symptoms of PMS has led to the development of this nutritional supplement, these gummies have the micronutrients and herbal extracts which help in reducing this condition. According to the findings of the study, treatment with PMS Gummies was more effective than Cognitive Behavioral Therapy (CBT) and counseling in reducing the overall severity of physical and emotional PMS symptoms, perceived stress, premenstrual tension in young women with PMS along with improvement in quality of sleep.

There was significant reduction in abdominal cramps, breast tenderness, acne and GI symptoms such as bloating and constipation with the treatment of PMS Gummies in two menstrual cycles. PMS Gummies treatment led to reduced stress and anxiety level, improved mood and quality of sleep.

90% of subjects in the PMS Gummies group did not require any rescue medication in the second menstrual cycle The strength of the study was the general representation of women in society as a study participant. An intervention like PMS Gummies having nutritional corrections along with herbal extract fortification could be an effective tool in management of PMS and related symptoms. The present study confirms safety and effectiveness of PMS Gummies in management of PMS.

Acknowledgements

The authors acknowledge the entire team involved in the clinical trial, including the clinical research associates, coordinators and entire back-office team and Aesthetic Nutrition Pvt. Ltd. to provide monetary support for this research.

References

1. Potter, J.; Bouyer, J.; Trussell, J.; Moreau, C. Premenstrual syndrome prevalence and fluctuation over time: Results from a French population-based survey. J. Women’s Health 2009, 18, 31–39.

2. Dickerson, Lori M.; Mazyck, Pamela J.; Hunter, Melissa H. (2003). "Premenstrual Syndrome". American Family Physician. 67 (8): 1743–52. PMID 12725453. Archived from the original on 2008-05-13.

3. "Premenstrual syndrome (PMS) fact sheet". Office on Women's Health. December 23, 2014. Archived from the original on 28 June 2015. Retrieved 23 June 2015.

4. Dutta, Abhijit, Sharma, Avinash. Prevalence of premenstrual syndrome and premenstrual dysphoric disorder in India: A systematic review and meta-analysis.