Scientific Research Clinical Cases

Homoeopathic Trifolium Pratense 30 As Clinical Alternative for Symptomatic Care of Menopausal Syndrome

dysmeno

In this study 15 female subjects were studied and those cases were purely managed with the help of Trifolium pratense 30. Every case was followed for a period of minimum 3 months.

Abstract

Objective: To determine the efficacy of Trifolium pratense 30 in Menopausal syndrome

Methodology: In this study 15 female subjects were studied and those cases were purely managed with the help of Trifolium pratense 30. Every case was followed for a period of minimum 3 months. The data were collected in standardized case record (SCR) format.

All the cases were analysed using AMS (Australian menopause society 2015) diagnosing menopause symptom score sheet before administration of homoeopathic medicine and three months after administration of medication.

Results: In this study Menopausal cases were reported in the age group of 46 to 50 years (8 patients – 53.3%), 40 to 45 years (6 patients – 40 %). and 1case (6.66%) in the age group of 51 to 55, mean age was 46.07 with Standard Deviation 2.66. and 100 % (15 cases) improvement after homoeopathic treatment using Trifolium pratense 30.

This study showed the mean score using Analysis of AMS diagnosing menopause: symptoms score sheet before the study was 23.47± 5.48 and after administration of Trifolium pratense 30, which reduced to 10.67± 4.56 showing 12.8 reduction in Analysis of AMS diagnosing menopause: symptoms score sheet with the p value of 0.000 which was statistically highly significant.

INTRODUCTION

The cases presented in this work were conducted to understand the efficacy of Trifolium pratense 30 in the treatment of menopausal syndrome. Menopause is one of the most significant events in a women’s life and brings in a number of physiological changes that affect the life of a women permanently and which incapacitate them from doing the day-to-day activities. 1

The average age of menopause in India is 47.5 years with an average of life expectancy of 71 years. Therefore, Indian women are likely to spend almost 23.5 years in menopause. About 35-40% women between 40 and 65 years have been diagnosed to suffer from Osteopenia and 8-30% suffers from Osteoporosis.2
Management and treatment of Menopausal symptoms depends on each individual woman. In conventional medicine the treatment for menopausal syndrome is hormonal therapy, but it has severe adverse effects.3

In a survey made by Katherine M. Newton for evaluating the use of alternative therapies for menopause symptoms, it was found that perimenopausal women were using alternative therapies and generally found them beneficial.4

The study done by M.M. Seidl and D.E. Wart on the treatment of menopausal symptoms has more than 200 reference cases showing that among them the strongest data support phytoestrogens for their role in diminishing menopausal symptoms related to Estrogen deficiency and for possible protective effects on bones and cardiovascular system.5

A randomized controlled clinical trial on 29 ladies to find the action of complementary and alternative medicines for menopausal symptoms showed that Black Cohosh and food that contain phytoestrogens show promise for the treatment of menopausal symptoms.

Clinical trials do not support the use of other herbs or CAM therapies, among the 29 of studies 12 dealt with soy/ soy extracts, 10 with herbs and 7 with other CAM therapies.6

Black cohosh may be effective for menopausal symptoms especially hot flushes, but the lack of adequate long-term safety data (mainly on estrogenic stimulation of the breast / endometrium) precludes recommending long term use.7

Modern studies confirm the anti-tumoral, anti-inflammatory and estrogenic effects of Trifolium pratense. The isoflavones biochanin A and genistein present in the leaves have estrogenic activity8. Methanol extract of Trifolium shows significant competitive binding to estrogen receptors alpha and beta.

In culture Ishikawa (endometrial) cells, Trifolium exhibited estrogenic activity, as indicated by induction of alkaline phosphatase activity and up-regulation of progesterone receptor activity.

In S 30 breast cancer cells, PS2 (presenelin-2) another estrogen- inducible gene, was up regulated in the presence of Trifolium pratense.9  Homoeopathy can help in such cases to reduce the frequency of the appearance and it gives complete improvement to the patient.10

Hence my research initiative is to clinically validate the effectiveness of Trifolium pratense (red clover) on Menopausal Syndrome and to prove the oestrogenic effect of this medicine. In the clinical setting, Menopausal Syndrome is evaluated by forming a questionnaire and analyzing the cases statistically.11

AIM AND OBJECTIVE:

To determine the efficacy of Trifolium pratense 30 in Menopausal syndrome

MATERIALS AND METHODS

This was a prospective observational study, conducted as a part of under graduate dissertation on the subjects reported to the OPD from July 2017 to February 2018.

Source of Data

The subjects were selected from the Out-Patient Department, in-patient department and peripheral centres of Father Muller Homoeopathic Medical College and Hospital, Mangalore.

Materials used

  • Standardized case record (SCR)
  • AMS (Australian Menopause society 2015) diagnosing menopause symptom score sheet.)

Table 1: AMS diagnosing menopause symptom score sheet

SYMPTOM SCORE SCORE BEFORE TREATMENT SCORE3 months AFTER TREATMENT
Hot flushes    
Light headed feelings    
Head aches    
Irritability    
Depression    
Unloved feelings    
Anxiety    
Mood changes    
Sleeplessness    
Unusual tiredness    
Back ache    
Joint pains    
Muscle pains    
New facial hairs    
 Dry skin    
Crawling feeling under the skin    
Less sexual feelings    
Dry vagina    
Uncomfortable intercourse    
Urinary frequency    
TOTAL    

 

SEVERITY OF PROBLEM IS SCORED AS FOLLOWS

SCORE: None =0; Mild =1; Moderate =2; Severe =3

NB: The symptoms are grouped into 4 categories, vasomotor, psychological, locomotor and urogenital.

Method of collection of data

A sample of 15 cases was studied using purposive sampling techniques as per the inclusion criteria and was followed for a minimum period of 3 months. There were not given any other drug during the period of treatment.

INCLUSION CRITERIA

  • The subjects included those whose age was above 40 years
  • The subjects included those whose age was below 55 years
  • Patients with clinical manifestation of menopausal syndrome

EXCLUSION CRITERIA

  • Patients with clinical manifestation of menopausal syndrome where they had been treated with other medication
  • Patients with clinical manifestation of menopausal syndrome who had undergone hysterectomy

RESEARCH HYPOTHESIS

  • ALTERNATIVE HYPOTHESIS
  • There is significant reduction in AMS diagnosing menopause: symptoms score after using Trifolium pratense 30
  • NULL HYPOTHESIS
  • There is no significant reduction in AMS diagnosing menopause: symptoms score after using Trifolium pratense 30

METHOD

The study was initiated after obtaining necessary permission from the institute’s authority. 15 female subjects were studied and those cases were purely managed with the help of Trifolium pratense 30.

Every case was followed for a period of at least3 months. The data were collected in standardized case record (SCR) format. All the cases were analysed using AMS (Australian menopause society 2015) diagnosing menopause symptom score sheet before administration of Homoeopathic medicine and three months after administration of medication.

Remedy

The remedy prescribed was manufactured at St. George Pharmaceutical Division Mangaluru, according to the standards of the Homoeopathic Pharmacopoeia of India (HPI) and dispensed at Father Muller Homoeopathic Medical College and Hospital, and its allied peripheral centres and subjects were advised to take 4 pills T.D.S. for 3 months.

Follow ups

All the 15 cases were reviewed after three months to assess the subjective and objective changes after the treatment. After following up the cases, the inferences were drawn by analysis of the outcome.

Diet and regimen

Patients were advised to have food rich in calcium, iron like milk, fish, egg, green leafy vegetables, legumes, nuts, soy products, include more fruits and vegetables in to the diet.

They were also advised to take sufficient water, avoid high fatty and high sugar foods and caffeinated drinks. A walk for at least 30 minutes to 1 hour daily is advised.

Assessment of effectiveness

Effectiveness of treatment was based on clinical improvement-disappearance or relief of symptoms. Post treatment intensity scores were compared with              pre- treatment disease intensity and statistically evaluated using paired ‘t’ test in GNU PSPP software installed  in windows 10 version.

RESULTS AND OBSERVATION

In this study the following observations were made:

Table 2: Distribution of cases according to age group

AGE NO. OF CASES PERCENTAGE
40 – 45 6 40%
46 – 50 8 53.33%
51 – 55 1 6.66%
TOTAL 15 100%

Homoeopathic Trifolium Pratense 30  As Clinical Alternative for Symptomatic Care  of Menopausal Syndrome 1

In this study, the highest number of menopausal cases was reported in the age group of 46 to 50 years (8 patients – 53.3%), 40 to 45 years (6 patients – 40 %). And 1case (6.66%) in the age group of 51 to 55

Table 2: Mean age Standard deviation

  N Minimum Maximum Mean Std deviation
Age 15 42 52 46.07 2.66

This present study showed mean age was 46.07 with Standard Deviation 2.66

Table 3: Distribution of cases according to the results

RESULT NO. OF CASES PERCENTAGE
Improved 15 100%
Not improved 0 0%

Homoeopathic Trifolium Pratense 30  As Clinical Alternative for Symptomatic Care  of Menopausal Syndrome 2

This study showed 100 % (15 cases) improvement after homoeopathic treatment using Trifolium pretense30.

Table 4: Distribution according to AMS diagnosing menopause: symptoms score sheet

SL.NO CASE SCORE BEFORE

TREATMENT

SCORE AFTER

TREATMENT

1 Case 1 33 9
2 Case 2 30 12
3 Case 3 29 10
4 Case 4 26 8
5 Case 5 25 4
6 Case 6 17 8
7  

Case 7

25 15
8 Case 8 20 5
9 Case 9 21 7
10 Case 10 19 10
11 Case 11 18 15
12 Case 12 19 12
13 Case 13 32 21
14 Case 14 18 16
15 Case 15 20 8

Homoeopathic Trifolium Pratense 30  As Clinical Alternative for Symptomatic Care  of Menopausal Syndrome 3

Table 5 Analysis of AMS diagnosing menopause: symptoms score sheet

  N Mean Std. Deviation S.E Mean
BEFORE 15 23.47 5.48 1.41
AFTER 15 10.67 4.56 1.18

Homoeopathic Trifolium Pratense 30  As Clinical Alternative for Symptomatic Care  of Menopausal Syndrome 4

Table 6: Paired sample test result

  Paired differences T value df P value
mean Std deviation S E Mean 95% CI interval of the difference

 

LOWER                UPPER

Before After 12.80 6.43 1.66 9.24 16.36 7.71 14 .000

In this study the mean score using Analysis of AMS diagnosing menopause: symptoms score sheet before the study was 23.47± 5.48 and after administration of Trifolium pratense 30 which reduced to 10.67± 4.56 showing 12.8 reduction in Analysis of AMS diagnosing menopause: symptoms score sheet with the p value of 0.000 which is statistically highly significant.

Question to be answered:

RESEARCH HYPOTHESIS

  • ALTERNATIVE HYPOTHESIS
  • There is significant reduction in AMS diagnosing menopause: symptoms score after using Trifolium pratense 30
  • NULL HYPOTHESIS
  • There is no significant reduction in AMS diagnosing menopause: symptoms score after using Trifolium pratense 30

Inference:

In this study, the highest number of menopausal cases was reported in the age group of 46 to 50 years (8 patients – 53.3%), 40 to 45 years (6 patients – 40 %). And 1case (6.66%) in the age group of 51 to 55, and the mean age was 46.07 with Standard Deviation 2.66. It showed 100 % ( 15 cases) improvement after homoeopathic treatment using Trifolium pratense30. In this study the mean score using Analysis of AMS diagnosing menopause: symptoms score sheet before the study was 23.47± 5.48 and after administration of Trifolium pratense 30 which reduced to 10.67± 4.56 showing 12.8 reduction in Analysis of AMS diagnosing menopause: symptoms score sheet  with the p value of 0.000 which is statistically highly significant.

Thus the research hypothesis is accepted, suggesting Trifolium pratense 30 is effective in treating menopausal syndrome.

DISCUSSION

In this survey a total of 15 cases were studied. The cases selected were relatively well taken and remedies prescribed on the basis of symptom totality. Out of 15 cases, all the cases showed improvement.

The average age of menopause in India is 47.5 years with an average of life expectancy of 71 years. Therefore Indian women are likely to spend almost 23.5 years in menopause. About 35-40% women between 40 and 65 years have been diagnosed to suffer from Osteopenia and 8-30% suffers from Osteoporosis.
Management and treatment of Menopausal symptoms depends on each individual woman. In Modern Medicine the treatment for Menopausal syndrome is Hormonal Therapy, but it has got severe adverse effects. 1

In this study a total of 15 cases were studied. The cases selected were relatively well taken and the highest number of menopausal cases was reported in the age group of 46 to 50 years (8 patients – 53.3%), 40 to 45 years (6 patients – 40 %). And 1case (6.66%) in the age group of 51 to 55, mean age was 46.07 with Standard Deviation 2.66.

This study showed 100 % (15 cases) improvement after homoeopathic treatment using Trifolium pratense30.

In this study the mean score using Analysis of AMS diagnosing menopause symptoms:  score sheet before the study was 23.47± 5.48 and after administration of Trifolium pratense 30 which reduced to 10.67± 4.56 showing 12.8 reduction in Analysis of AMS diagnosing menopause: symptoms score sheet with the p value of 0.000 which was statistically highly significant.

Trifolium pratense (red clover) contains chemicals called isoflavones, which belong to a larger class of plant chemicals known as phyto (plant-derived) estrogens, red clover is often taken to relieve symptoms of premenstrual syndrome (PMS).

Isoflavones are similar in shape to the female hormone, estrogen. Therefore, they may attach to estrogen receptors throughout the body particularly in the bladder, blood vessels, bones, and heart.

In the literature there is no clear mental picture of this remedy. The patients usually seem to have emotional problems. And also, action of the remedy on females is not well studied. There is an absence of scientific data on its mode of action when applied clinically on a homoeopathic basis and more research is needed. The Materia Medica recommends the use of the mother tincture, but I have experienced good improvement in the symptoms when it is given in 30C potency.

SUMMARY & CONCLUSION

  • This present study showed that red clover supplementation had a desirable effect on menopausal women’s quality of life with a detail study of efficacy of Trifolium pratense 30 in the treatment of Menopausal syndrome.15 cases were taken for the study.
  • Prevalence of menopausal syndrome is more common in the age group of 46-50 years.
  • Out of 15 cases all showed improvement after treatment.
  • This case study helped to understand various cases of menopausal syndrome and the action Trifolium pratense on it.

BIBILIOGRAPHY

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4539866/ Urvashi P J, Sonia M, Clinical Practice of Menopausal Medicine: How &  Why? elsevier india private limited2007;18-36
  2. Kass a, Barbara RNCNP, MSN, Alternative therapies for menopause;
  3. clinical obstetrics and gynecology: march 2000: 43; 162-183.
  4.           https://journals.lww.com
  5. M. Newton, Diana.S: Use of Alternative Therapies for Menopausal Symptoms: results of a population based survey; Obstetrics and Gynecology, Jan 2003; pg 205.
  6. Seidl M M, S tewart D E, Alternative treatments for menopausal symptoms. Systematic review of scientific and lay literature; 1998 Aug ;44:1598
  7. Kronenberg F, Fugh- Berman A. Complementary and alternative medicine for menopausal symptoms: a review if Randomized, Controlled Trials. Annals of Internal Medicine 2002; 137(10): 805-813. http://www.annals.org/cgi/content/full/137/10/805.
  8. K M Newton, SD Reed, AZ La Croix, Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo : a randomized controlled trial; Annals of internal; 2006
  9. JoannaT, CoonM, Pittler H, Trifolium pratense isoflavones in the treatment of Menopausal hot flushes: A systematic review and meta-analysis; https://doi.org/10.1016/j.phymed.2006.12.009Get rights and content
  10. Liu J, Burdette JE, XuHGu C, van Breemen RB, et al. Evaluation of estrogenic activity of plant extracts for the potential treatment of menopausal symptoms. J Agric Food Chem 2001; 49: 2472-2479.
  11. Murphy R. Lotus Materia medica. B Jain publishers (P) Ltd. New Delhi; 2010.
  12. Parvu E, Trifolium pratense for breast disease: a case series: Homoeopathy.2003 Sep; 93: 45-50.

About the author

Ancy George

Dr. Ancy George - Part I MD, Department Of Pediatrics, Father Muller Homoeopathic Medical College.

Leave a Comment