Homoeopathic treatment of heavy menstrual bleeding due to uterine fibroids in reproductive age group: An open-label, prospective, observational trial
Pritha Halder1*, Subhas Singh2
- Postgraduate Trainee, Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Govt. of India
- Head, Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Govt. of India
Background: Heavy menstrual bleeding (HMB) due to uterine fibroid is a debilitating condition where hysterectomy is one of the several surgical procedures as definitive treatment for it, which compromises fertility and or uterus in women. The primary objective of this study was to evaluate the effect of individualized homoeopathic medicines on HMB due to uterine fibroids in reproductive age group by Higham’s Pictorial Blood Loss Assessment Chart (PBAC). The secondary objectives were to assess the changes in the size of uterine fibroid and the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QOL).
Methods: An open label, observational, prospective, clinical trial was conducted on 30 patients at National Institute of Homoeopathy. The primary outcome measure was Higham’s PBAC score and the secondary outcomes were the sizes of the uterine fibroids and UFS-QOL questionnaire scores, all assessed at baseline and after 3 months of treatment. Individualized medicines were prescribed on the basis of homoeopathic principles.
Results: Sixty four patients were screened, 35 were enrolled, 5 dropped out, 30 completed the trial. Protocol-compliant sample (n=30) was analyzed in the end. There were statistically significant reductions in PBAC score [291.3 ± 159.4 vs. 106.3 ± 79.4; mean reduction 185.0, 95% CI 132.3 to 237.7, P < 0.001, paired t test], significant improvement in UFS-QOL transformed total scores [18.8 ± 17.4 vs. 49.5 ± 15.5; mean increase 30.7, 95% CI 25.0 to 36.4, P < 0.001, paired t test], and significant decline in size of fibroids [14449.4 (IQR 4270.3 to 808917.9) vs. 18648.5 (IQR 29993.8 to 76403.8), median reduction 4199.1 mm (IQR 1279.5 to 4414.1), P = 0.028, Wilcoxon signed rank test] after 3 months of individualized homoeopathic treatment.
Conclusion: Homoeopathic medicines appeared to be effective in uterine fibroids induced HMB in reproductive age group. Randomized trials are warranted
Keywords: Homoeopathy; Heavy menstrual bleeding; Uterine fibroids; Quality of life; Observational trial
Uterine fibroids are benign, monoclonal tumour of the smooth muscle cells in the human uterus and are composed of large amounts of extracellular matrix containing collagen, fibro-nectin, and proteoglycan [1, 2]. Cellular leiomyomas are defined by the World Health Organization (WHO) as leiomyomas having significantly high cellularity compared to surrounding myometrium; they lack tumor necrosis, atypia, and mitotic figures [3-5]. This benign gynaecological tumour occur in 25% of women in reproductive age and about 40% have symptoms severe enough to warrant therapy [6, 7] They are clinically apparent in up to 25% of women  and cause significant morbidity which includes prolonged or heavy menstrual bleeding (HMB), pelvic pressure or pain and in rare cases reproductive dysfunction . It leads to decreased quality of life. The distribution of fibroid in the body of the uterus can broadly be classified as intramural (75%), submucous (15%) and subserous (10%) . Uterine fibroids lead to nearly 600000 hysterectomies performed each year in the USA and 37000 myomectomies performed annually , nevertheless, epidemiological data on fibroid prevalence and incidence are limited and reliable population-based research is lacking . In India up to 30% women suffer from HMB at some point of their lives [12, 13]. Nearly, 20-30% women in reproductive age group have fibroid uterus .
HMB is defined as menstrual blood loss more than 80 ml per cycle, which is commonly accepted and is used in clinical researches . It has been well defined in the routine clinical context on the basis of the patients presenting complaint in the NICE Guidelines  – “heavy menstrual bleeding may be defined as excessive menstrual blood loss which interferes with the women’s physical, emotional, social and material quality of life, and which can occur alone or in combination with other symptoms”.
Predisposing factors generally overlap; nevertheless, it is assumed that the impact of each factor is related to its interference with the levels and metabolism of sex steroids and their metabolites . Classically recognized risk factors are obesity , a younger age at menarche , nulliparity, black ethnicity  and age, with incidence peaking at the fourth decade [17, 21]. The pathophysiology of myomas is not well understood. However, genetic predisposition, as well as steroid hormone concentrations, has a role in formation and growth of these tumors, as do growth factors important in fibrotic processes and angiogenesis. The function and structure of the endometrium are important to the pathogenesis of myoma-related bleeding .
Fibroids are asymptomatic in 20-50% cases . In symptomatic patients, the clinical features include menstrual abnormalities (especially progressive menorrhagia ), pelvic pain, dyspareunia and pressure , and fertility issues . Standard medical treatments may decrease symptoms potentially related to fibroids and this includes COC (Combined oral contraceptives), Progestogens, LNG-IUS (Levonorgestrel releasing intrauterine system), GnRH-a (Gonadotropin-releasing hormone analog), SPRM (Selective progesterone receptor modulators) etc. which although has potential benefits but are not devoid of potential risks and side-effects. Most of them are not capable of treating the tumor itself but leads to marked decrease in fibroid volume, symptomatic control in many patients, who may prefer treating their conditions medically rather than resorting to invasive procedures .
The most frequently consulted alternative therapist for uterine fibroids is a homoeopath ; however, there is an acute paucity of published research. In the single randomized trial  by CCRH on 216 patients, LM and CH potencies were found equally effective in giving symptomatic relief to patients. In a prospective observational study on 45 patients by Ghosh et al , there was significant reduction in fibroid size and symptom severity, and significant improvement in UFS-QOL scores over 6 months individualized homoeopathic treatment; however, the validity of the translated Bengali version of UFS-QOL questionnaire remained untested. In another prospective observational study by Quadri et al , on 103 patients, positive results in terms of reduction and resolution of fibroids with homoeopathic treatment. Another open observational study conducted by Gupta  on 557 patients revealed that 65.7% of patients were healed completely or at least significantly improved as evidence by ultrasonography. The author’s another observational study  on 217 patients showed that after homoeopathic treatment, 74 patients were cured, 21 were best improving, showing more than 50% reduction in the size of fibroid, 64 showed significant improvements. Popov’s study  showed that homoeopathic medicines not only controlled pain and abnormal endometrial bleeding, but also reduced the size and stopped the growth of the fibroid. Iqbal , in their cohort study showed positive results in terms of reduction and resolution of fibroids. Case reports [33, 34] demonstrated both symptomatic relief and reduction of fibroid size with homoeopathic medicines using both CH and LM potencies.
The primary objective of this study was to evaluate the effect of homoeopathic medicines in HMB due to uterine fibroids in reproductive age group by Higham’s Pictorial Blood Loss Assessment Chart (PBAC) . The secondary objectives were to assess the changes in the size of the uterine fibroids and to assess the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QOL) .
Trial design: This open label, prospective, observational, non-randomized, non-controlled clinical trial of pre-post comparison design was conducted at the Obstetrics and Gynecology out -patient department of National Institute of Homoeopathy, Kolkata, India. The study protocol was approved by the Institutional Ethical Committee (IEC) [Ref. No. 5-023/NIH/PG/Ethical Comm. 2009/Vol. III/ 1960 (A/S); dated March 27, 2017]. The trial protocol (unpublished) and full dissertation was submitted as postgraduate thesis of the corresponding author to the West Bengal University of Health Sciences.
Participants: Inclusion criteria were the patients who have been suffering from uterine fibroids (confirmed by pelvic and/or transvaginal ultrasonography; 2018/19 ICD-10-CM diagnosis code D 25.9) induced HMB, women of reproductive age group, i.e. between 18 and 45 years, literate patients who are able to read Bengali and/or English, and the patients willing to give written consent to participate in the trial. Patients taking oral contraceptive pills (OCPs) were advised to stop pills till it exhausted for the ongoing cycle, followed by re-assessment of symptoms in the next cycle enrolment. Patients under hormonal replacement therapy (HRT) were included after a washout period of 3 months. Exclusion criteria were asymptomatic fibroids, patients with calcified fibroid, coagulation disorders, extra-uterine fibroid, polyp, cervical fibroid, any fibroid causing hydronephrosis, fibroid with solid ovarian mass, unevaluated gynecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases (PID) within one month, patients with suspicious adenomyosis, gross developmental defect or congenital abnormalities of the uterus etc., patients with hemoglobin less than 7 gm/dl (severe anemia), recent rapid growth of fibroid; i.e. doubling in size within last one to six months, diagnosed or suspected genito-urinary tract malignancy or genito-urinary tract polyp, patients desiring or requiring immediate surgical management for uterine fibroid, previous history of myomectomy, myolysis, uterine artery embolisation, etc., for uterine fibroids, patients desiring for childbearing within next year, patients insisting to use OCPs, patients with psychiatric diseases, pregnancy and lactation, cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure, cases already undergoing homoeopathic treatment for any chronic purpose, and substance abuse and/or dependence.
Intervention: Intervention was planned as administration of indicated homoeopathic medicines in centesimal or 50 millesimal potencies and in individualized dosage, as decided appropriate to the case or condition. In centesimal potencies, each dose consisted of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 90% v/v ethanol. In 50 millesimal potencies, a single medicated cane sugar globule of poppy seed size (no.10) was dissolved in 50 ml distilled water with addition of 2 drops of 90% v/v ethanol, 10 doses were marked on the vial, each dose of 5 ml was instructed to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Each dose was directed to be taken orally on clean tongue with empty stomach. Duration of such therapy was 3 months. Medicines were obtained from SBL Pvt. Ltd. and Homoeopathy International® – Good Manufacturing Practice certified firms. Single individualized medicine was prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using RADAR® software when required with due consultation with Materia Medica. Subsequent prescriptions were generated as per Kent’s observations and Hering’s law. Participants were assessed by two homoeopaths at a time. Medicine was selected on each occasion by two homoeopaths by consensus. All the homoeopaths involved were affiliated with respective state councils.
General management: All patients were advised to take nutritious foods, iron, protein and vitamin rich diet, and to avoid all kinds of physical and mental over-exertions. They were advised to be present for monthly follow-ups.
Primary outcome measure: Primary outcome measure was Higham’s PBAC  (a score of ≥ 100 points indicates probable HMB); measured at baseline and after 3 months of treatment. The formula used for calculation was as follows:
((PBAC score at baseline-PBAC score after 3 months)/(PBAC score at baseline))*100
The chart consists of a series of diagrams representing lightly, moderately and heavily soiled tampons or towels. In addition, passage of clots and episodes of flooding were also recorded. A numerical scoring system was devised to coincide with the amount of blood lost. Higham et al reported that when the PBAC was used as a diagnostic clinical tool, a score of 100 or more diagnosed menorrhagia with a sensitivity and specificity of more than 80% . For each heavily, medium and lightly soaked pads 20, 5, and 1 point was given respectively.
Secondary outcome measures:
- As the received trans-abdominal ultrasonography reports did not contain dimensions of all the fibroids in case of multiple ones, the size of the largest fibroid was considered. The sizes of the fibroids were measured at baseline and after 3 months of treatment by using the following formula. The size of the uterine fibroids presented with 3 dimensions were measured taking the three main diameters (D1/D2/D3) and applying the formula of the ellipsoid (D1 × D2 × D3 × 0.52); and that of for 2 dimensional fibroid the size was measured using the formula 4 × π × D1/2 × D2/2; for 1 dimensional uterine fibroid the size was measured by the formula 4/3πr3 (r = radius of the fibroid) .
- The UFS-QOL questionnaire, as devised by Spies et al , was used at the baseline, and after 3 months of treatment to examine the effect of homoeopathic medicines on the quality of life of patients. The UFS-QOL is a disease-specific questionnaire that assesses symptom severity and HRQL in patients with uterine fibroids. It consists of an 8-item symptom severity scale and 29 HRQL items comprising 6 domains – Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function. All items are scored on a 5-point Likert scale, ranging from “not at all” to “a very great deal” for symptom severity items and “none of the time” to “all of the time” for the HRQL items. Symptom severity and HRQL subscale scores are summed and transformed into a 0-100 point scale. The Symptom Severity scale and HRQL subscale scores are inversely related with higher Symptom Severity scores indicating greater symptoms while higher HRQL subscale scores indicate better HRQL. Before this trial was initiated, the UFS-QOL questionnaires underwent standardized forward-backward translation into local vernacular Bengali, was checked for face and content validity, and subjected to pilot testing and thereafter formal psychometric validity and reliability testing, but will be reported elsewhere and beyond the scope of this paper.
Sample size: No relevant data was available on reduction of PBAC scores by individualized homoeopathic treatment using an open observational study design over 3 months of intervention. Thus assuming a medium effect size (d) of 0.5, alpha = 0.05 and power of 85%, to detect a significant difference between two dependent means of PBAC scores (primary outcome) by paired t test, we would have required a sample size of 35.
Statistical methods: The analysis was carried out with per protocol approach; i.e. only the protocol-compliant sample entered into the final analysis. The baseline descriptive data (categorical and continuous) were presented in terms of absolute values and percentages. Non-parametric (Wilcoxon signed rank test) or parametric tests (Student’s t test) were planned to be used as inferential statistics as per normality of data distribution comparing dependent observation of continuous outcomes at baseline and after 3 months. P values less than 0.01 were considered as statistically significant. No interim and subgroup analyses were planned. Reporting adhered to the CONSORT  and RedHot  guidelines for reporting trials, Mathie’s criteria for model validity of homoeopathic treatment [41, 42] (MVHT) and Saha’s criteria for reporting quality of homoeopathic individualization in clinical trials .
Participant flow: As per the pre-specified inclusion and exclusion criteria, 64 subjects suffering from uterine fibroids induced HMB were screened; 29 were excluded on account of various reasons; 35 met the eligibility criteria and were enrolled into the trial. Following that, baseline socio-demographic and outcome data was obtained. After 3 months of intervention, outcome data was recorded again. During course of treatment, 5 dropped out; 30 completed the trial. (Fig. 1)
Fig. 1: Study flow diagram
Recruitment: Starting from August 2017, follow up of the last enrolled patient was completed by the end of May 2018.
Baseline data: Different variables were studied for the baseline features of the subjects – age, marital status, parity, residence, religion, educational status, and employment status. (Table 1)
Table 1: Baseline socio-demographic data (N=30)
|Age groups (years):
§ 18 – 25
§ 26 – 30
§ 31 – 35
§ 36 – 40
§ 41 – 45
§ Married : Unmarried : Divorcee
27 (90) : 2 (6.7) : 1 (3.3)
§ Nullipara : Primipara : Multipara
5 (16.7) : 13 (43.3) : 12 (40)
§ Hinduism : Islam
25 (83.3) : 5 (16.7)
§ Rural : Urban : Sub-urban
8 (26.7) : 8 (26.7) : 14 (46.7)
§ Secondary : Higher secondary : graduation
13 (43.3) : 6 (20) : 11 (36.7)
§ Housewife : Employed
19 (63.3) : 11 (36.7)
§ Lower : Middle
11 (36.7) : 19 (63.3)
Numbers analyzed: Outcomes from 30 out of 35 subjects were complete and only those entered into the final analyses.
Outcomes and estimation: Reduction in PBAC score over 3 months of homoeopathic treatment was statistically significant [291.3 ± 159.4 versus 106.3 ± 79.4, mean reduction 185.0, 95% CI 132.3, 237.7, P < 0.001, paired t test]. Similarly, reductions in total raw and transformed UFS-QOL scores and improvements in its 7 domains – all were statistically significant (all P < 0.001, paired t test). Again, decrease in volume of the fibroids achieved near significance (P = 0.028, Wilcoxon signed rank test)
(Tables 2 and 3)
Table 2: Changes in outcomes over 3 months (N=30)
mean ± sd
|After 3 months: mean ± sd||Mean difference ± SE
|t29 value||P value|
|PBAC score||291.3 ± 159.4||106.3 ± 79.4||185.0 ± 25.7 (132.3 to 237.7)||7.185||< 0.001*|
§ Total raw score
§ Total transformed score
§ Transformed symptom severity score
§ Transformed concern score
§ Transformed activity score
§ Transformed energy score
§ Transformed control score
§ Transformed self-consciousness score
§ Transformed sexual function score
123.2 ± 20.2
39.9 ± 9.1
18.8 ± 17.4
35.6 ± 3.2 (29.0 to 42.2)
30.7 ± 2.8(25.0 to 36.4)
19.9 ± 1.6 (16.7 to 23.1)
-36.2 ± 3.7 (-43.7 to -28.6)
-40.9 ± 3.4 (-47.9 to -34.0)
-37.9 ± 2.9 (-43.9 to -32.1)
-42.2 ± 4.0 (-50.4 to -33.9)
-23.3±4.1 (-31.8 to -14.9)
-28.8 ± 5.7 (-40.4 to -17.1)
* Paired t test, P < 0.01 two-tailed considered as statistically significant
Table 3: Changes in fibroid volume (mm3) over time (N=30)
|After 3 months;
|Change (0-3 months);
|14449.4 (4270.3, 808917.9)||18648.5 (2993.8, 76403.8)||-4199.1 (1279.5, 4414.1)||0.028|
Wilcoxon signed rank test, P value near significant
Medicines used: The following medicines were indicated – Thuja occidentalis (13%), Lachesis mutans (13%), Thlaspi bursa pastoris (10%), Staphysagria (10%), Sabina (7%), Carcinosin (7%), Calcarea carbonicum (7%), Aurum muriaticum natronatum (3%), Natrium muriaticum (3%), Secale cornutum (3%), Arsenicum album (3%), Magnesia carbonicum (3%), Nux vomica (3%), Aurum iodatum (3%), and Sepia succus (3%). Percentages were calculated by dividing the number of prescriptions of each medicine by total number of prescriptions (i.e. 30) multiplied with 100.
Adverse events: Patients were instructed to report any harms, unintended effects, serious adverse events, and undue aggravations either directly in the outpatients or over phone, but no single incidence was reported.
Principal findings: An open observational clinical trial was carried out at National Institute of Homoeopathy on 30 subjects suffering from uterine fibroids induced HMB and was treated with indicated homoeopathic medicines following homoeopathic principles. The PBAC score, UFS-QOL score and volume of the uterine fibroid were taken as the outcome measures, measured at baseline and after 3 months of treatment. Statistically significant improvement was achieved in all the outcomes after homoeopathic treatment suggesting homoeopathy as a promising treatment option for uterine fibroids induced HMB and suggesting further substantiation using methodologically sound trials.
Strengths of the study: The possible effects of homoeopathic treatment in individuals suffering from HMB due to uterine fibroids were estimated systematically for the first time by using validated scales. Primary outcome was assessed using validated quantitative tool, Higham’s PBAC, a pre-validated outcome scoring tool with a sensitivity and specificity of more than 80% [36, 38]. The symptom severity and HQRL in patients with uterine fibroids was assessed by UFS-QOL, a disease-specific symptom severity and quality of life measuring questionnaire. Homoeopathic treatment was based on the principles of individualization. Formal validity and reliability of the Bengali version of UFS-QOL has also been addressed prior to enrolment in this study, but will be reported elsewhere and beyond the scope of this paper. Another important strength was the participation of qualified and experienced homoeopaths schooled in and practicing “classical” homoeopathy. Our study was representative of individualized (“classical”) homoeopathy only. In a broader interpretation of the law of similar, medicines were selected for symptoms both typical of the diagnoses and outside the predominating pathologies (“constitutional”).
Weaknesses of the study: Though the trial was adequately powered to detect significant change in the specified outcome measures over 3 months, still the sample size was inadequate to make a definite conclusion regarding the effectiveness of homoeopathic treatment in uterine fibroids induced HMB. The time period for the study was of short duration. Considerable heterogeneity existed in the collected data of fibroid measures, i.e. dimensions and numbers. The study was open and observational in design; hence did not involve any blinding, randomization or control. Thus efficacy data could not be generated and the effect sizes might have been overestimated. This might be partly explained by placebo and/or regression to the mean effects that our study was not designed to control. We also could not rule out the undisclosed use of concurrent therapeutic modalities, if any.
Comparison with other studies: In this study, women of age group of 41-45 years (33%) chiefly suffered from HMB due to uterine fibroids and this finding was in corroboration with Peddada et al . The majority of the sufferers were primipara women (48%) that were again in corroboration with Parazzini et al  and Lumbiganon et al . About 37% of women had dyspareunia at baseline which was in corroboration with the study of Lippman et al . Regarding dysmenorrhoea, 53% of women had severe, 27% had moderate, & 17% had suffered from mild dysmenorrhoea. The profile of this population is notable differing from other fibroid associated symptomatology studies where the subjects suffering from uterine fibroid did not experience dysmenorrhoea or cyclic pelvic pain in such severity which might be due to the patients who were seeking treatment at this tertiary care hospital were initially not so care seeking as that of the Lipmann et al study , but came much late in the course of their illness. In this research, the homoeopathic remedies prescribed were strictly based on the totality of symptoms and homoeopathic principles. Among the used medicines, Nux vomica, Calcarea carbonica, Sabina, Staphysagria, and Thuja occidentalis were proved to be quite beneficial in reducing HMB, which was also supported by the study findings of Popov , Quadri et al  and Ghosh et al .
Unanswered questions and future research: The trial would have been methodologically better if randomization and blinding techniques could have been included, thus warranting further efficacy or effectiveness trials to be undertaken. A comparative study can be carried out to assess whether treatment results vary with individualized medicines versus with specific medicines or effectiveness trials comparing centesimal and 50 millesimal potencies.
In this open label, prospective, observational, clinical trial of pre-post comparison design conducted on 30 subjects suffering from uterine fibroids induced HMB revealed statistically significant improvement in PBAC score, UFS-QOL score and volume of the uterine fibroids after 3 months of individualized homoeopathic treatment. Further explorations by randomized trials are warranted.
Conflict of interest statement: The authors declare that they have no competing interests. The trial was carried out as the postgraduate thesis of the corresponding author under guidance of Dr. Subhas Singh, who was a permanent teaching faculty of the institute.
Funding: We received no funding for the study. Funding required for the project was borne by the authors themselves.
Authors’ contributions: PH and SS conceived and designed the study, and collected data. PH ran the statistical analyses and interpreted the data and prepared the manuscript. Both the authors reviewed and approved the final manuscript.
Acknowledgements: We thank Dr. Ompriya Mishra, Head, Dept. of Obstetrics and Gynecology, National Institute of Homoeopathy; Dr. Prasanta Rath, Head, Dept. of Community Medicine, National Institute of Homoeopathy; and Dr. Chintamani Nayak, Lecturer, Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy for their valuable inputs in the study. We acknowledge Dr. Rajib Purkait, Postgraduate Trainee, Dept. of Homoeopathic Pharmacy, National Institute of Homoeopathy and Dr. Subhranil Saha, Independent Researcher for their help in statistical analysis, and interpretation and drafting of the manuscript. The authors are grateful to the institutional heads of both academic and hospital section for their cooperation. We thank the fellow postgraduate trainees, staff, pharmacists, and the patients for their sincere participation in the study.
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|Cite this article as: Halder P, Singh S. Homoeopathic treatment of heavy menstrual bleeding due to uterine fibroids in reproductive age group: An open-label, prospective, observational trial National Homoeo Recorder 2018;14(4):44-54.
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