A Detailed Study of Effectiveness of Individually Selected Homoeopathic Medicines in Comparison to Sabal Serrulata in Cases of Benign Hypertrophy of Prostate Using IPSS Score
ABSTRACT : Benign prostatic hyperplasia is a common condition as men get older. Enlarged prostate glands can cause uncomfortable urinary symptoms, such as blocking the flow of urine out of the bladder. Thirty patients of Benign Prostatic Hyperplasia (BPH) of NCR-Delhi area, were selected and divided into two groups one group of fifteen patients were given individualized medicines on the basis of subjective and objective symptoms in each case as per the law of similia and prescribed singly. Another group of fifteen patients was treated with ‘Sabal serrulata Ø’. Data was recorded and computed for the components of International Prostate Symptom Score like incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia.
The treatment provided using ‘Sabal serrulata Ø’ and ‘Individualized Medicines’ had a significant improvement in patients. The symptoms changed to the desirable category (up to < half the time) was considered, the improvement ranged from 33.3% (Nocturia) to 73.3% (Intermittency). The number of total patients in the desired category ranged from 33.3% (Weak Stream) to 100.0% (Straining). It was be observed that the components of International Prostate Symptom Score had improved after the administration of homoeopathic medications as compared to before the trial. On overall basis, in twenty-six (86.7%) patients there was marked improvement in International Prostate Symptom Score of Benign Prostatic Hyperplasia patients.
KEY/INDEX WORDS: Benign Prostatic Hyperplasia (BPH), Homoeopathy, International Prostate Symptom Score (IPSS), Paired t-test, Sabal serrulata Ø, Incomplete emptying (IE), Frequency (F), Intermittency (I), Urgency (U);,Weak Stream (WS); Straining (S), Nocturia (N)
Introduction
Today, Homoeopathy is the 2nd most used health-care system in the world according to the World Health Organization1. The Homoeopathic system of medicine treats the patient and not the disease. About 105 million people affected globally by Benign Prostatic Hyperplasia (BHP)2. The Prostate (Prostata; Prostate Gland) is an organ linked inextricably with the endocrine system. The main role of the prostate as a male reproductive organ is to produce prostatic fluid, which up accounts for to 30 per cent of the semen volume. Sperm motility and nourishment are aided by the prostatic fluid constituents and the environment they create. Prostatic fluid is a thin, milky alkaline fluid containing citric acid, calcium, zinc, acid phosphatase and fibrinolysin among its many constituents. Prostate specific antigen (PSA) is also a constituent found in prostatic secretions.
Benign Prostatic Hyperplasia condition prevalence increases markedly with age and are the most common condition in men especially over 50 years of age. BPH is rarely life-threatening but often affects the individual’s quality of life of the patient in varying degrees in similar ways as other chronic diseases such as diabetes mellitus, hypertension, and heart disease3,4. The symptoms of hesitancy in urinary flow, poor urinary stream, intermittent urinary stream, dribbling of urine, incomplete emptying of bladder, episodes of near retention of urine increased frequency, nocturia, urgency, urge incontinence, and nocturnal incontinence may be observed in patients with benign hypertrophy of prostate. William Osler (1849-1919) once said “The good physician treats the disease; the great physician treats the patient who has the disease”.
Numerous studies have been done to investigate the efficacy of homoeopathic medicine in cases of BHP. It has been observed that despite some limitations, there is increasingly clear evidence that Sabal serrulataextract along with homoeopathic similima based on symptom totality exerts beneficial effects by improving a number of urological symptoms and flow measures in cases of benign hypertrophy of prostate. The objective of the present investigation was to study the components of IPSS for effective individualized homoeopathic medicine and Sabal Serrulata Ø in cases of BHP.
Material and Methods
A randomised controlled trial was conducted on patients suffering from BHP of Delhi National Capital Region, OPDs of Bakson Homeopathic Medical College and Hospital, Greater Noida. A sample size of 30 patients was selected on the basis of random sampling method. The patients were screened in the outpatient departments of respective centres and as per the inclusion and exclusion criteria, and were enrolled and followed up for six months of the trial.
The study was conducted in two randomly allocated groups, the ‘Individualised medicine’ (Group 1) intervention group and the ‘Sabal serrulata Ø’ (Group 2) intervention group. On the basis of the symptoms with intension of the investigator was to cure the patients. A prospective randomised control single blind trial was performed to study the efficacy if individualised homoeopathic medicine selected on the basis of symptom totality over organ specific ‘Sabal serrulata Ø’ in cases of BHP.
The Individualised Homoeopathic Medicine Intervention Group (Group 1)
Medicines in this group of patients were selected on the basis of subjective and objective symptoms in each case. The totality of symptoms is taken for prescription and the symptoms of each individual patient are taken as a whole.
The homoeopathic medicines were selected as per the law of similia and prescribed singly at one occasion. Detailed case taking, its recording and interpretation of the symptoms was done in standard case record. The symptoms were classified and evaluated to erect the totality. Help of repertorization was taken as and when required. Cases were either repertorized by conventional repertories (Kent’s repertory, Boger Boenninghausen’s characteristic repertory) or modern repertories (Synthesis, Murphy’s homeopathic repertory). Constitutional prescriptions were based on the totality formed by analysing and evaluating the mental generals, physical generals, characteristic particulars, and miasm.
The potency selection and repetition of doses are done according to the need and susceptibility of every individual case. The medicines were prescribed in accordance with instruction in Hahnemann’s Sixth Edition of Organon of Medicine.
The ‘Sabal Serrulata Ø’ Intervention Group (Group 2)
The symptoms of each patient were studied in detail and every patient of this group was prescribed ‘Sabal serrulata Ø’ on the basis of its established value as an organopathic medicine in cases of BHP and administered in tincture form. Dosage- Patients were instructed to take 10 drops of the ‘Sabal Serrulata Ø’ in half cup of water three times a day
One group of 15 patients was prescribed ‘Sabal serrulata Ø’ and other group of 15 patients was prescribed medicines on the basis of symptom totality obtained from a complete and detailed case taking. Ignatia (2), Conium Mac (2), Causticum (1), Medorrhinum (1), Selenium (1), Sulphur (2), Baryta carb (2), Pulsatilla (1) and Lycopodium (2) were used. All the medicines were obtained by the researcher from the pharmacy of Bakson Homeopathic Medical College and Hospital, Greater Noida to avoid any variation caused by any unforeseen variation in the preparation of medicines by different medicine company.
Data Recording and Analysis
Patients were reviewed regularly during follow ups as per the requirement of the case. Majority of the patients were reviewed, during the follow ups on a fortnightly basis to assess the subjective and objective symptoms. Each case was followed for a minimum of six-months from the commencement of treatment was analysed according to follow-up criteria to elicit the prognosis of the treatment like aggravation, amelioration, no change, disappearance of chief complaints, improvement in generals of the patient and emergence of new complaints.
International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (IPSS) (1992) by the American Urological Association (AUA) adopted by the World Health Organization as the IPSS was used in the study. An additional 8th Question on QOL was added later on5. The components of IPSS like incomplete emptying (IE) frequency (F), intermittency (I), urgency (U), weak stream (WS), straining (S) and nocturia (N) were also studied and understood through paired t-test.
The responses of the BHP patients at the hospital towards the Personal Data Schedule, IPSS (before the start of the experiment) and IPSS (at the end of experiment) were quantified. The statistics like paired t-test help the researcher to find the significance of the treatment before and after the treatment. The paired t-test were computed to test the significance of differences between IPSS (before the treatment) and IPSS (after the treatment) of the patients as well as for treatment by ‘Sabal serrulata Ø’ and other specific medicines in combination with ‘Sabal serrulata Ø’ to BHP patients.
Results and Discussion
Study of treatment effects using ‘Sabal serrulata Ø’ and ‘Individualized Medicines’
Among a total of 30 patients, 15 patients were given ‘Sabal serrulata Ø’ and 15 patients given medicines that were individually selected for them after detailed case taking and study of the totality of symptoms by the process of individualization. The significant paired t-test values showed that the treatment provided by researcher using ‘Sabal serrulata Ø’ and ‘Individualized Medicines’ had a significant improvement in patients (Table 1). According to W. Boericke’s Pocket Manual of Homoeopathic Materia-Medica and Repertory, ‘Sabal serrulata’ mother tincture has unquestioned value in cases of prostatic enlargement 6. In a study on ‘Sabal serrulata’ mother tincture showed the reduction of prostate tumour xenograft size significantly in an in vivo trial 7. Moreover, ‘Sabal serrulata’ decreased PC-3 cell proliferation and DU-145 cell proliferation.
On looking at the components of IPSS score i.e. showed significant improvement in both ‘Sabal serrulata Ø’ and ‘Individualized Medicines’, however if computed over both the treatments than paired t-test was non-significant in all the IPSS components (Table 1). Hence, we also conclude that paired t-test should be separately computed for different treatments.
Table 1: Effect of treatments by Sabal serrulata Ø and Individualized Medicines using Paired t- Values on the components of IPSS
| Character | Sabal serrulata Ø (Total Patients: 15) | Individualized Medicines (Total Patients: 15) | Over treatment (Total Patients: 30) |
| IE | 18.873** | 25.051** | 1.155ns |
| F | 11.374** | 17.576** | 0.615ns |
| I | 18.699** | 15.984** | 1.314ns |
| U | 7.897** | 25.200** | 0.901ns |
| WS | 33.500** | 75.093** | 1.420ns |
| S | 4.961** | 1.520** | 0.583ns |
| N | 8.290** | 16.897** | 0.742ns |
Note: IE: Incomplete emptying; F: Frequency; I: Intermittency; U: Urgency; WS: Weak Stream; S: Straining; N: Nocturia
Components of IPSS before and after the experiment
IPSS was computed from its components like, incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The details of these are studies indicating number of patients before and after the experimentation. In our study, there was desired improvement in the symptoms for the components of the IPSS score. When the change in symptoms was considered, the change in the desirable category (up to < half the time) was considered, the improvement ranged from 33.3% (Nocturia) to 73.3% (Intermittency) (Table 2). On the other hand, it was important to look into the number of patients in desired category (up to < half the time) of components of IPSS score symptoms. The number of total patients in the desired category ranged from 33.3% (Weak Stream) to 100.0% (Straining) (Table 2).
Table 2: Status of the patients with desired level of symptoms for the components of IPSS (BHP) before and after the treatment of BHP.
| Status of Patient | Components of IPSS for BHP | |||||||
| IE | F | I | U | WS | S | N | ||
| Not at all | Before | 0 | 0 | 0 | 0 | 0 | 1 | 3 |
| After | 1 | 5 | 0 | 1 | 0 | 6 | 13 | |
| Change | 1 | 5 | 0 | 1 | 0 | 5 | 10 | |
| <1 in 5 times | Before | 0 | 8 | 0 | 3 | 0 | 5 | 11 |
| After | 1 | 16 | 4 | 9 | 1 | 15 | 11 | |
| Change | 1 | 8 | 4 | 6 | 1 | 10 | 0 | |
| <Half the time | Before | 3 | 14 | 1 | 8 | 0 | 9 | 9 |
| After | 14 | 6 | 10 | 12 | 9 | 9 | 4 | |
| Change | 11 | -8 | 9 | 4 | 9 | 0 | -5 | |
| About half the time | Before | 9 | 8 | 2 | 10 | 0 | 10 | 2 |
| After | 9 | 3 | 11 | 7 | 11 | 0 | 0 | |
| Change | 0 | -5 | 9 | -3 | 11 | -10 | -2 | |
| More than half the time | Before | 9 | 0 | 14 | 6 | 12 | 5 | 3 |
| After | 4 | 0 | 5 | 1 | 8 | 0 | 2 | |
| Change | -5 | 0 | -9 | -5 | -4 | -5 | -1 | |
| Almost Always | Before | 9 | 0 | 13 | 3 | 18 | 0 | 2 |
| After | 2 | 0 | 0 | 0 | 1 | 0 | 0 | |
| Change | -7 | 0 | -13 | -3 | -17 | 0 | -2 | |
| Patients (%) with improved symptoms | (After-Before) | 13 (43.3%) | 13 (43.3%) | 22 (73.3%) | 11 (36.7%) | 21 (70.0%) | 15 (50.0%) | 10 (33.3%) |
| Total (%) Patients with Desirable Symptoms after the treatment | Sum of desired symptoms (< half the time) | 16 (53.3%) | 27 (90.0%) | 14 (46.7%) | 22 (73.3%) | 10 (33.3%) | 30 (100.0%) | 28 (93.3%) |
Note: IE: Incomplete emptying; F: Frequency; I: Intermittency; U: Urgency; WS: Weak Stream; S: Straining; N: Nocturia; Before: Before the start of treatment; After: After5-6months of treatment; Change: Change in symptoms
Incomplete Empting
An open observational study was conducted at Central Council for Research in Homoeopathy including its Clinical Research Unit (Homoeopathy) at Tirupati (Andhra Pradesh) from Oct ’05 to May ’09. Clearance of the Ethical Committee and informed consents from the patients were obtained before initiation of the study 8. Eleven cases suffering from benign prostatic hyperplasia that followed up for one year were assessed on American Urological Association Symptom Index (AUASI) to quantify the severity of illness and assess the outcome. Seven cases were relieved of their urinary symptoms with Pulsatilla nigricans and four cases with Thuja. In all the cases, reduction in AUA score was found. In six cases prostate volume was reduced; in three cases prostate size and volume increased, while in two cases prostate volume remained unchanged. For prostate pathology ‘Sabal serrulata’ (synonym to ‘Serenoa repens’ [W. Bartram] Small, family Arecaceae, commonly known as saw palmetto is the most commonly used medicine.
The patients were asked “How often have you had the sensation of not empting your bladder?”. The Grading of the Sensation of Incomplete Emptying of the Urinary Bladder was done for the entire sample within the International Prostate Symptom Score (IPSS) into grades 5 to 0 which were: almost always, more than half the time, about half the time, less than half the time, less than 1 in 5 times and not at all. The data was collected before and after the trial and is represented in Table 2. It can be observed that before the trial a greater number of patients reported having the sensation of incomplete emptying of the bladder about half the time, more than half the time and almost always. Whereas, after the completion of trial a greater number of patients reported the sensation of incomplete emptying of bladder was less than half the time. Thus this showed improvement with the respective homoeopathic medicines. ‘Sabal serrulata’ is known for its anti-inflammatory activity, anti-androgen properties, anti-oedema effects, and spasmolytic and smooth muscle relaxant activity 9. It is used as an herbal medicine to treat a variety of conditions, including chronic pelvic pain, bladder and urinary disorders, and hormone imbalances 10.
Frequency
The Grading of the Frequency to urinate in less than every 2 hours was done for the entire sample within the International Prostate Symptom Score (IPSS) into grades 5 to 0 which were: almost always, more than half the time, about half the time, less than half the time, less than 1 in 5 times and not at all. The data was collected before and after the trial for all the patients and is represented in Table 2 It can be observed that the frequency of urination in less than every 2 hours in the patients was higher before the trial and a large number of patients had reported increased frequency of urination, with 14 out of 30 patients under study reporting to have the need to urinate in less than every 2 hours to be less than half the time. In the post trail representation it can be observed that 16 out of 30 patients reported having the need to pass urine every 2 hours to be less than 1 in 5 times. The increased frequency of urination due to BHP can be observed to have decreased after the administration of Homoeopathic medication.
Intermittency
The Grading of the Intermittency of Urine was done for the entire sample within the International Prostate Symptom Score (IPSS). The patients were asked if they found that while urinating they stopped and started again several times to urinate and the severity of the symptom was given grades from 5 to 0 which were: almost always, more than half the time, about half the time, less than half the time , less than 1 in 5 times and not at all. The data was collected before and after the trial and is represented in Table 2.
It can be observed from the figure that the symptom of intermittency was reported as almost always or more than half the time by nearly all the patients before the trial. The complaint of intermittency improved with the administration of the homoeopathic medication and the after the trail most of the patients reported to have a decrease in the intermittency of urine to about half the times or even less.
Urgency
The Grading of the Urgency to pass Urine was done for the entire sample within the International Prostate Symptom Score (IPSS). The patients were asked “How often they found it difficult to postpone urination” and the severity of the symptom was given grades from 5 to 0 which were: almost always, more than half the time, about half the time, less than half the time , less than 1 in 5 times and not at all. The data was collected before and after the trial and is represented in Table 2. It can be observed that the urgency to urinate has decreased after the administration of homoeopathic medications as compared to before the trial.
Weak Stream
The Grading of the Weakness Urinary Stream was done for the entire sample within the International Prostate Symptom Score (IPSS). The sequelae of BPH include a decreased urinary flow and advancing voiding and storage symptoms; these may eventually result in acute or chronic UR 11. The patients were asked to report how often they had a weak urinary stream and their symptom were graded from 5 to 0 which were: almost always, more than half the time, about half the time, less than half the time , less than 1 in 5 times and not at all. The data was collected before and after the trial and is represented in Table 2.
It can be observed that all patients reported a weak urinary stream either always or more than half the time. In the data collected after the trial it was observed that almost all patients experienced an improved flow of urine after administration of homoeopathic medications. Thus this showed the high efficacy of homoeopathic medications. BPH patients with bladder outflow obstruction complaint of initial increased detrusor contractility in the compensatory phase with normal bladder emptying 12,13. Prolonged obstruction to urine outflow results in detrusor hypertrophy and bladder wall thickening, ultimately culminating in DUA and emptying failure 13,14.
Straining
The Grading of the need for straining to start urination was done for the entire sample within the International Prostate Symptom Score (IPSS). The patients were asked to report how often they had to strain to start urination and their symptom were graded from 5 to 0 which were: almost always, more than half the time, about half the time, less than half the time, less than 1 in 5 times and not at all. The data was collected before and after the trial and is represented in Table 4.6. A decrease in need to strain in an increased number of patients was observed after the homoeopathic medications were used and data collected post the trial.
Nocturia
The number of times a patient needs to urinate at night was recorded for the entire sample population before and after the trail as a component of the International Prostate Symptom Score (IPSS). The symptom were graded from 5 to 0 which were: almost always, more than half the time, about half the time, less than half the time, less than 1 in 5 times and not at all (Table 4.6). A decrease in frequency was observed in a number of patients after the trial.
IPSS score before and after the experiment
IPSS score indicated that the efficacy of homeopathy in case of BHP through various homoeopathic medications was subjective. More patients shifted from severe grade of IPSS score to moderate grade (Fig 1). On the basis of the clinical symptoms collected from the patients related to BHP, the patients were categorized into mild (0), moderate (7) and severe (23) before the conduct of the experiment on the basis of the information provided by them with respect to the various items (Subheadings/Points). Similarly, after the conduct of the experiment, the patients were again categorized into mild (3), moderate (23) and severe (2) (Fig. 1).
The results of the trial indicated that most of the patients with severe BHP were improved to moderate or mild BHP. This indicated the overall subjective improvement of the patients through various homoeopathic medications, thus showing the efficacy of homeopathy in case of BHP.
Conclusion
Paired t-test showed that the treatment provided
using ‘Sabal serrulata Ø’ and ‘Individualized
Medicines’ had a significant
improvement in patients. The symptoms changed to the desirable category
(up to < half the time) was considered, the improvement ranged from 33.3% (Nocturia)
to 73.3% (Intermittency). The number of total patients in the desired category
ranged from 33.3% (Weak Stream) to 100.0% (Straining). It was be observed that
the sensation of incomplete emptying of the urinary bladder, frequency of
urination, complaint of intermittency, urgency to urinate, improved flow of
urine, decrease in need to strain and needs to urinate at night has improved after
the administration of homoeopathic medications as compared to before the trial.
On overall basis, in twenty-six (86.7%) patients there was marked improvement
in IPSS score of BPH patients.
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