Efficacy of Kanchanara Guggulu and Matra Basti of Dhanyaka Gokshura Ghrita in Mootraghata (benign prostatic hyperplasia).

BACKGROUND: Benign prostatic hyperplasia (BPH), a senile disorder affects male of and above 40 years characterized by retention, incomplete voiding, dribbling, hesitancy, and incontinence of urine. This condition is comparable with Mootraghata in Ayurveda. Surgical intervention has been accepted as standard management, but has acute cystitis, acute epididymitis, erectile dysfunction, retrograde ejaculation, etc. as complications. Conservative treatment with modern medicine is also associated with side effects. Hence, to avoid such complications and improve the quality of life in senile age, conservative management with Ayurveda is attempted. AIM: To evaluate clinical efficacy of Kanchanara Guggulu and Dhanyaka Gokshura Ghrita Matra Basti in Mootraghata.
MATERIALS AND METHODS: Total 30 patients having signs and symptoms of BPH were selected from OPD and IPD of Shalya Tantra and enrolled equally into three groups (n = 10). Patients of Group A were administered with Kanchanara Guggulu (500 mg, 3 times a day orally), Group B were with Dhanyaka Gokshura Ghrita Matra Basti, while patients of Group C were administered both the drugs for 21 days. International prostate symptom score (IPSS) was used to assess the efficacy. paired and unpaired "t" test, Chi-square test were applied for significance.
RESULTS: In IPSS, Group B had shown the better results (84.27%) than the Group A (72.68%) and Group C (82.10%). In all objective parameters, Group C had shown better effect (23.60%) than Group A (15.70%) and Group B (18.24%). Symptomatic relief was better in Group B than Groups A and C. Comparison between three groups on objective parameters was better in Group C than in Group A and B.
CONCLUSION: Kanchanara Guggulu orally and Dhanyaka Gokshura Ghrita Matra Basti is effective conservative management for symptomatic relief in BPH of senile age.

Introduction

Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate gland caused by excessive growth of prostatic tissue and is the most common benign neoplasm[1] of senile men which affects above the age of 40 years. In modern medicine, the management of BPH is either through a surgical approach, e.g., open prostatectomy, trans-urethral resection of the prostate, cryotherapy, etc., or by conservative treatment using drugs, e.g., hormonal therapy, chemotherapy, etc.[2] In old age, surgery is associated with many complications such as postoperative morbidity, impotence, retrograde ejaculation.[3] In case of hormonal therapy, there are complications like loss of libido, impotence, gynecomastia and such interventions are expensive too.

This condition is comparable to Mootrghata in Ayurveda, which is manifested because of deranged Apana Vayu. Basti (Matra Basti)is an authentic treatment for vitiated Vayu,[4] where no strict restrictions are required. In Mootraghata, Mootravaha Srotodushti and vitiation of Vata and Kapha are involved. So, Vata-Kapha Shamaka (pacifying) drugs along with Matra Basti may be helpful in reducing the size of the prostate and enhancing the tonicity of urinary bladder. Considering these properties, Kanchanara Guggulu[5] and Dhanyaka Gokshura Ghrita[6] [Table 1] were selected to evaluate the clinical efficacy in Mootraghata (BPH).

Table 1

Ingredients of test drugs

Materials and Methods

Total 30 patients having signs and symptoms of Mootraghata (BPH) were selected from Outpatient Department and Inpatient Department of Shalya Tantra, IPGT, and RA, Gujarat Ayurved University, Jamnagar. Ethical clearance was obtained from Institutional Ethics Committee (No. PGT/7-A/Ethics/2011-12/2087/38, dt. 5/9/2010) before commencement of the study. Informed consent was taken from each registered patient before starting the treatment. The trial is also registered to Clinical Trial Registry of India (CTRI/2015/08/006095) retrospectively.

Inclusion criteria

Male patients of age above 50 years having signs and symptoms of Mootraghata (BPH) such as Bahumutrata (increased frequency of micturition), Manda Mootradhara (weak stream of urine), Mootravarodha (acute/chronic urine retention), Mootradaha (painful micturition), Vrita Granthi (oval shaped enlarged prostate), Ashtilavat Granthi (soft consistency), Alpa Granthi (mild to moderate enlargement in size of prostate), etc., were included in the study.

Exclusion criteria

Patients below age of 50 years, suffering with malignancy, congenital abnormalities of urogenital tract or any other pelvic pathologies, uncontrolled hypertension, diabetes mellitus, tuberculosis, hemiplagia, parkinsonism, etc. were excluded from the study.

Drug and posology

Patients of Group A received 500 mg of Kanchanara Guggulu thrice a day, orally, with lukewarm water, half an hour before food.

Patients of Group B received 60 ml Dhanyaka Gokshura Ghrita once a day as Matra Basti, just before breakfast

Patients of Group C received both the drugs in the same dose as above.

The drugs were administered for 21 days in all groups. Both the trial drugs were prepared and procured from Pharmacy, Gujarat Ayurved University, Jamnagar.

Criteria for assessment

Subjective criteria

The symptoms of BPH were assessed by adopting International Prostate Symptom Score (IPSS).[7]

Objective criteria

Assessment of prostate size, Post Voidal Residual Urine (PVRU) volume, Average Urine Flow Rate (AUFR).

Criteria for overall assessment

Complete remission: 100% relief in subjective, objective findings and IPSS parameters

Marked improvement: 76–99% relief in subjective, objective findings and IPSS parameters

Moderate improvement: 51–75% relief in subjective, objective findings and IPSS parameters

Mild improvement: 26–50% relief in subjective, objective findings and IPSS parameters

Unchanged: Up to 25% relief in subjective, objective findings and IPSS parameters.

Statistical analysis

The statistical tests like paired and unpaired “t” test, Chi-square test were applied for significance.

Observations

Among 30 patients, 27 completed the treatment and follow-up (9 in each group). Maximum patients belonged to 61–70 years of age group (46.66%), retired from service (60%), Hindu religion (100%), economically middle class (90%), married (96.67%), educated (83.33%), normal built (80%), Madhyama Koshtha (63.33%), Samagni (40%), and Vatakaphaja Prakriti (43.33%). The symptoms of BPH like, nocturia (93.33%), weak stream (93.33%), increased frequency (90.00%), incomplete voiding (73.33%), dysuria (73.33%), burning micturition (70.00%), urgency (56.67%), dribbling (46.67%) of patients were noted. On per rectal examination; maximum patients (46.67%) were noted having enlargement of the right lobe. The shape of the prostate was oval in 53.33% of cases and smooth in surface 96.67% of cases while free rectal mucosa was noted in 100% of cases. The median groove was palpable in 86.67% of cases, and the upper border was approachable in 86.67% of cases. Prostate consistency was soft in 73.33% of cases, and mild enlargement was found in 80.00% of patients.

Results

Effect of therapy on subjective parameters

Group A depicted highly significant (P < 0.001) results in IPSS like incomplete voiding, frequency, intermittency, weak stream, straining, quality of life and significant effect (P < 0.01) was seen in nocturia and urgency [Table 2]. In Group B (Matra Basti) highly significant (P < 0.001) effect on IPSS as well as also improved the quality of life by 80.85% relief [Table 3], while Group C exhibited highly significant (P < 0.001) results in all the mentioned symptoms of IPSS including 71.73% improvement in the quality of life [Table 4].

Table 2

Effect of therapy on International Prostate Symptom Score in Group A

Table 3

Effect of therapy on International Prostate Symptom Score in Group B

Table 4

Effect of therapy on International Prostate Symptom Score in Group C

Effect of therapy on objective parameters

Kanchanara Guggulu rendered significant (P < 0.01) results in AUFR as well as PVRU (P < 0.05) and insignificant (P > 0.05) changes in prostate size in Group A [Table 5]. Dhanyaka Gokshura Ghrita Matra Basti in Group B rendered statistically highly significant (P < 0.001) effect on improving AUFR and significant (P < 0.05) effect on PVRU while insignificant (P > 0.05) changes were observed in the size of enlarged prostate gland [Table 6]. Kanchanara Guggulu orallyand Dhanyaka Gokshura Ghrita as Matra Basti in Group C rendered statistically highly significant (P < 0.001) effect on improving AUFR and significant (P < 0.05) effect on PVRU. In the case of a reduction in the size of prostate gland insignificant (P > 0.05) changes were observed [Table 7].

Table 5

Effect of therapy on objective parameters in Group A (n=9)

Table 6

Effect of therapy on objective parameters in Group B (n=9)

Table 7

Effect of therapy on objective parameters in Group C (n=9)

Comparative effective of therapy

In IPSS, Group B had shown better results than Group A and C. In all objective parameters, Group C had shown better effect than other groups [Table 8].

Table 8

Comparative mean effect of therapy in percentage

The observations of the contingency table were not significantly related as P values in comparative groups such as A and B (P > 0.05), A and C (P > 0.05) and B and C (P > 0.05), respectively. This suggested that change occurred with the treatment was not enough to exclude the possibility that the difference was due to chance. Hence, all these three groups have given parallel effect on symptoms/IPSS score of disease according to statistical analysis [Table 9]. The comparative effect on objective parameters was calculated by using unpaired “t” test. Statistically insignificant difference was found between all the three groups in all parameters (P > 0.05). Hence, it can be said that there was no difference in all three groups in relieving the signs (objective) or are equally effective [Tables 10–12].

Table 9

Comparative effect on subjective parameters between all the three groups

Table 10

Comparative effect on objective parameters between Group A and B

Table 12

Comparative effect on objective parameters between Group B and C

Overall effect of therapy

In overall effect of therapy, complete cure was not observed in any patients as the disease is progressive and age-related degenerative geriatric disease. The maximum improvement was seen in 33.34%, 55.56% and 33.34% of patients in Group A, Group B and Group C, respectively. Moderate improvement was seen in 44.44% of patients in all three groups. The mild improvement was seen in 11.11% and 22.22% in Group A and Group C, respectively [Figure 1].

Figure 1

Overall effect of therapy

Discussion

Mootraghata is a broad term and it can be considered as a syndrome, because it covers most of the pathological entity of the urinary system into 12 types.[8] These types may be co-related with three major groups of modern parlance that is, neurogenic bladder distubances, bladder outflow obstruction and lower urinary tract symptoms.

Most of the patients in this study (46.66%) were from the age group of 61–70 years, which is to be expected since BPH is a disease related to aging. 60.00% of patients had chronicity of BPH up to 1 year, which suggested slow progressive nature of BPH. Maximum patients have the habit of consuming diet of Madhura Rasa (sweet taste) (86.67%), Snigdha (unctous) Guna (80.00%) and Laghu (light) Guna (83.33%) predominance. These types of food increase Kapha Dosha in the body, which is the major causative factor for Mootraghata. Maximum 43.33% patients were belonging to Vata-Kaphaja Prakriti, which is important risk factor for this Prakriti individual for the development of Mootraghata.

In this study, the symptoms of BPH like weak stream, nocturia, and increased frequency was observed in more than 90% of patients that are cardinal symptoms of BPH. Per rectal digital examination findings of BPH having the symptoms that is a smooth surface, upper border approachable, median grove palpable, soft consistency, and free rectal mucosa. These findings suggest that the selected patients had benign enlargement of the prostate and there was no possibility of malignant changes.

In Group A, symptomatic relief in dribbling, dysuria, incomplete voiding, weak stream and increased frequency of micturition was found statistically highly significant [Table 2]. In this group, patients were administered Kanchanara Guggulu which had Vata-Kapha Shamaka (pacifying Vata-Kapha) properties. Recent studies on Kanchanara Guggulu also proved in treating urinary disorders. Ingredients of Kanchanara Guggulu contains kaempferol and quercitin flavonoids which prevents estrogen receptor conditions such as urinary incontinence and urogenital atrophy.[9] In objective parameters, a significant result was observed in AUFR and PVRU because of Kanchanara Guggulu contents that are, Triphala, Trikatu which have ascorbic acid (Vitamin C) which helps to relax the smooth muscle of the prostate and bladder neck to relieve pressure and improve urine flow.[10] Insignificant result was observed in prostate size, which might be due to the short duration of therapy.

In Group B, maximum patients have shown symptomatic relief in signs and symptoms of BPH, which are statistically significant (P < 0.001) [Table 3]. In Ayurveda, it is mentioned that Basti is the choice of treatment in controlling Vata Dosha.[11] Thus Matra Basti helps in improving functions of Apana Vayu and relieves the symptoms of Mootraghata. One of the ingredient Dhanyaka (Coriandrum sativum L.) contains choriandrol, which is diuretic. Gokshura (Tribulus terrestris L.) another component contains diosgenin, which has anti-proliferative activity helps to relieve symptoms of BPH like, nocturia, increased the frequency and prostate enlargement.[12] Increased average AUFR is positive finding in cases of BPH and it increased due to Dhanyaka Gokshura Ghrita which has Mootrala (diuretic) and Vata-Kapha Shamaka properties.

Patients of Group C showed highly significant, symptomatic relief in signs and symptoms of BPH [Table 4]. Amalaki rich in ascorbic acid plays important role as antioxidant. Gokshura, the component of Matra Basti has beta-sitosterol, cow ghee, and Dhanyaka contains linoleic acid and oleic acid. Beta-sitosterol is effective in symptoms like nocturia while linoleic acid and oleic acid inhibit 5-α reductase activity.[1314] The inhibition of 5-α reductase controls the dihydrotestosterone (DHT). So, decrease or controlling in DHT ultimately control further growth of prostate gland and relieve symptoms of BPH. Highly significant results were observed in AUFR possibly by improving the functions of Apana Vayu. In the case of PVRU, in individual patients before and after, was markedly reduced by 72.16% and showed statistically significant result [Tables 5–7].

Conclusion

The study concluded that individual oral drug Kanchanara Guggulu and Matra Basti with Dhanyaka Gokshura Ghrita is effective in cases of BPH for symptomatic relief. The combined therapy showed more effective conservative treatment than the single therapy. This conservative treatment is said to be safe and effective alternative management in cases of Mootraghata (BPH) in senile age and improve the quality of life of patients.

Financial support and sponsorship

IPGT and RA, Gujarat Ayurved University, Jamnagar.

Conflicts of interest

There are no conflicts of interest.

Table 11

Comparative effect on objective parameters between Group A and C