Gokshuradi Vati and Dhanyaka-Gokshura Ghrita Matra Basti in the management of Benign Prostatic Hyperplasia.

Benign Prostatic Hyperplasia (BPH) is a burning senile problem of elderly men and no definitive conservative cure is available. The present available surgical and minimal invasive methods have their own limitations. Hence, to find out a suitable Ayurvedic approach, an effort has been made towards the management of BPH, In this study, 32 selected patients of Mootraghata at par to BPH were divided into three groups randomly and treated accordingly. In group A, Gokshuradi compound (GC) Vati (GV) 500 mg was given three times a day with luke-warm water after food; while in group B, Dhanyaka-Gokshura Ghrita (DGG) as Matra Basti (MB) of 60 ml, once in a day, just after lunch and combined therapy of both formulations in group C was administered. Out of 32 patients, total 30 patients (10 in each group) were completed the treatment course of 21 days. In results, 54.09% improvement was seen in group C, 45.67% in group A and 47.99% in group B. The size of prostate gland was found reduced highly significant in group C. Hence, it is concluded that combined therapy of GV and DGG MB is beneficial without developing any adverse drug reactions and can be prescribed safely for Mootraghata (BPH).

RCT Entities:   Population Interventions Outcomes

Introduction

The term Mootraghata stands for low urine output due to obstruction in the passage of urine. It can be considered as a syndrome, because it covers most of the pathological entity of the urinary system into 12 types[1] except urolithiasis and reflect the symptoms of retention of urine, incomplete voiding, dribbling, hesitancy, increased frequency of micturition, weak stream, and nocturia. These features are related to the Lower Urinary Tract Symptoms (LUTS)[2] and Bladder Outflow Obstruction (BOO),[3] hence, it can be co-related with the disease Benign Prostatic Hyperplasia (BPH) at modern parlance.

BPH is a senile disorder of the geriatric men with histologically proven high incidence of 92.97% (n = 185) and 93.3% (n = 200)[4] in India. For this notorious problem there is no concrete conservative measure available until now. BPH involves multi-factorial pathogenesis caused by not only involvement of prostate and bladder, but also involves the hypothalamus-pituitary-gonads axis. The scope for medical therapy is still high because of the limitation of surgical approaches due to greater morbidity and failure to consistently achieve a successful outcome.[5] Therefore, to find out solutions through minimal invasive surgical techniques and use of phytotherapeutic treatment as an alternative approach for BPH has been taken as a research problem in this particular field. In this regard, for the treatment of LUTS/BPH, phytotherapeutic agents in USA have gained widespread usage since 1990.[6]

In the context of manifestation of Mootraghata, developed due to deranged function of Vayu, particularly Apana Vayu leads to this condition. The authentic treatment for deranged Vata is the Basti and among them the Matra Basti (MB) is a safe one, which can be adopted without any restriction.[7] Mootraghata can be correlated to BPH and is caused due to vitiated Vata and Kapha which involve Mootravaha Srotodushti. Present clinical study was planned as per management principles[8] to evaluate the clinical efficacy of Gokshuradi Vati (GV) orally and Dhanyaka-Gokshura Ghrita (DGG) Matra Basti (MB) in the management of Mootraghata with reference to BPH.

Materials and Methods

Selection of patients

Total 32 male patients having signs and symptoms of Mootraghata (BPH) were selected randomly from outpatient department of Shalya Tantra and from two special diagnostic camps irrespective of religion and occupation.

Inclusion criteria

Male patients of age - 50 to 80 years.

Patients having signs and symptoms of Mootraghata (BPH).

Exclusion criteria

Patients not fulfilling age criteria and those suffering from malignancy, congenital deformities of urogenital tract,

Systemic diseases such as uncontrolled hypertension, diabetes mellitus, liver, renal, and cardiac diseases.

Diagnostic criteria

Diagnosis was made on the basis of classical signs and symptoms of Mootraghata, per rectal digital examination and on the basis of the findings of Ultra Sonography for Kidney, Ureter, Bladder Region (KUB) and prostate.

Trial drugs

GV: It contains Punarnava (Boerhavia diffusa L. nom. Cons.) and Devadaru (Cedrus deodara (Roxb.) G. Don) as additional Kwatha Dravyas to classical formulation of Gokshuradi Guggulu.[9] It was prepared as per Guggulu Kalpana.[10]

DGG: In this formulation, Dhanyaka (Coriandrum sativum L.) and Gokshura (Tribulus terrestris L.) were used as Kalka and Kwatha Dravya; and cow ghee as Sneha Dravya.[11] It was prepared as per classical Snehapaka Kapana.[12]

Both the drugs were prepared and supplied by the Pharmacy, Gujarat Ayurved University, Jamnagar.

Clinical study design

Grouping and posology

Patients were divided into three groups by simple random sampling method:

Group A: GV 500 mg was administered orally three times in a day, with luke-warm water, 30 min. after food.

Group B: DGG was administered as MB of 60 ml, once in a day, just after lunch[13] possible at 12.30 pm.

Group C: Combined therapy of GV and DGG MB was administered as per above mentioned schedule.

Total duration of therapy in each group was of 21 days.

Follow-up period was of 1 month.

Assessment criteria

Subjective assessment of results was carried out by scoring pattern of symptoms of Mootraghata/BPH and by using International Prostate Symptom Score[14] sheet for subjective complaints.

Objective assessment of results was done by Average Urine Flow Rate (AUFR) measurement and USG findings of prostate weight and Post-voidal Residual Urine Volume (PRUV) were considers as objective parameters [Table 1].

Table 1

Overall assessment of result

Statistical analysis

For assessing effect of therapy on each subjective and objective parameters, paired ‘t’ test for significance was applied. For comparison among the three groups, for objective parameters un-paired ‘t’ test is used whereas for subjective parameters Chi-square test with Yate's correction was adopted.

Observations and Results

Out of 32 patients, 10 in each group were completed the therapy and follow-up period. So, in this study, general observations were made on 32 patients as mentioned in Tables 2-4 and results were made on 30 patients as shown in Tables 5-12.

Table 2

General observations (n=32)

Table 4

General observations on objective findings (n=32)

Table 5

Effect of therapy on subjective parameters in group A (n=10)

Table 12

Overall effect of therapy (n=30)

Discussion

Mootraghata (BPH) is a most common obstructive urological condition of old age. In pathophysiology of Mootraghata, there is involvement of Mootravaha Srotasa especially Basti (bladder). It may occur due to complex phenomena such as BOO, LUTS, and BPH. The symptoms of all types of Mootraghata may be classified under three groups for clinical assessment of BPH.

Voiding symptoms include Pravaahato Shanaih Shanaih (decreased urine flow rate/weak stream of urine), Pravaahato Punah Punaha (increased frequency/urgency of micturition), Mootrasanga (retention of urine, acute/chronic), Srijeda-Alpaalpam (scanty micturition/dribbling), Adhahasroto Nirodhanam (constipation), Yobhuyah Srashtumichchhati (hesitancy), etc., which are resembling with LUTS and BOO and generally exist in Vatakundalika, Mootrasanga, Vatashtheela, and Mootrateeta – all are the types of Mootraghata.

Findings of per rectal digital examination such as Vritta Granthi (round/oval shaped mass), Sthira-Ghana-Astheela Vata Granthi (hard/firm in consistency), and Unnata Granthi (convex surface), which are found in Vatashtheela and Mootragrathi. Hence, these types of Mootraghata may be related to be more nearer to the disease of BPH.

Rest of symptoms of Mootraghata which are grouped under the findings of urine examinations such as Mootram Haridram (yellow urine), Mootram Bahalam (large quantity urine), and Raktam Mootram (reddish urine) are found in Bastikundal, Mootrotsanga, Vatabasti, Mootrajathara, Ushnavata, and Mootraukasada types of Mootraghata. These features are helpful in making differential diagnosis of BPH from other pathological conditions.

Out of total 32 patients registered in this study, maximum number of patients, i.e. 17 (53.13%) were found in age group of 60-80 years because it is the Sheeryamanadhatvavastha (elderly age) dominated by Vata Prakopa. Remaining patients were above 50 years, i.e. in Vriddhavastha (senile age), which is the natural period of Vata Vriddhi in the body.[1516] Hence, it is attributed that the provoked Vata is a prime causative factor for manifestation of Mootraghata.[17] In this study, 59.37% patients had the history of tobacco chewing or smoking. As per the research studies on BPH in Europe, there is no strong evidence for smoking, tobacco chewing and high alcohol intake as the risk-factors for the causing BPH.[18] However in Ayurveda, it has been cited that Teekshna Aushadha or Aahara[19] (drugs/diet of strong potency like tobacco) are traced as the leading causative factors for Mootraghata. In the present research work, 71.88% patients had positive history of Adhyashana and Vishamashana. Such kind of dietetic habits lead to formation of Kleda and Aama in Dhatus[20] which might be produced Srotoavarodha in Dhatu. This phenomenon is treated as one of the important factors in the etiopathogenesis of Mootraghata. Maximum number of patients, i.e. 56.25% were belonging to Vata-Kaphaja Prakriti, the data itself revealed Dosha dominancy for individual in older age group and hence it can be presumed that Prakriti may play an important role for susceptibility or development of Mootraghata. Highest number of patients, i.e. 43.57% had chronicity of 1-3 years which suggests that Mootraghata is a slow and gradually disorder and had chronic history of onset [Table 2].

The result of study in group A showed statistically significant relief in all subjective parameters. Further, the trial formulation has given highly significant result by increasing AUFR; significant result was observed in reduction of prostate size while insignificant change was observed over PRUV. Overall, it was concluded that out of 10 patients, 3 patients (30.00%) were shown moderate improvement, while 7 patients (70.00%) were got mild improvement. These results were found due to GV, which possess properties such as Vatakapha Shamaka, Lekhana, Pachana, Bastishodhana, Mootrala, Grahee, Pramathee qualities and played vital role in breaching Samprapti of Mootraghata [Tables 5, 6, 12].

Table 6

Effect of therapy on objective parameters in group A (n=10)

In group B, all subjective parameters had showed highly significant (P < 0.001) relief except in dribbling of micturition feature, which was statistically insignificant. DGG MB showed highly significant result in AUFR, while significant result was found in the reduction in size of enlarged prostate gland and in feature of PRUV the result was insignificant. Finally, out of 10 patients, 4 patients (40.00%) had shown moderate improvement and 6 patients (60.00%) got mild improvement. The deranged function of Apana Kshetra would have been corrected by virtue of Mootrala, Tridoshahara, and Basti Shodhana properties of DGG MB. It may be attributed also that the nourishment of the nervous systems through Enteric Nervous System (ENS) and Central Nervous System (CNS) theory[21] would have been much impact on bladder physiology and in correction of pathogenesis of BOO [Tables 7, 8, 12].

Table 7

Effect of therapy on subjective parameters in group B (n=10)

Table 8

Effect of therapy on objective parameters in group B (n=10)

Group C showed statistically highly significant relief in all subjective parameters. Combined therapy of GV and DGG MB in this group had shown highly significant improvement in urine flow rate and reduction in size of the prostate gland followed by significant reduction in PRUV. Overall in this group, out of 10 patients, 7 patients (70.00%) had got moderate improvement and 3 patients (30.00%) had shown mild improvement. Hence, group C showed better result in all parameters due to the synergistic effect of GV and DGG MB [Tables 9, 10, 12].

Table 9

Effect of therapy on subjective parameters in group C (n=10)

Table 10

Effect of therapy on objective parameters in group C (n=10)

As per assessment, group C showed better improvement in objective parameters (36.41%) than group A (20.90%) and group B (26.70%). However, when data was analyzed statistically with un-paired ‘t’ test for three group comparison, insignificant difference was observed. In the same way, for subjective parameters, group C showed percentage wise better results, i.e. 56.33% than group A (51.50%) and group B (51.60%). However, when data was analyzed statistically with Chi square test with Yates correction; insignificant difference between all the groups was recorded [Table 11].

Table 11

Comparative mean effect of therapy in percentage (n=30)

The Samyak Yoga Lakshanas of MB were observed in 95.00% of patients due to Deepana, Pachana, and Niratyaya[7] (without complications) effects of DGG MB. No adverse drug reactions were observed during this clinical study.

Conclusion

Gokshuradi Vati and Gokshura-Dhanyaka Ghrita Matra Basti are proven clinically to be safe and effective therapy in the management of Vriddhavastha-Janya Mootraghata i.e. BPH.

Table 3

General observations on subjective findings (n=32)