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MANAGEMENT OF BPH BY PHYTOTHERAPY
From The Vault: Dr. Amarprakash P. Dwivedi, M.S. (Ayu.), Ph.D. (Scholar - MUHS, Nashik) - Senior Residence Officer, Shalyatantra Department ABSTRACT: Benign Prostatic Hypertrophy (BPH) is a common condition in men above 50, characterized by a non-malignant enlargement of the prostate. The clinical features include incomplete emptying, frequency, intermittency, weak stream, straining & nocturea. Ayurveda looks at this senile problem in a different way. This B.P.H. can be correlated with Vata-ashthila, described by Acharya Sushruta. Drugs advocated in Ayurvedic texts not only take care of the symptoms, but also aims to break the pathology. All this has inspired us to conduct clinical trials of Phytotherapy treatment comprising Ghana of Ashwagandha, Varun, Gokshur, Haritaki & Punarnava in the patients of B.P.H. The statistics obtained revealed that the Phytotherapy combination (Tab. EASYPROST) effectively reduce the symptoms of B.P.H. and worked as good as the highly selective a 1 blocker (Tamsulosin hydrochloride). Introduction: Benign Prostatic Hypertrophy (B.P.H.) is characterized by a non-malignant enlargement of the prostate resulting from excessive cellular growth of both the glandular and the stromal elements of the gland. Due to the enlargement of prostate gland, a group of symptoms develop which is called as Prostatism. Prostatism is divided into two groups: Obstructive Irritative Hesitancy – worsened if the bladder is very full Frequency Dysuria - Poor flow – unimproved by straining Nocturea Intermittent stream – stops and starts Urgency Dribbling – including after micturition Urge incontinence Episodes of near retention Nocturnal Sensation of poor bladder emptying incontinence Aetiology of B.P.H.: The aetiology of BPH is unknown. One hypothesis infers that the prostate converts testosterone to a more powerful androgen called Dihydrotestosterone (DHT), which stimulates cell growth in the tissue that lines the prostate gland (the glandular epithelium) and is the major cause of the rapid prostate enlargement. Incidence and Epidemiology: Benign Prostatic Hypertrophy (BPH) is a common condition in older men; approximately 50% of men aged 60 years and 90% of those aged 85 years present with BPH. In India, prostatic hypertrophy is common over the age of 60 years. Established Treatment of B.P.H. Conservative medical management - For Curative relief – 5 alpha reductase inhibitors like Finasteride and Dutasteride and for Symptomatic relief – Alpha blockers like Terazosin, Doxazosin, Tamsulosin, and Alfuzosin are given. However, these medicines have got side effects and adverse effects like Sexual dysfunction, Postural hypotension, Asthenia and Dizziness, etc. Similarly, long-term therapy is required to maintain the benefits. Surgical procedures - Supra pubic Prostatectomy, Retro pubic Prostatectomy, Transurethral prostatectomy, Perineal prostatectomy, Laser treatment & Microwave treatment. However, TURP, i.e. transurethral resection of the prostate, has been the mainstay of treatment. B.P.H. and Ayurveda: There is a lot of similarity between Vata-ashthila described by Acharya Sushruta and B.P.H. Vata-ashthila is said to develop due to vitiated Vayu which gets lodged in the space between Basti and Guda and gives rise to a hard, thick cystic (Granthi sadrushya) structure, which is non-shifting in character and produces various obstructive and irritative urinary symptoms and cause pain in the bladder. These symptoms and cystic (Granthi sadrushya) structure can be correlated with B.P.H. Need for Herbal approach in the Management of BPH: In patients of BPH, treating only the symptoms is not sufficient. Modern medicines, though effective, have a number of side effects. Similarly surgical techniques demand not only money factor, but also there are many other complications after surgery. Additionally, about 20 to 25% of patients do not have a long-term satisfactory outcome from surgery. Herbal drugs advocated in Ayurvedic texts not only takes care of symptoms of BPH, but also aims to break the pathology & improves quality of life of patient with B.P.H. Similarly, Phytotherapy gives curative relief along with the symptomatic relief to the patients of B.P.H. They are cost effective and free from any adverse effect. Aims and objectives of the study: The study entitled “Randomized Controlled clinical study of Phytotherapy combination (Tab. EASYPROST) in the patients of B.P.H. (Grade I & II)”primarily aims at evaluating the treatment result in B.P.H. First line therapy – To substitute Medical Therapy for Surgery in the patients of B.P.H.– Grade I & II, free from adverse reactions and side effects of Allopathic drugs. Economic Therapy – To give cost effective treatment in the patients of B.P.H. Materials and Methods Title of the study - “Randomized Controlled clinical study of Phytotherapy combination (Tab. EASYPROST) in the patients of B.P.H. (Grade I&II)”. Type of study - Open Randomized Controlled Clinical Trial. Centre of study - Dr. D. Y. Patil Ayurvedic Hospital, Nerul, Navi Mumbai. Sample size - 60 (30 + 30) Grouping of patients – Randomly selected patients were divided into: Group A – Tab. EASYPROST (Phytotherapy combination) Group B – Capsule of Tamsulosin Hydrochloride 0.4 mg Duration of treatment - 3 months for both the groups. Follow Up – Every 3 weeks. Criteria for the selection of the patients Inclusion criteria: Male patients around the age of 50, Prostrate size Grade I & II Exclusion criteria: Complicated B.P.H. with Grade III, Ca prostate, Diabetes Mellitus, Oliguria, Stricture Urethra, Major disease like HIV, Liver cirrhosis, Koch’s, IHD, Nephrotic syndrome, etc. Baseline assessment & Investigations: Investigations: All Routine investigations CBC, ESR, BSL, BUN, Sr. Creatinine, Urine R/M, etc., Digital rectal examination (DRE), USG for prostate to observe weight and size of the prostate, Post- void residual urine volume (before and after treatment), PSA (Prostate specific antigen) and AUA Score (American Urological Association Symptom Score). Assessment of Efficacy of Therapy The assessment of the effect of therapy was totally based on the standard AUA symptom score. Symptomatic relief of the patient was the main aim and the effect of therapy was assessed in terms of: Cured 100% relief, in all symptoms. Relieved 75% to 100% relief in the symptoms. Markedly Improved 50% to 75% relief in the symptom. Improved 25% to 50% relief in the symptoms. Unchanged Less than 25% or no relief to symptoms Drugs and Doses Group A - Tab. EASYPROST (Phytotherapy combination) - Two tablets twice a day for three months, with luke warm water. Ashwagandha Ghana (Withania somnifera) - 100 mg Varun Ghana (Crataeva nurvala) - 100 mg Gokshura Ghana (Tribulis terrestris) - 100 mg Haritaki Ghana (Terminalia chebula) - 100 mg Punarnava Ghana(Boerhavia diffusa) - 100 mg Group B – (Alpha blocker) - Capsule of Tamsulosin Hydrochloride 0.4 mg 1 H.S. for three months. Drug Profile: Drug Doshaghnata Rogaghanata Pharmacological activities Ashwagandha(Withania somnifera) Kapha Vata shamak Granthishotha Mootraghata Antibacterial, Immuno modulatory Antitumor, Antioxidant, Anti-inflammatory, Antispasmodic, Analgesic, Cytoprotective Varun(Crataeva nurvala) KaphaVata shamak Pittavardhak Vranshoth, Gulma, Vidradhi, Shool, Ashmari, Bastishool, Mootrakrichra Diuretic, Lithotriptic, Antibacterial, Anti-inflammatory, Stimulant, Astringent, Spasmolytic, Corticosteroid like activity Gokshura(Tribulis terrestris) Vata Pitta shamak Nadidaurbalya, Ashmari, Mootrakrucha, Bastishoth Diuretic, Aphrodisiac, Antiinflammatory, Lithotriptic, Astringent, Analgesic, Antiurolithialic, Muscle relaxant Excellent result in UTI Haritaki(Terminalia chebula) Tridosha shamak, especially Vatashamak Shotha, Ashmari, Vedanayuktavikara, Vrana, Shoola, Gulma, Mootrakrichchra, Mootraghata Astringent, Diuretic, Anti-inflammatory, Antiseptic, Antifungal, Antibacterial, Laxative, Carminative, Digestive, Antispasmodic Punarnava(Boerhavia diffusa) Tridosh shamak Shoth, Mutrakrichchra Diuretic, Hepatoprotective, Anti-inflammatory, Antibacterial, Antifibrinolytic, Antiviral agent Group B Tamsulosin hydrochloride (Symptomatic relief – Alpha blockers) This drug relaxes smooth muscles, especially in the urinary tract and prostate. Helps relieve BPH symptoms, but do not reduce the size of the prostate. Helps to improve urine flow and reduce risk of bladder obstruction. Also, it increases the urine flow rate significantly in 90 minutes after administration of a single dose. Adverse effects: Postural hypotension, retro-grade ejaculation, dizziness, asthenia. Indications and usage: Treatment of symptoms of Benign Prostatic Hyperplasia. Dosage and administration: PO 0.4 mg/day, administered approximately 30 minutes following the same meal each day. If the patient fails to respond after 2 to 4 weeks, the dose may be increased to 0.8 mg/day. Method: A good clinical examination was done and patients with Grade I & II of B.P.H were selected in the study randomly. After starting the treatment, patients were called for visit after 1 week and were asked for the compliance of the tablet and side effects or the adverse effect, if any. No such adverse effects were found and so the treatment was then continued with the patient thoroughly examined in every 3 weeks. The AUA Score was assessed and a Digital rectal examination was carried out in 3 weeks. Statistical analysis was done from the data obtained and final results were found out. Statistical Analysis Parametric tests for objective Parameters (Quantitative Data, i.e. Improvement in Physical parameters & improvement in haematological parameters) Non –Parametric test for subjective parameters (Qualitative Data, i.e. Relief in Symptoms) Observation and Results Assessment of observed Parameters Table showing effect on general AUA symptom (Score of 30 patients of B.P.H.) GROUP A Sr. No. Symptoms BT AT Difference % of Relief 1 Incomplete Emptying 45 3 42 93.33 2 Frequency 95 24 71 74.73 3 Intermittency 38 4 34 89.47 4 Urgency 86 11 75 87.20 5 Weak stream 58 7 51 87.93 6 Straining 40 7 33 82.50 7 Nocturea 88 21 67 76.13 GROUP B Sr.No. Symptoms BT AT Difference % of Relief 1 Incomplete Emptying 48 6 42 89.36 2 Frequency 103 28 75 72.81 3 Intermittency 37 2 35 94.59 4 Urgency 78 6 72 92.30 5 Weak stream 65 9 56 86.15 6 Straining 58 5 53 91.37 7 Nocturea 84 17 67 79.76 WILCOXON TEST Sr. No. Symptoms Group A Group B 1 Incomplete Emptying 3.51 P Read the full article
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