Management of Benign Hyperplasia of Prostate with Polyherbal Unani Formulation- An Open Ended Pilot

Study

Dr. Younis Munshi (BUMS, MD)

Scientist-4Regional Research Institute of Unani Medicine,

Kolkata

Introduction:

•Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate, common problem of aging for men.

• It has been proposed that the disorder has two phases, one that involves no clinical signs and the other that manifests clinical signs.

• Signs and symptoms related to BPH are related to lower urinary tract or we call it LUTS.

LUTS:

•Nocturia, dribling of urine, incomplete emptying, hesitancy, weak stream, frequency, urgency are the symptoms which are called as LUTS. •Sometimes the LUTS are related to other diseases also so there is dire need of differential diagnosis, those disease are Cystitis, Over Reactive Bladder etc.

This is one of the most common problems in older men, and by the seventh decade affect nearly 75% of them [Litwin MS, et al 2007].

Autopsy studies have observed the histological prevalence of 8% in 4th decade 50% in 6th decade and 80% in 9th decade of life

Incidence:

•It is estimated that in the USA 30–90% of patients seen by urologists for putative BPH may be taking some form of alternative therapy [Gerber GS, et al 1998, Lowe FC et al, 1996]. •A number of different herbal therapies have been documented useful for BPH including Seronoa repens (Saw palmetto berry extract), Hypoxis rooperi (South African star grass), Pygeum africaneum (African plum), Secale cerale (Rye pollen), Soy, showing improvement in signs and symptoms when compared with placebo [Raj C. et al-2008].

Treatment Options:

In India Ayurveda and Unani alternative medical system have a long history and are very popular. The popularity is based on the fact that these systems use natural products having good efficacy with insignificant or no side effects.

The Unani Medicine with therapeutic properties, are being used as a way of treatment with reasonable success rate.

Treatment Options:

An open ended pilot study was conducted in the OPD of Regional Research Institute for Unani Medicine (RRIUM) Srinagar from 2008-2009 to evaluate the efficacy of this combination treatment on BPH patients. Patients attending OPD of RRIUM with the history of increased urination frequency, urgency, urgency incontinence, and voiding at night (nocturia), were evaluated for BPH. 30 patients aged between 39 and 71 with a mean age 50.04 ± 10.56 fulfilling the criteria were selected for this study. The experimental strategy was explained to them fallowed by written consent. Diagnosis was made by the physicians based on complaints of LUTS and Ultrasonography. The patients were given 500mg capsule Siras thrice in a day and two Habbi Muqil (250 mg tablets) thrice in a day for the duration of two and half month. The follow up appointments were made after every 15 days. International prostatic symptoms Score (IPSS) was utilize to observe the changes.

Methodology:

Total score: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.

Results & Discussion:

The results thus obtained were evaluated and were very encouraging as evident from the tables. The mean body mass index was 25.72 ± 3.61 and the mean of disease distribution was 14.40 ± 10.95. The mean IPSS before treatment was 15.6 ± 6.68 which was reduced to 3.33 ± 3.38 with P Value <.0001 which proves the significance of the treatment

Results & Discussion:

Pre-Treatment Mean IPSS 15.60±6.68 6 to 30

1st Fallow up 12.32±6.22 4 to 28

2nd Fallow up 9.32±6.60 2 to 26

3rd Fallow up 5.92±4.23 2 to 17

4th Fallow up 4.42±3.62 1 to 15

5th Fallow up 3.33±3.38 0 to 14

IPSS score before the treatment and during the treatment (Table-1).

Results & Discussion:

Pretreatment Quality of Life

3.76 ± 1.98 0 to 6

Posttreatment Quality of Life

1.42 ± 1.42 0 to 6 P Value <.0001

The quality of life index for Urology was evaluated on specially formulated questionnaire and there was marked improvement in quality of life index after the completion of the treatment (Table-2). Comparison of life quality before and after the treatment (Table-2).

Different scientific studies on experimental drug.The poly-herbal formulation used in the study has different effect and are widely being used in the Unani System of Medicine for different ailments. The latest studies have shown that Saponins of Albizia lebbeck bark show antifertility activity in male rats. This activity may be due to the disturbances induced by the saponins in testicular somatic cell functions [R.S. Guptaa, et al, 2005].Administering the A. lebbek rise in plasma cortisol has been observed and the action is similar to ACTH, it may be through the pituitary or by direct action on the adrenal gland.[Tripathi P, et al 1983]

Results & Discussion:

One of the study revealed a differential cytotoxic activity of the petroleum ether extract (IC₅₀ =5 μg/mL) of the resinous exudates of Commiphora species against two mouse cell lines KA31T and NIH3T3 (untransformed and transformed mouse fibroblasts, respectively).[Ayyad SE, et al 2015]The results denote that Comiphora species extract has significant analgesic, anti-inflammatory and anti-hyperlipidemic effects and reduces body weight gain and improves blood lipids profile. These results affirm the traditional use of C. Species for the treatment of pain, inflammations, and hyperlipidemia.[Shalaby MA, et al. 2014]

Different scientific studies on experimental drug.

Terminalia chebula significantly increased Pain Threshold time and Pain Tolerance time compared to Placebo. Study medications were well tolerated[Kumar CU, et al. 2015].T. chebula has also been reported to display potent antibacterial activity against a microbial panel (Aneja and Joshi 2009).

Different scientific studies on experimental drug.

So from the above studies there seems that the medicine used in the study have some anti-inflammatory effect. Also Albezia lebbek has some effect on hormones and different enzymes responsible for the enlargement of Prostate. While as Habbe Muqil being anti-inflammatory in can be of help for the patients suffering from Hyperplasia of Prostate.Further studies are needed in this direction so that a comprehensive Unani drug is developed to overcome this disease which is one of the most common geriatric problems of the developing as well as developed world

Conclusion…...