Benign Prostatic Hyperplasia (BPH) affects most men over 40 years of age. This is part of the normal aging process of the prostate gland. However as the gland grows larger, various complications can occur which can affect urinary and reproductive health. Himplasia was introduced by Himalaya Herbals to provide relief with no side-effects and to improve the quality of life. Studies have shown that after taking Himplasia, prostate size reduced by almost 22% while prostate weight reduced by 70%

Role of herbal drugs in the management of benign prostatic hyperplasia: Clinical trial to evaluate the efficacy and safety of Himplasia

Arora, R.P., CMO, Rajiba L. Nayak, Senior Resident Vineet Malhotra, Senior Resident Mohanty, N.K., Head, Department of Urology, Safdarjang Hospital, New Delhi, India. and Kala Suhas Kulkarni Medical Advisor, R&D Center, The Himalaya Drug Company, Makali, Bangalore, India.

ABSTRACT

This was a double-blind placebo-controlled clinical trial, which included 98 patients clinically diagnosed with various degrees of benign prostatic hyperplasia and confirmed by pelvic ultrasonography along with uroflowmetry investigations. Himplasia was administered as 1 tablet, twice daily for 6 months. All the patients were clinically examined every month for 6 months and we repeated ultrasonography and uroflowmetry after 6 months treatment. There was excellent compliance with Himplasia. All 98 patients completed the treatment and no patient reported any side effects.

Himplasia significantly relieved the symptoms of BPH along with reduction in prostate size revealed by pelvic ultrasonography. Himplasia acts by dual mode of action by inhibition of 5-alpha reductase enzyme inhibition with alpha receptor blocking action. By this Himplasia controls the conversion of testosterone to dihydrotestosterone along with relaxation of prostatic smooth muscles. Himplasia may be considered as a therapy for patients with benign prostatic hyperplasia.

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Evaluation of the efficacy and safety of Himplasia in BPH: A randomised, double-blind, placebo-controlled, phase III clinical trial

Dr. Saswata Chakraborty, M.S.1, Dr. Dilip Karamakar, M.S., M.Ch.2, Dr. S.A. Kolhapure, M.D.,3* 1Research Assistant, 2Professor & Head, Department of Urology, Calcutta National Medical College & Hospital, Kolkata, India. 3Senior Medical Advisor, R&D Center, The Himalaya Drug Company, Bangalore, India [*Corresponding author] Medicine Update (2004): 12(4), 39-48

ABSTRACT

Benign prostatic hyperplasia is a non-malignant enlargement of the prostate gland affecting aging men and is responsible for great compromises in the quality of life in the geriatric population. Due to frequent adverse reactions of available drug therapy, phytotherapy has been extensively researched and some polyherbal formulations have been shown beneficial in the management of BPH. This study was planned to evaluate the efficacy and safety of Himplasia in BPH and it was a randomized, placebo-controlled, double-blind, phase III clinical trial, approved by the Institutional Ethics Committee.

A total of 48 patients suffering from BPH were included in the study and were categorised by the AUA symptom score index. At the initial randomisation visit, a detailed medical history, with special emphasis on history of urinary symptoms was obtained from all patients. All patients underwent a thorough systemic examination, which was followed by DRE. Routine biochemical blood tests and specific tests were done for all patients. All patients were investigated by uroflowmetry and abdominal ultrasonography. All patients were advised to consume 1 tablet of Himplasia, twice daily, for a period of 6 months. All patients were followed for a period of 6 months. At each monthly follow-up visit the AUA symptom score and prostate size was evaluated. An uroflowmetry examination was done at the end of 3rd and 6th month and a complete clinical, biochemical and ultrasonographic examination was carried out at the end of the 6th month. The predefined primary endpoints for efficacy were decrease in total AUA score, decrease in prostate volume, and improvement in uroflowmetry parameters. The predefined secondary endpoints were short-term and long-term safety, patient compliance to the drug therapy, and improvement in haematological and biochemical parameters. All adverse events reported or observed by patients were recorded with information about severity, date of onset, duration and action taken regarding the study drug. Statistical analysis was done according to intention-to-treat principles.

This study observed a highly significant reduction in the mean AUA symptom score, prostate volume, PVR urine volume and a highly significant increase in urinary PFR in the Himplasia group at the end of the study. There were no significant changes in the haematological and biochemical parameters, in the Himplasia group. There were no clinically significant adverse reactions, either reported or observed during the study period and overall compliance to the treatment was excellent.

ABBREVIATIONS:
AUA : American urological association
AUR : Acute urinary retention
BPH : Benign prostatic hyperplasia
CRF : Case report form
DHT : Dihydrotestosterone
DLC : Differential leucocyte count
DRE : Digital rectal examination
Hb : Haemoglobin
IL : Interleukin
LUTS : Lower urinary tract symptoms
PFR : Peak flow rate
PSA : Prostate-specific antigen
PVR : Post-void residual volume
TLC : Total leucocyte count
TNF-a : Tumor necrosis factor- alpha

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[Medicine Update (2003): (11), 1, 75-78]
Clinical evaluation of Himplasia in Benign Prostatic Hyperplasia: An Open Clinical Trial
Manoranjan Sahu, Reader and Head, Ramesh Bhat, P. Research Scholar, Department of Shalya Shalakya, Sir Sundarlal Hospital , Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India. and Kala Suhas Kulkarni, M.D., Medical Advisor, R&D Center, The Himalaya Drug Company, Makali, Bangalore, India.

ABSTRACT
This was an open clinical trial undertaken in 25 elderly male patients in the age group of 45-90 years diagnosed with Benign Prostatic Hyperplasia (BPH) in the Department of Shalya Shalakya, Sir Sundarlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi. Himplasia was administered at a dose of 2 tablets, twice daily for a period of 3 months. All the patients were followed-up for 3 months at an interval of 4 weeks. They were evaluated on IPSS score along with uroflowdynamics. Himplasia significantly relieved the symptoms of BPH along with improvement in urinary flow rates and reduction in post-void residual urine.

INTRODUCTION
Benign prostatic hyperplasia (BPH) is a disorder, which leads to urinary symptoms in elderly males. More than 90% of the males over 80 years of age have histological evidence of BPH (Fang-Liu, 1993). Worldwide more than 25 million of elderly men suffer from moderate to severe degree symptoms of BPH. The symptoms of BPH include poor flow of urine, difficult micturition, intermittent flow, dribbling, poor bladder emptying, hesitancy, urinary frequency, nocturia, urge incontinence etc., which affects the physical activities, mental health leading to deterioration of the “quality of the life” of the patients.
Medical therapy is effective in reducing the symptoms, prostate size and improving the quality of life of the patients. As the disease affects elderly males, they carry risks for surgery due to other geriatric problems like associated hypertension, diabetes, ischemic heart diseases etc. Medical therapy is supported worldwide in part, by limitations of the surgery and post-operative complications (Lepor et al., 1993). Many herbal formulations are getting popularized worldwide for the management of BPH (Fitzpatrick and Lynch 1995).
Himplasia is a polyherbal formulation, which has proved beneficial in reducing the symptoms of prostatic hyperplasia. This clinical trial was planned to substantiate its therapeutic benefits and to evaluate the efficacy in various clinical and uroflowmetric parameters in patients with BPH.
MATERIAL AND METHODS This was an open clinical trial undertaken in 25 male patients in the age group of 45-90 years diagnosed with Benign Prostatic Hyperplasia in the Department of Shalya Shalakya, Sir Sundarlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi. Himplasia was administered at a dose of 2 tablets, twice daily for a period of 3 months. All the patients were followed-up for 3 months at an interval of 4 weeks. Clinical, biochemical and uroflowmetry was repeated at three months following completion of treatment. The objective of this study was to evaluate the benefits of Himplasia in terms of the following parameters.

Decrease of AUA score

Decrease in bladder outlet obstruction

Reduction in post-void residual urine

Improvement in urinary flow rate

Reduction in the incidence of urinary retention

Improvement in the quality of life

All the patients were examined and written informed consent was obtained from all of them. The scoring of the symptoms was done on the basis of International Prostatic Symptom Score (IPSS).
The investigations done were as follows:
Hematological: hemoglobin percentage, total and differential count, erythrocyte sedimentation rate.
Blood urea and serum creatinine
Urine routine, microscopic and culture
Serum prostate specific antigen (PSA)
Trans abdominal ultrasonography (USG) for prostate size, weight, lobes involved, echo texture and post-void residual urine.
Uroflowmetry for voided volume (V), peak flow rate (Qmax), average flow rate (Qave), voided time, flow time and time of maximum flow.
Fasting and post prandial blood sugar

Following parameters were evaluated before and after treatment:
International prostatic symptom score (IPSS): Mild 0-7; Moderate 7-19; Severe 20-35
Prostate weight
Post-void residual urine
Serum PSA
Peak flow rate
Average flow rate
As this was an open study where the results were evaluated before and after treatment, Mann-Whitney test was performed to determine the level of significance.

RESULTS
Twenty-five patients in the age group of 45-90 years suffering from BPH were selected from the Department of Shalya Shalakya, Sir Sundar Lal Hospital, IMS, BHU, Varanasi. A complete clinical examination along with investigations was undertaken for the study.
More than 72% of the patients (i.e. 18 patients) were in the age group of 59-80 years (Table 1). The maximum number of patients, i.e. 12 (48%), were retired or in-service employees or officials. Only 8 (32%) patients were farmers and 5 (20%) patients were businessmen (Table 2). Among the symptoms, difficulty in micturition (92%), frequency (88%), poor flow (68%), dribbling (56%) were major symptoms in majority of patients. Burning micturition was another common (more than 68% of the patients) associated symptom. Three patients (12%) had hematuria (Table 3). Himplasia was effective in relieving signs and symptoms of BPH after 3 months of therapy.
International Prostate Symptom Score reduced up to 64% and mean value reduced significantly from 23.73 to 8.52.
Serum prostate specific antigen (Serum PSA) is the glycoprotein secreted in the epithelial cells of the prostate, which increases in BPH. On administering Himplasia for a period of 3 months serum prostate specific antigen reduced significantly from 4.57 to 2.89.
Prostate weight: There was a reduction in the mean prostate weight, which is indicative of prevention and check on further growth along with reduction in the size. There was a reduction in the mean prostate weight from 37.72 to 34.02
Post-void residual urine: Post-void residual urine volume was assessed on ultrasound. Following treatment it reduced by more than 50%. The post-void residual urine reduced significantly from 80.01 to 39.91. This suggests that Himplasia helps in effective evacuation of the bladder
Maximum flow rate: Peak flow rate was considered an important criterion to assess the response in patients with BPH.
Himplasia improved the peak flow rate significantly, which was more than 50% when compared to the pre-therapy
Average flow rate: Average flow rate improved markedly after the treatment and was normalized over a period of time with continued treatment. This was also highly significant
Tenderness of the prostate: Himplasia was found to be very effective in relieving tenderness of the prostate. Five patients, who revealed tenderness of prostate on digital rectal examination before treatment, did not show tenderness following treatment.
CONCLUSION

Thus, Himplasia is effective in controlling the symptoms of BPH, improving the maximum flow rate, average flow rate and peak flow rate. The size of the prostate was reduced in a significant number of patients. During the therapy none of the patients showed any adverse effects. The therapy was well tolerated and accepted by the patients. Thus, Himplasia can be considered as a drug of choice in the management of patients with symptomatic BPH.

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