for the use only of registered medical practitioners or a hospital or a laboratory

DOUBLE BLIND CROSS-OVER RE-CHECK STUDY of

BANGSHIL

in CHRONIC URETHRITIS & PROSTATITIS

S.S. Bapat, MS, FRCS, FRCS (E) B.J. Medical College & Consulting Urologist, Pune, Maharashtra.

Paper read at the 21st Annual Conference of International College of Surgeons, Indian Section, Gulbarga, 5-7 October 1975.

Abstract

BANGSHIL (Alarsin) in the management of • URETHRITIS • PROSTATITIS

Confirms that Bangshil (Alarsin) has a definite place in armamentarium of a clinician for use in cases of U.T. Infections where there does not exist any obstructive uropathy. Almost all the cases had various antibiotics many times in the past with recurrence and relapses before Bangshil trial.

INTRODUCTION:

Genito urinary infections are now a world problem. Numerous drugs which are the outcome of vast researches in the field of medicine, have been tried in the management of this malady. In acute stages of urinary tract infection, newer and highly potent antibiotics are usually used successfully. But many of these drugs are prohibitively costly and have undesirable side effects with emergence of bacterial resistance and hence cannot be used over length of time. Thus resistance of drugs and thereby recurrence and relapse of infection is a very common phenomenon.

This is more particularly so about infections of prostate and urethra because of the anatomical construction of prostatic gland with long and short ducts. This encourages the chronicity and relapse by two methods. (A) Incomplete expulsion of infected debris (B) Inability of the drug to reach the site of target. Therefore, a search for a safer, least toxic, satisfactory and economical drug in urinary tract infection has become a paramount need of the day. This is more so because the treatment is more often prolonged over weeks or months.

Hence, after initial encouraging results with the commercially available tablet Bangshil (Alarsin), it was decided to test its efficacy by Double blind Cross-over Re-check trial.

MATERIALS AND METHODS: SELECTION OF CASES:

During the trial period spreading over two and half years from March 1972 to August 1974, one hundred cases were studied. These cases were divided in two groups A & B of 50 each, for the purpose of double blind study. One of these groups was treated by capsules containing drug powder and the other by identical looking capsules containing placebo. Those dropping out of the trial any time before completion of trial period or follow up, were not considered in final assessment. All these cases were fully investigated and documented on their first attendance and results of various investigations were noted. All the cases were males above 18 years. All had definite urinary tract infection past or present and symptoms predominantly referred to lower urinary tract. Cases with obstructive uropathy were not included in this study.

OCCUPATION:

Occupation did not show any specific preponderance to the disease.

PAST HISTORY:

Revealed 28% cases with previous exposure to V.D., retention of urine in 4% cases and catheterization in 4% cases.

Showing past History - Table I
History	Gr. A	Gr. B	Total	%
Exposure to V.D.	18	10	28	28%
Retention of Urine	1	3	4	4%
Catheterisation	2	2	4	4%
Prostatectomy	0	1	1	1%
Stone crushed (in the bladder)	1	0	1	1%
Appendectomy	0	1	1	1%
Tonsillectomy	0	1	1	1%
Jaundice	0	2	2	2%

PREVIOUS TREATMENT:

It was found out that almost all the cases had various antibiotics many times in the past, with recurrence and relapses.

Presenting Complaints -Table 11

Complaints	Gr. A	Gr. B	Total	%
Burning Micturition	36	33	69	69%
Frequency	33	34	67	67%
Strangury	11	12	23	23%
Dysuria	9	13	22	22%
Haematuria	8	9	17	17%

CLINICAL EXAMINATION:

Was remarkably uninformative ex,~ept that in a few cases it revealed bilateral iriguinal hernia (3 cases).

P.R. EXAMINATION:

Prostate was found 'enlarged and/or tender in 32 cases. One case had a peasized nodule in prostate, while one had prostate operated before.

ASSOCIATED DISEASES:

No associated diseases significance were detected. INVESTIGATIONS:

INVESTIGATIONS:

All the cases were subjected to the following investigations and diagnosis was confirmed in each case by panendoscopy.

1 Urinalysis 4 V.D.R.L

2 Urine culture 5 Plain x-Ray (K.U.B.)

3 Blood examination 6 PANENDOSCOPY

(Haemogram, Blood

urea & BI. sugar)

of - any

URINE CULTURE:

Out of 100 cases 24 cases were found with sterile pyuria. In remaining 76 cases, the urine cultures were positive.

Types of Organisms – Table III
Organisms	Gr. A	Gr. B	Total	%
E. Coli	27	21	48	48%
Proteus	4	6	10	10%
Pseudomonas	5	6	11	11%
Streptococcus	3	1	4	4%
Staphylococcus	1	1	2	2%
Klelisiella	-	1	1	1 %

Total	40	36	76	76%

Panendoscopic Examination - Table IV

Findings	Gr. A	Gr. B	Total	%
Prostatitis	29	31	60	60
Urethritis	12	15	27	27
Trigonitis & Prostatitis	9	4	13	13

PANENDOSCOPY:

Showed 60% cases with prostatitis and 27% cases of urethritis while 13% cases suffering from Trigonitis with prostatitis.

DRUGS and DOSAGE SCHEME:

The drugs for this double blind crossover study were supplied by `ALARSIN' in two identical capsules 'X' and `Y'. The contents of the capsules were not disclosed till the end of trial.

for RE-CHECK:

The drug Bangshil as commercially available was used.

I DOUBLE BLIND METHOD:

Patients were divided at random into two Groups A & B. All the drugs used in the trial were started after previously out-lined investigations were carried out. Group `A' cases were given 'X' capsules initially 2 tid for 16'h days, i.e 100 capsules course. A similar course of 100 capsules of 'Y' was given to each patient from Group `B' in the same dosage. In addition to above, every patient was given alkaline mixture to be taken for 3 to 4 days and vit. C. 500 mg: twice a day for 16'/2 days.

SEX ADVICE:

In addition, regular sexual intercourse was advised to all who were married and living with their wives and other were encouraged to do masturbation twice a week. Those who got complete relief with 100 capsules of either `X' or `Y' and confirmed by objective assessment were recorded as completely relieved and were not considered further.

II CROSS-OVER PHASE

Remaining non-relieved cases were crossed over, i.e Group `A' unrelieved cases were given 100 capsules of Y in the same dosage and Group 'B' unrelieved cases were given 100 capsules of X in the same dosage.

111 RE-CHECK PHASE

Again at the end of second course the results were assessed. Those who got total relief with 2nd course were recorded as such. Those who failed to show any response even after cross-over phase, were given commercially available Bangshil tablets in the same dosage and for same period as above. Final results were assessed at the end of this re-check phase as "Complete Relief" "Partial Relief" and "No Relief".

CRITERIA for ASSESSMENT of RELIEF BASED on:

1) Subjective feeling ' of the patient. i.e. symptomatic relief.

2) Objective assessment by urinalysis.

3) Panendoscopic examination could be carried out only in 23 cases as others refused. (14 cases from Group A and 9 cases from Group B).

ANALYSIS OF RESULTS-GROUPWISE:

`X' Capsules (BANGSHIL)-`Y' Capsules (PLACEBO)

Results of Group A-Table V

‘X' Capsules				`Y'Capsules
DIAGNOSIS	No. of Cases	Complete Relief	No Relief	No. of Complete Cases Relief	No. Relief
Prostatitis	29	20	9	9	- 9
Urethritis	12	5	7	7	- 7
Trigonitis	9	7	2	2	- 2
TOTAL	50	32	18	18	- 18

Out of 50 cases of Group A, 32 cases showed complete relief with first course of 100 capsules of 'X' only, while remaining 18 cases were crossed over to `Y' capsules course. But all 18 cases did not show any further improvement at all.

Results of Group B-Table VI

`Y' Capsules				`X' Capsules
DIAGNOSIS	No. of Cases	Complete Relief	No Relief	No. of Complete Cases Relief	No. Relief
Prostatitis	31	5	26	26 19	7
Urethritis	15	-	15	15 12	3
Trigonitis	4	-	4	4 3	1
TOTAL	50	5	45	45 34	11

Out of 50 cases of Group B, 5 cases showed complete relief with first 'Y' capsules course, out of remaining 45 cases which were crossed over to `X' capsules course, 34 showed total relief, while 11 cases could not get relief.

RE-CHECK PHASE:

Unrelieved crossed-over cases from both the Groups were later treated with commercially available Bangshil tablets. Tablet BANGSHIL

Response-Table VII

Thus unrelieved 29 cases from both the Group (18 cases from Group A and 11 cases from Group B) were treated with Bangshil Tablets. Out of which 14 cases were totally relieved of their complaints, 7 cases were relieved partially, while 8 cases failed to get any relief.

At this stage, the compositions of 'X' and `Y' capsules were revealed, `X' capsule was equal to one tab. of Bangshil and `Y' capsule served as placebo, contained lactose powder.

THE OVER ALL RESPONSE

Response to `X' Capsule (Bangshil) and Bangshil tablets

Total No. Total . Partial No

of Cases of Relief Relief Relief

95 80 7 8

% 84.2% 7.4% 8.4%

Relief by `Y' (Placebo) Capsules-5(5%) Cases:

Thus the overall response to this double blind cross-over and re-check study of Bangshil can be recorded, excluding 5 cases who had relief with placebo (Y) capsules 80 cases showed total relief, that is 84.2% & 7 cases (7.4%) showed partial relief, while 8 cases (8.4%) showed no relief.

A noteworthy point is that there were absolutely no side effects of the drugs.

DISCUSSION:

Foregoing clinical trial proves that Bangshil has a definite place in the armamentarium of a clinician for use in cases of U.T. infection where there does not exist any obstructive uropathy.

TREATMENT PROBLEMS:

In treating chronic infection of Prostate and Urethra mainly arise due to inability of expulsion of infected debris from Prostatic ducts and probable inability of the drug to reach the target zone in adequate concentration and over an adequate length of time. Hence the treatement is necessarily a long drawn affair.

RELEVANT FACTORS:

To be considered in any drug therapy in such types of cases are (1) length of treatement (2) dosage schedule (3) drug tolerance (4) side effects (5) contra-indications (6) cost.

Hence a search for safer and effective drug has been going on for many years all over the world.

BANGSHIL an AYURVEDIC approach:

Commercially available tablet Bangshil gave encouraging results and hence it was put to a double blind crossover recheck trial which has shown very satisfactory results. Mode of action of Bangshil is not known. Every case from the above series which was infected has his urine culture. Along with standard drugs, Bangshil was also used over the culture plates. But it showed no inhibition of bacterial growth. Nevertheless, in vivo it acted very satisfactorily.

Ayurveda has got its own theories of drug composition and drug action based largely on Dash-Dhatu-Mala theory of physiology and pathogenesis of diseases. The correct equivalent of these concepts in terms of modern medical science is still not possible.

In Ayurvedic system of medicine the drugs are used in total alkaloid form and thus the action is considered in its entirety, unlike the modern medicine which advocates the use of isolated active principle or pure alkaloid in the treatment of disease.

CONCLUSIONS:

1) In this double blind-crossover-recheck study of Bangshil, 100 male cases of Prostatitis, Urethritis and Trigonitis were included. The compositions of capsules `X' and `Y' were not revealed during the course of this study.

2) 66 cases (70%) showed complete relief with first course (i.e. 100 capsules of X) while 14 cases (14.4%) needed another course of 100 tabs. for complete relief. 7 cases (7.4%) showed partial relief and 8 cases (8.4%) dij not respond.

3) No untoward side effects of Bangshil were observed in this study.

4) Bangshil has got a definite place in the management of Urethritis and Prostatitis.

ACKNOWLEDGEMENT:

I wish to offer my sincere thanks to Shri Vilas Mohadikar of Alarsin Pharmaceuticals, for generous supply of drugs and his co-operation to conduct this study.

REFERENCES:

(1) Bapat, S.S.: Chronic Urethritis-A Psychosomatic Syndrome: (1969) : Indian Practitioner.

(2) Chopra, N.N.: Indigenous Drugs of India, Second Edition.

(3) Dwarakanath, C: Forward to "Studies in Indian Medical Plants used in Ayurveda-Cathartics". Publication No. 2 of LD.M.A., Pune 1962.

For Information on ALARSIN products: Please write to:

ALARSIN , A/32 Road No.3, MIDC Andheri (E), Bombay-400 093.

Dr. Bapat