Alternative Urological Drug Treatment For Urinary Stones

“ SAMBONG” ( Blumea balsamifera L. ) Releaf

SAMBONG ( Blumea balsamifera ) I. Folkloric Validation a. Used by most traditional healers for Cough, Colds, Fever, Headaches & Post-Partum bath b. 100% of healers reported the same side effect: DIURESIS Philippine Herbs

II. Scientific Validation 1. Biological Assay i. LD 50% = 62gm/kg AAM = 40 Kg Sambong powder single dose = 80,000 tablets single dose ii. ED 50% = 500mg/dose (HUMAN) 2. Toxicity Studies Negative but with some incidence of hyperemic renal parenchyma 3. Mutagenecity, Clastogenecity i. Rec Assay, Ames Test, Host-Mediated Assay, Micronucleus Test o All negative results ii. Exhibited anti-mutagenic potential vs. Tetracycline, Mitomycin D, and Dimethylnitrosoamine Philippine Herbs

II. Scientific Validation

1. Biological Assay

i. LD 50% = 62gm/kg AAM

= 40 Kg Sambong powder single dose

= 80,000 tablets single dose

ii. ED 50% = 500mg/dose (HUMAN)

2. Toxicity Studies

Negative but with some incidence of hyperemic renal parenchyma

3. Mutagenecity, Clastogenecity

i. Rec Assay, Ames Test, Host-Mediated Assay, Micronucleus Test

o All negative results

ii. Exhibited anti-mutagenic potential vs. Tetracycline, Mitomycin D,

and Dimethylnitrosoamine

Chemical research Identification of volatile components in Sambong by GC-MS

Chemical research Identification of volatile components in sambong by GC-MS Flavanone-A

Summary: Phytochemical Analysis (>12 biochemicals) Terpenes Cineol, Limonene, Camphor, Borneol Sesquiterpene (Drug for Toshida’s Sarcoma) Monoterpenes Triterpenes Alkaloids Flavanoids

Terpenes

Cineol, Limonene, Camphor, Borneol

Sesquiterpene (Drug for Toshida’s Sarcoma)

Monoterpenes

Triterpenes

Alkaloids

Flavanoids

FIG 1. Diuretic Effect of Sambong (By NIRPROMP) 60% Average Increase in 24 hr. Urine Volume

FIG 2. Effect of Sambong on Blood Electrolytes (By NIRPROMP) *Changes not statistically significant Mean Serum Electrolyte Before Sambong After Sambong % Change * Sodium (mEq/L) 139.9 136.7 2.3% Potassium (mEq/L) 4.6 4.3 6.5% Chloride (mEq/L) 101.7 101.3 0.3%

Fig 3. Extended Open Phase 3 Clinical Trial: Effectivity of Sambong vs. Urolithiasis (By Jaime Purification, MD) * 89% Effectivity Rate vs. Urinary Tract Stones

Indications of Sambong (Re-Leaf) For Hypertension Replacement for synthetic diuretics For Urinary Stones In patients who are contraindicated as far as surgery and lithotripsy is concerned In patients who fear or are perverse to the above-mentioned procedures In patients who are economically-challenged As prophylaxis

For Hypertension

Replacement for synthetic diuretics

For Urinary Stones

In patients who are contraindicated as far as surgery and lithotripsy is concerned

In patients who fear or are perverse to the above-mentioned procedures

In patients who are economically-challenged

As prophylaxis

Cost of Treatment Releaf Forte Cost per tablet (Forte)… P 6.60 Dose TID……………….. P 19.80 Duration – 1 month .……P 594.00 Follow-up Consultation Professional Fee ………..P1000.00 2 Visits per month ………P2000.00 Diagnostics/Laboratory Fees ……………………...P1000.00 Grand Total………………………………….P3594

Releaf Forte

Cost per tablet (Forte)… P 6.60

Dose TID……………….. P 19.80

Duration – 1 month .……P 594.00

Follow-up Consultation

Professional Fee ………..P1000.00

2 Visits per month ………P2000.00

Diagnostics/Laboratory

Fees ……………………...P1000.00

Grand Total………………………………….P3594

Alternative Urological Drug Treatment For Benign Prostatic Hypertrophy

PROSTACTIVE ® Evidence-based v 1.7

ProstActive ® Chemical Research Concentrated (12:1) lipophilic extract Fruit of Saw Palmetto (Serenoa repens or Sabal serrulata) Purified liposterolic extract contains 80-95% fatty acids and sterols Including beta-sitosterol Other constituents include esters, long-chain alcohols, and polysaccharides

Concentrated (12:1) lipophilic extract

Fruit of Saw Palmetto (Serenoa repens or Sabal serrulata)

Purified liposterolic extract contains

80-95% fatty acids and sterols

Including beta-sitosterol

Other constituents include esters, long-chain alcohols, and polysaccharides

Indications: Early stages of Benign Prostatic Hyperplasia Pre- and post-operative prostate treatment Chronic Prostatitis

Early stages of Benign Prostatic Hyperplasia

Pre- and post-operative prostate treatment

Chronic Prostatitis

ProstActive Clinical Results

ProstActive Clinical Results

ProstActive Clinical Results

ProstActive Clinical Results

Dosage Prevention/Maintenance: one softgel per day Therapeutic: one softgel 2X/day One softgel delivers 320 mg saw palmetto Study used 160 mg delivery unit 4X/day Take with water at mealtime Increased absorption when taken with food Take continuously for maximum benefit Allow two to eight weeks for noticeable results Fortschr Med 1995; 113:37-40

Prevention/Maintenance: one softgel per day

Therapeutic: one softgel 2X/day

One softgel delivers 320 mg saw palmetto

Study used 160 mg delivery unit 4X/day

Take with water at mealtime

Increased absorption when taken with food

Take continuously for maximum benefit

Allow two to eight weeks for noticeable results

Fortschr Med 1995; 113:37-40

Precautions Very rare occurrence of acute urinary retention after initiating therapy for BPH (Phytosterol supplementation should be avoided by pregnant women and nursing mothers)

Very rare occurrence of acute urinary retention after initiating therapy for BPH

(Phytosterol supplementation should be avoided by pregnant women and nursing mothers)

Contraindications Phytosterol supplementation is contraindicated in those with the rare genetic disorders Sitosterolemia and Cerebrotendinotic Xanthomatosis ProstActive is contraindicated in persons known to be allergic to Saw Palmetto

Phytosterol supplementation is contraindicated in those with the rare genetic disorders Sitosterolemia and Cerebrotendinotic Xanthomatosis

ProstActive is contraindicated in persons known to be allergic to Saw Palmetto

Adverse Reactions Generally well tolerated Mild gastrointestinal reactions reported with phytosterol ingestion at > 1 g/day dosage including occasional indigestion, feeling of fullness, gas, diarrhea and constipation

Generally well tolerated

Mild gastrointestinal reactions reported with phytosterol ingestion at > 1 g/day dosage including occasional indigestion, feeling of fullness, gas, diarrhea and constipation

Interactions Drugs None known to date Phytosterol supplementation may be additive to the cholesterol-lowering effects of such cholesterol-lowering drugs as the statins. Nutritional Supplements & Food Some randomized trials have indicated that phytosterols, may lower serum levels of alpha- and beta-carotene, lycopene and vitamin E, probably by interfering with their absorption Neither vitamin A nor vitamin D levels appear to be affected

Drugs

None known to date

Phytosterol supplementation may be additive to the cholesterol-lowering effects of such cholesterol-lowering drugs as the statins.

Nutritional Supplements & Food

Some randomized trials have indicated that phytosterols, may lower serum levels of alpha- and beta-carotene, lycopene and vitamin E, probably by interfering with their absorption

Neither vitamin A nor vitamin D levels appear to be affected

Laboratory Tests Several clinical studies have shown no effect on prostate-specific antigen (PSA) 1 year ( Phytotherapy Res 1997;11:558-63) 6 months ( Urology 1998;51:1003-7) 6 months ( Prostate 1996;29:231-40)

Several clinical studies have shown no effect on prostate-specific antigen (PSA)

1 year ( Phytotherapy Res 1997;11:558-63)

6 months ( Urology 1998;51:1003-7)

6 months ( Prostate 1996;29:231-40)

Advantage/Disadvantage A meta-analysis of 18 randomized, clinical trials involving extracts of S aw Palmetto in patients with BPH Study volunteers were significantly less likely to report erectile dysfunction when taking saw palmetto compared to finasteride (1.1% vs. 4.9%, p<0.001) Slow Onset of Action JAMA 1998;280:1604-9.

A meta-analysis of 18 randomized, clinical trials involving extracts of S aw Palmetto in patients with BPH

Study volunteers were significantly less likely to report erectile dysfunction when taking saw palmetto compared to finasteride (1.1% vs. 4.9%, p<0.001)

Slow Onset of Action

Thank You Very Much Eliseo T. Banaynal Jr., MD Medical Director for Natural and Semi-Synthetic Products Pascual Laboratories Inc.