
Last Updated on Sunday, 15 November 2009 23:14 Saturday, 05 September 2009 15:11
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GastroDefense Overnight Relief Summary of Clinical Trial of Active Ingredients It is well-known that chronic constipation and dyspepsia can complicate medical conditions such as hypertension and coronary heart disease, which in turn can lead to strokes, heart attacks and sudden death. Therefore it is important to heed the warning signs of constipation, gas and acid reflux. Recently clinical trials of the key active ingredients in GASTRO DEFENSE Overnight Relief Formula were carried out to test its effectiveness compared to a control group of over-the-counter medication (OCM). In every test, the Gastro Defense formula exceeded the results from OCM remedies and gave overall relief to symptoms with no negative side effects. In a trial comparing the effects of the Gastro Defense formula with an OCM laxative, the Gastro Defense formula was effective in 97% of the cases, while the OCM laxative was effective in 90%. Gastro Defense also had a greater percentage of “completely effective” results than the OCM laxative. No side effects were noted. Several trials were conducted on the effectiveness of the Gastro Defense formula with dyspepsia, using either untreated controls or controls treated with OCM remedies. Again, the Gastro Defense formula was more effective than the OCM remedies in every instance with 87% of 105 test subjects receiving benefit. In another study, the Gastro Defense formula was shown to be effective in dyspepsia-related hypomotility (slowing down of the rate of flow through the gastrointestinal tract) in 86% of cases studied, ulceration in 75%, and acid reflux in 72%. Two other studies showed that not only can the Gastro Defense formula dramatically reduce fat in the gut (hyperlipemia), but balance the fats and help reduce excess weight as well. In one study, the Trulax formula was given to 45 patients with excess body weight of at least 20% over normal with hyperlipemia while a control group of 45 patients was given Fenfluramine, a popular weight loss drug. At the end of 90 days, 96% of the treatment group showed improvement while only 80% of the control group did. No side effects were noted with the Gastro Defense formula, while Fenfluramine has sometimes lethal side effects, including heart valve disease and pulmonary hypertension (it was banned in the US in 1997). Another study looked at hyperlipemia alone. Patients with total cholesterol greater than 6.5 mmol/L or triglycerides greater than 1.58 mmol/L were divided into two groups, one receiving the Gastro Defense formula and the other group serving as a control. Results showed significant decreases in lipids, including total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and very low density lipoproteins (VLDL) while increasing the levels of high density lipoproteins (HDL). Studies have shown that higher proportions of HDL to LDL and VLDL is better for heart health. The following chart shows that the changes seen were significant, particularly in comparison to control levels.
Gastric reflux is a serious condition that can erode the lining of the esophagus, resulting in ulceration of the esophagus. The Gastro Defense formula is effective in resolving gastric reflux. In one study, a group of 24 patients with acid reflux disease was given the Gastro Defense formula for 4 weeks, and a control group was given acid reflux medications, Ranitidine and Pefloxacin, for the same period. The Gastro Defense formula showed significantly better results in treating both the reflux and associated symptoms (tumescence, burning pain, nausea and vomiting, and anorexia), as shown in the following tables:
Finally, one of the conditions associated with gastrointestinal problems such as chronic constipation, dyspepsia, and acid reflux is heart pain due to a distended abdomen. In a study of 90 patients with heart pain due to gastrointestinal problems, 92% experienced complete or partial relief of symptoms. 92% also experienced full or partial relief of symptoms of dyspepsia. The Gastro Defense formula is a natural compound with rhubarb root, aloe vera, chebulic myrobalan (or Terminalia Chebula), dandelion root, passion flower, and peppermint leaves.
This compound is safe, free of significant side effects, and easy to use. [i] Tseng, SH, et al. Effects of three purgative decoctions on inflammatory mediators. Journal of Ethnopharmacology 105(1-2):118-124 (2006). Rhubarb (Rheum palmatum) is one of the main ingredients in three traditional Chinese medicine (OCM) decoctions used to treat bloated and painful abdomen, hard stools, fever, etc. Of the three decoctions, the one known as Ta-Cheng-Chi-Tang (TCCT) showed the strongest purgative and anti-inflammatory effects. [ii] Cai, J, et al. [Effects of perioperative administration of Rhubarb on acute inflammatory response in patients with gastric cancer] Zhong Xi Yi Jie He Xue Bao 3(3):195-198 (2005). Following surgery for gastric cancer, patients often suffer an acute inflammatory response. In a study done on patients following surgery for gastric cancer, patients were fed rhubarb before the operation, 1 day after and 2 days after. Those receiving rhubarb had significantly lower levels of inflammatory markers (C-reactive protein, IL-6, tumor necrosis factor-alpha) than those who did not. [iii] Peng, SM, et al. [Effect of rhubarb on inflammatory cytokines and complements in patients with systemic inflammation reaction syndrome and its significance] Zhongguo Zhong Xi Yi Jie He Za Zhi 22(4):264-266 (2002). Treatment of systemic inflammatory reaction syndrome (SIRS) with rhubarb showed significantly reduced levels of Tumor Necrosis Factor-alpha, C-reactive protein, and complement 3 and 4. [iv] Li, Y, et al. [Study on the mechanism by which Rhubarb protects the mucosal barrier of intestine of mouse] Sichuan Da Xue Xue Bao Yi Xue Ban 36(2):210-212 (2005). Samples of mouse intestine were assayed for Type II PLA2 and lysozyme levels in controls and mice fed rhubarb. Samples from the rhubarb group showed significantly higher levels of Type II PLA2 (type II phospholipase A2) and lysozyme, indicating that the rhubarb helps to protect the mucosal barrier. [v] Ho, TY, et al. Emodin blocks the SARS coronavirus spike protein and angiotensin-converting enzyme 2 interaction. Antiviral Research (prepublication) (2006). [vi] Huang, Q, et al. Emodin inhibits tumor cell adhesion through disruption of the membrane lipid Raft-associated integrin signaling pathway. Cancer Research 66(11):5807-5815 (2006). [vii] Langmead, L, et al. Anti-inflammatory effects of aloe vera gel in human colorectal mucosa in vitro. Alimentary Pharmacology and Therapeutics 19(5):521-527 (2004). Aloe vera gel stimulated the release of eicosanoids and IL-8 (anti-inflammatory cytokines) in vitro. It shows promise in the treatment of inflammatory bowel disease. [viii] Fantus, B. Aloes as a medicine. Journal of the American Pharmaceutical Association 11:616–621 (1922). [ix] Vyth, A, Kamp, PE. Detection of anthraquinone laxatives in the urine. Pharmaceutisch Weekblad 114:456–459 (1979). [x] Che, QM, et al. Isolation of a human intestinal bacterium capable of transforming barbaloin to aloe-emodin anthrone. Planta Medica 57:15–19 (1991). A strictly anaerobic bacterium, Eubacterium sp. BAR, was isolated from human feces as one of the intestinal bacteria capable of metabolizing barbaloin. The bacterium grew in PYF broth containing barbaloin and converted barbaloin to aloe-emodin anthrone. On the other hand, the bacterium had little metabolic activity in GAM broth. [xi] Hattori, M, et al. Metabolism of barbaloin by intestinal bacteria. Chemical and Pharmaceutical Bulletin (Tokyo) 36:4462–4466 (1988). [xii] Langmead, L, et al. Randomized, double-blind, placebo-controlled trial of oral aloe vera gel for active ulcerative colitis. Alimentary Pharmacology and Therapeutics 19(7):739-747 (2004). Oral aloe vera taken for four weeks produced a clinical response to active ulcerative colitis more often than placebo, reduced disease activity, and had no side effects. [xiii] Borrelli, F, Izzo, AA. The plant kingdom as a source of anti-ulcer remedies. Phytotherapy Research 14(8):581-591 (2000). Aloe gel is one of the herbs extensively used for the treatment of peptic ulcers, and its clinical efficacy is well documented. [xiv] Cheng, HY, et al. Antioxidant and free radical scavenging activities of Terminalia chebula. Biological and Pharmaceutical Bulletin 26(9):1331-1335 (2003). Free radicals react with biological molecules and destroy the structure of cells. This can eventually cause diseases such as cancer, renal failure, aging, etc. In this study, 6 extracts and 4 pure compounds of Terminalia chebula Retz. were investigated for anti-lipid peroxidation, anti-superoxide radical formation and free radical scavenging activities. The superoxide radical scavenging of the 4 pure compounds was further evaluated using electron spin resonance (ESR) spectrometry. The results showed that all tested extracts and pure compounds of T. chebula exhibited antioxidant activity at different magnitudes of potency. The antioxidant activity of each pure compound was derived from different pathways and was suggested to be specific. [xv] Na, M, et al. Cytoprotective effect on oxidative stress and inhibitory effect on cellular aging of Terminalia chebula fruit. Phytotherapy Research 18(9):737-741 (2004). The ethanol extract from the fruit of Terminalia chebula (Combretaceae) exhibited significant inhibitory activity on oxidative stress and the age-dependent shortening of the telomeric DNA length. The life-span of HEK-N/F cells was elongated by 40% as a result of the continuous administration of 3 microg/ml of the T. chebula extract compared to that of the control. These observations were attributed to the inhibitory effect of the T. chebula extract on the age-dependent shortening of the telomere, length as shown by the Southern blots of the terminal restriction fragments (TRFs) of DNA extracted from subculture passages. [xvi] Malekzadeh, F, et al. Antibacterial activity of black myrobalan (Terminalia chebula Retz) against Helicobacter pylori. International Journal of Antimicrobial Agents 18(1):85-88 (2001). Black myrobalan showed significant antimicrobial activity when applied to cultures of Helicobacter pylori and other bacterial species. This activity was heat stable. [xvii] Ahn, MJ, et al. Inhibition of HIV-1 integrase by galloyl glucoses from Terminalia chebula and flavonol glycoside gallates from Euphorbia pekinensis. Planta Medica 68(5):457-459 (2002). The bioassay-directed isolation of Terminalia chebula fruits afforded four human immunodeficiency virus type 1 (HIV-1) integrase inhibitors, gallic acid ( 1) and three galloyl glucoses ( 2 - 4). In addition, four flavonol glycoside gallates ( 5 - 8) from Euphorbia pekinensis containing the galloyl moiety also showed the inhibitory activity at a level comparable to those of 2 - 4. By comparison with the activities of the compounds not bearing this moiety, it is proposed that the galloyl moiety plays a major role for inhibition against the 3'-processing of HIV-1 integrase of these compounds. [xviii] Saleem, A, et al. Inhibition of cancer cell growth by crude extract and the phenolics of Terminalia chebula Retz fruit. Journal of Ethnopharmacology 81(3):327-336 (2002). A 70% methanol extract of Terminalia chebula Retz fruit inhibited the growth of several malignant cell lines, including a human and mouse breast cancer line, a human osteosarcoma line, a human prostate line, and a non-tumorigenic, immortalized human prostate line. Chebulinic acid, tannic acid, and ellagic acid were the three most growth inhibitory phenolics of the fruit. [xix] Seo, SW, et al. Taraxacum officinale protects against cholecystokinin-induced acute pancreatitis in rats. World Journal of Gastroenterology 11(4):597-599 (2005). Taraxacum officinale (dandelion) reduced levels of TNF-alpha and IL-6 (inflammatory cytokines) in experimentally produced pancreatitis in rats. [xx] Chakurski, I, et al. [Treatment of chronic colitis with an herbal combination of Taraxacum officinale, Hipericum perforatum, Melissa officinalis, Calendula officinalis and Foeniculum vulgare] Vutreshni Bolesti 20(6):51-54 (1981). Twenty four patients with chronic non-specific colitis were treated with a herb combination. As a result from the treatment, the spontaneous and palpable pains along the large intestine disappeared in 95.83 per cent of the patients by the 15th day of their admission to the clinic. Defecation became daily in the patients with constipation syndrome, but a combination of Rhamus frangula, Citrus aurantium, C. carvi was added to the herb combination already indicated. Defecation was normalized in patients with diarrhea syndrome. The pathological admixtures in feces disappeared. [xxi] Trojanova, I, et al. The bifidogenic effect of Taraxacum officinale root. Fitoterapia 75(7-8)760-763 (2004). The infusion of dandelion root (Taraxacum officinale) stimulated in vitro the growth of 14 strains of bifidobacteria. The utilization of oligofructans, glucose, fructose and total saccharides was determined by enzymatic and phenol-sulfuric methods. Dandelion oligofructans were important source of carbon and energy for bifidobacteria tested. [xxii] Dhawan, K, et al. Anti-anxiety studies on extracts of Passiflora incarnata Linneaus. Journal of Ethnopharmacology 78(2-3):165-170 (2001). Passiflora incarnata Linneaus has been used since time immemorial to cure anxiety and insomnia. The active anxiolytic fraction of passiflora extract was isolated and possibly consisted of a bioflavone nucleus [xxiii] Dhawan, K, et al. Passiflora: a review update. Journal of Ethnopharmacology 94(1):1-23 (2004). Review of the morphology, microscopy, traditional and folklore uses, phyto-constituents, pharmacological reports, clinical applications and toxicological reports of the prominent species of the genus Passiflora. Passiflora incarnata Linneaus possesses significant CNS depressant properties due to a benzoflavone moiety. [xxiv] Mowrey, Daniel. The Scientific Validation of Herbal Medicine. Keats Publishing Inc, New Canaan CT. 1986. [xxv] Yasukawa, K., et al. Inhibitory effect of edible plant extracts on 12-o-tetradecanoylphorbol-13-acetate-induced ear edema in mice. Phytotherapy Research 7(2):185-189 (1993). [xxvi] Grigoleit, HG, Grigoleit, P. Pharmacology and preclinical pharmacokinetics of peppermint oil. Phytomedicine 12(8):612-616 (2005). Peppermints principal pharmacodynamic effect in the gastrointestinal system is as an antispasmodic. The mechanism of operation is related to the interference of menthol (the principal active ingredient in peppermint oil) with the movement of calcium across the cell membrane. [xxvii] Grigoleit, HG, Grigoleit, P. Gastrointestinal clinical pharmacology of peppermint oil. Phytomedicine 12(8):607-611 (2005). Nine clinical studies were done on 269 healthy subjects or patients. The main effect of the peppermint oil was an antispasmodic effect on the smooth musculature of the gastrointestinal tract. [xxviii] Grigoleit, HG, Grigoleit, P. Peppermint oil in irritable bowel syndrome. Phytomedicine 12(8):601-606 (2005). In 16 clinical trials (9 of which were randomized, double-blind studies), showed significantly better results compared to placebo and similar results compared to anticholinergics (smooth muscle relaxants). [xxix] Schelz, Z, et al. Antimicrobial and antiplasmid activities of essential oils. Fitoterapia 77(4):279-285 (2006). Peppermint oil showed antibacterial activity against both gram-positive (Staphylococcus epidermis) and gram-negative (E. coli) bacteria as well as two yeast (Saccharomyces cerevisiae) strains. [xxx] Murray, MT. The healing power of herbs. Healing Arts Press, 1995. Peppermint is used medicinally to treat indigestion and intestinal colic, as well as colds, fever, and headache. The pharmacology of peppermint focuses almost entirely on its menthol components. Peppermint and menthol possess carminative, antispasmodic, and choleretic properties, and are also used as an external analgesic and nasal decongestant. The mechanism behind peppermint oil's antispasmodic effects has recently been determined. Researchers believe that peppermint oil's inhibition of isolated smooth muscle contractions occurs via blockage of calcium influx into the muscle cells. Researchers hypothesize that the clinical effectiveness of peppermint oil in the treatment of irritable bowel syndrome results from inhibition of the hyper contractility of intestinal smooth muscle, thereby returning the muscle to its proper tone. The pharmacological effects of peppermint and peppermint oil are useful in a number of clinical situation; the most notable include irritable bowel syndrome, intestinal colic, gallstones, musculoskeletal pain, and the common cold. [xxxi] Madisch, A, et al. Management of functional dyspepsia: Unsolved problems and new perspectives. World Journal of Gastroenterology 11(42):6577-6581 (2005). A survey of remedies for functional dyspepsia, a condition which affects a large proportion of the general population in Western countries, shows that a combination of peppermint oil and caraway oil may provide the greatest effect with the highest degree of safety. [xxxii] Sroka, Z, et al. Antiradical and anti-H2O2 properties of polyphenolic compounds from an aqueous peppermint extract. Zeitschrift für Naturforschung. Section C: Biosciences 60(11-12):826-832 (2005). Eriocitrin, a polyphenol in peppermint oil, is a powerful antioxidant and free radical scavenger. |
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