NSAIDS:

Possible Side Effects

There are a number of mild problems that can be associated with NSAID use. Mild nausea, indigestion or heartburn can be common and are often prevented by taking the medication on a full stomach with plenty of water. Other mild side effects include mild diarrhea and mild lightheadedness and /or drowsiness. These mild side effects will usually go away. However, if they continue or are bothersome, check with your healthcare provider and stop taking the medication.

Although rare, severe side effects can occur with NSAID use that affect many different organ systems. You should immediately stop taking the medication and contact your healthcare provider if you notice any of the following:

Precautions While Using NSAIDs

A Partial List Of Non-Steroidal Anti-Inflammatory Drugs

Traditional NSAIDs

Serrapeptase: A Natural Anti-Inflammatory

Serrapeptase, also known as Serratia peptidase, is a proteolytic enzyme isolated from the non-pathogenic enterobacteria Serratia E15. When consumed in unprotected tablets or capsules, the enzyme is destroyed by acid in the stomach. However, enterically-coated tablets enable the enzyme to pass through the stomach unchanged, and be absorbed in the intestine. Serrapeptase is found in negligible amounts in the urine, suggesting that it is transported directly from the intestine into the bloodstream.(15,16)

Clinical studies show that serrapeptase induces fibrinolytic, anti-inflammatory and anti-edemic (prevents swelling and fluid retention) activity in a number of tissues, and that its anti-inflammatory effects are superior to other proteolytic enzymes.(18)

Besides reducing inflammation, one of serrapeptase's most profound benefits is reduction of pain, due to its ability to block the release of pain-inducing amines from inflamed tissues.(18) Physicians throughout Europe and Asia have recognized the anti-inflammatory and pain-blocking benefits of this naturally occurring substance and are using it in treatment as an alternative to salicylates, ibuprofen and other NSAIDs.(19)

In Germany and other European countries, serrapeptase is a common treatment for inflammatory and traumatic swellings, and much of the research that exists on this substance is of European origin. One double-blind study was conducted by German researchers to determine the effect of serrapeptase on post-operative swelling and pain. This study involved sixty-six patients who were treated surgically for fresh rupture of the lateral collateral ligament of the knee. On the third post-operative day, the group receiving serrapeptase exhibited a 50 percent reduction of swelling, compared to the controls. The patients receiving serrapeptase also became more rapidly pain-free than the controls, and by the tenth day, the pain had disappeared completely.(20)

Cystic Breast Disease

Serrapeptase has also been used in the successful treatment of fibrocystic breast disease. In a double-blind study, 70 patients complaining of breast engorgement randomly were divided into a treatment group and a placebo group. Serrapeptase was superior to the placebo for improvement of breast pain, breast swelling and induration (firmness). 85.7 percent of the patients receiving serrapeptase reported moderate to marked improvement. No adverse reactions to serrapeptase were reported and the researchers concluded that "serrapeptase is a safe and effective method for the treatment of breast engorgement."(21,19)

Serrapeptase And Sinusitis

Due to its inflammatory properties, serrapeptase has been shown in clinical studies to benefit chronic sinusitis sufferers. In this condition, the mucus in patients' nasal cavities is thickened and hypersecreted. This thickening causes mucus to be expelled less frequently. Japanese researchers evaluated the effects of serratiopeptidase (30 mg/day orally for four weeks) on the elasticity and viscosity of the nasal mucus in adult patients with chronic sinusitis. Serratiopeptidase reduced the viscosity of the mucus, improving the elimination of bronchopulmonary secretions.(23)

Other clinical trials support serrapeptase's ability to relieve the problems associated with chronic sinusitis. In one study, 140 patients with acute or chronic ear, nose and throat pathologies were evaluated with either a placebo or the active serratia peptidase. Patients taking the serrapeptase experienced a significant reduction in severity of pain, amount of secretion, purulence of secretions, difficulty in swallowing, nasal dysphonia, nasal obstruction, anosmia, and body temperature after three to four days and at the end of treatment. Patients suffering from laryngitis, catarrhal rhinopharyngitis and sinusitis who were treated with serrapeptase experienced a significant and rapid improvement of symptoms after 3-4 days. Physicians assessed efficacy of treatment as excellent or good for 97.3 percent of patients treated with serrapeptase compared with only 21.9 percent of those treated with a placebo.(24)

Respiratory diseases are characterized by increased production of a more dense mucus modified in viscosity and elasticity. Traditionally, in respiratory diseases, muco-active drugs are prescribed to reestablish the physicochemical characteristics of the mucus in order to restore respiratory function. Some of these drugs, however, cause a functional depletion of mucus, whereas Serrapeptase alters the elasticity of mucus without depleting it.(25,10)

A powerful agent by itself, serrapeptase teamed with antibiotics delivers increased concentrations of the antimicrobial agent to the site of the infection. Bacteria often endure a process called biofilm formation, which results in resistance to antimicrobial agents. In an attempt to prevent this bacterial immunity, researchers have experimented with various means of inhibiting biofilm-embedded bacteria. Their search may have ended with serrapeptase. One study conducted by Italian researchers suggests that proteolytic enzymes could significantly enhance the activities of antibiotics against biofilms. Antibiotic susceptibility tests showed that serratiopeptidase greatly enhances the activity of the antibiotic, ofloxacin, and that it can inhibit biofilm formation.(28)

Another double-blind randomized study evaluated the effects of administering the antibiotic cephalexin in conjunction with serrapeptase or a placebo to 93 patients suffering from either perennial rhinitis, chronic rhinitis with sinusitis or chronic relapsing bronchitis. The serratia peptidase treated group experienced significant improvement in rhinorrhea, nasal stuffiness, coryza and improvement of the para-nasal sinus shadows.(24)

Researchers witnessed equally impressive results in the treatment of infections in lung cancer patients undergoing thoracotomy. Serrapeptase and cefotiam, an antibiotic with a broad spectrum of activity against both Gram-positive and Gram-negative microorganisms, were administered to 35 thoracotomy patients with lung cancer. The patients were divided into two groups. A single dose of cefotiam was administered to the 17 subjects in Group I. The 18 subjects in Group II received a combination of Cefotiam and serrapeptase. The level of the antibiotic in the tissues versus the blood was significantly higher in the serrapeptase group than the single dose group.(22)

Cardiovascular Implications

Hans A. Nieper, M.D., an internist from Hannover, Germany, studied the effects of serrapeptase on plaque accumulations in the arteries. The formation of plaque involves deposits of fatty substances, cholesterol, cellular waste products, calcium and fibrin (a clotting material in the blood) on the inner lining of the arteries. Excessive plaque results in partial or complete blockage of the blood's flow through an artery, resulting in arteriosclerosis, or hardening of the arteries, and an ensuing stroke or heart attack. The evidence to support serrapeptase's role in preventing plaque build-up is anecdotal. Still, further studies are called for in this area as Nieper's research indicated that the protein-dissolving action of serrapeptase will gradually break down atherosclerotic plaques.(24)

Conclusion

Regardless of whether serrapeptase is used for inflammatory diseases or to prevent plaque build up on the arteries, it is well-tolerated. Due to its lack of side effects and anti-inflammatory capabilities, serrapeptase is a logical choice to replace harmful NSAIDs. Thanks to the tiny larvae of the silk moth, researchers have taken a large step toward finding relief for inflammatory disease sufferers.

References

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2. No author listed. Regular Use of Pain Relievers Can Have Dangerous Results. Kaleidoscope Interactive News, American Medical Association media briefing. July 24, 1997.

3. Fung HB, Kirschenbaum, HL. Selective cyclooxygenase-2 inhibitors for the treatment of arthritis. Clin Ther. 1999; 21(7):1131-57.

4. Geis GS. Update on clinical developments with celecoxib, a new specific COX-2 inhibitor: what can we expect? Scand J Rheumatol Suppl. 1999; 109:31-7.

5. Cheatum DE, Arvanitakis C, Gumpel M, Stead H, Geis GS. An endoscopic study of gastroduodenal lesions induced by nonsteroidal anti-inflammatory drugs. Clin Ther. 1999; 21(6):992-1003.

6. Tibble JA, Sigthorsson G, Foster R, Scott D, Fagerhol MK, Roseth A, Bjarnason I. High prevalence of NSAID enteropathy as shown by a simple faecal test. Gut. 1999; 45(3):362-6.

7. Dingle JT. The effects of NSAID on the matrix of human articular cartilages. Z Rheumatol. 1999; 58(3):125-9.

8. Murphy PJ, Badia P, Myers BL, Boecker MR, Wright KP Jr. Nonsteroidal anti-inflammatory drugs affect normal sleep patterns in humans. Physiol Behav. 1994; 55(6):1063-6.

9. Metz SA, Robertson RP, Fujimoto WY. Inhibition of prostaglandin E synthesis augments glucose-induced insulin secretion in cultured pancreas. Diabetes. 1981; 30(7):551-7.

10. Marriott C. Modification in the rheological properties of mucus by drugs. Adv Exp Med Biol. 1982; 144:75-84.

11. Tokumine F, Sunagawa T, Shiohira Y, Nakamoto T, Miyazato F, Muto Y. Drug-associated cholelithiasis: a case of sulindac stone formation and the incorporation of sulindac metabolites into the gallstones. Am J Gastroenterol. 1999;94(8):2285-8.

12. Jiang HK, Chang DM. Non-steroidal anti-inflammatory drugs with adverse psychiatric reactions: five case reports. Clin Rheumatol. 1999;18(4):339-45.

13. Fung HB, Kirschenbaum, HL. Selective cyclooxygenase-2 inhibitors for the treatment of arthritis. Clin Ther. 1999; 21(7):1131-57.

14. FDA MedWatch: The FDA Medical Products Reporting Program. May 12, 1999. FDA Talk Paper.

15. Moriya N, Nakata M, Nakamura M, Takaoka M, Iwasa S, Kato K, Kakinuma A. Intestinal absorption of serrapeptase (TSP) in rats. Biotechnol Appl Biochem. 1994; 20(Pt1):101-8.

16. Miyata, K. Intestinal absorption of Serratia Peptidase. J Appl Biochem. 1980;2:111-16.

17. Perna L. Osservazionl Clniche sui traitamento in osppio cleco con Serratio peptidasl nella neifre perenna naila ninite cronica nacutizzata con sinusopattia, nella bronchia cronica nacutizzata. Rlv Pat Clin Tuberc Penumol. 1985; 56:509-516.

18. Mazzone A, et al. Evaluation of Serratia peptidase in acute or chronic inflammation of otorhinolaryngology pathology: a multicentre, double-blind, randomized trial versus placebo. J Int Med Res. 1990; 18(5):379-88.

19. Aso T et al. Breast engorgement and its treatment: Clinical effects of Danzen an anti-inflammatory enzyme preparation. The world of Obstetrics and Gynecology (Japanese). 1981; 33:371-9.

20. Esch PM, Gerngross H, Fabian A. Reduction of postoperative swelling. Objective measurement of swelling of the upper ankle joint in treatment with serrapeptase-a prospective study (German). Fortschr Med. 1989;107(4):67-8, 71-2.

21. Kee WH, Tan SL, Lee V, Salmon YM. The treatment of breast engorgement with Serrapeptase (Danzen): a randomized double-blind controlled trial. Singapore Med J. 1989;30(1):48-54.

22. Koyama A, Mori J, Tokuda H, Waku M, Anno H, Katayama T, Murakami K, Komatsu H, Hirata M, Arai T, et al. Augmentation by serrapeptase of tissue permeation by cefotiam (Japanese). Jpn J Antibiot. 1986; 39(3):761-71.

23. Majima Y, Inagaki M, Hirata K, Takeuchi K, Morishita A, Sakakura Y. The effect of an orally administered proteolytic enzyme on the elasticity and viscosity of nasal mucus. Arch Otorhinolaryngol. 1988;244(6):355-9.

24. Brewer Science Library website. 1999.

25. Tomoda K, and Miyatam K. Some information on the composition of trachael secretions before and after the administration of Danzen. Exper Ther. 1972; 477:9-16.

26. Kase Y, et al. A new method for evaluating mucolytic expectorant activity and its application to two proteolytic enzymes, serratiopeptidase and seaprose. Arznelrnitteltorachung. 1982; 32:374-378.

28. Selan L, Berlutti F, Passariello C, Comodi-Ballanti MR, Thaller MC. Proteolytic enzymes: a new treatment strategy for prosthetic infections? Antimicrob Agents Chemother. 1993; 37(12):2618-21.

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