Serrapeptase, or serra-tiopeptidase, is a proteolytic (protein-digesting) enzyme with a long history of use in Germany and Japan. Now known worldwide for its anti-inflammatory effects, it's purported to treat everything from arthritis to heart disease and infections. But what does the science say about serrapeptase?

What the studies say

Serrapeptase has been the subject of intense study in recent decades and, although much of the research has been in humans, larger-scale higher-quality trials are needed.

Nevertheless, so far, the evidence suggests that the enzyme may be useful for a range of conditions.

o Postoperative pain and swelling. In a study of 24 healthy subjects undergoing tooth extraction, all were given a treatment combina-tion of either serrapeptase (5 mg) or placebo tablets and parace-tamol (acetaminophen) tablets (1000 mg) at the time of the operation. Those taking serrapeptase reported significantly less pain and swelling after surgery compared with the placebo-control group (Int J Oral Maxillofac Surg, 2008; 37: 264-8).

In a much larger study, this time in patients with chronic empyema (where pus collects around the lungs and in the chest wall) undergoing surgery, the patients were given either serrapeptase or a placebo both before and after their operation. Here again, the degree of post-operative swelling was signifi-cantly less with serrapeptase than with the placebo (Pharmathera-peutica, 1984; 3: 526-30).

Yet another study showed that serrapeptase is better than the traditional post-surgery advice: bed rest, elevation and the application of ice. In patients undergoing surgery of the ankle, those treated with serrapeptase had 50-per-cent less postopera-tive swelling compared with those who followed the traditional advice. The serrapeptase group also became pain-free sooner than the control group did (Fortschr Med, 1989; 107: 67-8, 71-2).

o ENT disorders. An Italian study of 193 patients suffering from ear, nose and throat disorders (acute or chronic) found that serrapeptase treatment led to a significant reduction in symp-toms compared with a placebo. In addition, not only did the enzyme act rapidly on localized inflamma-tion, but it also led to less water retention, while boosting clot-busting effects (fibrinolysis), thus speeding up healing (J Int Med Res, 1990; 18: 379-88).

o Chronic obstructive pulmonary disease (COPD). A small study carried out in Japan investigated the effects of serrapeptase in patients with COPD, such as emphysema and bronchitis. Compared with no treatment, 30 mg/day of the enzyme for four weeks reduced both the amount of phlegm (sputum) produced and the frequency of coughing (Respirology, 2003; 8: 316-20).

o Carpal tunnel syndrome (CTS). Twenty CTS patients were enrolled in a clinical study to investigate whether serrapeptase could help in the treatment of their symptoms. Following a short course of the non-steroidal anti-inflammatory drug (NSAID) nimesulide, the patients were given 10 mg of serrapeptase twice a day for six weeks. At the end of the study, 65 per cent reported significant improvements in their symptoms, with no serious side-effects (J Assoc Physicians India, 1999; 47: 1170-2). Larger, higher-quality trials are now needed to confirm these findings.

o Breast disease. Serrapeptase may be beneficial for breast engorge-ment, the painful overfilling of the breasts with milk. When 70 women with the condition were given either Danzen, a Japanese serrapeptase preparation, or a placebo for three days, Danzen proved to be superior to placebo for improving breast pain, breast swelling and induration (harden-ing). Indeed, while 86 per cent of the Danzen patients achieved "moderate to marked" improvements, only 60 per cent of the patients taking the placebo saw similar improvements. Also, a "marked" improvement was seen in 23 per cent of the treatment group vs just 3 per cent with the placebo (Singapore Med J, 1989; 30: 48-54).

o Infections. Serrapeptase was effective for eradicating infection caused by Staphylococcus epidermidis bacteria-at least in rats, so this may not apply to humans. Nevertheless, these findings led the researchers to conclude that the enzyme might be able to "enhance antibiotic efficacy in the treatment of staphylococcal infections" (J Bone Joint Surg Am, 2006; 88: 1208-14).

Heart disease and beyond

The potent anti-inflammatory effects of the enzyme make it a good candidate for treating a variety of other disorders, including arthritis, fibromyalgia, migraine, irritable bowel syndrome and even heart disease. Indeed, the late German physician Dr Hans Nieper reported that serrapeptase is an invaluable agent for the safe removal of fibrous clots from coronary arteries and, in particular, from the carotid arteries in the neck, which supply blood to the brain (www.serrapeptase.info/content. asp?page=Dr-H-A-Nieper).

However, more clinical studies are needed to ascertain whether or not serrapeptase is, in fact, effective for any of these conditions.

Serrapeptase safety

In general, no significant side-effects have been reported with the use of this enzyme, although there have been a few case reports of eosinophilic pneumonia (usually triggered by an allergic reaction, often to a medication) in response to serrapeptase (Nihon Kokyuki Gakkai Zasshi, 2009; 47: 254-8; 2000; 38: 540-4).

Although the reaction is unusual, it nevertheless highlights the fact that natural is not always harmless.

Other potential adverse effects include diarrhoea and gastro-intestinal problems. However, these effects are usually mild, especially in comparison to the often severe side-effects of NSAIDs. Yet, until we know more, it's up to users to monitor their own health when using this product.

Joanna Evans

WDDTY VOL. 21 ISSUE 5