Systemic Enzyme Studies & Trials

A preliminary trial of serrapeptase 
in patients with carpal tunnel syndrome.

Panagariya A, Sharma AK

Dept. of Neurology, SMS Medical College and Hospital, Jaipur.
J Assoc Physicians India 1999 Dec;47(12):1170-2

OBJECTIVES: This study was planned to assess the response of serrapeptase in patients with carpal tunnel syndrome (CTS). 

METHODS: Twenty patients with CTS were evaluated clinically. After baseline electrophysiological studies, these patients were given serrapetase10 mg twice daily with initial short course of nimesulide.  Clinical and electrophysiological reassessment was done after 6 weeks. 

RESULTS: Mean age was 43.9 years with male to female ratio of 1:2.33. Sixty five percent cases showed significant clinical improvement which was supported by significant improvement in electrophysiological parameters. Recurrence was reported in four cases. No significant side effect was observed. 

CONCLUSIONS: serrapeptase therapy may proved to be a useful alternative mode of conservative treatment.  Larger study may be further helpful to establish the role of serrapeptase in CTS.

Proteolytic enzymes: a new treatment strategy for prosthetic infections?

by Selan L, Berlutti F, Passariello C, Comodi-Ballanti MR, Thaller MC

Istituto di Microbiologia, Facolta di Farmacia, Universita La Sapienza, Rome, Italy.
Antimicrob Agents Chemother 1993 Dec;37(12):2618-21

Among the different mechanisms of bacterial resistance to antimicrobial agents that have been studied, biofilm formation is one of the most widespread.  This mechanism is frequently the cause of failure in the treatment of prosthetic device infections, and several attempts have been made to develop molecules and protocols that are able to inhibit biofilm-embedded bacteria.  We present data suggesting the possibility that proteolytic enzymes could significantly enhance the activities of antibiotics against biofilms.  Antibiotic susceptibility tests on both planktonic and sessile cultures, studies on the dynamics of colonization of 10 biofilm-forming isolates, and then bioluminescence and scanning electron microscopy under seven different experimental conditions showed that serrapetase greatly enhances the activity of ofloxacin on sessile cultures and can inhibit biofilm formation.

A new method for evaluating mucolytic expectorant activity and its application. II. Application to two proteolytic enzymes, serratiopeptidase and seaprose.

Kase Y, Seo H, Oyama Y, Sakata M, Tomoda K, Takahama K, Hitoshi T, Okano Y, Miyata T. Arzneimittelforschung. 1982;32(4):374-8. PMID: 7049188 [PubMed - indexed for MEDLINE]
Using our new method described in a preceding paper, in vivo effects of two proteolytic enzymes such as serratiopeptidase (SER) and seaprose (SAP) on sputa collected from bronchitis rabbits were examined. SER (20 mg/kg) and SAP (30 mg/kg) significantly reduced the viscosity of sputum (P less than 0.05) at the 1-3-h periods and the 4-6-h periods, respectively, after intraduodenal administration. 50 mg/kg of SER also significantly decreased not only viscosity (P less than 0.001) but also amount of freeze-dried substance (P less than 0.05) of sputum at the 1-3-h periods, but SAP did not affect the amount of dried substance. Both enzymes significantly increased the volume of sputum, probably as the result of liquefaction. Thus, mucolytic expectorant activity of both enzymes can be demonstrated first by the reduction in viscosity and next of the increase in volume of sputa. However, the decrease in amount of freeze-dried substance is not always in accord with the reduction viscosity.

Evaluation of Serratia Peptidase in Acute or Chronic Inflammation of Otorhinolaryngology Pathology: a Multicentre, Double-blind, Randomized Trial versus Placebo

A. Mazzone, M. Catalan, M. Costanzo, A. Drusian, A. Mandol, S. Russo, E. Guarini and G. Vesperini 

The efficacy and tolerability of Serratia peptidase were evaluated in a multi-centre, double-blind, placebo-controlled study of 193 subjects suffering from acute or chronic ear, nose or throat disorders. Treatment lasted 7 - 8 days, with the drug or placebo being administered at a rate of two tablets three times a day. After 3-4 days' treatment, significant symptom regression was observed in peptidase-treated patients. There was also a significant reduction in symptoms after 7 -8 days for patients in both treatment groups but the response was more marked in those patients receiving the active drug. Statistical comparison between the two groups confirmed the greater efficacy and rapid action of the peptidase against all the symptoms examined at both stages. Tolerance was found to be very good and similar for both groups. It is concluded that Serratia peptidase has anti-inflapimatory, anti-edemic and fibrinolytic activity and acts rapidly on localized inflammation. 

The treatment of breast engorgement with Serrapeptase (Danzen): a randomised double-blind controlled trial.

Kee WH, Tan SL, Lee V, Salmon YM.

Singapore Med J 1989 Feb;30(1):48-54

We evaluated an anti-inflammatory enzyme drug Danzen (Serrapeptase: Takeda Chemical Industries, Ltd.) on 70 patients complaining of breast engorgement. These patients were randomly divided into 2 groups, a treatment group and a placebo group. A single observer, unaware of the group the patients were in, assessed the severity of each of the symptoms and signs of breast engorgement before treatment was commenced, and daily for 3 days, during which therapy was administered. Danzen (Serrapeptase) was noted to be superior to placebo for improvement of breast pain, breast swelling and induration and while 85.7% of the patients receiving Danzen (Serrapeptase) had "Moderate to Marked" improvement, only 60.0% of the patients receiving placebo had a similar degree of improvement. "Marked" improvement was found in 22.9% of the treatment group and 2.9% of the placebo group. These differences were statistically significant (P less than 0.05). No adverse reactions were reported with the use of Danzen (Serrapeptase). Danzen (Serrapeptase) is a safe and effective method for the treatment of breast engorgement.

A multi-centre, double-blind study of serrapeptase versus placebo in post-antrotomy buccal swelling.

Tachibana M, Mizukoshi O, Harada Y, Kawamoto K, Nakai Y.

Pharmatherapeutica 1984;3(8):526-30

A multi-centre, double-blind, placebo-controlled trial was carried out to investigate the clinical efficacy of the anti-inflammatory enzyme serrapeptase in a total of 174 patients who underwent Caldwell-Luc antrotomy for chronic empyema. Eighty-eight patients received 10 mg serrapeptase 3 times on the day before operation, once on the night of the operation and 3 times daily for 5 days after operation; the other 86 received placebo. Changes in buccal swelling after operation were observed as a parameter of the response to treatment. The degree of swelling in the serrapeptase-treated patients was significantly less than that in the placebo-treated patients at every point of observation after operation up to the 5th day (p less than 0.01 to p less than 0.05). Maximal swelling throughout all the post-operative points of observation was also significantly smaller in size in the serrapeptase-treated group than in the placebo-treated group. No side-effects were reported.