Digestase-SP by Premier Research Labs

Proteolytic enzymes represent a wide group of enzymes that are used alone or in combination. See specific monographs for effectiveness information.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bronchiectasis. A small clinical study in patients with bronchiectasis shows that taking serrapeptase 30 mg daily for 4 weeks significantly reduces frequency of cough and also seems to decrease sputum viscosity and neutrophil counts in sputum samples when compared with no treatment (13153).
• Chronic bronchitis. A small clinical study in patients with chronic bronchitis shows that taking serrapeptase 30 mg daily for 4 weeks significantly reduces frequency of cough and expectoration and also seems to decrease sputum viscosity and neutrophil counts in sputum samples when compared with no treatment (13153).
• Laryngitis. A clinical study in patients with acute or chronic ear, nose, or throat disorders, including laryngitis, shows that taking serrapeptase 10 mg three times daily reduces pain, secretions, difficulty swallowing, and body temperature after 3-4 days of treatment when compared with placebo (13152).
• Pharyngitis. A clinical study in patients with acute or chronic ear, nose, or throat disorders, including pharyngitis, shows that taking serrapeptase 10 mg three times daily reduces pain, secretions, difficulty swallowing, and body temperature after 3-4 days of treatment when compared with placebo (13152).
• Postoperative swelling. Serrapeptase has been evaluated for reducing facial swelling after a variety of procedures. A clinical study in patients undergoing maxillary antrostomy for empyema shows that taking serrapeptase 10 mg orally three times on the day before surgery, once in the evening after surgery, and three times daily for 5 days after surgery modestly reduces buccal swelling when compared with placebo (13151). In patients requiring removal of impacted mandibular third molars, a small clinical study in healthy adults suggests that taking serrapeptase 10 mg three times daily for 5 days improves postoperative trismus and swelling by the fourth postoperative day when compared with placebo; however, no difference in pain scores was observed (106013). The validity of these findings in limited by a lack of consistent comparison to baseline in both groups. Conversely, two other small studies in patients requiring removal of impacted mandibular third molars suggest that serrapeptase is less effective than dexamethasone or another proteolytic enzyme, consisting of trypsin, bromelain, and the flavonoid rutin, for improving swelling or facilitating wound healing (106011,106012). The validity of these findings is limited due to poor study methodologies.
• Rhinosinusitis. A clinical study in patients with acute or chronic ear, nose, or throat disorders, including rhinosinusitis, shows that taking serrapeptase 10 mg three times daily reduces pain, nasal secretions, nasal obstruction, and anosmia after 3-4 days of treatment when compared with placebo (13152). More evidence is needed to rate serrapeptase for these uses.

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POSSIBLY SAFE ...when used orally and appropriately. Various proteolytic enzymes have been safely used orally in clinical research (716,964,965,968,969,6252,6253,10622,11457,18281,18284) (91104,91105,91106,91111,96449). Side effects are typically mild to moderate and most often include gastrointestinal effects. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes. ...when used topically and appropriately. Various proteolytic enzymes have been safely used topically in clinical research (67835,67843,67845,91113). Some proteolytic enzymes might cause allergic reactions when used topically. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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POSSIBLY SAFE ...when used orally and appropriately, short-term. Serrapeptase seems to be safe when used in clinical trials lasting up to 4 weeks (13151,13152,13153). There is insufficient reliable information available about the safety of serrapeptase when used long-term.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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General ...Orally, proteolytic enzymes are generally well tolerated. See specific monographs for detailed safety information related to individual proteolytic enzymes.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Serious Adverse Effects (Rare):
Topically: Allergic reactions.

Gastrointestinal ...Orally, some patients taking proteolytic enzymes may have gastrointestinal complaints (101517).

Immunologic ...Proteolytic enzymes are commonly found in laundry detergents and pre-spotter products. Rarely, protease specific IgE positive tests possibly related to these products have occurred. Exposure may be airborne or topical (102705). In addition, in case reports, occupational exposure to the airborne proteolytic enzyme pepsin has resulted in allergic rhinoconjunctivitis or asthma (102706,102707).

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General ...Orally, serrapeptase seems to be well-tolerated. Some patients have reported epigastric pain, gastrointestinal upset, and nausea; however, these side effects appear to occur at the same rate as placebo (13152).

Gastrointestinal ...Orally, some patients have reported experiencing epigastric pain, gastrointestinal upset, and nausea; however, these side effects appear to occur at the same rate as placebo (13152).

Immunologic ...There is a case report of bullous pemphigoid, an autoimmune subepidermal dermatosis, in an elderly man who took serrapeptase (13154).

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