Hi Pan 8X by Vinco Inc

EFFECTIVE

• Cataracts. Chymotrypsin is effective when used as an adjunct in cataract surgery according to FDA-approved prescription product labeling (9,509).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Burns. There is some evidence that taking a trypsin / chymotrypsin mixture orally might decrease tissue destruction in burn patients (716).
• Chronic obstructive parotitis. Preliminary clinical research shows that injecting a combination of chymotrypsin 5 mg and gentamicin into the parotid salivary gland ducts and then draining after 3-5 minutes improves subjective measures of pain and swelling in chronic obstructive parotitis when compared with gentamicin alone (99720).
• Fractures. Preliminary clinical research shows that taking a combination of trypsin and chymotrypsin orally seems to reduce inflammation and edema associated with hand fractures (717,718). More evidence is needed to rate chymotrypsin for these uses.

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EFFECTIVE

• Pancreatic insufficiency. Oral prescription pancreatic enzyme products improve digestion in patients with exocrine pancreatic insufficiency due to various causes. It is unclear if non-prescription pancreatic enzyme products would be beneficial; their use is not recommended. Details: Prescription pancreatic enzyme products are effective for improving fat, protein, and total energy absorption in patients with exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreas resection or removal, or other conditions (67622,67634,67676,67688,67694,67699,67714) (98667,98674,98676,98677,99115,99116,99118,99119,99120,99122)(99124,99125,99126,99127). Improvement in fat absorption and digestion occurs in as little as 1 week. Symptoms such as gas and abdominal discomfort are also improved in most patients (98667,98674,98677). Various prescription products have been approved by the US Food and Drug Administration (FDA) for this indication (95743). These prescription pancreatic enzyme products are typically used at a starting dose of 500-1000 lipase units/kg body weight per meal to a maximum of 2500 lipase units/kg body weight per meal or 10,000 lipase units/kg body weight daily or 4000 lipase units/gram of fat daily (99130). Despite being beneficial for most patients with exocrine pancreatic insufficiency, there is some evidence that prescription pancreatic enzyme products might not be beneficial in all patients. In patients with pancreatic insufficiency following gastrectomy for gastric cancer, research on prescription pancreatic enzyme products shows conflicting results (67617,95744). Also, a small study shows that taking a prescription pancreatic enzyme product for 26-30 days does not improve time to recovery from pancreatic insufficiency related to acute pancreatitis (99117). However, the small size of most of these studies limit the reliability of the results. One large clinical study shows that taking prescription pancreatic enzyme products for pancreatic insufficiency following pancreatoduodenectomy does not improve body weight or serum albumin levels. However, the dose used in this study was lower than recommended in the US guidelines, and adherence to the prescribed regimen was poor (102322). There is no strong evidence that supplemental forms of pancreatic enzyme products help with digestion in patients with pancreatic insufficiency. Non-prescription pancreatic enzyme products are not recommended for this use.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Atopic dermatitis (eczema). It is unclear if oral pancreatic enzyme products are beneficial in children with atopic dermatitis. Details: A small clinical study in children with refractory atopic dermatitis and food allergies shows that taking a specific prescription pancreatic enzyme product (Creon, Solvay Pharma) 37,500 or 75,000 protease units with each meal and 18,750 or 37,500 protease units with each snack for 6 weeks reduces the severity of atopic dermatitis when compared with baseline (102321). The validity of this finding is limited by the lack of a comparator group.
• HIV/AIDS. It is unclear if oral pancreatic enzyme products are beneficial in children with HIV. Details: Nutrient malabsorption is common in individuals with HIV/AIDS, possibly leading to malnutrition. Preliminary clinical research in children aged 1-14 years with HIV shows that taking a prescription pancreatic enzyme product (Creon 10,000) 1000 lipase units per gram of digested fat for 2 weeks reduces fecal fat loss when compared with baseline. Although improvement occurred in all of the children, a complete response, resulting in no steatorrhea, occurred in only 33% (99123). The validity of these findings is limited by the lack of a comparator group.
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral pancreatic enzyme products are beneficial in patients with NAFLD following pancreaticoduodenectomy. Details: NAFLD is a common complication post-pancreaticoduodenectomy (PD). A small clinical study in patients who developed NAFLD after PD shows that taking a prescription pancreatic enzyme product (LipaCreon, marketed as Creon in the US) 1800 mg daily for 6 months improves the liver-to-spleen attenuation ratio on computed tomography when compared with baseline, suggesting a reduction in hepatic fat content. Liver function was also improved, and most patients showed improvement in symptoms such as diarrhea (99113). The validity of these findings is limited by the lack of a comparator group. Although another preliminary clinical study shows that taking this prescription product for 12 months is as effective for preventing NAFLD after PD as taking specific non-prescription pancreatic enzyme products, including Politose (Takeda Pharmaceutical Co. Ltd) 1800 mg daily or Toughmac-E (Ono Pharmaceutical Co. Ltd) 3 grams daily for 10-12 months (99112), this study was underpowered and was not necessarily designed to detect between-group differences.
• Pancreatic cancer. It is unclear if oral pancreatic enzyme products improve nutrition status and health in patients with clinically overt exocrine pancreatic insufficiency resulting from pancreatic cancer. Details: Exocrine pancreatic insufficiency can be a complication of pancreatic cancer. One clinical study in patients with unresectable pancreatic cancer shows that taking a prescription pancreatic enzyme product (Norzyme, Nordmark Arzneimittel GmbH & Co. KG; not available in the US) 6-9 capsules daily for 8-24 weeks does not increase body weight, global assessment, quality of life, or survival when compared with placebo (99114). Another preliminary clinical study shows that taking a high-dose pancreatic enzyme product providing 48,000 lipase units per meal for 8 weeks during chemotherapy does not improve body mass index, nutritional parameters, or survival when compared with no treatment (99111). However, in both studies, clinically overt exocrine pancreatic insufficiency was absent in most of the patients. In a study in which clinically overt exocrine pancreatic insufficiency was more prevalent, taking a prescription pancreatic enzyme product (Panzytrat 25,000, Nordmark GmbH; not available in the US) 50,000 lipase units per meal three times daily for 8 weeks appears to increase body weight by about 5% when compared with placebo (67708). More evidence is needed to rate pancreatic enzyme products for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Colorectal cancer. A small clinical study in patients with colorectal cancer receiving chemotherapy shows that taking a specific combination supplement containing trypsin and other enzymes (Wobe-Mugos E) attenuates worsening quality of life, modestly increases relapse-free survival, and increases the number of patients surviving over 42 months (99474). The effects of trypsin alone are unclear.
• Diabetes. A small observational study in patients with a family history of type 1 diabetes found that taking a product containing trypsin 48 mg, bromelain 90 mg, and rutin 100 mg (Mucos Pharma) daily for 24 months is not associated with reduced incidence of type 1 diabetes at 8 years (99472). Further higher quality research is needed to draw a conclusion.
• Exercise-induced muscle soreness. A small clinical study shows that taking a combination protease tablet containing papain 50 mg, trypsin 75 mg, bromelain 50 mg, amylase 10 mg, lipase 10 mg, lysosome 10 mg, and chymotrypsin 2 mg, four times in one day before downhill running can improve recovery of contractile muscle function and decrease muscle soreness compared to placebo (67838). The effects of trypsin alone are unclear.
• Exercise-induced respiratory infections. A small clinical study in non-elite male runners shows that taking a combination product (Wobenzym Plus, Mucos Pharma) providing rutin 600-1200 mg, trypsin 288-576 mg, and bromelain 540-1080 mg daily for 3 weeks starting one week before a marathon, does not reduce the risk of a post-race upper respiratory tract infection when compared with placebo (96766). A limitation of this study is that it was not powered to detect a difference in exercise-induced infections between groups.
• Multiple sclerosis (MS). A preliminary clinical study in patients with relapsing-remitting MS shows that taking an enzyme combination containing trypsin 48 mg, bromelain 90 mg, and rutin 100 mg per tablet for at least 3 months does not affect disability progression, relapses or central nervous system lesions when compared with placebo (99468). The validity of these results are limited by the short duration of treatment, and the effects of trypsin alone are unclear.
• Osteoarthritis. Taking trypsin orally in combination with rutin and bromelain seems to be effective for treating osteoarthritis of the knee. Most clinical research in patients with knee osteoarthritis shows that taking the combination enzyme product (Wobenzym PS, formerly Phlogenzym, Mucos Pharma) at a dose providing up to 600 mg rutin, 288 mg trypsin, and 540 mg bromelain daily for 3-12 weeks, is as effective as diclofenac (Voltaren) 50 mg two to three times daily for relieving pain and improving knee function. This product also seems to reduce the need for rescue medication by 95% compared to placebo (6252,92235,99467,99477). It is unclear if these improvements are due to trypsin, other ingredients, or the combination. Trypsin has not been studied for osteoarthritis as a single-ingredient product.
• Postoperative swelling. A small preliminary clinical study in patients undergoing surgery of the jaw shows that taking an enzyme combination of trypsin 96 mg, bromelain 180 mg, and rutin 200 mg twice daily for 5 days in addition to standard treatment reduces soft-tissue thickness (indicating the amount of swelling) at most of the nine assessed facial-points compared to control (99476). This study is limited by its small size and significant differences in swelling at pre-determined points during the first postoperative day. This suggests that factors in addition to enzyme therapy might have influenced the differences in results.
• Radiation dermatitis. There is conflicting evidence whether taking a combination supplement containing trypsin reduces adverse effects from radiation. Some low quality clinical research in cancer patients receiving radiation therapy suggests that a specific combination product (Wobe-Mugos E, Mucos Pharma), which contains trypsin 40 mg, and other enzymes might reduce adverse reactions at the site of radiation, such as skin deterioration, when compared to no additional treatment (67831,99471). The results are these studies are limited by a lack of blinding and a lack placebo control. Evidence from another small, but higher quality clinical study shows that taking the same product beginning 3 days prior to radiation and continuing until the last day of radiation therapy does not reduce acute radiation-related complications such as skin deterioration when compared to placebo (67834).
• Sprains. A preliminary clinical study in patients with a sprained ankle shows that taking a specific enzyme combination (Phlogenzym, Mucos Pharma) containing trypsin 48 mg, bromelain 90 mg, rutin 100 mg, or taking different combinations of the individual enzymes three times daily for 10 days is not more effective for relieving pain than placebo (99473). The effects of trypsin alone are unclear.
• Wound healing. Some preliminary evidence suggests that applying trypsin topically in combination with chymotrypsin may be helpful for cleansing wounds of necrotic material and enhancing wound healing (715,716). Other preliminary research suggests that applying trypsin topically in combination with castor oil and Peru balsam may improve wound healing, including the healing of infected wounds. However, as a debriding agent, trypsin seems to be no better than mechanical gauze (99573). In fact, the US Food and Drug Administration (FDA) determined in the 1970s that trypsin is ineffective as a debriding agent (95757). There is insufficient reliable information available about the effectiveness of trypsin for these uses.

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LIKELY SAFE ...when used ophthalmically, as approved by the US Food and Drug Administration (9).

POSSIBLY SAFE ...when used orally in combination with trypsin for up to 10 days (716). There is insufficient reliable information available about the safety of chymotrypsin when administered by other routes.

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

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LIKELY SAFE ...when prescription pancreatic enzyme products are used orally and appropriately under the guidance of a healthcare professional (98667,98674,98676,98677,99115,99116,99118,99120,99122,99124)(99125,99126,99127). Prescription pancreatic enzyme products are typically initiated at a dose of 500-1000 lipase units/kg body weight per meal to a maximum of 2500 lipase units/kg body weight per meal or 4000 lipase units/gram of fat daily. Doses higher than 2500 lipase units/kg body weight per meal are prescribed only if medically necessary (99130).

POSSIBLY UNSAFE ...when prescription pancreatic enzyme products are used orally at doses over 2500 lipase units/kg body weight per meal or 10,000 lipase units/kg body weight daily. Higher doses, especially those greater than 6000 lipase units/kg body weight per meal, have been associated with fibrosing colonopathy (99130). There is insufficient reliable information available about the safety of supplemental forms of pancreatic enzyme products.

CHILDREN: LIKELY SAFE
when prescription pancreatic enzyme products are used orally and appropriately under the guidance of a healthcare professional (99118,99119,99120,99121,99122,99124,99125,99126). Prescription pancreatic enzyme products are usually initiated at a dose of 500-1000 lipase units/kg body weight per meal to a maximum of 2500 lipase units/kg body weight per meal or 4000 lipase units/gram fat daily. Doses higher than 2500 lipase units/kg body weight per meal are prescribed only if medically necessary (99130).

CHILDREN: POSSIBLY UNSAFE
when prescription pancreatic enzyme products are used orally at doses over 2500 lipase units/kg body weight per meal or 10,000 lipase units/kg body weight daily. Higher doses, especially those greater than 6000 lipase units/kg body weight per meal, have been associated with fibrosing colonopathy (99130). There is insufficient reliable information available about the safety of supplemental forms of pancreatic enzyme products.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using unless essential for replacement therapy (15).

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POSSIBLY SAFE ...when used topically by healthcare professionals trained in wound debridement (506). There is insufficient reliable information available about the safety of trypsin for its other uses. Although trypsin has been safely used in clinical research in doses of up to 288 mg orally daily in combination with other enzymes for up to 3 months, it is unclear if trypsin taken orally alone is safe (37193,92235,99473).

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

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ACARBOSE (Precose, Prandase) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, pancreatic enzyme products may reduce the effects of acarbose.  Details The digestive enzymes present in pancreatic enzyme products may break down acarbose, reducing its effects (9).

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General ...There is currently a limited amount of information available about the adverse effects of chymotrypsin. Orally, hypersensitivity reactions, including anaphylaxis, have been reported (9). When injected into the eye, chymotrypsin has been reported to cause increased intraocular pressure and uveitis (9,509).

Immunologic ...Rarely, chymotrypsin has been reported to cause anaphylactic reactions characterized by dyspnea, urticaria, edema, shock, vascular collapse, and unconsciousness, which can lead to death (9,509).

Ocular/Otic ...Intraocular injections of chymotrypsin have been reported to cause increased intraocular pressure, corneal edema, striation, uveitis, iridoplegia, and filamentary keratitis (9,509).

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General ...Orally, prescription pancreatic enzyme products are generally well tolerated when used at prescribed doses in adults and children.
Most Common Adverse Effects:
Orally: Prescription pancreatic enzyme products can cause abdominal pain, constipation, diarrhea, dry mouth, flatulence, irritation of the skin around the mouth and anus, nausea, steatorrhea, and vomiting.
Topically: Pancreatic enzyme product powder is irritating to the skin, eyes, mucus membranes, and respiratory tract. Pancreatic enzyme products that are held in the mouth prior to swallowing can cause irritation of the mucosa, including ulceration and stomatitis.
Serious Adverse Effects (Rare):
Orally: Prescription pancreatic enzyme products can worsen glucose control. Extremely high doses have been associated with fibrosing colonopathy and high uric acid levels in blood and urine.
Topically: Inhalation of dust containing pancreatic enzyme products has been associated with asthma, bronchospasm, and pulmonary hypersensitivity reactions.

Dermatologic ...Orally, rash or skin conditions have been reported rarely in individuals taking prescription pancreatic enzyme products (67709,98667). A pruritic rash occurred in one patient taking a prescription pancreatic enzyme product in one clinical trial; this event was considered by the investigators to be possibly related to treatment (98667). Erythema also occurred in an 84-year-old patient who had taken a digestive enzyme supplement containing pancreatic enzymes and other enzymes (67709). In a case report, taking a supplemental form of pancreatic enzymes also containing hemicellulose and dried ox bile extract powder (Festal, Handok Inc) was thought to be the cause of an acute generalized exanthematous pustulosis (AGEP). The patient required an antihistamine and an oral and topical corticosteroid. Since this product contained more than one ingredient, the role of the pancreatic enzymes in this specific adverse event is unclear (98675).
Topically, exposure to pancreatic enzyme product powder is irritating to the skin. Hypersensitivity reactions such as skin rash have been reported (15).

Endocrine ...Orally, prescription pancreatic enzyme products may cause hypoglycemia or hyperglycemia in some patients (67622,98676,98677). In a double-blind trial of a prescription pancreatic enzyme product compared with placebo in patients with unresectable pancreatic cancer and associated pancreatic duct obstruction, one patient developed diabetes during the study period (67708).

Gastrointestinal ...Orally, prescription pancreatic enzyme products can cause abdominal pain, constipation, diarrhea, dry mouth, irritation of the skin around the mouth and anus, flatulence, nausea, steatorrhea, and vomiting. However, these symptoms can be controlled by following prescription dosing recommendations (67617,67618,67645,67648,67651,67653,67657,67666,67714,98667)(98676,99115,99117,99123,99130). Doses of higher than 2500 lipase units/kg body weight per meal are not recommended unless medically necessary in order to prevent serious side effects, including fibrosing colonopathy and colonic strictures. These side effects are associated with the higher doses of lipase in prescription pancreatic enzyme products (2382,67677,67678,67679,67680,67682,67689,67690,67696,67701,99130).
Topically, pancreatic enzyme products that are held in the mouth prior to swallowing can cause irritation of the mucosa, including ulceration and stomatitis (15).

Hematologic ...Orally, severe neutropenia has been reported with a pancreatic enzyme product. In one case report, a 61-year-old patient taking a prescription pancreatic enzyme product for chronic pancreatitis developed agranulocytosis that persisted despite a trial of filgrastim. Upon discontinuation of the pancreatic enzyme product, marked improvement in neutropenia occurred within 7 days, with full resolution within 6 weeks (107411).

Neurologic/CNS ...Orally, headache and dizziness have been reported rarely in individuals taking prescription pancreatic enzyme products (67618,98667,99120).

Ocular/Otic ...Topically, exposure to pancreatic enzyme product powder is irritating to the eyes. Hypersensitivity reactions such as watery eyes have been reported (15).

Pulmonary/Respiratory ...Topically, exposure to pancreatic enzyme product powder is irritating to the respiratory tract. Hypersensitivity reactions such as sneezing have been reported (15). Inhalation of dust containing pancreatic enzyme products has been associated with allergic rhinitis, asthma, bronchospasm, and pulmonary hypersensitivity reactions (11768,11769,67641).

Renal ...Orally, extremely high doses of pancreatic enzyme products containing more than 10,000 lipase units/kg body weight daily have been associated with high uric acid levels in blood and urine (67673,67693,67705). Rarely, kidney pain has been reported (98667).

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General ...Topically, trypsin can cause localized pain and transient burning (506). Orally, trypsin taken in combination with other enzymes can cause mild-to-moderate gastrointestinal symptom such as nausea, heartburn, and stomach pain (37193,92235). It is not known if trypsin or other enzymes causes these adverse effects.

Dermatologic ...Topically, trypsin can cause localized pain and transient burning (506).

Gastrointestinal ...Orally, trypsin taken in combination with other enzymes can cause mild-to-moderate gastrointestinal symptom such as nausea, heartburn, and stomach pain (37193,92235). It is not known if trypsin or other enzymes causes these adverse effects.

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