Perna [Discontinued] by DaVinci Laboratories Of Vermont

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. Although there has been interest in using oral alfalfa for diabetes, there is insufficient reliable information about the clinical effects of alfalfa for this purpose.
• Dyspepsia. Although there has been interest in using oral alfalfa for dyspepsia, there is insufficient reliable information about the clinical effects of alfalfa for this purpose.
• Hypercholesterolemia. It is unclear if oral alfalfa seeds are beneficial in patients with hypercholesterolemia. Details: A small, uncontrolled clinical study in patients with hypercholesterolemia shows that taking heat-prepared alfalfa seeds 40 grams three times daily for 8 weeks reduces total cholesterol and low-density lipoprotein (LDL) cholesterol levels when compared to baseline (5816). The validity of these findings is limited by the lack of a control group.
• Menopausal symptoms. Although there has been interest in using oral alfalfa for menopausal symptoms, there is insufficient reliable information about the clinical effects of alfalfa for this purpose. There is insufficient reliable information available about the effectiveness of alfalfa for its other uses.

(Read more about ALFALFA)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. Small clinical studies suggest that oral New Zealand green-lipped mussel extract may modestly improve symptoms and measures of lung function in adults with asthma. It is unclear if oral New Zealand green-lipped mussel is beneficial in children with asthma. Details: One small clinical study in adults with mild-to-moderate atopic asthma shows that taking a specific lipid extract of New Zealand green-lipped mussel (Lyprinol, Pharmalink), providing 50 mg omega-3 fatty acids, twice daily for 8 weeks decreases daytime wheezing and increases morning peak expiratory flow (PEF) when compared with placebo. However, this extract does not improve evening PEF or forced expiratory volume (FEV1) (15048). Another small clinical study in college students with persistent asthma shows that taking this same extract, providing 400 mg omega-3 fatty acids, daily for 3 weeks improves symptoms, reduces use of bronchodilators by about 7 puffs per day, and increases mean morning and evening peak flow by about 22 L/min when compared with placebo in patients with persistent asthma (94493). However, a small clinical study in children with moderate asthma shows that taking this extract providing 200 mg omega-3 fatty acids daily for 16 weeks does not reduce the use of asthma medication or improve symptoms when compared with placebo (94495). Reasons for these discrepancies are unclear but may relate to the age of the patients or the severity of asthma at baseline.
• Attention deficit-hyperactivity disorder (ADHD). It is unclear if oral New Zealand green-lipped mussel extract is beneficial in children with ADHD. Details: A small clinical study in children aged 6-14 years with ADHD shows that taking a specific lipid extract of New Zealand green-lipped mussel (Lyprinol), 780 mg daily in children weighing less than 45 kg and 1040 mg daily in children weighing over 45 kg, for 14 weeks does not improve parent-rated levels of hyperactivity, inattention, or impulsivity when compared with placebo. However, it might modestly improve symptoms of hyperactivity and inattention in children without ADHD who are rated as hyperactive or inattentive at baseline (102378).
• Breast cancer. Although there has been interest in using oral New Zealand green-lipped mussel for breast cancer, there is insufficient reliable information about the clinical effects of New Zealand green-lipped mussel for this purpose.
• Exercise-induced muscle damage. It is unclear if oral New Zealand green-lipped mussel extract is beneficial for reducing exercise-induced muscle damage. Details: A small clinical study in untrained males shows that taking a specific blend of New Zealand green-lipped mussel lipid extract and Antarctic krill oil (ESPO-572, sold as Lyprinol Advanced, Pharmalink), providing 200 mg daily for 30 days, starting 26 days before a downhill run, reduces plasma creatine kinase and tumor necrosis factor-alpha levels when compared with placebo. The effects were similar to those seen with a specific lipid extract of only New Zealand green-lipped mussel (PCSO-524 sold as Lyprinol or Omega XL, Pharmalink) (105509).
• Exercise-induced muscle soreness. Small clinical studies suggest that oral New Zealand green-lipped mussel extract may reduce exercise-induced muscle soreness in trained and untrained individuals. Details: Several small clinical studies in long distance runners and untrained males show that taking a specific lipid extract of New Zealand green-lipped mussel (PCSO-524, sold as Lyprinol or Omega XL, Pharmalink) or a specific blend of New Zealand green-lipped mussel lipid extract and Antarctic krill oil (ESPO-572, sold as Lyprinol Advanced, Pharmalink) reduces delayed-onset muscle soreness when compared with placebo (101896,102379,105509). In long distance runners, taking 400 mg daily for 11 weeks modestly reduces muscle soreness 24- and 48-hours after a 30 km training run (102379). In untrained males, taking 400 mg daily for 30 days, starting 26 days before a downhill run, reduces muscle soreness 72 and 96 hours later. However, there was no effect on pain threshold, thigh swelling, or strength recovery (101896). Also, taking the combination product (ESPO-572), providing 200 mg daily for 30 days, starting 26 days before a downhill run, reduces muscle soreness and increases pain threshold and range of motion when compared with placebo. This product also improved range of motion, but not other measures, when compared with taking the PCSO-524 single-ingredient product (105509).
• Osteoarthritis. It is unclear if oral New Zealand green-lipped mussel extract is beneficial for improving symptoms of osteoarthritis; the available research is conflicting. Details: Several small clinical studies show that some New Zealand green-lipped mussel extracts might reduce symptoms of osteoarthritis, such as pain and stiffness, when compared to baseline (15022,15055,15056,54188,94492). However, other research shows little or no benefit (15022,54190). Most studies have used a specific extract (Seatone, MacFarland Laboratories) (15022,15056,54188). However, other brands (Lyprinol, Pharmalink; GlycOmega PLUS, Aroma NZ Ltd.) have also been used (54190,94492). Doses used in some studies include New Zealand green-lipped mussel powder 1050 mg-1150 mg daily or lipid extract of New Zealand green-lipped mussel 210 mg daily for 3 months (15055,15056). In another study, a freeze-dried extract of New Zealand green-lipped mussel (GlycOmega PLUS, Aroma NZ Ltd.) 1500 mg twice daily for 8 weeks was used (94492).
• Prostate cancer. Although there has been interest in using oral New Zealand green-lipped mussel for prostate cancer, there is insufficient reliable information about the clinical effects of New Zealand green-lipped mussel for this purpose.
• Rheumatoid arthritis (RA). It is unclear if oral New Zealand green-lipped mussel extract is beneficial for improving symptoms of RA; the available research is conflicting. Details: Some small clinical studies and anecdotal reports suggest that New Zealand green-lipped mussel lipid extracts or powders (including Seatone, McFarlane Laboratories) can reduce symptoms of RA, including pain and stiffness, when compared to baseline (15022,15047,15055,15056). However, other research shows no benefit (935,15022,15053,15054,16050). Doses used in two of these studies include New Zealand green-lipped mussel powder 1050 mg-1150 mg daily or lipid extract of New Zealand green-lipped mussel 210 mg daily for 3 months (15055,15056). More evidence is needed to rate New Zealand green-lipped mussel for these uses.

(Read more about NEW ZEALAND GREEN-LIPPED MUSSEL)

POSSIBLY SAFE ...when the leaves are used orally and appropriately, short-term (4,6,12).

LIKELY UNSAFE ...when large amounts are used long-term. Chronic ingestion of alfalfa has been associated with drug-induced lupus effects (381,14828,30602).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in medicinal amounts. Alfalfa contains constituents with possible estrogenic activity (4,11,30592).

(Read more about ALFALFA)

POSSIBLY SAFE ...when used orally. New Zealand green-lipped mussel extract has been safely used at doses of up to approximately 3000 mg daily for up to approximately 10 months or 4160 mg daily for approximately 3 months (935,15048,94492,94494).

CHILDREN: POSSIBLY SAFE
when used orally in children 6-14 years of age. New Zealand green-lipped mussel extract has been used with apparent safety at doses of up to approximately 780 mg daily for 14 weeks in children weighing up to 45 kg and 1040 mg daily for 14 weeks in children weighing over 45 kg (102378).

PREGNANCY: POSSIBLY UNSAFE
when used orally; avoid using. It may cause retarded fetal development and delay in parturition (936).

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about NEW ZEALAND GREEN-LIPPED MUSSEL)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, alfalfa might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Animal research suggests that alfalfa decreases blood sugar in diabetic mice (30605). Also, in one case report, a diabetic patient experienced hypoglycemia after consuming alfalfa extract (30608). Monitor blood glucose levels closely. Dose adjustments might be necessary.

CONTRACEPTIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, alfalfa might interfere with the activity of contraceptive drugs.  Details Alfalfa contains coumestrol, a phytoestrogen, and isoflavonoids, which have estrogenic effects (4,30592).

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, alfalfa might interfere with hormone therapy.  Details Alfalfa contains coumestrol, a phytoestrogen, and isoflavonoids, which have estrogenic effects (4,30592).

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, alfalfa might decrease the efficacy of immunosuppressive therapy.  Details In vitro research and human case reports suggest that alfalfa may have immunostimulant effects (12174,14828,14829).

PHOTOSENSITIZING DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of alfalfa with photosensitizing drugs might have additive effects.  Details Animal research suggests that excessive doses of alfalfa may increase photosensitivity, possibly due to its chlorophyll content (106043). It is unclear if this effect would be clinically relevant in humans.

WARFARIN (Coumadin) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = D Theoretically, alfalfa might reduce the anticoagulant activity of warfarin.  Details Alfalfa contains a large amount of vitamin K (4,6). This could theoretically interfere with the activity of warfarin.

(Read more about ALFALFA)

(Read more about NEW ZEALAND GREEN-LIPPED MUSSEL)

General ...Orally, alfalfa leaf seems to be well tolerated. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Abdominal discomfort, diarrhea, and flatulence.
Serious Adverse Effects (Rare):
Orally: Lupus-like syndrome after chronic ingestion of alfalfa.

Dermatologic ...Dermatitis associated with alfalfa use has been reported. In a 1954 publication, dermatitis was noted in a 61-year-old female consuming 4-6 cups of tea made with two tablespoonfuls of alfalfa seeds for approximately two months prior to onset. Examination revealed diffuse, confluent edema and erythema on the face, eyelids, ears, hands, forearms, and distal humeral regions. The dermatitis improved with treatment; re-exposure to alfalfa resulted in a similar reaction (30609).

Endocrine ...Alfalfa contains constituents, including coumestrol, with reported estrogenic activity (30586,30592,4753). Effects in humans are not known.
One case report documents hypokalemia in a female who had been drinking a "cleansing tea" containing alfalfa, licorice, and stinging nettle. The potassium level returned to normal after discontinuing the tea and initiating potassium supplementation. The specific cause of the hypokalemia is not clear. Notably, both stinging nettle and licorice have been associated with hypokalemia and may have been responsible for this effect (30562).

Gastrointestinal ...Orally, flatulence and bulkier feces were reported during the first week of a case series of three subjects ingesting alfalfa (30598). In a case series of 15 patients ingesting alfalfa, increased fecal volume and increased stool frequency was reported. Additional adverse effects included abdominal discomfort in two patients, diarrhea in two patients, loose stools in six patients, and intestinal gas in 13 patients (5816).

Hematologic ...Pancytopenia and splenomegaly were reported in a 59-year-old male who had been taking 80-160 grams of ground alfalfa seeds for up to six weeks at a time, for a five month period. Hematologic values and spleen size returned to normal when alfalfa was discontinued (381).

Other ...Alfalfa products, including sprouts, seeds, and tablets, have been found to be contaminated with Escherichia coli, Salmonella, and Listeria monocytogenes, which have caused documented infections (5600,30566,30568,30572,30569,30564,30604,30610,30563,30607) (30566,30564,30604,30610,30563,30607,30576).
Orally, alfalfa has been associated with the development of a lupus-like syndrome in animals and humans (30594,14828,14830,30602), as well as with possible exacerbations of lupus in patients with known systemic lupus erythematosus (SLE). These reactions may be associated with the amino acid L-canavanine (30594), which appears to be present in alfalfa seeds and sprouts, but not leaves, and therefore should not be present in alfalfa tablets manufactured from the leaves (30601). However, case reports have included individuals ingesting tablets. A lupus-like syndrome was described in four patients taking 12-24 alfalfa tablets per day. Symptoms included arthralgias, myalgias, and rash; positive antinuclear antibodies (ANA) arose anywhere from three weeks to seven months after initiating alfalfa therapy. Upon discontinuation of alfalfa tablets, all four patients became asymptomatic. In two patients, ANA levels normalized (14828). Two additional reports have documented possible exacerbation or induction of SLE associated with alfalfa use. One case involved a female with a 26-year history of SLE, who had been taking 15 tablets of alfalfa daily for nine months prior to an exacerbation. Because of the delay in onset of the exacerbation from the initiation of alfalfa therapy, causation cannot be clearly established (30575). In a different report, SLE and arthritis were found in multiple family members who had been taking a combination of vitamin E and alfalfa tablets for seven years (30602). It is not known what other environmental or genetic factors may have affected these individuals, and the association with alfalfa is unclear.

(Read more about ALFALFA)

General ...Orally, New Zealand green-lipped mussel seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, acid reflux, diarrhea, flatulence, and nausea.
Serious Adverse Effects (Rare):
Orally: Hepatitis.

Dermatologic ...Generalized itching has occurred in one child using a lipid extract of New Zealand green-lipped mussel extract (94495).

Gastrointestinal ...Orally, New Zealand green-lipped mussel or lipid extract can cause reflux, abdominal pain, diarrhea, nausea, or flatulence (15055,15056,54177,54190,54191,94492,94494).

Hepatic ...Several cases of possible toxic hepatitis and granulomatous hepatitis have been reported for patients taking a specific New Zealand green-lipped mussel extract (Seatone) (54173,54182,54183). Liver function abnormalities have also been reported (94494).

Musculoskeletal ...Orally, two reports of gout have been associated with the use of freeze-dried New Zealand green-lipped mussel ) 3000 mg daily in clinical research (94492).

Renal ...Orally, fluid retention has been reported as an adverse effect of New Zealand green-lipped mussel (15055,54189).

(Read more about NEW ZEALAND GREEN-LIPPED MUSSEL)