Glucosamine Pain Relief Plus by Cenovis Health Co.

POSSIBLY EFFECTIVE

• Back pain. Oral willow bark extract has been evaluated for the treatment of back pain, with promising results. Details: Clinical research in patients with chronic low back pain shows that taking a standardized willow bark extract providing salicin 120 mg or 240 mg daily for 4 weeks reduces lower back pain and decreases the need for rescue analgesia when compared with placebo. Salicin 240 mg appears to be more effective than salicin 120 mg, and significant pain relief may be observed after 1 week of high-dose use (6456). Additional research suggests that taking willow bark extract providing salicin 240 mg daily for 4 weeks is as effective as rofecoxib (Vioxx) for lower back pain (12804).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Ankylosing spondylitis. Although there has been interest in using oral willow bark for pain associated with ankylosing spondylitis, there is insufficient reliable information about the clinical effects of willow bark for this purpose.
• Common cold. Although there has been interest in using oral willow bark for common cold symptoms, there is insufficient reliable information about the clinical effects of willow bark for this purpose.
• Dysmenorrhea. Although there has been interest in using oral willow bark for dysmenorrhea, there is insufficient reliable information about the clinical effects of willow bark for this purpose.
• Gout. Although there has been interest in using oral willow bark for gout, there is insufficient reliable information about the clinical effects of willow bark for this purpose.
• Headache. Although there has been interest in using oral willow bark for headache, there is insufficient reliable information about the clinical effects of willow bark for this purpose.
• Influenza. Although there has been interest in using oral willow bark for pain and fever associated with influenza, including swine flu, there is insufficient reliable information about the clinical effects of willow bark for this purpose.
• Joint pain. Oral willow bark has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with joint pain shows that taking capsules of a specific combination product (Instaflex Joint Support, Direct Digital) containing glucosamine sulfate 500 mg, methylsufonlylmethane 167 mg, white willow bark extract 83 mg, ginger root concentrate 17 mg, boswellia extract 42 mg, turmeric root extract 17 mg, cayenne 40 m H.U. 17 mg, and hyaluronic acid 1.3 mg three times daily for 8 weeks reduces joint pain severity by 37% compared to only 16% with placebo. However, the specific combination product does not appear to significantly improve joint stiffness or function when compared with placebo (89560). It is unclear if these findings are due to willow bark, other ingredients, or the combination.
• Myalgia. Although there has been interest in using oral willow bark for myalgia, there is insufficient reliable information about the clinical effects of willow bark for this purpose.
• Obesity. Oral willow bark has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research suggests that willow bark in combination with ephedra and cola nut might cause modest weight loss in overweight and obese people. Willow bark 600 mg daily (containing 90 mg salicin) in divided doses given for 3 months in combination with these central nervous system stimulants might cause a 2 kg reduction in weight (12811). However, this combination may not be appropriate due to safety concerns associated with ephedra. Ephedra is banned in the US due to severe adverse effects (10055).
• Osteoarthritis. Small clinical studies suggest that oral willow bark extract may improve symptoms of osteoarthritis, although some conflicting evidence exists. Details: Some preliminary clinical research in patients with osteoarthritis shows that taking willow bark extract standardized to contain 240 mg of salicin daily for 2 weeks produces moderate analgesic activity when compared with placebo (12474,86490). Additional research shows that taking a specific willow bark extract (Optovit actiFLEX, Hermes Arzneimittel GmbH) standardized to contain salicin 120-240 mg daily for 6 weeks improves swelling, tenderness, and physical function similarly to conventional non-steroidal anti-inflammatory drugs (NSAIDs) (91406). However, other research shows that taking willow bark extract standardized to 240 mg of salicin daily for 6 weeks does not improve pain, stiffness, or physical function when compared with placebo (12475).
• Rheumatoid arthritis (RA). It is unclear if oral willow bark is beneficial in patients with RA. Details: Clinical research in a small number of patients with RA shows that willow bark extract standardized to 240 mg of salicin daily for 6 weeks does not improve pain when compared with placebo (12475). However, it is possible this study was underpowered to detect a significant difference in pain in these patients. More evidence is needed to rate willow bark for these uses.

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POSSIBLY SAFE ...when used orally and appropriately, short-term. Willow bark has been used safely for up to 12 weeks (6456,12474,12475,12804,12811,86473,91406).

CHILDREN: POSSIBLY UNSAFE
when used orally for viral infections. Salicylic acid and aspirin are contraindicated in children with viral infections (12801). Although Reye's syndrome has not been reported, the salicin constituent in willow bark is similar to aspirin and might pose the same risk.

PREGNANCY:
Insufficient reliable information available; avoid using.

LACTATION: POSSIBLY UNSAFE
when used orally. Willow bark contains salicylates which are excreted in breast milk and have been linked to adverse effects in breast-fed infants (12802,12803).

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ACETAZOLAMIDE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, willow bark might result in additive adverse effects associated with acetazolamide.  Details Willow bark contains salicin, a plant salicylate. Human case reports suggests that a combination of acetazolamide and salicylate increases unbound plasma levels of acetazolamide, as well as adverse effects related to acetazolamide (86481).

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = D Theoretically, willow bark might increase the risk of bleeding when taken with anticoagulant/antiplatelet drugs.  Details Willow bark has antiplatelet effects, but less so than aspirin (12810).

ASPIRIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, willow bark might increase the effects and adverse effects of aspirin.  Details Willow bark contains salicin, a plant salicylate. It might have an additive effect when taken with other salicylate-containing drugs such as aspirin (12808).

CHOLINE MAGNESIUM TRISALICYLATE (Trilisate) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, willow bark might increase the effects and adverse effects of choline magnesium trisalicylate.  Details Willow bark contains salicin, a plant salicylate. It might have an additive effect when taken with other salicylate-containing drugs such as choline magnesium trisalicylate (12808).

SALSALATE (Disalcid) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, willow bark might increase the effects and adverse effects of salsalate.  Details Willow bark contains salicin, a plant salicylate. It might have an additive effect when taken with other salicylate-containing drugs such as salsalate (12808).

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General ...Orally, willow bark seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, dyspepsia, heartburn, and vomiting. May cause itching and rash in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal bleeding and renal impairment. May cause serious allergic reactions, including anaphylaxis, in people who are allergic to aspirin.

Cardiovascular ...In one clinical trial, a single patient withdrew from the study investigating oral willow bark due to blood pressure instability that the authors determined was 'possibly' related to treatment (12804).

Dermatologic ...Orally, willow bark may cause itching and rash in some people due to allergy (6456,12474,12475,12804,86459).

Gastrointestinal ...Orally, willow bark extract can cause gastrointestinal adverse effects, but these appear to be less frequent than those caused by NSAIDs. Examples include diarrhea, heartburn, vomiting, and dyspepsia (12474,12475,12804,86459). In a case report of a child, severe gastrointestinal bleeding occurred following use of a specific syrup (FreddoBaby), which contained ribwort plantain, licorice, willow bark, black elder, meadowsweet, and propolis. The adverse effect was attributed to salicylate content of the syrup. This product has since been withdrawn from the market (86477).

Immunologic ...Orally, willow bark may cause serious allergic reactions, including anaphylaxis, in people who are allergic to aspirin (10392)

Neurologic/CNS ...Orally, willow bark may cause headache and dizziness (12804). In a clinical trial evaluating a combination product containing willow bark, black cohosh, sarsaparilla, poplar bark, and guaiac wood (Reumalex), severe headaches occurred (35946).

Ocular/Otic ...Orally, symptoms of allergy to willow bark have included swollen eyes (6456).

Renal ...Salicylates can inhibit prostaglandins, which can reduce renal blood flow (12805). Salicin can cause renal papillary necrosis (12806). The risk for toxicity is greater with high acute doses or chronic use (12805).

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