Alyostal by Stallergenes Greer

LIKELY EFFECTIVE

• Bee sting allergy. Subcutaneous use of bee venom seems to be effective for bee sting desensitization in patients with severe allergy to bee stings. Bee venom immunotherapy provides 98% to 99% protection from systemic reactions to bee stings. Once immunotherapy is stopped, the risk of a systemic reaction over the next 5 to 10 years is about 5% to 15% (6043,6075,6076). Bee venom is an FDA-approved subcutaneous injectable product for the treatment of severe allergies to bee stings (2619).

POSSIBLY INEFFECTIVE

• Multiple sclerosis (MS). Administering live bee stings in graduated doses up to 20 stings given three times weekly does not seem to improve multiples sclerosis. Treatment for 24 weeks does not seem to reduce gadolinium-enhancing lesions on MRI or improve fatigue, disability, or quality of life (13222).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Frozen shoulder. A small clinical study in patients with frozen shoulder shows that receiving bee venom diluted 1:10,000 as injections into acupuncture points twice a week for 8 weeks, as an adjunct to other therapy, improves pain and disability but not range of motion when compared with injection with normal saline. Bee venom injections diluted to 1:30,000 did not improve pain and disability when compared with placebo (96573). One year after receiving bee venom acupuncture, scores on the Shoulder Pain and Disability Index remained improved over placebo in these patients; however, verbal rating scale scores did not differ from placebo (105772).
• Hemiplegic shoulder pain. Pooled analyses of two small clinical studies shows that bee venom acupuncture modestly decreases pain, but does not affect motor function, when compared with control in patients with shoulder pain after stroke (96575,105771).
• Neck pain. In patients with chronic neck pain, receiving 6 sessions of bee venom acupuncture over a 3-week period reduces the impact of the neck pain and improves quality of life more than taking the nonsteroidal anti-inflammatory drug loxoprofen 180 mg orally daily for 3 weeks. Pain intensity and neck disability index decreased similarly with both treatments when compared to baseline (111471).
• Notalgia paresthetica. Preliminary clinical research in a small number of patients with notalgia paresthetica shows that applying a product containing bee venom 0.04% and capsaicin 0.025% to the affected skin daily for 2 weeks reduces pruritus when compared to baseline (102530). A lack of control group limits the validity of these findings. Also, it is unclear if the effects are due to bee venom, capsaicin, or the combination.
• Osteoarthritis. Preliminary clinical research on the use of injected bee venom for the treatment of osteoarthritis is mixed (6045). However, a high-quality clinical trial in patients with osteoarthritis of the knee shows that injecting bee venom 100 mcg intradermally at 15 acupuncture points on the knees and back weekly for 12 weeks reduces knee pain and increases physical function scores when compared with a histamine control injection (102531).
• Parkinson disease. Data on the effect of bee venom in patients with Parkinson disease are conflicting. Preliminary clinical studies in a small number of patients with Parkinson disease, stable on medication for at least four weeks, shows that receiving injections of dilute bee venom into 10 acupuncture points twice weekly, with or without traditional acupuncture, for 8-12 weeks improves motor symptoms, walking speed, quality of life, and ability to perform activities of daily living when compared with baseline, placebo, and/or conventional anti-Parkinson medications alone (95900,96571,102532). However, it is unclear whether bee venom acupuncture provides long-term benefits. Also, other research shows no benefit of bee venom therapy. One clinical study in patients with Parkinson disease shows that receiving a specific bee venom 100 mcg (Alyostal) injection subcutaneously once monthly for 11 months does not improve symptoms when compared with placebo. The researchers speculate that the monthly dose may have been too low to have an effect (96572). Higher quality research is needed to determine the benefits of bee venom, if any, in these patients. More evidence is needed to rate the effectiveness of bee venom for these uses.

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LIKELY SAFE ...when FDA-approved purified bee venom is given by subcutaneous injection by a trained medical professional (2619,6070,96572).

POSSIBLY SAFE ...when applied using stings from live bees. Live bee stings have been safely administered under medical supervision in doses up to 20 bee stings three times weekly for up to 24 weeks (13222). There is insufficient reliable information available about the safety of bee venom when used topically or injected in combination with acupuncture.

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used by subcutaneous injection by a trained medical professional. Significant adverse effects to fetus or mother have not been reported. However, some clinicians decrease maintenance dose by half during pregnancy (2619).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used by subcutaneous injection in high doses. High doses of bee venom can increase release of histamine, which can cause uterine contraction (2619); avoid using in high doses.

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General ...Purified bee venom given subcutaneously by a trained medical professional is generally well tolerated when used for diagnosis or immunotherapy of bee sting allergy.
Most Common Adverse Effects:
Parenterally: Dizziness, injection site erythema, itching, nausea and vomiting, swelling, tenderness, urticaria.
Serious Adverse Effects (Rare):
Parenterally: Anaphylaxis, asthma, chest pain or tightness, coagulation abnormalities, confusion, edema, hypotension, laryngeal edema, malaise, palpitations, respiratory distress, somnolence.

Cardiovascular ...Case reports have described stroke, and bradycardia associated with bee venom therapy (96576). Other reported adverse cardiovascular effects include cardiac dysfunction, palpitations, hypotension, and chest pain or tightness (1343,2619,6070,6078,111472,111474).

Dermatologic ...Local adverse effects of parenteral bee venom include erythema, swelling, numbness, pain, and tenderness at the injection site, itching, urticaria, and edema (1343,13222,102531). Bee stings have been associated with eosinophilic foreign body granuloma (111482), and bee venom acupuncture can cause dermatitis, contact urticaria, skin infection with Mycobacterium chelonae (11483), giant dermatofibroma, or chronic folliculitis (96576). A case report describes panniculitis associated with bee venom immunotherapy (96576).

Hematologic ...Bee venom therapy has been associated with coagulation abnormalities including intravascular hemolysis and thrombocytopenia (6046,96576,111474). Bee venom given with acupuncture can cause disseminated intravascular coagulation (6046,96576).

Hepatic ...Two case reports describe hepatotoxicity, including acute icteric hepatitis associated with bee venom acupuncture (96576). Another case report describes hepatitis B reactivation complicated by nephritic syndrome during bee venom immunotherapy (96576).

Immunologic ...Immune-mediated reactions associated with bee venom include rash, itching, generalized hypersensitivity reaction, anaphylaxis, serum sickness reaction, and immune thrombocytopenia 6077,95899,96576,11470). Estimates of the rate of immunologic reactions to various forms of bee venom range from 0.025% to 29% (96576,105770,11470,111475). They occur most frequently when doses are increased rapidly. Females and people with a c-KIT mutation may have more severe and frequent adverse effects (1343,6077,102533,11470). Doses of bee venom associated with adverse effects vary from 0.1 to 2 mL, and anaphylaxis has occurred after 1-24 doses (11470).
Bee venom is also associated with autoimmune disorders, including systemic lupus erythematosus, rheumatoid arthritis, Guillain-Barre syndrome, and pemphigus vulgaris (96574,111473). In a case report, a 68-year-old female developed Guillain-Barré syndrome with progressive quadriplegia ten days after receiving acupuncture with honeybee venom for pain (96573). In another case, a 64-year-old female developed pemphigus foliaceus, involving pruritic, erythematous, erosive skin lesions with crusting and plaques, after bee venom acupuncture twice weekly for 2 months. Immunoglobulin G was detected in the intercellular spaces between keratinocytes. Partial resolution occurred after 2 months of treatment with oral corticosteroids and azathioprine (111473).

Musculoskeletal ...Bee venom can cause rhabdomyolysis (111474). A 63-year-old female who received an accidental injection into the psoas muscle of 2 mL of normal saline containing bee venom diluted in a 1:2000 ratio, experienced severe burning pain at the injection site which persisted for 1 month, with imaging showing inflammation of the muscle. The pain gradually resolved over the following 5 months (11475).

Neurologic/CNS ...Bee venom can cause pain, headache, somnolence, and confusion (1343,2619,6070,6078,96576,111472). It has also been associated with a case of neuralgic amyotrophy (96576).

Pulmonary/Respiratory ...Bee venom has been associated with asthma, hyperventilation, respiratory distress, paralysis of respiratory muscles, and pulmonary or laryngeal edema (1343,2619,6070,6078,96576,111474).

Renal ...Bee venom immunotherapy has been associated with nephrotic syndrome, acute interstitial nephritis, and acute tubular necrosis (96576,111474). A case report describes a 50-year-old male with type 2 diabetes and normal renal function who developed acute kidney injury with combined features of interstitial nephritis and tubular necrosis after being stung by more than 1000 bees. He made a full recovery over several weeks with intermittent hemodialysis (111474).

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