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Complementary and alternative medicine (CAM) products are any medicinal drugs that are not covered under the standard medical care. These products are used alongside or instead of standard medical drugs. The Food and Drug Administration (FDA) regulation of CAM products has been a controversial topic. Different industry players endeavor to determine what should or not be regulated under the FDA provisions. These products are regulated as drugs, devices, cosmetics, biological agents, or food materials depending on their use. The applicable laws in the regulation of these products the Public Health Service Act (PHSA) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which is popularly known as “the Act” (FDA, 2006).
Given that CAM products fall outside the domain of standard medicine, they normally have major pros and cons that should be considered before use. The pros include – CAM products are natural, and thus they are deemed safe for use without serious side effects (Winter & Korzenik, 2017). Besides, these products are used for alternative medicine practices, which focus on whole-person treatments, hence their popularity. However, limited scientific research is associated with these products, and thus they could be potentially harmful, which is the major concern of their usage.
CAM products are appealing to patients for diverse reasons. First, most patients with chronic conditions have tried the standard medical care drugs, which may not be effective. Therefore, they opt for CAM products as an alternative. Besides, patients like these products because they are natural. Nevertheless, despite the growing popularity of CAM products, patients may experience some problems by taking them. For instance, due to the lack of scientific research, these products may cause organ toxicity or interact with other drugs to present various side effects, such as diarrhea, allergy, digestion problems, hypertension, and other related problems.
Arnica is a common CAM product used as a pain reliever in most cases. The major brand name is Arnica, but other generic names, such as Arnica cordifolia, Arnica fulgens, Arnica Montana, Mountain tobacco, Mountain snuff, and Arnica sororia are available in the market. Arnica grows naturally as an herb in parts of central Europe, North America, and Serbia. The flowers are extracted and used as drugs due to their medicinal value.
Arnica is usually used to relieve different forms of pain including arthritis, muscle pain, bruises, and general pain reduction. The mode of action of Arnica is not fully known. However, two active chemicals – helenalin and dihydrohelenalin, have been associated with their pain-relieving properties. These chemicals work by modifying the activity of blood cells and other substances that cause inflammation. By interfering with these substances, helenalin and dihydrohelenalin reduce the intensity of the pain associated with the inflammation. These chemical compounds are also suspected to initiate immune response towards inflammation and other pain-inducing activities.
For instance, a study by Marzotto et al. (2016) showed that Arnica stimulates the up-regulation of genes that function in the expression of macrophages that initiate a cascade of immune system events leading to therapeutic pain relief. Another theory on the mode of action highlights the role of sesquiterpene lactones as active compounds. Chadwick, Trewin, Gawthrop, and Wagstaff (2013) posit, “Other theories on the anti-inflammatory effects of sesquiterpene lactones include activation of p53 and an increase in ROS as cytotoxic effects of sesquiterpene lactone” (p. 12787). However, currently, there lack enough scientific studies and evidence on how these drugs function to cause the relief to the different forms of pain that they allegedly treat.
The common routes of administration include by mouth or topical application as fresh plant gels or ointments. Dosage – for topical application, a thin layer of Arnica gel or cream should be applied immediately after an injury to reduce inflammation. The process should be repeated two or three times a day. Precaution should be taken to avoid eye contact or open wounds. For oral use, two tablets should be taken by mouth every six hours. They can be dissolved in a tablespoon of water. Arnica is recommended for use for children aged above 2 years and adults.
Negative Issues of Arnica
Pure Arnica has been shown to have adverse effects on the liver. Therefore, the drug should be used in its diluted homeopathic form. However, even when diluted, Arnica can irritate its area of contact including the mouth, throat, esophagus, and stomach. Therefore, it may lead to stomach pains, nausea and vomiting, diarrhea, and skin rashes. In extreme conditions, it could lead to organ failure through elevated toxicity, high blood pressure, bleeding, damage to the heart, coma, or death.
Therefore, given its adverse effects, care should be taken by different users in diverse conditions. For instance, Arnica should not be used when breastfeeding or pregnant. In breastfeeding, the active compounds could be passed to the child through the mother’s milk and cause damage. Similarly, in pregnancy, the drug could bypass the placental barrier and enter the unborn child to cause irreparable damage including death. Additionally, people with known allergies to ragweed and other plants belonging to the Asteraceae family should avoid this product. Arnica is likely to initiate allergic reactions to such individuals.
Similarly, people with digestive problems should not take this drug by mouth. As noted earlier, it irritates, and thus it may affect the digestive system hence aggravating the condition. Arnica should also not be applied in areas with broken skin as it may be absorbed in large adverse amounts leading to organ toxicity. It could also irritate the broken skin areas leading to sepsis. As Arnica is known to cause elevated blood pressure, people with a history of hypertension should not use it, as it could potentially worsen the health condition. The same applies to individuals with fast heart rate problems.
Finally, it should not be used immediately before or after surgery as it may lead to excessive bleeding, which could be life-threatening. Drug interactions – Arnica should not be mixed with anticoagulants or any other medication that is involved in blood clotting. Arnica has been shown to antagonize the activity of these drugs thus leading to excessive bleeding.
Numerous studies have been conducted to investigate the effectiveness of Arnica as an analgesic, and they indicate varying results. In one study by Seamont, Vrcek, Nakra, and Mancini (2018), the efficacy of Arnica used together with Bromelain to reduce inflammation associated with blepharoplasty was investigated. 64 patients were given Arnica and Bromelain 7 days before and after surgery. The effectiveness of these two drugs to reduce inflammation was measured by grading the severity of ecchymosis on a visual analog scale (Seamont et al., 2018). The results showed a lack of sufficient evidence that Arnica and Bromelain reduce blepharoplasty-related inflammation.
In another study, Chaiet and Marcus (2016) sought to establish the ability of Arnica Montana to reduce ecchymosis during rhinoplasty surgery. Participants were randomly selected from a group of patients scheduled to undergo nasal bone osteotomies. Nine participants were selected for the study together with 13 control cases. Arnica was administered before and after the operation, but the researchers did not indicate for how long the drug was taken. The results were measured using three-quarter view photographs three times at different postoperative stages. The results indicated that Arnica Montana is effective in accelerating postoperative healing of ecchymosis.
Nejadbagheri, Hosseini, and Kazemi (2018) studied the effects of Arnica cream in reducing pain after arteriovenous fistula puncture among patients undergoing hemodialysis. 71 participants were randomly selected among patients receiving hemodialysis. The patients were treated with 5 ml of Arnigol cream for 10 minutes at the site of needle insertion. Pain intensity at the site of puncture was measured using a visual analog scale. The results showed that Arnica is effective in the reduction of pain associated with arteriovenous fistula puncture. The researchers thus recommended the use of this cream as an affordable alternative to standard medicine drugs.
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Another study by Raghibi, Salar, Askari, and Keykha (2018) sought to establish the effectiveness of Arnica ointment in the reduction of pain associated with fistula needle insertion especially in patients under hemodialysis. 93 patients were randomly selected for the study and divided into three groups – test, distraction, and placebo. Arnica ointment was used on the participants 1 hour before the insertion of a fistula needle.
The intensity of pain caused by the insertion of the needle was measured using a visual analog scale. From the results obtained, the researchers concluded that arnica ointment works to reduce the intensity of pain associated with the insertion of fistula needles among patients receiving hemodialysis.
Paris et al. (2008) conducted a study to establish the effect of Arnica as an analgesic after knee ligament reconstruction. 158 patients were randomly selected to participate in the study. Arnica Montana 5 CH was given to the participants the previous night before surgery and it was continued for 72 hours after the operation. The effectiveness of this treatment was measured by the amount of morphine that each participant needed to use to reduce pain. If the participants reduced the use of morphine, it would indicate the effectiveness of Arnica Montana as an analgesic. The results indicated that this homeopathic treatment does not relieve pain significantly after knee reconstruction surgery.
In a study by Karow, Abt, Fröhling, and Ackermann (2008), the objective was to establish whether Arnica Montana D4 was more effective in wound healing after surgery as compared to diclofenac. 88 patients about to undergo hallux valgus surgery were randomly selected for this study. The participants were given 10 oral pills of Arnica D4 three times a day for four days after surgery. The effectiveness of the medication was measured by establishing postoperative irritation and the intensity of associated pain. It was concluded that Arnica D4 has the same effect as diclofenac in pain management after a foot operation.
In another study, Widrig, Suter, Saller, and Melzer (2007) sought to establish whether Arnica was a better analgesic as compared to other non-steroid anti-inflammatory drugs in the pain management of hand osteoarthritis. 204 patients were randomly selected for this study. Arnica cream was topically applied to the participants for 21 days to determine its effectiveness as a pain reliever. The control group was given ibuprofen as an analgesic.
The level of pain was measured using a visual analog scale as a primary measure and considering the number of joints with pain as a secondary parameter. The results indicated that arnica cream was as effective as ibuprofen in the management of pain associated with hand osteoarthritis. Therefore, it could be concluded that arnica cream is an effective pain reliever for osteoarthritis.
Patients should receive thorough teaching concerning this product given that the scientific evidence on its safety is limited. For instance, pure arnica is toxic to body organs, and thus patients should be educated on the same. Besides, patients should be educated on the safe dosages that one can take without adverse reactions. Other important information that should be passed to users includes side effects, drug interactions, related drug complications, who should avoid the products, such as pregnant women and people with a history of blood-related complications, and the benefits of arnica as a pain reliever.
In my opinion, there is enough research to recommend this product to patients. I would also try the drug myself. The research studies reviewed in this paper offer compelling evidence that arnica is an effective analgesic for different forms of pain. Some studies compared arnica with other standard care drugs, such as ibuprofen and diclofenac, and showed that this product is as effective as the commonly used pain relievers. The samples used in these studies were also large enough to generalize the results in other populations, hence the validity of the results.
Chadwick, M., Trewin, H., Gawthrop, F., & Wagstaff, C. (2013). Sesquiterpenoids lactones: Benefits to plants and people. International Journal of Molecular Sciences, 14(6), 12780-12805. Web.
Chaiet, S. R., & Marcus, B. C. (2016). Perioperative Arnica montana for reduction of ecchymosis in rhinoplasty surgery. Annals of Plastic Surgery, 76(5), 477-482.
FDA. (2006). Complementary and alternative medicine products and their regulation by the Food and Drug Administration. Web.
Karow, J. H., Abt, H. P., Fröhling, M., & Ackermann, H. (2008). Efficacy of Arnica montana D4 for healing of wounds after hallux valgus surgery compared to diclofenac. The Journal of Alternative and Complementary Medicine, 14(1), 17-25.
Marzotto, M., Bonafini, C., Olioso, D., Baruzzi, A., Bettinetti, L., Di Leva, F., … Bellavite, P. (2016). Arnica Montana stimulates extracellular matrix gene expression in a macrophage cell line differentiated to wound-healing phenotype. PloS One, 11(11), 1-25. Web.
Nejadbagheri, S., Hosseini, H. S., & Kazemi, M. (2018). The effects of arnigol cream on pain associated with arteriovenous fistula puncture in patients receiving hemodialysis: A randomized double-blind clinical trial study. Nursing and Midwifery Studies, 7(3), 100-104.
Paris, A., Gonnet, N., Chaussard, C., Belon, P., Rocourt, F., Saragaglia, D., & Cracowski, J. L. (2007). Effect of homeopathy on analgesic intake following knee ligament reconstruction: A phase III monocentre randomized placebo controlled study. British Journal of Clinical Pharmacology, 65(2), 180-187.
Raghibi, A., Salar, A., Askari, H., & Keykha, R. (2018). Investigating the effect of Arnica ointment and distraction on the pain caused by fistula needle insertion in hemodialysis patients: A clinical trial. Medical-Surgical Nursing Journal, 7(2), 1-7.
Seamont, D., Vrcek, I., Nakra, T., & Mancini, R. (2018). Arnica and Bromelain for blepharoplasty-associated ecchymosis. The American Journal of Cosmetic Surgery, 35(3), 130-134.
Widrig, R., Suter, A., Saller, R., & Melzer, J. (2007). Choosing between NSAID and arnica for topical treatment of hand osteoarthritis in a randomized, double-blind study. Rheumatology International, 27(6), 585-591.
Winter, R. W., & Korzenik, J. R. (2017). The Practical pros and cons of complementary and alternative medicine in practice. Gastroenterology Clinics of North America, 46(4), 907-916.