Osteoarthritis (OA) is the most common form of arthritis. Currently, 27 million people in the United States have OA, and the numbers are expected to rise significantly with an aging population. Two-thirds of the population that receive a doctor’s diagnosis will be women.1 By the age of 85 years, nearly 1 in 2 patients will have osteoarthritis.2 There are numerous studies documenting lost wages and limitations of both paid work and social activities due to OA.2
The American College of Rheumatology has established treatment guidelines for OA, the most recent of which were published in 2012.3 The emphasis of treatment depends on the site involved with OA. The guidelines promote nonpharmacologic therapy and the use of acetaminophen, topical or oral nonsteroidal anti-inflammatory agents (NSAIDs), and finally opioids if other therapies fail. Physicians are hesitant to use opioids for many reasons, but particularly because of abuse and stricter monitoring by states. Physicians are also reluctant to use NSAIDs because of the risk of renal, gastrointestinal, and cardiovascular side effects, to which elderly patients are particularly vulnerable.
More and more patients and doctors are turning to topical agents as an alternative. Is there good evidence to support the use of topical medication for the treatment of arthritis? Diclofenac sodium gel 1% (Voltaren Gel, Novartis Consumer Health) is a topical NSAID that was approved by the US Food and Drug Administration (FDA) in 2007 for the treatment of OA.4 Diclofenac gel 1% was studied in 513 patients with OA of the knee and 400 patients with OA of the hands.4 These studies had placebo-controlled periods of up to 6 to 12 weeks, with results showing about a 50% reduction in pain (46% in hand, 51% in knee).5 Uncontrolled safety studies of up to 12 months’ duration revealed the medication was well tolerated, with 7% experiencing skin reactions.4 Diclofenac gel does carry similar labeling as oral NSAIDs, despite an approximate 6% absorption rate.6
Additionally, there are nonprescription topical agents that mainly use menthol and methyl salicylate as their active ingredients. Unfortunately, it is difficult to study the efficacy of these products.7 Recently, another alternative for analgesic relief of a number of conditions has become a viable option, and that is the use of compounding creams. A variety of local and national compounding pharmacies compound oral analgesics, antidepressants, anticonvulsants, muscle relaxants, anti-inflammatories, and a number of other ingredients into a cream base. These compounded creams, while not FDA approved for any indication, have garnered countless patient testimonials praising their use. I have used some of these creams in my practice with moderate success, especially for OA of the hands and feet.
There is no doubt that compounding pharmacies are being aggressive in marketing to doctors. Within a period of 6 months, I encountered 5 representatives trying to peddle their versions of compounding creams. I was also approached by a company to do a “study” using their compounding creams, whereby patients would fill out surveys at the start of treatment and again after having used the cream for a certain time span to document their pain levels and progress. Physicians participating in these studies receive compensation for each patient completing the study.
Regrettably, some pharmacists have risked having their licenses suspended because they accepted kickbacks involving a massive compounding fraud scheme.8 Workers’ compensation insurance has also been faced with considerable prescription bills for compounded creams.8,9 For example, in 2006, California’s Division of Workers’ Compensation was billed $10 million for compounded creams; by 2013 that number had increased to more than $145 million.8 The cost of compounded creams has also increased greatly over the years, with charges ranging up to hundreds of dollars and in some cases over thousands per prescription.8 Insurers have taken notice, and many no longer will cover compounded creams.9 Congress has passed legislation that should improve the federal oversight of compounding pharmacies; however, the FDA still lacks the unequivocal authority to regulate compounding medications.10
Nevertheless, patients do report pain relief with these creams. Particularly, patients with neuropathic pain have reported benefit with such topical medications as lidocaine 5% patches (Lidoderm, Endo Pharmaceuticals), which is FDA approved for postherpetic neuralgia syndrome and other focal neuropathic syndromes.7,11 Some of my patients with OA also report benefit with lidocaine 5% patches, likely due to its topical anesthetic properties. Often compounded creams will combine lidocaine with diclofenac, amitriptyline, and/or gabapentin. Again, there is little evidence that these combinations are more effective than a single ingredient or even better than placebo. However, short-term safety studies have not noted any severe adverse events. In my practice, the only side effects noted with any frequency were topical irritation or rashes that resolved with discontinuation of use. Certainly, studies would be required to provide long-term safety and capture serious adverse events. Since these products are not regulated, there is little chance of long-term monitoring.
What is a clinician who treats OA to do? Injections into joints often have short-term benefit, but patients do not want long-term treatment with injections, and there can be risks associated with repeated injections. Likewise, many patients cannot take narcotics or NSAIDs. Although rheumatologists do follow American College of Rheumatology guidelines, there is frustration that we do not have better medications for the treatment of pain associated with OA. Topical agents are poorly covered by Medicare, whereas compounded creams are not covered at all; thus, patients must resort to paying high out-of-pocket costs for these medications. It seems clear that studies are needed to document efficacy and safety of topical agents, and pharmacoeconomic studies are needed to look at long-term outcomes, especially if these agents can help reduce comorbidities such as cardiovascular disease, gastrointestinal bleeds, and renal failure. Positive outcomes from these studies could drive insurers to provide coverage for these topical medications. Until then, physicians and patients should be made aware of the benefit/cost ratio in regard to topical medications, including compounded creams.
- Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006;54(1):226-229.
- Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults—United States, 2005. MMWR Morb Mortal Wkly Rep. 2009;58(16):421-426.
- Hochberg MC, Altman RD, April KT, et al; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012;64(4):465-474.
- Voltaren [package insert]. Parsippany, NJ: Novartis Consumer Health, Inc; October 2009.
- Barthel HR, Haselwood D, Longley S 3rd, et al. Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis. Semin Arthritis Rheum. 2009;39(3):203-212.
- Kienzler JL, Gold M, Nollevaux F. Systemic bioavailability of topical diclofenac sodium gel 1% versus oral diclofenac sodium in healthy volunteers. J Clin Pharmacol. 2010;50(1):50-61.
- Jorge LL, Feres CC, Teles VE. Topical preparations for pain relief: efficacy and patient adherence. J Pain Res. 2010;4:11-24.
- Forshay K. The price of pain: questionable marketing, loose oversight of compound creams—parts 1-3. 89.3 KPCC Southern California Public Radio website. www.scpr.org/news/2014/09/09/46554/the-price-of-pain-high-costs-spur-questions-about/. Published September 10, 2014. Accessed March 2, 2015.
- Webb G. Compounding pharmacies engaging in profiteering with “designer medications”? The Legal Examiner. August 25, 2014. http://charlottesville.legalexaminer.com/uncategorized/compounding-phar macies-profit-from-designer-medications. Accessed March 2, 2015.
- Goldman TR. Health policy briefs: regulating compounding pharmacies. Health Affairs website. www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=114. Published May 1, 2014. Accessed March 2, 2015.
- Comer AM, Lamb HM. Lidocaine patch 5%. Drugs. 2000;59(2):245-249.