Heard about the serious safety concerns with diclofenac and other NSAIDs? I update the safety section of this article in mid-March, 2013. Topical usage is extremely different than swallowing pills, and much safer.
Think of Voltaren® Gel as ibuprofen in a gel. (It’s actually diclofenac, but ibuprofen is a much more familiar drug name in NA, where the product is still fairly new.) It’s a topical anti-inflammatory medication,NSAID“Non-steroidal anti-inflammatory drug,” usually pronounced “en-said.” and FDA-approved to treat osteoarthritis in “joints amenable to topical treatment, such as the knees and those of the hands.” The evidence shows that it “provides clinically meaningful analgesia.”1 This is an appealing treatment idea that actually works reasonably well: what a pleasure to be able to say that!2
Funny how things like this slip through the cracks. I communicate with patients and professionals locally and abroad more or less all day every day, study and research musculoskeletal pain problems obsessively, and am more or less constantly immersed in answering the question, “What can you do for body parts that hurt?” And yet I didn’t hear about this stuff for a good year after it had already hit the shelves.
Although it’s been available in Europe for many years, it was only approved for use in the United States in 2007. Also, other topical treatments (salicylates and capsaicin) have shown little potential in the past. And Arnica montana creams (Traumeel, for example) are extremely popular, but it’s unlikely that even full-strength arnica is medically potent, let alone when it is diluted down to traces.3
So, a rub-on pain killer that is actually promising is a pretty new idea!
What makes a joint “amenable”? Is it relaxed and agreeable? No, just accessible: a pain-killing gel is useful only for joints that aren’t covered by a thick layer of muscle (like the shoulder). The medication can only get into joints if the joint is just under the surface of the skin.
For those amenable joints, though, Voltaren® Gel delivers medication directly to the joint, while sparing the gastrointestinal tract from the harshness of NSAIDs — which are actually known as “gut burners,” and many people just can’t stomach ibuprofen. A gel almost eliminates the risks associated with digesting the stuff.
There are probably some good uses for Voltaren® Gel above and beyond what it’s already been specifically approved for (“off-label” uses). Here are some of the common injuries conditions I think it might be most useful for:
I’ve just emphasized that Voltaren is mainly appropriate for shallow inflammation, but there is some evidence that Voltaren might be able to “reach deeper.” This is hardly the stuff of medical certainty yet, but researchers Huang et al found that Voltaren treated pain coming from deep inside the spine, right in the centre.4 They concluded that it could be a “convenient and safe clinical intervention” for a few types of back pain. An anti-inflammatory gel will likely fail with many kinds of back pain, but there’s also virtually no down-side to trying. See my low back pain tutorial for extremely detailed information about medications for back pain.
Ice is good stuff. I have some really thorough icing advice on this website.5 But Voltaren® Gel strikes me as being, well, better. Or at least more convenient.
Obviously icing has some advantages. Other than the cost of running your freezer, it’s free. And extremely safe. And “natural.”6 But Vitamin I (for “ibuprofen”) in a gel? C’mon! That’s just awesome! Medication delivered straight to the inflammed tissues, and only the inflammaed tissues … it’s kind of futuristic.
There’s no reason not to use both, of course. But Voltaren® Gel has the potential to make ice nearly obsolete as a treatment choice, except for situations where you don’t have any Voltaren® Gel handy.
On the other hand, there are some risks …
Many readers assume that “skeptics” will always favour mainstream and pharmaceutical treatments like Voltaren, but nothing could be further from the truth. Indeed, some skeptics are leading the charge against bad pharmaceutical industry science and practices (and a great example is Ben Goldacre’s new book, Bad pharma: how drug companies mislead doctors and harm patients). Pharmacist Scott Gavura of Science-Based Pharmacy was certainly skeptical about topical NSAIDs like Voltaren when he first tackled the topic early in 2011.7 “When I recently noticed a topical NSAID appear for sale as an over-the-counter treatment for muscle aches and pains … I was confident it would make a good case study in bad science.”
He was surprised, however, and he changed his mind when he read the evidence. Having worked with Scott as an editor, I know he can’t be persuaded by anything less than good evidence. On a few occasions, Scott has proven himself to be even harder to impress than I am (which is really saying something). He concludes:
Over the past two decades, evidence has emerged to demonstrate that topical versions of NSAIDs are well absorbed through the skin and reach therapeutic levels in synovial fluid, muscle, and fascia. … For chronic conditions like osteoarthritis, the data are of fair quality and are persuasive. On balance, there’s good evidence to show that topical NSAIDs are clinically- and cost-effective for short term (< 4 weeks) use, especially when pain is localized.
Nothing’s perfect, however, and some concerns about Voltaren are covered below.
Are you sure that you’re actually inflamed? Don’t answer too quickly.
One major concern about the use of products like Voltaren is that several conditions that seem to involve inflammation actually do not. Patients usually assume that the “burning” pain of repetitive strain injuries like tendinitis is caused by inflammation, but in fact this is not the case. It is possible that some inflammation is present, and it is possible that and NSAID will still have some pain-killing properties — the chemistry is rather complex, so it’s just unknown — but for the most part an anti-inflammatory medication is going to be relatively useless for a problem that involves no inflammation.
You are probably surprised to hear that tendinitis involves little or no inflammation. You can read all about it in my RSI article:
Long term and large oral doses of NSAIDs can be extremely dangerous, even lethal. Oral NSAIDs “nuke” your entire system with much more active ingredient than you really need, all of it absorbed through the digestive tract and distributed through your entire circulatory system. Diclofenac in particular is an extremely popular drug — again, we’re talking oral here — and it is associated with serious cardiovascular risks: “There is increasing regulatory concern about diclofenac. … Diclofenac has no advantage in terms of gastrointestinal safety and it has a clear cardiovascular disadvantage.”8 This has been in the news quite a bit lately, and NPR had a hit with this headline: “World's Most Popular Painkiller Raises Heart Attack Risk.” And it’s not wrong, that headline. It’s not hype and alarmism — there is a real problem.
But the difference between oral and topical is extremely important. Topical is not the same thing as swallowing at all. Voltaren Gel puts the medication only right where you need it. Because Voltaren Gel is applied to the skin, dramatically less medication reaches the bloodstream — only a tiny fraction of what you would get from oral usage. It is safe to assume that cardiovascular risks of moderate topical use are negligible compared to oral diclofenac, because so much less medication is actually getting into general circulation. At correct dosages for limited time periods, I think Voltaren Gel is probably very safe: the worst side effect is probably the chance of a irritated skin. ScienceBasedMedicine.org agrees:9
The main advantage of topical NSAIDs is the reduced exposure of the rest of the body to the product, which reduces the side effect profile. Given the toxicity of NSAIDs is related in part to the dose, it follows that topical treatments should have a better toxicity profile. Consequently, the cardiovascular risks of topical diclofenac, even in those with a high baseline risk of disease, should be negligible with the topical forms.
I am definitely not saying Voltaren is completely safe or risk free. No drug is! The drug is still being absorbed, but instead of being a “gut burner” it can be a “skin burner.” From the Voltaren® Gel website …
The most common adverse reactions reported in Voltaren Gel clinical trials were application site reactions in 7% of treated patients. With all NSAIDs there may be an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.
Sounds bad, doesn’t it? But those warnings are primarily there in an abundance of legal and medical caution provoked by the problems with oral NSAIDs. For short-term, moderate topical use, I believe the benefits clearly outweigh the minor risks.
A lot of people who read this are going to want to try it on their low back pain, neck pain, and/or other kinds of muscle pain. Will it work? The only honest answer is, “Who knows?” I have no clinical experience with this yet, and certainly it’s unstudied. It might be worth trying, in moderation, with the full awareness that there’s every possibility that it could be a waste of time and money.
Here’s why it probably won’t work …
Low back pain and neck pain often involve a substantial amount of muscle pain,10 and muscle pain is not particularly inflammatory by nature. Muscle knots (trigger points) are more like poisoned muscle than injured muscle. Although there’s some anecdotal evidence that taking an anti-inflammatory medication reduces muscle pain, mostly it doesn’t seem to work very well. One of the classic signs of low back pain powered by muscle, for instance, is that ibuprofen doesn’t have much effect!
A topical NSAID gel isn’t likely to either.
Also, many painful factors in neck, back and muscle pain are deep inside the body — probably much deeper than Voltaren® Gel can “reach.” For instance, if your low back pain is coming from the facet joints — small joints deep in the spine, under a thick layer of muscle — chances are that a topical treatment simply doesn’t stand a chance of having an effect.
That said, why not try it? It’s almost certainly safer than popping ibuprofen! Although not tested and approved for reckless experimentation on any pain problem, obviously the entire point of Voltaren® Gel is to limit exposure to the active ingredient. So you might choose to experiment — taking full responsibility for your actions, of course, and not suing me if something goes horribly wrong, because of course I’m not actually recommending it, wink. Seriously: just run it by your doctor.
BACK TO TEXT
Nonsteroidal anti-inflammatory drugs (NSAIDs) have shown efficacy in patients with osteoarthritis (OA) pain but are also associated with a dose-dependent risk of gastrointestinal, cardiovascular, hematologic, hepatic, and renal adverse events (AEs). Topical NSAIDs were developed to provide analgesia similar to their oral counterparts with less systemic exposure and fewer serious AEs. Topical NSAIDs have long been available in Europe for the management of OA, and guidelines of the European League Against Rheumatism and the Osteoarthritis Research Society International specify that topical NSAIDs are preferred over oral NSAIDs for patients with knee or hand OA of mild-to-moderate severity, few affected joints, and/or a history of sensitivity to oral NSAIDs.
In contrast, the guidelines of the American Pain Society and American College of Rheumatology have in the past recommended topical methyl salicylate and topical capsaicin, but not topical NSAIDs. This reflects the fact that the American guidelines were written several years before the first topical NSAID was approved for use in the United States. Neither salicylates nor capsaicin have shown significant efficacy in the treatment of OA.
In October 2007, diclofenac sodium 1% gel (Voltaren Gel) became the first topical NSAID for OA therapy approved in the United States following a long history of use internationally. Topical diclofenac sodium 1% gel delivers effective diclofenac concentrations in the affected joint with limited systemic exposure. Clinical trial data suggest that diclofenac sodium 1% gel provides clinically meaningful analgesia in OA patients with a low incidence of systemic AEs.
This review discusses the pharmacology, clinical efficacy, and safety profiles of diclofenac sodium 1% gel, salicylates, and capsaicin for the management of hand and knee OA.