Clinical Review

Background

When you use most topical arthritis products, you are taking a leap of faith, since they typically offer no proof that they actually work to reduce arthritis pain.

Zostrix is different—it has been tested in rigorous clinical studies, involving hundreds of patients and careful procedures to prevent any bias. We don’t ask you to accept our claims on faith; we ask you to look at the evidence. Summarized below are the results of several arthritis and neuralgia studies conducted using Zostrix.

Clinical Reviews: Arthritis
Among topical arthritis pain relievers, Zostrix is unique in that its safety and efficacy have been documented in published, double-blind, placebo-controlled studies. No other topical arthritis pain reliever has been tested as extensively as Zostrix in large, well-controlled clinical studies. This is an important factor that distinguishes Zostrix from all other arthritis pain relievers, including “knock-off” products containing capsaicin—only Zostrix has a vehicle delivery system proven to release the active ingredient capsaicin in a therapeutically effective manner.

The proven effectiveness of Zostrix in treating arthritis pain is one reason why doctors have recommended Zostrix for arthritis pain more than all other topical analgesics combined. Below we briefly review two key studies highlighting the effectiveness of Zostrix cream on relieving arthritis pain. We also provide the study references, so if you wish you can read the published articles in their entirety.

1. Study of Zostrix in Treating Arthritis Pain

Study Description:
113 patients were enrolled in a 12-week, double-blind, vehicle-controlled, randomized, multi-center trial evaluating the clinical safety and efficacy of topically applied Zostrix for the relief of pain associated with osteoarthritis. Subjects were not allowed to use any other pain reliever, whether oral or topical. Each patient randomly received either Zostrix or a placebo cream, four times per day for 12 weeks.

Key Findings:

• Nine out of ten (86%) of patients treated with Zostrix experienced a reduction in pain by week 4.
• Zostrix-treated patients reported an average reduction in pain of 53% by week 4.

Reference:
Altman RD, Aven A, Holmburg CE, et al: Capsaicin cream 0.025% as monotherapy for osteoarthritis: a double-blind study. Semin Arthritis Rheum. 1994; 23(suppl3): 25-33.

2. Study of Zostrix Used With Oral Pain Relievers to Treat Arthritis Pain

Study Description:
101 patients who were already taking oral pain medications for osteoarthritis (OA) and rheumatoid arthritis (RA) enrolled in a 4-week, double-blind, vehicle-controlled, randomized, multi-center trial evaluating the clinical safety and efficacy of topically applied Zostrix for the relief of pain associated with OA and RA. During the study, each subject continued to use a constant baseline dose of oral pain relievers and also applied either Zostrix or a placebo cream, four times per day for four weeks.

Key Findings:

• OA patients reported an average reduction in pain of 21% in week 1 and 33% by week 4 when using Zostrix along with oral pain medications.
• RA patients reported an average reduction in pain of 31% in week 1 and 57% by week 4 when using Zostrix along with oral pain medications.
• The above pain reductions were measured from baseline and thus indicate relief above and beyond that already provided by their existing oral pain medications.
• 96% of the Zostrix-treated patients found that they could better perform acts of daily living such as walking, sitting, and driving, relative to when they used their oral pain medications alone.

Reference:
Deal CL, Schnitzer TJ, Lipstein E, et al. Treatment of arthritis with topical capsaicin: a double-blind trial. Clinical Therapeutics. 1991;13:383-395.
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Clinical Reviews: Diabetic Neuropathy
Clinical studies demonstrate the effectiveness of the active ingredient present in Zostrix® Diabetic Foot Pain Relieving Cream in treating diabetic foot pain when used as part of a treatment regiment under the supervision of a physician.

The effectiveness of treating diabetic foot pain is one reason why Doctors and Pharmacists recommend Zostrix®.

Below we briefly review a key clinical study highlighting the effectiveness of 0.075% Capsaicin Cream in relieving diabetic foot pain. Study references are also provided if you wish to read the published article in its entirety.

Treatment of Painful Diabetic Neuropathy with Topical Capsaicin

Study Description:
A multicenter study was conducted to establish the efficacy of topical 0.075% capsaicin cream in relieving the pain associated with diabetic neuropathy. 252 patients were enrolled in an 8 week randomized, double-blind trial study, comparing 0.075% capsaisin with a placebo. Capsaicin or the placebo cream was applied to painful areas four times per day for 8 weeks in patients randomly assigned to one of the two groups. Patients returned at weeks 2, 4, 6 and 8 weeks for efficacy and safety evaluations during the treatment period.

Key Findings:
Pain intensity and relief were recorded at 2-week internals using physician’s global evaluation and visual analog scales. Analysis at final visit for 252 patients showed statistical significance favoring capsaicin compared with placebo for the following: 69.5% vs 53.4% pain improvement by the physician’s global evaluation scale, 38.1% vs 27.4% decrease in pain intensity, and 58.4% vs 45.3% improvement in pain relief. Capsaicin was well tolerated, and study results suggest that topical capsaicin cream is safe and effective in treating painful diabetic neuropathy.

Reference:
The Capsaicin Study Group. Treatment of Painful Diabetic Neuropathy with Topical Capsaicin: a multicenter, double-blind, vehicle-controlled study. Arch Intern Med. 1991; 151: 2225-2229.
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