Efficacy of betamethasone valerate medicated plaster on painful chronic elbow tendinopathy: a double-blind, randomized, placebo-controlled trial

Abstract

SummaryObjective: to investigate the efficacy and safety of a medicated plaster containing betamethasone valerate (BMV) 2.25 mg in patients with chronic elbow tendinopathy.Methods: randomized, double-blind, placebo-controlled study with assignment 2:2:1:1 to BMV medicated plaster applied daily for 12 hours, daily for 24 hours or matched placebo. 62 patients aged ≥18 years with chronic lateral elbow tendinopathy were randomized. The primary efficacy variable was pain reduction (VAS) at day 28. Secondary objectives included summed pain intensity differences (SPID), overall treatment efficacy and tolerability. Results: mean reduction in VAS pain score at day 28 was greater in both BMV medicated plaster groups, -39.35±27.69 mm for BMV12-h and -36.91±32.50 mm for BMV24-h, than with placebo,-20.20±27.32 mm. Considering the adjusted mean decreases, there was a statistically significant difference between BMV12-h and placebo (p=0.0110). Global pain relief (SPID) and overall treatment efficacy were significantly better with BMV. BMV and placebo plasters had similar local tolerability and there were few treatment-related adverse events. Conclusions: BMV plaster was significantly more effective than placebo at reducing pain in patients with chronic elbow tendinopathies. The BMV plaster was safe and well tolerated.

Short-Term Efficacy and Safety of Betamethasone Valerate 2.25 mg Medicated Plaster in Patients with Chronic Lateral Epicondylitis: Results of a Randomised, Double Blind, Placebo-controlled Study

“…Compared with findings observed with the same BMV regimen used in the previous phase II study, 13 there was a lower pain reduction with BMV, however not compromising the clinically and statistically significant superiority of BMV over placebo. The longer mean duration of tendinopathy in the BMV arm compared to placebo (62.9 and 42.0 months, respectively) and to that observed in the same arm in the phase II study (49.4 months) suggests that a significant proportion of patients in the BMV arm might have had a long-lasting chronic form of tendinopathy, in which corticosteroids have limited effects (16).…”

“…The study met the ethical standards of the Muscle, Ligaments and Tendons Journal (15). The sample size calculation was based on the results of the previous phase II study (Frizziero et al, 2016) (13) in which the mean difference observed between BMV and placebo in pain reduction at 28 days ranged between 16 and 19 mm depending on the plaster dose regimen and application duration (12 or 24 hours daily). In this study, it was hypothesized that a sample size of 86 patients in each group would have had a 90% power to detect a difference of 15 mm between BMV and placebo in mean pain reduction at Day 28, assuming a standard deviation (SD) equal to 30 mm and using a two group t-test with a 0.05 two-sided significance level.…”

“…This BMV medicated plaster is marketed in several European countries in the treatment of inflammatory skin disorders which do not respond to treatment with less potent corticosteroids, such as eczema and psoriasis, lichenification, lichen planus, granuloma annulare, palmoplantar pustulosis and mycosis fungoides (12). In a phase II, placebo-controlled study (13), 102 patients with chronic LET and chronic Achilles tendinopathy were randomised to receive two different dose regimens (i.e., 12 or 24 hours of application/day) of BMV 2.25 mg medicated plaster over a maximum period of 4 weeks. The active plaster was effective and superior to placebo in pain relief, without significant difference between the two treatment regimens.…”

Topical patches as treatments for the management of patient musculoskeletal and neuropathic pain

“…The clinical trials in patients with non-articular rheumatism and traumatic painful soft tissue injuries showed that the patches containing ketoprofen (100 mg as the active principle) was significantly effective at reducing pain after 7 days' treatment [9]. The efficacy of a betamethasone valerate medicated plaster was reported in improving pain and functional disability in patients with arthritis and osteoarthritis [10].…”

Topical polidocanol application in combination with static stretching in tendinopathies: a prospective pilot study

“…In that sense, a natural based oxygen oil with an unknown active component showed significant effects in acute tendinopathies compared to a placebo 12 . Concerning conventional active pharmaceutical ingredients, Frizziero et al examined a betamethasone plaster in elbow tendinopathy significantly reducing the VAS score by twice with a 12 hour application compared to a placebo 13 . Furthermore, there is a growing interest of alternative options like nutraceutical supplements e.g.…”