Low-dose oral soft capsules of diclofenac epolamine provided quick, effective, and safe relief of mild-to-moderate acute musculoskeletal pain, with patient satisfaction exceeding 90%, according to results from a prospective, open-label, phase IV clinical study published in Pain and Therapy.
Researchers assessed patient-reported outcome measures to gauge treatment satisfaction over a 3-day period among outpatients with mild-to-moderate acute musculoskeletal pain who presented to hospital clinic departments or general practitioner clinics at 8 sites in Italy.
A total of 182 participants were included in the study. The mean age was 56.2 years (range, 20-92 years) and 54.4% of the participants were women. The most common musculoskeletal conditions reported were arthralgia (39.0%) and low back pain (23.1%).
The primary efficacy variable was measured by asking patients to rate their treatment satisfaction level 72 hours after initiation of therapy, using the Pain Treatment Satisfaction Scale (PTSS) questionnaire’s Overall Satisfaction Question. The researchers also evaluated the degree to which low-dose diclofenac epolamine reduced pain, the duration of pain relief, and any treatment-related side effects. Patients were instructed to take 1 to 2 capsules initially, then 1 or 2 capsules every 4 to 6 hours as needed but no more than 6 capsules in a 24-hour period. Healthcare providers were also asked to rate their level of satisfaction with the treatment.
All participants completed the study, and 90.7% (95% CI, 0.86-0.95) reported feeling satisfied or very satisfied with their treatment 72 ± 7 hours after the first dose (the primary efficacy variable). Investigators rated their overall treatment satisfaction as 92.9%. The diclofenac epolamine regimen was well tolerated and safe; only 2 adverse events were recorded during the study, and both were mild and self-resolving. Similar percentages of satisfaction were reported for other efficacy parameters.
The analgesic effect was rapid, with complete pain relief achieved after an average of 49.45 minutes and moderate pain relief reached after a mean of 42.32 minutes. Within 1 hour after intake, 78.6% of study participants reported relief from their initial pain. A total of 5 participants [2%] reported no pain relief, and among the remaining 34 participants either the question was not answered or the answer was not applicable.
Pain intensity decreased by nearly half within 3 hours of treatment initiation, from a mean baseline visual analogue scale (VAS) pain score of 46.45 at baseline to a score of 24.24, translating to a mean pain reduction of 46.5%. After 3 days, the mean VAS score had decreased by 75%.
Study limitations included that was a single-arm study with no control group, so definitive conclusions cannot be drawn regarding the efficacy of low-dose diclofenac epolamine. Also, acute, mild, or moderate musculoskeletal pain may be self-limiting, regardless of the medication used.
In conclusion, the authors wrote, “Diclofenac epolamine soft capsules are a practical treatment option for patients with mild-to-moderate acute musculoskeletal pain, and future controlled studies against an active comparator would allow further evaluation of their benefits in this patient population.”
Disclosure: This research was supported by IBSA Institut Biochimique S.A. Please see the original reference for a full list of disclosures.
Trevisan CLM, Carraro A, Baldari GLA; Study 18I-Fsg08 Investigators. Treatment satisfaction, efficacy, and tolerability of low-dose diclofenac epolamine soft capsules in acute, mild, or moderate musculoskeletal pain: a prospective open-label, single-arm interventional study. Pain Ther. Published online June 14, 2023. doi:10.1007/s40122-023-00531-z