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Pharmaceuticals (Basel). 2018 Nov 12;11(4). pii: E122. doi: 10.3390/ph11040122.

Single-Blind Placebo-Controlled Response Test with Phenytoin 10% Cream in Neuropathic Pain Patients.

Author information

1
Institute for Neuropathic Pain, Vespuccistraat 64-III, 1056 SN Amsterdam, The Netherlands. info@neuropathie.nu.
2
Institute for Neuropathic Pain, Spoorlaan 2a, 3735 MV Bosch en Duin, The Netherlands. jan@neuropathie.nu.

Abstract

BACKGROUND:

Phenytoin cream applied topically has been explored in neuropathic pain conditions. In several case series, phenytoin 5% and 10% cream could reduce pain in a clinically relevant way with a fast onset of action within 30 min, and with positive effects on sleep.

OBJECTIVE:

To evaluate a single-blind placebo-controlled response test (SIBRET) for use in clinical practice.

MATERIALS AND METHODS:

Patients with localized neuropathic pain, having an equal pain intensity in at least 2 areas (e.g., both feet), and a pain intensity of at least 4 on the 11-point numerical rating scale (NRS), were selected to perform the SIBRET. In one area, placebo cream consisting of the base cream was applied, and on the other area, phenytoin 10% cream was applied with separate hands to avoid contamination. Responders were defined as patients who experienced within 30 min at least 2-points difference as scored on the NRS, between the phenytoin 10% and the placebo cream applied areas, in favor of the former. Responders were subsequently prescribed phenytoin 10% cream.

RESULTS:

Of the 21 patients, 15 patients (71.45%) were classified as responders. The mean pain reduction after 30 min as measured with the NRS in the phenytoin 10% cream area was 3.3 (SD: 1.3) and in the placebo cream area 1.2 (SD: 1.1). The difference of the mean percentage pain reduction between phenytoin 10% cream and placebo cream was 33.2% (SD: 17.6, p < 0.001). Using a 50% reduction on the NRS as a full response criterion, we could identify 57.1% of responders on phenytoin 10% cream and only 9.5% responders on placebo cream.

CONCLUSIONS:

The SIBRET helps patients and clinicians to quickly identify the appropriate treatment and can thus be seen as an important contributor to the domain of personalized medicine in pain. These results can also be regarded as a proof of principle for the analgesic activity of 10% phenytoin cream.

KEYWORDS:

analgesia; neuropathic pain; phenytoin; response test; single-blind; topical

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