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Abstract
PURPOSE:
Neuropathic pain is an unavoidable treatment-related adverse event among patients with head and neck cancer who are undergoing radiotherapy. We aimed to test the efficacy and safety of pregabalin versus placebo in the treatment of radiotherapy-related neuropathic pain.

PATIENTS AND METHODS:
This randomized, double-blind, placebo-controlled trial was conducted in four centers in China. Eligible patients with a mean pain intensity score of 4 or more on an 11-point numeric rating scale were randomly assigned to receive either active treatment with a flexible dose of pregabalin or placebo for 16 weeks. The primary efficacy outcome was pain reduction measured on the numeric rating scale.

RESULT:
There were 128 patients who received treatment as randomly assigned. Pain intensity reduction was 2.44 in the pregabalin arm and 1.58 in the placebo arm at week 16, yielding an adjusted mean difference of 0.87 (95% CI, 0.30 to 1.44; P = .003). In the pregabalin arm, 38 patients (59.4%) achieved at least 30% pain relief versus 21 (32.8%) in the placebo arm ( P = .006). Nineteen patients (29.7%) in the pregabalin group and five (7.8%) in the placebo group achieved 50% or greater pain relief ( P = .003). Total scores on the Profile of Mood States-Short Form, pain severity and functional interference of Brief Pain Inventory-Short Form, as well as the physiology and psychology domain of the WHO Quality of Life-BREF all were reduced significantly at week 16 in patients who received pregabalin compared with those who received placebo. There was no significant difference ( P = .29) in the incidence of experiencing at least one adverse event in the pregabalin arm (n = 35; 54.7%) versus the placebo arm (n = 29; 45.3%).

CONCLUSION:
Patients treated with pregabalin with radiotherapy-related neuropathic pain had greater pain alleviation, better mood states, and higher quality of life compared with patients in the placebo group, with a good tolerability.

Author information

Jiang J1, Li Y1, Shen Q1,2, Rong X1, Huang X1, Li H1, Zhou L3, Mai HQ4, Zheng D5, Chen MY4, Xu Y1, Li J4, Hui X6, Simone CB 2nd7, Gaertner J8, Argyriou AA9, Chow E10, Chen P3, Tang Y1.
1
1 Sun Yat-Sen Memorial Hospital; Sun Yat-Sen University, Guangzhou, People's Republic of China.
2
2 Zengcheng District People's Hospital of Guangzhou, Guangzhou, People's Republic of China.
3
3 Southern Medical University, Guangzhou, People's Republic of China.
4
4 Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China.
5
5 Guangzhou Huiai Hospital, Guangzhou, People's Republic of China.
6
6 Johns Hopkins University School of Medicine, Baltimore, MD.
7
7 University of Maryland School of Medicine, Baltimore, MD.
8
8 Palliative Care Center Hildegard, Basel, Switzerland.
9
9 Saint Andrew's State General Hospital of Patras, Patras, Greece.
10
10 Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.