The efficacy of prostaglandin E1 derivative in patients with lumbar spinal stenosis.
METHODS
Randomized controlled trial.


OBJECTIVE
To examine the effect of limaprost, an oral prostaglandin (PG) E1 derivative, on health-related quality of life (HRQOL) in patients with symptomatic lumbar spinal stenosis (LSS), compared to etodolac, a NSAID.


BACKGROUND
Limaprost, an oral PGE1 derivative, was developed in Japan to treat numerous ischemic symptoms of thromboangiitis obliterans (TAO) and LSS. Previous studies have demonstrated the effectiveness of limaprost in the symptoms in patients with LSS. However, the evidence for effect on patient-reported outcomes, such as patient's HRQOL or satisfaction, is limited.


METHODS
This study was conducted at 4 study sites in Japan. Briefly, inclusion criteria were: age between 50 and 85 years; presence of both neurogenic intermittent claudication (NIC) and cauda equina symptoms (at least presence of bilateral numbness in the lower limbs); and MRI-confirmed central stenosis with acquired degenerative LSS. Limaprost (15 microg/d) or etodolac (400 mg/d) was administered for 8 weeks. The primary outcome was Short Form (SF)-36, and the secondary outcomes were the verbal rating scale of low back pain and leg numbness, walking distance, subjective improvement, and satisfaction.


RESULTS
A total of 79 participants were randomized (limaprost:etodolac = 39:40). Thirteen participants withdrew from the study (limaprost:etodolac = 5:8) and 66 completed the study (limaprost:etodolac = 34:32). Comparisons showed that limaprost resulted in significantly greater improvements in the SF-36 subscales of physical functioning, role physical, bodily pain, vitality, and mental health. Limaprost was also significantly better than etodolac for leg numbness, NIC distance, and subjective improvement and satisfaction. In the subgroup analysis stratified by symptom severity, limaprost seemed more effective for milder symptoms. No serious adverse effects were reported in either treatment group.


CONCLUSIONS
In this study, limaprost was found to be efficacious on most outcome measures, such as HRQOL, symptoms and subjective satisfaction, in LSS patents with cauda equina symptoms.
Matsudaira
Ko
K
Department of Orthopaedic Surgery, Faculty of Medicine, University of Tokyo, Tokyo, Japan. kohart801@gmail.com
Seichi
Atsushi
A
Kunogi
Junichi
J
Yamazaki
Takashi
T
Kobayashi
Atsuki
A
Anamizu
Yorito
Y
Kishimoto
Junji
J
Hoshi
Kazuto
K
Takeshita
Katsushi
K
Nakamura
Kozo
K
D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000527:Alprostadil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D001416:Back Pain / Q000188:drug therapy*; D017308:Etodolac / Q000008:administration & dosage; D005260:Female; D020233:Gait Disorders, Neurologic / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D006987:Hypesthesia / Q000188:drug therapy / Q000209:etiology; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D017060:Patient Satisfaction; D011128:Polyradiculopathy / Q000188:drug therapy; D013130:Spinal Stenosis / Q000188:drug therapy*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D017308:Etodolac; D000527:Alprostadil; C059238:limaprost