Spine Surgery and Related Research (Jul 2021)

Comparison of the Effectiveness of Pharmacological Treatments for Patients with Chronic Low Back Pain: A Nationwide, Multicenter Study in Japan

  • Gen Inoue,
  • Takashi Kaito,
  • Yukihiro Matsuyama,
  • Toshihiko Yamashita,
  • Mamoru Kawakami,
  • Kazuhisa Takahashi,
  • Munehito Yoshida,
  • Shiro Imagama,
  • Seiji Ohtori,
  • Toshihiko Taguchi,
  • Hirotaka Haro,
  • Hiroshi Taneichi,
  • Masashi Yamazaki,
  • Kotaro Nishida,
  • Hiroshi Yamada,
  • Daijiro Kabata,
  • Ayumi Shintani,
  • Motoki Iwasaki,
  • Manabu Ito,
  • Naohisa Miyakoshi,
  • Hideki Murakami,
  • Kazuo Yonenobu,
  • Tomoyuki Takura,
  • Joji Mochida

DOI
https://doi.org/10.22603/ssrr.2020-0083
Journal volume & issue
Vol. 5, no. 4
pp. 252 – 263

Abstract

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Introduction: Chronic low back pain (CLBP) is a leading cause of disability, yet there is limited high-quality evidence to identify the most suitable pharmacological therapy. The purpose of this Japanese nationwide, multicenter, prospective study was to compare the effectiveness of four representative drug therapies―acetaminophen, celecoxib, loxoprofen, and a tramadol and acetaminophen (T+A) combination drug―to establish evidence for a drug of choice for CLBP. Methods: Patients with CLBP (N=471) received one of the four treatments and were evaluated, prospectively and comprehensively, once every month for six months using a visual analog scale (VAS) for LBP, the Japanese Orthopedic Association (JOA) score, the JOA Back Pain Evaluation Questionnaire (JOABPEQ), the Roland-Morris Disability Questionnaire (RDQ), the EuroQol five-dimensions three-levels (EQ-5D-3L), and the Short Form-8 item health survey (SF-8). We conducted multivariable linear regression analyses of the four drugs at 1 and 6 months after drug allocation. Differences with P<0.05 were considered statistically significant. Results: Patients who received acetaminophen showed a significant improvement from baseline in the mental health subscale of the JOABPEQ at one month (P=0.02) and the JOA score at six months (P<0.01). None of the other outcome measures among the four drugs differed significantly. Across groups, all outcome measures, except the mental component summary (MCS) score of the SF-8, improved equivalently, although most measurements showed no obvious cumulative effect over six months. The MCS score of the SF-8 decreased gradually over six months in all groups. Conclusions: Most of the outcome measures among the treated groups were not significantly different, indicating similar treatment effects of the four drugs for CLBP. Our study indicated the limit of each outcome measure for evaluating the patient status, suggesting that a single outcome measure is insufficient to reflect treatment effectiveness.

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