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:10.22603/ssrr.2020-0083

ORIGINAL ARTICLE

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

Author information

Gen Inoue
Department of Orthopaedic Surgery, Kitasato University School of Medicine
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Takashi Kaito
Department of Orthopaedic Surgery, Osaka University Graduate School of Medicine
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Yukihiro Matsuyama
Division of Orthopedic Surgery, Hamamatsu University School of Medicine
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Toshihiko Yamashita
Department of Orthopaedic Surgery, Sapporo Medical University School of Medicine
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Mamoru Kawakami
Department of Orthopaedic Surgery, Saiseikai Wakayama Hospital
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Kazuhisa Takahashi
Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Munehito Yoshida
Sumiya Orthopaedic Hospital
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Shiro Imagama
Department of Orthopaedics/Rheumatology, Nagoya University Graduate School of Medicine
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Seiji Ohtori
Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Toshihiko Taguchi
Department of Orthopaedic Surgery, Yamaguchi Rosai Hospital
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Hirotaka Haro
Department of Orthopaedic Surgery, University of Yamanashi
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Hiroshi Taneichi
Department of Orthopaedic Surgery, Dokkyo Medical University
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Masashi Yamazaki
Department of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Kotaro Nishida
Department of Orthopaedic Surgery, University of the Ryukyus, Faculty of Medicine
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Hiroshi Yamada
Department of Orthopaedic Surgery, Wakayama Medical University
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Daijiro Kabata
Department of Medical Statistics, Osaka City University Graduate School of Medicine and Faculty of Medicine
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Ayumi Shintani
Department of Medical Statistics, Osaka City University Graduate School of Medicine and Faculty of Medicine
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Motoki Iwasaki
Department of Orthopaedic Surgery, Osaka Rosai Hospital
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Manabu Ito
Department of Orthopaedic Surgery, National Hospital Organization, Hokkaido Medical Center
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Naohisa Miyakoshi
Department of Orthopedic Surgery, Akita University Graduate School of Medicine
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Hideki Murakami
Department of Orthopaedic Surgery, Nagoya City University, Graduate School of Medical Sciences
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Kazuo Yonenobu
Osaka Yukioka College of Health Science
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Tomoyuki Takura
Department of Healthcare Economics and Health Policy, Graduate School of Medicine, The University of Tokyo
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)
Joji Mochida
Department of Orthopaedic Surgery, Japan Medical Alliance, Ebina General Hospital
The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR)

Keywords: chronic low back pain, pharmacological treatment, analgesics, effectiveness

JOURNAL OPEN ACCESS

2021 Volume 5 Issue 4 Pages 252-263

DOI https://doi.org/10.22603/ssrr.2020-0083

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Abstract

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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