Safety and Efficacy of Compound Methyl Salicylate Liniment for Topical Pain: a Multicenter Real-World Study in China
Condition: Pain
Study type: Observational

Summary: 
      The purpose of this phase Ⅳ clinical trial was to evaluate the safety and efficacy of
      compound methyl salicylate liniment (Ammeltz) in a real-life environment in China. This
      multicenter clinical trial was conducted at 22 hospitals/centers in China between May 2014
      and March 2015.

      The primary aim of the trial was to evaluate the safety of Ammeltz in a real-life
      environment. The secondary monitoring objective was to evaluate the efficacy of Ammeltz in
      the treatment of soft tissue injury pain in a real-life environment.

      In principle, according to the guide for drug monitoring in production enterprises in China,
      the number of patients included in the statistical analysis of key drug monitoring should not
      be less than 3000 in order to provide ample information about the trial drug. Therefore, the
      sample size of this study was chosen to be 3600 cases, considering the dropout rate of the
      subjects.
    

Detailed description: 
      The investigators collected demographic data, vital signs, current medical history (type of
      soft tissue damage), and allergy history of the eligible patients on the day of Ammeltz
      prescription. At the same time, a doctor conducted the physical examination and evaluated the
      visual analog scale (VAS) score of each patient. On the seventh day of the drug
      administration (one course of the treatment lasts seven days), the investigator asked each
      patient by telephone about the actual use of the study drug, whether adverse events occurred,
      and about the self-assessment pain VAS score. On the 37th day of the treatment, the patients
      were interviewed again by telephone to inquire about the occurrence of adverse events .

      The inclusion criteria for the patients were as follows: 1) age 3-75 years, male or female
      sex; 2) soft tissue pain caused by shoulder and neck pain, back pain, muscle pain, sprain,
      strain, contusion, muscle swelling and pain, and arthritis; local symptoms included pain,
      swelling, bruising, or tenderness; 3) signed informed consent and willing to participate in
      the study.

      Patients were excluded if they met the following criteria: 1) allergy to any of the
      ingredients in this drug; 2) pregnant women, lactating women, and infants aged 0-3 years; 3)
      the affected area in the eye or mucous membranes, eczema, macules, wounds, and damaged skin;
      4) patients without indications for the use of this drug.
    

Intervention name(s): The compound methyl salicylate liniment
Intervention type(s): Drug
Intervention description(s): The compound methyl salicylate liniment (Ammeltz) has been developed by Japan Sendai Kobayashi Pharmaceutical Co. and has been listed in Japan for many years. It is composed of various components, such as methyl salicylate, menthol, camphor, chlorpheniramine maleate, and thymol.
Other intervention name(s): Ammeltz
Intervention MeSH terms: Salicylates; Methyl salicylate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        people with soft tissue pain caused by shoulder and neck pain, back pain, muscle pain,
        sprain, strain, contusion, muscle swelling and pain, and arthritis; local symptoms included
        pain, swelling, bruising, or tenderness