Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute Low Back Pain

2019-10-07 08:56:50 | BioPortfolio


The EMISI trial is a randomized, double blind, controlled trial (RCT) using a factorial design in patients with a new low back pain episode. The study aims to assess (A) whether metamizole, a non-opioid drug approved in Switzerland for pain treatment, is non-inferior to ibuprofen in a new episode of acute or subacute LBP and (B) whether a short educational intervention including evidence-based patient information is superior to usual care alone. Despite its increased use, the role of metamizole for the treatment of LBP is unclear and has so far not been systematically studied.


Purpose Low back pain (LBP) is among the top three most common diseases worldwide resulting in a life with pain-related disability. In patients with persistent LBP over 3 months, the risk for chronic pain increases dramatically and effective interventions should aim to prevent pain persistence without overtreatment. Therefore, during an acute LBP episode, the most common recommendations are to use pain medication to alleviate pain and to keep patients physically active. Non-opioid and opioid pain medication is increasingly used to control pain. Despite the frequency of LBP, only few high-quality studies assessed the efficacy of pain medication. Since the 1990s, the use of opioid pain medication for non-cancer pain has soared and resulted in an epidemic of opioid dependence and abuse in the U.S. This, despite the fact that randomized clinical trials found little or no additional efficacy of opioids compared to non-opioid medication in LBP. Moreover, opioids are associated with potentially severe side-effects, including confusion, sedation, respiratory depression and dependence. Therefore, non-opioid pain medications that are safe and effective are urgently needed to control pain.

Non-steroidal anti-inflammatory drugs (NSAIDs) are considered to be effective for LBP and recommended by guidelines. However, adverse events including kidney injury and gastrointestinal bleeding, limit the use of NSAIDs in many patients. Metamizole is an effective non-opioid analgesic and antipyretic with a favorable gastrointestinal and renal safety profile and therefore, a valuable treatment option in many LBP patients with contraindications for NSAIDs. Metamizole has been increasingly used in many countries such as Germany, France, Spain, and Switzerland. Despite its increased use, the role of metamizole for the treatment of LBP is unclear and has so far not been systematically studied. This surprising lack of efficacy data may be due to an ongoing controversy over the risk of metamizole-associated agranulocytosis, a serious hematological adverse event. Even though the overall risk of agranulocytosis is increased compared to other drugs, it only occurs in a small proportion of susceptible patients and the overall safety profile of metamizole is still favorable compared to other analgesics such as NSAIDs or opioids, which carry their own specific risks.

Many patients have reservations against regular intake of pain medication and limit physical activity to keep pain manageable without medication, which is against the guidelines' recommendation. However, education to encourage activity may help to improve pain control and function as well. In a busy primary care practice extended educational sessions that have been shown to be effective are not feasible. A short educational intervention that provides evidence-based information on the nature of LBP and promotes physical activity may also improve outcome.

Objectives This study aims to assess (A) whether metamizole is non-inferior to ibuprofen in a new episode of acute or subacute LBP and (B) whether a short educational intervention including evidence-based patient information is superior to usual care alone.

Methods The EMISI trial is a randomized, double-blind, controlled trial (RCT) using a factorial design recruiting patients consulting general practitioners (GP) practices and the outpatient Division of the Department of General Internal Medicine at the University Hospital Bern, Switzerland. Patients are randomized into one of four groups (1:1:1:1): metamizole + educational intervention vs. metamizole + standard care vs. ibuprofen + educational intervention vs. ibuprofen + standard care. Patients assigned to the educational information will receive an information leaflet and a phone call by a member of the research team to discuss evidence based information on LBP. All patients will receive usual care provided by their GPs that includes additional pain medications and non-pharmacological measures at the GPs discretion.

The primary outcome (A) Comparison of ibuprofen vs. metamizole: change from baseline pain on the numeric rating scale (NRS) to day 14 (non-inferiority).

B) Comparison of the short intervention vs. usual care: change from baseline Core Outcome Measures Index (COMI) sum-score to 42 days follow-up (superiority).

Statistical analysis Analysis will include an intention-to-treat (ITT) and a per-protocol (PP) analysis for the comparison of the primary between metamizole and ibuprofen outcome (NRS change from baseline to follow-up at 14 days). Both analyses need to meet non-inferiority in order to claim success. The comparison of the primary outcome between the intervention and the usual care group (COMI change from baseline to day 42) will be performed according to intention-to-treat principle. Based on the sample size calculation for both interventions, 120 patients will be included into the study.

Study Design


Low Back Pain


Metamizole Sodium, Ibuprofen 600 mg, Patient education


University Hospital Bern


Not yet recruiting


University Hospital Inselspital, Berne

Results (where available)

View Results


Published on BioPortfolio: 2019-10-07T08:56:50-0400

Clinical Trials [4696 Associated Clinical Trials listed on BioPortfolio]

Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction

Postoperative pain is common and particularly outpatients may experience unsatisfactory pain relief. This randomized, double-blind, crossover study of postoperative pain in outpatients und...

Ibuprofen With or Without Acetaminophen for Low Back Pain

This is a randomized clinical trial in which we compare two interventions for acute low back pain: 1. Ibuprofen + acetaminophen 2. Ibuprofen + placebo We will include pa...

Effects of Pain Neuroscience Education vs. Pain Self-Management Education in Low Back Pain

Chronic low back pain interventions may include exercises, manual therapy, health education, and pain education, strategies based on psychological or behavioral change approaches, as well ...

Effect of Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain

The aim of this study is to investigate effects of interdisciplinary group based patient education in patients with low back pain. The patients will be recruited to four group based patie...

Evaluation of the Added Value of Metamizole to Standard Post-operative Treatment After Ambulant Surgery

The aim of this study is to investigate if the addition of metamizole to the standard post-operative treatment, i.e. paracetamol and ibuprofen, is superior in reducing post-operative pain ...

PubMed Articles [17700 Associated PubMed Articles listed on BioPortfolio]


Sodium metamizole (Optalgin) is one of the most prevalent analgesic and anti-pyretic medications used in Israel. We describe a case of acute kidney injury subsequent to the use of metamizole in a heal...

Development of an Evaluative, Educational, and Communication-Facilitating App for Older Adults with Chronic Low Back Pain: Patient Perceptions of Usability and Utility.

The purpose of this study is to examine the usability and utility of an office-based iPad app that we developed for older adults with chronic low back pain (CLBP). The app screens for conditions that ...

Back Pain: When do I Have to Commit?

In the case of acute back pain, the indication for inpatient diagnosis and therapy is rarely given. The indication is provided if a potentially dangerous disease situation is suspected and if the pain...

Back beliefs among elderly seeking health care due to back pain; psychometric properties of the Norwegian version of the back beliefs questionnaire.

The Back Beliefs Questionnaire (BBQ) is a 14-item patient-reported questionnaire that measures attitudes and beliefs about the consequences of back pain. The BBQ has recently been translated into Norw...

Treatment of Discogenic Low Back Pain: Current Treatment Strategies and Future Options-a Literature Review.

Many studies have demonstrated that discogenic low back pain is the most common type of chronic low back pain (CLBP), one of the major causes of disability, and has a major socioeconomic impact. Our a...

Medical and Biotech [MESH] Definitions

A condition of persistent pain and discomfort in the BACK and the LEG following lumbar surgery, often seen in patients enrolled in pain centers.

Pain associated with OBSTETRIC LABOR in CHILDBIRTH. It is caused primarily by UTERINE CONTRACTION as well as pressure on the CERVIX; BLADDER; and the GASTROINTESTINAL TRACT. Labor pain mostly occurs in the ABDOMEN; the GROIN; and the BACK.

Acute or chronic pain in the lumbar or sacral regions, which may be associated with musculo-ligamentous SPRAINS AND STRAINS; INTERVERTEBRAL DISK DISPLACEMENT; and other conditions.

Acute or chronic pain located in the posterior regions of the THORAX; LUMBOSACRAL REGION; or the adjacent regions.

Inflammation of the SACROILIAC JOINT. It is characterized by lower back pain, especially upon walking, fever, UVEITIS; PSORIASIS; and decreased range of motion. Many factors are associated with and cause sacroiliitis including infection; injury to spine, lower back, and pelvis; DEGENERATIVE ARTHRITIS; and pregnancy.

More From BioPortfolio on "Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute Low Back Pain"

Quick Search

Relevant Topics

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Pain Disorder
Pain is a feeling (sharp or dull) triggered in the nervous system which can be transient or constant. Pain can be specific to one area of the body eg back, abdomen or chest or more general all over the body eg muscles ache from the flu. Without pain ...

Searches Linking to this Trial