MyrliMax® and Low Back Pain: A Multicentric, Observational, Post-Marketing Surveillance Study in Indian Patients Suffering from Chronic Low Back Pain of Various Pain Intensity

Abstract

Background: Chronic low back pain (LBP) is the most common musculoskeletal condition affecting a person's quality of life. Over the past decades, a lot of work was done in an attempt to reduce the negative impact of LBP, and help patients recover and maintain a better quality of life. Nevertheless, there is still a lot to be done to fully understand the problem of underlying chronic LBP and a wide gap that exist between basic science and applied rehabilitation research on LBP. Objectives: This was an open label, multicentric, observational, post-marketing surveillance study in a real-world setup designed to evaluate the efficacy and safety of MyrliMax® capsules containing standardised Commiphora myrrha gum resin extract in Indian subjects with chronic LBP varying in intensity. Materials and methods:This study included 204 subjects diagnosed with chronic LBP at the outpatient department of 20 centres under the supervision of a medical doctor. All subjects took MyrliMax® capsules twice daily for 20 days. Visual Analogue Scale (VAS) pain score, rescue medicine requirement, therapy satisfaction scores and safety parameters were assessed as per the schedule. Outcomes:Treatment with MyrliMax® capsules significantly (p<0.01) and progressively reduced the VAS score throughout treatment. A significant pain reduction was observed from the second visit. The mean VAS score was 6.58, 4.66, 2.99 and 1.88 on Day 0, Day 7, Day 14 and Day 20, respectively. A similar trend was also observed in subgroups based on gender and severity score. The need of rescue analgesics/NSAIDs was significantly reduced from the second week, indicating a potential of MyrliMax® capsules to increase the pain threshold. All physicians and patients were satisfied with the efficacy of MyrliMax® capsules assessed by physician's satisfaction score and patient's satisfaction score. There were no significant serious adverse events due to treatment during the study, which indicated that the treatment with MyrliMax® was well tolerated by subjects. Conclusion:MyrliMax® capsule is a potentially effective and safe therapy for pain reduction in patients suffering from chronic LBP. MyrliMax® capsules can be used to reduce pain in NSAIDs intolerant subjects suffering from chronic LBP.

FIGURE 1.

Analytical results confirming the presence of bioactive components in MyrliMax® capsules

TABLE 1.

Centers involved in the pilot study and number of volunteers and dropouts per center

TABLE 2.

Population pain score subdivision

FIGURE 2.

VAS pain scores (mean±SD) for female, male and female + male subjects during the 20 days of MyrliMax® administration; *significant (p <0.01) differences with respect to day 0

FIGURE 3.

Therapy satisfaction scores (mean±SD) of MyrliMax® capsule administration in subjects and physicians expressed as 0=not at all satisfied; 1=poorly satisfied; 2=satisfied; 3=highly satisfied. Metric bars represent standard deviation (SD).

FIGURE 4.

Subjects’ opinion – total and gender-based satisfaction of MyrliMax® capsule efficacy expressed as percentage values

TABLE 3.

Average number of rescue medicine units consumed per subject during the study