Probiotics for pain of osteoarthritis; An N-of-1 trial of individual effects

Abstract

Objective: This study aimed to investigate the safety and effectiveness of probiotics in osteoarthritic pain for one individual.

Methods: The study was an N-of-1 trial design, divided into 3 blocks of 10 weeks. Each block included one pair of randomized interventions (AB), separated by a washout period. The trial took place in a private naturopathic practice in Sydney, Australia. The participant was a 67 year old female with osteoarthritis in her lower back and right ankle. The active intervention was two daily capsules that contained Lactobacillus rhamnosus (LGG®), Saccharomyces cerevisiae (boulardii) and Bifidobacterium animalis ssp lactis. The placebo was an identical capsule that did not contain probiotics. The primary outcome was daily pain scores, measured by the participant on a Visual Analogue Scale (VAS). Secondary outcome measures included patient preference (of intervention), General Health Questionnaire (GHQ-12), Patient Specific Functional Scale (PSFS), Comprehensive Digestive Stool Analysis (CDSA) and rescue medication usage. A dependent t-test analysed mean pain scores for the last week of each intervention across the three blocks of the study.

Results: The probiotic intervention was associated with lower pain scores and was the preferred intervention chosen by the participant. The mean pain score on the VAS was 4.9 ± 2.2 in the placebo condition compared to 4.0 ± 1.7 in the probiotic condition (t(20) = 2.2, p = 0.04, difference = 0.9, 95 % CI [0.04, 1.77]).

Conclusions: The reduction in pain scores associated with the probiotic intervention was small but clinically significant for this patient. A holistic view of the patient focusing on digestive integrity and function may be crucial for clinical applications of interventions such as probiotics. N-of-1 trial designs allow for the measurement of a holistic approach to an individual, which is aligned with naturopathic practice. Further trials are required to generate data to enable reliable estimation of population effects.

Keywords: Alternative medicine; Complementary medicine; N-of-1 trials; Osteoarthritis; Probiotics; Single-Case study.