Efficacy and safety of the Tibetan medicine Baimai ointment for patients with lumbar disc herniation: Protocol for a multicenter, randomized, double-blind, placebo-controlled trial

Objective

To evaluate the efficacy and safety of Baimai ointment in patients with lumbar disc herniation (LDH).

Methods

This study presents a prospective randomized, double-blind, placebo-controlled, multicenter clinical trial protocol. A total of 194 cases will be employed, with a 1:1 allocation ratio for each group. Patients will receive either Baimai ointment or placebo over a 14-day treatment period, which will be followed by a 1-week follow-up period. Visual analogue scale scores will be used for the level of pain, the Japanese Orthopedic Association score will be measured primarily to determine the functional status, the Likert scale will be graded for the level of numbness, and rescue therapy use and compliance with health education will be recorded. Laboratory tests and adverse event records will also be applied for safety assessments.

Discussion

In summary, this trial will assess the clinical efficacy and safety of Baimai ointment for LDH for the first time. The use of a placebo has the advantage of precluding anticipatory biases resulting from inadequate blinding. Outcome assessors, data managers, statisticians, and all related study staff will be blinded to avoid any bias caused by subjective factors in the study subjects and investigators. Valuable information for clinical LDH treatment and future research on Baimai ointment will be generated from the findings.