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Published on: September 13, 2024
Feasibility of Individualized Homoeopathic Treatment in Temporomandibular Joint Dysfunction: A Randomized,
Baidurjya Bhattacharjee1, Sayani Ghosh2, Nilay Basu1
1Regional Research Institute for Homoeopathy, Central Council for Research in Homoeopathy, Siliguri, India.
Objectives:
To assess the feasibility of conducting a randomized controlled trial and to explore preliminary effects of individualized homoeopathic medicines (IHMs) compared with placebo in patients with temporomandibular joint dysfunction (TMJD).
Trial Design:
A double-blind, randomized, parallel-arm, placebo-controlled pilot feasibility trial with equal allocation to IHMs or placebo.
Methods:
Adults with clinically and radiologically confirmed TMJD were randomized to receive IHMs or matched placebo for 3 months. Participants, investigators, outcome assessors, and statisticians were blinded to allocation. The primary clinical outcome was the Graded Chronic Pain Scale (GCPS), which was assessed monthly. Secondary outcomes included the Jaw Functional Limitation Scale-20 (JFLS-20), Patient Health Questionnaire-4 (PHQ-4), and qualitative assessment of pre-post cone beam computed tomography (CBCT) findings. Feasibility outcomes included recruitment, retention, adherence, blinding, and safety. Repeated-measures analysis of covariance was used for exploratory analysis.
Results:
Sixty participants were randomized, with a retention rate of 91.7% and high intervention adherence (>80% in 91.7% of participants). No statistically significant intergroup difference was observed for overall GCPS scores (F = 2.151, p = 0.126). JFLS-20 scores showed a statistically significant group-by-time interaction (F = 3.642, p = 0.033). No significant differences were observed for PHQ-4 scores. Qualitative CBCT assessments demonstrated a statistically significant difference between groups (χ2 = 13.404, p = 0.001); these findings are exploratory and should be interpreted with caution.
Conclusion:
This pilot study demonstrates that the study is feasible; however, methodological challenges and potential confounding factors require careful consideration and additional safeguards before undertaking future definitive trials.Trial Identifier:Clinical Trials Registry of India, CTRI/2023/05/052919, registered on May 19, 2023.
