Acupuncture Treatment for Individuals With Myasthenia Gravis - A Pilot Randomized Clinical Trial

Abstract

Background: Myasthenia gravis (MG) is a rare autoimmune disease resulting in muscle weakness. Although pharmacologic treatments are typically effective at managing symptoms, prolonged use is associated with safety issues. Acupuncture treatment may have a significant positive effect in treating MG symptoms and may enhance the efficacy of medications.

Objective: The overall goal was to examine the feasibility and safety of a pilot randomized controlled trial of acupuncture treatment in individuals with MG.

Methods: Participants were randomized into 2 arms: (1) immediate start and (2) delayed start. Participants in the immediate start arm underwent twice weekly acupuncture for 12 weeks, whereas participants in the delayed start arm underwent a 12-week delay period, followed by twice weekly acupuncture for 12 weeks. A base treatment of 21 acupoints was used for all study participants. Acupuncturists made a Traditional Chinese Medicine differential diagnosis to determine whether the patient was yang deficient, yin deficient, or stagnation pronounced, and could add up to 9 additional acupoints. Participants received the same acupuncture protocol for all 24 treatments.

Results: Twenty-four individuals with MG were enrolled in the study. The average age of participants was 62 (SD = 13) with an average of 8 years (SD = 9) between diagnosis and enrollment. Seventeen of the 24 individuals who signed the consent form completed 100% of acupuncture treatment sessions and completed the full study. Only 17 adverse events were determined to be definitely or probably related to treatment, which were mostly mild site reactions. Barriers to participation included transportation issues, travel time, and the overall time commitment.

Conclusion: The results demonstrated that acupuncture treatment was overall feasible and safe in individuals with MG. Participants also self-reported improvements in MG symptoms. Next steps will include development of an efficacy RCT with a rigorous study design to examine the clinical significance and efficacy of acupuncture for MG.

Keywords: activities of daily living; acupuncture; myasthenia gravis; neuromuscular disease; neurorehabilitation; quality of life; traditional Chinese medicine.

Figure 1.

Study Timeline of Participant Activities

Figure 2.

Acupuncture Treatment Points Used for the Study Intervention. *Note: Bilateral Acupuncture Points Were Utilized, when Appropriate

Figure 3.

Symptom Severity Scale Developed by Study Investigators for Determining Individualized Acupuncture Treatment Plan for the Study

Figure 4.

CONSORT Diagram of Study Enrollment

Figure 5.

Participant Assessment Data Availability. Note: Data labels represent the number of responses at each timepoint; Assessments from early withdrawals grouped with post-treatment 1 (Immediate start, n = 1) and post-treatment (Delayed start, n = 1)