Single-blind, randomized, pilot study combining shiatsu and amitriptyline in refractory primary headaches

Area of Science:

• Neurology
• Integrative Medicine
• Clinical Pharmacology

Background:

• Refractory primary headaches often require multimodal treatment approaches.
• Evidence for combining complementary therapies like shiatsu with conventional pharmacotherapy is limited.
• Shiatsu is a non-pharmacological therapy with potential benefits for headache management.

Purpose of the Study:

• To evaluate the efficacy and safety of combining shiatsu with amitriptyline for treating refractory primary headaches.
• To compare the effects of shiatsu plus amitriptyline, shiatsu alone, and amitriptyline alone.
• To assess the impact on headache frequency, pain intensity, and medication use.

Main Methods:

• A single-blind, randomized pilot study involving 37 patients with refractory primary headaches.
• Participants were randomized to receive shiatsu plus amitriptyline, shiatsu alone, or amitriptyline alone for 3 months.
• Primary endpoint: proportion of patients with ≥50% reduction in headache days. Secondary endpoints: headache days/month, visual analogue scale (VAS), painkiller use.

Main Results:

• All treatment groups showed improvement in headache frequency, VAS, and painkiller use (p < 0.05).
• No significant difference was observed between groups for the primary endpoint (≥50% reduction in headache days).
• Shiatsu (alone or combined) significantly reduced monthly painkiller consumption compared to amitriptyline alone (p < 0.05).
• Adverse events (19%) were solely attributed to amitriptyline; shiatsu treatment was associated with no side effects.

Conclusions:

• Shiatsu demonstrates safety and potential utility as an alternative approach for refractory headaches.
• Combining shiatsu with amitriptyline did not yield additive or synergistic benefits compared to monotherapy.
• Preliminary findings suggest shiatsu's value, but cautious interpretation is needed due to the small sample size.