Effect of herbal medicine (Huanglian-jie-du granule) for somatic symptoms and insomnia in patients with Hwa-byung: A randomized controlled trial

Background: Huanglian-jie-du (HJD) granule, which is composed of representative “heat-clearing” herbs has been used for Hwa-byung. Hwa-byung is a culture-bound syndrome in Korea, characterized by distinct somatic symptoms such as chest congestion and heat sensation resulting from suppressed anger. We investigated the effect of HJD in patients with Hwa-byung. Methods: Forty-four patients with Hwa-byung were recruited, and HJD or placebo granules were administered orally three times daily for seven days. The two primary outcomes were somatic symptoms, which were measured by Patient Health Questionnaire of physical symptoms (PHQ-15), and insomnia, which was measured by Insomnia Severity Index (ISI) at post-treatment. Results: Between July 10 and October 31, 2017, 44 patients with Hwa-byung (mean age 36.68 years; and 38 female) were randomly assigned to HJD (n = 22) or placebo (n = 22) group. After administration of HJD or placebo granule for seven days, ISI score was lower in the HJD group compared to placebo group at post-treatment (adjusted mean difference -2.56 [95% CI -4.72 to -0.39], p = 0.0208). Meanwhile, there was no difference in PHQ-15 score between HJD group and placebo group at post-treatment (adjusted mean difference -0.50 [95% CI: -3.02–4.02], p = 0.7812). Conclusions: Our results suggest that the administration of HJD granule has a potential to improve insomnia in Hwa-byung patients. Effect of HJD granule for general somatic symptoms in Hwa-byung patients is unclear, and further researches are needed. Trial registration: Clinical Research Information Service, KCT0002379.