{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T05:59:51Z","timestamp":1781243991575,"version":"3.54.1"},"reference-count":18,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T00:00:00Z","timestamp":1781222400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pediatr."],"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess efficacy and safety of Sini San combined with Xiaoxianxiong Tang as add-on therapy for adolescents (12\u201318 years) with liver qi stagnation and phlegm-heat depression, and to provide preliminary evidence for TCM syndrome-based treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Sixty adolescents (12\u201318 years) with moderate depression (DSM-5 criteria) meeting TCM syndrome standards were recruited from Youxian Branch of Mianyang Third Hospital (Jan 2024\u2013Dec 2025). Sample size was calculated via G*Power 3.1 (effect size=0.8,\n                      <jats:italic>\u03b1<\/jats:italic>\n                      =0.05,\n                      <jats:italic>\u03b2<\/jats:italic>\n                      =0.2). A conservative effect size of 0.6 for TCM add-on trials in adolescent depression required 44 participants per group. Our sample size was calculated using the commonly adopted large effect size (0.8) for such trials, which was adequate to detect the predefined clinically meaningful effect. Participants were randomly assigned to TCM decoction+psychological counseling (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200930) or psychological counseling alone (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200930) with allocation concealment, receiving 8-week intervention.Intention-to-treat (ITT) analysis with last observation carried forward (LOCF) for missing data was used. All outcomes were assessed by independent blinded evaluators. Primary outcomes: CDRS-R and TCM syndrome scores; secondary outcomes: PedsQL score, clinical effective rate, adverse events. Cohen's d and 95% CIs were calculated with Bonferroni correction for multiple comparisons.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Baseline characteristics were comparable between groups (all\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&amp;gt;\u20090.05). After 4 and 8 weeks, both groups showed improved outcomes (all\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&amp;lt;\u20090.001). At 8 weeks, the study group had lower CDRS-R (13.02\u2009\u00b1\u20093.25 vs. 21.85\u2009\u00b1\u20093.56, t\u2009=\u200910.23,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&amp;lt;\u20090.001, Cohen's d\u2009=\u20092.64, 95%CI:1.72\u20133.56), lower TCM syndrome scores (3.21\u2009\u00b1\u20091.35 vs. 6.98\u2009\u00b1\u20091.62, t\u2009=\u20099.87,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&amp;lt;\u20090.001, Cohen's d\u2009=\u20092.52, 95%CI:1.61\u20133.43), higher PedsQL scores (79.35\u2009\u00b1\u20097.61 vs. 66.89\u2009\u00b1\u20097.43, t\u2009=\u20096.54,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&amp;lt;\u20090.001, Cohen's d\u2009=\u20091.68, 95%CI:0.92\u20132.44), and higher clinical effective rate (90.0% vs. 63.3%,\n                      <jats:italic>\u03c7<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      \u2009=\u20096.67,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.010, 95%CI:9.7%\u201343.3%). The study group reported 6.7% mild gastrointestinal discomfort, with no serious adverse events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>As an add-on therapy to psychological counseling, Sini San combined with Xiaoxianxiong Decoction shows preliminary short-term efficacy in alleviating depressive symptoms and improving quality of life in adolescents with target TCM syndrome, with favorable short-term safety. Due to small sample size, single-center design, lack of double-blinding and placebo control, the findings are hypothesis-generating and cannot support broad clinical promotion.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fped.2026.1787781","type":"journal-article","created":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T05:46:21Z","timestamp":1781243181000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of sini powder combined with Xiaoxianxiong decoction for adolescent depression with liver qi stagnation and phlegm-heat obstruction syndrome: a randomized controlled trial"],"prefix":"10.3389","volume":"14","author":[{"given":"Ruiyu","family":"Lin","sequence":"first","affiliation":[{"name":"The Third Hospital of Mianyang","place":["Mianyang, Sichuan, China"]},{"name":"Sichuan Mental Health Center","place":["Mianyang, Sichuan, China"]},{"name":"The Affiliated Mianyang Hospital of Chongqing Medical University","place":["Mianyang, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yangzhen","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Youxian District Hospital of Traditional Chinese Medicine (Youxian Branch of The Third Hospital of Mianyang)","place":["Mianyang, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juncheng","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Youxian District Hospital of Traditional Chinese Medicine (Youxian Branch of The Third Hospital of Mianyang)","place":["Mianyang, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia","family":"Gao","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Youxian District Hospital of Traditional Chinese Medicine (Youxian Branch of The Third Hospital of Mianyang)","place":["Mianyang, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liting","family":"He","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Youxian District Hospital of Traditional Chinese Medicine (Youxian Branch of The Third Hospital of Mianyang)","place":["Mianyang, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shanying","family":"Huang","sequence":"additional","affiliation":[{"name":"The Third Hospital of Mianyang","place":["Mianyang, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,6,12]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"667","DOI":"10.1056\/NEJMcp012249","article-title":"Adolescent depression","volume":"347","author":"Brent","year":"2002","journal-title":"N Engl J Med"},{"key":"B2","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1016\/s0883-9417(95)80017-4","article-title":"Adolescent depression: a review of the literature","volume":"9","author":"Brage","year":"1995","journal-title":"Arch Psychiatr Nurs"},{"key":"B3","doi-asserted-by":"publisher","first-page":"100277","DOI":"10.1016\/j.gpeds.2025.100277","article-title":"The pivotal role of mental health in child and adolescent development: brief review by the working group on child and adolescent mental health of the\u201d GE ghirardi\u201d foundation on the occasion of the world mental health day 2024","author":"Suppiej","year":"2025","journal-title":"Glob. 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