{"title":"藏红花作为成人注意力缺陷/多动障碍辅助治疗的有效性和安全性:一项随机、双盲、安慰剂对照的临床试验","authors":"Benyamin Pazoki , Nadia Zandi , Zeinab Assaf , Hossein Sanjari Moghaddam, Arefeh Zeinoddini, Mohammad Reza Mohammadi, Shahin Akhondzadeh","doi":"10.1016/j.aimed.2022.01.002","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>Around 30% of patients with Attention-Deficit/Hyperactivity Disorder (ADHD) do not respond to Ritalin or cannot tolerate its side effects, which necessitates the consideration of alternative options. Previous studies have shown the beneficial effects of <em>Crocus sativus</em> (saffron) in children with ADHD. However, its potential therapeutic effects in adults with ADHD is unknown. This study aimed to evaluate the efficacy and safety of saffron as an adjuvant to Ritalin for improving symptoms in adults with ADHD.</p></div><div><h3>Design</h3><p>This was a randomized, double-blind, placebo-controlled clinical trial.</p></div><div><h3>Methods</h3><p>Fifty-six patients diagnosed with ADHD were assigned into two parallel groups to receive Ritalin (30 mg/day) plus placebo or Ritalin plus saffron (15 mg twice daily) for six weeks. The patients were assessed with Conners' Adult ADHD Rating Scales (CAARS) and the Adult ADHD Self-Report Scale (ASRS) at baseline, week 3 and week 6.</p></div><div><h3>Results</h3><p>Forty-four patients completed the trial. GLM repeated-measure analysis demonstrated significant time × treatment interaction effect for ASRS (df=2, F=3.455, and P-value=0.036) and CAARS (df=1.584, F=3.939, and P-value=0.033) score from baseline to the study endpoint. We found a significantly greater reduction in ASRS scores in the saffron group compared with the placebo group from baseline to the study endpoint (week 6) (P-value=0.024). However, the change score from baseline to week 3 was not significantly different between trial groups (P-value=0.269). There was no significant difference in the improvement of CAARS scores between saffron and placebo from baseline to week 3 or 6 (P-value=0.564 and 0.089, respectively). There was no significant difference between the two groups in baseline parameters and frequency of side effects.</p></div><div><h3>Conclusions</h3><p>Saffron combination therapy with Ritalin can effectively improve symptoms of patients with ADHD. However, further studies with larger sample sizes and longer follow-up treatment are needed to confirm our findings.</p><p>This trial was registered with the Iranian Registry of Clinical Trials (www.irct.ir; No IRCT20090117001556N111).</p></div>","PeriodicalId":7343,"journal":{"name":"Advances in integrative medicine","volume":"9 1","pages":"Pages 37-43"},"PeriodicalIF":1.7000,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"4","resultStr":"{\"title\":\"Efficacy and safety of saffron as adjunctive therapy in adults with attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled clinical trial\",\"authors\":\"Benyamin Pazoki , Nadia Zandi , Zeinab Assaf , Hossein Sanjari Moghaddam, Arefeh Zeinoddini, Mohammad Reza Mohammadi, Shahin Akhondzadeh\",\"doi\":\"10.1016/j.aimed.2022.01.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>Around 30% of patients with Attention-Deficit/Hyperactivity Disorder (ADHD) do not respond to Ritalin or cannot tolerate its side effects, which necessitates the consideration of alternative options. Previous studies have shown the beneficial effects of <em>Crocus sativus</em> (saffron) in children with ADHD. However, its potential therapeutic effects in adults with ADHD is unknown. This study aimed to evaluate the efficacy and safety of saffron as an adjuvant to Ritalin for improving symptoms in adults with ADHD.</p></div><div><h3>Design</h3><p>This was a randomized, double-blind, placebo-controlled clinical trial.</p></div><div><h3>Methods</h3><p>Fifty-six patients diagnosed with ADHD were assigned into two parallel groups to receive Ritalin (30 mg/day) plus placebo or Ritalin plus saffron (15 mg twice daily) for six weeks. The patients were assessed with Conners' Adult ADHD Rating Scales (CAARS) and the Adult ADHD Self-Report Scale (ASRS) at baseline, week 3 and week 6.</p></div><div><h3>Results</h3><p>Forty-four patients completed the trial. GLM repeated-measure analysis demonstrated significant time × treatment interaction effect for ASRS (df=2, F=3.455, and P-value=0.036) and CAARS (df=1.584, F=3.939, and P-value=0.033) score from baseline to the study endpoint. We found a significantly greater reduction in ASRS scores in the saffron group compared with the placebo group from baseline to the study endpoint (week 6) (P-value=0.024). However, the change score from baseline to week 3 was not significantly different between trial groups (P-value=0.269). There was no significant difference in the improvement of CAARS scores between saffron and placebo from baseline to week 3 or 6 (P-value=0.564 and 0.089, respectively). There was no significant difference between the two groups in baseline parameters and frequency of side effects.</p></div><div><h3>Conclusions</h3><p>Saffron combination therapy with Ritalin can effectively improve symptoms of patients with ADHD. However, further studies with larger sample sizes and longer follow-up treatment are needed to confirm our findings.</p><p>This trial was registered with the Iranian Registry of Clinical Trials (www.irct.ir; No IRCT20090117001556N111).</p></div>\",\"PeriodicalId\":7343,\"journal\":{\"name\":\"Advances in integrative medicine\",\"volume\":\"9 1\",\"pages\":\"Pages 37-43\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2022-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in integrative medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2212958822000027\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in integrative medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2212958822000027","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
Efficacy and safety of saffron as adjunctive therapy in adults with attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled clinical trial
Objective
Around 30% of patients with Attention-Deficit/Hyperactivity Disorder (ADHD) do not respond to Ritalin or cannot tolerate its side effects, which necessitates the consideration of alternative options. Previous studies have shown the beneficial effects of Crocus sativus (saffron) in children with ADHD. However, its potential therapeutic effects in adults with ADHD is unknown. This study aimed to evaluate the efficacy and safety of saffron as an adjuvant to Ritalin for improving symptoms in adults with ADHD.
Design
This was a randomized, double-blind, placebo-controlled clinical trial.
Methods
Fifty-six patients diagnosed with ADHD were assigned into two parallel groups to receive Ritalin (30 mg/day) plus placebo or Ritalin plus saffron (15 mg twice daily) for six weeks. The patients were assessed with Conners' Adult ADHD Rating Scales (CAARS) and the Adult ADHD Self-Report Scale (ASRS) at baseline, week 3 and week 6.
Results
Forty-four patients completed the trial. GLM repeated-measure analysis demonstrated significant time × treatment interaction effect for ASRS (df=2, F=3.455, and P-value=0.036) and CAARS (df=1.584, F=3.939, and P-value=0.033) score from baseline to the study endpoint. We found a significantly greater reduction in ASRS scores in the saffron group compared with the placebo group from baseline to the study endpoint (week 6) (P-value=0.024). However, the change score from baseline to week 3 was not significantly different between trial groups (P-value=0.269). There was no significant difference in the improvement of CAARS scores between saffron and placebo from baseline to week 3 or 6 (P-value=0.564 and 0.089, respectively). There was no significant difference between the two groups in baseline parameters and frequency of side effects.
Conclusions
Saffron combination therapy with Ritalin can effectively improve symptoms of patients with ADHD. However, further studies with larger sample sizes and longer follow-up treatment are needed to confirm our findings.
This trial was registered with the Iranian Registry of Clinical Trials (www.irct.ir; No IRCT20090117001556N111).
期刊介绍：
Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.
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