Efficacy and safety of saffron as adjunctive therapy in adults with attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled clinical trial

IF 1.7 Q2 Medicine Advances in integrative medicine Pub Date : 2022-03-01 DOI:10.1016/j.aimed.2022.01.002

Benyamin Pazoki , Nadia Zandi , Zeinab Assaf , Hossein Sanjari Moghaddam, Arefeh Zeinoddini, Mohammad Reza Mohammadi, Shahin Akhondzadeh

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引用次数: 4

Abstract

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).

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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

约30%的注意力缺陷/多动障碍(ADHD)患者对利他林无反应或不能耐受其副作用，这就需要考虑其他选择。先前的研究表明，藏红花对患有多动症的儿童有益。然而，它对成人多动症的潜在治疗效果尚不清楚。本研究旨在评估藏红花作为利他林辅助治疗成人ADHD症状的有效性和安全性。这是一项随机、双盲、安慰剂对照的临床试验。方法将56例ADHD患者分为两组，分别接受利他林(30 mg/d) +安慰剂或利他林+藏红花(15 mg, 2次/d)治疗，疗程6周。在基线、第3周和第6周采用康纳斯成人ADHD评定量表(CAARS)和成人ADHD自我报告量表(ASRS)对患者进行评估。结果44例患者完成试验。GLM重复测量分析显示，从基线到研究终点，ASRS (df=2, F=3.455, p值=0.036)和CAARS (df=1.584, F=3.939, p值=0.033)评分的时间×治疗交互作用显著。我们发现，从基线到研究终点(第6周)，与安慰剂组相比，藏红花组的ASRS评分显著降低(p值=0.024)。然而，从基线到第3周的变化评分在试验组之间没有显著差异(p值=0.269)。从基线到第3周或第6周，藏红花和安慰剂对CAARS评分的改善无显著差异(p值分别为0.564和0.089)。两组在基线参数和副作用发生频率方面无显著差异。结论红花素联合利他林可有效改善ADHD患者的症状。然而，需要更大样本量的进一步研究和更长的随访治疗来证实我们的发现。该试验已在伊朗临床试验登记处注册(www.irct.ir;没有IRCT20090117001556N111)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in integrative medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

3.20

自引率

11.80%

发文量

审稿时长

15 weeks

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.