Crocus sativus L. Versus Methylphenidate in Treatment of Children with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Pilot Study

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Methylphenidate is the most common prescribed drug for treatment of ADHD and can improve cognitive function through a dopaminergic effect.

“The most common prescribed drug for treatment of ADHD is methylphenidate (MPH) and it is believed that it can improve cognitive function through a dopaminergic effect (Storebø et al. 2015).”

• cites Storebø et al. 2015 sourcePartly supported

  The Introduction (page unavailable) calls methylphenidate globally the most common drug treatment for ADHD. The Results and Discussion report possible improvements in ADHD symptoms and general behaviour in children and adolescents, but do not establish improved cognitive function through a dopaminergic effect; searches for that mechanism found only related reference titles. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

May combine two claims.

The diagnosis of ADHD was confirmed by the participant's child psychiatrist based on DSM-5 criteria, the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime diagnostic interview, and a thorough medical evaluation.

“Before entry, the diagnosis of ADHD was confirmed by the participant's child psychiatrist based on the DSM-5 criteria for ADHD, the Kiddie Schedule for Affective Disorders, and Schizophrenia-Present and Lifetime diagnostic interview and a thorough medical evaluation was performed (Ghanizadeh et al. 2006).”

• cites Ghanizadeh et al. 2006 sourcePartly supported

  The Methods > Measure passage identifies K-SADS-PL as a diagnostic interview that covers ADHD, supporting the citation’s use for the instrument. But it says the interview is based on DSM-IV criteria, not DSM-5, and the paper does not establish that the citing study’s participants received the stated psychiatric confirmation or thorough medical evaluation. (LLM, conf=0.86)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim. May combine two claims.

Saffron was more effective than placebo therapy and could be compared with conventional antidepressants like fluoxetine and imipramine.

“In addition, saffron was more effective than placebo therapy and could be compared with conventional antidepressants like fluoxetine and imipramine (Akhondzadeh et al. 2004(Akhondzadeh et al. , 2005;;Akhondzadeh Basti et al. 2007).”

• cites Akhondzadeh et al. 2004 sourcePartly supported

  The Discussion reports that saffron was similarly effective to imipramine in this small trial of mild to moderate depression, and the Results found no significant difference between the groups. The Discussion explicitly notes the lack of a placebo group; this paper also did not compare saffron with fluoxetine. It therefore supports the imipramine comparison, but not the placebo or fluoxetine parts of the sentence. (LLM, conf=0.90)

  Experimental — accuracy not yet measured
• cites Akhondzadeh et al. 2005 sourceNot checked — no full text of the source
• cites Akhondzadeh Basti et al. 2007Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Both treatments significantly improved Parent ADHD Rating Scale scores (p<0.001 for both saffron and MPH groups).

“Moreover, a significant effect of both treatments on improving Parent ADHD Rating Scale scores was demonstrated ( p < 0.001 for both saffron and MPH groups).”

May combine two claims.

No serious adverse event was observed in any of the patients and all noticed adverse effects were mild to moderate and tolerable.

“No serious adverse event was observed in any of the patients and all noticed adverse effects were mild to moderate and tolerable.”

The quote only partly states this claim.

No significant difference was observed on the score reductions of the Teacher ADHD Rating Scale at week 6 compared with baseline between the two groups (p=0.883).

“was observed on the score reductions of the Teacher ADHD Rating Scale at week 6 compared with baseline in the two groups ( p = 0.883).”

May combine two claims.

The patients, physicians who evaluated them and prescribed medications, and the statistician were all blind to allocation.

“The patients, physicians who evaluated them and prescribed medications, and the statistician were all blind to allocation.”

May combine two claims.

The study population size was small and the short follow-up period should also be considered.

“The study population size was small and the short follow-up period should also be considered.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Written informed consent was obtained from each patient's parent or legal guardian.

“After a complete description of the procedures and the purpose of the study, a written informed consent was obtained from each patient's parent or legal guardian.”

Classified as probably not a substantial claim.

Patients were randomized by the permuted block method using a computerized random number generator (allocation ratio 1:1, blocks of 4).

“Patients were randomized by the permuted block method using a computerized random number generator (allocation ratio 1:1, blocks of 4).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Saffron is generally a safe medication but there are some reports of adverse effects, such as nausea, vomiting, diarrhea, and bleeding after high-dose saffron use.

“It is generally a safe medication but there are some reports of some adverse effects, such as nausea, vomiting, diarrhea, and bleeding after high-dose saffron use (Schmidt et al. 2007;Modaghegh et al. 2008).”

• cites Schmidt et al. 2007 sourceNot checked — no full text of the source
• cites Modaghegh et al. 2008 sourceNot checked — no full text of the source

May combine two claims.

C. sativus was safe and showed equally or lesser adverse effects compared with methylphenidate.

“Also C. sativus was safe and showed equally or lesser adverse effects.”

• Also stated in: § Clinical Significance · plain

  “Also C. sativus was safe and showed equal or lesser adverse effects.”

Probably not a substantial claim: may not pass S2 (checkable).

The results of this study must be considered as preliminary.

“The results of this study must be considered as preliminary.”

May combine two claims.

About 30% of children with ADHD do not respond to methylphenidate, and its side effects have forced patients to give up their therapy period.

“In addition, *30% of children with ADHD do not respond to methylphenidate, and its side effects has forced patients to give up their therapy period (Spencer et al. 1996).”

• cites Spencer et al. 1996 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The study was approved by the Institutional Review Board of Tehran University of Medical Sciences and was consistent with the Declaration of Helsinki.

“The study was approved by the Institutional Review Board (IRB) of Tehran University of Medical Sciences (Grant No. 32600) and was in consistence with the Declaration of Helsinki and its subsequent revisions.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Antidepressants have been reported to be effective in improving ADHD symptoms.

“Among these medications, antidepressants are used and have been reported to be effective in improving ADHD symptoms (Banaschewski et al. 2004;Zarinara et al. 2010;Salardini et al. 2016).”

• cites Banaschewski et al. 2004 sourceNot checked — no full text of the source
• cites Zarinara et al. 2010 sourceNot checked — no full text of the source
• cites Salardini et al. 2016 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The trial was a single-center, randomized, double-blind, parallel-group clinical trial conducted over 6 weeks.

“A single-center, randomized, double-blind, parallel-group clinical trial conducted over 6 weeks from January 2017 to October 2018 at the outpatient child and adolescent psychiatry clinics at Roozbeh Psychiatric Hospital (affiliated with Tehran University of Medical Sciences).”

• Also stated in: § Abstract · plain

  “In a 6-week randomized double-blind study, 54 patients (children 6-17 years old) with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ADHD were randomly assigned to receive either 20-30 mg/d (20 mg/d for <30 kg and 30 mg/d for >30 kg) methylphenidate (MPH) or 20-30 mg/d saffron capsules depending on weight (20 mg/d for <30 kg and 30 mg/d for >30 kg).”

Probably not a substantial claim: may not pass S3 (load-bearing).

The trial was registered at the Iranian Registry of Clinical Trials (IRCT201701131556N94).

“The trial was registered at the Iranian Registry of Clinical Trials (registration No. IRCTID: IRCT201701131556N94).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Fifty patients completed the trial (25 in each group).

“Finally, 50 patients (25 patients in each group) completed the trial (Fig. 1).”

May combine two claims.

Saffron and its active constituents can increase the reuptake inhibition of dopamine and norepinephrine and are NMDA receptor antagonists and GABA-a agonists.

“It is thought that saffron and its active constituents can increase the reuptake inhibition of dopamine and norepinephrine and are N-methyl D-aspartic acid (NMDA) receptor antagonists and GABA-a agonists.”

• cites Sarris 2007 sourceNot checked — no full text of the source
• cites Alavizadeh and Hosseinzadeh 2014Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Different animal studies have shown that saffron and its products can improve sexual activity, reduce blood pressure, and enhance learning and memory in addition to their anticonvulsant, anti-Alzheimer, antidepressant, antischizophrenia, anti-Parkinson, and neuroprotective effects.

“Different animal studies have also shown that saffron and its products can improve sexual activity, reduce blood pressure, and enhance learning and memory in addition to their anticonvulsant, anti-Alzheimer, antidepressant, antischizophrenia, anti-Parkinson, and neuroprotective effects (Khazdair et al. 2015).”

• cites Khazdair et al. 2015 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S4 (based). May combine two claims.

Saffron is a putative antidepressant and antidepressant agents are acceptable for treatment of ADHD.

“Taken together, since saffron is a ''putative'' antidepressant and antidepressant agents are acceptable for treatment of ADHD, we hypothesized that saffron intake would be of benefit in these patients.”

May combine two claims.

The ADHD-RS-IV has been used extensively in Iran and offers valid measurement of attention and behavioral problems in school-age children.

“The ADHD-RS-IV has been used extensively in Iran and offers valid measurement of attention and behavioral problems in school-age children (Amiri et al. 2008;Abbasi et al. 2011;Jafarinia et al. 2012;Salardini et al. 2016).”

• cites Amiri et al. 2008 sourceNot checked — no full text of the source
• cites Abbasi et al. 2011 sourceNot checked — no full text of the source
• cites Jafarinia et al. 2012 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Evidence has proven that saffron can be useful in disorders involving memory and learning disorders like Alzheimer's disease.

“Evidence has proven that saffron can be useful in disorders involving the memory and learning disorders like Alzheimer's disease (Akhondzadeh et al. 2009;Moshiri et al. 2015).”

• cites Akhondzadeh et al. 2009Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Moshiri et al. 2015Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim. May combine two claims.

Assuming a mean difference of 3 on the Teacher and Parent ADHD Rating Scale, an SD of 3, a power of 90%, and a two-tailed significance level of 0.05, a sample size of 46 was calculated; with prediction of 10% attrition rate, 50 patients were needed (25 in each group).

“Assuming a mean difference (MD) of 3 on the Teacher and Parent ADHD Rating Scale, an SD of 3 on the Teacher and Parent ADHD Rating Scale (according to the pilot study), a power of 90%, and a two-tailed significance level of 0.05, a sample size of 46 was calculated.With prediction of 10% attrition rate, 50 patients were needed (25 in each group).”