[Summary text]
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Placebo
Overall
Included criteria: ADHD diagnosis was confirmed based on DSM-IV (4th ed.; American Psychiatric Association, 1994) criteria. All included patients also scored more than 20 based on the Parent ADHD Rating Scale.
Excluded criteria: Patients with any psychiatric disorder, except for oppositional defiant disorder (ODD) and learning disability (LD), based on Kiddi Scheduled for Affective Disorders Schizophrenia (K-SADS) questionnaire as well as those with intelligence quotient (IQ) less than 70; use of any psychotropic substance, opioid, or other drugs affecting central nervous system in two previous weeks; any significant neurologic disease; and use of any combination containing PUFAs more than once weekly were excluded from the study.
Pretreatment: None detected
Intervention Characteristics
Intervention 1
Placebo
ADHD kernesymptomer, forælderbestemt, SD, EoT
ADHD, kernesymptomer, lærerbestemt
Adfærdsforstyrelser, forælderbedømt (oppositionality)
Adfærdsforstyrrelse, lærerbestemt (oppositionality)
Diarré
Gastrointestinale gener
Kvalme
Sponsorship source: This work was supported in part by the grant from the Behavioral Sciences Research Center of Shahid Beheshti University of Medical Sciences (Tehran, Iran).
Country: Iran
Setting: An outpatient clinic of child psychiatry.
Comments: NA
Authors name: Rozita Davari Ashtiani
Institution: Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Email: rodavari@sbmu.ac.ir
Address: P.O. Box 1617763141, Tehran, Iran
Registration of Clinical Trials: Iranian Registration of Clinical Trials: IRCT138803122000N1
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
Study design: RCT
Study grouping: intervention vs placebo
Baseline Characteristics
Intervention 1
Placebo
Overall
Included criteria: Participants for the study were children 6 to 12 years of age, selected froman outpatient treatment program for ADHD. All children in the programwere clinically diagnosed (according to criteria from theDiagnostic andStatistical Manual of Mental Disorders, Fourth Edition), supported bypositive scores in Swanson, Nolan and Pelham version IV(SNAP) parentand teacher evaluation.
Excluded criteria: The ADHD treatment program had 422 registered children.Ninety-five were excluded for being registered for less than 6 months.Eleven children whose hyperactivity was primarily related to intellec-tual impairment, brain injury, and insult were also excluded. Another141 were excluded for satisfactory outcome in ADHD symptoms,behavior, and school-based learning, evidenced from clinical recordsfor 3 consecutive months or more. A further 77 were excluded formissed follow-up appointments and medication refills as they couldnot be counted as definitively ‘‘refractory to treatment.’
Pretreatment: No significant differences between groups.
Intervention Characteristics
Intervention 1
Placebo
ADHD kernesymptomer, forælderbestemt, SD, EoT
ADHD, kernesymptomer, lærerbestemt
Adfærdsforstyrelser, forælderbedømt (oppositionality)
Adfærdsforstyrrelse, lærerbestemt (oppositionality)
Diarré
Gastrointestinale gener
Kvalme
Sponsorship source: The authors disclosed receipt of the following financial support for theresearch, authorship, and/or publication of this article: The preparationof study material was sponsored by Igennus Ltd, Cambridge, UK /Gpristine Pvt Ltd, Sri Lanka.
Country: Sri Lanka
Setting: Outpatient hospital setting
Comments: NA
Authors name: Hemamali Perera, Kamal Chandima Jeewandara, Sudarshi Seneviratne, Chandima Guruge
Institution: Department of Psychological Medicine, Faculty of Medicine, University ofColombo, Sri Lanka and Lady Ridgeway Hospital for Children, Colombo, Sri Lanka
Email: hemamali_p@yahoo.com
Address: Department of Psychological Medicine,Faculty of Medicine, University of Colombo, and Lady Ridgeway Hospital forChildren, Colombo, 08, Sri Lanka
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
For more information, please see the following reference:
Gillies D, Sinn JKh, Lad SS, Leach MJ, Ross MJ. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD007986. doi: 10.1002/14651858.CD007986.pub2. Review.
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Gillies et al., 2012
Gillies et al., 2012
Quote: "The sample was randomly selected based on random numbers table from the outpatient clinic of child psychiatry. Patients were given numbers using order of attendance in clinic, and those with desired numbers were included in study."
Quote: "The study population was randomly assigned into two groups."
Gillies et al., 2012
Gillies et al., 2012
This was a double-blind, randomized, clinical trial performed using a parallel method
Both types of capsules were supplied in identical amounts in solid plastic bottles. The bottles were numbered consecutively and coded by a person uninvolved in the study, and each participant received three bottles that contained all pills necessary for the study duration. Each ADHD clinic received half of the bottles, numbered consecutively. The children that agreed to participate in the study received their designated bottles in consecutive order
Gillies et al., 2012
Gillies et al., 2012
The subjects were randomly assigned to the PS and control group. Unclear how randomization was done
Gillies et al., 2012
Gillies et al., 2012
During the double-blind phase, participants were randomly assigned to the study groups according to a computerised randomization process based on random block size using a 2:1 ratio (PS-Omega3: placebo) and stratified by gender.
Children were independently allocated to one of the three treatment conditions using the process of randomization by minimization on the basis of age and gender
Patients were randomly divided into two groups using a random numbers table.
Quote: "The eligible chil- dren were randomly assigned in a 1:1 ratio to receive active treatment or placebo, which were labeled in code."
Judgement Comment: it is unclear how the allocation were made. Was it done by computer or a person?
Gillies et al., 2012
Selection of patients in all groups was done based on block randomization. Uncertain how the block randomisation was done
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
A computer-generated random sequence was used to allocate the participants either to the supplement or the placebo group. Participants, parents and those assessing outcome measures were blind to the intervention condition. Blinding was maintained until data analysis was completed.
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Gillies et al., 2012
Gillies et al., 2012
Judgement Comment: Allocation concealment not described
Gillies et al., 2012
Nothing mentioned
Gillies et al., 2012
Not described
Both types of capsules were supplied in identical amounts in solid plastic bottles. The bottles were numbered consecutively and coded by a person uninvolved in the study, and each participant received three bottles that contained all pills necessary for the study duration. Each ADHD clinic received half of the bottles, numbered consecutively. The children that agreed to participate in the study received their designated bottles in consecutive order
Gillies et al., 2012
Gillies et al., 2012
Nothing mentioned
Gillies et al., 2012
Gillies et al., 2012
not described
Nothing mentioned
For the study being double blinded, patients were divided into placebo and PUFA groups randomly by the author and were referred to via a code to the person in charge of drug distribution.
Quote: "The true identity of the codes was revealed in the presence of authorized persons independent of the study, after all data were collected, verified, and analyzed."
Judgement Comment: masked to group allocation, allocation were done by a third person
Gillies et al., 2012
Nothing mentioned
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Blinding was maintained until data analysis was completed.
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Gillies et al., 2012
Gillies et al., 2012
Quote: "Patients and investigator were blind about the study groups (treatment or placebo)."
Gillies et al., 2012
Investigators, parents and participants were all blind to the treatment conditions
Gillies et al., 2012
Described as double-blinded, yet nothing further mentioned
All study participants, parents, teachers, and study personnel were blinded to the allocation until completion of all data collection
Gillies et al., 2012
Gillies et al., 2012
The parents were informed that the purpose of the study was to investigate the effects of a dietary supplement that might have beneficial effects on ADHD symptoms and cognition in a placebo-controlled manner. The pur- pose of the study was not shared with the children. Unclear if the personnel was blinded.
Gillies et al., 2012
Gillies et al., 2012
double-blind. Yet, nothing written about capsules being equal.
Study investigators involved in the recruitment and data collection, and parents and children were blinded to randomization until completion of data collection and analysis
During the study, the prescriber and patient rater were not aware of the type of prescribed medicine and they were different. For the study being double blinded, patients were divided into placebo and PUFA groups randomly by the author and were referred to via a code to the person in charge of drug distribution. In addition, methylphenidate and PUFA were taken to the patients in pre-prepared envelopes based on code 1 and 2. Considering the special PUFA form that is typically in capsules, its placebo was prepared and was taken to the other group to prevent drug takers from noticing the patient rater of their used drugs.
Quote: "The researchers and the patients were masked to group allocation, carried out by an indepen- dent third person. The"
Judgement Comment: Participants were blinded, as both groups recieved capsules - that it the risk of Bias for the participants are low. We also assume that the personnel is blinded
Gillies et al., 2012
Nothing mentioned
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Participants, parents and those assessing outcome measures were blind to the intervention condition.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Gillies et al., 2012
Gillies et al., 2012
Quote: "Patients and investigator were blind about the study groups (treatment or placebo). Dose"
Judgement Comment: As the parents were blinded about the study groups- we assume that the outcome assessors were blinded.
Gillies et al., 2012
Investigators, parents and participants were all blind to the treatment conditions
Gillies et al., 2012
Outcome is patient reported
All study participant, parents and teachers, and study personnel were blinded to the allocation until completion of all data collectiom
Gillies et al., 2012
Gillies et al., 2012
Unclear if the interviewer, who performed the interview with the parents was blinded
Gillies et al., 2012
Gillies et al., 2012
Not described but outcome probably not affected (blood tests and patient reported)
only patient (parent) reported outcome
During the study, the prescriber and patient rater were not aware of the type of prescribed medicine and they were different.
Quote: "The outcome of intervention was assessed by using an 11-item checklist, written in local language, which was self-administered by the parents. The"
Judgement Comment: Parrent answered the questionnaires, but as they were blinded for the intervention, the RoB is considered low
Gillies et al., 2012
Nothing mentioned
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
A computer-generated random sequence was used to allocate the participants either to the supplement or the placebo group. Participants, parents and those assessing outcome measures were blind to the intervention condition. Blinding was maintained until data analysis was completed
Attrition bias due to amount, nature or handling of incomplete outcome data
Gillies et al., 2012
Gillies et al., 2012
Quote: "our drop-out rate was zero during the follow-up."
Judgement Comment: No flow-chart presented.
Gillies et al., 2012
Gillies et al., 2012
It is mentioned that the study duration was longer than expected due to dropout rate. Nothing further was specified.
After 8 weeks, only 17 participants remained in the study, and underwent the post-supplementation assessment: nine in placebo group (six males, three females, mean age 10.9 ± 2.3 years) and eight in the oil group. Very large dropout and no ITT
Gillies et al., 2012
Gillies et al., 2012
One subject dropped out because of the subject’s refusal to comply with the daily supplementation. Seven- teen of the 20 children in the placebo group completed the study. Three children were withdrawn from the study by their parents without giving a specific reason. The drop- outs did not differ significantly from the completers in terms of age, severity of symptoms or symptom subgroups.
Gillies et al., 2012
Gillies et al., 2012
Dropouts were similarly distributed over the two groups (20% and 17.5%, respectively), and reasons for discontinuation were generally similar across the treatment groups
37% children discontinued the intervention over the 12 months. 56 for children receiving EPA, 54 for DHA and 57 after LA. Article referring to figure 1, which is not included in the article
There are no reports of dropouts. The total n for each group is missing
Quote: "From a total of 98 children recruited to the study, 1 from the active treatment group and 2 from the placebo group were dis- continued for refusal to take the supplement. One child from the placebo group dropped out of the study. All 4 left before the first outcome measure was made at 3 months. The total number who completed the study was 94 (48 and 46 receiving"
Gillies et al., 2012
Nothing reported on dropout or adverse events
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Thirteen (12%) children did not return to the follow-up assess- ment. In two cases the families were lost to follow-up. Eleven discontinued the intervention. Of those: five children had pro- blems swallowing the provided capsules. In 4 cases symptom severity required stimulant medication. Two families were unable to cope with the study protocol.
Reporting bias due to selective outcome reporting
Gillies et al., 2012
Gillies et al., 2012
Judgement Comment: Registrated with the number IRCT13880312200N1. Match to protocol
Gillies et al., 2012
In complicance with Clinical trial registered protocol
Gillies et al., 2012
The article refers to both the parents and teacher scoring the child after end treatment. It is not specified who scored the data provided in the article. Furthermore, it is not specified which sub-scale of the conners scale was used. In the protocol, they refer to conner patient rating scale.
all outcomes described are meassured
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
The primary outcome mentioned in the protocol includes behavioral and attention assessment. There is nothing mentioned on the behavioral outcome in the article. From the protocol: Primary measures of attention and behavior will be evaluated using Conners Rating Scale (CRS) teacher- rating scales. As a secondary endpoint, the attention and behavior will be measured by CRS and strength and difficulties questionnaires (SDQ) parental- and SDQ teacher-rating scales, assessment a continuous performance test (TOVA), and parental Child Health questionnaire (CHQ).
Outcomes unclearly reported
There is an ethics protocol aproved - difficult to asses but results could be more clearly reported. Unclear if SE or SD's are used
Judgement Comment: time to assess primary outcome: At 1 month, 3 months and 6 month after commencement of treatment - see trial registration: http://slctr.lk/trials/73
Gillies et al., 2012
Nothing mentioned
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Bias due to problems not covered elsewhere in the table
Gillies et al., 2012
Gillies et al., 2012
Judgement Comment: No other apparent sources of bias.
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Quote: "Small sample sizes as well as the relatively short period of intervention are also limitations."
Quote: "The study did not use a standardized schedule and relied on relatively subjective information from parents, although this information was clinically verified."
Gillies et al., 2012
The following is missing: Flow of participants, attrition data, adverse events.
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012
Gillies et al., 2012