Parent-reported social problems and clinician-evaluated adverse effects may be differentially affected by differing extended release methylphenidate formulations: a prospective, naturalistic study from Turkey

Figures & data

Table 1. Demographic characteristics for the both groups.

Group	OROS-MPH group mean ± SD/median (IR)	MPH-ER group mean ± SD/median (IR)	Group differences
Mean of age	8 (3)	7(1)	p = 0.003*
Gender [n (%)]
Female	7 (20%)	9 (74.3%)	p = 0.56
Male	28 (80%)	26 (25.7%)
Mean of mother’s age	35 (10)	32(10)	p = 0.32
Mother’s educational status [n (%)]
Primary School	14 (40%)	10 (28.6%)	p = 0.63
Secondary school	7 (20%)	12 (34.3%)
High school	11 (31.4%)	9 (25.7%)
University	3 (8.6%)	4 (11.4%)
Mother’s profession
House wife	32 (91.4%)	29 (82.9%)	p = 0.42
Public servant	2 (5.8%)	4 (11.5%)
Worker	–	1 (2.9%)
Self-employed	1 (2.9%)	1 (2.9%)
Median of Father’s age	39 (10)	36 (8)	p = 0.21
Father’s educational status
Primary school	10 (28.6%)	11 (31.4%)	p = 0.46
Secondary school	10 (28.6%)	11 (31.4%)
High school	10 (28.6%)	11 (31.4%)
University	5 (14.3%)	2 (5.7%)
Father’s profession
Worker	13 (37.1%)	15 (42.9%)	p = 0.67
Public servant	6 (17.2%)	5 (14.4%)
Self-employed	6 (17.1%)	9 (25.7%)
No employment	3 (8.6%)	1 (2.9%)
Other	7 (20%)	5 (14.3%)
ADHD subtype
Combined type	33 (94.3%)	30 (85.7%)	p = 0.23
Inattentive sub-type	2 (5.7%)	5 (14.3%)
Hyperactive/ impulsive sub-type;	–	–
Mean of weight (kg)	32.8 ± 9.82	23.97 ± 4.21	p < 0.001*
Mean of drug daily dosage (mg)	32.4 ± 9.81	20 ± 5.94	p < 0.001*
Drug dosage/weight (mg/kg)	1.00 ± 0.21	0.84 ± 0.23	p = 0.005*
Weight loss
Yes	15 (42.9%)	8 (22.9%)	p = 0.07
No	20 (57.1%)	27 (77.1%)

Note: SD: Standard deviation; IR: Interquartile range.

Table 2. Differences in WFIRS-P scores between baseline and post-treatment for the both groups.

WFIRS-P		OROS-MPH group Mean ± SD			MPH-ER group Mean ± SD
		Baseline	Post treatment	P value	Baseline	Post treatment	P value
Family domain		12.08 ± 6.95	4.28 ± 3.07	p < 0.001*	12.05 ± 7.80	4.82 ± 3.65	p < 0.001*
School	Learning	7.88 ± 3.7	2.25 ± 1.94	p < 0.001*	8.48 ± 3.22	1.85 ± 2.43	p < 0.001*
	Behaviour	4.68 ± 3.94	0.97 ± 1.27	p < 0.001*	6.14 ± 4.78	1.71 ± 2.53	p < 0.001*
	Total	12.57 ± 6.43	3.22 ± 2.53	p < 0.001*	14.06 ± 5.95	3.57 ± 4.01	p < 0.001*
Life skills domain		9.8 ± 5.36	5.74 ± 3.45	p < 0.001*	10.68 ± 6.75	6.62 ± 3.54	p < 0.001*
Self-Concept		1.25 ± 1.31	7.8 ± 5.27	p < 0.001*	3.17 ± 2.47	1.08 ± 1.54	p < 0.001*
Social		6.20 ± 4.84	2.82 ± 2.78	p < 0.001*	8.22 ± 5.65	2.14 ± 2.13	p < 0.001*
Risk		2.2 ± 2.09	0.88 ± 1.23	p < 0.001*	3.25 ± 3.48	0.91 ± 0.98	p < 0.001*
Number of scoring 2 and 3 item		13.68 ± 8.26	2.42 ± 2.61	p < 0.001*	16.08 ± 9.44	2.74 ± 2.90	p < 0.001*
Total Score		46.05 ± 19.5	18.22 ± 10.4	p < 0.001*	52.02 ± 23.6	19.17 ± 10.32	p < 0.001*

Table 3. Reducing of mean ratings by parents for Each of WFIRS-P domains and differences between groups.

WFIRS-P		OROS-MPH group Mean ± SD	MPH-ER group Mean ± SD	ANCOVA p-value
				Without drug dosage	With drug dosage
					For drug dosage	For group
Family domain		7.8 ± 5.27	7.22 ± 6.88	p = 0.69	p = 0.94	p = 0.69
School	Learning	5.62 ± 3.2	6.62 ± 3.32	p = 0.2	p = 0.42	p = 0.14
	Behaviour	3.71 ± 3.32	4.42 ± 4.76	p = 0.47	p = 0.002*	p = 0.07
	Total	9.34 ± 5.72	11.05 ± 5.87	p = 0.22	p = 0.009*	p = 0.03*
Life skills domain		4.05 ± 3.94	4.05 ± 5.43	p = 1	p = 0.68	p = 0.22
Self-Concept		1.94 ± 2.38	2.08 ± 1.86	p = 0.78	p = 0.96	p = 0.8
Social		3.37 ± 3.54	6.08 ± 5.57	p = 0.01*	p = 0.02*	p = 0.003*
Risk		1.31 ± 1.84	2.34 ± 3.12	p = 0.09	p = 0.45	p = 0.07
Number of scoring 2 and 3 item		11.25 ± 7.25	13.34 ± 9.15	p = 0.29	p = 0.09	p = 0.11
Total Score		27.82 ± 13.6	32.8 ± 21.25	p = 0.24	p = 0.08	p = 0.07

*Reducing of mean rating for these domains in the MPH-ER group higher than the OROS-MPH group.

Table 4. Percentage of subjects displaying each of the 17 side effects during each treatment option.

Side Effect	Total side effect			Severe side effect (%)*
	(%)OROS-MPH	(%)ER-MPH	p-Value	(%)OROS-MPH	(%)ER-MPH	p-Value
Insomnia	54.3	31.4	0.05**	14.3	2.9	0.08
Decreased appetite	80	82.9	0.75	25.8	37.1	0.3
Irritable	34.3	31.4	0.79	0	0	–
Prone to crying	22.9	31.4	0.42	0	11.4	0.11
Anxious	25.7	20	0.56	0	2.9	0.5
Sadness	37.1	17.1	0.06	0	0	–
Headaches	25.7	31.4	0.59	0	0	–
Stomach aches	8.6	20	0.17	0	0	–
Nightmares	11.4	8.6	0.69	0	0	–
Stares a lot	17.1	17.1	1	0	0	–
Talks less	28.6	22.9	0.58	0	0	–
Uninterested	22.9	17.1	0.55	0	0	–
Drowsiness	11.4	14.3	0.72	0	0	–
Bites fingernails	14.3	8.6	0.45	0	0	–
Euphoria	25.7	5.7	0.02**	0	0	–
Dizziness	8.6	5.7	0.64	0	0	–
Tics	5.7	2.9	0.55	0	0	–

*% refers to percentage of subjects in whom the side effect was rated 1 or higher on the scale of the severity (1–9); %severe refers to the percentage of subjects in whom the side effect was rated 7 or higher.

**Percentage of insomnia and euphoria in the OROS-MPH group higher than the ER-MPH group.

Table 5. Mean severity ratings by parents for each of 17 side effects for each drug condition.

Side Effect	OROS-MPH Mean ± SD	ER-MPH Mean ± SD	p-Value
Insomnia	2.14 ± 2.88	1.42 ± 2.36	0.26
Decreased appetite	4.31 ± 2.91	4.45 ± 2.86	0.83
Irritable	1 ± 1.68	0.85 ± 1.37	0.69
Prone to crying	0.77 ± 1.49	1.42 ± 2.42	0.17
Anxious	0.74 ± 1.35	0.6 ± 1.53	0.68
Sadness	0.82 ± 1.24	0.48 ± 1.17	0.24
Headaches	0.68 ± 0.8	1.32 ± 1.41	0.72
Stomach aches	0.31 ± 1.15	0.51 ± 1.26	0.49
Nightmares	0.17 ± 0.51	0.2 ± 0.67	0.84
Stares a lot	0.45 ± 1.12	0.37 ± 0.97	0.73
Talks less	0.71 ± 1.27	0.85 ± 1.73	0.69
Uninterested	0.71 ± 1.54	0.57 ± 1.39	0.68
Drowsiness	0.2 ± 0.63	0.4 ± 1.06	0.34
Bites fingernails	0.57 ± 1.63	0.28 ± 1.01	0.38
Euphoria	0.57 ± 1.06	0.14 ± 0.69	0.05*
Dizziness	0.22 ± 0.80	0.11 ± 0.47	0.47
Tics	0.22 ± 1.05	0.05 ± 0.33	0.36

*Euphoria scores significantly higher in the OROS-MPH group than the ER-MPH group.