Nutritional management of patients with diabetic peripheral neuropathy with L-methylfolate-methylcobalamin-pyridoxal-5-phosphate: results of a real-world patient experience trial

Figures & data

Table 1. Baseline patient characteristics (N = 544).

Gender, n (%)
Female	270 (49.6)
Male	252 (46.3)
Unknown	22 (4.1)
Mean (SD) age, years	65.5 (10.9)
Age range, n (%)
31–44 years	22 (4.0)
45–54 years	66 (12.1)
55–64 years	146 (26.8)
65–74 years	205 (37.7)
75+ years	105 (19.3)
Time since diabetes diagnosis, n (%)
Just diagnosed	41 (7.5)
Within the past year	52 (9.6)
1–5 years ago	121 (22.2)
6–10 years ago	118 (21.7)
More than 10 years ago	160 (29.4)
Unsure	52 (9.6)
Duration of DPN Symptoms, n (%)
<1 year	125 (23.0)
1–3 years	184 (33.8)
>3 years	188 (34.6)
Unsure	47 (8.6)
Prior prescription for DPN symptoms, n (%)	140 (25.7)
Mean (SD) Neuropathy Total Symptom Score-6 (NTSS-6)	4.3 (1.5)
Mean (SD) NTSS Item Scores
1	20 (3.7)
2	54 (9.9)
3	82 (15.1)
4	108 (19.9)
5	126 (23.2)
6	154 (28.3)

Table 2. Medication behavior (N = 544).

Characteristic	Number (%) of Patients
LMF-MC-PP monotherapy	350 (64.3)
Concomitant DPN medications with LMF-MC-PP*	194 (35.7)
Duloxetine	19 (3.5)
Gabapentin	81 (14.9)
Pregabalin	55 (10.1)
Other	47 (8.6)
LMF-MC-PP compliance
Took every dose or nearly every dose as directed	469 (86.2)
Took nearly every dose	52 (9.6)
Took most doses	11 (2.0)
Took half or less than half of doses	12 (2.2)

*Patients may have taken more than one concomitant drug.

Figure 1. Change in NTSS-6 score.

Figure 2. Change in individual NTSS-6 items.

Figure 3. Pain severity, before and after LMF-MC-PP.

Figure 4. Level of disruption in normal activities, before and after LMF-MC-PP.

Table 3. Change by baseline age, gender, time since diagnosis, and duration of DPN symptoms.

	Mean (standard error) change from baseline
Subgroups	NTSS-6	Pain severity	Disruption to work/social activities	Disruption to social life	Disruption to family life
Age
31–44 years	−1.4 (0.4)	−1.5 (0.5)	−1.4 (0.8)	−1.5 (0.7)	−1.5 (0.6)
45–54 years	−1.8 (0.3)	−2.6 (0.3)	−2.2 (0.4)	−2.3 (0.4)	−2.0 (0.4)
55–64 years	−1.3 (0.2)	−1.8 (0.2)	−1.8 (0.2)	−1.7 (0.2)	−1.9 (0.2
65–74 years	−1.5 (0.1)	−1.6 (0.2)	−1.7 (0.2)	−1.8 (0.2)	−1.7 (0.2)
75+ years	−1.7 (0.2)	−1.9 (0.3)	−1.8 (0.3)	−1.3 (0.3)	−1.3 (0.3)
Gender
Female	−1.6 (0.1)	−2.0 (0.2)	−2.0 (0.2)	−1.8 (0.2)	−1.7 (0.2)
Male	−1.4 (0.1)	−1.7 (0.2)	−1.5 (0.2)	−1.7 (0.2)	−1.6 (0.2)
Time since diabetes diagnosis
Just diagnosed	−1.5 (0.2)	−1.3 (0.3)	−2.0 (0.3)	−1.9 (0.3)	−1.8 (0.3)
Within the past year	−1.3 (0.2)	−1.9 (0.2)	−1.9 (0.3)	−1.5 (0.3)	−1.4 (0.3)
1–5 years ago	−1.5 (0.2)	−2.1 (0.2)	−2.1 (0.3)	−1.8 (0.3)	−1.7 (0.3)
6–10 years ago	−1.6 (0.1)	−2.0 (0.2)	−1.6 (0.2)	−1.8 (0.2)	−1.8 (0.2)
>10 years ago	−1.4 (0.3)	−1.8 (0.3)	−1.2 (0.4)	−1.7 (0.4)	−1.6 (0.4)
Time since first DPN symptoms
<1 year	−1.6 (0.2)	−1.5 (0.3)	−1.5 (0.3)	−1.4 (0.3)	−1.4 (0.3)
1–3 years	−1.4 (0.1)	−2.1 (0.2)	−2.0 (0.2)	−1.9 (0.2)	−1.8 (0.2)
>3 years	−1.5 (0.1)	−1.9 (0.2)	−1.7 (0.2)	−1.9 (0.2)	−1.8 (0.2)