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Vitamin B in Low Back Pain: A Randomised, Double-Blind, Placebo-Controlled Study
Vitamin B in Low Back Pain: A Randomised, Double-Blind, Placebo-Controlled Study
Abstract. – Objectives: The objective of tical benefits of B-vitamins given in high dose,
this double-blind randomised, placebo-con- and in particular vitamin B12, in painful disor-
trolled study was to examine the efficacy and ders of spinal nerve roots in the absence of
safety intramuscular vitamin B12 (Tricortin 1000)
in the treatment of low back pain in patients with typical signs of a nutritional deficiency have al-
mechanical or irritative lumbago. ready been demonstrated. This compound, af-
Methods: 60 patients aged between 18 and 65 ter conversion into co-enzymatic forms such as
years with lumbago or sciatic neuritis of mechani- methylcobalamin, is involved in the synthesis
cal origin without need for surgical procedures of nucleic acid and protein, based on the trans-
were enrolled. Patients had to present with a methylation reaction, as well as the metabo-
proven medical history for back pain (lasting from
6 months to 5 years) and a pain intensity [as eval-
lism of phospholipids and catecholamines. The
uated with a Visual Analogic Scale (VAS)] equal or methyl group is used in the synthesis of me-
greater than 60 mm. Efficacy primary end-point thionine from homocysteine as well as the syn-
was evaluated by means of a visual analogic scale thesis of phosphatidylcholine, a phospholipid
(VAS) and a Disability Questionnaire (DQ). important in the cell membrane structure. Part
Consumption of paracetamol during the study pe- of phosphatidylcholine becomes choline and is
riod was the secondary efficacy end-point. used in the synthesis of acetylcholine, a no-
Results: Both treatment groups experienced a
sharp decrease in pain and disability. However, table neurotransmitter.
comparison between groups at the end of the Animal models demonstrated that B-vita-
treatment period showed a statistically signifi- mins yield antinociceptive and antiinflamma-
cant difference in favour of the active treatment tory properties in the rat tail pressure test1,
both for VAS and DQ (p < 0.0001 and p < 0.0002, and are able to significantly decrease the re-
respectively). Consumption of paracetamol sponses evoked in spinal dorsal horn nocicep-
proved significantly higher in the placebo group
than in the active treatment (p < 0.0001).
tive neurons in the cat2.
Conclusions: The efficacy and safety of par- From a clinical standpoint, several studies
enteral Vitamin B12 in alleviating low back pain have documented the positive influence of B-
and related disability and in decreasing the con- vitamins of painful symptoms due to degenera-
sumption of paracetamol was confirmed in pa- tive disorders of the lumbar spine, and have in-
tients with no signs of nutritional deficiency. dicated that less nonsteroidal antiinflammatory
Key Words: drugs (NSAIDs) are needed for pain relief
Vitamin B12, low back pain, paracetamol. when combined with B-vitamins3,4. Further in-
vestigations conformed the efficacy of Vitamin
B12 in the treatment of peripheral neuropathy5.
In the present investigation, we have studied
the efficacy and safety of intramuscular vita-
Introduction min B12 (Tricortin® 1000 ampoules)* for the
treatment of low back pain in patients with me-
chanical or irritative lumbago.
Vitamins of the B group are known for their
established therapeutical role in neurologic
diseases related to a deficiency of these essen- *Fidia S.p.A., Via Ponte della Fabbrica, 3a
tial nutritional factors. Besides that, therapeu- 35031 Abano Terme (PD) - Italy
53
G. Letizia Mauro, U. Martorana, P. Cataldo, G. Brancato, G. Letizia
54
Vitamin B12 in low back pain: a randomised, double-blind, placebo-controlled study
VAS
100
0 -T
15 -T
75
0-P
15 - P
mm
50
0
0 -T 0-P 15 -T 15 - P
Figure 1.
55
G. Letizia Mauro, U. Martorana, P. Cataldo, G. Brancato, G. Letizia
groups at the end of the treatment period Safety was excellent in both groups. No
showed a statistically significant difference in changes in vital signs, nor adverse effects
favour of the active treatment (p < 0.0001). were noted.
The analysis of the Disability Questionnaire
showed a similar pattern. Total scores declined
from 13.27 ± 2.7 to 2.43 ± 2.6 in the active
treatment group (p < 0.0001) and again paring Discussion
proved to be effective (p = 0.0131; Spearman’s
approximation rs = 0.4057), and from 11.53 ± The vertebral pain syndrome is one of the
2.2 to 5.80 ± 3.3 in the placebo group (p < main problem both general practitioners and
0.0001). Between-group comparison at the end orthopaedics are confronted with, being as
of the treatment period demonstrated a signif- frequent as in 11% of all men and 9.5% of all
icant difference (p < 0.0002) in favour of women in the USA. 63% of all lost working
Tricortin (Figure 2). days in people with a physically demanding
ANCOVA corroborated these findings. job are caused by back pain8.
Mean consumption of paracetamol proved In a study conducted in the state of
significantly higher in the placebo group than in Washington, 321 patients with low back pain
the active treatment group (28.9 ± 11.32 vs. 9.9 persisting for one week were randomized to
± 8.04 tablets/15 days; p < 0.0001) (Figure 3). receive one of three treatments: physical
Eight patients in the active treatment therapy, chiropractic manipulation, or provi-
group did not take a single paracetamol sion of an educational booklet9. Most subjects
tablet, vs. only 1 subject in the placebo group. had had back pain for less than 6 weeks.
There was no linear correlation between Outcomes at 4- and 52-week time points were
basal VAS values and number of paracetamol similar between the physical therapy and chi-
tables taken during the treatment period in ropractic groups, and both groups were only
both groups (r2 = 0.0053 and 0.0014, respec- marginally better than patients who received
tively). A significant correlation was found the educational booklet only. Patients ran-
between VAS and DQ scores (r2 = 0.852 and domized to the educational booklet were
r2 = 0.845, respectively; p < 0.0001) in both treated at lower cost and tended to be dissat-
groups. Figure 4 shows the linear regression isfied with their care, but there were no dif-
line for this correlation in the active treat- ferences between the groups in numbers of
ment group. days of reduced activity, missed work, or re-
DQ
20
0 -T
15 -T
0-P
Scores
15 - P
10
0
0 -T 0-P 15 -T 15 - P
Figure 2.
56
Vitamin B12 in low back pain: a randomised, double-blind, placebo-controlled study
Paracetamol consumption
50
Tricortin 1000
N° of paracet tablets 40 Placebo
30
〈
20 〈 p < 0.0001 vs. placebo
10
0
T P
Figure 3.
currences of back pain. The authors conclude indicating that this vitamin contribute to sav-
that the benefits of physical therapy or chiro- ing of NSAIDs by shortening the treatment
practic manipulations may not be worth the time and reducing daily NSAID dosage, have
costs. been reported3,4,8.
NSAIDs are the therapy of choice in non- The benefits of Vitamin B12 and its con-
surgical patients, but the side effects of these geners has also been demonstrated in meta-
drugs are well-known and may limit their use bolic polyneuropathies, such as alcoholic
in selected patients. polyneuropathy10, and uremic and diabetic
Various studies of the clinical effects of neuropathy in patients receiving maintenance
Vitamin B12 on painful vertebral syndromes, haemodialysis11.
14
12
r2 = 0.852
p < 0.0001
10
DQ (score)
4
slope 95% confidence
intervals = 0.1200 to 0.1660
2
0
0 10 20 30 40 50 60 70
VAS (mm)
Figure 4.
57
G. Letizia Mauro, U. Martorana, P. Cataldo, G. Brancato, G. Letizia
58