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Efficacy and Tolerability of Sodium Picosulphate/Magnesium Citrate as a Bowel-cleansing Agent
search strategy used was ‘picosulphate or picosulfate or Picolax or Figure 1: Percentage of Patients with at Least Adequate
Picoprep’. Picoprep™ (Pharmatel) was included in this search since,
Bowel Cleansing with Sodium Picosulphate/Magnesium
Citrate Compared with Other Bowel-cleansing Agents
although it is not available in Europe, each dosing sachet contains the
Prior to Various Bowel Procedures
same amount of active ingredients as Picolax, namely sodium
picosulphate 10mg, magnesium oxide 3.5g and citric acid 12g.
100
Comparator
86.9
Magnesium and citrate/citric acid were not included in the search
SPMC
82.5
79.1
since these substances have many uses and physiological roles other 80
77.3
69.5
74.5
than in bowel cleansing. Abstracts of papers were reviewed and full
papers reviewed if necessary. Reference lists of identified studies and
60
review papers were examined for further studies that might be
eligible for inclusion in the review. The study inclusion criteria were:
40
Prospective efficacy studies (controlled or uncontrolled) in
Percentage of patients
20
bowel cleansing.
SPMC was used in accordance with the approved use of Picolax or
CitraFleet in the EU, namely to cleanse the bowel prior to X-ray
0
Colonoscopy Barium enema Bowel surgery
examination, endoscopy or surgery.
SPMC was used in at least one group of patients according to the Derived from data shown in Table 2.
recommended dose for Picolax and CitraFleet and according
to the recommended dose regimen: two sachets (less for children)
Table 3: Tolerability of Sodium Picosulphate/Magnesium
the day before the procedure along with a low-residue diet from
Citrate Compared with Other Bowel-cleansing Agents –
Results from Randomised, Observer- or Double-blind
that day. Studies in which patients had a low-residue diet for more
Clinical Studies Included in the Review
than one day before the examination were included, since there
appears to be no additional benefit of a low-residue diet lasting
Study Comparator SPMC Statistical Comparison
more than one day.
5
Active N N
The number of patients treated was reported and an intent-to-
Colonoscopy
treat analysis was undertaken. Dakkak et al.
1
Polyethylene glycol/ 30 29 Less vomiting with SPMC
The proportion of patients with at least adequate bowel sodium bicarbonate/ (p=0.044). NS different
cleansing for the whole colon was assessed or could be
sodium sulphate/ for taste, nausea,
calculated from the data.
sodium chloride/ abdominal pain, sleep
potassium chloride
a
disturbance, peri-anal
Studies in which SPMC was used in combination with other bowel
soreness
cleansing agent(s) were excluded.
Pinfield et al.
6,b
Bisacodyl plus sodium 31 32 Fewer gastrointestinal
phosphate enema adverse events with
SPMC (p<0.01)
Results
Clinical Effectiveness
Barium Enema
Hawkins et al.
5
Polyethylene glycol/ 47 96 Less nausea, abdominal
Fourteen studies involving 792 patients were included in the review.
sodium bicarbonate/ bloating and abdominal
Bowel procedures reported in these studies were colonoscopy (n=4),
sodium sulphate/ pain with SPMC (p<0.01
barium enema (n=6) and bowel surgery (n=4) (see Table 1). When all
sodium chloride/ in all cases). NS
studies are considered together, 82% of all patients were reported to potassium chloride
c
difference for vomiting,
have at least adequate bowel cleansing with SPMC. When separated headache, anal irritation
by indication, the proportion of patients with at least adequate bowel
McLeod et al.
10
Disodium phosphate 111 83 Less nausea, vomiting
cleansing with SPMC was 78, 82 and 83% for bowel surgery,
dodecahydrate/ and taste problems with
colonoscopy and barium enema, respectively.
sodium dihydrogen SPMC (p<0.001 in all
phosphate dihydrate
d
cases). NS difference for
Comparative Effectiveness
abdominal pain,
headache and sleep
Results from nine studies that compared SPMC with a variety of bowel-
disturbance
cleansing agents using a randomised observer- or double-blind design
Swarbrick Magnesium citrate 104 102 Less abdominal pain and
are shown in Table 2. From these nine comparative studies, at least
et al.
8
sleep interruptions with
adequate bowel cleansing with SPMC was achieved to a statistically
SPMC (p<0.01 for both).
significant greater degree than another bowel cleansing agent in three Nausea and taste were
studies (p<0.01 versus bisacodyl plus sodium phosphate enema in a NS different
paediatric population,
6
p<0.01 versus fluid diet, enema and rectal N = number; NS = not significant; SPMC = sodium picosulphate/magnesium citrate;
® ® ®
washout in an adult population,
7
p<0.001 versus magnesium citrate in
a. GoLytely ; b. Paediatric patients; c. Kleen-Prep ; d. Fleet Phospho-soda .
an adult population
8
), and to a statistically significant lesser degree than
GoLytely (based on polyethylene glycol) in one study (p=0.002 versus In other studies, the proportion of patients with at least adequate
SPMC).
1
In another study, the percentage of patients with at least bowel cleansing in those who received SPMC was not statistically
adequate bowel cleansing was numerically higher following SPMC significantly different to those who received X-prep
®
,
9
Fleet Phospho-
compared with Kleen-Prep (based on polyethylene glycol), but this was soda
®
,
10
oral sodium sulphate,
11
CP100 electrolyte solution
11
or oral
not statistically tested.
5
sodium phosphates.
12
EUROPEAN GASTROENTEROLOGY & HEPATOLOGY REVIEW 13
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