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A comparison of Fleet Phospho-soda with Picolax in the preparation of the colon for double contrast barium enema
Clinical Radiology (1998) 53, 612-614
A Comparison of Fleet Phospho-soda With Picolax in the Preparation of the Colon for Double Contrast Barium Enema A. J. M. MACLEOD, K. A. DUNCAN, R. H. PEARSON and R. R. BLEAKNEY
Academic Department of Radiology, Aberdeen Royal Infirmary, Aberdeen, UK This study was performed to compare the patient acceptability and the efficacy of two different agents for bowel preparation prior to double contrast barium enema. Onehundred and ninety-four outpatients were randomized to have either two sachets of Picolax or two bottles of Fleet Phospho-soda and restricted to clear fluids on the day prior to their examination. Patients answered a short questionnaire before their enema. The decubitus films were assessed for faecal residue and bowel coating by three observers blinded to the type of preparation used. There was no significant difference in faecal residue nor in the bowel coating between the preparations. However patients found Picolax significantly easier to take, being better tasting and provoking less nausea and vomiting than Fleet Phospho-soda. Macleod, A. J. M., Duncan, K. A., Pearson, R. H. & Bleakney, R. R. (1998). Clinical Radiology 53, 612-614. A Comparison of Fleet Phospho-soda With Picolax in the Preparation of the Colon for Double Contrast Barium Enema
Accepted for Publication 15 April 1998
Adequate colonic preparation is essential to obtain a high quality diagnostic double contrast barium enema (DCBE). There are a number of agents available to clean the colon. Picolax is a commonly used compound laxative containing sodium picosulphate, which has a contact laxative effect and magnesium citrate which is an osmotic purgative. Whilst this agent is generally well tolerated, there are reports of side-effects which include headaches, nausea and abdominal pain [1-4]. For this reason and the fact that there have been difficulties in obtaining Picolax due to supply problems, it was decided to compare the bowel cleansing and patient acceptance of Picolax with Fleet phospho-soda, which is a relatively recent arrival to the UK. The latter is an oral solution containing sodium dihydrogen phosphate and disodium phosphate. This acts as an osmotic purgative without the contact laxative effect present in Picolax. Several previous studies have compared Fleet Phospho-soda favourably with various whole-gut irrigation regimes prior to colonoscopy [5-7], and DCBE [8]. However, no previous study has compared the efficacy of Fleet Phospho-soda to that of Picolax prior to DCBE examination.
of water followed by a further 240 ml of water first thing in the morning and late in the afternoon on the day prior to their enema. They were also advised to take at least three glasses of clear fluid at midday. Prior to DCBE patients were asked to answer a simple questionnaire regarding the ease of taking the preparation, taste, the presence of any nausea, vomiting, headaches, abdominal pain, sleep disturbance or disturbance of daily activity. DCBE examinations were performed by various radiologists in the department using a standard barium preparation (Polibar ACB EZ-EM made up to a density of 100% w/v). The examinations were viewed by three observers (KD, RP, RB) who were unaware of the preparation used. The decubitus films were assessed for bowel coating and the presence of faecal residue. The degree of faecal residue was graded into four categories: none, minimal, right side only and throughout. Bowel coating was graded into: satisfactory, right side poor and all poor. The results were analysed using a statistical package (SPSS) for windows version 6.1.
RESULTS PATIENTS AND M E T H O D S One-hundred and ninety-four outpatients were randomized to have either Picolax or Fleet Phospho-soda for bowel preparation prior to DCBE. The patients given Picolax had one sachet in the morning, a further sachet in the afternoon on the day prior to the examination, and were restricted to clear fluids for the 24 h prior to their enema. The patients taking Fleet Phospho-soda were also restricted to clear fluids for 24 h prior to their enema. In addition they took a 45 ml bottle of Fleet Phospho-soda diluted in 120 ml Correspondence to: Dr A. J. M. Macleod, Academic Department of Radiology, Aberdeen Royal Infirmary, Foresterhill, Aberdeen AB25 2ZN, UK. 9 1998 The Royal College of Radiologists.
A total of 83 patients took Picolax and 111 took Fleet Phospho-soda. The age and sex distribution of the two groups is shown in Table l. The responses to the patient questionnaires were analysed using the xZ-test for trend
T a b l e 1 - S e x and age distribution o f test g r o u p s
Age:Mean (SD) Sex: Males Females
Picolax (n = 83)
Fleet (n = 111)
56.9 (16.6) 32 (39%) 51 (61%)
56.7 (14.9) 51 (46%) 60 (54%)
* Student's t-test; t xZ-test.
P>0.05* P>0.05t
613
FLEET PHOSPHO-SODA VS. PICOLAX Table 2 - Results of patient questionnaire
Acceptability
Easy to take
Tolerable
Difficult
66 38
15 44
2 24
Excellent
Good
Tolerable
Unacceptable
32 9
47 78
0 24
None
Mild
Moderate
Severe
60 46 81 86 46 54 55 59 25 29 38 57
19 43 1 10 25 42 l3 31 20 34 27 28
3 14 1 11 10 13 11 12 27 37 16 19
1 8 0 4 2 2 4 9 11 l1 2 7
Picolax Fleet
Taste
Picolax Fleet
Nausea
4 0
Picolax Fleet Picolax Fleet Picolax Fleet Picolax Fleet Picolax Fleet Picolax Fleet
Vomiting Abdominal pain Headache Daily activity disturbance Sleep disturbance
Unable to finish
X2-test for trend
0 5
P <0.001
P <0.001
P <0.001 P <0.001 NS* NS* NS* NS*
*NS, not significant (P >0.05).
Table 3 - Results of grading for faecal residue
Observer 1
Picolax Fleet Picolax Fleet Picolax Fleet
2 3
None
Minimal
Right side only
Throughout
Significance*
49 70 44 55 47 59
20 17 26 31 27 33
13 21 13 19 8 15
1 3 0 6 1 4
NS NS NS
* NS, not significant (P > 0.05) (x2-test for trend).
Table 4 - Results of grading for bowel coating
Observer
1 2 3
Satisfactory
Picolax 71 Fleet 101 Picolax 78 Fleet 98 Picolax 65 Fleet 97
Table 5 - Interobserver agreement using weighted kappa analysis
Right side poor
All poor
Significance*
Observers
Faecal residue K-value
Bowel coating K-value
12 10 5 13 17 14
0 0 0 0 1 0
NS
1 and 2 1 and 3 2 and 3
0.47 0.53 0.5
0.61 0.74 0.5
NS NS
* NS, not significant (P > 0.05) (x2-test for trend).
(Table 2). Picolax was found to be significantly easier to take and better tasting than Fleet Phospho-soda. In addition Picolax caused significantly less nausea and vomiting. There was no significant difference in the frequencies of the symptoms of abdominal pain, headache, daily activity and sleep disturbance. The results of grading for faecal residue (Table 3) and bowel coating (Table 4) show no significant difference between the preparations detected by any observer. The inter-observer variation for the grading of both faecal residue and bowel coating was calculated using weighted 9 1998 The Royal College of Radiologists, Clinical Radiology, 53, 612 614.
kappa analysis. This demonstrates that inter-observer agreement varies between moderate and good (Table 5).
DISCUSSION In order to diagnose colonic pathology it is essential that double contrast barium enemas are of high quality. This necessitates adequate bowel preparation which can result in some patient discomfort. A balance has to be struck between adequate preparation and discomfort caused to patients. Previous studies have shown both the effectiveness of Picolax in bowel preparation and also its relative lack of side-effects. Fleet Phospho-soda, which acts as a saline cathartic without the contact laxative properties of Picolax
614
CLINICALRADIOLOGY
might be expected to result in similar or possibly fewer sideeffects than Picolax. However the osmotic effect of Fleet phospho-soda is due to sodium rather than the magnesium salts found in Picolax. The former therefore has more contraindications, due to possible electrolyte imbalance and is not recommended in patients with cardiac or renal failure. There was no significant difference in disruption of sleep or daily activities, and abdominal pain or headache between the two preparations. However Picolax caused significantly less nausea and vomiting. As laxative preparations for DCBE are normally multidose it is important that patients find the first dose acceptable in taste and easy to take, otherwise subsequent doses may be missed, resulting in inadequate preparation. In this study patients found Picolax significantly easier to take and better tasting. As a result of these significant differences between the preparations and the finding of similar bowel cleansing properties, in our department we will continue to use Picolax, when available, in the outpatient preparation for DCBE examinations. Acknowledgements. The authors would like to thank Mr Neil Scott for his help and advice in the statistical analysis of the data.
REFERENCES 1 Lai AKH, Kwok PCH, Man SW, Lau SF, Chan SCH. A blinded chnical trial comparing conventional cleansing enema, Pico-salax and Golytely for barium enema bowel preparation. Clinical Radiology 1996;51:566-569. 2 Lawrence JAL, Massoud TF, Creasy TS, Shatwell W, Mason A, Nolan DJ. Colonic preparation with Picolax: patient tolerance and approaches to fluid replacement. Clinical Radiology 1994;49"35-37. 3 Swarbrick MJ, Colling MC, Moore DJ, Mcbride KD. A comparative trial of magnesium citrate (Citramag) and Picolax for barium enema bowel preparation. Clinical Radiology 1994;49:379-381. 4 Hughes K, Mann S, Cooke MBD, James WB. A new oral bowel evacuant (Picolax) for colon cleansing. Clinical Radiology 1983;34:75-77. 5 Vanner S J, Macdonald PH, Paterson WG, Prentice RSA, Da Costa LR, Beck IT. A randomized prospective trial comparing oral sodium phosphate with standard polyethylene glycol-based lavage solution (Golytely) in the preparation of patients for colonoscopy. American Journal of Gastroenterology 1990;85:422-427. 6 Marshall JB, Pineda JJ, Barthel JS, King PD. Prospective randomized trial comparing sodium phosphate solution with polyethylene glycolelectrolyte lavage for colonoscopy preparation. Gastrointestinal Endoscopy 1993;39:631-634. 7 Marshall JB, Barthel JS, King PD. Short report: prospective, randomized trial comparing a single dose sodium phosphate regimen with PEGelectrolyte lavage for colonoscopy preparation. Alimentary Pharmacology Therapy 1993;7:679-682. 8 O'Donovan AN, Somers S, Farrow R, Mernagh J, Rawlinson J, Stevenson GW. A prospective blinded randomized trial comparing oral sodium phosphate and polyethylene glycol solutions for bowel preparation prior to barium enema. Clinical Radiology 1997;52:791-793.
9 1998 The Royal College of Radiologists, ClinicalRadiology, 53, 612-614.
A Comparison of Fleet Phospho-soda With Picolax in the Preparation of the Colon for Double Contrast Barium Enema A. J. M. MACLEOD, K. A. DUNCAN, R. H. PEARSON and R. R. BLEAKNEY
Academic Department of Radiology, Aberdeen Royal Infirmary, Aberdeen, UK This study was performed to compare the patient acceptability and the efficacy of two different agents for bowel preparation prior to double contrast barium enema. Onehundred and ninety-four outpatients were randomized to have either two sachets of Picolax or two bottles of Fleet Phospho-soda and restricted to clear fluids on the day prior to their examination. Patients answered a short questionnaire before their enema. The decubitus films were assessed for faecal residue and bowel coating by three observers blinded to the type of preparation used. There was no significant difference in faecal residue nor in the bowel coating between the preparations. However patients found Picolax significantly easier to take, being better tasting and provoking less nausea and vomiting than Fleet Phospho-soda. Macleod, A. J. M., Duncan, K. A., Pearson, R. H. & Bleakney, R. R. (1998). Clinical Radiology 53, 612-614. A Comparison of Fleet Phospho-soda With Picolax in the Preparation of the Colon for Double Contrast Barium Enema
Accepted for Publication 15 April 1998
Adequate colonic preparation is essential to obtain a high quality diagnostic double contrast barium enema (DCBE). There are a number of agents available to clean the colon. Picolax is a commonly used compound laxative containing sodium picosulphate, which has a contact laxative effect and magnesium citrate which is an osmotic purgative. Whilst this agent is generally well tolerated, there are reports of side-effects which include headaches, nausea and abdominal pain [1-4]. For this reason and the fact that there have been difficulties in obtaining Picolax due to supply problems, it was decided to compare the bowel cleansing and patient acceptance of Picolax with Fleet phospho-soda, which is a relatively recent arrival to the UK. The latter is an oral solution containing sodium dihydrogen phosphate and disodium phosphate. This acts as an osmotic purgative without the contact laxative effect present in Picolax. Several previous studies have compared Fleet Phospho-soda favourably with various whole-gut irrigation regimes prior to colonoscopy [5-7], and DCBE [8]. However, no previous study has compared the efficacy of Fleet Phospho-soda to that of Picolax prior to DCBE examination.
of water followed by a further 240 ml of water first thing in the morning and late in the afternoon on the day prior to their enema. They were also advised to take at least three glasses of clear fluid at midday. Prior to DCBE patients were asked to answer a simple questionnaire regarding the ease of taking the preparation, taste, the presence of any nausea, vomiting, headaches, abdominal pain, sleep disturbance or disturbance of daily activity. DCBE examinations were performed by various radiologists in the department using a standard barium preparation (Polibar ACB EZ-EM made up to a density of 100% w/v). The examinations were viewed by three observers (KD, RP, RB) who were unaware of the preparation used. The decubitus films were assessed for bowel coating and the presence of faecal residue. The degree of faecal residue was graded into four categories: none, minimal, right side only and throughout. Bowel coating was graded into: satisfactory, right side poor and all poor. The results were analysed using a statistical package (SPSS) for windows version 6.1.
RESULTS PATIENTS AND M E T H O D S One-hundred and ninety-four outpatients were randomized to have either Picolax or Fleet Phospho-soda for bowel preparation prior to DCBE. The patients given Picolax had one sachet in the morning, a further sachet in the afternoon on the day prior to the examination, and were restricted to clear fluids for the 24 h prior to their enema. The patients taking Fleet Phospho-soda were also restricted to clear fluids for 24 h prior to their enema. In addition they took a 45 ml bottle of Fleet Phospho-soda diluted in 120 ml Correspondence to: Dr A. J. M. Macleod, Academic Department of Radiology, Aberdeen Royal Infirmary, Foresterhill, Aberdeen AB25 2ZN, UK. 9 1998 The Royal College of Radiologists.
A total of 83 patients took Picolax and 111 took Fleet Phospho-soda. The age and sex distribution of the two groups is shown in Table l. The responses to the patient questionnaires were analysed using the xZ-test for trend
T a b l e 1 - S e x and age distribution o f test g r o u p s
Age:Mean (SD) Sex: Males Females
Picolax (n = 83)
Fleet (n = 111)
56.9 (16.6) 32 (39%) 51 (61%)
56.7 (14.9) 51 (46%) 60 (54%)
* Student's t-test; t xZ-test.
P>0.05* P>0.05t
613
FLEET PHOSPHO-SODA VS. PICOLAX Table 2 - Results of patient questionnaire
Acceptability
Easy to take
Tolerable
Difficult
66 38
15 44
2 24
Excellent
Good
Tolerable
Unacceptable
32 9
47 78
0 24
None
Mild
Moderate
Severe
60 46 81 86 46 54 55 59 25 29 38 57
19 43 1 10 25 42 l3 31 20 34 27 28
3 14 1 11 10 13 11 12 27 37 16 19
1 8 0 4 2 2 4 9 11 l1 2 7
Picolax Fleet
Taste
Picolax Fleet
Nausea
4 0
Picolax Fleet Picolax Fleet Picolax Fleet Picolax Fleet Picolax Fleet Picolax Fleet
Vomiting Abdominal pain Headache Daily activity disturbance Sleep disturbance
Unable to finish
X2-test for trend
0 5
P <0.001
P <0.001
P <0.001 P <0.001 NS* NS* NS* NS*
*NS, not significant (P >0.05).
Table 3 - Results of grading for faecal residue
Observer 1
Picolax Fleet Picolax Fleet Picolax Fleet
2 3
None
Minimal
Right side only
Throughout
Significance*
49 70 44 55 47 59
20 17 26 31 27 33
13 21 13 19 8 15
1 3 0 6 1 4
NS NS NS
* NS, not significant (P > 0.05) (x2-test for trend).
Table 4 - Results of grading for bowel coating
Observer
1 2 3
Satisfactory
Picolax 71 Fleet 101 Picolax 78 Fleet 98 Picolax 65 Fleet 97
Table 5 - Interobserver agreement using weighted kappa analysis
Right side poor
All poor
Significance*
Observers
Faecal residue K-value
Bowel coating K-value
12 10 5 13 17 14
0 0 0 0 1 0
NS
1 and 2 1 and 3 2 and 3
0.47 0.53 0.5
0.61 0.74 0.5
NS NS
* NS, not significant (P > 0.05) (x2-test for trend).
(Table 2). Picolax was found to be significantly easier to take and better tasting than Fleet Phospho-soda. In addition Picolax caused significantly less nausea and vomiting. There was no significant difference in the frequencies of the symptoms of abdominal pain, headache, daily activity and sleep disturbance. The results of grading for faecal residue (Table 3) and bowel coating (Table 4) show no significant difference between the preparations detected by any observer. The inter-observer variation for the grading of both faecal residue and bowel coating was calculated using weighted 9 1998 The Royal College of Radiologists, Clinical Radiology, 53, 612 614.
kappa analysis. This demonstrates that inter-observer agreement varies between moderate and good (Table 5).
DISCUSSION In order to diagnose colonic pathology it is essential that double contrast barium enemas are of high quality. This necessitates adequate bowel preparation which can result in some patient discomfort. A balance has to be struck between adequate preparation and discomfort caused to patients. Previous studies have shown both the effectiveness of Picolax in bowel preparation and also its relative lack of side-effects. Fleet Phospho-soda, which acts as a saline cathartic without the contact laxative properties of Picolax
614
CLINICALRADIOLOGY
might be expected to result in similar or possibly fewer sideeffects than Picolax. However the osmotic effect of Fleet phospho-soda is due to sodium rather than the magnesium salts found in Picolax. The former therefore has more contraindications, due to possible electrolyte imbalance and is not recommended in patients with cardiac or renal failure. There was no significant difference in disruption of sleep or daily activities, and abdominal pain or headache between the two preparations. However Picolax caused significantly less nausea and vomiting. As laxative preparations for DCBE are normally multidose it is important that patients find the first dose acceptable in taste and easy to take, otherwise subsequent doses may be missed, resulting in inadequate preparation. In this study patients found Picolax significantly easier to take and better tasting. As a result of these significant differences between the preparations and the finding of similar bowel cleansing properties, in our department we will continue to use Picolax, when available, in the outpatient preparation for DCBE examinations. Acknowledgements. The authors would like to thank Mr Neil Scott for his help and advice in the statistical analysis of the data.
REFERENCES 1 Lai AKH, Kwok PCH, Man SW, Lau SF, Chan SCH. A blinded chnical trial comparing conventional cleansing enema, Pico-salax and Golytely for barium enema bowel preparation. Clinical Radiology 1996;51:566-569. 2 Lawrence JAL, Massoud TF, Creasy TS, Shatwell W, Mason A, Nolan DJ. Colonic preparation with Picolax: patient tolerance and approaches to fluid replacement. Clinical Radiology 1994;49"35-37. 3 Swarbrick MJ, Colling MC, Moore DJ, Mcbride KD. A comparative trial of magnesium citrate (Citramag) and Picolax for barium enema bowel preparation. Clinical Radiology 1994;49:379-381. 4 Hughes K, Mann S, Cooke MBD, James WB. A new oral bowel evacuant (Picolax) for colon cleansing. Clinical Radiology 1983;34:75-77. 5 Vanner S J, Macdonald PH, Paterson WG, Prentice RSA, Da Costa LR, Beck IT. A randomized prospective trial comparing oral sodium phosphate with standard polyethylene glycol-based lavage solution (Golytely) in the preparation of patients for colonoscopy. American Journal of Gastroenterology 1990;85:422-427. 6 Marshall JB, Pineda JJ, Barthel JS, King PD. Prospective randomized trial comparing sodium phosphate solution with polyethylene glycolelectrolyte lavage for colonoscopy preparation. Gastrointestinal Endoscopy 1993;39:631-634. 7 Marshall JB, Barthel JS, King PD. Short report: prospective, randomized trial comparing a single dose sodium phosphate regimen with PEGelectrolyte lavage for colonoscopy preparation. Alimentary Pharmacology Therapy 1993;7:679-682. 8 O'Donovan AN, Somers S, Farrow R, Mernagh J, Rawlinson J, Stevenson GW. A prospective blinded randomized trial comparing oral sodium phosphate and polyethylene glycol solutions for bowel preparation prior to barium enema. Clinical Radiology 1997;52:791-793.
9 1998 The Royal College of Radiologists, ClinicalRadiology, 53, 612-614.