|Year : 2016 | Volume
| Issue : 3 | Page : 110-115
Evaluation of two injection sclerosants in the treatment of symptomatic haemorrhoids in Nigerians
Cathlyn Akindiose1, Olusegun Isaac Alatise2, Olukayode Adeolu Arowolo2, Augustine E Agbakwuru2
1 Department of Surgery, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Osun State, Nigeria
2 Department of Surgery, College of Health Sciences, Obafemi Awolowo University/Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Osun State, Nigeria
|Date of Web Publication||12-Sep-2016|
Olusegun Isaac Alatise
Department of Surgery, College of Health Sciences, Obafemi Awolowo University/Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Osun State
Source of Support: None, Conflict of Interest: None
Objectives: The objective of this study was to compare the efficacy and safety of 5% phenol in almond oil with 50% dextrose water as sclerosants in the treatment of first- to third-degree haemorrhoids.
Patients and Methods: This was a prospective, comparative study conducted on eighty patients with first-, second- and third-degree haemorrhoids who consented to treatment by injection sclerotherapy with either 5% phenol in almond oil or 50% dextrose water. They were randomised equally into two groups.
Results: A total of eighty patients including 58 males and 22 females whose age ranged from 19 to 61 years were included in the study. Bleeding was the chief symptom which was present in 78 (97.5%) patients, and there was complete resolution of this in 92.3% and 89.7% in the 5% phenol in almond oil and 50% dextrose water groups, respectively, at 6 months (P = 0.905). Similar degrees of resolution were noted for anal protrusion (89.1% and 85.3% in the 5% phenol in almond oil and 50% dextrose water group, respectively, P = 0.899). The overall complication rate was 3.6% with anal mucosa ulceration being the only complication, occurring in three patients who had 5% phenol in almond oil. Peri-procedure pain, patients satisfaction and acceptability were not significantly different in both groups (P = 0.912, 0.928 and 0.926 respectively).
Conclusion: Five percent phenol in almond oil and 50% dextrose water are equally effective sclerosants in the treatment of haemorrhoids with very low complication rates.
Keywords: 5% phenol in almond oil, 50% dextrose water, haemorrhoids, injection sclerotherapy
|How to cite this article:|
Akindiose C, Alatise OI, Arowolo OA, Agbakwuru AE. Evaluation of two injection sclerosants in the treatment of symptomatic haemorrhoids in Nigerians. Niger Postgrad Med J 2016;23:110-5
|How to cite this URL:|
Akindiose C, Alatise OI, Arowolo OA, Agbakwuru AE. Evaluation of two injection sclerosants in the treatment of symptomatic haemorrhoids in Nigerians. Niger Postgrad Med J [serial online] 2016 [cited 2019 Feb 17];23:110-5. Available from: http://www.npmj.org/text.asp?2016/23/3/110/190347
| Introduction|| |
Haemorrhoids are very common anorectal conditions, defined as the symptomatic enlargement and distal displacement of the normal anal cushions. They affect millions of people around the world and represent a major medical and socioeconomic problem., Before the 1800s, haemorrhoids were treated simply by poultice, bed rest and in difficult cases, application of a red-hot poker. In certain instances, prayers were offered to the patron saint of haemorrhoid sufferers, Saint Fiacre, an Irish priest, who lived in the seventh century. The poor results associated with these modes of treatment led to the development of injection sclerotherapy which was first introduced in 1869 by Morgan of Dublin, who injected iron persulphate to the dilated anal cushion. This gave relief to many who had endured the medical treatment of the time. From 1871, this technique was advertised in the United States as a 'painless cure for piles without surgery'. Unfortunately, inappropriate technique of injection and the use of toxic chemical agents were linked to serious complications which included death, leading to this technique being abandoned until 1923 when Morley in Britain described the proper and improved method of submucosal haemorrhoidal injection using 5% phenol in almond oil. He also emphasised the need for repeated injections at 2–3 weeks intervals using 2–5 ml sclerosant per haemorrhoidal cushion. Since then, injection sclerotherapy has been one of the cardinal methods of treating haemorrhoids, particularly first- and second-degree haemorrhoids.
Over the years, the search for the ideal sclerosant has led to the introduction of other agents such as ethanolamine oleate, quinine and urea hydrochlorides, sodium morrhuate and sodium tetradecyl sulphate.,, Most of these agents have been used in the developed nations of the world with very satisfactory outcomes, with surgical excision commonly reserved for third and fourth degrees or complicated haemorrhoids. In Nigeria as well as in most nations in Sub- Saharan Africa, most of these standard sclerosants are not readily available and affordable making conservative management with sitz baths and laxatives or haemorrhoidectomy, the most readily available treatment options in most instances., Most patients presenting with haemorrhoids in Nigeria decline surgical excision of haemorrhoids partly due to pain, following the procedure or as a result of the widely believed myth that surgical intervention is associated with impotence in men. In view of the foregoing, most patients in Nigeria with haemorrhoids would have preferred the painless alternatives to surgery; however, they had long been denied this due to unavailability of the standard sclerosants. The search for a readily available sclerosing agent which may serve as an alternative to any of the standard agents led to the introduction of 50% dextrose water. A study evaluating its use in our environment showed satisfactory outcomes with over 90% of patients reported to have had significant improvement in their symptom. It is however yet to be determined that how the use of 50% dextrose water compared with any of the standard agents in terms of efficacy and frequency of complications to justify its use when any of the standard agents is not available. This study was conducted to compare the therapeutic effect, complication and acceptability of 50% dextrose water with 5% phenol in almond oil as sclerosants in the management of first-, second- and third-degree haemorrhoids.
| Patients and Methods|| |
Study setting and design
The study was a prospective, comparative study comparing the sclerosing effect of two injection sclerotherapy agents in the treatment of first-, second- and third-degree haemorrhoids. The study was carried out at the endoscopic unit of Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Osun State, Nigeria. The hospital's complex has three general surgery units and provides tertiary level services being mostly accessed by patients from Osun, Ondo, Ekiti and some parts of Kwara, Kogi, Oyo and Edo States with an estimated population of about 10 million according to the 2006 National population census. The patient population is predominantly made up of Yorubas and a few other Nigerian tribes and ethnic groups. Peasant farming is the major occupation of the people. A sizeable number are engaged in commercial and small-scale industrial enterprises while the creams of the educated ones are the civil servants.
Study participants and patients selection
The study was approved by the ethical committee of Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria. Consecutive adult males and females who consented to injection sclerotherapy for the treatment of their first-, second- and third-degree haemorrhoids were recruited into the study from May 2013 to April 2014. The patients were recruited from the general surgery outpatient clinics. Diagnosis was made from combination of clinical evaluation and proctoscopic examination. Colonoscopy or barium enema was done when indicated to rule out the possibility of other lesions particularly colonic tumours. The inclusion criteria include adult males and females aged 18 years and above with first-, second- or third-degree haemorrhoids, who were healthy, with no significant co-morbidity that could interfere with the ability to communicate or respond correctly to the researcher who obtained consents for recruitment into the study. Patients who met the inclusion criteria were randomised into two groups. This was done by simple randomisation with eighty ballot papers (based on the calculated sample size) labelled with either of the treatment options, forty in each group. Each pre-labeled paper was sealed in an opaque envelope. The envelopes were shuffled, and each patient pick one shortly before the procedure was performed. The sclerosant selected by each patient was used for the treatment of his or her haemorrhoids. The exclusion criteria include patients with other anorectal lesions such as fissure-in-ano, fistula-in-ano, perianal dermatoses, skin tags, anorectal neoplasia, inflammatory bowel disease and faecal incontinence. Other exclusion criteria include patients who had history of hypersensitivity reaction to phenol, patients with immunosuppressive diseases such as diabetes mellitus, retroviral disease, malignancies or on steroids immunosuppressant, patients who had history of bleeding disorders or who were on anticoagulants and finally, patients who had had previous anorectal surgery.
Five percent phenol in almond oil (LOT 1305189, manufactured date January 2013, expiry date January 2016) was procured from Martindale Pharmaceuticals, Romford, United Kingdom while 50% dextrose water (Batch No: 14BJ03, manufactured date October 2012, expiry date, September 2016) was procured from the Pharmacy Unit of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria. The drugs were at no cost to the patients.
Clinical pre-procedural assessment including proctoscopy was done on all patients, followed by packed cell volume and urine analysis. Patients who were older than 50 years underwent flexible colonoscopy to exclude other sources of bleeding. Patients who were below 50 years but had symptoms such as tenesmus, weight loss, anorexia and anaemia also underwent colonoscopy to rule out possibility of colorectal malignancy. Pre-operative antibiotics using intramuscular gentamicin (80 mg) was administered 30 min before the procedure. Procedures were undertaken with patients in left lateral decubitus position with topical anorectal administration of 2% lignocaine hydrochloride gel. Rectal examination followed by proctoscopy was performed in all cases to identify the haemorrhoidal swellings. About 1–2 ml of 5% phenol in almond oil or 2–4 ml of 50% dextrose water was injected into the base of each haemorrhoidal swelling in the submucosal plane about 1 cm above the dentate line using a 23-guage needle. All haemorrhoidal swellings seen in each patient at the time of procedure were injected. Pain due to the therapy was assessed immediately after the conclusion of the procedure using a 10-point visual analogue scale, with 0 representing no pain and 10 representing the worst pain imaginable. The pain scores obtained were categorised into: no pain = 0, mild pain = 1–3, moderate pain = 4–6 and severe pain = 7–10. Post-operative oral analgesic using 50 mg tramadol hydrochloride was administered immediately after intra-procedure pain has been assessed following the conclusion of the procedure to all patients and was repeated after 6 h by the patients at home. Each patient was observed for 2 h before being allowed to go home. The procedure was repeated once at 3 weeks interval for patients who did not have resolution of their symptoms after the first 3 weeks.
Follow-up and assessment of outcome
Each patient was followed up at 1 week, 2 weeks, 3 weeks, 1 month, 3 months and 6 months following the procedure. They were reminded of their clinics appointments through telephone calls a few days before their appointments. At each visitation, parameters such as recurrence of bleeding, anal protrusion, anal pain, anal discharge/perianal soilage and pruritus ani were assessed. Fever, urinary symptoms, anal ulcers and stenosis were also assessed using the proforma specially designed for the research. Assessments of the outcome were done by blinded general surgeons. The outcome was assessed by comparing the resolution of the following symptoms: anal bleeding, anal protrusion, anal pain, perianal soilage/anal discharge and pruritus ani before and after the sclerotherapy. Rectal examination and protoscopic examination were carried out on each patient at each visit to look for the presence of anal ulcer and stenosis. Patient's satisfaction about the treatment was also assessed using categorised responses as satisfied, not satisfied and indifferent. Patient's acceptability of the procedure and the sclerosant used was also assessed.
Data collected were imputed into a personal computer and analysed using the Statistical Package for Social Sciences software for Windows version 22 (IBM Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp). Graphs and other charts were generated using the New Microsoft Office Excel Worksheets (version 2007). The mean and standard deviation of age of patients were determined. The frequency distribution of the age groups, gender, degree of haemorrhoids, duration of first symptom use, number of haemorrhoidal tissue among others were presented in tables and charts. The effect of 5% phenol in almond oil and 50% dextrose in water was determined for each of the symptoms the patients presented with using the Pearson Chi-square and Fisher's test as applicable. The level of statistical significance at 95% confidence level was determined and set at P < 0.05.
| Results|| |
A total of eighty patients were recruited into the study and were randomised equally into the two treatment groups. Their ages ranged from 19 to 61 years with the mean age and standard deviation of the sample population being 43.9 ± 11.1 years, with the peak age at the fourth decade of life [Table 1]. There were 58 males (72.5%) and 22 females (27.5%), with a male to female ratio of 2.6:1.
|Table 1: Demographic and clinical variables distributions among two study groups|
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The duration of the first symptom of haemorrhoids before presentation for treatment ranged from 3 months to 22 years, with a mean duration and standard deviation of 7.4 ± 5.4 years [Table 1]. Forty-five (56.2%) of the patients had third-degree haemorrhoids while 26 (32.5%) and 9 (11.3%) of the patients had second- and first-degree haemorrhoids, respectively. Bleeding was the chief pre-treatment symptom which was present in 78 (97.5%) patients. Other symptoms include anal protrusion in 71 (88.6%) patients, anal pain in 9 (11.3%) patients, anal discharge in 26 (32.5%) patients and pruritus ani in 49 (61.3%) patients. As shown in [Figure 1], patients with third-degree haemorrhoids were found to have more pre-treatment symptoms of various types compared with those with second- and first-degree haemorrhoids. Majority of these patients, 59 (73.8%), had three enlarged haemorrhoidal tissues, 16 (20.0%) had two haemorrhoidal tissues while 5 (6.3%) patients had one haemorrhoidal tissue [Table 1].
|Figure 1: Frequency distribution of the pre-treatment symptoms based on degrees of haemorrhoids|
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As shown in [Table 1], there were no statistically significant differences in the distributions of patients within the two treatment groups with regard to patients age (P = 0.137), degrees of haemorrhoids (P = 0.332), mean duration of the first symptoms before presentation (P = 0.094) and the numbers of enlarged haemorrhoidal tissues before treatment (P = 0.449), although the difference in the distribution of patients within the two treatment groups with respect to gender was statistically significant with P = 0.012.
The treatment efficacy of the two sclerosants administered was assessed in terms of resolution of haemorrhoidal symptoms. Thirty-nine of the forty patients in each treatment group had anal bleeding before treatment. Only three patients in 5% phenol in almond oil group and four patients in 50% dextrose water group still had anal bleeding 6 months post-treatment with 92.3% and 89.7% resolution of anal bleeding in phenol group and dextrose water group, respectively. There was significant reduction in the proportion of patients with anal bleeding following treatment with either of the agents for all the degrees of haemorrhoids (P = 0.001); however, there was no statistically significant difference (P = 0.905) in the resolution of bleeding after 6 months of commencement of sclerotherapy in both treatment groups [Table 2].
|Table 2: Degree of resolution of symptoms 6 months after treatment with either of the sclerosants|
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Considering anal protrusion, 71 of the eighty patients had anal protrusion. Thirty-seven of these patients had phenol in almond oil and 34 patients had 50% dextrose water for their therapy. Only four patients in the phenol group and five in the dextrose water group still had their anal protrusion 6 months post-treatment with 89.1% and 85.3% anal protrusion resolution rate in phenol group and dextrose group, respectively. This showed significant reduction in the proportion of patients with anal protrusion at 6 months post-treatment with either sclerosant (P = 0.001) but with no statistically significant difference between the two treatment groups (P = 0.899).
Only nine of the eighty patients had anal pain before treatment – six patients were among the phenol group while three patients were among the dextrose water group. All of the nine patients had complete resolution of their anal pain. Similarly, 26 of the eighty patients had anal discharge before treatment. Twelve patients were among the phenol group and 14 patients among the dextrose water group. None of the patients in the phenol group and only one in the dextrose water group still had anal discharge 6 months post-treatment with 100% and 92.9% anal discharge resolution rate in phenol group and dextrose water group, respectively. This showed significant reduction in the proportion of patients with anal discharge at 6 months post-treatment with either sclerosant (P = 0.001) with no statistically significant difference between the two treatment groups (P = 0.845).
Forty-nine of the eighty patients had pruritus ani before treatment. Twenty-eight patients were among the phenol group and 21 patients were among the dextrose water group. Only one patient in each group had pruritus ani at 6 months post-treatment with 96.4% and 95.2% resolution rate in phenol group and dextrose group, respectively, with no statistically significant difference between the two treatment groups (P = 0.972) [Table 2].
Regarding the number of times, the procedure was carried out on individual patients to achieve resolution of haemorrhoidal symptoms, 27 (67.5%) of patients in the phenol group and 25 (62.5%) of the patients in the dextrose water group required single doses of injection while 13 (32.5%) of patients in the phenol group and 15 (37.5%) of the patients in the dextrose water group required additional one dose of injections. There was no statistically significant difference observed in the number of doses of injection in both treatment groups for the resolution of symptoms (P = 0.815) [Table 3].
With regard to patients' assessment of intra-procedure pain experienced, 4 (10%) patients in 5% phenol in almond oil group and 1 (2.5%) patient in 50% dextrose water group had no pain. Thirty-four (85%) of the patients in 5% phenol in almond oil group, and 36 (90%) patients in 50% dextrose water group had mild degree of anal pain. Two (5%) of patients in 5% phenol in almond oil group and 3 (7.5%) in 50% dextrose water group had moderate degree of anal pain. None of the patients had severe pain. There was no statistically significant difference between the degrees of intra-operative pain experienced in both treatment groups (χ2 = 0.61 df = 1; P = 0.912).
The only complication found in this study was anal ulcer which occurred in only three patients, all of whom had treatment with 5% phenol in almond oil. These, however, resolved spontaneously within 3 weeks. As shown in [Table 4] and [Table 5], there were no statistically significant differences in assessment of patients' satisfaction and acceptability in both treatment groups with P = 0.928 and 0.926, respectively.
| Discussion|| |
In view of earlier claims of its effectiveness, this study sets out to test the use of 50% dextrose water, which is a readily available agent against 5% phenol in almond oil which is a standard sclerosing agent in terms of effectiveness and safety in the management of first-, second- and third-degree haemorrhoids. The pattern of presentation of this study showed that anal bleeding was the most common presenting complaint. It was therefore considered the most appropriate outcome measure to assess the efficacy of treatment, more so it could be easily assessed with much objectivity as being present or absent. In terms of efficacy and resolution of rectal bleeding, both sclerosants showed comparable efficacy. The study showed complete resolution of anal bleeding at 6 months in 92.3% and 89.7% of patients in the 5% phenol in almond oil group and 50% dextrose water group, respectively (P = 0.905). This finding is similar to the findings by Khazaie et al. in Iran, who evaluated 144 patients with first-, second- and third-degree haemorrhoids in a prospective randomised study using 50% glucose water and 5% phenol in olive oil recording complete bleeding resolution rate of 90.1% and 91.8%, respectively. Other symptoms such as anal protrusion, anal discharge, perianal pain and pruritus ani similarly showed comparable response when the two agents were used.
Regarding the number of doses of injection required to achieve resolution of symptoms, more patients in the 50% dextrose water group required more than one dose of injection. However, this difference was marginal and did not reach statistical significance. Previous study which used 5% phenol in olive oil for injection of haemorrhoids had shown that 60% of their patients requiring only a single injection dose, this is comparable to the 67.5% and 62.5% noted in the 5% phenol and 50% dextrose groups in this study, respectively. Contrary to the previous report, however, we found satisfactory results in patients who had more than one injection dose in both groups., We therefore recommend that patient should be offered multiple injections before this modality of treatment is regard as failed. Although the reasons for this was not very obvious in this study, further studies will be needed to evaluate response to treatments in patients needing more than one dose of injection sclerotherapy.
We also found comparably low incidence of complication, following the use of the two sclerosants. The generally low complication rate noted in the study is an attestation to the safety of either of the two agents being studied. The occurrence of anal ulcers only in the group of patients who had 5% phenol injection may suggest that it is more toxic to the anal canal mucosa than 50% dextrose water.
While resolution of symptoms appears to be the most important measure of success, the perception of the patients with regards to satisfaction is also very important in promoting a particular practice.,, A generally satisfied patient will gladly recommend the same treatment to other sufferers. The fact that patients who had 50% dextrose injection were equally as satisfied as those who had 5% phenol injection favours its adoption as an effective substitute in the absence of any of the standard agents.
The limitations of this study include the fact that it is a single-centred and it was not blinded. Similarly, only short-term outcomes were assessed. We therefore recommend that a multi-centred study which will also evaluate the long-term treatment outcome of the two sclerosants should be undertaken. Nevertheless, this study equivocally showed that 50% dextrose water as a sclerosant in the treatment of first to third degrees haemorrhoids compared favourably with 5% phenol in almond oil with regards to the short-term efficacy in resolution of haemorrhoidal symptoms. Fifty percent dextrose water was also found to be very safe in this study as it had no recorded complication in all the patients treated with this sclerosant when compared to 5% phenol in almond oil. Patients' satisfaction and acceptability of both sclerosants in this study showed that 50% dextrose water also compared favourably with 5% phenol in almond oil.
| Conclusion|| |
Since 50% dextrose water is comparably effective, safe and acceptable to 5% phenol in almond oil by patients with haemorrhoids, with the added advantage of lesser cost and readily availability; it is therefore recommended as a suitable alternative for 5% phenol in almond oil in our environment where 5% phenol in almond oil is not readily available.
Special appreciation to all the staffs in the endoscopy unit of Obafemi Awolowo University Teaching Hospitals Complex for their support and assistance while the study was being conducted.
Financial support and sponsorship
Obafemi Awolowo University Teaching Hospital Complex research fund was provided for this study.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]