INTRODUCTION
For injection therapy for hemorrhoids, two agents are primarily used. A well-established agent, 5% phenol in almond oil (PAO), has commonly been used in the world for several decades [
1,
2]. A newer agent, aluminum potassium sulfate and tannic acid (ALTA; Zion, Mitsubishi Pharma Corp., Osaka, Japan), has recently been introduced in Japan and Korea [
3,
4]. As to the efficacy of injection sclerotherapy (IS) for the treatment of grade 3 hemorrhoids, PAO was reported to be ineffective [
1] whereas ALTA was reported to be very effective [
3]. However, IS with ALTA has not yet been commonly applied in the world. The reason, in our opinion, is that no study has compared the two agents; thus, confidence in ALTA therapy is lacking. Therefore, many proctologists may hesitate to select ALTA therapy. In this study, we compared the efficacies of the two agents for treating grade 3 hemorrhoids.
METHODS
A retrospective observational study was conducted in 135 of the 149 patients who underwent injection therapy with PAO or ALTA for the treatment of grade 3 hemorrhoids for the first time in Yano Clinic of Proctology between April 2013 and March 2014. Sixteen patients were excluded because we could not get in touch with them (PAO, five patients; ALTA, 11 patients), and one patients with an anal fissure was excluded (ALTA, one patient). The subjects consisted of 55 treated with PAO and 80 treated with ALTA. The efficacy after one year was established as the primary endpoint. We compared the efficacies between the two agents.
Treatment
The subjects were placed in the Sims' position, and an anoscope was inserted. An injection needle was inserted into the submucosal hemorrhoid tissue to infuse the solution with the agent (PAO or ALTA). For injection therapy, one physician was in charge of a single agent. The physician responsible for PAO therapy provided it for patients who visited our clinic on Wednesday or Thursday. The physician responsible for ALTA therapy provided it for those who visited our clinic on Monday, Tuesday, or Friday. The two physicians received the same training program for IS.
Evaluation and definitions
Prior to treatment, inquiries into two symptoms, hemorrhage and prolapse, was conducted by the physicians, and responses were recorded. At this point, hemorrhage was classified into three grades (
Table 1) and prolapse into four grades (grade 1, no prolapse; grade 2, prolapse with spontaneous reduction; grade 3, prolapse with manual reduction; and grade 4, irreducible prolapse). One year after injection therapy for treating the hemorrhoids, the same inquiry was conducted by telephone. The treatment response was then evaluated. Only patients with "no hemorrhage" and "no prolapse" one year after treatment were regarded as responders. The other patients were regarded as nonresponders. Furthermore, patients who received additional treatment for hemorrhoids within one year after injection therapy were regarded as nonresponders. The efficacy rate (%) was calculated by using the following formula: number of responders/(number of responders + nonresponders) × 100.
Statistical analysis
To identify the factors affecting the efficacy, we conducted univariate analyses for the following four parameters for comparison between the responder and the nonresponder groups: sex, age, number of treated hemorrhoids, and agent (ALTA/PAO). Continuous and ordinal variables were analyzed by using the Mann-Whitney U-test, and categorical variables were analyzed by using the chi-square test. The four parameters were forcibly included in the logistic multivariate analysis. The odds ratios are reported with 95% confidence intervals. All of the statistical analyses were performed using the SPSS ver. 12 (SPSS Japan Inc., Tokyo, Japan). For all comparisons, a value of P < 0.05 was considered to indicate a statistically significant difference.
RESULTS
The characteristics of the 135 patients are presented in
Table 1. The efficacy rates of ALTA and PAO were 75% and 20%, respectively, showing a significant difference (P < 0.01). The results of the univariate analysis using four variables (sex, age, number of treated hemorrhoids, and agent [ALTA/PAO]) for the efficacy are shown in
Table 2. Those of the multivariate analysis using the four variables for the efficacy are presented in
Table 3. Only the agent (ALTA/PAO) was an independent significant factor influencing the efficacy (P < 0.01).
DISCUSSION
The results of IS with PAO for the treatment of grade 3 hemorrhoids are unfavorable [
1]. A poor impression of IS has, for many years, caused proctologists to hesitate to select it. The current study showed that ALTA therapy was markedly more useful than PAO therapy. This may change the unfavorable impression of IS. Although surgery alone has been recommended as a treatment option [
5], ALTA injection therapy may become a new treatment option.
In this study, the efficacy rates of ALTA and PAO after 1 year were 75% and 20%, respectively. When these values were compared with those in a previous study (84% and 20%, respectively [
1,
3]), there were no marked differences. However, this is the first study comparing the two agents. A marked difference was observed in the efficacies of two agents, possibly because the sclerosing/hemostatic actions of ALTA were more potent than those of PAO. Thus, the application of PAO for the treatment grade 3 hemorrhoids should be avoided.
This study has some limitations: It was a retrospective, nonrandomized study, and it was only based on inquiries. Only with a prospective, randomized, controlled, multicenter study involving a practical anal examination can these limitations be finally removed. In conclusion, this study suggests that ALTA is markedly more useful than PAO for IS for the treatment of grade 3 hemorrhoids. We should select ALTA, not PAO, as the agent for treating grade 3 hemorrhoids.
Table 1
Comparison between PAO and ALTA for the treatment of hemorrhoids
Table 2
Univariate variables of efficacy
Table 3
Multivariate variables of efficacy