John F. Johanson, M.D., and Alfred Rimm, Ph.D.
Department of Medicine, University of Illinois College of Medicine, Rockford, Illinois, and Department of Epidemiology and Biostatistics, Medical College of Wisconsin, Milwaukee, Wisconsin
RESULTS Characteristics of trials
A total of seven randomized, controlled clinical trials comparing the use of IRC, sclerotherapy, and rubber band ligation in the treatment of hemorrhoids were identified in the published literature (3—9). One trial was excluded because of incongruous treatment methodology (3). In this particular study, patients underwent only one treatment session rather than continued sessions until the hemorrhoids were adequately obliterated. Two other studies (8, 9) utilized the same data, one being a continuation of the follow-up period of the other. Hence, these data were included only once. Therefore, the final number of clinical trials analyzed was five: two comparing IRC with rubber band ligation. two comparing sclerotherapy with rubber band ligation, and one study comparing all three techniques.
The demographic characteristics of the individual trials are outlined in Table 1. The number of patients in each treatment group was 307, 366, and 189 for IRC, rubber band ligation, and sclerotherapy, respectively. Because all studies included follow-up at 12 months, assessment of therapeutic response was performed at this time. The male:female ratio was approximately 2:1, and was similar in all studies. This ratio coincides with the sex distribution of hemorrhoids observed in previous studies (12). The distribution of hemorrhoid severity among the various trials was less consistent, although the more severe cases (second-degree) appeared to be equally dispersed among the different therapies.
Comparison of JR C and rubber band ligation
The percent response and complication rates for the individual trials are shown in Table 2. There was no significant difference between treatments with regard to any of the response variables. Moreover, no difference was observed in the frequency of posttreatment bleeding. However, a significant difference was observed in the number of patients complaining of severe pain in two of the studies.
The test for homogeneity revealed that the studies were sufficiently similar to be safely combined. Upon performing the meta-analysis, no significant difference was again observed in treatment response between IRC and rubber band ligation at 12-month follow-up (Table 3). However, three times as many patients who were initially treated with IRC required additional treatments for recurrence of symptoms (p = 0.0002). Stratification by severity revealed no particular advantage for either modality. Both were similarly efficacious in treating first- and second-degree hemorrhoids (p = 0.19). Symptomatic response was also assessed 3 months after the completion of treatment and, again, revealed no significant difference between IRC and rubber band ligation (p = 0.4). With regard to the frequency of complications, a fivefold difference was observed in the development of pain after treatment with rubber band ligation (p = 0.02).
Comparison of sclerotherapy and rubber band litigation
The percent response and complication rates for individual trials comparing sclerotherapy and rubber band ligation are shown in Table 4. No significant matic response rate associated with rubber band ligation was better than the rate associated with sclerotherapy, although this difference failed to achieve statistical significance (p = 0.07) (Table 5). Nearly three times more patients who were initially treated with sclerotherapy required additional treatments either by the same or alternative techniques (p = 0.009). Stratification by hemorrhoid severity revealed similar response rates for first-degree hemorrhoids (p = 0.22). Comparison of sclerotherapy and rubber band ligation in second-degree hemorrhoids, however, demonstrated a 25% difference, with the response rate of rubber band ligation being significantly better (p = 0.0001). Assessment of the early treatment response (3 months posttreatment) was not possible, due to insufficient data. With regards to complications, the frequency of pain and bleeding were similar.
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