| Optimal Nonsurgical Treatment of Hemorrhoids: A Comparative Analysis of Infrared Coagulation, Rubber Band Ligation, and Injection Sclerotherapy |
Methods | Results | Discussion |
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
METHODS
Selection of clinical trials
Because only infrared photocoagulation (IRe), injection sclerotherapy, and rubber band ligation have been compared in randomized, controlled clinical trials, the present analysis was restricted to these modalities. The results of all published trials comparing these treatments were obtained from a computer-assisted literature search (MEDLINE) and from review of appropriate English language journals over the past 10 yr. The following criteria were used for inclusion of a trial in the meta-analysis: patients with either first- or second-degree hemorrhoids, randomization at initial presentation, follow-up of at least 12-month duration and documentation of outcome, including patient response (asymptomatic vs. no change in symptoms), need for retreatment, and complications (bleeding and pain).
Treatment techniques were comparable among the individual trials. Infrared photocoagulation was performed through a proctoscope with the patient in the left lateral decubitus position. Up to four pulses of 1-s duration were applied just above the base of the hemorrhoid. Injection sclerotherapy was likewise performed through a proctoscope with the patient in the left lateral decubitus position. Up to 5 ml of 5% phenol in arachis oil were injected submucosally into the base of each hemorrhoid above the dentate line. Rubber band ligation was performed in the usual manner (I, 2), with up to three sites banded during a single session.
Statistical analysis
The following outcome variables were analyzed: the patient"s symptomatic response to treatment, the necessity for retreatment, and the complications associated with each treatment. Response to treatment was evaluated by questionnaire during the 12-month post-treatment follow-up visit in all studies. For the purposes of this analysis, patients were considered responders if they became asymptomatic after treatment. Nonresponders were those who continued to have similar symptoms or were worse after treatment. Because of the vague definition of "improvement" and the potential for considerable variation among the different trials, "improvement" alone was not considered a sufficient treatment outcome. In addition to the patients" symptomatic response, the necessity for retreatment was examined. This measure provided an additional criterion of treatment efficacy. The final outcome measure was the occurrence of complications, i.e., bleeding and pain. Bleeding typically occurred 7—10 days after treatment and was considered a complication if the patient required additional medical attention, such as a physician visit or hospitalization. Although more difficult to quantify, pain also was considered a treatment complication if it necessitated a follow-up visit.
The statistical methods used in this analysis have been described previously by DerSimonian and Laird (11). Using this approach, data from individual trials were compiled into a number of"2 x 2" tables. Because individual trials may vary according to sample size and patient population, a test of homogeneity was performed to assess the amount of disparity among the trials quantitatively. Each individual trial was weighted according to the relative value of the information contained therein (I 1). Response rates of the individual therapies were compared within the same trial to avoid direct comparisons of patients between trials. Results from the individual trials were combined to yield a pooled estimate of the difference in outcome rates, that is, response rates, retreatment rates, and complications. The statistical significance of the rate difference was calculated with a z test. The same analysis was performed for all hemorrhoids and for hemorrhoids stratified by severity: first- or second-degree.
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