Pycnogenol® and Aloe Cream Effective in Treating Hemorrhoidal Pain in 2 Trials
Reviewed: Belcaro G, Cesarone MR, Errichi B, et al. Pycnogenol® treatment of acute hemorrhoidal episodes. Phytother Res. 2010;24:438-444.
Reviewed: Eshghi F, Hosseinimehr SJ, Rahmani N, Khademloo M, Norozi MS, Hojati O. Effects of Aloe vera cream on posthemorrhoidectomy pain and wound healing: results of a randomized, blind, placebo-controlled study. J Altern Complement Med. 2010;16(6):647-650.
Although many people suffer from hemorrhoids, most do not report any signs or symptoms to their healthcare provider until bleeding occurs. Most patients can control their hemorrhoidal symptoms with lifestyle changes, topical over-the-counter medications, diet modifications, and careful hygiene. Of those who seek help from their physician, about 10% to 20% require surgical treatment. A hemorrhoidectomy (surgical removal of hemorrhoids) causes significant postoperative pain as a result of numerous variables, including inflammation and wound healing.
Two recent studies assessed botanical-based preparations for treating pain associated with hemorrhoids. The first study evaluated the efficacy and tolerability of a high-dose oral Pycnogenol® supplement on the symptoms and signs of acute hemorrhoidal episodes, either administered alone or combined with a topical preparation containing Pycnogenol. The second study evaluated the effect of an Aloe Vera (Liliaceae) topical preparation on reducing postoperative pain and pain upon defecation after open hemorrhoidectomy.
Pycnogenol (Horphag Research, Geneva, Switzerland) is a standardized extract of French maritime pine bark (Pinus pinaster, Pinaceae).1,2 The extract is standardized to contain 65-75% procyanidins, which consist of condensed catechin and epicatechin. Pycnogenol’s anti-inflammatory, antithrombotic, and venotropic (having a beneficial effect on venous pathology) properties may benefit patients with hemorrhoids, both for acute and chronic treatment. (A comprehensive monograph on Pycnogenol research, including pharmacological and clinical studies testing its safety and activity in treating chronic venous insufficiency, thrombosis, diabetes, hypertension, and other conditions, is available on the American Botanical Council website at www.herbalgram.org/site/PageServer?pagename=Pycnogenol.)
Eighty-four patients suffering from an acute episode of external hemorrhoids (lasting 24 to 48 hours before the study) participated in the randomized, controlled, comparative study on Pycnogenol, which took place at the University of Chieti in Italy. The most frequently observed signs and symptoms of a typical hemorrhoidal attack were evaluated during the 2-week study period. Evaluation targets included the duration of the persistence (in hours) of peak pain and pain intensity.
The patients were assigned randomly to one of the following treatment groups:
Group A: 300 mg Pycnogenol (6 tablets, 50 mg each) daily for 4 days, and then 150 mg (3 tablets) daily for 3 days (taken at 8 am, 4 pm, and midnight).
Group B: Comparable placebo (identical tablets without active ingredient).
Group C: Topical 0.5% Pycnogenol cream (in an emulsion prepared by the hospital pharmacy solely for use in this study) in combination with Pycnogenol oral treatment as described for Group A.
Group D: Oral Pycnogenol as in Group A in combination with topical sham cream (identical to emulsion used in Group C but lacking Pycnogenol).
The patients were treated for 7 days and were followed up with for another 7 days after treatment.
All groups received lifestyle management of their hemorrhoids, including dietary changes (e.g., addition of bulking agents and increased intake of fluids), changes in daily routines, and moderate, continuous exercise.
Symptoms and signs of hemorrhoidal attacks were scored by using an analog scale line (from 1 [absent] to 4 [severe]) at baseline and at 7 and 14 days. Pain was assessed by using the 10-point Karnofsky Scale, which provides a rapid screening of a patient’s condition on a given day. Blood pressure, heart rate, and standard blood chemistry and rheology (the study of flow of fluids) parameters were all within normal limits at baseline, including fasting blood sugar, hemoglobin, electrolytes, and liver and kidney function tests but excluding white-cell count.
Patients kept a 2-month diary, showing lost working days, costs of controlling hemorrhoidal symptoms, and the occurrence of any complication or comparable recurrent attacks. Social quality-of-life parameters were evaluated on a scale at days 7 and 14. The authors report that the most important and most frequently observed signs and symptoms were acute intravascular thrombus, acute severe perianal pain, purple/black edematous and tense subcutaneous perianal mass, tenderness, ischemia/necrosis of the overlying skin, and bleeding. The scores for signs and symptoms decreased progressively in all groups (P<0.05) during the 2-week study period. The decrease was significantly higher in all 3 of the Pycnogenol groups as compared with the placebo group (P<0.05).
Of the 3 treatment groups, the scores for signs and symptoms were decreased most significantly in Group C. Results for Groups A and D were statistically comparable. Hemorrhoidal bleeding was completely absent in all 3 treatment groups at days 7 and 14, but it was still observed in the placebo group at day 14.
Regarding quality-of-life, the most important and most frequently observed social impairment problems decreased progressively in all groups during the 2 weeks (P<0.05). However, the improvement was significantly better in the 3 treatment groups when compared with the placebo group (P<0.021). Patients in Group C reported significantly decreased scores for each quality-of-life item (P<0.05), which included impairment in walking, standing, sitting, work performance, and embarrassment or social withdrawal. Again, the results in Groups A and D were comparable. The duration of peak pain was on average 17.8 hours in Group A, compared with 23.6 hours in the placebo group (P<0.05). In Group C, the peak pain duration (16 hours) was significantly lower (P<0.05) than in Group A. The number of working days missed decreased in the treatment groups: Group A averaged 65% of that for controls, with a minimum of 63% as many lost work days in Group C (P<0.05). Treatment costs decreased significantly (P<0.05) in the treatment groups compared to controls: Group A costs were 57.8% as much, while Group C had only 33% of control costs.
Within the month following the study period, there was a significant (P<0.05) decrease in the occurrence of hemorrhoidal events in the treatment groups (5% incidence for Group A, 3% for Group C, and 6% for Group D), when compared with an 18% incidence in Group B.
The authors conclude that Pycnogenol treatment significantly reduced the intensity and duration of pain and bleeding in acute hemorrhoidal episodes. Also reduced were costs of treatment, the number of complications, and the number of lost working days. This study indicates that “Pycnogenol (both in oral and topical forms) represents an effective way for controlling the common, disabling problem of acute hemorrhoidal attacks. Pycnogenol should be effective for the management of hemorrhoids and the prevention of future acute outbreaks,” write the authors. Studies in progress are investigating its chronic use for management of hemorrhoids and prevention of new episodes.
For the aloe trial, 49 patients with symptomatic III and IV degree hemorrhoidal disease and undergoing open hemorrhoidectomy surgery participated in the randomized, double-blind, prospective, placebo-controlled study. The study was conducted at Imam Hospital, Sari, Iran. Patients who were pregnant or had anal fissure, heart disease, or liver disease were excluded. Patients were randomized to receive placebo or aloe cream, specially compounded for the study.
Liquid white paraffin, sterile alcohol, cetyl alcohol, solid white paraffin, and propylene paraben were mixed and heated to boiling, as the oil phase. Aloe vera inner leaf (gel) powder 0.5% (Zarband Phytopharmaceutical Company; Iran) mixed with deionized water was added to a mixture of propylene glycol, sodium lauryl sulfate, and methylparaben, and heated as the aqueous phase. The 2 separate phases were mixed continuously while being cooled. The resulting cream was packaged into an aluminum tube for the study. The placebo cream was made the same way, but the aloe was left out of the mix.
The first application of the cream was immediately after surgery and was part of the postoperative dressing. Cream was reapplied 12 hours later. The patient then applied approximately 3 g of the cream to the surgical site 3 times per day for up to 28 days. Patients could take analgesic drugs as needed, and the analgesic requirement was recorded. Postoperative pain was recorded with a visual analog scale. At 2 and 4 weeks post-operation, an expert surgeon evaluated wound healing.
There were no significant differences between groups at baseline. Pain scores immediately following surgery were not significantly different between groups. The aloe group had significantly less pain than the placebo group at 12, 24, and 48 hours, as well as 2 weeks post-surgery (P<0.001). The aloe group also had significantly less pain upon defecation 24 and 48 hours after hemorrhoidectomy (P<0.001), but there was no significant difference between groups at 2 and 4 weeks. At 2 weeks post-surgery, the aloe group had significantly better wound healing (P<0.001), but there was no significant difference between groups at 4 weeks. Narcotic use was significantly less in the aloe group than in the placebo group 12 hours postsurgery (P<0.001), and non-narcotic use was significantly less in the aloe group than in the placebo group 2 weeks post-surgery (P<0.001). No adverse side effects or allergic reactions were reported.
The authors conclude that Aloe vera cream provided significant pain relief after open hemorrhoidectomy. Also, aloe cream produced significant wound healing 14 days post-surgery. The authors point out that the use of fewer analgesics by the aloe treated patients supports the findings. Aloe may be producing these effects through a variety of mechanisms. Aloe may decrease inflammation, which is the first step to wound healing; it may also be enhancing production of collagen, which provides strength and integrity to the skin and supporting tissues.
The findings of this study are particularly credible since the study was not sponsored by a commercial company and does not promote a specific product. Aloe vera 0.5% products are available commercially, which enables the findings from this study to be relatively easily put into clinical practice. (An HerbalGram peer reviewer notes that “Inner leaf (gel) juice with 0.5% solids is the standard for what is commonly known as single strength juice. Not all aloe juice products in the US have this level of solids but they are available.”)
—Shari Henson and Heather S. Oliff, PhD
- Rohdewald, P. A review of the French maritime pine bark extract (Pycnogenol®), a herbal medication with a diverse pharmacology. Int J Clin Pharmacol Ther. 2002;40:158-168.
- Rohdewald, P. Pycnogenol®, French maritime pine bark extract. In: Coates P (ed). Encyclopedia of Dietary Supplements. New York: Marcel Dekker; 2005:545-553.