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Efficacy of aloe vera cream versus transcutanous electrical nerve stimulation on post-hemorrhoidectomy pain.

Introduction

Haemorrhoid is a common disease worldwide and causes symptoms in 4.4% of the population. [1] Among several modalities studied for the treatment of haemorrhoids, surgical resection seems effective in eradicating the symptoms about which patients complain. [2] However, agonizing postoperative pain and thus the need of hospitalization for pain relief remains the major drawback for a patient undergoing haemorrhoidectomy. [3] Several interventions, for example, transdermal delivery of fentanyl, intraoperative use of Toradol[R] (Syntex Laboratories, Palo Alto, CA), and use of a subcutaneous morphine pump, have been used to relieve postoperative pain after haemorrhoidectomy. [3-6] Nevertheless, the results are unsatisfactory.

Although, diet bowel regulation, or elastic ligation will alleviate most symptoms of internal haemorrhoids, occasionally, an excisional haemorrhoidectomy will be necessary. The excision of haemorrhoids should be limited to large third and fourth degree haemorrhoids that cannot treated on an outpatient basis, mixed haemorrhoids, acutely thrombosed, incarcerated haemorrhoids with severe pain and impending gangrene. [7] Numerous approaches have been used for the surgical removal of haemorrhoids. Closed haemorrhoidectomy involves resection of Haemorrhoidal tissue and closure of the wound with absorbable suture.

Although, pain is not actually a complication of surgery, it is nonetheless the single most important reason why patients avoid haemorrhoidectomy. [8] A great deal of emphasis has been applied to the management of this pain, not only because of the pain itself, but because of the role it plays in urinary symptoms. Pain and fluid overload are the primary factors that cause urinary retention, which is the most complication after haemorrhoidectomy. If pain medication is inadequate, the patient cannot relax the sphincter mechanism sufficiently to urinate. Different options has been employed for analgesia after haemorrhoidectomy such as narcotics, injection of Tradol (Ketorolac tromethamine) into the anal sphincter at the time of operation, application of transdermal Fentanyl. [5] Attempts to reduce this pain have been continued. Even postoperative oral or topical Metronidazole is used. [9-11]

Transcutaneous electrical nerve stimulation (TENS) is peripheral stimulation via electrodes applied to the skin used as a medical procedure for health care and pain control. [12] Several lines of evidence suggest a similar effect in TENS and electroacupuncture. [13] Moreover, TENS has been shown to relax the lower oesophageal sphincter in patients with achalasia and to relax the sphincter of Oddi in patients with biliary dyskinesia. [14,15] Because of present management methods for post-haemorrhoidectomy pain remain unsatisfactory; the effect of TENS for pain relief on patients undergoing haemorrhoidectomy is worth investigation.

Aloe Vera (family: Liliaceae) has been used in traditional medicine for a long time. Aloe Vera gel, obtained by breaking or slicing its leaf (the principle part of the plant), is used in herbal medicine. Aloe vera contains many important nutrients including amino acids, B group vitamins, polysaccharides, and other nutrients that support general health. It also has many pharmacological properties including antioxidant, wound healing, antibacterial, analgesic, antifungal, antiviral, and immunomodulating effects. [16-18]

Realizing the importance of reducing pain after haemorrhoidectomy, we examined the effects of Aloe vera cream vs. TENS in reducing postoperative pain after open haemorrhoidectomy.

Materials and Methods

Patients

Sixty consecutive patients with symptomatic haemorrhoids, Grade III to IV, were eligible for surgical resection of the haemorrhoids (open haemorrhoidectomy). Patients with chronic liver insufficiency (serum bilirubin > 2.0 mg/dl), massive ascites, chronic renal insufficiency (serum creatinine > 1.5 mg/dl), pregnancy, involvement of colorectal cancer, history of bleeding, long-term analgesic intake, cardiac arrhythmia, and pacemaker implantation were excluded from the study. Under regulations of Om El Masryine General Hospital, Cairo, Egypt, patients who given informed consent were prospectively assigned to three groups as described below. Surgical procedures, including one to three wedge resection(s) of the haemorrhoids, were standardized and performed by a single surgical team. Perioperative prescriptions for haemorrhoidectomy included preoperative sedation (diazepam, 10 mg intramuscularly), intraoperative perineal anaesthesia with 30 ml of a mixture of 0.25% Marcaine[TM] (bupivacaine, Winthrop Pharmaceuticals, New York, NY), with units of epinephrine at 1:200,000 and two ampules of Wydase(tm) (hyaluronidase; Wyerst-Ayerth Laboratories, Philadelphia, PA). After the operation, patient-controlled analgesia (PCA) was administered by an ambulatory infusion pump (model 5800, Pharmacia Deltec, Inc., St. Paul, MN) administering morphine intravenously. A bolus dose of 2 mg of morphine sulphate was given, followed by patient controlled bolus doses of 0.5 mg every six hours. The PCA ambulatory infusion pump was programmed to administer bolus doses with a lockout feature to prevent overdosing. This dose was not enough for adequate pain relief, so that it was feasible to evaluate the usefulness of postoperative TENS and Aloe vera cream.

Preparation of Aloe Vera Cream

Liquid white paraffin (2 g), sterile alcohol (7.5 g), cetyl alcohol (7.5 g), solid white paraffin (3 g), and propylene paraben (0.015 g) were mixed and heated to the boiling point as the oil phase. Aloe vera powder (0.5 g) mixed with 70 mL deionized water was added to a mixture of propylene glycol (7 g), sodium lauryl sulfate (3 g), and methylparaben (0.025 g). The mixture was heated as the aqueous phase. These two separate phases were mixed continuously while being cooled. Thus, after cooling, the uniform cream that was produced was placed in an aluminum package similar to a placebo tube, weighing 50 g. The cream contained Aloe vera gel powder 0.5%. Placebo creams were prepared according to similar protocol without aloe powder. Our experimental research and formulations were carried out under sterile conditions. The final creams were tested for any probable contamination microbes, which were not detected during the applications. [19]

Study Procedure

In this study, 30 patients were randomized into three groups. Aloe Vera group; 10 patients applied Aloe Vera cream (3 g of aloe cream to the wounds outside) immediately after surgery and 12 hours after haemorrhoidectomy. Patients were discharged from the hospital 24 hours after surgery. Patients were instructed to apply the cream with the tip of the index finger to the wounds three times daily This treatment was continued on the surgery site 3 times a day up to 28 days postoperatively. [19]

Transcutaneous Electrical Nerve Stimulation (TENS) group: consisted of 10 patients who received TENS from a pocket stimulator (Han Acutens, WQ1002F, Beijing, China) was given two times per day. The stimulation was pulse-waved with frequency alternating between 2 and 100 Hz, 300 u sec pulse duration and 30 - minute stimulation duration. The intensity was adjusted until rhythmic flexion of thumb and index finger was obtained without producing pain, usually at 20 to 30 mA. Two electrodes, were applied to the skin areas on the dorsal web between the first and the second metacarpal bones (Hegu, Large Intestine meridian, 4th ampoint, negative electrode) and on the radial side 3 cm proximal to the wrist crease (Lieque, Lung meridan, 7th ampoint, positive electrode) of the same hand as shown in figure (1). Patients were discharged from the hospital 24 hours after surgery. Patients were instructed to apply TENS two times daily and continued up to 28 days postoperatively. [20]

Control group consisted of 10 patients who applied the same quantity of placebo cream in a similar fashion. In addition to sham TENS application

All patients were supplied with the same analgesic drugs as needed. The patients were followed up after discharge from the hospital. Postoperative pain was evaluated by using a visual analog scale (VAS) [21], which was scored as 0 (no pain) to 10 (very severe pain). Pain score were obtained immediately postoperatively and at days 14 and 28. On the same time the amount of analgesic requirements [22] was recorded in the two treatment groups and the control group.

Statistical Analysis

Data were analyzed using the ANOVA test and MANOVA, as appropriate, to compare patients' demographics, pain score, and analgesic drug use. P<0.05 was considered a significant difference. Statistical analysis performed using SPSS software (version 12, SPSS Inc., Chicago, IL).

Results

Thirty five patients enrolled into the study that all of them were female, 2 patients in the aloe vera group due to severe headache and three patients from the control group due to loss of follow up were excluded. At the end, thirty patients, 10 for each group entered the study. As shown in table 1, mean of age and grades of haemorrhoid in treatment groups and control group show no significant differences.

Post- haemorrhoidectomy pain was measured by visual analogue scale as stated earlier in the material and method section have been reduced significantly either at 1st and 2nd week postoperatively in both treatment groups (aloe vera group and TENS group) when compared with control group. More over aloe vera group showed a highly significant difference (p<0.05) when compared with TENS group either at 1st or 2nd week as shown in table 2.

An indirect measure of Post-haemorrhoidectomy pain is the measurement of Non-narcotic Analgesic Consumption. As shown in table 3 there was a significant decrease in Analgesic Consumption in both treatment groups when compared to control group(p<0.05), more over there was a a significant decrease in Analgesic Consumption in aloe vera group when compared with TENS group.

Discussion

The pain after haemorrhoidectomy has always been a major concern for both surgeons and the patients. [23] It is associated with hypertonia of internal sphincter [24], and the traditional therapy of lateral sphincterotomy has been effective in muscle relaxation and thus pain relief. [25] but it was found to be associated with fecal incontinence (up to 8-30%). [26,27] That why, the aim of the current study is to determine the best Medical alternatives by either using natural pharmacological agents like aloe vera or simple non-invasive inexpensive physiotherapeutic modality such as TENS.

Earlier studies [19,20] have proved that either TENS or Aloe vera was effective in reducing the post-haemorrhoidectomy pain but no studies have been made to detect what is the superior treatment modality. In our current study all confounding variable such as age, sex, degree of haemorrhoid and technique of haemorrhoidectomy was controlled and there was no significant difference between both treatment groups and control group.

Our current study revealed that there was no significant difference (p>0.05) between both treatment groups and control group on the amount of pain experienced post-haemorrhoidectomy measured by VAS which mean that any reduction will be due to the application of either TENS or aloe vera cream.

The current study revealed that aloe vera cream was highly effective in reducing post-haemorrhoidectomy pain either at the end of 1st or 2nd week (p<0.05) when compared with the control group, This results goes hand in hand with the result of Eshghi et al [19] who studied the effect of aloe vera cream on the reduction of pain and enhancement of wound healing on forty nine patients undergoing haemorrhoidectomy and found that Application of Aloe vera cream on the surgical site is effective in reducing postoperative pain both on resting and during defecation, healing time, and analgesic requirements in the patients compared with the placebo group.

Similarly TENS application on acupuncture point was effective in reducing post-haemorrhoidectomy pain either at the end of 1st or 2nd week (p<0.05) when compared with the control group. This results goes hand in hand with the result of Chiu et al [20] who studied the effect of application of TENS on acupuncture point on reducing post-haemorrhoidectomy pain and found that, TENS is effective for pain relief in patients receiving haemorrhoidectomy. Its efficacy and safety could assist outpatient pain management after haemorrhoidectomy.

On the other hand, our study revealed that aloe vera cream was more superior than TENS application on acupuncture point (p<0.05) and this results was documented by a significant reduction in the analgesic consumption in aloe vera group when compared with either TENS or control group. The superior efficacy might be due to the ability of aloe vera cream in enhancing wound healing, decreasing inflammation and edema [18] which are considered as a primal factors in post-haemorrhoidectomy pain.

Conclusion

The result of the current study have showed that aloe vera cream is more superior to TENS application in reducing post- haemorrhoidectomy pain and decreasing analgesic consumption.

ACKNOWLEDGEMENT

We are indebted to Cairo University, Cairo, Egypt, Faculty of Physical Therapy, Department of Physical therapy for Surgery, for their permission to commencement the study in the Om El Masryine Teaching Hospital/physiotherapy departments and to the participants.

References

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[8.] Svendsen CBS, Matzen P. Treatment of chronic anal fissure with topically applied nitroglycerin ointment. A systematic review of evidence-based results. Ugeskrift for laeger 2002, 164:3845-9.

[9.] Balfour L, Stojkovic SG, Botterill ID, Burke DA, Finan PJ, Sagar PM: A randomized, double-blind trial of the effect of metronidazole on pain after closed hemorrhoidectomy. Diseases of the colon and rectum 2002, 45:1186-90; discussion 1190-1.

[10.] Carapeti EA, Kamm MA, McDonald PJ, Phillips RK: Double-blind randomised controlled trial of effect of metronidazole on pain after day-case haemorrhoidectomy. Lancet 1998, 351:169-72.

[11.] Nicholson TJ, Armstrong D: Topical metronidazole (10 percent) decreases posthemorrhoidectomy pain and improves healing. Diseases of the colon and rectum 2004, 47:711-6.

[12.] Han JS, Chen XH, Sun SL, Xu XJ, Yuan Y, Yan SC, Hao JX, Terenius L: Effect of low- and high-frequency TENS on Met-enkephalin-Arg-Phe and dynorphin A immunoreactivity in human lumbar CSF. Pain 1991, 47:295-8.

[13.] Han JS, Wang Q: Mobilization of specific neuropeptides by peripheral stimulation of identified frequencies. NIPS 1992, 7:176-180.

[14.] Kaada B: Successful treatment of esophageal dysmotility and Raynaud's phenomenon in systemic sclerosis and achalasia by transcutaneous nerve stimulation. Increase in plasma VIP concentration. Scandinavian journal of gastroenterology 1987, 22:1137-46.

[15.] Guelrud M, Rossiter A, Souney PF, Mendoza S, Mujica V: The effect of transcutaneous nerve stimulation on sphincter of Oddi pressure in patients with biliary dyskinesia. The American journal of gastroenterology 1991, 86:581-5.

[16.] Habeeb F, Shakir E, Bradbury F, Cameron P, Taravati MR, Drummond AJ, Gray AI, Ferro VA: Screening methods used to determine the antimicrobial properties of Aloe vera inner gel. Methods (San Diego, Calif.) 2007, 42:315-20.

[17.] Maenthaisong R, Chaiyakunapruk N, Niruntraporn S, Kongkaew C: The efficacy of aloe vera used for burn wound healing: a systematic review. Burns: journal of the International Society for Burn Injuries 2007, 33:713-8.

[18.] Surjushe A, Vasani R, Saple DG: Aloe vera: a short review. Indian journal of dermatology 2008, 53:163-6.

[19.] 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-control study. Journal of alternative and complementary medicine (New York, N.Y.) 2010, 16:647-50.

[20.] Chiu JH, Chen WS, Chen CH, Jiang JK, Tang GJ, Lui WY, Lin JK: Effect of transcutaneous electrical nerve stimulation for pain relief on patients undergoing hemorrhoidectomy: prospective, randomized, controlled trial. Diseases of The Colon And Rectum 1999, 42:180-185.

[21.] DeSantana JM, Santana-Filho VJ, Guerra DR, Sluka KA, Gurgel RQ, da Silva WM: Hypoalgesic effect of the transcutaneous electrical nerve stimulation following inguinal herniorrhaphy: a randomized, controlled trial. The journal of pain: official journal of the American Pain Society 2008, 9:623-9.

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[24.] Garcea G, Sutton C, Mansoori S, Lloyd T, Thomas M: Results following conservative lateral sphincteromy for the treatment of chronic anal fissures. Colorectal disease: the official journal of the Association of Coloproctology of Great Britain and Ireland 2003, 5:311-4.

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Source of Support: Nil

Conflict of interest: None declared

Emad Ahmed

Physical Therapy Department for Surgery, Faculty of Physical Therapy, Cairo University, Egypt

Correspondence to: Emad Ahmed (emadtawfik72@yahoo.com)

DOI: 10.5455/ijmsph.2013.2.221-226

Received Date: 27.11.12012

Accepted Date: 28.11.2012

Table-1: Prevalence of Confounding Variable in
both Treatment Groups and Control Group

Variables                Aloe         TENS        Control     p value *

Age (Mean [+ or       34.1 [+ or   3 5.0 [+ or   33.8 [+ or    > 0.05
  -] SD)                -] 0.7        -] 0.5       -] 0.7
Haemorrhoid Gr. III       7             6            7         > 0.05
Haemorrhoid Gr. IV        3             4            3         > 0.05

* p value > 0.05: Not significant

Table-2: Postoperative Pain Scores in Aloe vera, TENS
and Control Groups

Time                             Groups

                        Aloe               Control

Immediately       8.10 [+ or -] 0.7   8.50 [+ or -] 0.5
  postoperative
At the end of     2.70 [+ or -] 0.6   6.10 [+ or -] 0.7
  1st week
At the end of     1.00 [+ or -] 0.3   3.70 [+ or -] 0.9
  2nd week

Time                   Groups                  p value

                        TENS            X        Y        Z

Immediately       8.50 [+ or -] 0.7   >0.05    >0.05    >0.05
  postoperative
At the end of     4.10 [+ or -] 0.7   <0.001   <0.001   <0.001
  1st week
At the end of     2.90 [+ or -] 0.7   <0.001   <0.01    <0.001
  2nd week

X: Comparison between Aloe Group vs. Control Group; Y:
Comparison between TENS Group vs. Control Group; Z:
Comparison between TENS Group vs. Aloe Group; P value:
>0.05--Not Significant, <0.01--Significant, <0.001--Highly
Significant

Table-3: Post-haemorrhoidectomy Nonnarcotic Analgesic Consumption
in Aloe, TENS and Control Groups during 2 Weeks after Discharge from
Hospital

Time           Groups                     p value

               Aloe    Control    TENS      X        Y       Z

At the end     500.0   1500.0    1000.0   <0.001   <0.05   <0.05
 of 2nd week

X: Comparison between Aloe Group vs. Control Group; Y: Comparison
between TENS Group vs. Control Group; Z: Comparison between TENS
Group vs. Aloe Group; P value: >0.05--Not Significant,
<0.01--Significant, <0.001--Highly Significant
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Title Annotation:RESEARCH ARTICLE
Author:Ahmed, Emad
Publication:International Journal of Medical Science and Public Health
Article Type:Report
Geographic Code:7EGYP
Date:Apr 1, 2013
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