Traditional Chinese medicine herbs for preventing bleeding from haemorrhoids
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
This review will compare the effects of Chinese medical herbs with other therapeutic interventions such as surgery, 'western medicines' (the use of Indometacin, Furazolidone Suppositories, Paraphlebon, etc) for prevention of bleeding from haemorrhoids.
This review will also evaluate the adverse events associated with the use of medical herbs in the treatment of bleeding from haemorrhoids.
Background
Haemorrhoids is a common disease, whose etiological factors are still not clarified completely. According to the anocutaneous site, haemorrhoids are divided into three types: internal, external, or mixed haemorrhoids. The incidence of haemorrhoids increases by age, and 60 to 80% of adults will have some degree of discomfort from them (An 1998).
Symptoms of haemorrhoids varies. Some are only identified upon anorectal examination (An 1998), whereas others give symptoms, such as bleeding after defecation, pain in the anal area, perianal inflammation, perianal venous prolapse or incarceration, pruritus ani e.g..
Main viewpoints are that haemorrhoids is caused mainly by anal pulvinus pathological hypertrophy (An 1998) and perianal varicosis (Liu 1995). Anatomical examinations point out that there are many arteriovenous anastomosis and venous lacuna‐change, telangiectasis, many of the blood vessels are full of thromboses (Li 1990). Other researches report that haemorrhoids are caused by hypertension of the anal cushions (Sun 1992), and constipation and anal hypertonia have also played an important role in the onset of haemorrhoids (Gibbons 1988).
Traditional therapeutic strategies of western medicine include surgical as well as non‐surgical treatment (Johanson 2002). To alleviate some symptoms caused by haemorrhoids, such as hematochezia or pain in the anal area e.g., oral medicine, such as fibre supplements and oral Diosmin (Daflon), has been given to the patients. Other non surgical treatments, such as Infrared Photocoagulation (Dimitroulopoulos 2005) and injection sclerotherapy, rubber band ligation (Dennison 1989), are used to fixate the haemorrhoidal cushion, when the efficacy of the medicine is too weak. And finally, if non surgical treatment is without any effect, the surgical Hemorrhoidectomy (Mikubi 2004) is used as treatment.
According to the traditional Chinese medical theory (pathogenesis), haemorrhoids is caused by imbalance of Yin and Yang, and influenced by six climatic conditions in excess of pathogenic factors, such as wind, cold, summer‐heat, dampness, dryness and fire. Overall, these factors have a negative impact on human emotions, including joy, anger, melancholy, anxiety, grief, and fear. Clinical manifestation consists of large intestinal heat‐accumulation, continuing to diarrhoea, deficiency of qi and blood, collapse of qi e.g..
Traditional China medical herbs(TCMHs) have been used for the treatment of haemorrhoids for many years: Rhubarb, Baikal skullcap root, Chinese nut‐gall, Bitter orange (Wang 2001), Radix Angelicae Sinensis, Radix Rehmanniae Praeparata, Rhizaoma Ligustici Chuanxiong, Radix Paeoniae Alba, Radix Sanguisorbae, Herba Agrimoniae (An 1998), have all showed beneficial effects on the treatment of symptomatic haemorrhoids on outcomes, such as bleeding, incarceration, inflammation,etc. Specially bleeding, which is mainly caused by internal haemorrhoids, can be evoked repeatedly by many factors, such as constipation, pungent food etc. In TCM, some herbs would be added to the main recipes for bleeding from haemorrhoids, for example Galla Chinensis or Borneolum (Liu 1999).
Although a number of trials, clinical case reports, RCT's and CCT's (quasi‐RCT) (Xu 2002), have reported effects of Chinese medical herbs in the treatment of symptoms from haemorrhoids (beneficial as well adverse effects), the quality of these studies have not been assessed systematically.
Objectives
This review will compare the effects of Chinese medical herbs with other therapeutic interventions such as surgery, 'western medicines' (the use of Indometacin, Furazolidone Suppositories, Paraphlebon, etc) for prevention of bleeding from haemorrhoids.
This review will also evaluate the adverse events associated with the use of medical herbs in the treatment of bleeding from haemorrhoids.
Methods
Criteria for considering studies for this review
Types of studies
All parallel‐group randomised controlled trials (RCTs) involving medical herbs in the treatment of haemorrhoids. Controlled clinical trials and cohort studies will not be eligible for inclusion in the Review. There will be no language restrictions.
Types of participants
All patients diagnosed with haemorrhoids, either confirmed by surgery or diagnosed clinically at anorectal examination, rectoscopy etc., will be included.
Patients diagnosed with other anorectal diseases accompanied with bleeding (for example malignant anorectal tumour, anal fistula, perianal abscess or inflammation ,etc.) will be excluded.
Definitions of haemorrhoids will include any relevant symptoms referred to in 'Practical Internal Medicine (Chen 1993)', the new 'Chinese Traditional Medicine Study and Instruction Principle in Clinic' (Wang 1993) and the 'Chinese Traditional Sign and Diagnosis' (Zhang 1987). Diagnosis standard as described by Li et al. (Li 1990) encompasses:
a. typical history of haemorrhoids, accompanied with positive physical signs or not.
b. results of some auxiliary equipments, such as anorectoscopy, etc, which confirm that haemorrhoids are present in the anorectal sites of the patient.
c. haemorrhoids diagnosed by the findings during the operation of anorectum.
Types of interventions
Medical herbs (single herb or herbal compounds) will be compared to drug treatments, such as Paraphlebon and Indometacin and Furazolidone Suppositories , and with placebo or no intervention.
Trials with medical herbs plus other treatment versus other treatment alone will also be included.
Types of outcome measures
The following outcomes will be evaluated:
Primary outcome measures:
1) Number of patients having complication caused by haemorrhoids, i.e. hematochezia, anal constriction, anal fistula, anal fissure, or similar clinical manifestation.
2) Number of patients relieving from the complication, i.e. hematochezia, pain in the anal area, perianal inflammation, perianal venous prolapse or incarceration, pruritus ani, etc., after TCMHs intervention.
3) Number of patients without recurrent symptoms, i.e., hematochezia, pain in the anal area, perianal inflammation, perianal venous prolapse or incarceration, pruritus ani, etc.
4) Number of patients with adverse events. Adverse events will be defined as any untoward medical occurrence not necessarily having a causal relationship with the treatment, but resulting in a dose reduction or discontinuation of treatment. Severe adverse events will be defined according to the ICH guidelines (ICH‐GCP 1997), and include mortality; morbidity; prolonged hospitalisation; persistent or significant disability; or any important medical event which may jeopardise the patient or requires intervention to prevent it.
Search methods for identification of studies
We will search the following bibliographic databases in order to identify relevant trials: The Cochrane Colorectal Cancer Group Controlled Trials Register, The Cochrane Central Register of Contolled Trials (CENTRAL) on The Cochrane Library, MEDLINE, EMBASE, and CMCD (Chinese Medicine Conference Disc), and CBMD (Chinese Bio‐Medicine Disc) from 1966 to 2007, we will use text words combined with MeSH terms; i.e., haemorrhoids, medicine‐Chinese‐traditional, plants‐medical, drugs‐Chinese‐herbal, plants extracts, and herbs.
We will search the following journals for relevant studies from the first publication date onwards: Chinese Journal of Integrated Traditional and Western Medicine of Zhejiang (from 1991 to 2007), Chinese Journal of Being University of Traditional Chinese Medicine (from 1980 to 2007), Chinese Surgical Journal of Integrated Traditional and Western Medicine (from 1994 to 2007) and the Chinese Journal of Integrated Traditional and Western Medicine (from 1980 to 2007). Conference proceedings unpublished in journals, such as Chinese anorectal conference proceedings, etc. in a word, the main Chinese journals about TCMHs for haemorrhoids will be handsearched, and other RCTs about TCMHs for haemorrhoids will be registered if we can obtain them.
If missing information or data in the trial reports, we shall correspond with the principal investigator of the relevant study.
Data collection and analysis
Study selection:
Two reviewers (Li Y and Gan T) will independently select the trials to be included in the review according to the pre‐stated eligibility criteria. Disagreements will be resolved by discussion, and if this does not solve the disagreement a third reviewer (Wang Y) will be consulted. These included/excluded decisions will be based on the whole contents of the trials if available, and the included ones will be recorded on a specially developed form.
Assessment of trial quality:
The methodological quality will be assessed by four separate components, i.e., adequacy of generation of the allocation sequence, allocation concealment, double blinding, and follow‐up ‐ according to Kjaergaard et al. (Schulz 1995; Moher 1998; Kjaergaard 2001).
generation of the allocation sequence: adequate (computer generated random numbers or similar) or inadequate (other methods, or not described);
‐ allocation concealment: adequate (central independent unit, sealed envelopes, or similar) or inadequate (not described, or open table of random numbers, or similar);
‐ double‐blinding: adequate (identical placebo tablets, or similar) or inadequate (not performed, or tablets versus injections, or similar);
‐ follow‐up: >half a year at least; adequate (number and reasons for drop‐outs and withdrawals described) or inadequate (number or reasons for drop‐outs and withdrawals not described).
Further, we will register whether the trials reported on whether intention‐to‐treat analysis was used or not (Gluud 2001).
Extraction of data:
We will extract and report data onto specially developed forms. Extraction will be undertaken by one reviewer (Li Y) and checked by a second (Yang J). Data entry into RevMan will also be double‐checked.
The following characteristics will be recorded for each trial:
Details of the participants including demographic characteristics, source of recruitment, criteria for diagnosis, and haemorrhoids symptoms on presentation. Trials will be categorised where possible according to the most prevalent type of haemorrhoids, such as hematochezia, pain in the anal area,perianal inflammation,perianal venous prolapse or incarceration, pruritus ani,etc.
Details of the experimental and control interventions including intervention type, names. Dosages and schedules will be included where appropriate.
The prevalence of individual haemorrhoids, symptoms before and after the intervention will be noted.
Data will be extracted from intention to treat analyses if they are presented.
Statistical analysis:
All analyses will be performed according to the intention‐to‐treat principle including all randomised patients. Patients without the outcome variable will be considered failures ('worst case scenario analysis' will be carried out).
For binary outcomes, such as the presence or absence of symptoms, the impact of the intervention will be expressed as relative risks together with 95% confidence intervals. For continuous outcomes, means and standard deviations will be used to summarise the value in each group. Weighted mean difference or standardised mean differences for continuous outcomes will be used depending on whether the continuous data have used the same scale or not. We will conduct all meta‐analyses by both the random effects model and the fixed effect model. However, we will only report the results of the random effects model analyses unless the results of the two models differ (one significant, the other insignificant). In the latter case we will report both model analyses.
‐ Subgroup analysis
We will compare subgroups of trial with and without adequate methodological components (generation of allocation sequence, allocation concealment, double‐blinding, follow‐up) regarding the primary outcome measures.
Further subgroup analyses will analyse the association between dose and duration of experimental interventions and intervention effect as well as the association between disease severity at entry and intervention effect.
‐ Funnel plot analysis
Funnel plot asymmetry will be estimated by regression analysis as described by Egger 1997.
