Writing For The Sciences 2019

Literature Review Final Draft

Ifeoluwa Tugbobo          May 6th , 2016

Writing For The Sciences        Deeadra Brown

Efficacy of Herbal Therapy on Arthritic Pain: A Review of Literature

Abstract

Herbal medicines are a growing market amongst those with rheumatoid arthritis, so there is the same desire to assess their efficacy. The objective of this review was to investigate the use of several herbal therapies for arthritis using the results and conclusions from randomized clinical and non-clinical trials. A computerized search of electronic databases and the bibliographies of identified articles resulted in 4 studies meeting the criteria for this literature review. There is support that several of the treatments-OTC Reumalex, Hyben Vital, rosehip, and ginger- for a reduction in pain, tender joints, and stiffness. The various herbal medicines had only a single study accessible.  In general, the researchers stated that the preparation of the herbal therapies was safe to consume. Further evidence is needed to support, however, that herbal medicines are effective and safe for treatment of rheumatoid arthritis.

 

Introduction

Rheumatoid arthritis (RA) is a chronic condition that affects over 1.3 million Americans and about 1% of the world population (McInnes & Schett, 2017). RA is a progressive, inflammatory disorder that irreversibly affects the joints, especially those in the hands and feet, which causes painful swelling.  Over time, the inflammatory processes involved in RA can lead to bone erosion and joint deformity. RA is distinguished from other inflammatory illnesses in the bone loss in the joints, somatic bone loss, and thinning of the tissue around the joints persisting over time Joint erosion, one of the symptoms of RA, has been linked to functional disability and bone fracture amongst RA sufferers (Willich et al., 2010). As for RA treatment, there is no known cure or way to prevent developing RA (5). The American College of Rheumatology advocates that patients get diagnosed as early as possible and recommends treatment with modifying antirheumatic agents, including Otezla and Arava, to hinder the magnitude of joint damage. Current medications for RA  are limited in their efficacy and are frequently toxic (5).

Osteoarthritis (OA) affects up to 20 million people every day in the United States. OA is a subset of arthritis that occurs when the flexible, pliable tissue at the ends of the bones begin to deteriorate. OA is characterized by joint pain in the hands, neck, lower back, knees or hips. Other symptoms include joint stiffness, joint swelling, joint tenderness, bony growths in fingers and toes, and limping (Berenbaum, 2013).

The importance of herbal therapies as a potential avenue for medicine is understanding that human-made medicine may cause more detrimental effects than positive effects. The benefits of herbal medicine may outweigh the damaging effects of traditional medicine. Herbal medicine is considered more affordable, often more comfortable to obtain,  and has been known to have fewer side effects than conventional drugs. The world population increase has influenced increased use of plant materials for medicine for a variety of human illnesses, the rising cost of treatment and overall adverse side effects of synthetic drugs and the resistance of pathogens to currently used drugs for communicable diseases (Long, Soeken, & Ernst, 2001).

This literature review focused primarily on four distinct herbal therapies: Reumalex, rosehip powder, Hyben Vital powder, and ginger extract. Reumalex is an over the counter (OTC) herbal treatment containing pulverized white willow bark, guaiacum resin, black cohosh, and extracted poplar bark. Willow bark and poplar bark has been known to treat inflammatory diseases. In North American Indian and settler traditions, the other ingredients in Reumalex have been known to treat rheumatic diseases. Because the parts are in low doses, no dramatic effect was expected, and physicians can be sure it is unlikely to interfere with other prescribed medications. In numerous studies, rose hip powder has been characterized as having strong antioxidant properties  (Halvorsen et al. 2002 cited in Willich et al., 2009 ) when compared to various fruits, vegetables, and berries. Scientifically, rose hip extract reduces the release of reactive oxygen species from neutrophils, which indicates that it may protect different tissues (Kharazmi and Winther 1999; Deals-Rakotoarison et al. 2002, cited in Willich et al., 2009). Antioxidant capacity was noted to be reported to be reduced in RA (Sarban et al. 2005, cited in Willich et al., 2009). It had been suggested that antioxidants may prevent symptoms of RA by modifying cartilage destruction(Schwager et al. 2008, cited in Willich et al., 2009). There were also several findings from randomized clinical studies in OA patients where results showed rosehip powder reduced pain and improved physical activity (Warholm et al. 2003; Winther et al. 2005, cited in Willich et al., 2009). Hyben Vital powder contains seeds from a specific subtype of Rose canina, pectins, b-carotene, b-sitosterol, folic acid, Vitamin E, copper, and flavonoids. Hyben Vital helps to control the inflammation for RA by reducing chemotaxis and generation of free radicals in white blood cells. In a study investigating OA and Hyben Vital powder, many patients reported the pain symptoms diminished after a few weeks of treatment (Winther et al., 1999; Kharazmi and Winther, 1999 cited in Rein et al., 2004). Zingiber, a species of Zingiberaceae family (gingers), is the commonly used herbal supplement and its effects have been shown since ancient times; in ancient China it had been used to treat upset stomach, nausea, vomiting, and diarrhea (Altman, 1992; Ali et al., 2008, cited in Zakeri et al., 2011). Several studies have shown that is effective in relieving symptoms of OA by reducing inflammation with the inhibition of the tumor necrosis factor alpha and cyclooxygenase expression   (Altman et al., 1986; Srivastava and Mustafa, 1992; Bliddal et al., 2000; Wigler et al., 2003; Frondoza et al., 2004; Chrubasik et al., 2007; Ali et al., 2008, cited in Zakeri et al., 2011 ).

   Organizationally, this literature review comparatively analyzed patient selection/group matching process with patients with RA/OA/back pain, questionnaire assessment to quantitatively evaluate the state of the patients’ pain symptoms, and adverse effects of the various herbal treatments in clinical trials. With thorough investigation and extensive research, the literature review provided information about the effectiveness and efficacy of herbal therapies as a method for treating RA, OA and back pain when compared to manufactured counterparts. Therefore, the purpose of this literature review was to examine the current clinical trials for the use of herbal medicines for RA based on randomized clinical trials of herbal therapies against placebos. Recent research has indicated that when compared to current conventional treatments for RA, herbal therapies are safer and more cost effective to consume. In terms of treating the painful symptoms of RA, herbal remedies are relatively effective in reducing the extent of the symptoms; however, there are still adverse side effects with herbal therapies.

 

Analysis

Patient selection/Group Matching

Each of the four studies all selected patients with similar criteria, and this was an essential factor in determining the matching of the treatment/placebo group. The subjects chosen for the study where Reumalex was investigated as an herbal therapy were relatively elderly with a mean age of approximately 62 years (standard deviation of 12.05 years). Subjects were recruited from Exeter (and its surrounding areas), pharmacies, health store outlets, magazine articles and local newspapers (Mills et al., 1996). The subjects chosen for the study done by Willich were about 90% female with a mean age of approximately 57 years. The duration of the RA progression for patients was about 13 years. Researchers stated that there were no relevant differences between the groups (Willich et al., 2009). Subjects chosen for the Rein study chose were Caucasian and were specifically recruited via local newspapers. Each subject had been diagnosed early by a general practitioner or local rheumatologist or suffering from OA. Each had an X-ray verified diagnosis and symptoms of RA/OA in the hip, knee, hand, shoulder, neck or combination of these for at least a year. All subjects chosen had reported pain of the affected joints of at least mild or moderate severity. 63% of the patients enrolled were female with a mean age of 68 years (ranging from 33-93). The other 37% of the patients were men with a mean age of the 64 years (ranging from 35-89). Researchers stated that there were no relevant differences between the groups demographically or in the severity of OA (Rein et al., 2004). Subjects chosen for the Zakeri study were patients with specifically knee OA and were recruited from the rheumatologic clinic of Imam-Ali hospital of Zahedan from September 2006 to May 2008. Patients had to report that they have knee pain while standing that was between 40 mm and 90 mm on 100 mm visual analog scale (VAS). Approximately 80% of the patients who completed the study were women. The other 20% of the patients were men (Zakeri et al., 2011). The mean age for the subjects in the treatment group was about 48 years and in the placebo group was about 45 years. The researchers all investigated a cohort of individuals, all around the same age group, further indicating that the age group known most for the diagnosis of RA and OA. The range of patients’ mean age is 45 years to 68 years old.

 

Questionnaire assessment

To assess whether the patients honestly had pain reduction, researchers provided standardized questionnaires including the improved Arthritis Impact Measurement Scales (AIMS2) health status questionnaire, Health Assessment Questionnaire (HAQ), and Western Ontario and McMaster Universities (WOMAC) questionnaire. Mills et al. (1996), who researched the over-the-counter herbal medicine Reumalex, employed a secondary version of the AIMS2 Health Status Questionnaire which is useful in establishing validity, reliability, and sensitivity in monitoring alterations in patients before and after treatment. Results showed that the statistical analysis of the AIMS2  scores between the experimental treatment group and the placebo group had no significant differences. Willich et al. (2009) experimented with a rose hip herbal remedy in RA patients and used the Health Assessment Questionnaire after a six month treatment period. HAQ and its new disability index measure the scale to which patients can carry everyday activities such as walking, dressing, hygiene ranging from 0-3 (where higher scores indicate more disability). HAQ also measures the patient’s pain level and the patient’s global scale(where the patient’s perspective is reflected), both range from 0-100. Results showed that the statistical analysis of the HAQ Patient Pain Scale scores between the experimental treatment group and placebo group had no significant differences; however HAQ Patient Global Scale, the trend was in favor of the treatment group. Rein et al. (2004) investigated herbal medicine Hyben vital on the reduction of pain symptoms. Researchers obtained assessments of changes in pain level after each treatment using an unnamed 5 step categorical scale ranging from 0 to 4, where 4 represented total relief of pain. Patients also made an assessment of joint stiffness ranging from 0 to 4, where 4 represented total relief of pain. Statistically analyzed results showed that active treatment reduced pain level scale, but this was not a statistically significant result.  Zakeri et al. (2011) evaluated the effect ginger extract on RA patients and assessed their Western Ontario and McMaster Universities (WOMAC) questionnaire. Results from the WOMAC indexes showed a greater reduction in the treatment group in pain, stiffness, and difficulty with common activities after six weeks of treatments.

 

Adverse effects

Mills reported that due to unforeseen adverse effects some patients decided to withdraw from the clinical trial. Eight subjects in all withdrew- 4 from the treatment group and four from the placebo group. From the treatment group, these adverse effects include dyspeptic symptoms, diarrhea, and severe headaches. The placebo group reported headaches, digestive upsets, angina, anxiety, and stomach cramps  (Mills et al., 1996). Similarly, Willich explained that there were about 14 reports on side effects in the treatment group and 26 placebo group. There was a severe event where a patient was suffering from vasculitis allergica, an inflammatory condition based on the reaction to allergens and characterized by itching, malaise and fever.; however, it was unclear if the patient had a specific response to the treatment considering the other medications the patient was taking.  Four patients dropped out from the treatment group whereas the placebo group lost only one patient. The researchers did not detect adverse effects were a direct effect of the use of rose hip and seed powder (Willich et al., 2009). Rein also reported that three of the hundred and twelve subjects dropped out of the clinical trial because of the study. In the placebo group there was one report of acid regurgitation, one report of diarrhea, one of frequent urination, one of constipation, one  of waterbrash and one for itchy hives; for the treatment group it was just one report of acid regurgitation, three reports of frequent urination, one report of constipation, and two reports of water brash. Researchers also stated that there were no major side effects of any kind in the whole group (Rein et al., 2004). Zakeri, comparably, reported that there was no statistically significant difference between the treatment and placebo group in terms of reported side effects. There were five cases of dyspepsia and heartburn in the treatment group whereas there were seven cases in the placebo group  (Zakeri et al., 2011). All studies mentioned concluded that there were no significant side effects that came as a result of using select herbal therapies. There were side effects noticed in both the experimental and placebo group, indicating that the side effects and herbal treatments may not be entirely related.

 

Conclusion

In summation, research on herbal therapies has shown that there is a potential to increase in the efficacy of treatment for RA. The studies also found that across multiple assessment platforms results were varied. In some cases there were non-statistically significant results in favor of the treatment; in other cases, there were statistically significant results in favor of the treatment. The incidence of reported adverse effects across the trials of herbal treatment for RA and OA is low and most adverse effects were minor. Potential adverse side effects noticed were diarrhea, digestive upset, and other gastrointestinal complications. Given the number of clinical trials in this literature review, further research is needed to examine the herbal therapies mentioned as a treatment for RA in terms of efficacy in reduction of pain symptoms, interactions with other drugs and overall safety of the herbal preparations.

 

References

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  6. Zakeri Z, Izadi S, Bari Z, Soltani F, Narouie B, Ghasemi-rad M. 2011. Evaluating the effects of ginger extract on knee pain, stiffness, and difficulty in patients with knee osteoarthritis. Journal of Medicinal Plants Research 5:3375–3379. [accessed 2019 May 13]. http://www.academicjournals.org/JMPR
  7. Willich S., Rossnagel K., Roll S., Wagner A., Mune O., Erlendson J., Kharazmi A., Sörensen H., Winther K. 2010. Rose hip herbal remedy in patients with rheumatoid arthritis – a randomized controlled trial. Phytomedicine 17():87–93. [accessed 2019 Apr 28]. https://www.ncbi.nlm.nih.gov/pubmed/19818588
  8. Rein E, Kharazmi A, Winther K. 2004. A herbal remedy, Hyben Vital (stand. powder of a subspecies of Rosa canina fruits), reduces pain and improves general well being in patients with osteoarthritis—a double-blind, placebo-controlled, randomized trial. Phytomedicine 11(8):383–391. [accessed 2019 Apr 28]. https://www.ncbi.nlm.nih.gov/pubmed/15330493