Research Commentary [21] August 2018

Aug 1, 2018

This review focuses on Complementary Medicines.

It is a 4-part series about complementary medicines and alternative healthcare in New Zealand. The reviewed topics will include

  1. Complementary medicines
  2. Traditional Chinese Medicines (TCM)
  3. Yoga 
  4. Mindfulness, meditation and relaxation 

This issue will focus on the growing use of herbal medicines, community pharmacist’s views on the regulation of complementary medicines in New Zealand, and integrating complementary medicines into pharmacy and medical practice. 

Pharmacists need to be knowledgeable about complementary products and medicines to manage drug interactions and to assist consumers to make informed decisions, particularly as the Natural Health and Supplementary Products Bill is making its way through the legislative process. The bill will establish a new regulatory regime, separate from those in place for food and medicines. It will control low-risk natural health products such as garlic capsules and Echinacea, and supplementary products such as vitamin tablets. The full regulatory scheme will be phased in over three years after the legislation comes into force. The regime is intended to ensure that the natural health and supplementary products consumers use to support their health and wellbeing are safe to use, that the health claims are true and that the products are made and contain what their label says they do.

The regulatory scheme will cover over-the-counter products. Products made by a practitioner for an individual patient are exempt from the legislation – this includes rongoā Māori, and traditional Chinese medicine, as traditionally practiced, though if these products are subsequently sold over the counter they will be covered. For further information go to: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/natural-health-and-supplementary-products

Commentary provided by Dr Annette Mortensen, eCALD® Services Project Manager: Research and Development 

The following articles are reviewed:

Article 1: The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety

The use of herbal medicinal products and supplements is increasing significantly, with 80% of people worldwide including them in their primary healthcare. Although therapies involving these agents have shown promising potential, with the efficacy of a good number of herbal products clearly established, many remain untested and their use is either poorly monitored or not monitored at all. The consequences of this are an inadequate knowledge of their mode of action, potential adverse reactions, contraindications, and interactions with prescribed pharmaceuticals. As safety continues to be a major issue with the use of herbal remedies, having regulations in place is essential to ensure that all herbal medicines are safe and of a suitable quality. This review discusses toxicity-related issues and major safety concerns arising from the use of herbal medicinal products and also highlights some important challenges associated with effective monitoring of their safety.

The use of herbal medicines represents approximately 40% of all healthcare services delivered in China while the percentage of the population which has used herbal medicines at least once in Australia, Canada, USA, Belgium, and France is estimated at 48%, 70%, 42%, 38%, and 75%, respectively. In spite of patient’s positive perceptions of the use of herbal medicines and satisfaction with therapeutic outcomes the problem of safety of herbal remedies continues to remain a major issue of concern. The general perception that herbal remedies or drugs are safe and “natural” and devoid of adverse effects is misleading. Herbs have been shown to be capable of producing a wide range of undesirable or adverse reactions some of which are capable of causing serious injuries, life-threatening conditions, and even death.

Health practitioners, often have little training in and understanding of how herbal medicines affect the health of their patients. Many are also poorly informed about these products and how they are being used. Training on asking about the use of CM is now essential as many patients take a combination of prescription or non-prescription medicines. Importantly, the author highlights the need for health practitioners to make a commitment to understanding their patient’s use of herbal medicines and to have an appropriate knowledge of herbal drug interactions. It’s best to ask your patients if they are taking herbal remedies and what they are taking. 

Author: Ekor, M.

Citation: Ekor, M. (2014). The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Frontiers in Pharmacology, 4, (177), 1-10. 

Publication

Article 2: Community pharmacists’ views on the regulation of complementary medicines and complementary-medicines practitioners: a qualitative study in New Zealand

The study indicates general support among NZ community-pharmacist respondents for some form of regulation for CMs in NZ. In particular, participants recognised the inadequacies of the current situation with respect to providing assurances on product quality, and believed an appropriate regulatory system that required adherence to the principles of good manufacturing practice would remedy this. Participants stopped short of supporting full regulation of CMs in line with requirements for conventional medicines, recognising that requiring efficacy data from clinical trials, and comprehensive safety/toxicity testing, would place unachievable demands on CMs manufacturers and stringent regulations would negatively impact the CMs market.

The findings of the study are consistent with those from studies involving pharmacists outside New Zealand, particularly with respect to pharmacists’ demands for impartial evidence to support CMs’ health claims and stronger assurances on product quality. However, in countries where CMs are already regulated under a simplified framework (such as Australia), pharmacists still believe information on CMs is lacking, and that CMs require further testing before they can be used in conventional medicine. 

Studies consistently report that pharmacists should be knowledgeable about CMs (but generally are not). There has been a decline in pharmacognosy (the scientific discipline underpinning natural products as medicines) in many Schools/Departments of Pharmacy. However, interestingly the authors note that teaching on CMs is re-emerging in some pharmacy curricula. 

Authors: Barnes, J. & Butler, R.

Citation: Barnes, J. & Butler, R. (2018). Community pharmacists’ views on the regulation of complementary medicines and complementary-medicines practitioners: a qualitative study in New Zealand. Int J Pharm Pract. 2018; Jan 19 [Epub ahead of print]  

Publication

Article 3: Development of a strategic model for integrating complementary medicines into professional pharmacy practice

This Australian investigation used focus groups to explore pharmacists’ opinions about how to integrate traditional medicine (TM) and complementary medicine (CM) products into pharmacy practice. Eleven registered pharmacists who had worked in community pharmacy for more than 6 months participated in focus groups. The focus groups identified that professional pharmacy organisations, universities, government, pharmacy owners, and pharmacists need to collaborate to develop education and training, reliable TM/CM information resources, and workplace practice standards. This study highlights the view that pharmacists need to be knowledgeable about CM products to manage drug interactions and assist consumers in making informed decisions. 

The authors note that some of the actions identified in the study, namely: education and training; build CM evidence base; CM resources and; workplace support for best CM practice, are already underway. The Australian Therapeutic Goods Administration (TGA) has launched a consultation paper about CMs regulatory process reform. Among the numerous recommendations, the TGA proposes a new assessment process to evaluate and identify CMs with evidence base for efficacy. CMs which have been fully assessed by the TGA for efficacy would be placed in a new class of medicine for easy identification. Some Australian universities are already teaching CMs to pharmacy students and are testing and validating the teaching model.The evaluation could inform and contribute to the standardisation of CMs teaching in undergraduate pharmacy courses in New Zealand.

These findings of the study are informative for the New Zealand Natural Health and Supplementary Products Bill 

Authors: Ung, C. O. L., Harnett, J. & Hu, H.

Citation: Ung, C. O. L., Harnett, J. & Hu, H. (2017). Development of a strategic model for integrating complementary medicines into professional pharmacy practice. Res Social Adm Pharm, 14 (7), 663-672.

Publication

Article 4: Key stakeholder perspectives on the barriers and solutions to pharmacy practice towards complementary medicines: an Australian experience

This Australian study based on key complementary medicine and conventional medicine stakeholders including practicing pharmacists, pharmacy owners, pharmacist professional organisations, consumer advocacy groups, physician professional organisations, CM practitioner professional organisations, pharmacy schools, regulatory authority, and the CM industry provides insight into the major barriers hindering pharmacists from taking up a role in CMs and their suggestions about the actions that are required to move forward. The findings have value for informing and guiding quality improvement in the area of CMs in New Zealand pharmacy practice in the areas of CM education and training, a clearer definition of pharmacists’ responsibilities and standard of practice related to CMs, and reliable and reputable information resources.

The demand for education and training in the area of CMs is a recurrent message throughout the key stakeholder interviews. The need for teaching about evidence-based CMs for pharmacy students was reinforced in this study. Specifically, focused learning about CM products, analytical skills to support the pharmacists’ consultative role, communication skills to facilitate cooperation with doctors and to reduce non-disclosure, and ethics to optimise pharmacist’s moral sensitivity when working in a pharmacy business setting have been suggested as the building blocks of the syllabus. 

Authors: Ung, C.O.L., Harnett, J. & Hu, H.

Citation: Ung, C.O.L., Harnett, J. & Hu, H. (2017). Key stakeholder perspectives on the barriers and solutions to pharmacy practice towards complementary medicines: an Australian experience. BMC Complementary and Alternative Medicine, 17, 394.

Publication

Article 5: Do NHS GP surgeries employing GPs additionally trained in integrative or complementary medicine have lower antibiotic prescribing rates? Retrospective cross-sectional analysis of national primary care prescribing data in England in 2016

This study aimed to determine differences in antibiotic prescription rates between conventional General Practice (GP) surgeries and GP surgeries employing general practitioners (GPs) additionally trained in integrative medicine (IM) or complementary and alternative medicine (CAM) (referred to as IM GPs) working within National Health Service (NHS) England.IM GP surgeries were comparable to conventional GP surgeries in terms of list sizes, demographics, deprivation scores and comorbidity prevalence. Negative binomial regression models showed that statistically significant fewer total antibiotics and Respiratory Tract Infection (RTI) antibiotics were prescribed at NHS IM GP surgeries compared with conventional NHS GP surgeries. In contrast, the number of antibiotics prescribed for Urinary Tract Infections (UTI) was similar between both practices. The authors concluded that NHS England GP surgeries employing GPs additionally trained in IM/CAM have lower antibiotic prescribing rates. However, in England as in New Zealand the accessibility of IM/CAM in the publicly provided primary health system is limited. Lack of information on the number of consultations is an important limitation of this study. 

The lower antibiotic prescription rates of IM GPs are in line with the current British and New Zealand guidance aimed at reducing antibiotic usage and anti-microbial resistance (AMR).IM GPs might possibly comply more closely with this guidance. However, the difference found could also be partly explained by the fact that patients who consult IM GPs might demand less antibiotics, and that GPs in IM surgeries have other avenues to offer to patients than antibiotics or that they are more confident to delay prescriptions and to assert themselves against the wishes of those patients who appear to want antibiotics. 

For the majority of RTIs it is recommended that antibiotics should be avoided or delayed, so that this is an area where the desired reduction in prescribing could take place. In the case of UTIs, antibiotics are advised more readily. For several RTIs, including common colds, sore throat, sinusitis and acute bronchitis, randomised controlled trials (RCTs) have shown that antibiotics provide no, or negligible benefit compared with placebo. As such, symptom management with paracetamol, ibuprofen or the use of CAM therapies proven to be effective and safe for RTIs may safely reduce antibiotic prescribing among patients with a low risk for pneumonia. 

Having even one CAM contact within a general practice might give the possibility for others to experience CAM perspectives either formally or informally, and for long-held attitudes to be perhaps modified.  

Authors: van der Werf, E.T., Duncan, L.J., Flotow, P., et al.

Citation: van der Werf, E.T., Duncan, L.J., Flotow, P., et al. (2018). Do NHS GP surgeries employing GPs additionally trained in integrative or complementary medicine have lower antibiotic prescribing rates? Retrospective cross-sectional analysis of national primary care prescribing data in England in 2016. BMJ Open,8, e020488. doi: 10.1136/bmjopen-2017-020488.

Publication

Article 6: Effectiveness of two different herbal toothpaste formulations in thereduction of plaque and gingival inflammation in patients with established gingivitis-A randomized controlled trial

Plant based toothpastes have received great attention in reducing gingival inflammation. This study compared two herbal toothpastes while the majority of the studies have compared herbal with non-herbal toothpaste.

Studies show contrasting results regarding the effectiveness of these toothpastes. In the present study, the effectiveness of two herbal tooth paste formulations in the reduction of plaque and gingival inflammation was assessed.  When the two groups (test and control groups) were evaluated, after 30 days, the test group presented an average 21.08% reduction in plaque and the control group showed 31.85% reduction in plaque scores. The mean reduction in gingival index (GI) scores was 25.92% and 19.14% in the test and control groups respectively. Both herbal based toothpastes reduced plaque levels and gingival inflammation. There were no additional benefits of the Parodontax® toothpaste over Colgate® Herbal toothpaste. 

There is a renewed interest in using herbal based products. In the indigenous systems of medicine, different components of different plants have been used in medicinal preparations to clean teeth or to treat oral diseases including periodontal disease. Herbal-based toothpastes are as effective as the conventionally formulated toothpastes in the control of plaque and gingivitis. Unfortunately neither of these products is available in New Zealand supermarkets.

Authors: Hosadurga, R., Boloor, V.A., Rao, S.N. & MeghRani, N.

Citation: Hosadurga, R., Boloor, V.A., Rao, S.N. & MeghRani, N. (2018). Effectiveness of two different herbal toothpaste formulations in the reduction of plaque and gingival inflammation in patients with established gingivitis-A randomized controlled trial. Journal of Traditional and Complementary Medicine 8, 113e119. 

Publication