To critique the available homeopathic research on musculoskeletal disorders a literature review was undertaken with searches conducted on databases Cinahl, AMED, Embase and Cochrane using terminology including, ‘homeopathy’, ‘musculo-skeletal’, ‘musculoskeletal’, ‘skeletal’, ‘arthritis’, ‘joints’ and ‘muscle’ or combinations of these words. This literature review found a range of research trials, systematic reviews and literature relating to homeopathy and musculoskeletal complaints. This report will give evidence of why research into homeopathy in musculoskeletal disorders is important; examine the findings of 3 relevant systematic reviews and critically examine 9 homeopathic musculoskeletal trials found in more detail (see appendix 1). An overview of common problems found in the research designs used and the impact these designs have on the current state of knowledge in this field will then be discussed.
Why musculoskeletal disorders are important
Over the last decade the average life expectancy has risen by almost 20 years, however, even though much public attention is focused upon fatal diseases, chronic musculoskeletal and rheumatic diseases are a major cause of morbidity in the world today (World Health Organisation [WHO], 2003). Persistent pain associated with musculoskeletal disorders often increases with age, and morbidity factors include pain, inflammation, depression, anxiety, physical disability, sleep disturbance and impaired cognitive function (Weiner & Ernst, 2004). These factors have a major impact on quality of life and create substantial economic burden on health systems (WHO, 2003). Approximately one tenth of all General Practitioner consultations are related to musculoskeletal complaints, impacting indirect costs, as one fifth of incapacity claims sought in Great Britain are for musculoskeletal disorders (Clarke & Symmons, 2006).
Common medications used to conventionally treat musculoskeletal disorders such as arthritic pain are nonsteroidal anti-inflammatory drugs (NSAIDs) or opiods prescribed as analgesics. However, whilst these drugs may mask the pain experienced by patients, the chronicity of the complaint usually requires medication for a long period of time, which often leads to adverse drug reactions (Weiner et al., 2004). Thus patients often seek other forms of alternative or complementary treatments to improve their quality of life. This move to alternative treatment is illustrated by the patient benefit survey, conducted at the Department of Homeopathic Medicine in Liverpool, where the largest diagnostic group treated were for musculoskeletal conditions, representing 261 of the 1100 completed questionnaires (23.7%) (Richardson, 2001). A similar survey conducted by the Tunbridge Wells Homeopathic Hospital also lists musculoskeletal conditions as the second highest diagnostic group treated, accounting for 13% of its patients surveyed (Clover, 2000). Therefore, given that musculoskeletal complaints are highly prevalent in modern society with many patients seeking alternative treatment to manage their condition, it is important that we understand the available evidence for how effective homeopathy is in treating the symptoms associated with musculoskeletal disorders.
Summary and critique of the current state of knowledge
Soeken (2004) who examines systematic reviews of CAM therapies for arthritis-related pain cites one review of homeopathy and rheumatic disease by Jonas, Linde & Ramirez (2000). This review included 6 trials using either random assignment or double-blinding. Three trials were on rheumatoid arthritis (RA) and 3 other trials on osteoarthritis (OA), fibromyalgia, and myalgia. Soeken (2004) states that, using the Jadad scale, 5 of the 6 trials rated as high quality, but the interventions varied as individualized (classical) homeopathy, where the physician selects a remedy based on each patient’s individual symptoms, and complex homeopathy (where one or more remedies are given for a clinical condition) were used. Meta-analysis of these trials shows homeopathy to be twice as effective as placebo although the number of studies is small to reach a definitive conclusion (Soeken, 2004).
However, Kleignen, Knipschild & Riet (1991), reviewed 107 clinical trials of homeopathy generally, stating that most trials conducted were of low quality but that there were many exceptions. Trials were scored out of 100 for methodological soundness with points awarded for criteria including:
· Patient characteristics described
· Number of patients analysed
· Intervention well described
· Double blinding
· Effect measurement relevant and described
· Clarity of results presentation enabling results to be checked by readers.
Of the 107 trials examined by Kleignen et al. (1991) only 6 investigated rheumatological disease, with 4 showing positive and 2 showing negative results. However, generally the methodological scores were low, ranging from 33 to 50 (see details in appendix 2).
Kleignen et al. (1991) states, only 14 trials used individualised classical homeopathy, 58 used one homeopathic remedy for a comparable diagnosis, 26 trials used complex homeopathy and 9 trials used isopathy. This is an important factor in homeopathic research generally, as many classical homeopaths would not count isopathy, complex homeopathy or using one homeopathic remedy for a diagnosed complaint as the practice of homeopathy. Classical (individualised) homeopathy, based on the principle that ‘like treats like’, requires the homeopath to select the most similar homeopathic remedy to the totality of symptoms presented by each individual patient (Hahnemann, 1996). Thus it is questionable if these non-classical interventions used in clinical trials have clinical significance, as it does not represent conventional practice.
Long & Ernst (2001) conducted a systematic review on the homeopathic treatment of OA. In this, 4 randomized controlled trials (RCTs) met the inclusion criteria and were described to be of high average methodological quality, with 2 of the studies giving a positive result in the efficacy of homeopathic treatment in OA. Overall this review concluded that the research data shows homeopathy to be more effective than placebo, but that the small number of studies again prevents firm conclusions being made (Weiner et al., 2004).
Three trials were found assessing if homeopathy can reduce delayed onset muscle soreness (DOMS). Vickers, Fisher, Smith, Wyllie & Lewith (1997) conducted a randomised, double blind placebo controlled trial (RDBPCT), in which 58 subjects undertook a bench stepping exercise test and then the treatment group took a combination of potentised (30c) arnica, rhus tox and sarcolactic acid. Participants were then asked to complete an outcome form for the next 5 days. Homeopathy was shown to be no more effective than placebo (Vickers et al., 1997). However, the trial was flawed as: the sample size was too small to reach statistical significance; there were big variations in participant muscle soreness scores which could effect comparisons of the groups, due to many variations in individual fitness and lifestyle post or prior to the exercise test; and the homeopathic remedy was not individualised for the subjects, thus not reflecting the practice of homeopathy.
A second RDBPCT conducted by Vickers, Fisher, Smith, Wyllie and Rees (1998) examined the effect of arnica 30x compared to placebo on DOMS following long distance running. Vickers et al. (1998) concluded that arnica 30x is ineffective for DOMS. This trial had a larger sample size, but subjects ran in one of 114 different races of varying distances, with the difficulty of the races not being specified. There were also no exclusion criteria. These variables, coupled with the potentially differing fitness levels / characteristics of participants could have a significant impact on muscle soreness scores and thus the outcome for participants. This point is highlighted as the trial showed that muscle soreness was higher the greater the distance ran (Vikers et al., 1998). Again the treatment was not individualized in remedy or potency, thus not reflecting homeopathic practice and potentially leading to negative results due to ineffective medication of the treatment group.
Tveiten, Bruset, Borchgrevink & Norseth (1998) conducted another RDBPCT examining the effect of potentised arnica (D30) on muscle soreness in Oslo marathon runners. This trial concluded that arnica did have a statistically significant effect on lowering muscle soreness immediately after the marathon, but there was no difference between the treatment and placebo group 3 days after the marathon, thus showing that arnica does not seem to shorten the recovery time of marathon runners (Tveiten et al., 1998). Tveiten et al.’s trial does not contain as many race variables (i.e. in distance and difficulty) as the Vikers et al. trial (1998), but there are still many uncontrolled variables in the population characteristics and their pre and post race activities, such as diet and exercise levels that could effect the trial’s results. Once again this research does not reflect classical homeopathic practice, as it is not based on individualised homeopathy.
Sajedi, Alizad, Alaeddini, Fatemi & Mazaherinezhad (2008) conducted a RDBPCT to examine the effect of individualized homeopathic treatment on the muscle tone of 24 children with spastic cerebral palsy over a 4 month period. Sajedi et al. state that whilst some children on homeopathic treatment showed some positive effect on motor development criteria, there was no evidence to show a reduction of muscle spasticity (2008). Whilst this trial did replicate the practice of classical homeopathy in terms of individualised remedy selection, there was a very small sample size and a short space of time to obtain results, to give conclusive evidence. In addition, the fact that some children did show some signs of motor development also indicates that with homeopathic treatment, a positive effect may be happening in participants, but not necessarily where the trial objectives and measures are set. With individualised classical homeopathy, the homeopath is basing a prescription on the symptom totality of the patient (Hahnemann, 1996), not necessarily a specific tissue or organ focused on in a trial. Therefore, this presents a problem with researching the effects of homeopathy using RDBPCTs when often only specific quantifiable outcomes are measured. Perhaps more qualitative outcomes should be included in homeopathy trials to examine the patient effect as a whole.