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Section: Clinical Research CMO (CERASOMOL-CIS-9-CETYL MYRISTOLEATE) IN THE TREATMENT OF FIBROMYALGIA: AN OPEN PILOT STUDYAbstract Purpose: To investigate the efficacy and tolerability of CMO (cerasomol-cis-9-cetyl myristoleate) in the treatment of fibromyalgia. Design: Open study: 21 days' treatment following a 7-day baseline without treatment. Materials and Methods: Thirteen adult patients with fibromyalgia. Following a 7-day pre-treatment baseline, patients were treated with a mixture of CMO + sea cucumber and shark cartilage extracts. All treatments were administered orally. Patients kept daily diary cards recording the severity of generalized pain, fatigue and sleep disturbance (scale 0-4). A symptom profile was made using an 84-point questionnaire. Adverse events were recorded. Results: Ten patients completed the study. One subject did not record baseline symptoms. Two patients bad to discontinue treatment because of adverse effects. One had severe indigestion and the other developed muscle spasms and a skin rash. The mean (SD) scores for the severity of pain, fatigue, and sleep disturbance during the baseline were 2.63 (0.55), 2.50 (0.54) and 2.33 (0.480). These improved to 1.70 (0.82), 1.83 (0.82) and 1.73 (1.11) during the last 7 days of treatment. There were individual differences in response with five patients showing good response and five showing little or no response. From the questionnaires those showing the best response bad more severe pain and cognitive dysfunction than the non-responders. In addition to the two withdrawals, one further patient reported gastrointestinal symptoms. Conclusions: This open study provides evidence of a beneficial effect of CMO in the treatment of fibromyalgia. A double-blind, placebo-controlled study is now required to confirm this. This should also include a symptom profile questionnaire, which may help to distinguish responders and non-responders. Keywords: fibromyalgia, CMO, cerasomol-cis-9-cetyl myristoleate, clinical trial, symptom questionnaire. INTRODUCTION CMO (cerasomol-cis-9-cetyl myristoleate) is a mixture of fatty acids derived from beef tallow. It is classified as a food supplement recommended for the treatment of rheumatoid and osteo-arthritis and a number of other conditions. Following the experience of beneficial effects of taking a course of CMO by a single individual with primary fibromyalgia, it was decided to carry out an open pilot study of CMO in patients with fibromyalgia. MATERIALS AND METHODS Patients The patients were adults who had been diagnosed with fibromyalgia, who wished to try treatment with CMO and who agreed to complete a symptom profile questionnaire and to keep daily diary cards. Patients heard of the treatment at a meeting of the Reading Fihromyalgia Support Group, bought the product in the normal way from the distributors but then received a discount on the cost, provided they kept records. Assessments Patients recorded each day the severity of pain, fatigue and sleep disturbance on a daily diary card. This was done for 7 days before starting the CMO treatment, and for at least 21 days whilst the treatment was being taken. In some cases records continued to he kept for longer than 28 days. The effectiveness of the treatment was assessed by comparing the change in the mean scores for the pre-treatment 7-day period and the last 7 days of treatment. This was done for each symptom. In addition all patients completed an 86-question symptom questionnaire (Bioscreen Pty Ltd, PO Box 145, Jesmond, NSW 2299, Australia. http://www.bioscreen.com.au). This questionnaire asks how much patients were affected during the previous 7 days by a range of symptoms. They scored using the following scale. 0 = not at all 1 = a little bit 2 = moderately 3 = quite a bit 4 = extremely The questionnaire has been used mainly in the assessment of chronic fatigue syndrome (CFS) [1]. Symptoms are grouped according to disease syndromes, the scores summed, divided by the number of symptoms in the group and then multiplied by 10 to arrive at an index score for that group. For example the CFS Symptom Index, groups together the scores for migraine headaches, sore throats or nasal infections, dislike of strong light or photophobia, muscle soreness or stiffness, hot and cold spells or recurrent feverishness, sore or swollen lymph glands in the neck, muscle weakness or weak feeling in the body, sore or swollen lymph glands under arms and/or in the groin, and feelings of mental fatigue or fatigue. Index scores of 2 are classed as low, 4 as moderate, 8 as high and 10 as extreme. The questionnaire was completed before starting treatment. Analysis of the questionnaires used a Microsoft(R) Access 2000 database provided by Bioscreen. Test Treatment Although the primary treatment being tested was CMO, in the individual in whom the beneficial effects were seen, CMO was taken in conjunction with other substances as a treatment course as recommended by the suppliers, Natural Essentials, PO Box 351, Gresham Square, Peterborough PE1 5BR, UK. The full treatment course lasted for 12 weeks and consisted of taking two types of capsule: Quorus(TM) One and Quorus(TM) Two. As recommended by the distributors, treatment stopped at the end of the 12-week course. For the first 4 weeks both Quotas One and Quorus Two were taken. For the last 8 weeks only Quorus Two capsules were taken. The dose of Quorus One was two capsules twice a day with no food being taken for one hour before and two hours after taking the capsules. The dose of Quorus Two was four capsules each day to be taken at night. Each capsule of Quorus One contains 382 mg of CMO in a mixture of tallow-derived fatty acids and 100 mg of extract of sea cucumber. Quorus Two capsules contain 500 mg of shark cartilage extracts and 250 mg of sea cucumber extracts. Digestive enzymes containing lipase, alpha amylase and protease (Natural Essentials, PO Box 351, Gresham Square, Peterborough PE1 5BR, UK) were also taken during the course and patients were asked to avoid, or restrict severely, tea, coffee, chocolate, alcohol and the nightshade group of vegetables (potatoes, tomatoes and peppers). Ethical Review and Informed Consent As the patients taking part in this study requested to participate themselves and purchased the product, formal informed consent was not requested and the study was not reviewed by an ethical review committee. Subjects were given full information about the nature of the product being taken and the purpose of the record keeping. They were also assured about individual confidentiality. RESULTS Thirteen adult patients, 11 female and 2 male, started the course of treatment and returned records. One male subject did not record symptoms before commencing the treatment. His results were excluded from the analysis but he did not think he derived any benefit. Two patients, both female, started the course but had to discontinue because of adverse effects. One had severe indigestion and the other developed muscle spasms and a skin rash. The results from these two patients were also excluded. One further patient, female, completed the course of Quorus One but was unable to complete the course of Quorus Two because of adverse effects--indigestion. Her data are included in the analysis, which is therefore based on 10 patients. Baseline Symptom Severity The mean (SD) scores for the severity of pain, fatigue and sleep disturbance for the 7 days of the baseline were 2.63 (0.55), 2.50 (0.54), 2.33 (0.48), respectively. For each symptom this represents symptom severity of moderate to severe and these scores are comparable with a previous study [2] using the same means of assessment. Change in Symptom Scores The mean scores for the final 7 days of treatment were 1.70 (0.82) for pain, 1.83 (0.82) for fatigue, and 1.73 (1.11) for sleep disturbance. These changes are illustrated in Fig. 1. Figure 2 shows the change in mean daily symptom scores. Using median values these changes represent a 35% improvement in pain, a 28% improvement in fatigue and a 22% improvement in sleep disturbance. When the symptom scores are added together to give a total symptom score the overall improvement was 30%, a change from a mean score of 7.46 (1.40) to 5.26 (2.43). These overall figures disguise a marked variation in individual response. Changes in total symptom scores showed that five patients had an improvement in scores of between 38% and 89% (38%, 43%, 50%, 57%, 89%) and five patients had either a small response (20%, one patient) or no response (0%, four patients). For the scores for the key symptom of pain, five patients showed a marked improvement (50%, 50%, 56%, 67% and 68%) and five patients showed no improvement (all 0%). For fatigue five patients improved (33%, 50%, 67%, 67%, 100%), four showed no improvement (0%) and one became worse (- 100%). For sleep disturbance five improved (50%, 50%, 50%, 67%, 100%), and five showed no improvement (0%). Three patients showed improvement in all three symptoms, pain improved in two patients, with improvement in fatigue in one, but no improvement in sleep in either, and in two patients fatigue improved with sleep improvement in one. Symptom Questionnaire The symptom questionnaire was completed by eight of the patients who completed the study, four who responded and four who did not. Examination of the symptom indices showed that those who responded to the CMO had higher pain index scores, mean (SD) 7.66 (2.99) for responders and 6.09 (2.67) for non-responders and higher cognitive index scores, 8.28 (2.13) compared to 5.16 (3.24). The symptoms grouped in the pain index were "joint movement pain, arthritis, stiff joints, and low hack pain" and those for the cognitive index were "having to do things slowly to ensure correctness, difficulty in making decisions, mind going blank, trouble concentrating." There were no differences in the CFS Symptom Index, mean scores for responders and non-responders being 4.60 (1.03) and 4.15 (2.00). Adverse Effects Three patients reported adverse effects whilst taking the capsules. One patient had severe headache, difficulty in swallowing the capsules and severe indigestion and had to stop the course of treatment. One patient who took CMO alone also had to stop because of an itchy skin rash and severe muscle spasm and a third patient reported headaches, nausea and abdominal bloating but was able to complete the course of Quorus One. DISCUSSION This open, uncontrolled, pilot study of CMO in fibromyalgia has shown improvement in the total symptom scores of pain, fatigue and sleep disturbance in five of the ten patients for whom records were complete. For the key symptom of pain, five of the ten patients showed improvement and the mean improvement in pain severity in the responders was 60% compared with no improvement (0%) in the non-responders. It is possible that the overall improvement in the symptom of pain is a placebo effect. The patients recruited into this study came from a patient support group and had chronic, moderately severe symptoms. This is reflected in the mean score for pain during the baseline period of 2.63 on a scale of 0-4. In a previous double-blind, placebo-controlled study in patients recruited from the same source and using the same scoring system, the mean baseline score for pain was 2.25 [2]. In this latter study after placebo treatment the mean score for pain was 2.49 compared to a score after CMO treatment of 1.70. Although one cannot compare effects between studies this difference, combined with the marked differences between responders and non-responders in the present study, suggest that it is unlikely that the effect seen is a placebo effect. However, this remains a possibility and a placebo-controlled trial is now necessary. There is also a suggestion that the responders may have a different symptom profile to the responders with more frequent pain and cognitive symptoms. This also requires further investigation. This study was not of CMO alone as this was mixed with extract of sea cucumber and taken in conjunction with shark cartilage, a major source of glucosamine and chondroitin sulphate. In addition digestive enzymes were consumed and patients were asked to stick to a diet excluding tea, coffee, chocolate, alcohol and the nightshade group of vegetables (potatoes, tomatoes and peppers). The capsules containing the CMO and other substances were taken according to a defined dosing regimen. It is not clear what, if any, these additional substances and restrictions contributed to the beneficial results seen in the responders. The distributor's leaflet describing CMO and related products contains the statement: "Other research indicates that the effectiveness of CMO is enhanced when taken in combination with sea cucumber extracts"--although no evidence is provided in support of this statement. Siemandi [3], reported a double-blind, placebo-controlled trial comparing CMO alone, CMO with glucosamine hydrochloride, sea cucumber extract and hydrolysed cartilage and placebo in patients with `inflammatory arthritis.' Although the overall reported response rate to treatment was significantly greater for both the CMO treatments compared to placebo, the response rate for the combination of CMO with glucosamine hydrochloride, sea cucumber and hydrolysed cartilage was significantly greater than for CMO alone. It was therefore decided in this pilot study to follow exactly the recommendations of the distributors although no check was made as to whether patients complied with this. The relative importance of these requirements will need to be investigated in further studies. It is not clear why CMO should apparently provide benefit in this condition. It has been shown in studies by Dunstan et al. [4] that in the related condition CFS there are changes in plasma lipid homeostasis. The primary changes they found were a reduction in trans-9-octadecenoic acid (elaidic acid) and an increase in octadecenoic acid (stearic acid) in CFS patients compared to control subjects. In addition to cis-9-cetyl myristoleate, CMO contains a mixture of 10 fatty acids so that it is possible that, if abnormalities in plasma lipid homeostasis also occur in fibromyalgia, CMO may be correcting those abnormalities in some patients. This course of treatment is not without adverse effects with two patients having to stop the treatment and a third reporting severe gastrointestinal symptoms. Fibromyalgia is a difficult condition to manage and no drugs are currently specifically indicated for treatment. Tri-cyclic antidepressants, selective serotonin reuptake inhibitors, non-steroidal anti-inflammatories, conventional analgesics, and food supplements including magnesium and malic acid are all commonly used, but adequately conducted and analysed clinical trials have either not been done or have failed to demonstrate any clear benefits [2, 5]. If the results obtained in this pilot study can be repeated in a controlled trial and the clinical profile of the responders confirmed then this degree of improvement would allow this treatment to be recommended. In addition to profiling patients according to symptom profile, screening of the plasma fatty acids should also be undertaken. The results of this pilot study do pose a series of questions that need to be answered by further investigations. GRAPH: FIG. 1. Mean symptom scores for the symptoms of pain, fatigue and sleep disturbance recorded by patients on daily diary cards for the 7 days before starting CMO treatment and the last 7 day s of CMO treatment. Error bars show SEM. n = 8. Percentage improvements are calculated from median scores. GRAPH: FIG. 2, Mean daily symptom scores for the symptoms mores of pain, fatigue and sleep disturbance from the 7 days before CMO treatment and for 21 days during CMO treatment. Error bars show SEM. n = 8. REFERENCES [1] McGregor NR, Hugh Dunstan R, Zerbes M, Butt HL, Roberts TK, Klineberg IJ. Preliminary determination of the association between symptom expression and urinary metabolites in Chronic Fatigue Syndrome. Biochem Molec Med 1996;58:85-62. [2] Edwards AM, Blackburn L, Christie S, Townsend S, David J. Food supplements in the treatment of primary fibromyalgia. J Nutr Environ Med 2000;10(3):189-99. [3] Siemandi H. Townsend letters for Doctors and Patients; ISSUE #169/170:58-63. [4] Dunstan HR, McGregor NR, Watkins JA, Donohoe M, Roberts TK, Butt HL, Murdoch RN, Taylor WG. Changes in plasma lipid homeostasis observed in Chronic Fatigue Syndrome patients. J Nutr Environ Med 1999;9(4):267-80. [5] White KP, Harth M. An analytical review of 24 controlled trials for fibromyalgia syndrome. Pain 1996;64:211-19. ~~~~~~~~ By A.M. Edwards, Ma MB BCHIR MRCGP DIP PHARM MED, Department of Medical Specialties, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, UK |
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