Okada Purifying Therapy in combination with duloxetine vs. duloxetine alone in patients with TMD and fibromyalgia: a randomized clinical study

Introduction

Fibromyalgia (FM) is a chronic disorder characterized by widespread musculoskeletal pain and tenderness at specific anatomic spots (so called tender points) [1], [, 2]. Over the years the association of FM with other comorbidities, such as Temporomandibular Disorders (TMDs) has been a trend topic among the clinicians [3], [, 4].

Many published studies on FM and TMDs have analyzed the effectiveness of several pharmacologic and/or non-pharmacologic treatments [5] and the ones on biofield therapies are yet few and still controversial [6]. The type of therapeutic approach to the patients with FM and associated TMDs should be considered. The treatment of the “basic” pathology before opting for any kind of gnathological auxiliary local therapy is recommended by the authors of this study. In fact, FM and TMDs are likely just not merely coexisting conditions [7]. According to the literature, the authors are led to consider that FM may lead to TMDs symptoms or at least that FM and TMDs share a common pathogenesis [8], such as the current hypothesis of Central Sensitization [9], [, 10].

Duloxetine hydrochloride proved to be effective for FM as evidenced in scientific literature [11], [, 12]. Nonetheless, the greater impact of duloxetine in FM appears to be lower than the one observed in other clinical conditions, suggesting the need for a more holistic approach for FM patients [13], [, 14]. In this regard, a multidisciplinary approach combining traditional and complementary treatments is required [15]. Therefore, Okada purifying therapy (OPT) [16], [17], [18], [19] has been put forward in combination with duloxetine. OPT is included among the biofield therapies and it was initially formulated and developed by Mokichi Okada during 1930s in Japan. OPT is based on principles developed by a unique understanding of the human body, illness and health, and it has the purpose to allow the self-healing process through the use of subtle energy. In OPT, trained practitioners place their palms on the surface of the patient’s body in order to find stiff and/or warm spots, which are sites of accumulated toxins. Then, they perform therapy with the emission of bioenergy, or qi, conveyed through their hand palm, without touching the patient, in correspondence of key areas. The distance between the practitioner’s palm and the patient’s body is usually 30–60 cm. Every anatomical spot was “irradiated” for 5–10 min particularly in the areas of the hot points, reported by the patients as the most painful ones. This practice might enhance natural healing abilities, possessed by any human being and toxins are purged as the natural healing ability is gradually activated. In turn, the enhancement of such abilities turns out to improve psychological and physical health [16], [17], [18], [19].

The study aimed at evaluating the effectiveness of OPT in combination with duloxetine in improving pain, related disability and quality of life in patients with fibromyalgia and TMDs.

Methods

Randomization

This study was carried out as a randomized clinical study characterized by two different phases (Figure 1).

Figure 1:

Study design showing all study periods.

Dlx, Duloxetine; OPT, Okada Puryfing Therapy.

Participants were told that they had an equal chance of being assigned to one of the two treatments.

Besides, an additional research operator, not involved with initial screening and clinical evaluations, randomized participants using a computer-generated blocked random allocation sequence with a block size of 2.

Group I or CONTROL GROUP: standard treatment with duloxetine

Group II: administration of duloxetine in combination with OPT.

During the study phase II (SPII), all subjects of the study (Group I e II) began with duloxetine 30 mg QD for the first week, while for the remaining seven weeks of SPII they were treated with duloxetine 60 mg QD.

In addition, group II was treated with two OPT sessions per week for a total of 16 treatments over a period of eight weeks. All OPT sessions were performed by a single trained certified practitioner for a period of 50 min [26].

Each patient signed the informed consent.

One operator of the study, previously tailored to it, repeated all initial clinical evaluations at T1 (after four week) and at T2 (after eight weeks). Another operator checked the reliability of all data collected.

Results

Patients who met inclusion and exclusion criteria as summarized in Table 1 were enrolled in the study.

Patient flow

The flow of patients through the study is reported in Figure 2.

Figure 2:

Flow of patients through the study.

The final sample was composed by 31 females (average age in years ± standard deviation, 47.71 ± 12.26).

Thirty-one patients completed the study (72%), 15 subjects were in the group of duloxetine only (Group I) and 16 subjects were in the group of duloxetine and OPT (Group II). The main reason for the suspension of the treatment was adverse side effects due to the pharmacological treatment. In particular, 7 out of the 12 patients of the group I not completing the study, dropped out because of duloxetine adverse events like nausea, drowsiness, insomnia, anorexia, headache, and stiffening of limbs, whereas five patients of the group II dropped out because they did not respect timing of the OPT sessions.

Discussion

In this in vivo study the authors proposed an holistic approach for the management of patients affected by FM and TMDs, consisting in the introduction of Okada Purifying Therapy alongside the traditional one used for this type of chronic diseases. In the scientific literature, the study of Sarmento et al. [27] assessed the effectiveness of OPT for patients with fibromyalgia. Despite the limitations of the study deriving from the small sample size, the research reported a decrease of depression symptoms, chronic widespread pain and tenderness, due to the administration of this type of biofield therapy. Compared to the current study, in the research of Sarmento et al. the patients did not receive any treatment other than OPT throughout the study period. Furthermore, the evaluation of temporomandibular disorders was not performed.

Among the alternative therapies proposed in the scientific literature for the treatment of FM patients, Reiki, a biofield therapy very similar to OPT in both rationale and method of energy administration, can be cited. However, compared to OPT, Reiki seems not to play an additional role in FM treatment, as suggested by Assefi et al. [6] and Langhorst et al. [28]. Such studies do not include any considerations of the impact of TMDs in patients selected for Reiki therapy and so therefore no analysis of craniomandibular indexes before and after treatments.

In compliance with the outcome of the above mentioned research studies, our results showed that the combination of OPT with duloxetine did not have any added value in terms of benefits of the clinical outcome in comparison with the treatment with duloxetine alone (Table 2, 3). Indeed in both groups, craniomandibular indexes, total tenderness scores and general parameters improved rapidly but there were not statistically significant differences between the two groups. The interaction between treatment and time was statistically significant, only as to one parameter, i.e. the Ability to walk at the BPI-I; F=7.57, p=0.002. As stated in the results section, this outcome could be explained in line of the circumstance that the ability to walk was already statistically different in this group compared to group II, at T0. The sample was certainly limited and a wider one might be required for any further investigations. Most likely, the results observed might be due to the fact that the treatment intensity and duration might have been insufficient for a chronic pain disorder, also considering the nebulous understanding of energy medicine mechanisms by the scientific community, as suggested by Assefi et al. [6].

However, an interesting aspect observed is that patients of the Group II (duloxetine plus OKADA) did not drop out for adverse side effects due to duloxetine, unlike what happened to patients of Group I (n=7 patients). This circumstance must not be random and might be explained as follows. No drop outs in the group II might be connected with the therapeutic effect of OPT in improving tolerability of duloxetine. Moreover, the high rate of drop-outs due to side effects and the decrease of duloxetine effectiveness in the medium-long term might suggest the clinicians either opting for the choice of new pharmacological solutions or non-pharmacological treatments like cognitive-behavioral therapies.

Furthermore, the data collected imply that, at least in our study population, FM patients do not easily accept traditional pharmacological treatment. The chronic assumption of preventive and symptomatic medications without a significant therapeutic success together with the chronic trend of the disease might be the underlying reason. Therefore any further future investigation could be aimed at administering OKADA therapy only in patients who do not accept pharmacological therapy with duloxetine, then at comparing results with a Control Group with a placebo therapy, or OKADA therapy in combination with other complementary treatments, such as cognitive-behavior therapy.

Conclusion

In conclusion, the study results suggest that OPT did not improve the effectiveness of duloxetine in clinical outcomes but might increase the tolerability of medications, by improving the pharmacological effectiveness. In the future it would be interesting to try new complementary therapies or OPT in combination with interventions that currently work better in central sensitization such as cognitive behavioral therapy.

However, such results should be necessarily validated by further studies, considering the limits of the study itself.