Mental silence and its associated yogic philosophy may provide a basis for taxonomy of meditation that is practically useful in the delivery of healthcare. An intervention with a specific effect such as Sahaja Yoga meditation has a wide range of applications in medicine, psychology and neuroscience. It is particularly relevant to the growing field of Complementary and Alternative Medicine (CAM) since meditation represents an important genre of CAM modalities and the apparent therapeutic effects of mental silence that are apparent in this thesis now position this genre of CAMs in a higher category of practical importance to healthcare.

Dr Ramesh Manocha

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Like any other evaluation of therapeutics, the detectable effect of the intervention will be determined by the degree to which the participant complies with the treatment. This is particularly important in meditation research because meditation requires considerable active involvement and commitment. There are several ways to assess compliance, including attendance rates at supervised treatment sessions, home-practice diaries and subjective experience reports.

Dr Ramesh Manocha

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An extensive search of the scientific literature identified 3,500 peer-reviewed publications that featured “meditation” as a key word. Yet, of these, only 135 (approximately 4%) fulfilled the very basic requirements of experimental evaluation, i.e. they were prospective trials using control groups and random allocation. Importantly, even within this subset of more rigorous studies, there is no convincing evidence that meditation has a specific effect. In fact within this set of randomised controlled trials (RCTs), there appeared to be an inverse relationship between methodological rigour and likelihood of an outcome that is favourable to meditation.

Dr Ramesh Manocha

3 com

With regard to the physiology of meditation, research designs can be divided into 3 categories:

1) Case studies of meditation featuring small numbers of participants in which there is no attempt to control for confounding variables. While these are useful for generating hypotheses, they do not provide scientifically valid insights into meditation’s purportedly unique effects.

2) Own-control studies use participants in time sequential series (ie ab, aba or similar designs) in which the “a” condition is pre-meditation or non-meditation and the “b” condition is meditation. The “a” and “b” conditions are then compared. These studies have generally demonstrated significant differences (interpreted to be in favour of meditation) but they suffer from substantial limitations because they compare meditation to non-meditation and then assume that any differences are due to meditation, whereas they may in fact be due to methodological factors not specific to meditation at all (such as rest, expectancy, researcher demand and environmental issues). Further, this design is vulnerable to the possibility that one condition might be contaminated by carry-over effects from the preceding condition. A further important consideration applies especially to the case of novices — if the meditator is not sufficiently skilled then they may have difficulty in generating physiological changes and the effects (although potentially real) may not become detectable.

3) Experimental control studies are much more reliable as they involve two independent groups in which one meditates and the other engages in a control activity such as rest. There are however, methodological difficulties associated with this approach as well. First, use of novices (who are introduced to meditation during the trial) may mean that the effects of meditation are not large enough to generate a detectable change. Second, while use of advanced meditators (those who have practiced meditation over many years) may ensure that the necessary magnitude of effect is achieved, the question of selection bias becomes a significant consideration.

An ideal strategy would involve an experiment in which participants are randomly assigned from the same sample to either a meditation or a control group. This approach is rarely feasible however, since it would conventionally require many months or even years of practice before the participants achieved competence. With such lengthy time-lines the accumulation of drop-outs may in any case lead to selection bias. Therefore, a reasonable compromise strategy might involve using experienced meditators and comparing them to non-meditators who have either been matched for parameters including interest in meditation, or have been randomly selected from the population. This latter design was selected for the study described in this chapter.

Dr Ramesh Manocha

3 com

Neki (1975) describes the sahaja state as a mental health ideal in more detail, asserting that it combines the elements of illumination (the direct experience of reality, devoid of the filtering effect of the mind), equipoise (the absence of emotional turbulence) and its replacement with a sense of underlying joy and spontaneity. It creates a personality that is well adjusted but without pretence, affectation or hidden agenda and also freedom from the desires and motivations that give rise to frustration and destructive behaviours. It leads to harmonisation of the subtle inner rhythms of one’s being and the greater cosmos, a sort of suprasensory perception. All of this suggests a positive, robust and fully functional state of health combined with ongoing and continuous perception of the deeper significance of reality.

Dr Ramesh Manocha

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It seems obvious that the non-specific effect of any intervention is closely related to its credibility and plausibility as a therapeutic intervention i.e. its “face validity”. Now, some of the effects associated with meditation must be non-specific, i.e. comprising a mixture of placebo, therapeutic contact, spontaneous improvement, and so on, whereas some, hopefully, are specific to meditation alone. One might even propose that different meditation techniques have varying proportions of specific and non-specific effects. Within the context of an RCT, the control strategy should ideally:

• elicit all the non-specific effects that meditation might have, but have none of meditation’s specific effects;
• not have any specific effects of its own.

By fulfilling these criteria the control strategy makes the RCT methodology sensitive to any specific effects of meditation that might be detectable.

Dr Ramesh Manocha

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Methodological validity is therefore the major challenge to meditation research, and the chief problems within this broad category are first, the use of appropriate control strategies, second, the need for randomisation and other strategies to exclude bias and third, a definition of meditation that allows inter-trial comparability and remains consistent with the traditional ideas of meditation as a state of non-thought.

Plausible controls
Plausible control groups are critical in behaviour therapy research because of the need to exclude the significant confounding effects of non-specific factors (such as placebo, therapeutic contact and researcher expectancy). The significance of this issue is borne out by the fact that even comparative trials of behaviour therapies often end up demonstrating equivalence of effect255. Such non-specific factors are also significant in meditation research. Expectancy alone, for instance, has been shown in a number of studies to positively influence the apparent effect of meditation4.
The essential criteria for a control strategy in meditation trials should therefore be first, convincing plausibility as an active intervention in its own right and second, a process that involves relaxation and reduction of somatic arousal (since this is the nearest conventionally understood phenomenon that resembles meditation).

Randomisation and other strategies to exclude bias

There are a large number of controlled meditation trials using dissimilar cohorts in non-randomised trials. The need for randomisation to exclude selection bias is obvious, yet as previously pointed out, less than 4% of the total number of peer-reviewed publications used random allocation of participants.

Dr Ramesh Manocha

none

Examining randomised controlled trials exploring meditation in my review, control methods were presumptively categorized according to their face-validity into low, moderate or high face validity categories.

The low face-validity controls used strategies that were:
Passive and unstructured: Participants were involved in minimal or no activity relating to the trial and had no interaction with researchers as a result of being allocated to the control group (e.g. waiting list, no treatment, self-directed reading, or referral to community resources). This kind of comparator controls for minor non-specific effects, such as regression to the mean, the natural history of disease states and environmental factors common to all participants. It does not however, control for any non-specific effects that may be elicited by behaviour therapies.

The moderate face-validity controls use strategies:
Passive and structured. These involved some sort of regular and structured interaction with personnel associated with the experiment (e.g. regular lectures, specific reading, structured educational sessions on unrelated topics, regular blood pressure checks). This controls for the same confounders as Category 1 in addition to the effects of therapeutic contact and sense of active involvement.
• That were active in nature and generated some expectation of benefit but did not have effects or credibility as either a method of relaxation or meditation e.g. support groups, education about health factors measured in the study, or lectures on stress and lifestyle management. This controls for the same as Categories 2 and 3 in addition to the effects of social support, improved lifestyle, etc. Social support has been repeatedly demonstrated to be effective in improving mood and quality of life and reducing the severity of disease symptoms. “Standard treatment” was included in this category.

High face-validity controls use strategies that were:
• That were active in nature but not designed to generate significant expectation of therapeutic benefit (e.g. exercise). This controls for the same as Category 2 in addition to the effects of regular physical activity. Regular physical exercise has been shown to improve mood.
Active in nature, generated some expectation of benefit and elicited the simple physiological effects on rest but did not have specific credibility as a meditative method (e.g. progressive muscle relaxation, other relaxation methods, hypnosis, biofeedback, psychotherapy).
• The same as above but also had credibility as a meditative method (e.g. meditation techniques, strategies designed to convincingly mimic meditation) or constituted a legitimate form of psychotherapy (e.g. desensitisation, cognitive behaviour therapy, counselling).

Dr Ramesh Manocha

none

In view of the seriousness of some of the reactions described above it is questionable whether all forms of meditation can be viewed as “generally safe for general consumption”. Moreover, given that recent reviews of meditation have clearly demonstrated a lack of convincing evidence for a specific effect, the importance of developing a comprehensive understanding of meditation’s adverse effects, and the risk to both healthy and unwell populations is of considerable importance. I propose that a more cautious set of clinical recommendation guidelines be considered until more thorough, independent studies are done.

A simple guideline may be that candidates should be recommended to experienced instructors with health professional backgrounds and that referring clinicians should screen for history/susceptibility to serious mental illness. It may be also appropriate to avoid recommending methods in which commercialisation or similar considerations may lead to a conflict of interest. There are many meditation techniques that can be accessed on a low fee/non-commercial or free of charge basis and these ought to be recommended over expensive, commercialised methods. Should negative experiences occur, novices should be advised to cease practising the techniques immediately.

Dr Ramesh Manocha

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Follow-up data, data obtained some time after the trial, is important as it gives an indication of how durable the effects of meditation might be. Unlike modern Western therapeutic thinking however, meditation was not originally designed to be used as a course of treatment so much as to be part of an ongoing lifestyle thus implying that the benefits of meditation are likely to persist in the follow-up phase only so long as the person chooses to meditate regularly. Meditation instructional programs are usually relatively intense and it is therefore worthwhile determining whether changes brought on by the instructional program can be maintained when participants are left to continue unsupervised with whatever skills they have acquired in the more formal phase of their training. Given that consistent evidence for a specific effect is lacking even within the intervention phase of the 120 randomised controlled trials my review, it is even more unlikely that evidence for an effect will be detectable in the follow-up phases. Of the entire sample of 120 studies in my review, 76 studies did not include any follow-up assessment strategies.

It might also be argued that, since researchers tend to be hampered by lack of resources, the primary question as to whether meditation has any specific effects ought to take priority over questions about the durability of its effects, if there are any. It is therefore understandable that many trials have not included follow-up assessments in their design. For this reason, it was decided that more in depth analysis of follow up data would be of little value to the primary questions set out in my review.

Dr Ramesh Manocha

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